Method and device for treating eye diseases

Abstract

The invention relates to a method and device for treating eye diseases, and belongs to the field of medical treatment. In order to treat ocular hypertension and glaucoma, a device for reducing intraocular pressure is provided, the device comprising: a plate having a first end and a second end, the plate comprising opposing first and second surfaces wherein the first surface comprises a series of fluid channels, the series of fluid channels are configured in an open cross-network pattern extending from a first end of the plate to a second end of the plate, the width of the first end of the plate being narrower than the width of the second end of the plate to enable the first end of the plate to be inserted into the anterior chamber of the patient, and wherein the second surface comprises a plurality of open cells formed by the fluid channels; a first coating on the first surface, the first coating conforming to a topography of the series of fluid channels, and a second coating on the second surface. The devices described herein can be used to reduce intraocular pressure and treat glaucoma.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 202080021797.7, which is the national stage entry of International Application No. PCT / US2020 / 014173, having an international filing date of January 17, 2020, which claims the benefit of U.S. Provisional Patent Application No. 62 / 794,139, filed January 18, 2019, the entire disclosures of which are incorporated by reference herein.

[0002] Cross Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 794,139, filed January 18, 2019, the entire disclosure of which is incorporated by reference herein. TECHNICAL FIELD

[0003] The present application relates to the field of medicine, and in particular to devices to treat ocular hypertension and glaucoma. BACKGROUND

[0004] Millions of people suffer from eye diseases, particularly glaucoma. Most patients with glaucoma have abnormally high intraocular pressure (IOP) because they lack the ability to drain excess aqueous humor from the anterior chamber of the eye through the trabecular meshwork. If the high IOP is not reduced through adequate treatment, the high IOP will continue to damage the optic nerve, leading to decreased vision and even total blindness as the disease progresses. Current medical treatments, surgical procedures, and implants have proven inadequate to reduce or maintain normal intraocular pressure over time. Thus, new methods of reducing IOP, and thus treating glaucoma, are needed. SUMMARY

[0005] Described herein are therapeutic devices (or simply devices) that can be used to treat eye conditions. In one embodiment, the eye condition is elevated intraocular pressure, and the devices herein reduce intraocular pressure. The devices generally include a plate structure or core component that includes 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, such that the first and second coatings are not defined.

[0006] The plate structure or plate can have a thickness ranging from about 1 nm to about 1,000 nm, or from about 50 nm to about 800 nm.

[0007] The plate structure can include channels to assist in moving ocular fluid, thereby reducing intraocular pressure.

[0008] Other embodiments include methods of reducing intraocular pressure. In one embodiment, the method includes securing a device as described herein to the eye, thereby moving ocular fluid and reducing intraocular pressure.

[0009] In some embodiments, the described device is used to reduce or decrease intraocular pressure. The device can include a plate structure comprising opposing first and second surfaces, wherein the first surface comprises a series of fluid channels, a first coating on the first surface, and a second coating on the second surface.

[0010] In some embodiments, the plate structure is formed from a ceramic material. The ceramic material can be selected from alumina, silicon nitride, silica, hafnium dioxide, titanium nitride, and titanium.

[0011] In some embodiments, the first coating is a polymeric material. The polymeric material can be a parylene polymer. The parylene polymer can be parylene C, parylene D, parylene N, derivatives thereof, or combinations thereof.

[0012] In other embodiments, the polymeric material comprises rubber, synthetic rubber, silicone polymer, parylene, thermoplastic, thermoset, polyolefin, polyisobutylene, acrylic polymer, ethylene vinyl acetate, polymethyl methacrylate, vinyl halide polymer, polyether, polyethylene halide, polyacrylonitrile, polyvinyl ketone, polyvinyl alcohol 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, polyether ether ketone, polylactic acid such as PLA, PLGA, PLLA, derivatives thereof, or combinations thereof.

[0013] In some embodiments, the second coating comprises alumina and / or a parylene polymer.

[0014] In some embodiments, the second coating comprises alumina in combination with rubber, synthetic rubber, silicone polymer, thermoplastic, thermoset, polyolefin, polyisobutylene, acrylic polymer, ethylene vinyl acetate, polymethyl methacrylate, vinyl halide polymer, polyether, polyethylene halide, polyacrylonitrile, polyvinyl ketone, polyvinyl alcohol 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, polyether ether ketone, polylactic acid such as PLA, PLGA, PLLA, derivatives thereof, or combinations thereof.

[0015] The series of fluidic channels can comprise a plurality of open channels interconnected to form a cross network of fluidic pathways. In some embodiments, the channels are microchannels.

[0016] In some embodiments, the device further comprises a drug. In some embodiments, the drug can be within the microchannels. In some embodiments, the drug can be immobilized in the microchannels by a coating.

[0017] Methods of treatment are also described. In one embodiment, the described method comprises injecting a device into an eye having high intraocular pressure, the device comprising a plate structure comprising opposing first and second surfaces, wherein the first surface comprises a series of fluidic channels, a first coating on the first surface, and a second coating on the second surface; and treating the high or elevated intraocular pressure.

[0018] The method can further comprise securing the device to the eye. The securing can be to the sclera or any other part of the eye.

[0019] 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.

[0020] In other embodiments, the device forms fluidic pathways that provide fluid flow communication between the anterior chamber of the eye and the device location.

[0021] Further, the fluidic pathways comprise a series of fluidic channels.

[0022] In some embodiments, treating the high intraocular pressure is treatment of glaucoma.

[0023] Other applications for the application will become apparent to those skilled in the art from consideration of the description provided herein. It is intended that the specification and examples be considered as illustrative only, with the true scope of the application being indicated by the following claims. BRIEF DESCRIPTION OF DRAWINGS

[0024] The application will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which: Figure 1 is a perspective view of a device according to one embodiment; Figure 2 is a close-up view of the device according to Figure 1 the identified section; Figure 3 is a cross-sectional view of the device shown along Figure 2 the median line III-III; Figure 4 is a perspective view of a device according to another embodiment; Figure 5Ais a perspective view of a device according to one embodiment Figure 4 is a section of a cross-sectional view of the device of section A shown; Figure 5B is a perspective view of a device according to one embodiment Figure 4 is a section of a cross-sectional view of the device of section A shown; Figure 5C is a perspective view of a device according to one embodiment Figure 4 is a section of a cross-sectional view of the device of section A shown; Figure 6 is a perspective view of a device according to another embodiment of the application; Figure 7 is a cross-sectional view of the device of section B shown along the Figure 6 median line XII-XII according to one embodiment; Figure 8 is a top view of a device according to another embodiment of the application; Figure 9 is a cross-sectional view of the device of section C shown along the Figure 8 median line XIV-XIV according to one embodiment; Figure 10 is a perspective view of a device according to another embodiment; Figure 11 is a cross-sectional view of the device of section D shown along the Figure 10 median line XVI-XVI according to one embodiment; Figure 12 is a cross-sectional view of the device of section E shown along the Figure 10 median line XVII-XVII according to one embodiment; Figure 13 is a close-up view of an implantation device for implanting a device as described herein; Figure 14A is a cross-sectional view of an eye implanted with a device using Figure 13 an implantation device; Figure 14B is a close-up cross-sectional view of an eye implanted with a device using Figure 13 an implantation device; Figure 15 is a cross-sectional view of a device of section F shown during implantation; Figure 13 is a cross-sectional view of a device of section G shown during implantation; Figure 16 Figure 13 is a cross-sectional view of a device of section H shown during implantation; Figure 17 is an implantation device for implanting a device as described herein, the implantation device being in a first state; Figure 18 is an implantation device for implanting a device as described herein, the implantation device being in a second state;​ Figures 19 to 20 An implant device for an implant device according to another embodiment; Figure 21 An eye implanted with a device as described herein using Figures 19 to 20 A close-up cross-sectional view of an eye implanted with a device as described herein using Figure 22 An embodiment of a device as described herein is shown. Figure 23 An embodiment of an inserter or insertion device as described herein is shown. Figure 24 Intraocular pressure after insertion of a device as described herein is shown. Figure 25 Intraocular pressure comparison between a device described herein and a SIBS device is shown. DETAILED DESCRIPTION

[0025] The following description of the embodiments is merely exemplary in nature and is in no way intended to limit the application, its application, or uses.

[0026] As used throughout, ranges are used as shorthand for describing each and every value that falls within the range. Any value within the range can be selected as the terminus of the range. In addition, all references cited herein are hereby incorporated by reference in their entirety. In the event of a conflict in terminology, the present disclosure controls.

[0027] The description of illustrative embodiments according to principles of the present application is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. In the description of embodiments of the application disclosed herein, any reference to direction or orientation is merely intended for convenience of description and is not intended in any way to limit the scope of the present application. Relative terms such as "lower," "upper," "horizontal," "vertical," "above," "below," "up," "down," "top" and "bottom" as well as derivative thereof (e.g., "horizontally," "downwardly," "upwardly," etc.) should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description only and do not require that the apparatus be constructed or operated in a particular orientation unless explicitly indicated otherwise.

[0028] Unless explicitly described otherwise, terms such as "attach," "attached," "connecting," "coupled," "interconnected" and similar terms are meant to refer to a relationship wherein structures are secured or attached to one another either directly or indirectly, and are both movable or fixed in relation to one another. Further, the features and benefits of the application are illustrated by reference to the exemplified embodiments. Accordingly, the application expressly should not be limited to such exemplary embodiments illustrating some possible non-limiting combination of features that can exist alone or in other combinations of features; the scope of the application being defined by the claims appended hereto.

