Methods and devices for treating eye diseases

Abstract

Described herein is a device for reducing intraocular pressure, the device comprising a plate structure having an upper surface opposite a lower surface, the plate structure being formed of a multi-directional plate having a plate thickness in the range of about 1 nm to about 1,000 nm.

Description

[0001] Cross - Reference to Related Applications

[0002] This application is a PCT international application of U.S. Provisional Application No. 62 / 620,922, filed on January 23, 2018, and U.S. Provisional Application No. 62,794,139, filed on January 18, 2019. The disclosures of the above applications are incorporated herein by reference. Background of the Invention

[0003] Millions of people suffer from eye diseases, particularly glaucoma. Most glaucoma patients are associated with abnormally high intraocular pressure (IOP), which is due to the patient's inability to drain excess aqueous humor from the anterior chamber of the eye through the trabecular meshwork. If not reduced by appropriate treatment, as the disease progresses, the high IOP will continuously damage the optic nerve, leading to vision loss and even complete blindness. Current medications, surgeries, and implants have been shown to be insufficient in reducing the pressure inside the eye or maintaining normal intraocular pressure for many years. Therefore, new ways are needed to relieve IOP and thus treat glaucoma. Summary of the Invention

[0004] Described herein is a device for reducing intraocular pressure, the device comprising: a plate structure including a first major exposed surface opposite a second major exposed surface, the plate structure formed from a multidirectional plate having a plate thickness in the range of about 1 nm to about 1,000 nm.

[0005] In other embodiments, the present invention includes a method for reducing intraocular pressure, the method comprising: a) fixing a treatment device to the eye, the treatment device including a plate structure having an upper surface opposite a lower surface, the plate structure formed from a multidirectional plate having a thickness in the range of about 1 nm to about 1,000 nm.

[0006] Other embodiments of the present invention include a device for reducing intraocular pressure, the device comprising: a plate structure including an upper surface opposite a lower surface, the lower surface including a plurality of open channels; wherein the plate structure has a height in the range of about 5 μm to about 20 μm as measured by the distance between the upper surface and the lower surface of the plate structure.

[0007] Other embodiments of the present invention include a device for reducing intraocular pressure, the device comprising: a first plate structure including an upper surface opposite a lower surface, the first plate structure formed from a first multidirectional plate having a plate thickness in the range of about 1 nm to about 1,000 nm; a second plate structure including an upper surface opposite a lower surface, the second plate structure formed from a second multidirectional plate having a plate thickness in the range of about 1 nm to about 1000 nm.

[0008] Other embodiments of the present invention include a device for reducing intraocular pressure, the device comprising: a plate structure having a first major surface opposite a second major surface, the plate structure including a multi-directional plate having a thickness in the range of about 1 nm to about 1,000 nm; and a penetrating element fixed to the first major surface of the plate structure.

[0009] Other embodiments of the present invention include a method for reducing intraocular pressure, the method comprising: implanting a treatment device in the anterior portion of the eye, the treatment device including a plate structure formed of a multi-directional plate, whereby after implantation, a first end of the plate structure is located between the sclera and the conjunctiva of the eye.

[0010] Other embodiments of the present invention include a method for reducing intraocular pressure, comprising: a) fixing a treatment device to the eye, the treatment device including: a plate structure including a top surface opposite a bottom surface; a plurality of open channels formed in the bottom surface; wherein the plate structure has a height in the range of about 5 μm to about 20 μm as measured by the distance between the top surface and the bottom surface of the plate structure.

[0011] Other application areas of the present invention will become apparent from the detailed description provided below. It should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are provided for purposes of illustration only and are not intended to limit the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The present invention will be more fully understood from the detailed description and the accompanying drawings, in which:

[0013] Figure 1 is a perspective view of a treatment device according to the present invention;

[0014] Figure 2 is Figure 1 a top view of the treatment device;

[0015] Figure 3 is according to Figure 1 a close-up view of the treatment device along section A in;

[0016] Figure 4 is a cross-sectional view of the treatment device taken along line IV-IV in Figure 3 ;

[0017] Figure 5 is a front perspective view of an eye including the treatment device of the present invention implanted thereon;

[0018] Figure 6 is a close-up view of a portion of an eye including the treatment device of the present invention implanted thereon;

[0019] Figure 7of an eye including a treatment device implanted thereon Figure 5 Cross-sectional view of the eye;

[0020] Figure 8 is an eye according to the present invention with a treatment device implanted thereon Figure 7 Close-up cross-sectional view of the eye;

[0021] Figure 9 is a perspective view of a treatment device according to another embodiment of the present invention;

[0022] Figure 10 is Figure 9 Top view of the treatment device;

[0023] Figure 11 is an eye including a treatment device implanted thereon Figure 9 Front perspective view of the eye;

[0024] Figure 12 is a part of an eye including a treatment device implanted thereon Figure 9 Close-up view;

[0025] Figure 13 is a part of an eye including a treatment device implanted thereon Figure 9 Another close-up view;

[0026] Figure 14 is an eye with a treatment device implanted thereon Figure 9 of the treatment device Figure 11 Close-up cross-sectional view of the eye;

[0027] Figure 15 is a perspective view of a treatment device according to another embodiment of the present invention;

[0028] Figure 16 is according to Figure 15 Close-up view of the treatment device at the section X indicated;

[0029] Figure 17 is a cross-sectional view of the treatment device shown along the line XVII-XVII in Figure 16 ;

[0030] Figure 18A is a top view of a treatment device according to another embodiment of the present invention;

[0031] Figure 18B is a top view of a treatment device according to another embodiment of the present invention;

[0032] Figure 18C is a top view of a treatment device according to another embodiment of the present invention;

[0033] Figure 18DIs a top view of a treatment device according to another embodiment of the present invention;

[0034] Figure 18E Is a top view of a treatment device according to another embodiment of the present invention;

[0035] Figure 18F Is a top view of a treatment device according to another embodiment of the present invention;

[0036] Figure 19 Is a perspective view of a treatment device according to another embodiment of the present invention;

[0037] Figure 20 Is Figure 19 A side view of the treatment device;

[0038] Figure 21 Is a perspective view of a treatment device according to another embodiment of the present invention; and

[0039] Figure 22 Is Figure 21 A side view of the treatment device. Detailed Description

[0040] The following description of the preferred embodiments is merely exemplary in nature and is in no way intended to limit the invention, its application, or its use.

[0041] Throughout, ranges are used as a shorthand for describing every value within the range. Any value within the range can be selected as the end point of the range. Additionally, all references cited herein are incorporated by reference in their entirety. In the event of a conflict between the definitions in this disclosure and those in the cited references, this disclosure shall control.

[0042] The description of the illustrative embodiments in accordance with the principles of the present invention is intended to be read in conjunction with the accompanying drawings, which are considered to be a part of the entire written description. In the description of the embodiments of the invention disclosed herein, any reference to direction or orientation is for convenience of description only and is not intended to limit the scope of the invention in any way. For example, "lower", "upper", "horizontal", "vertical", "above", "below", "above", "below", "top", and "bottom" and their derivatives (e.g., "horizontally", "downward", "upward", etc.) should be construed to refer to the orientation described at that time or the direction shown in the drawings under discussion. These relative terms are for convenience of description only and do not require the structure to be constructed or operated in a particular orientation unless so expressly stated.

[0043] Unless otherwise expressly described, the terms "attached", "affixed", "coupled", "interconnected", etc. refer to such a relationship: wherein structures are secured or attached to each other directly or indirectly through intervening structures, and either a movable or rigid attachment or relationship. Further, the features and advantages of the present invention are illustrated by reference to exemplary embodiments. Accordingly, the present invention should not be specifically limited to the exemplary embodiments showing some possible non-limiting combinations of features that may exist alone or in other combinations of features; the scope of the present invention is defined by the appended claims.

[0044] Unless otherwise indicated, all percentages and amounts expressed herein and elsewhere in the specification are to be understood as being by weight percentage. The amounts given are based on the weight of the materials. As used in this application, the term "about" means + / - 5% of the reference value. As used in this application, the term "substantially free of" means less than about 0.1 wt% based on the total amount of the reference value.

[0045] As used herein, a "subject" 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, etc.

[0046] Reference Figures 1 - 4 , the present invention includes a therapeutic device 1 (also referred to as a "device") for reducing intraocular pressure. Additionally, the device 1 of the present invention can provide improvements in the treatment of eye diseases - particularly glaucoma.

[0047] The device 1 can include a plate structure 200 having a first major exposed surface 201 opposite a second major exposed surface 202 and side surfaces 203 extending therebetween. The plate structure 200 can include a topmost surface 206 opposite a lowermost surface 207. The first major exposed surface 201 can include the topmost surface 206 of the plate structure 200. The second major exposed surface 202 can include the lowermost surface 207 of the plate structure 200.

[0048] The overall shape of the first major exposed surface 201 and the second major exposed surface 202 of the plate structure 200 can be defined by the side surfaces 203. The side surfaces 203 can define the perimeters of the first major exposed surface 201 and the second major exposed surface 202. The overall shape of the plate structure can be selected from a variety of geometric shapes. Non-limiting examples of such geometric shapes include a butterfly shape with wings, polygon, circle, mushroom shape, oval, oblong, ovoid, or amoeba.

[0049] The plate structure 200 can have a plate structure height H1, which is the total distance measured between the topmost surface 206 and the lowermost surface 207 of the plate structure 200. The range of the plate structure height H1 can be from about 5 μm to about 20 μm, including all distances and sub-ranges therebetween.

[0050] The plate structure 200 can be formed at least in part by a multi-directional plate 210 (also referred to as the "plate" 210). The plate 210 is a three-dimensional body. The plate 210 can include a first major surface 211 opposite to a second major surface 212 and side surfaces 213 extending between the first major surface 211 and the second major surface 212. When observed with the naked eye, the first major surface 211 of the plate 210 can be substantially continuous and appear smooth. When observed with the naked eye, the second major surface 212 of the plate 210 can be substantially continuous and appear smooth. The plate 210 can be translucent. The plate 210 can be light transmissive.