[0029] Unless otherwise indicated, all percentages and amounts expressed herein and elsewhere in the specification should be understood and interpreted to be meant in a recal basis. The given amounts 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 less than 0.1 wt. % based on the total amount of the reference value.

[0030] A "subject" herein can be a human or non-human animal, such as, 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, and the like.

[0031] With reference to Figures 1 to 3 The treatment device 1 (or simply device) can include a plate structure 200 (or simply plate) having opposing first and second major exposed surfaces 201 and 202, and a side surface 203 extending therebetween. The plate structure 200 can include an extension portion 250 and a main body portion 240.

[0032] The plate structure 200 can be formed from any material having suitable properties for implantation and treatment. In some embodiments, the plate structure 200 can be formed from a metal, a polymer, a ceramic, other composite material, or combinations thereof. The metal can include, but is 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, the alloys can include steel and nickel titanium, such as, nitinol.

[0033] The polymer or polymeric material used to form the plate structure 200 can include any of the polymers described herein.

[0034] Composites, such as, silicon composites, can also be used. In one embodiment, the composite can include silicon nitride (Si3N4). The silicon nitride can have any known crystalline structure, such as, but not limited to, trigonal a-Si3N4, hexagonal β-Si3N4, or cubic γ-Si3N4.

[0035] The plate structure or plate can have a thickness ranging from about 1 nm to about 1,000 nm, from about 1 nm to about 500 nm, from about 1 nm to about 400 nm, from about 100 nm to about 1,000 nm, from about 200 nm to about 1,000 nm, from about 300 nm to about 1,000 nm, from about 400 nm to about 1,000 nm, from about 1 nm to about 900 nm, from about 1 nm to about 800 nm, from about 1 nm to about 700 nm, from about 1 nm to about 600 nm, from about 300 nm to about 500 nm, from about 300 nm to about 600 nm, from about 400 nm to about 600 nm, from about 200 nm to about 600 nm, from about 200 nm to about 500 nm, or from about 50 nm to about 800 nm.

[0036] The plate structure 200 can include a multi-directional plate 210 including opposing first and second major surfaces 211, 212. The multi-directional plate 210 can form a plurality of topographies (e.g., a repeating honeycomb pattern) on each of the first and second major surfaces 211, 212. Each of the first and second topographies can independently include a plurality of channels 232 and / or a plurality of open cells 222.

[0037] The plurality of channels 232 can be interconnected and can form a network of channels. The channels can be open, allowing fluid to readily enter and flow through each of the plurality of channels 232. The network can include intersecting channels in any suitable configuration to greatly facilitate the flow of fluid through the plate structure 200 via the plurality of channels 232. In one embodiment, the channels can be configured to form a hexagonal pattern. Once implanted Figure 1 With the illustrated treatment device 1, fluid (e.g., aqueous humor) can be driven by a pressure gradient to flow through the channels and over the surface of the plate structure 200.

[0038] In some embodiments, the channels can include a rib pattern. The rib pattern and / or geometry of the channels in the plate can vary based on the different severities of glaucoma. In one embodiment, larger or smaller channels can be used to lower intraocular pressure by different amounts. Lowering intraocular pressure by smaller amounts can reduce the risk of hypotony, a condition that can exist if intraocular pressure is reduced too much, and increase the efficacy of the pressure reduction. In some embodiments, devices with smaller channels as described herein can reduce flow and reduce the risk of hypotony. Similarly, larger channels can increase flow and increase the efficacy of the device in lowering intraocular pressure.

[0039] The panel structure 200 can further include a first coating 280 applied to the first major surface 211 of the multidirectional panel 210. The first coating 280 can conform to the first topography of the first major surface 211 of the multidirectional panel 210. In other embodiments, the first coating 280 can form a topography that does not conform to the first topography of the first major surface 211 of the multidirectional panel 210.

[0040] The first coating 280 can have a thickness in a range of about 0.1 pm to about 10 pm or about 0.1 pm to about 1 pm, including all thicknesses and subranges therebetween. In one embodiment, the thickness is about 0.4 pm (400 nm) to 0.6 pm (600 nm). In one embodiment, the thickness is about 0.4 pm (400 nm). In other embodiments, the thickness is about 1 pm to about 5 pm, about 1 pm to about 3 pm, about 2 pm to about 5 pm, or about 2 pm to about 4 pm. In one embodiment, the thickness is about 2 pm.

[0041] The panel structure 200 can further include a second coating 290 applied to the second major surface 212 of the multidirectional panel 210. The second coating 290 can conform to the plurality of surface features of the second major surface 212 of the multidirectional panel 210. In other embodiments, the second coating 290 can form a topography that does not conform to the second topography of the second major surface 212 of the multidirectional panel 210.

[0042] The second coating 290 can have a thickness in a range of about 0.1 pm to about 10 pm or about 0.1 pm to about 1 pm, including all thicknesses and subranges therebetween. In one embodiment, the thickness is about 0.4 pm (400 nm) to 0.6 pm (600 nm). In one embodiment, the thickness is about 0.4 pm (400 nm). In other embodiments, the thickness is about 1 pm to about 5 pm, about 1 pm to about 3 pm, about 2 pm to about 5 pm, or about 2 pm to about 4 pm. In one embodiment, the thickness is about 2 pm.

[0043] In some embodiments, the panel structure 200 can include only the first coating 280, i.e., no second coating. In other embodiments, the panel structure 200 can include only the second coating 290, i.e., no first coating. In other embodiments, the panel structure 200 can include both the first coating 280 and the second coating 290, whereby the first and second coatings overlap to completely enclose the multidirectional panel 210. In such embodiments, the side surface 203 of the panel structure 200 can include at least one of the first coating 280 and the second coating 290.

[0044] In some embodiments, the first and second coatings, and any edge coatings, can be thicker than the board itself. In some embodiments, the coating thickness can be one, two, or three orders of magnitude thicker than the board structure. However, in other embodiments, the board can be thicker than the thickness of each coating or the sum of the two coatings.

[0045] The coatings described herein can be applied by any suitable deposition method, such as, but not limited to, chemical vapor deposition, atomic layer deposition, spray coating, dip coating, or brush coating.

[0046] The first coating 280 can be applied to the first major surface 211 by any suitable deposition method. In a non-limiting embodiment, the first coating 280 can be applied to the first major surface 211 by chemical vapor deposition. In another non-limiting embodiment, the first coating 280 can be applied to the first major surface 211 by atomic layer deposition. In another non-limiting embodiment, the first coating 280 can be applied to the first major surface 211 by spray coating. In another non-limiting embodiment, the first coating 280 can be applied to the first major surface 211 by dip coating. In another non-limiting embodiment, the first coating 280 can be applied to the first major surface 211 by brush coating.

[0047] The second coating 290 can be applied to the second major surface 212 by any suitable deposition method. In a non-limiting embodiment, the second coating 290 can be applied to the second major surface 212 by chemical vapor deposition. In another non-limiting embodiment, the second coating 290 can be applied to the second major surface 212 by atomic layer deposition. In another non-limiting embodiment, the second coating 290 can be applied to the second major surface 212 by spray coating. In another non-limiting embodiment, the second coating 290 can be applied to the second major surface 212 by dip coating. In another non-limiting embodiment, the second coating 290 can be applied to the second major surface 212 by brush coating.

[0048] The first coating 280 can be the same as the second coating 290. The first coating 280 can be different than the second coating 290. The first coating 280 can be hydrophilic. The first coating 280 can be hydrophobic. The first coating 280 can be lipophilic. The first coating 280 can be lipophobic. The second coating 290 can be hydrophilic. The second coating 290 can be hydrophobic. The second coating 290 can be lipophilic. The second coating 290 can be lipophobic. Each of the first coating 280 and the second coating 290 can independently be continuous. Each of the first coating 280 and the second coating 290 can independently be discontinuous. In some embodiments, the first coating 280 and the second coating 290 can both be hydrophobic. In some embodiments, the first coating 280 and the second coating 290 can both be hydrophilic. In some embodiments, the first coating 280 and the second coating 290 can both be lipophilic.

[0049] The first coating 280 can be organic. The first coating 280 can be inorganic. The second coating 290 can be organic. The second coating 290 can be inorganic.

[0050] 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. Making at least one of the first coating 280 and / or the second coating 290 hydrophobic can help prevent the therapeutic device 1 from sticking to tissue adversely during implantation.

[0051] In some embodiments, the first coating and / or the second coating are intended to increase the tenacity of the device. Additionally, the first coating and / or the second coating can increase the biocompatibility of the device and / or decrease scarring by reducing tissue and / or fibroblast adhesion. In some embodiments, the coatings described herein are hydrophobic and reduce tissue adhesion. In some embodiments, the tissue adhesion can be reduced by greater than about 50%, greater than about 60%, greater than about 70%, greater than about 80%, greater than about 90%, greater than about 95%, greater than about 96%, greater than about 97%, greater than about 98%, or greater than about 99% compared to the case of an uncoated plate.

[0052] In non-limiting embodiments, the first coating and / or the second coating can include a parylene polymer, such as, for example, parylene polymer (poly(p-xylylene)) or a derivative thereof. In other embodiments, the first coating and / or the second coating can include aluminum oxide. In one embodiment, the parylene polymer is chloro-modified poly(p-xylylene), chloro-modified poly(p-xylylene). In one embodiment, the parylene polymer can be parylene C, parylene D, parylene N, a derivative thereof, or a combination thereof. In other embodiments, the first coating and / or the second coating can include aluminum oxide.

[0053] In other embodiments, other polymers can be used in addition to or in lieu of, or in conjunction with, parylene polymers and / or aluminum oxide. In some embodiments, the other polymer material can include, but is not limited to, rubber, synthetic rubber, silicone polymer, thermoplastic, thermoset, polyolefin, polyisobutylene, acrylic polymer, ethylene vinyl acetate, polymethyl methacrylate, vinyl halide polymer (e.g., polyvinyl chloride), polyether (e.g., polyvinyl ether), polyvinylidene halide, polyacrylonitrile, polyvinyl ketone, polyvinyl alcohol ester, acrylonitrile-styrene copolymer, ABS resin, ethylene-vinyl acetate copolymer, polyamide (e.g., Nylon 66 and polycaprolactam), alkyd resin, polycarbonate, polyformaldehyde, polyimide, polyether, epoxy resin, polyurethane, rayon, cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ether, carboxymethyl cellulose, polytetrafluoroethylene (e.g., Teflon), polyether ether ketone, polylactic acid, such as, for example, PLA, PLGA, PLLA, a derivative thereof, or a combination thereof.

[0054] The resulting therapeutic device 1 can include a first plurality of channels 222 present on the first exposed major surface 201 of the plate structure 200, wherein the first plurality of channels 222 are hydrophilic due to the presence of the first coating 280. The resulting therapeutic device 1 can include a second plurality of channels 232 present on the second exposed major surface 202 of the plate structure 200, wherein the second plurality of channels 232 are hydrophilic due to the presence of the second coating 290. As discussed, the hydrophilic channels can facilitate fluid flow through the channels after implantation of the therapeutic device 1 into the eye of a subject.

[0055] With reference to Figure 4 , Figure 5A , Figure 5B and Figure 5CAn example of a treatment device 1001 according to another embodiment is illustrated. The treatment device 1001 is similar to the treatment device 1, except as described hereinafter. The above description of the treatment device 1 generally applies to the treatment device 1001 described hereinafter, except as specifically set forth hereinafter. A numbering scheme similar to that of the treatment device 1 will be used for the treatment device 1001, except that the “1000” series of numbers will be used.

[0056] The treatment device 1001 includes a plate structure 1200 having a first exposed major surface 1201 opposite a second exposed major surface 1202. The plate structure 1200 can include a multidirectional plate 1210 including opposing first and second major surfaces 1211, 1212. The multidirectional plate 1210 can form a plurality of topographies (e.g., a repeating honeycomb pattern) on each of the first and second major surfaces 1211, 1212. Each of the first and second topographies can independently include a plurality of channels 1232 and / or a plurality of open cells 1222.

[0057] Reference is now made to Figure 5B The plate structure 1200 can include a first delivery component 1070 present in open voids created by the first topography formed by the first exposed surface 1211 of the multidirectional plate 1210. In particular, the first delivery component 1070 can be present in open voids created by the open cells 1222 of the first topography formed by the first major surface 1211 of the multidirectional plate 1210.

[0058] The first delivery component 1070 can include one or more active agents, such as but not limited to therapeutic and / or pharmacological components. The first delivery component 1070 can occupy some, all, or substantially all of the free volume present in the open cells 1222 formed by the first topography.

[0059] In other embodiments, the active agent can include any compound or drug that has a therapeutic effect on a subject. Non-limiting active agents include anti-proliferative agents, including but not limited to macrolide antibiotics including FKBP-12 binding compounds, female hormones, chaperone inhibitors, protease inhibitors, protein tyrosine kinase inhibitors, miniprotein B, peroxisome proliferator-activated receptor gamma ligands (PPAR ), bleomycin, nitric oxide, bisphosphonates, epidermal growth factor inhibitors, antibodies, steroids, proteasome inhibitors, antibiotics, anti-inflammatory agents, antisense nucleic acids, transforming nucleic acids, IOP-reducing drugs, prostaglandins, cell growth inhibiting compounds, toxic compounds, anti-inflammatory compounds, chemotherapeutic agents, analgesics, antibiotics, protease inhibitors, statins, nucleic acids, polypeptides, growth factors, and delivery vehicles including recombinant microorganisms, liposomes, antimetabolites such as, for example, mitomycin C, combinations thereof, prodrugs thereof, pharmaceutically acceptable salts thereof, derivatives thereof, and the like.

[0060] The treatment device 1001 can also include a first coating 1050 applied to the first major surface 1211 of the multidirectional plate 1210. The first coating 1050 can cover both the first major surface 1211 of the multidirectional plate 1210 and the first delivery component 1070 present in the open cell 1222 formed in the first major surface 1211 of the multidirectional plate 1210. The first coating 1050 can be in the form of a continuous film. The first coating 1050 can be planar. In other embodiments, the first coating 1050 can conform to the underlying pattern formed by the multidirectional plate 1210 and the first delivery component 1070.

[0061] Referring now to Figure 5A The plate structure 1200 can include a second delivery component 1080 present in open voids created by the second topography formed by the second exposed surface 1212 of the multidirectional plate 1210. In particular, the second delivery component 1080 can be present in open voids created by the open channels 1232 of the second topography formed by the second major surface 1212 of the multidirectional plate 1210.

[0062] The second delivery component 1080 can be the same as or different from the first delivery component 1070.

[0063] The second delivery component 1080 can include one or more therapeutic and / or pharmacological components including, but not limited to, anti-inflammatory agents, steroids, antibiotics, analgesics. The second delivery component 1080 can occupy some, all, or substantially all of the free volume present in the channels 1232 formed by the first topography.

[0064] The therapeutic device 1001 can also include a second coating 1060 applied to the second major surface 1212 of the multidirectional plate 1210. The second coating 1060 can cover both the second major surface 1212 of the multidirectional plate 1210 and the second delivery component 1080 present in the open channel 1232 formed in the second major surface 1212 of the multidirectional plate 1210. The second coating 1060 can be in the form of a continuous film. The second coating 1060 can be flat. In other embodiments, the second coating 1060 can conform to the underlying pattern formed by the multidirectional plate 1210 and the second delivery component 1080.

[0065] The second coating 1060 can be the same as or different from the first coating 1050. For each of the first coating 1050 and the second coating 1060, the resulting film can be formed from a slow-release material that dissolves slowly upon exposure to aqueous humor or other biological fluids, thereby releasing the first delivery component 1070 from the channel 1232 of the therapeutic device 1001 after implantation into a subject.

[0066] Referring now to Figure 5C In other embodiments, the therapeutic device 1001 can include both the first delivery component 1070 and the second delivery component 1080, as well as the first coating 1050 and the second coating 1060 to encapsulate the first delivery component 1070 and the second delivery component 1080.

[0067] In other embodiments, the plate structure 1200 can include at least one of the first coating 1050 and / or the second coating 1060, while the first delivery component 1070 and / or the second delivery component 1080 are not present. In such embodiments, the first coating 1050 and / or the second coating 1060 can form a film that covers the open cells 1222 and / or the open channel 1232 created by the multidirectional plate.

[0068] The presence of the film resulting from the first coating 1050 and / or the second coating 1060 can enhance the overall strength of the resulting therapeutic device. In particular, the layered structure of the film formed by the first coating 1050 and the second coating 1060 (bonded to the first major surface 1211 and the second major surface 1212 of the multidirectional plate 1210) provides additional mechanical integrity to the resulting therapeutic device.

[0069] In addition to achieving baseline flexibility to conform to the curvature of the eye, the addition of the first coating 1050 and / or the second coating 1060 can provide a mechanism to allow the overall therapeutic device to match the elastic modulus of the surrounding conjunctival and scleral tissue to maximize biointegration. Results from studies on brain implants have demonstrated that flexibility of the implant in soft tissue improves the compliance of the implant to micro-scale motion of the surrounding tissue and reduces tissue displacement and trauma, as well as facilitating implantation of the therapeutic device.

[0070] With reference to Figure 6 and Figure 7 a therapeutic device 2001 according to another embodiment is illustrated. The therapeutic device 2001 is similar to the therapeutic device 1, 1001, except as described hereinafter. The above description of the therapeutic device 1, 1001 generally applies to the therapeutic device 2001 described hereinafter, except where explicitly set forth hereinafter. A numbering scheme similar to the therapeutic device 1, 1001 will be used for the therapeutic device 2001, except that the "2000" series of numbers will be used.

[0071] The therapeutic device 2001 can include a penetrating element 2100 and a plate structure 2200 provided as separate components, such that the penetrating element 2100 is coupled to the plate structure 2200. The penetrating element 2100 and the plate structure 2200 can be coupled together by any suitable means, such as but not limited to an adhesive, a fastener, and the like. Non-limiting examples of adhesives include a glue, an acrylic resin cyano, such as, for example, a base acrylate, an epoxy, a thermoset plastic, a thermoplastic, an elastomer, a polydimethylsiloxane (PDMS), a silicone, a siloxane-based, a polyurethane, and the like. Non-limiting examples of fasteners include an anchor, a cleat, a clasp, a buckle, or any other restraining means. In some embodiments, a fastener can be used in conjunction with an adhesive.