[0051] The plate 210 can have a thickness T, which is measured as the distance extending between the closest portions of the first major surface 211 and the second major surface 212 of the plate 210 in the orthogonal direction of the first major surface 211 and the second major surface 212. The thickness T can range from about 1 nm to about 1,000 nm, including all thicknesses and sub-ranges therebetween. In some embodiments, the thickness T can range from about 50 nm to about 500 nm, including all thicknesses and sub-ranges therebetween. In some embodiments, the thickness T can range from about 100 nm to about 400 nm, including all thicknesses and sub-ranges therebetween. In some embodiments, the thickness T can range from about 100 nm to about 250 nm, including all thicknesses and sub-ranges therebetween. In some embodiments, the thickness T can range from about 250 nm to about 500 nm, including all thicknesses and sub-ranges therebetween. In some embodiments, the thickness T can range from about 300 nm to about 550 nm, including all thicknesses and sub-ranges therebetween.

[0052] The multi-directional plate 210 can be a single layer patterned in three-dimensional space, thereby forming the multi-directional geometry of the multi-directional plate 210. Although the geometry of the multi-directional plate 210 can result in the entire plate structure 200 having a height H greater than 20 μm, the thickness of the multi-directional plate 210 (i.e., the thickness of the single layer patterned into the multi-directional plate 210) remains within the thickness T range of 1 nm to 1000 nm described above.

[0053] In some embodiments, the first major surface 211 of the plate 210 may at least partially constitute the first major exposed surface 201 of the plate structure 200. In other words, the first major exposed surface 201 of the plate structure 200 may at least partially include the first major surface 211 of the plate 210. In some embodiments, the second major surface 212 of the plate 210 may at least partially constitute the second major exposed surface 202 of the plate structure 200. In other words, the second major exposed surface 202 of the plate structure 200 may at least partially include the second major surface 212 of the plate 210. In some embodiments, the side surface 213 of the plate 210 may at least partially constitute the side surface 203 of the plate structure 200. In other words, the side surface 203 of the plate structure 200 may at least partially include the side surface 213 of the plate 210.

[0054] Now referring Figure 4 , and in particular, the first major exposed surface 201 of the plate structure 200 may include a first topography 204. Due to the multi-directional patterned geometry of the multi-directional plate 210, the first topography 204 may be formed by the first major surface 211 of the plate 210. The first topography 204 may include surface features formed into the uppermost surface 206 of the plate structure 200, whereby the surface features extend from the uppermost surface 206 in a direction toward the lowermost surface 207 of the plate structure 200 and terminate at the bottom plate 224, as discussed in more detail herein.

[0055] The plate structure 200 may further include a second topography 205. Due to the multi-directional patterned geometry of the multi-directional plate 210, the second topography 205 may be formed by the second major surface 212 of the plate 210. The second topography 205 may include surface features formed into the lowermost surface 207 of the plate structure 200, whereby the surface features extend from the lowermost surface 207 in a direction toward the uppermost surface 206 of the plate structure 200 and terminate at the top plate 234, as discussed in more detail herein.

[0056] The surface features of the first topography 204 and / or the second topography 205 may include one or more cells 222. As described in more detail herein, the cells 222 may be open cells. In other embodiments, the surface features of the first topography 204 and / or the second topography 205 may include one or more channels 232. As described in more detail herein, the channels 232 may be open channels.

[0057] The above discussion will refer to the first topography 204 including one or more cells 222 and the second topography 205 including one or more channels 232, but is not limited thereto. Although not shown in the figures, other embodiments of the present invention include: the first topography 204 may include one or more channels 232, while the second topography 205 may include one or more cells 222.

[0058] Each cell 222 may include a cell floor 224 and at least one cell wall 226. The cell wall 226 may circumscribe the cell floor 224. The cell wall 226 may extend downward from the uppermost surface 206 of the plate structure 200 to the cell floor 224 in a direction toward the lowermost surface 207 of the plate structure 200, whereby the cell wall 226 may terminate at the cell floor 224. The cell wall 226 may extend upward from the cell floor 224 in a direction toward the uppermost surface 206 of the plate structure 200, whereby the cell wall 226 may terminate at the uppermost surface 206 of the plate structure 200.

[0059] Each of the cells 222 may include a cell axis C A -C A . Unit axis C A -C A The cell wall surface 226 may be oriented substantially perpendicular to the floor surface 224. A -C A Directional.

[0060] The cell wall 226 may form the periphery of each cell 222. Although not shown in the figures, the cell wall 226 may be a single continuous wall surface, thereby forming the cell 222 into a cylindrical shape. Non-limiting examples of cylindrical shapes include cylinders and elliptical cylinders. Figure 3 As shown, other embodiments provide that each cell 222 may be formed by a plurality of cell walls 226 that intersect with each other to form a polygonal perimeter. In such an embodiment, the number of cell walls 226 forming the polygonal perimeter may range from 3 to 20 sides, including all sides and sub-ranges therebetween, but is not limited thereto. Figure 3 In the illustrated embodiment, each cell 222 is formed by six intersecting cell walls 226 forming a hexagonal perimeter.

[0061] Collectively, the uppermost surface 206, the cell walls 226, and the cell floors 224 may form at least a portion of the first major exposed surface 201 of the plate structure 200. The first major surface 211 of the plate 210 may include the first exposed major surface 201 of the plate structure 200. In other words, the first major surface 211 of the plate 210 may include the uppermost surface 206 and the cell walls 226 and the cell floors 224 formed by the first topography 204.

[0062] Each unit 222 may also include an open end 228 positioned opposite the unit base 224. Unit axis C A -C AIt can intersect with the open end 228. The open end 228 can provide a fluid path for accessing the open space of the cell 222 located between the cell wall surface 226 and the bottom plate surface 224. In other words, each of the cells 222 can be open (also referred to as "end-open"), such that there is no top plate opposite the cell bottom plate 224 that would otherwise enclose the cell 222 and encapsulate the open space of the cell 222.

[0063] Each of the cells 222 can be isolated from each other by their respective cell walls 226, such that the open space of each cell 222 is not in fluid communication with the open spaces of other cells 222.

[0064] The first topography 204 can be formed by the multi-directional nature of the multi-directional plate 210. Thus, the dimensions of the plate structure 200, specifically the dimensions of the first topography 204, can be determined relative to the thickness T of the plate 210.

[0065] For each cell 222, the cell bottom plate 224 can be offset from the uppermost surface 206 of the plate structure 200 by a first distance D1 (also referred to herein as the "cell depth"). The offset between the uppermost surface 206 and the bottom plate surface 224 can be referred to as a "vertical offset" or "vertical displacement", but is not limited thereto. The first distance D1 is a non-zero value. The first distance D1 can be equal to the difference between the first height H2 of the plate structure 200 and the thickness T of the plate 210, and thus the first distance D1 can be calculated according to the following formula:

[0066] D1 = H2 - T.

[0067] For each cell 222, the cell bottom plate 224 can be offset from the lowermost surface 207 by a second distance D2. The offset between the lowermost surface 207 and the bottom plate surface 224 can be referred to as a "vertical offset" or "vertical displacement", but is not limited thereto. The second distance D2 is a non-zero value. The second distance D2 can be substantially equal to the thickness T of the plate 210. The sum of the first distance D1 and the second distance D2 can be substantially equal to the first height H2.

[0068] Now refer to Figure 3 and Figure 4, each unit 222 can have a unit length L2 and a unit width W2 measured according to the distance extending between opposite unit walls 226 within each unit chamber 222. In some embodiments, the unit length L2 and the unit width W2 can be equal. In other embodiments, the unit length L2 and the unit width W2 can be different. The range of the unit length L2 can be from about 10 μm to about 110 μm, including all lengths and sub - ranges therebetween. In some embodiments, the range of the unit length L2 can be from about 30 μm to about 70 μm, preferably from about 40 μm to about 60 μm, including all lengths and sub - ranges therebetween. The range of the unit width W2 can be from about 10 μm to about 110 μm, including all lengths and sub - ranges therebetween. In some embodiments, the range of the unit width W2 can be from about 30 μm to about 70 μm, preferably from about 40 μm to about 60 μm, including all lengths and sub - ranges therebetween.

[0069] Each channel 232 can be formed by a channel top plate 234 and at least one channel wall 236. The channel wall 236 can extend downward from the channel top plate 234 and in a direction toward the lowermost surface 207 of the plate structure 200, whereby the channel wall 236 terminates at the lowermost surface 207 of the plate structure 200. The channel wall 236 can extend upward from the lowermost surface 207 in a direction toward the channel top plate 234, whereby the channel wall 236 can terminate at the channel top plate 234.

[0070] Collectively, the lowermost surface 207, the channel wall 236, and the channel top plate 234 can form at least a portion of the second major exposed surface 202 of the plate structure 200. The second major surface 212 of the plate 210 can include the second exposed major surface 202 of the plate structure 200. In other words, the second major surface 212 of the plate 210 can include the lower surface 207 and the channel wall 236 and the channel bottom plate 234 formed by the second topography 205.

[0071] Each channel 232 can further include an open end 238 positioned opposite the channel top plate 234. The open end 238 can be a fluid path providing access to the open space of the channel 232 located between the channel wall 236 and the channel top plate 234. In other words, each of the channels 232 can be open (also referred to as "end - open") such that there is no bottom plate opposite the channel top plate 234 that would otherwise enclose the channel 232 or encapsulate the channel space formed by the channel wall 236 and the channel bottom plate 234.

[0072] There can be a plurality of intersecting channels 234 on the second major surface 202 of the plate structure 200, thereby forming a network of channels. Each of the channels in the network can be in fluid communication with each other, thereby allowing fluid to flow along the second major surface 202 of the plate structure 200 via the channels 232.

[0073] The second topography 205 of the present invention can be formed by the multi-directional nature of the multi-directional plate 210. Thus, the dimensions of the plate structure 200, specifically the dimensions of the second topography 205, can be determined relative to the thickness T of the plate 210.

[0074] For each channel 232, the channel top plate 234 can be offset from the lowermost surface 207 of the plate structure 200 by a third distance D3 (also referred to herein as the "channel depth"). The offset between the lowermost surface 207 and the channel top plate 234 can be referred to as a "vertical offset" or a "vertical offset", but is not limited thereto. The third distance D3 is a non-zero value. The third distance D3 can be equal to the difference between the first height H2 of the plate structure 200 and the thickness T of the plate 210, and thus the third distance D3 can be calculated according to the following formula:

[0075] D3 = H2 - T.

[0076] For each channel 232, the channel top plate 234 can be offset from the uppermost surface 206 by a fourth distance D4. The offset between the uppermost surface 206 and the channel top plate 234 can be referred to as a "vertical offset" or a "vertical offset", but is not limited thereto. The fourth distance D4 is a non-zero value. The fourth distance D4 can be substantially equal to the thickness T of the plate 210. The sum of the third distance D3 and the fourth distance D4 can be substantially equal to the first height H2.