[0072] The plate structure 2200 can include opposing first and second exposed major surfaces 2201, 2202, and an exposed side surface 2203 extending between the first and second exposed major surfaces 2201, 2202. The first exposed major surface 2201 of the plate structure 2200 can be substantially continuous and appear smooth when viewed with the naked eye. The second exposed major surface 2202 of the plate structure 2200 can be substantially continuous and appear smooth when viewed with the naked eye.

[0073] The penetrating element 2100 can include an outer surface 2101 and an inner surface 2102. The penetrating element 2100 can include an elongate body 2110. The elongate body 2110 can include an outer surface 2112 and an inner surface 2111. The penetrating element 2100 can also include a path 2140 (also referred to herein as an "inner lumen path") extending through the elongate body 2110. The inner surface 2111 can be continuous and form a D-shaped cross-section. The D-shaped cross-section can result in the outer surface 2112 having a rounded portion 2118 and a generally flat portion 2117, whereby the generally flat portion 2117 is engaged to at least one of the first exposed major surface 2201 or the second exposed major surface 2202 of the plate structure. The flat portion 2117 provides a good fit with the smooth and / or flat major surfaces 2201, 2202 of the plate structure.

[0074] Referring to Figures 8 to 9 A treatment device 3001 according to another embodiment is illustrated. The treatment device 3001 is similar to the treatment devices 1, 1001, 2001, except as described hereinafter. The above description of the treatment devices 1, 1001, 1002 generally applies to the treatment device 3001 described hereinafter, except where explicitly set forth hereinafter. A numbering scheme similar to the treatment devices 1, 1001, 1002 will be used for the treatment device 3001, except that the "3000" series of numbers will be used.

[0075] The treatment device 3001 can include a penetrating element 3100 and a plate structure 3200 provided as separate components, whereby the penetrating element 3100 is coupled to the plate structure 3200. The penetrating element 3100 and the plate structure 3200 can be coupled together by any suitable means, such as but not limited to an adhesive, a fastener, and the like. Non-limiting examples of fasteners include an anchor, a cleat, a clasp, a buckle, or any other restraining means.

[0076] The plate structure 3200 can include a first exposed major surface 3201 opposite a second exposed major surface 3202. The first exposed major surface 3201 of the plate structure 3200 can appear or be generally continuous and appear smooth when viewed with the naked eye. The second exposed major surface 3202 of the plate structure 3200 can be generally continuous and appear smooth when viewed with the naked eye.

[0077] The first exposed major surface 3201 can include a first region 3211 and a second region 3212. The first region 3211 can be offset from the second major surface 3202 by a first thickness ti. The second region 3212 can be offset from the second major surface 3202 by a second thickness t2. The first thickness ti and the second thickness t2 can be different. The second thickness t2 can be less than the first thickness ti, such that the second region 3212 forms a recess in the first exposed major surface 3201 of the plate structure 3200.

[0078] The penetrating element 3100 can include an outer surface 3101 and an inner surface 3102. The penetrating element 3100 can include an elongate body 3110. The elongate body 3110 can include an outer surface 3111 and an inner surface 3112. The penetrating element 3100 can also include a pathway 3140 (also referred to herein as an “inner lumen pathway”) extending through the elongate body 3110. The inner surface 3112 can be continuous and form a circular cross-section. The circular cross-section can result in an outer surface 3111 that is also circular in shape. The recess formed by the second region 3212 on the first exposed major surface 3201 can accommodate at least a portion of the circular cross-section of the penetrating element 3100, thereby allowing the penetrating element to extend to the plate structure 3200 such that the penetrating element 3100 has an inner lumen pathway 3140 to allow fluid flow without the penetrating element 3100 protruding too far beyond the first region 3211 of the first exposed major surface 3201 of the plate structure 3200.

[0079] Reference is made to Figures 10 to 12 , illustrating a treatment device 4001 according to another embodiment. The treatment device 4001 is similar to the treatment devices 1, 1001, 2001, 3001, except as described hereinafter. The above description of the treatment devices 1, 1001, 2001, 3001 generally applies to the treatment device 4001 described hereinafter, except where explicitly set forth hereinafter as being different. A numbering scheme similar to that of the treatment devices 1, 1001, 2001, 3001 will be used for the treatment device 4001, except that the “4000” series of numbers will be used.

[0080] The treatment device 4001 includes a first plate structure 4200a and a second plate structure 4200b. The first plate structure 4200a can include opposing first and second major surfaces 4201a, 4202a. The second plate structure 4200b can include opposing second and first major surfaces 4202b, 4201b.

[0081] The first major surface 4201a of the first plate structure 4200a can include a first topography. The second major surface 4202a of the first plate structure 4200a can include a second topography. The first major surface 4201b of the second plate structure 4200b can include a first topography. The second major surface 4202b of the second plate structure 4200b can include a second topography.

[0082] The second major surfaces 4202a, 4202b of the first plate structure 4200a and the second plate structure 4200b can face one another. In some embodiments, at least portions of the second major surfaces 4202a, 4202b of the first plate structure 4200a and the second plate structure 4200b can be in contact with one another. In some embodiments, at least portions of the second major surfaces 4202a, 4202b of the first plate structure 4200a and the second plate structure 4200b can be in free-floating contact with one another. In some embodiments, at least portions of the second major surfaces 4202a, 4202b of the first plate structure 4200a and the second plate structure 4200b can be offset from one another such that there is no contact between the second major surfaces 4202a, 4202b of the first plate structure 4200a and the second plate structure 4200b.

[0083] The treatment device 4001 can also include a penetrating element 4100 positioned between the first plate structure 4200a and the second plate structure 4200b. The penetrating element 4100 can be coupled to at least one of the first plate structure 4200a and the second plate structure 4200b by any suitable means, such as but not limited to one of the aforementioned adhesives, fasteners, and the like. The penetrating element 4100 can be coupled to portions of the second major surfaces 4202a, 4202b of the first plate structure 4200a and the second plate structure 4200b.

[0084] According to this embodiment, the penetrating element 4100 extends between the first plate structure 4200a and the second plate structure 4200b such that a path 4140 formed by the elongate body 4110 of the penetrating element 4100 also extends between the plate structures 4200a, 4200b. In this configuration, fluid can enter the elongate body 4110 and travel along the path 4140 and exit between the second major surfaces 4202a, 4202b of the first plate structure 4200a and the second plate structure 4200b. Portions of the second major surfaces 4202a, 4202b of the first plate structure 4200a and the second plate structure 4200b that are in free-floating contact can separate in the presence of such fluid to allow the fluid to spread along the second major surfaces 4202a, 4202b of the first plate structure 4200a and the second plate structure 4200b.

[0085] The first major surface 4201a and the second major surface 4202a of the first plate structure 4200a can have a first surface area, and the first major surface 4201b and the second major surface 4202b of the second plate structure 4200b can have a second surface area. The first surface area can be the same as the second surface area. In other embodiments, the first surface area can be different from the second surface area. The second surface area can be greater than the first surface area.

[0086] The first plate structure 4200a can have a first width and a first length LI. The second plate structure 4200b can have a second width and a second length L2. The first width can be the same as the second width. In other embodiments, the first width can be different from the second width. The first length LI can be the same as the second length L2 (not shown). In other embodiments, as shown, the first length LI can be different from the second length L2. The second length L2 can be greater than the first length LI such that at least a portion of the second major surface 4202b of the second plate structure 4200b does not overlap the second major surface 4202a of the first plate structure 4200a. Figure 10

[0087] Referring to Figure 13 , Figure 14A and Figure 14B , embodiments further comprise an implantation device 90 configured to implant the treatment device 1 into the eye 900. The following discussion will refer to the treatment device 1, but is also applicable to the treatment devices 1001, 2001, 3001, 4001 exemplified according to other embodiments of the present application.

[0088] The implantation device 90 can comprise a handle portion 93 and an insertion portion 91, which can comprise a housing 92 for securing the treatment device 1. The housing 92 can be configured in any geometry suitable for securing the treatment device 1. In a non-limiting embodiment, the housing 92 can be an open cavity into which the treatment device 1 is placed.

[0089] During implantation, the implantation device 90 can be inserted into the eye 900 such that the treatment device 1 can be positioned to contact the eye 900 for treating an eye disease, such as glaucoma. In particular, the insertion portion 91 can be inserted through the sclera 913 and into the anterior chamber 988 of the eye 900 such that the distal portion of the treatment device 1 is located within the anterior chamber 988 of the eye 900. Once the treatment device 1 is in place, the implantation device 90 can be removed from the eye 900, whereby the treatment device 1 exits the housing 92 of the implantation device 90 and remains in the eye 900.

[0090] ​In place, the plate structure 200 of the therapeutic device 1 can be positioned between the sclera 913 and the conjunctival tissue 950. In this configuration, the plate structure 200 can act as a tissue separator and / or an external reservoir for excess fluid as fluid is absorbed into the surrounding tissue of the subject.

[0091] Referring now to Figure 15 and Figure 16 , a release decal 400 can be coupled to at least one of the major surfaces of the therapeutic device 1. The release decal 400 can be reversibly adhered to one of the major surfaces 201, 202 of the plate structure 200 of the therapeutic device 1 such that the release decal 400 can be removed by peeling from the major surface of the therapeutic device 1, but will resist shearing separation from the major surface of the therapeutic device 1.

[0092] The release decal 400 can be formed from a material including, but not limited to, polytetrafluoroethylene (PTFE), one or more metals, silicone, PDMS, glass, and / or one or more plastics.

[0093] The release decal 400 can include a decal nub 410 that provides a feature to allow a user to directly or indirectly manipulate the position of the therapeutic device 1 relative to the underlying ocular tissue, specifically the sclera 913. For example, after the therapeutic device 1 has been released from the housing 92 on the implant device 1, the decal nub can be manipulated by the insertion portion 91 of the implant device 1. In other embodiments, a separate tool can be used to engage the decal nub 410 in order to manipulate the position of the therapeutic device 1 on the sclera 913.

[0094] With the decal nub 410, the position of the plate structure 200 of the therapeutic device 1 can be precisely adjusted along the sclera 913, and Figures 6 to 12 The penetrating element 100, 2100, 3100, 4100, or Figure 1 The extension portion 250 of the embodiment shown can be precisely placed within the anterior chamber 988 in order to provide optimal release of excess fluid present in the eye 900.

[0095] The strength of the bond between the release decal 400 and the therapeutic device 1 can be strong enough to resist shearing, allowing lateral movement of both the release decal 400 and the therapeutic device 1. However, once precise positioning of the therapeutic device 1 is achieved, the release decal 400 can be removed from the therapeutic device 1 by lifting the release decal 400 from the therapeutic device in a direction generally orthogonal to the major surface of the therapeutic device 1, that is, by peeling the release decal 400 from the therapeutic device 1.

[0096] Referring now to Figure 17 and Figure 18, embodiments further include an implantation device 80 that can be configured to implant the therapeutic device 1 into the eye 900. The following discussion will refer to the therapeutic device 1, but also applies to the therapeutic devices 1001, 2001, 3001, 4001.

[0097] According to this embodiment, a support stand can be used in conjunction with the therapeutic device 1. Specifically, the therapeutic device 1 can be placed on top of the support stand, and the implantation tool including the first support 81 and the second support 82 can simultaneously grasp both the therapeutic device and the support stand. In a non-limiting embodiment, the implantation device 80 can be a forceps. As shown in Figure 17 It is shown that in the first state, the first support 81 and the second support 82 are clamping the therapeutic device 1 and the stand.

[0098] During implantation, the scleral tissue 913 on the eye 900 can be formed with an opening. The implantation device 80 in the first state can then be inserted into the opening, such that the first support 81 and the second support 82 are positioned within the opening. The implantation device 80 can then be transitioned to the second state (as shown in Figure 18 It is shown that in the first state, the first support 81 and the second support 82 are clamping the therapeutic device 1 and the stand.

[0099] Once in the second state, the therapeutic device 1 can be transferred from the first support 81 to the eye 900. In one embodiment, both the therapeutic device 1 and the support stand can be transferred to the eye, and once properly positioned, the support stand can be removed, leaving only the therapeutic device in its final implantation position. In another embodiment, the therapeutic device 1 can be transferred to the eye in the absence of the support stand, which remains on the first support 81. The transfer of the therapeutic device 1 can be performed by moving the implantation device 80 (such as a slight oscillatory movement) in order to push the therapeutic device 1 from the first support 81.

[0100] Reference is now made to Figures 19 to 21 , embodiments further include an implantation device 80 that can be configured to implant the therapeutic device 1 into the eye 900. The following discussion will refer to the therapeutic device 1, but also applies to the therapeutic devices 1001, 2001, 3001, 4001.

[0101] According to this embodiment, the devices described herein can further include an injectable therapeutic device 71 that includes a support rod 72 for use in conjunction with the therapeutic device 1. Specifically, the therapeutic device 1 can be wrapped around the support rod 72, forming an elongated columnar shape. In other embodiments, the injectable therapeutic device 71 can not include the support rod 72, and instead the therapeutic device 1 can be self-wrapped.

[0102] The injectable therapeutic device 71 can then be placed in an injection apparatus 74 configured to inject the injectable therapeutic device 71 into the eye 900 via a fluid passageway 75. In a non-limiting embodiment, the injection apparatus 74 can be a syringe, and the fluid passageway 75 can be formed by a needle.

[0103] During implantation, the fluid passageway 75 can enter a bottom portion of the anterior chamber 988 and extend upwardly toward the sclera 913, whereby the therapeutic device 1 can be expelled from the implant device 70 by a pumping mechanism and delivered to the sclera 913. Once delivered, the therapeutic device 1 can uncoil from a coiled position about the support rod 72, thereby creating a fluid passageway from the anterior chamber 988 to a location between the conjunctiva and the sclera 913 for excess aqueous humor to exit the anterior chamber 988.

[0104] In one embodiment, Figure 22 An apparatus as described herein is illustrated. The apparatus 2200 includes a plate structure 2202 having first and second opposed major exposed surfaces 2204, 2206 and a side surface 2208 extending therebetween. The plate structure 2202 includes an extension portion 2210 and a main body portion 2212.

[0105] Generally, in Figure 22 In the illustrated embodiment, the extension portion 2210 includes two generally parallel side surfaces 2212, 2212' meeting a generally flat end surface 2214. This portion can be referred to as a core or neck. In this embodiment, the junctions of the parallel side surfaces 2212, 2212' and the generally flat end surface 2214 are radiused. These radiused corners 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. However, in other embodiments, the junctions need not be radiused.

[0106] Similarly, the main body portion 2212 includes two generally parallel side surfaces 2216, 2216'. These parallel side surfaces meet at a generally radiused end surface 2218. In other embodiments, the generally radiused end surface 2218 can be a generally flat end surface with radiused or un-radiused junctions.

[0107] The distance 2220 between the two generally parallel side surfaces 2212, 2212' is less than the distance 2222 between the generally parallel side surfaces 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 generally 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.

[0108] The distance 2224 between the generally flat end surface 2214 and the interface of the extension portion 2208 and the main 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. The distance 2226 between the interface of the extension portion 2208 and the main body portion 2210 and the generally 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, between about 10 mm and about 15 mm, or between about 9 mm and about 11 mm.

[0109] Furthermore, the main body portion 2210 includes two generally rounded corners 2228 and 2228' at the interface between the extension portion 2208 and the main body portion 2210. However, these corners do not need to be rounded. In some embodiments, the generally rounded corners 2228 and 2228' may have radii 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 main body portion 2210 is curved. However, this portion does not need to be curved. The bend may 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.

[0110] In some embodiments, device 2200 may include a marking indentation 2212. The marking indentation 2212 may be located anywhere on the periphery of the upper surface 2206 of the extension 2208 or the main body portion 2210.

[0111] In some embodiments, device 2200 may include two or more marking indentations.

[0112] The marking indentation can have almost any shape. Shapes can include curved shapes, straight shapes, and so on. In one implementation, such as... Figure 22 As illustrated, the marking indentation 2212 has a semi-circular shape. However, the marking indentation 2212 may have a straight shape, such as a pyramid or a dot.

[0113] Marking indentations may be present to assist in correct placement during implantation. In some embodiments, having a single marking indentation provides a visual indication of the correct side-facing orientation of the device to the implanter.

[0114] Figure 23A non-limiting embodiment of an inserter to implant a device as described herein is illustrated. Inserter 2300 includes a body or housing 2302. The housing includes a needle 2304 pinned to a proximal end 2306 thereof. Needle 2304 has a sharp proximal end 2308. Sharp proximal end 2308 is to pierce ocular tissue during device implantation. In some embodiments, needle 2304 is a small 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.

[0115] A camera 2310 is included on needle 2304. Camera 2310 is to visualize the implantation process and can be a wired or wireless camera.

[0116] Device 2312 is housed within housing 2302 in a compartment 2314 proximate proximal end 2306 thereof. However, in other embodiments, device 2312 can be housed within needle 2304.

[0117] A slider 2316 can be located on the housing. Although slider 2316 is illustrated as being on the top of the housing, it can be located almost anywhere on the housing. The shape of the slider is also shown for illustrative purposes and can be almost any shape that can slide. Furthermore, a mechanical slider can not be necessary. In some embodiments, slider 2316 can be replaced by a button and an electronic sliding mechanism (not illustrated).

[0118] A circuit board 2318 can include a memory and a processor to execute programs stored in the memory. For example, if a button is used in place of a slider, the circuit board can perform this function. Circuit board 2318 is powered by a battery 2320. Battery 2318 can be any battery that can power inserter 2300. The battery can include, but is not limited to, round cylindrical batteries such as AA, AAA, AAAA, C, D, and button batteries such as lithium button, coin cells, and non-round batteries such as 4.5V box and 9V box batteries, among others. Furthermore, a button battery or coin cell can also be used. The battery can be removed as needed. In some embodiments, the battery can be rechargeable.

[0119] A wireless interface 2322 is also associated with circuit board 2318. This interface can be any wireless interface type such as WiFi, Bluetooth, cellular, among others. This interface can transmit camera data, device data, among others.

[0120] In some embodiments, inserter 2300 is disposable. In other embodiments, inserter 2300 can be a multi-use device that can be cleaned and sterilized between uses.

[0121] During use, the device 2312 is positioned within the compartment 2314. In some embodiments, the device 2312 is pre-loaded in an inserter. As the slider is moved, the device is extruded from the sharp proximal end 2308 of the needle 2304. In some embodiments, a coiling device 2324 is positioned within the compartment 2314 or needle 2304 to coil the device after it is extruded. In other embodiments, the device is pre-coiled, or coiled when loaded at the factory of the pre-loaded inserter.