[0077] Each channel 232 can have a channel length and a channel width W1. The channel width W1 is measured by the distance extending between the opposing channel walls 236 within each channel 222. The channel length is measured by the distance extending along the channel 232 between the other intersecting channels 232. In some embodiments, the channel length is greater than the channel width W1. The channel length can range from about 10 μm to about 110 μm, including all lengths and sub-ranges therebetween. In some embodiments, the channel length can range from about 30 μm to about 70 μm, preferably from about 40 μm to about 60 μm, including all lengths and sub-ranges therebetween. The channel width W1 can range from about 10 μm to about 40 μm, including all lengths and sub-ranges therebetween. In a preferred embodiment, the channel width W1 can range from about 10 μm to about 15 μm, including all lengths and sub-ranges therebetween.

[0078] It has been found that a channel depth and a channel width W1 of about 10 μm to 15 μm provide a normal physiological flow of aqueous humor along the plate structure 200. The flow rate of aqueous humor along such a plate ranges from about 1.75 μL / min (minute) to about 2.75 μL / min, preferably about 2 μL / min, including all flow rates and sub-ranges therebetween.

[0079] In some embodiments, the plate 210, and the resulting plate structure 200, can be formed of various materials. The material forming the plate is preferably a biocompatible material. As used herein, the term "biocompatible" refers to compatibility with living tissue or a living system by being non-toxic, non-harmful or non-physiologically reactive and not causing immune rejection. Non-limiting examples of materials for forming the plate 210 include ceramic materials, polymeric materials, metallic materials, and composites thereof.

[0080] Non-limiting examples of ceramic materials include alumina (Al2O3), silicon nitride (Si x N y ), silicon dioxide (SiO2), hafnium oxide (HfO2), titanium nitride (TiN x ), titanium carbide (TiC), derivatives thereof, and combinations thereof. In a preferred embodiment, the ceramic material includes alumina. In another preferred embodiment, the ceramic material includes silicon nitride. Non-limiting examples of metallic materials include platinum, gold, or tungsten.

[0081] Compared with a planar film, the plate 210, and the resulting plate structure 200, can have a higher flexural stiffness. For example, the plate 210 can have the same thickness as a planar structure and have a much higher spring constant when used as a cantilever and / or a beam fixed at both ends. Similarly, the plate 210 can have the same spring constant as a planar structure and can be significantly thinner. For example, the plate 210 of the present invention can be at least about 20 times thinner, at least about 15 times thinner, at least about 10 times thinner, or at least about 5 times thinner than a planar structure having the same flexural stiffness.

[0082] The plate 210 of the present invention can be flexible. According to the present invention, the term "flexible" means that the plate 210 is capable of deforming without any or a significant amount of fracture or permanent deformation, also referred to as having shape recoverability. Specifically, the flexibility of the plate 210 can be such that the first major surface 211 and the second major surface 212 can be folded at least 90° without fracturing the plate 210. In some embodiments, the flexibility of the plate 210 can be such that the first major surface 211 and the second major surface 212 can be folded to 180° without fracturing the plate 210. Similarly, the flexibility of the plate structure 200 can be such that the first exposed major surface 201 and the second exposed major surface 202 can be folded at least 90° without fracturing the plate structure 200. In some embodiments, the flexibility of the plate structure 200 can be such that the first exposed major surface 201 and the second exposed major surface 202 can be folded up to 180° without fracturing the plate structure 200.

[0083] Thus, the present invention enables the plate 210, and the resulting plate structure 200, to be formed entirely of metallic and / or ceramic materials, which can also be flexible (i.e., capable of being folded up to 180°, preferably at least 90°, without fracturing).

[0084] In some embodiments, the plate structure 200 can be ultra-light. The term "ultra-light" refers to the plate structure 200, and the corresponding plate 210, having a relative density on the order of about 10 -4 and a surface density on the order of 100 milligrams per square meter. For example, the plate structure 200 can have a surface density of about 10 mg / m 2 to about 1000 mg / m 2 , including all densities and sub-ranges therebetween.

[0085] Now referring to Figure 1 and Figure 2 , the device 1 can include a plate structure 200 extending along a longitudinal axis A-A. The plate structure 200 can also include a proximal end 208 opposite a distal end 209, whereby the longitudinal axis A-A intersects both the proximal end 208 and the distal end 209 of the plate structure 200. The plate structure 200 can have a plate structure length L spanning the distance from the proximal end 208 to the distal end 209 of the plate structure 200 PS . The plate structure length L PS can range from about 10 mm to about 24 mm, including all lengths and sub-ranges therebetween. In a preferred embodiment, the plate structure length L PS can be about 17 mm.

[0086] The plate structure 200 can also include a body portion 240 and an extension portion 250. The body portion 240 can include a proximal end 241 opposite a distal end 242. The extension portion 250 can include a proximal end 251 opposite a distal end 252. The proximal end 251 of the extension portion 250 can extend from the distal end 242 of the body portion 240. The proximal end 241 of the body portion 240 can overlap with the proximal end 208 of the plate structure 200. The distal end 252 of the extension portion 250 can overlap with the distal end 209 of the plate structure 200.

[0087] The body portion 240 can include a first major surface 243 opposite a second major surface 244. The first major exposed surface 201 of the plate structure 200 can include the first major surface 243 of the body portion 240. The second major exposed surface 202 of the plate structure 200 can include the second major surface 244 of the body portion 240.

[0088] The body portion 240 can extend across a body length L spanning the distance from the proximal end 241 to the distal end 242 of the body portion 240 MB . The body length L MB can range from about 8 mm to about 16 mm, including all lengths and sub-ranges therebetween. In a preferred embodiment, the body length L MB can be about 12 mm.

[0089] The main body portion 240 may have a main body width W measured as a distance in a direction extending across a direction perpendicular to the longitudinal axis A-A. MB . The main body width W MB may range from about 4 mm to about 8 mm, including all lengths and sub-ranges therebetween. In a preferred embodiment, the main body width W MB may be about 6 mm.

[0090] The extension portion 250 may include a first main surface 253 opposite to the second main surface 254. The first main exposed surface 201 of the plate structure 200 may include the first main surface 253 of the extension portion 250. The second main exposed surface 202 of the plate structure 200 may include the second main surface 254 of the extension portion 250.

[0091] The extension portion 250 may extend across an extension length L of a distance from the proximal end 251 to the distal end 252 of the extension portion 250 E . The extension length L E may range from about 1 mm to about 4 mm, including all lengths and sub-ranges therebetween. In a preferred embodiment, the extension length L E may be about 2 mm.

[0092] The extension portion 250 may have an extension width W measured as a distance in a direction extending across a direction perpendicular to the longitudinal axis A-A E . The extension width W E may range from about 1.0 mm to about 6.0 mm, including all lengths and sub-ranges therebetween. In a preferred embodiment, the extension width W E may be about 2.6 mm.

[0093] In some embodiments, the main body length L MB and the extension length L E may be equal. In other embodiments, the main body length L MB and the extension length L E may be different. In some embodiments, the ratio of the main body length L MB to the extension length L E may range from about 1:1 to about 5:1, including all ratios and sub-ranges therebetween. In some embodiments, the ratio of the main body length L MB to the extension length L E is greater than 1:1. In some embodiments, the ratio of the main body length L MB to the extension length L E may range from about 3:1 to about 5:1, including all ratios and sub-ranges therebetween.

[0094] In some embodiments, the main body width W MB and the extension width WE may be equal. In other embodiments, the body width W MB and the extension width W E may be different. In other embodiments, the body width W MB may be greater than the extension width W E . In some embodiments, the ratio of the body width W MB to the extension width W E may range from about 1:1 to about 4:1, including all ratios and sub-ranges therebetween. In some embodiments, the ratio of the body width W MB to the extension width W E may range from about 1.1:1 to about 4:1, including all ratios and sub-ranges therebetween. In some embodiments, the ratio of the body width W MB to the extension width W E may range from about 1.5:1 to about 3:1, including all ratios and sub-ranges therebetween.

[0095] The first major surface 253 of the extension portion 250 may be substantially coplanar with the first major surface 243 of the body portion 240. The second major surface 254 of the extension portion 250 may be substantially coplanar with the second major surface 244 of the body portion 240.

[0096] The body portion 240 may have a height that is substantially equal to the first height H1 of the plate structure 200, which is measured as the distance between the first major surface 243 and the second major surface 244 of the body portion 240. The extension portion 250 may have a height that is substantially equal to the first height H1 of the plate structure 200, which is measured as the distance between the first major surface 243 and the second major surface 244 of the extension portion 250.

[0097] Now referring to Figures 5 - 8 , the treatment device 1 of the present invention may be positioned in contact with the eye 900 to treat eye diseases. Non-limiting examples of such eye diseases include glaucoma. The eye 900 generally includes external tissues, which include the sclera 913, the cornea 910, the conjunctiva 950, and the limbus. There are two chambers within the eye 900, including the posterior chamber 995 located behind the lens 930 of the eye 900 and the anterior chamber 990 located in front of the lens 930 of the eye 900. The posterior chamber 995 contains vitreous humor, while the anterior chamber 990 contains aqueous humor.

[0098] As described herein, the eye 900 includes an anterior region 901 and a posterior region 902, wherein a boundary 903 typically exists between the anterior region 901 and the posterior region 902. The anterior region 901 of the eye 900 includes the cornea 910, iris 911, pupil 912, conjunctival tissue 950, ciliary body 915 and lens 930, a portion of the sclera 913, and the anterior chamber 990 that surrounds the eye 900. The anterior region 901 may further include the limbal region 980, the limbus-corneal limbus region 982, and the anterior scleral region 950.

[0099] The posterior region 902 includes extraocular muscle tissue 920 (also referred to as "extraocular muscles"), a portion of the sclera 913, the optic nerve 942, the retina 941, and the posterior chamber 995 that surrounds the eye 900. The extraocular muscles 920 are present within the orbital cavity of the subject. The extraocular muscles 920 include the superior rectus muscle 921 located at the top of the eye 900, the inferior rectus muscle 922 located at the bottom of the eye 900, and the lateral rectus muscle 923 located between the superior rectus muscle 921 and the inferior rectus muscle 922.