[0122] In some embodiments, the devices described herein can be used to augment glaucoma treatment even when other devices and methods are used. The device can be inserted before or after insertion of another ocular device, such as a stent. The device can be used with another glaucoma stent, where the current device acts as a tissue separator of the ocular tissue. Such tissue separation can augment the effect of the ocular stent on treating glaucoma.

[0123] In some embodiments, the current device can be used as a replacement for mitomycin C injection after eye surgery. In some embodiments, the device is inserted into the eye during surgery. In other embodiments, the device is inserted in a follow-up procedure after surgery. The device can assist in reducing intraocular pressure associated with the surgery.

[0124] The present invention can be further characterized by the following embodiments: Embodiment 1. A device for reducing intraocular pressure, the device comprising: a plate comprising opposing first and second surfaces, wherein the first surface comprises a series of fluid channels, a first coating on the first surface, and a second coating on the second surface.

[0125] Embodiment 2. The device of embodiment 1, wherein the plate has a thickness of about 50 nm to about 800 nm.

[0126] Embodiment 3. The device of embodiment 1, wherein the plate is formed of a ceramic material.

[0127] Embodiment 4. The device of embodiment 3, wherein the ceramic material is selected from the group consisting of: aluminum oxide, silicon nitride, silicon dioxide, hafnium dioxide, titanium nitride, and titanium carbide.

[0128] Embodiment 5. The device of embodiment 1, wherein the first coating has a thickness of about 0.1 pm to about 1 pm.

[0129] Embodiment 6. The device of embodiment 1, wherein the first coating is a parylene polymer.

[0130] Embodiment 7. The device of embodiment 6, wherein the parylene polymer is parylene C, parylene D, parylene N, a derivative thereof, or a combination thereof.

[0131] Embodiment 8. The device of embodiment 1, wherein the first coating is a polymeric material selected from the group consisting of rubber, synthetic rubber, silicone polymer, parylene, thermoplastic, thermoset, polyolefin, polyisobutylene, acrylic polymer, ethylene vinyl acetate, polymethyl methacrylate, vinyl halide polymer, polyether, polyvinylidene halide, polyacrylonitrile, polyvinyl ketone, polyvinyl alcohol arylate, polyvinyl alcohol ester, acrylonitrile-styrene copolymer, ABS resin, ethylene-vinyl acetate copolymer, polyamide, alkyd resin, polycarbonate, polyformaldehyde, polyimide, polyether, epoxy resin, polyurethane, rayon, cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ether, carboxymethyl cellulose, polytetrafluoroethylene, polyether ether ketone, polylactic acid such as, PLA, PLGA, PLLA, a derivative thereof, or a combination thereof.

[0132] Embodiment 9. The device of embodiment 1, wherein the second coating has a thickness of about 0.1 pm to about 1 pm.

[0133] Embodiment 10. The device of embodiment 1, wherein the second coating is alumina or a parylene polymer.

[0134] Embodiment 11. The device of embodiment 1, wherein the second coating comprises alumina, rubber, synthetic rubber, silicone polymer, parylene, thermoplastic, thermoset, polyolefin, polyisobutylene, acrylic polymer, ethylene vinyl acetate, polymethyl methacrylate, vinyl halide polymer, polyether, polyvinylidene halide, polyacrylonitrile, polyvinyl ketone, polyvinyl alcohol arylate, polyvinyl alcohol ester, acrylonitrile-styrene copolymer, ABS resin, ethylene-vinyl acetate copolymer, polyamide, alkyd resin, polycarbonate, polyformaldehyde, polyimide, polyether, epoxy resin, polyurethane, rayon, cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ether, carboxymethyl cellulose, polytetrafluoroethylene, polyether ether ketone, polylactic acid such as, PLA, PLGA, PLLA, a derivative thereof, or a combination thereof.

[0135] Embodiment 12. The device of embodiment 1, wherein the series of fluidic channels comprises a plurality of open channels interconnected to form a cross network of fluidic pathways.

[0136] Embodiment 13. The device of embodiment 1, further comprising a drug.

[0137] Embodiment 14. A method of reducing intraocular pressure, comprising: injecting a device into an eye having high intraocular pressure, the device comprising a plate comprising opposing first and second surfaces, wherein the first surface comprises a series of fluidic channels, a first coating on the first surface, and a second coating on the second surface; and treating the high intraocular pressure.

[0138] Embodiment 15. The method of embodiment 14, further comprising securing the device to the eye.

[0139] Embodiment 16. The method of embodiment 15, wherein the securing is to the sclera.

[0140] Embodiment 17. The method of embodiment 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.

[0141] Embodiment 18. The method of embodiment 17, wherein the device forms fluidic pathways that provide fluid flow communication between the anterior chamber of the eye and a device location.

[0142] Embodiment 19. The method of embodiment 18, wherein the fluidic pathways comprise the series of fluidic channels.

[0143] Embodiment 20. The method of embodiment 14, wherein treating the high intraocular pressure is treating glaucoma.

[0144] Example 1 Studies were conducted to assess the ability of the devices described herein to reduce eye pressure and protect the optic nerve. The implanted devices were determined to allow aqueous humor to flow through the network of microchannels in the device to the subconjunctival space in a slow, controlled manner, thereby forming low and diffuse blebs.

[0145] Experimental Design

[0146] The poly(p-xylylene)-alumina composite materials manufactured via atomic layer deposition and chemical vapor deposition as described herein are provided as test articles. The articles are stored at room temperature and standard atmospheric pressure.

[0147] Prior to study initiation, each animal will be subjected to an ophthalmic examination (slit lamp microscopy and indirect ophthalmoscopy) by the study director or designee. The ocular study findings will be scored according to the modified McDonald-Shadduck scoring system. The entry criteria for study is a score of "0" for all variables.

[0148] Prior to study initiation, each animal will be subjected to an ocular pressure (IOP) measurement procedure once daily for 5 to 7 days prior to study initiation to acclimate the animals to the ocular pressure (IOP) measurement procedure, to habituate the animals to the IOP procedure, and to determine baseline IOP levels. IOP measurements will be performed by Tonovet rebound tonometry at the same time each day (± 1 hour) according to the IOP measurement procedure. At least three measurements will be taken for each eye per measurement event.

[0149] Anesthetize the animals with ketamine hydrochloride (up to about 50 mg / kg) and xylazine (up to about 10 mg / kg) or dexmedetomidine (about 0.25 mg / kg) by intramuscular (IM) injection. Glycopyrrolate (about 0.01 mg / kg, IM) can be administered concurrently. Atipamezole hydrochloride (up to 1 mg / kg) can be used as a reversal agent.

[0150] Following surgical preparation of the eye, apply one to two drops of topical proparacaine hydrochloride anesthetic (0.5%) to the animal's eye. Additional topical ocular anesthetic can be administered during the procedure, if needed.

[0151] On Day 0, implant the test article into the subconjunctival space of the right eye (OD).

[0152] Clean the eye with betadine and then irrigate with balanced salt solution (BSS). Apply one to two drops of topical proparacaine hydrochloride anesthetic (0.5%) to the animal's eye. Additional topical ocular anesthetic can be administered during the procedure, if needed. The eye can be covered and a sterile wire speculum can be placed to retract the eyelids.

[0153] The conjunctival flap based on a 60- to 90-degree fornix is in the superotemporal quadrant with the initial conjunctival incision 2 mm posterior to the limbus. The length of the fornix should be 8 mm from the initial incision.

[0154] Create a stab incision into the anterior chamber with a keratome blade 1 mm from the limbus to create a scleral tunnel between the subconjunctival fornix and the anterior chamber.

[0155] Gently grasp the test article with forceps. Handle the test article carefully as the material is very delicate and can stick to wet surfaces. Insert the implant gently into the subconjunctival pocket.

[0156] Carefully insert the implant through the rounded notch on the left hand side to ensure proper orientation of the implant, i.e. the channel is facing upwards. Gently guide the neck of the implant into the scleral tunnel to ensure easy access. Smooth the body of the implant gently to ensure it is properly positioned and lying flat. If necessary, use BSS to wet the tissue.

[0157] If the anterior chamber collapses or a globe hypotony occurs, use a 27 gauge needle and 3 mL syringe to inflate the anterior chamber with BSS. Inflating the AC with viscoelastic can make it difficult to keep the neck of the implant in the AC, but the viscoelastic can be used to lubricate the implant.

[0158] Use 10-0 nylon or prolene suture to anchor the implant to the sclera by passing the suture through the device at each of the corners and the tail.

[0159] Close the conjunctiva with 10.0 nylon suture or similar to create a water tight closure using a simple running pattern to avoid the implant body as much as possible.

[0160] If the test article is difficult to see, use a felt tip surgical marker to mark the bulbous body portion of the implant.

[0161] The animal recovers immediately after test article administration and is monitored during recovery until the animal is fully recovered.

[0162] A single injection of buprenorphine (0.02-0.05 mg / kg IM / SC) is given for analgesia proximate to the procedure. Additional buprenorphine administration is given twice daily (approximately 12 hours apart) on days 1-3 after test article administration. Alternatively, a sustained release buprenorphine (approximately 0.1 mg / kg SC) can be administered on day 1.

[0163] A drop of 0.3% ofloxacin and a drop of 1% prednisolone acetate is applied on day 0 after implant surgery is complete, and then 4 times daily on days 1-7 after test article administration.

[0164] Clinical ophthalmic examinations (slit lamp only) of both eyes (OU) of all study animals are performed at baseline (prior to test article administration), at Day 0 immediately following test article implantation, and at Days 1, 3, 7 (±1), 14 (±1), and 21 (±3). Additional examinations are performed at Days 35 (±3), 49 (±3), 63 (±3), 77 (±3), and 91 (±3) in the event of an optional study extension.

[0165] Intraocular pressure (IOP) measurements of both eyes (OU) of all study animals are performed at baseline (prior to test article administration), at Day 0 immediately following test article implantation, and at Days 1, 3, 7 (±1), 14 (±1), and 21 (±3). Additional IOP measurements are performed at Days 35 (±3), 49 (±3), 63 (±3), 77 (±3), and 91 (±3) in the event of an optional study extension.

[0166] IOP measurements are performed by Tonovet rebound tonometry by the same technician at the same time (±1 hour) each day. At least three measurements are taken for each eye per measurement event.

[0167] Slit lamp photographs are taken of both eyes (OU) of all study animals at baseline (prior to test article administration), at Day 0 immediately following test article implantation, and at Days 1, 7 (±1), and 21 (±3).

[0168] At Day 21 (±3), fluorescein testing is performed on all right eyes (OD) to assess for unocclusion of the test article and the aqueous humor pathway from the anterior chamber to the subconjunctival space.

[0169] A small (approximately 30 gauge) needle is used to access the anterior chamber and allow for drainage of the aqueous humor to avoid high intraocular pressure (IOP). A second small needle is introduced into the anterior chamber and approximately 0.5 mL of a 0.01% sodium fluorescein solution in balanced salt solution (BSS) is slowly instilled into the anterior chamber over 20 minutes. IOP is monitored during the procedure to ensure that it does not exceed safe levels.

[0170] Observations following the injection are recorded in the raw data, including a description of the fluorescein pathway (or lack thereof) into the test article and into the subconjunctival space.

[0171] Digital photographs of the eyes can be taken using a slit lamp or DSLR camera as needed to document study results. Additional photographs can be taken using a fluorescein filter and / or a cobalt blue filter.

[0172] As Figure 24As exemplified, intraocular pressure in the treated eyes was reduced by an average of 25% from baseline at day 7 and remained below baseline and controls. The baseline score was the average of intraocular pressure 5 days prior to the implantation procedure.

[0173] Bubbles were present on all implants.

[0174] In addition, all ocular observations had low scores according to the McDonald-Shadduck scoring system.

[0175] Example 2 The results of the Example 1 study were compared to the results using the InnFocus SIBS device. As Figure 25 As exemplified, intraocular pressure in the treated eyes was reduced by an average of 25% from baseline at day 7 and remained below baseline and controls. The baseline score was the average of intraocular pressure 5 days prior to the implantation procedure.

[0176] Conversely, no statistically significant reduction in intraocular pressure was observed between eyes implanted with SIBS implants and control eyes over the 7 days post- procedure.

[0177] Example 3 The Example 1 population was used for further study. At 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 blebs created by the current device, indicating that the channels were not closed. In addition, large and diffuse infiltrates remained outside the device surface area and outside the anatomical area, exemplifying egress from the anterior chamber.

[0178] Example 4 A single or multi-layered plate is implanted into the subconjunctival space using an ab-interno and minimally-invasive approach using an insertion device such as, but not limited to, a gelatin scaffold. A small portion of the device (a few millimeters in length) is located in the anterior chamber, allowing aqueous humor to flow along it to the subconjunctival space (between the conjunctival sac membrane and the sclera) via capillary action.

[0179] Fluid flows through and above / below the microchannels in the plate. The orientation of the microchannels can face the conjunctiva or the sclera to maximize flow.

[0180] The device is pre-loaded into a capsule or cartridge fitted with an insertion device. The insertion device facilitates deposition in the correct location in the eye, and then the insertion device is withdrawn from the eye while the device remains behind.

[0181] The insertion device has a tapered, flat / rectangular blade that forms a minimally invasive cut that starts on the cornea in the inferonasal quadrant of the eye, moves superiorly and pushes the tissue in the superotemporal quadrant out of the way. The blade can be tapered or can be open to prevent tissue from clogging the opening and to prevent the plate from being deposited. The tip of the insertion device or the body of the blade of the insertion device has a ridge to prevent the tissue from being cut too deeply. The ridge also aids in the positioning and cutting of the blade.

[0182] Once the blade has opened an outflow pathway from the anterior chamber to the subconjunctival space, the insertion device will deposit the device through the blade or via some system to push the device into the open space, such deposition being just enough so that the majority of the plate is in the tissue but with a few millimeters extending into the anterior chamber. The insertion device is then removed and the surgeon closes any openings left in the eye.

[0183] Example 5 This example illustrates the use of the device to lower intraocular pressure and the tolerance of the device implantation under the conjunctiva in New Zealand white rabbits.

[0184] Surgical Procedure: Three young experimental New Zealand white rabbits (one male and two females) approximately 5 months old and weighing 2.8 to 3.3 kg (irrespective of sex) at the start of the study were assigned to the treatment group as shown in Table 1 below.

[0185] Table 1

[0186] To implant the therapeutic device, each rabbit was subcutaneously anesthetized with a combination of ketamine (40 mg / kg) and xylazine (4 mg / kg). Anesthetic was supplemented as needed. All drugs used are noted in the raw data. At this time, a few drops of 1% proparacaine (topical anesthetic) were added to each eye. Once anesthetized, the rabbit was placed on its side and the area around the eye was prepared with a Swapstick containing 10% povidone-iodine. The eye was then irrigated with 0.9% sterile saline and additional drops of proparacaine were given. A sterile drape was placed over the rabbit, allowing the eye to be exposed. Sterile instruments (steam autoclaved prior to the first surgery, then chemically sterilized in a chlorhexidine solution between animals and rinsed with sterile water / saline) were used. Sterile gloves were worn.

[0187] The eyelids were held open manually or using an eyelid speculum for surgery. Using a Colibri forceps, the eye was rotated inward and a small incision was made in the conjunctiva lateral to the iris. A subconjunctival pocket was created on the anterior side and the therapeutic device was placed within it. After placement, the eye was allowed to rotate back to the normal position and the placement of the therapeutic device was observed to ensure good lying flat within the subconjunctival pocket. The rabbit was then rotated to the other side and a sham surgery was performed similarly on the contralateral eye without implantation of the therapeutic device or other material. Sterile ophthalmic ointment was applied to both eyes during the recovery period.

[0188] Observations and Measurements: On Day 1, the therapeutic device was implanted into the eye of the subject via a conjunctival incision between the sclera and the conjunctiva. Mortality and clinical observations were assessed daily. Ocular inflammation scores were recorded once daily on Day 1 prior to dosing, Days 2-5, Day 12, and Day 19. Body weights were recorded weekly. Food consumption was recorded daily. On Day 21, all animals were sacrificed. The eyes with optic nerves of all animals were obtained at necropsy and evaluated by microscopy.

[0189] Histological Analysis: On Day 21, animals were sacrificed by intravenous injection of an overdose of barbiturate. All animals were necropsied. The eyes with optic nerves were collected and immediately fixed in Davidson's fixative for 24 to 48 hours. After dehydration of the nerve samples with increasing concentrations of ethanol (30-100%), the nerves were sectioned by a sharp blade. The sections were then embedded in descending order in paraffin and cut into 3 mm thick sections. The sections were stained with hematoxylin and eosin. Two sections with pupil-optic disc orientation were cut from each eye (two halves of the globe) and each paraffin block was cut into two sections, resulting in four slides per eye available for microscopic examination.

[0190] Results and Discussion On Day 1, one male and two female New Zealand white rabbits were administered the therapeutic device once via a conjunctival incision between the sclera and the conjunctiva.

[0191] Mortality / Morbidity: There were no premature deaths during the study. All animals survived until the scheduled sacrifice on Day 21.

[0192] Clinical Observations: On Day 1, mild to moderate decreased activity was noted post-surgery and all animals closed their eyes or partially closed their eyes 2 to 4 hours after dosing. These findings were considered unrelated to the test article and secondary to the anesthetic and surgical procedures. All animals appeared normal on Days 2 to 21 of the study.

[0193] Ocular Observations: Prior to dosing on Day 1, the ocular Draize scores for all animals' eyes (both left and right eyes) were 0. The minimum overall Draize scores were recorded on Days 2 and 3 of the study. Note the scores for both the left eye and right eye (implant and sham, respectively). By Day 4, ocular scores were no longer noted. Table 2 below summarizes the overall ocular Draize scores recorded during the study.

[0194] Table 2

[0195] Body Weights: No test article-related effects on body weights or body weight gains were noted.

[0196] Food Consumption: No test article-related effects on food consumption were noted. Animals consumed all food offered throughout the day.

[0197] Necropsy Observations Gross Necropsy Findings: On Day 21, no gross necropsy findings were noted at the time of scheduled sacrifice.

[0198] Histopathology: The treatment devices in any animal were not visible microscopically. Focal scleral changes consisting of elevations and separation of the conjunctival and superficial collagenous fibers from the deeper collagenous fibers of the sclera forming empty spaces were noted near the limbus in several eyes. No significant observable tissue reactions were noted other than disruption of the collagen. Although minimal (grade 1) severity defects were noted in both control (right) eyes, there was clearly a mild (grade 2) to moderate (grade 3) severity defect in two of the three treated (left) eyes, suggesting at least in part that the implant site was suspect, the implant was disrupted or washed out during the handling. Minimal severity conjunctival hyperplasia, lymphoplasmacytic infiltration, and / or fibrosis were noted near the limbus in both the right and left eyes of all three animals. These lesions can be interpreted as spontaneous background study findings and / or associated with the surgical manipulation.