[0100] The present invention includes a method for treating an eye disease (such as glaucoma) by reducing the intraocular pressure of a subject using a treatment device 1. Specifically, the treatment device 1 provides a fluid path for excess fluid present in either the anterior chamber 990 and / or the posterior chamber 995 to leave the eye 900. In a preferred embodiment, the treatment device 1 reduces the intraocular pressure of the subject by providing a fluid path for excess fluid to leave the anterior chamber 990 to a location external to the sclera 913.

[0101] The term "excess fluid" refers to an additional volume of aqueous humor present in the anterior chamber 990 that raises the intraocular pressure to greater than the normal intraocular pressure of a healthy eye. For an eye 900 that cannot release this excess fluid, the increased intraocular pressure is a factor contributing to blindness in glaucoma patients. Thus, providing a fluid path for draining excess fluid from the anterior chamber 990 of the eye 900 can help reduce the intraocular pressure and thus help treat glaucoma.

[0102] In a non-limiting embodiment, the methods described herein may be applicable to treating any type of ophthalmic disorder associated with intraocular pressure. Non-limiting examples of ophthalmic disorders include primary open-angle glaucoma, normal-tension glaucoma, ocular hypertension, primary angle-closure glaucoma, congenital and juvenile glaucoma, and secondary glaucoma, including exfoliative, uveitic, neovascular, pigmentary, and other secondary glaucomas. In particular, the ophthalmic disorder includes glaucoma and all subtypes of glaucoma.

[0103] The treatment device 1 of the present invention provides such a fluid path for excess fluid to leave the eye 900. Specifically, the treatment device 1 can be implanted on the eye 900 such that it forms a fluid path from the anterior chamber 990 to the exterior of the sclera 913 to form a subconjunctival bleb. The term "subconjunctival bleb" refers to a fluid pocket containing aqueous humor, where the fluid pocket is located between the conjunctiva and the scleral tissue. Once the excess fluid is on the outer surface of the sclera 913, it can be removed from the eye 900 by absorption into the surrounding tissue of the subject.

[0104] In particular, the treatment device 1 can be implanted on the eye 900 such that the plate structure 200 is located between the tissues of the sclera 913 and the conjunctiva 950. The extension portion 250 can extend from the body portion 240 through the sclera 913 and into the anterior chamber 990 of the eye 900 such that the distal end 209 of the plate structure 200 is located within the anterior chamber 990. In such a configuration, the plate structure 200 can serve as an external reservoir for excess fluid until the excess fluid is absorbed by the surrounding tissue of the subject. In some embodiments, the plate structure 200 can be sterilized prior to implantation of the treatment device 1 to minimize postoperative complications.

[0105] The extension portion 250 can extend from the body portion 240 through the sclera 913 and into the anterior chamber 990 of the eye 900 (as shown in the figure), or can extend from the body portion 240 through the sclera 913 and into the posterior chamber 989 of the anterior chamber 990 of the eye 900. The treatment device 1 can be implanted such that the extension portion 250 extends through the limbal region 980, the limbal region 981, or the anterior scleral region 982.

[0106] In such embodiments, the first topography 204 and / or the second topography 205 of the plate structure 200 can provide a fluid path for excess fluid to leave the anterior chamber 990 of the eye 900, thereby releasing excess intraocular pressure.

[0107] The treatment device 1 can be implanted such that the treatment device 1 is fixed to the eye 900. In some embodiments, the treatment device 1 can be implanted between the conjunctiva 95 and the sclera 913. In non-limiting examples, a conjunctival incision can be formed to allow sufficient exposure for insertion of the treatment device 1. In non-limiting embodiments, the treatment device 1 can be fixed to any eye 900 by suturing or by extending through the plate structure 200 to the sclera 913.

[0108] Once implanted, the first major exposed surface 201 of the plate structure 200 can face the sclera 913, while the second major exposed surface 202 of the plate structure 200 can face the conjunctiva 950. In such an embodiment, the first major exposed surface 201 of the plate structure 200 can contact the sclera 913, while the second major exposed surface 202 of the plate structure 200 can contact the conjunctiva 950. In other embodiments, the treatment device 1 can be implanted such that the first major exposed surface 201 of the plate structure 200 faces the conjunctiva 950, while the second major exposed surface 202 of the plate structure 200 faces the sclera 913. In such an embodiment, the first major exposed surface 201 of the plate structure 200 can contact the conjunctiva 950, while the second major exposed surface 202 of the plate structure 200 can contact the sclera 913.

[0109] In other embodiments, the treatment device 1 can include a plate structure 200 that extends from the outer surface of the sclera 913 through the sclera 913 and into the anterior chamber 990 of the eye 900, whereby the plate structure 200 itself provides a fluid path for excess fluid to leave the eye 900. In such an embodiment, the excess intraocular fluid can travel along the treatment device 1 and leave the eye 900 by capillary action.

[0110] According to the present invention, the plate structure 200 having the previously discussed thickness T and material properties allows the treatment device 1 to be at least partially placed within the anterior region 901 of the eye 900. In some embodiments, the treatment device 1 can be fully implanted within the anterior region 901 of the eye 900, herein referred to as "forward placement". Such forward placement can allow at least a portion of the treatment device 1 to be present within the anterior portion 901 of the eye 900, as further discussed herein. Additionally, compared to previous implant devices, such forward placement of the treatment device 1 can allow for a minimally invasive implantation procedure. Additionally, such forward placement can also provide greater comfort to the subject. Furthermore, the translucent appearance of the plate structure 200 can enable the treatment device 1 to be at least partially implanted within the anterior region 901 of the eye and not be easily detectable when the subject's eye 900 is observed with the naked eye.

[0111] Reference Figure 5 and Figure 6, the treatment device 1 can be implanted on the eye 900 such that the treatment device 1 is at least partially located between the superior rectus muscle 921 and the lateral rectus muscle 923. In such an embodiment, the treatment device 1 can be fully located between the superior rectus muscle 921 and the lateral rectus muscle 923 such that there is no overlap with the superior rectus muscle 921 or the lateral rectus muscle 923. In other embodiments, the treatment device 1 can be implanted on the eye 900 such that the treatment device 1 is at least partially located between the inferior rectus muscle 922 and the lateral rectus muscle 923. In such an embodiment, the treatment device 1 can be fully located between the inferior rectus muscle 922 and the lateral rectus muscle 923 such that there is no overlap with the inferior rectus muscle 923 or the lateral rectus muscle 934.

[0112] Now referring simultaneously to Figures 18A - 18F , a plurality of treatment devices 1d to 1i according to another embodiment of the present invention are shown. Except as described below, the devices 1d, 1e, 1f, 1g, 1h, 1i are similar to the device 1. Except for the differences specifically pointed out below, the above description of the device 1 generally applies to the following devices 1d, 1e, 1f, 1g, 1h, 1i. For the devices 1d, 1e, 1f, 1g, 1h, 1i, a numbering scheme similar to that of the device 1 will be used, except that the suffixes d, e, f, g, h, and i will be used.

[0113] As described above, the overall shape of the plate structures 200, 200d, 200e, 200f, 200g, 200h, 200i can be selected from various geometric shapes. Non-limiting examples of such geometric shapes include a butterfly shape with flanks, a polygon, a circle, a mushroom shape, an ellipse, an oblong, an oval, or an amoeba shape.

[0114] In non-limiting embodiments, the treatment devices 1d to 1i can include polygonal extensions 250d, 250e, 250f, 250g, 250h, 250i. According to these embodiments, the extensions 250d, 250e, 250f, 250g, 250h, 250i can include peripheral portions 255d, 255e, 255f, 255g, 255h, 2551i composed of substantially straight line portions, thereby forming the polygonal shape of the extensions 250d, 250e, 250f, 250g, 250h, 250i. The peripheral portions 255d, 255e, 255f, 255g, 255h, 255i of the extensions 250d, 250e, 250f, 250g, 250h, 250i form a part of the peripheries 203d, 203e, 203f, 203g, 203h, 203i of the plate structures 200d, 200e, 200f, 200g, 200h, 200i.

[0115] In a non - limiting embodiment, the peripheral portions 255d, 255e, 255f, 255g, 255h, 255i of the extension portions 250d, 250e, 250f, 250g, 250h, 250i can form part of a rectangle, square, or triangle. Refer to Figure 18D , and in particular, the extension portion 250g can include a rectangular portion and a triangular tip 256g that terminates at a vertex 257g, whereby the vertex 257g coincides with the distal end 209g of the treatment device 1g. Although not shown, the peripheral portions 255d, 255e, 255f, 255g, 255h, 255i of the extension portions 250d, 250e, 250f, 250g, 250h, 250i can be curved or non - polygonal. In other embodiments, the distal ends 209d, 209e, 209f, 209h, and 209i can include peripheral portions 255d, 255e, 255f, 255h, 255i formed by straight lines.

[0116] In a non - limiting embodiment, the treatment devices 1d to 1i can include body portions 240d, 240e, 240f, 240g, 240h, 240i, which include peripheral portions 245d, 245e, 245f, 245g, 245h, 245i. The peripheral portions 245d, 245e, 245f, 245g, 245h, 245i of the body portions 240d, 240e, 240f, 240g, 240h, 240i form part of the perimeter 203d, 203e, 203f, 203g, 203h, 203i of the plate structures 200d, 200e, 200f, 200g, 200h, 200i.

[0117] The peripheral portions 245d, 245e, 245f, 245g, 245h, 245i of the body portions 240d, 240e, 240f, 240g, 240h, 240i intersect the peripheral portions 255d, 255e, 255f, 255g, 255h, 255i of the extension portions 250d, 250e, 250f, 250g, 250h, 250i.

[0118] In a non - limiting embodiment, the peripheral portions 245d, 245e, 245f, 245g, 245h, 245i of the body portions 240d, 240e, 240f, 240g, 240h, 240i can be curved or non - polygonal in shape. Specifically refer to Figure 18C, the peripheral portions 245f, 245g of the main body portions 240f, 240g may include both straight segments and curved segments, whereby the straight segments intersect the peripheral portions 255f, 255g of the extension portions 250f, 250g. The proximal ends 208d, 208e, 208f, 208g, 208h and 208i may include peripheral portions 245d, 245e, 245f, 241h, 245i formed by curves.

[0119] The curved shapes of the peripheral portions 245d, 245e, 245f, 245g, 245h, 245i of the main body portions 240d, 240e, 240f, 240g, 240h, 240i may be ideally circular or oval.

[0120] Now referring to Figure 18F , the treatment device 1i may have a main body portion 240i including a multi-lobed geometry. Specifically, the main body portion 240i may include two or more lobes 246i that extend outwardly and form part of the peripheral portion 245i of the main body portion 240i. Each lobe 246i may include a portion of a circle, i.e., a portion of a circle, an ellipse. Each lobe may be a symmetric shape or an asymmetric shape. Each of the lobes 246i may be symmetrically oriented with respect to a central point 249i on the main body portion 240i.

[0121] In a non-limiting example, the multi-lobed geometry of the main body portion 240i may be a three-lobed geometry. The multi-lobed geometry may increase the surface area of the treatment device 1i while avoiding the eye muscles, such that two lobes are in front of the eye muscles and the third lobe extends between the eye muscles to the back of the eye. This increased surface may be advantageous for fluid absorption to reduce intraocular pressure. According to an embodiment where the multi-lobed geometry is three-lobed, the main body portion 240i may have a generally triangular shape, whereby the corners may be rounded.

[0122] Now referring to Figure 9 and Figure 10 , a treatment device 1001 according to another embodiment of the present invention is shown. Except as described below, the device 1001 is similar to the device 1. Except for the differences specifically noted below, the above description of the devices 1 and 1d to 1i generally applies to the device 1001 described below. Except that 1000 series numbers will be used, a numbering scheme similar to that for the devices 1, 1d to 1i will be used for the device 1001.

[0123] The device 1001 may include a main body portion 1240, an extension portion 1250, and further include a barb portion 1260. The barb portion 1260 may include a proximal end 1261 opposite to a distal end 1262. The proximal end 1261 of the barb portion 1260 may extend from the distal end 1252 of the extension portion 1240. According to this embodiment, the distal end 1262 of the barb portion 1260 may overlap with the distal end 1209 of the plate structure 1200. The longitudinal axis A-A may intersect both the proximal end 1261 and the distal end 1262 of the barb portion 1260.

[0124] The barb portion 1260 may include a first main surface 1263 opposite to a second main surface 1264. The first main exposed surface 1201 of the plate structure 1200 may include the first main surface 1263 of the barb portion 1260. The second main exposed surface 1202 of the plate structure 1200 may include the second main surface 1264 of the barb portion 1260.

[0125] The barb portion 1260 may extend over a barb length L which is the distance from the proximal end 1261 to the distal end 1262 of the barb portion 1260 B . The barb length L B may range from about 1 mm to about 3 mm, including all lengths and sub-ranges therebetween. In a preferred embodiment, the barb length L B may be about 2 mm.

[0126] The barb portion 1260 may have a maximum barb width W measured as the maximum distance in a direction extending perpendicular to the longitudinal axis A-A B . The maximum barb width W B may range from about 1.0 mm to about 54.0 mm, including all lengths and sub-ranges therebetween. In a preferred embodiment, the maximum barb width W B may be about 3.6 mm.

[0127] The maximum barb width W B may be greater than the extension width W E . In some embodiments, the ratio of the maximum barb width W B to the extension width W E may range from about 1.01:1 to about 3:1, including all ratios and sub-ranges therebetween. In some embodiments, the ratio of the barb width W B to the extension width W E may range from about 1.1:1 to about 2:1, including all ratios and sub-ranges therebetween. In a preferred embodiment, the ratio of the barb width W B to the extension width W E may be about 1.4:1.

[0128] The first major surface 1263 of the barb portion 1260 may be substantially coplanar with the first major surface 1253 of the extension portion 1250. The second major surface 1264 of the barb portion 1260 may be substantially coplanar with the second major surface 1254 of the extension portion 1250.

[0129] The barb portion 1260 may have a height that is substantially equal to the first height H1 of the plate structure 1200, which is measured as the distance between the first major surface 1263 and the second major surface 1164 of the barb portion 1260. The barb portion 1260 may include a triangular configuration that includes a vertex 1265. The vertex 1265 may overlap with the distal end 1209 of the plate structure 1200.

[0130] Now referring Figure 11 、 Figure 12 and Figure 14 ,the treatment device 1001 provides such a fluid path for excess fluid to leave the eye 900. Specifically, the treatment device 1 may be implanted onto the eye 900 such that it forms a fluid path from the anterior chamber 990 to the exterior of the sclera 913 to form a bleb. Once the excess fluid is on the outer surface of the sclera 913, it can be removed from the eye 900 by absorption into the surrounding tissue of the subject.

[0131] In particular, the treatment device 1001 may be implanted onto the eye 900 such that the plate structure 1200 is located between the tissues of the sclera 913 and the conjunctiva 950. The barb portion 1260 may extend from the extension portion 1250 through the sclera 913 and into the anterior chamber 990 of the eye 900 such that the distal end 1209 of the plate structure 200 is positioned within the anterior chamber 990.

[0132] Now referring Figure 13 ,a portion of the sclera 913 may be cut to form a slit 914, and the barb portion 1260 may be inserted through the slit 914 to anchor the device 1 to the sclera 913. The slit 913 may have a width that is substantially equal to the width W of the extension portion, such that the barb portion 1260 and the body portion 1240 abut the scleral tissue 913 surrounding the slit 914, and the extension portion 1250 is anchored inside the slit beneath the scleral tissue 913. According to this embodiment, the implantation of the device 1001 may be performed by temporarily deforming the barb portion 1260 such that it has a reduced barb width W that is equal to or less than the width of the slit 914 E ,thereby allowing the barb portion 1260 to enter the slit 914. Once through the slit 914, the barb portion 1260 may resume its deformation such that the barb portion 1260 has the barb portion width W of the undeformed state B 。 B

[0133] Now referringFigures 15 - 17 , shows a treatment device 2001 according to another embodiment of the present invention. Except as described below, device 2001 is similar to devices 1, 1001. Except for the differences specifically pointed out below, the above descriptions of devices 1, 1d to 1i and 1001 generally apply to device 2001 described below. Except that 2000 series numbers will be used, a numbering scheme similar to that of devices 1, 1d to 1i, 1001 will be used for device 2001.

[0134] Device 2001 may include a plurality of plate structures 2200. The foregoing discussion will apply to the first plate structure 2200a and the second plate structure 2200b, but is not limited to two plate structures. Except for the differences specifically pointed out below, the above descriptions of plate structures 200, 1200 generally apply to the first plate structure 2200a and the second plate structure 2200b described below. Except that 2000 series numbers and suffixes will be used, a numbering scheme similar to that of plate structures 200, 1200 will be used for the first plate structure 2200a. Except that 2000 series numbers and suffixes will be used, a numbering scheme similar to that of plate structures 200, 1200 will be used for the second plate structure 2200b.

[0135] Device 2001 may include a first plate structure 2200a and a second plate structure 2200b stacked together. As Figure 17 shown, the second major surface 2202a of the first plate structure 2200a may face the second major surface 2202b of the second plate structure 2200b. The second major surface 2202a of the first plate structure 2200a may be in direct contact with the second major surface 2202b of the second plate structure 2200b. In other embodiments, the device of this embodiment may include one or more intermediate layers located between the second major surface 2202a of the first plate structure 2200a and the second major surface 2202b of the second plate structure 2200b. Non-limiting examples of additional intermediate layers include adhesives, drug layers, and additional multi-directional plates according to the present invention.

[0136] The second major surface 2202a of the first plate structure 2200a may face the second major surface 2202b of the second plate structure 2200b such that the open channels 2232a present on the second major surface 2202a of the first plate structure 2200a are mirror images of the open channels 2232b present on the second major surface 2202b of the second plate structure 2200b. The term "mirror image" means that the open ends of each open channel 2232a, 2232b completely overlap each other, such that the combination of the open channels 2232a, 2232b of the first plate structure 2200a and the second plate structure 2200b together form a common enclosed channel. In this way, the treatment device 2001 can be a composite structure with insulating properties.

[0137] Although not shown, in other embodiments, the second major surface 2202a of the first plate structure 2200a may face the second major surface 2202b of the second plate structure 2200b such that the open channel 2232a present on the second major surface 2202a of the first plate structure 2200a is horizontally offset from the open channel 2232b present on the second major surface 2202b of the second plate structure 2200b. The term "horizontally offset" means that the open ends of each of the open channels 2232a, 2232b only partially overlap or the open ends of each of the open channels 2232a, 2232b do not overlap at all.

[0138] Although not shown, in other embodiments, the second major surface 2202a of the first plate structure 2200a may face the first major surface 2201b of the second plate structure 2200b such that the open channel 2232a present on the second major surface 2202a of the first plate structure 2200a faces the open cell 2228b present on the first major surface 2201b of the second plate structure 2200b. In other embodiments, the first major surface 2201a of the first plate structure 2200a may face the second major surface 2202b of the second plate structure 2200b such that the open cell 2228a present on the first major surface 2201a of the first plate structure 2200a faces the open channel 2232b present on the second major surface 2202b of the second plate structure 220b.

[0139] Although not shown, in other embodiments, the first major surface 2201a of the first plate structure 2200a may face the first major surface 2201b of the second plate structure 2200b such that the open cell 2228a present on the first major surface 2201a of the first plate structure 2200a is a mirror image of the open cell 2228b present on the first major surface 2201b of the second plate structure 2200b. The term "mirror image" means that the open cells 2228a, 2228b completely overlap each other such that the combination of the open cells 2228a, 2228b of the first plate structure 2200a and the second plate structure 2200b together form a common enclosed cell. In this way, the treatment device 2001 can be a composite structure with insulating properties.

[0140] Although not shown, in other embodiments, the first major surface 2201a of the first plate structure 2200a may face the first major surface 2201b of the second plate structure 2200b such that the open cells 2228a present on the first major surface 2201a of the first plate structure 2200a are horizontally offset from the open cells 2228b present on the first major surface 2201b of the second plate structure 2200b. The term "horizontally offset" means that the open ends of each of the open cells 2228a, 2228b only partially overlap or do not overlap at all.

[0141] The device 2001 according to this embodiment can be formed by separately manufacturing each of the first plate structure 2200a and the second plate structure 2200b and then manually stacking the first plate structure 2200a on top of the second plate structure 2200b. Alternatively, two or more plate structures can be manufactured in a pre-stacked arrangement. The device 2001 according to this embodiment can be formed by a lithography or etching process that forms the stacked plate structures.

[0142] Now referring Figure 19 , a treatment device 3001 according to another embodiment of the present invention is shown. Except as described below, the device 3001 is similar to the devices 1, 1d to 1i, 1001, 2001. Except for the differences specifically noted below, the above description of the devices 1, 1d to 1i, 1001, 2001 generally applies to the device 3001 described below. A numbering scheme similar to that of the devices 1, 1d to 1i, 1001, 2001 will be used for the device 3001, except that 3000 series numbers will be used.