[0199] Overall, no test-related clinical observations, effects on body weights or body weight gains, or effects on food consumption were noted. By Day 4, the overall Draize scores post-surgery were minimal and all eyes appeared normal. On Day 21, no gross necropsy findings were noted at the time of scheduled sacrifice. The treatment devices were not visible following tissue processing and no tissue reactions were noted at the implant site. In summary, the treatment devices were well tolerated when implanted under the conjunctiva of New Zealand White rabbits.

[0200] It should be understood that the foregoing merely demonstrates the tolerance of the therapeutic device when implanted into the eye and merely illustrates the principles of the present disclosure, and that various modifications can be made by those skilled in the art without departing from the scope and spirit of the present disclosure.

[0201] Example 6 Fibroblast cells were cultured on a plain plastic cell culture dish, a patterned silicon wafer coated with parylene-C, and a cell culture dish coated with parylene-C. After 24 hours of keeping the samples, the cells were attached to the surface at 37°C. Cell culture medium was added and then allowed to grow for another 48 hours. Fibroblast cells attached to the plain plastic dish and grew normally, but floated in a mass of cells and could not be counted on the parylene-coated samples. These results indicate that the hydrophobicity of parylene prevents the adhesion of fibrotic cells. Further, the results indicate that parylene can prevent tissue adhesion.

[0202] Example 7 Devices with parylene-C coatings described herein were implanted into the subconjunctival space of New Zealand white rabbits, which communicates with the anterior chamber. After an 83-day period, the implants and bullae were sectioned, fixed, and histologically examined.

[0203] The fibrotic bulla thickness was measured for 3 rabbits and the results are recorded in Table 3.

[0204] Table 3

[0205] The thickness of fibrosis was the average of four measurements: anterior, sclera, posterior, and conjunctiva. The thickness of fibrosis on the sclera and conjunctiva sides was the average of four evenly distributed measurements on the respective sides of the implant.

[0206] The results in Table 4 were compared to implantation of glaucoma valves (AGVs) with or without amniotic membrane in the same space. The devices of the present invention exhibited much lower fibrotic capsule thickness than AGVs.

[0207] Table 4

[0208] These results indicate that hydrophilic coatings, such as parylene and / or patterned surfaces, such as the surfaces of the described devices, reduce fibrotic growth and scarring.

[0209] Although the invention has been described in detail for illustrative purposes based on specific embodiments now considered the most practical and preferred, it should be understood that such details are for illustrative purposes only, and the technology is not limited to the disclosed specific embodiments, but rather is intended to cover modifications and equivalent implementations within the spirit and scope of the appended claims. For example, it should be understood that the invention covers the possibility of combining one or more features of any specific embodiment with one or more features of any other specific embodiment to the extent possible.

[0210] Unless otherwise specified, all figures used in the specification and claims regarding the amount of components, properties such as molecular weight, reaction conditions, etc., should be understood to be modified by the term "about" in all cases. Therefore, unless otherwise indicated, the numerical parameters listed in the specification and appended claims are approximate values, which may vary depending on the desired properties the invention aims to obtain. To a minimum, and without attempting to limit the application of the teachings of equivalents to the scope of the claims, each numerical parameter should be understood at least based on the number of significant digits reported and by applying conventional rounding. Although the numerical ranges and parameters illustrating the broad scope of the invention are approximate, the values ​​set forth in the specific embodiments are reported as precisely as possible. However, any numerical value inherently includes some errors that inevitably arise from the standard deviation obtained in the corresponding test measurements.

[0211] The terms “a / an” and “the,” and similar designations, used in the context of describing the invention (particularly in the context of the appended claims), are to be regarded as encompassing both the singular and plural forms simultaneously, unless otherwise indicated herein or clearly contradicted by the context. The application of ranges of values ​​herein is intended merely as a contractual method for individually referring to each independent value falling within the range. Each individual value is incorporated into the specification as if it were individually referenced herein, unless otherwise indicated herein or clearly contradicted by the context. All methods described herein may be performed in any suitable order, unless otherwise indicated herein or clearly contradicted by the context. The use of any and all exemplary or illustrative language (e.g., “such as”) provided herein is intended only to better illustrate the invention and, unless otherwise required, does not limit the scope of the invention. The language in this specification should not be construed as indicating any non-claimed element as necessary for practicing the invention.

[0212] The grouping of alternative elements or embodiments of the application disclosed herein should not be interpreted as limiting. Each group member can be meant to be a member of more than one group or other elements mentioned herein, and the protection sought for each group member is individually and collectively claimed independent of any other member of the group or other element. It is contemplated that one or more members of a group can be included in, or deleted from a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the modified group as set forth above and the written description is deemed amended by the inclusion of such variation within the scope of the appended claims.

[0213] Certain embodiments of the application are described herein, including the best mode of the inventors known to perform the application. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the application to embrace all such modifications and permutations of the application claimed herein. Additionally, the inventor intends for the application to encompass all possible combinations of the above-described elements, unless the context clearly indicates otherwise or the modification is expressly excluded herein.

[0214] The specific embodiments disclosed herein can further limit the claims using the transitional language "consisting of and "consisting essentially of. When used in the claims, the transitional term "consisting of excludes any element, step, or ingredient not specified in the claim. The transitional term "consisting essentially of limits the scope of a claim to the specified materials or steps and to materials or steps that do not materially affect the basic and novel characteristic(s). Embodiment embodiments of the application so claimed and described herein inherently or expressly.

[0215] Finally, it should be understood that the embodiments of the application disclosed herein are illustrative of the principles of the present application. Other modifications that can be employed are within the scope of the application. As such, the application is not limited to that precisely as shown and described.

Claims

1. A device for lowering intraocular pressure, the device comprising: A plate having a first end and a second end, the plate including opposing first and second surfaces, wherein the first surface includes a series of fluid channels configured in an open, cross-network pattern extending from the first end of the plate to the second end of the plate, the first end of the plate being narrower than the second end of the plate, so that the first end of the plate can be inserted into the anterior chamber of the patient's eye. The second surface includes a plurality of open chambers formed by the fluid channels; A first coating on the first surface, the first coating conforming to the morphology of the series of fluid channels, and The second coating on the second surface.

2. The apparatus of claim 1, wherein the cross-network pattern comprises a hexagonal grid pattern, and each of the plurality of open chambers is hexagonal.

3. The apparatus of claim 1, wherein the plate has a thickness between about 50 nm and about 800 nm.

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

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

6. The apparatus of claim 1, wherein the first coating is a poly(p-xylene) polymer.

7. The apparatus of claim 6, wherein the poly(p-xylene) polymer is poly(2-chlorop-xylene), poly(2,5-dichlorop-xylene), poly(p-xylene), derivatives thereof, or combinations thereof.

8. The apparatus of claim 1, wherein the first coating is a polymer material selected from the group consisting of: rubber, synthetic rubber, siloxane polymers, poly(p-xylene) polymers, thermoplastics, thermosetting plastics, polyolefins, polyisobutylene, acrylic polymers, ethylene-vinyl acetate copolymers, polymethyl methacrylate, vinyl halogenated polymers, polyethers, polyethylene halides, polyacrylonitrile, polyvinyl ketone, polyvinyl alcohol aromatics, polyvinyl alcohol esters, acrylonitrile-styrene copolymers, ABS resins, ethylene-vinyl acetate copolymers, polyamides, alkyd resins, polycarbonates, polyoxymethylene, polyimide, polyethers, epoxy resins, polyurethanes, synthetic fibers, cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ethers, carboxymethyl cellulose, polytetrafluoroethylene, polyetheretherketone, polylactic acid, or combinations thereof.

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

10. The apparatus of claim 1, wherein the second coating is alumina or a poly(p-xylene) polymer.

11. The apparatus of claim 1, wherein the second coating comprises alumina, rubber, synthetic rubber, siloxane polymer, poly(p-xylene) polymer, thermoplastic, thermosetting plastic, polyolefin, polyisobutylene, acrylic polymer, ethylene-vinyl acetate copolymer, polymethyl methacrylate, vinyl halogenated polymer, polyether, polyethylene halogen, polyacrylonitrile, polyvinyl ketone, polyvinyl alcohol aromatics, polyvinyl alcohol ester, acrylonitrile-styrene copolymer, ABS resin, ethylene-vinyl acetate copolymer, polyamide, alkyd resin, polycarbonate, polyoxymethylene, polyimide, polyether, epoxy resin, polyurethane, synthetic fiber, cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ether, carboxymethyl cellulose, polytetrafluoroethylene, polyetheretherketone, polylactic acid, or combinations thereof.

12. The apparatus according to claim 1, further comprising a drug.

13. The device of claim 1, wherein the device is configured for placement in an eye with high intraocular pressure for treating the high intraocular pressure.

14. The device of claim 13, wherein the device is fastened to the eye.

15. The device of claim 14, wherein the fastening is fastened to the sclera of the eye.

16. The apparatus of 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 of claim 13, wherein the treatment of high intraocular pressure is the treatment of glaucoma.

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

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

20. The apparatus of claim 1, wherein the first coating is configured to be hydrophilic and the second coating is configured to be hydrophobic.

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