[0143] The treatment device 3001 may include a plate structure 3200 and a piercing element 3100. The piercing element 3100 and the plate structure 3200 may be provided as separate components, whereby the piercing element 3100 is coupled to the plate structure 3200. The piercing element 3100 and the plate structure 3200 may be coupled together by any suitable means, such as but not limited to adhesives, fasteners, etc. Non-limiting examples of fasteners include micro-anchors, straps, buckles, strips, or any other restraint. Non-limiting examples of adhesives include cyanoacrylates, epoxies, thermosetting resins, thermoplastics, elastomers, PDMS, epoxies, silicone-based, polyurethanes, etc.

[0144] The piercing element 3100 may include an outer surface and an inner surface. The piercing element may be flexible and include an elongate body 3110 extending along a longitudinal axis. The elongate body 3110 may include a first end 3120 (also referred to as the "distal end") opposite a second end 3130 (also referred to as the "proximal end"), whereby the longitudinal axis intersects both the first end 3120 and the second end 3130 of the elongate body 3110. The elongate body 3110 may extend an extension length L3 measured from the first end 3120 to the second end 3130, whereby the length L3 ranges from about 5 mm to about 32 mm, including all lengths and sub-ranges therebetween.

[0145] The elongate body 3110 may include an outer surface and an inner surface, whereby the inner surface defines a passageway 3140 (also referred to herein as the "lumen passageway") extending through the elongate body 3110 along the longitudinal axis. The inner surface may be continuous and form a circular cross-section. The passageway 3140 may intersect the first end 3120 of the elongate body 3110. The passageway 3140 may intersect the second end 3130 of the elongate body 3110. The inner surface of the elongate body 3110 may form an open conduit as the passageway 3140 providing fluid communication between the first end 3120 and the second end 3130 of the elongate body 3110. The outer surface of the piercing element 3100 may include the outer surface of the elongate body 3110.

[0146] In some embodiments, a coating may be applied to the inner surface of the elongate body 3110 such that the inner surface of the piercing element includes the coating. In such embodiments, the coating may form the surface defining the lumen passageway 3140. In some embodiments, a coating may be applied to the outer surface of the elongate body 3110 such that the outer surface of the piercing element 3100 includes the coating.

[0147] The outer surface of the elongate body 3110 may circumscribe the inner surface of the elongate body 3110, whereby both the inner surface and the outer surface are oriented about the longitudinal axis. The outer surface and the inner surface of the elongate body 3110 may be concentrically oriented about the longitudinal axis.

[0148] The elongate body 3110 may form a hollow cylindrical shape. The passageway 3140 may have an inner diameter measured in a radial direction from the longitudinal axis to the inner surface of the piercing element 3100. The inner diameter of the passageway 3140 may range from about 0.01 mm to about 5 mm, including all diameters and sub-ranges therebetween. In a preferred embodiment, the inner diameter of the passageway 3140 may be less than about 1 mm. In non-limiting examples, the inner diameter of the passageway 3140 may be 0.01 mm, 0.05 mm, 0.11 mm, 0.15 mm, 0.2 mm, 0.25 mm, 0.3 mm, 0.35 mm, 0.4 mm, 0.45 mm, 0.5 mm, 0.55 mm, 0.6 mm, 0.65 mm, 0.7 mm, 0.75 mm, 0.8 mm, 0.85 mm, 0.9 mm, 0.95 mm, 1 mm, 2 mm, 3 mm, 4 mm, and 5 mm.

[0149] The elongate body 3110 may have an outer diameter measured in a radial direction from the longitudinal axis. The outer diameter is the distance across opposite portions of the outer surface 3111 of the elongate body 3110. The outer diameter may be equal to about 101% to about 150% of the inner diameter, including all percentages and sub-ranges therebetween. In other words, the inner diameter of the passageway 3140 is less than the outer diameter of the channel 3104.

[0150] The piercing element 3100 (including the elongate body 3110) may be formed of a polymeric material. In some embodiments, the elongate body 3110 may be a polymeric tube having a lumen. As presented herein, the polymer may be a biocompatible polymer. The biocompatible polymer may be an organic polymer, an inorganic polymer, or a blend thereof. Non-limiting examples of biocompatible polymers include silicone rubber, polyethylene, polypropylene, polymethyl methacrylate (PMMA), polytetrafluoroethylene (PTFE), polystyrene, polyethyl cyanoacrylate, polyvinyl chloride (PVC), polyetheretherketone (PEEK), polyethersulfone (PES), polymer gels, and combinations thereof. In certain embodiments, the biocompatible polymer may include a single type of polymer or a combination of different polymers, such as a polymer blend and / or copolymer. In certain embodiments, the polymer matrix may be one or more flexible polymers and / or one or more solid polymers.

[0151] Although not shown, the penetrating element 3100 may further include at least one perforation in the elongate body 3110. Specifically, the perforation may extend radially outward from the longitudinal axis. The perforation may extend continuously from the inner surface of the elongate body 3110 to the outer surface 3110 of the elongate body. The perforation provides a passage for forming fluid communication between the inner surface and the outer surface of the elongate body 3110. The perforation may extend continuously from the inner surface of the penetrating element 3100 to the outer surface of the penetrating element 3100. The perforation provides a passage for forming fluid communication between the inner surface and the outer surface of the penetrating element 3100.

[0152] The perforation may be present on the penetrating element 3100 at a location adjacent to the first end 3120 of the elongate body 3110. The perforation may be present on the penetrating element 3100 at a location adjacent to the second end 3130 of the elongate body 3110. The perforation may increase the flow rate of fluid (e.g., aqueous humor) through the penetrating element 3100 via the passage 3140.

[0153] According to some embodiments of the present invention, the treatment device 3001 may include a penetrating element 3100 coupled to a plate structure 3200. Specifically, at least a portion of the outer surface of the penetrating element 3100 may directly contact the first major exposed surface 3201 of the plate structure 3200. The direct contact may be maintained by thermally bonding or welding the two surfaces together.

[0154] In other embodiments, at least a portion of the outer surface of the penetrating element 3100 may indirectly contact the first major exposed surface 3201 of the plate structure 3200, whereby the indirect contact is due to the presence of a coupling element between the outer surface of the penetrating element 3100 and the first major exposed surface 3201 of the plate structure 3200. Non-limiting examples of the coupling element may include an adhesive or a separate fastener, such as one or more anchors (e.g., silicon anchors formed on a multi-directional plate), a band, a buckle, an elastic loop, a strip, or any other suitable fixing feature. As further described herein, the penetrating element 3100 may also be coupled to the plate structure by geometric modifications designed to secure the tube to the plate.

[0155] When the penetrating element 3100 is coupled to the plate structure 3200, the penetrating element 3100 may cover at least a portion of the first major exposed surface 3201 of the plate structure 3200 such that that portion of the first major exposed surface 3201 of the plate structure 3200 is no longer exposed (i.e., that portion is covered by the penetrating element 3100). In such a configuration, at least one open cell present on the first topography may be enclosed by the outer surface of the penetrating element 3100.

[0156] Although not shown, other embodiments include that the penetrating element 3100 can be coupled to the plate structure 3200 such that the penetrating element 3100 can cover at least a portion of the second major exposed surface 3202 of the plate structure 3200, such that this portion of the second major exposed surface 3202 of the plate structure 3200 is no longer exposed (i.e., this portion is covered by the penetrating element 3100). In such a configuration, at least one open channel present on the second topography can be closed by the outer surface of the penetrating element 3100.

[0157] The penetrating element 3100 can be positioned relative to the plate structure 3200 such that the longitudinal axis of the elongated body 3110 is oriented substantially orthogonal to the unit axis A-A of the plate structure 3200. In other embodiments, the penetrating element 3100 can be positioned relative to the plate structure 3200 such that the longitudinal axis A-A of the elongated body 3110 is oriented inclined to the unit axis A-A of the plate structure 3200.

[0158] The side surface 3203 of the plate structure 3200 can form the periphery of the first major exposed surface 3201 of the plate structure 3200. Similarly, the side exposed surface 3203 forms the periphery of the second major exposed surface 3202 of the plate structure 3200.

[0159] The following discussion refers to the first major exposed surface 3201, but is also applicable to the second major exposed surface 3202. The first major exposed surface 3201 of the plate structure 3200 includes a peripheral region P adjacent to the periphery formed by the side surface 3203 R . The first major exposed surface 3201 of the plate structure 3200 includes a central region C circumscribed by the peripheral region P R . R .

[0160] The periphery of the plate structure 3200 can form a symmetric or asymmetric boundary. In any embodiment, the plate structure 3200 can be centered approximately around the center point 3208. The peripheral region P R and the central region C R can be concentric around the center point 208. In a non-limiting embodiment, the transition portion between the peripheral region P R and the central region C R can be depicted by a dashed boundary 3209 between the central region C R and the peripheral region P R .

[0161] The boundary 3209 can be inserted a peripheral distance D from the periphery of the plate structure 3200 P , whereby the peripheral distance D Pis a non-zero value. The boundary 3209 can conform to the geometry of the periphery; however, the present invention does not limit the shape of the dashed boundary 3209 to any particular shape (e.g., polygon, circle, ellipse, non-geometric shape, etc.).

[0162] The first major exposed surface 3201 of the plate structure 3200 can have a first surface area. The peripheral distance D P can be equal to a value such that the peripheral region P R is equal to about 1% to about 50% of the first surface area. The peripheral distance D P can be equal to a value such that the central region C R can be equal to about 50% to about 99% of the first surface area.

[0163] The treatment device 1 can include a penetrating element 3100 such that the second end 3130 of the elongate body 3110 is within the peripheral region P R while the first end 3120 extends beyond the periphery of the first major exposed surface 3201 of the plate structure 200. In other words, as Figure 19 shown, the penetrating element 3100 can not cover the central region C R of the plate structure 3200. In such an embodiment, the amount of overlap between the penetrating element 3100 and the first major exposed surface 3201 of the plate structure 3200 can be equal to from 1% to about 99% of the peripheral distance D P , including all amounts and sub-ranges therebetween.

[0164] According to this embodiment, the treatment device 3001 can be implanted onto the eye 900 such that the plate structure 3200 is located between the tissues of the sclera 913 and the conjunctiva 950. The penetrating element 3100 can extend from the plate structure 3200 through the sclera 913 and into the anterior chamber 990 of the eye 900 such that the first end 3120 of the penetrating element 3100 is within the anterior chamber 990. In such a configuration, the penetrating element 3100 can serve as a passage for delivering excess fluid from the anterior chamber to the plate structure 3200 which serves as an external reservoir for the excess fluid until the excess fluid is absorbed by the surrounding tissues of the subject.

[0165] According to an embodiment in which the plate structure 3200 includes a three-lobed multi-lobed geometry, the plate structure 3200 can have a generally triangular shape, whereby the corners can be rounded. In such an embodiment, the penetrating element 3100 can cover the peripheral region P R (and optionally, the central region C R ) such that the penetrating element 3100 does not intersect any of the lobes.

[0166] In this configuration, the elongate body 3110 of the penetrating element 3100 can intersect the perimeter 3203 of the plate structure 3200 and be located between the first lobe and the second lobe without intersecting the third lobe. In other embodiments, the elongate body 3110 of the penetrating element 3100 can intersect the perimeter 3203 of the plate structure 3200 and be located between the first lobe and the third lobe without intersecting the second lobe. In other embodiments, the elongate body 3110 of the penetrating element 3100 can intersect the perimeter 3203 of the plate structure 3200 and be located between the second lobe and the third lobe without intersecting the first lobe.

[0167] Now referring Figure 21 and Figure 22 , a treatment device 4001 according to another embodiment of the present invention is shown. Except as described below, the treatment device 4001 is similar to the treatment devices 1, 1d to 1i, 2001, 3001. Except for the differences specifically noted below, the above descriptions of the treatment devices 1, 1d to 1i, 2001, 3001 generally apply to the treatment device 4001 described below. Except that 4000 series numbers will be used, a numbering scheme similar to that for the treatment devices 1, 1d to 1i, 2001, 3001 will be used for the treatment device 4001.

[0168] According to this embodiment, the treatment device 4001 can include a penetrating element 4100 that forms a protrusion from at least one of the major surfaces 4201, 4202 of the plate structure 4200. The penetrating element 4200 according to this embodiment can be coupled to the plate structure 4200 or, alternatively, integrally formed with the plate structure 4200. In such an embodiment, the protrusion member 4100 can be formed of the same material as that used to form the plate structure 4200. In other embodiments, the penetrating element 4200 can be of the same general material type (e.g., ceramic material) as that used to form the plate structure 4200, while each specific material can be different. In a non-limiting example, both the plate structure 4200 and the penetrating element 4200 can be formed of ceramic materials, where the multi-directional plate is formed of a first ceramic material (e.g., alumina) and the penetrating element 4200 is formed of a second ceramic material (e.g., silica), and the first ceramic material and the second ceramic material are different.

[0169] The penetrating element 4200 can extend along a longitudinal axis that is substantially orthogonal to the first major exposed surface 4201 and the second major exposed surface 4202 of the plate structure 4200. The penetrating element 4200 can extend from a proximal end 4330 to a distal end 4320, where the proximal end 4330 is coupled to the plate structure 4200 or integrally formed with the plate structure 4200.

[0170] The penetrating element 4300 can be used as an integrally formed flow channel or path through or along the plate structure 4200. The flow channel 4340 can extend along a longitudinal axis such that it is oriented orthogonally to the first major exposed surface 4201 and the second major exposed surface 4202 of the plate structure 4200. Alternatively, the outer surface of the penetrating element 4300 can form a path along which the intraocular fluid flows.

[0171] In other embodiments, the treatment device 1 of the present invention can be a material suitable for implantation into other regions of the eye 900, the other regions including but not limited to the cornea 910, the retina 941, the lens 930, and stable structures between various eye tissues, as well as structures for guiding fluids, chemicals, and / or signals between parts of the eye. Additional spaces suitable for implantation of the treatment device 1 of the present invention include the uveoscleral outflow pathway, Schlemm's canal and collector channels, the trabecular meshwork, and the suprachoroidal space. In certain embodiments, more than one treatment device 1 can be implanted in one or more quadrants of the eye 900.

[0172] Example

[0173] This example illustrates the use of the drainage device for reducing intraocular pressure and the tolerance of the device when implanted subconjunctivally in New Zealand white rabbits.

[0174] Materials and Methods

[0175] Fabrication of the drainage device: The honeycomb structure was designed and fabricated from 53 nm thick ALD alumina (Al2O3) and silica (SiO2). The honeycomb structure was fabricated into different geometries with lateral dimensions varying between 0.5 and 10 millimeters. Three clamping configurations were used: cantilever, beam fixed at both ends, and rectangular plate clamped on all four sides.

[0176] Fabrication began with a double-sided polished silicon wafer. A SiN film with a thickness of 180 nm was deposited on both sides using PECVD. A honeycomb structure with a height of 10 μm was formed in the silicon using photolithography and reactive ion etching (RIE) techniques. The back side was patterned via photolithography, and openings were obtained by RIE etching of the SiN. The SiN mask was removed from the front side, and then the ALD layer was deposited. For alumina deposition, trimethylaluminum (TMA) and water were used as precursors, and two different temperatures, 150 °C and 250 °C, were used. The deposition rate measured using an ellipsometer was / cycle at 150 °C and / cycle at 250 °C.

[0177] To pattern the ALD layer, a thick layer of SPR 220 resist was spin-coated onto the structure. The measured thickness of the resist was 14 μm. After spin-coating and soft baking at 105 °C, the wafer was slowly cooled to ensure that the photoresist did not crack. After lithography, inductively coupled plasma etching (ICP) using a BCl3-based chemical process was used to pattern the alumina ALD layer. In contrast, RIE was used to pattern the silica ALD layer. Anisotropic KOH etching was then performed. Before placing the wafer in KOH, the top surface was covered with ProTek to prevent the ALD layer from being etched in the KOH solution. At 80 °C, the silicon etch rate was measured to be 75 μm / h in a 30% KOH solution. By precisely timing the KOH etching process, the process could be stopped ∼20 μm from the top surface. The precise depth was measured using a Zygo profiler. After that, the ProTek layer was removed and an oxygen plasma was performed to ensure that the wafer surface was completely clean and free of any polymer residue. In some embodiments, as an alternative to KOH etching, a laser micromachining system (such as IPG Photonics IX-280-DSF) could be used to partially remove the silicon substrate. XeF2 etching was used for the final release of the structure. For complete release of the structure, approximately 100 cycles (30 seconds each) of XeF2 etching at a ratio of 3.2:2 (XeF2:N2) were required. The silicon tube was coupled to the plate structure through a silicon anchor. The inner diameter of the tube was 0.5 mm. Before surgery, the geometry of the plate structure was modified and the tube was perfused with balanced salt solution to obtain the desired length and shape.

[0178] Surgical method: Three experimental native New Zealand white rabbits (1 male and 2 females), approximately 5 months old and weighing 2.8 to 3.3 kg for males and females at the start of the study, were assigned to the treatment groups as shown in Table 1 below.

[0179] Table 1

[0180]

[0181] To implant the treatment device, each rabbit was anesthetized subcutaneously with a combination of ketamine (40 mg / kg) and xylazine (4 mg / kg). Anesthetic was supplemented as needed. All drug usage was recorded in the raw data. At this time, a few drops of 1% proxymetacaine (topical anesthesia) were also placed in each eye. Once anesthetized, the rabbit was placed in the lateral position and the area around the eye was prepped with a swab (Swapstick) containing 10% povidone iodine. Then the eye was rinsed with sterile 0.9% saline and a few more drops of proxymetacaine were instilled. A sterile drape was placed over the rabbit, allowing the eye to be exposed. Sterile instruments (steam autoclaved before the first surgery, then chemically sterilized in chlorhexidine solution and rinsed with sterile water / saline between animals). Sterile gloves were worn.

[0182] During the operation, the eyelids are held open manually or by an eyelid speculum. The eye is centered and rotated using Colibri forceps, and a small incision is made in the conjunctiva on the side of the iris. A subconjunctival pocket is formed ventrally, and the treatment device is placed therein. During placement, the eye is allowed to rotate back to its normal position, and the placement of the treatment device is observed to ensure that it is well within the subconjunctival pocket. The rabbit is then rotated to the other side, and a sham operation is similarly performed on the contralateral eye without implanting the treatment device or other materials. Sterile eye ointment is applied to both eyes during the recovery period.

[0183] Observation and measurement: The treatment device is implanted into the eyes of the subjects via a conjunctival incision between the sclera and the conjunctiva on day 1. Mortality and clinical observations are evaluated daily. The ocular irritation score is recorded before dosing on day 1 and once daily on days 2 to 5, 12, and 19. Body weight is recorded once a week. Food consumption is recorded daily. All animals are sacrificed on day 21. At autopsy, the eyes with the optic nerves of all animals are collected and subjected to microscopic evaluation.

[0184] Histological analysis: The animals are sacrificed on day 21 by an overdose of intravenous barbiturate. Autopsies are performed on all animals. The eyes with the optic nerves are collected and immediately fixed in Davidson's fixative for 24 to 48 hours. After dehydration of the nerve samples through increasing concentrations of ethanol (30 - 100%), the nerves are sectioned with a sharp blade. The sections are then embedded in paraffin in descending order and sectioned at a thickness of 3 mm. The sections are stained with hematoxylin and eosin. Two sections (hemispheres) with pupil - optic disc orientation are trimmed from each eye, and two levels are sectioned for each paraffin block so that four slides are available for each eye for tremor examination.

[0185] Results and discussion

[0186] One male and two female New Zealand white rabbits are dosed once on day 1 with the treatment device via a conjunctival incision between the sclera and the conjunctiva.

[0187] Mortality / morbidity: There are no early death cases during the study. All animals survive until they are sacrificed on their scheduled day 21.

[0188] Clinical observations: On day 1, a mild to moderate decrease in post - operative behavioral activity is noted, and all animals close their eyes or partially close their eyes 2 to 4 hours after dosing. These findings are considered unrelated to the test article and occur after anesthesia and surgery. On days 2 to 21 of the study, all animals appear normal, and no clinical symptoms are noted.

[0189] Eye observations: Before dosing on Day 1, the eye irritation scores for the eyes (left and right) of all animals were 0. The lowest overall eye irritation scores were recorded on Days 2 and 3 of the study. Scores were recorded in both the left and right eyes (implantation of the drainage device and sham surgery, respectively). By Day 4, no eye scores were noted. The following Table 2 summarizes the overall eye irritation scores recorded during the study.

[0190] Table 2

[0191]

[0192]

[0193] Body weight: No significant test article-related effects on body weight or weight gain were noted.

[0194] Food consumption: There were no test article-related effects on food consumption. The animals ate essentially all of their food throughout the day.

[0195] Postmortem observations

[0196] Gross necropsy findings: No gross necropsy findings were noted at the scheduled euthanasia on Day 21.

[0197] Histopathology: The treatment device was not visible microscopically in any of the animals. Local scleral [defects] ← [or "changes" as "defects" may imply a problem] were noted near the limbus in several eyes, including elevation and separation of the conjunctiva and surface collagen fibers from the deeper collagen fibers of the sclera, creating empty spaces. There was no significant tissue reaction other than collagen debris. Although defects of the lowest (Grade 1) severity were found in two of the control (right) eyes, two of the three treated (left) eyes showed defects of mild (Grade 2) to moderate (Grade 3) severity, raising suspicion that the tissue defects in the eyes receiving the treatment device may at least partly represent the implant site where the implant fragmented or was cleaned during handling. In the right and left eyes of all three animals, conjunctival hyperplasia, lymphoplasmacytic infiltration, and / or fibrosis of minimal severity were noted near the limbus. These lesions could be interpreted as spontaneous background findings and / or related to the surgical procedure.

[0198] In summary, no test-related clinical observations, effects on body weight or weight gain, or effects on food consumption were found. After surgery, the overall eye irritation scores were minimal, and by Day 4 all eyes appeared normal. No gross necropsy findings were noted at the scheduled euthanasia on Day 21. After tissue processing, the treatment device was not visible, and no tissue reaction was noted at the implant site. In summary, the treatment device was well tolerated when implanted subconjunctivally in New Zealand white rabbits.

[0199] It should be understood that the foregoing only demonstrates the tolerance of the treatment device when implanted into the eye and only illustrates the principles of the present disclosure, and various modifications can be made by those skilled in the art without departing from the scope and spirit of the present disclosure.

Claims

1. A device for reducing intraocular pressure, the device comprising: A continuous plate structure that enables aqueous humor to flow from a first end to a second end, the continuous plate structure comprising: A first major exposed surface opposite a second major exposed surface, the first major exposed surface comprising a plurality of open cells, each of the plurality of open cells comprising a cell bottom plate, at least one cell wall, and an open end positioned opposite the corresponding cell bottom plate, thereby forming an open space between the corresponding cell wall and the corresponding cell bottom plate that can be entered through the corresponding open end; and A fluid path that includes a plurality of open channels formed into the second major exposed surface, the plurality of open channels configured in a cross-grid pattern extending from the first end to the second end, each of the plurality of open channels comprising a channel top plate, at least one channel wall, and an open end positioned opposite the corresponding channel top plate, thereby forming an open space between the corresponding channel wall and the corresponding channel top plate that can be entered through the corresponding open end, wherein the continuous plate structure enables aqueous humor to flow along the fluid path, thereby reducing the intraocular pressure within the eye, and wherein the first end of the continuous plate structure is inserted into the anterior chamber of the eye.

2. The device according to claim 1, wherein The thickness of the continuous plate structure ranges from 50 nm to 500 nm.

3. The device according to any one of claims 1 to 2, wherein, The continuous plate structure is flexible.

4. The device according to any one of claims 1 to 2, wherein The continuous plate structure is formed of a ceramic material.

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

6. The device according to any one of claims 1 to 2, wherein The continuous plate structure has a height measured as the distance between the first major exposed surface and the second major exposed surface, the height ranging from 5 µm to 20 µm.

7. The device according to any one of claims 1 to 2, wherein The continuous plate structure extends along a longitudinal axis, and the continuous plate structure further comprises: A body portion having a proximal end opposite a distal end, the body portion having a first length measured as the distance between the proximal and distal ends of the body portion; and An extension portion having a proximal end opposite a distal end, the extension portion having a second length measured as the distance between the proximal and distal ends of the extension portion, wherein the longitudinal axis intersects both the proximal and distal ends of the body portion and the extension portion, and the proximal end of the extension portion extends from the distal end of the body portion.

8. The apparatus according to claim 7, wherein, The ratio of the first length to the second length ranges from 1:1 to 5:

1.

9. The device according to claim 7, wherein The first length is greater than the second length.

10. The apparatus according to claim 7, wherein, The body portion has a first width measured in a direction perpendicular to the longitudinal axis, and the extension portion has a second width measured in a direction perpendicular to the longitudinal axis.

11. The device according to claim 10, wherein, The first width is greater than the second width.

12. The apparatus according to claim 10, wherein The ratio of the first width to the second width ranges from 1.1:1 to 4:

1.

13. The device according to claim 10, wherein, The body portion includes a first major surface opposite a second major surface, and The extension portion includes a first major surface opposite a second major surface; wherein the first major surface of the body portion and the first major surface of the extension portion are substantially coplanar.

14. The apparatus according to claim 10, wherein, The continuous plate structure further includes a barb portion having a proximal end opposite to the distal end, wherein the longitudinal axis intersects the proximal and distal ends of the barb portion, and the proximal end of the barb portion extends from the distal end of the extension portion.

15. The device according to claim 14, wherein, The barb portion has a third length and a third width, the third length being measured as the distance between the proximal and distal ends of the barb portion, and the third width being the maximum distance measured in a direction perpendicular to the longitudinal axis.

16. The device according to claim 15, wherein, The ratio of the second length to the third length ranges from 1:1 to 2:

1.

17. The device according to any one of claims 15 to 16, wherein, The ratio of the third width to the second width ranges from 1.1:1 to 2:

1.

18. The device according to claim 14, wherein The barb portion includes a first major surface opposite to the second major surface, and wherein the first major surface of the barb portion is substantially coplanar with the first major surface of the body portion and the first major surface of the extension portion.

19. The apparatus according to claim 13, wherein The first major exposed surface of the plate structure includes the first major surface of the body portion and the first major surface of the extension portion.

20. The device according to claim 1, wherein each of the plurality of open cells is isolated from each other.

21. A device for reducing intraocular pressure, the device comprising: A continuous plate structure that enables aqueous humor to flow from a first end to a second end, the first end having a maximum width that is narrower than the maximum width of the second end, the continuous plate structure including: A topmost surface opposite to the bottommost surface, the topmost surface including a plurality of open cells, each of the plurality of open cells including a cell bottom plate, at least one cell wall, and an open end positioned opposite to the corresponding cell bottom plate, thereby forming an open space between the corresponding cell wall and the corresponding cell bottom plate that can be entered through the corresponding open end; and; A fluid path including a plurality of open channels formed in the bottommost surface, the plurality of open channels configured in a cross-grid pattern extending from the first end to the second end, each of the plurality of open channels including a channel top plate, at least one channel wall, and an open end positioned opposite to the corresponding channel top plate, thereby forming an open space between the corresponding channel wall and the corresponding channel top plate that can be entered through the corresponding open end, wherein the continuous plate structure enables aqueous humor to flow along the fluid path, thereby reducing the intraocular pressure within the eye, and wherein the first end of the continuous plate structure is inserted into the anterior chamber of the eye.

22. The apparatus according to claim 21, wherein, The continuous plate structure is flexible.

23. The device according to any one of claims 21 to 22, wherein, The continuous plate structure is formed of a ceramic material selected from the group consisting of alumina, silicon nitride, silica, hafnium oxide, titanium nitride, and titanium carbide.

24. A device for reducing intraocular pressure, the device comprising: A continuous plate structure that enables aqueous humor to flow from a first end to a second end, the first end having a maximum width that is narrower than the maximum width of the second end, the continuous plate structure including: A first major surface opposite to the second major surface, the first major surface including a plurality of open cells, each of the plurality of open cells including a cell bottom plate, at least one cell wall, and an open end positioned opposite to the corresponding cell bottom plate, so as to form an open space between the corresponding cell wall and the corresponding cell bottom plate that can be entered through the corresponding open end; A fluid path, which includes a plurality of open channels formed in the second major surface, the plurality of open channels configured in a cross-grid pattern extending from the first end to the second end, each of the plurality of open channels including a channel top plate, at least one channel wall, and an open end positioned opposite to the corresponding channel top plate, so as to form an open space between the corresponding channel wall and the corresponding channel top plate that can be entered through the corresponding open end; and A penetrating element fixed to the first major surface of the plate structure, wherein, the continuous plate structure enables aqueous humor to flow along the fluid path, thereby reducing the intraocular pressure within the eye, and wherein, the penetrating element is inserted into the anterior chamber of the eye.

25. The device according to claim 24, wherein, The continuous plate structure is flexible.

26. The apparatus according to any one of claims 24 to 25, wherein, The continuous plate structure is formed of a ceramic material.

27. The apparatus according to claim 26, wherein The ceramic material is selected from the group consisting of alumina, silica, hafnium oxide, titanium nitride, and titanium carbide.

28. The apparatus according to claim 27, wherein, The ceramic material is alumina.

29. The device according to any one of claims 24 or 25, wherein The penetrating element includes an elongate body having a first end and a second end, the elongate body extending between the first end and the second end of the elongate body, and wherein, an internal channel extends from the first end to the second end of the elongate body, so as to form an open channel through the elongate body.

30. The apparatus according to claim 29, wherein The elongate body includes an outer surface opposite to an inner surface, and the inner surface forms a wall defining the internal channel.

31. The apparatus according to claim 29, wherein, The penetrating element is formed of a polymer material.

32. The apparatus according to claim 31, wherein, The polymer material is selected from the group consisting of silicone rubber, polyethylene, polypropylene, polymethyl methacrylate, polytetrafluoroethylene, polystyrene, cyanoacrylate, polyvinyl chloride, polyetheretherketone, and polyethersulfone.

33. The apparatus according to claim 29, wherein, A side surface extends between the first major surface and the second major surface, the side surface defining a periphery of the first major surface, whereby the first end of the elongate body covers the first major surface, and the second end of the elongate body extends beyond the periphery of the first major surface.

34. The apparatus according to claim 29, wherein, The first major surface of the plate structure includes a central region and a peripheral region, whereby the central region is circumscribed by the peripheral region, and the peripheral region is adjacent to the periphery of the first major surface, and wherein, the first end of the elongate body covers the central region of the first major surface.

35. The apparatus according to claim 34, wherein, The peripheral region is equal to 1% to 75% of the area of the first major surface.

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