Method and device for treating ocular 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 formed from a multidirectional plate having a plate thickness ranging from about 1 nm to about 1,000 nm.

Description

[0001] This application is a divisional application of the patent application with PCT application number PCT / US2019 / 014663 filed on January 23, 2019, application number 201980020255.5 entering the Chinese national phase, and invention name “Methods and devices for treating eye diseases”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application is a PCT international application based on 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 Art

[0004] Millions of people suffer from eye diseases, particularly glaucoma. Most glaucoma patients are associated with abnormally high intraocular pressure (IOP) because they cannot drain excess aqueous humor from the anterior chamber of the eye through the trabecular meshwork. If not reduced by appropriate treatment, high IOP will continue to damage the optic nerve as the disease progresses, leading to vision loss or even complete blindness. Current medications, surgeries, and implants have proven to be insufficient in reducing intraocular pressure or maintaining normal intraocular pressure for many years. Therefore, new approaches are needed to alleviate IOP and thus treat glaucoma. Summary of the Invention

[0005] Described herein is a device for reducing intraocular pressure 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 ranging from about 1 nm to about 1,000 nm.

[0006] In other embodiments, the present invention includes a method of reducing intraocular pressure, the method comprising: a) securing a therapeutic device to an eye, the therapeutic device comprising a plate structure having an upper surface opposite a lower surface, the plate structure being formed of a multidirectional plate having a thickness ranging from about 1 nm to about 1,000 nm.

[0007] Other embodiments of the present invention include a device for reducing intraocular pressure, comprising: a plate structure comprising an upper surface opposite to a lower surface, the lower surface comprising a plurality of open channels; wherein the plate structure has a height in a range of about 5 μm to about 20 μm measured as the distance between the upper surface and the lower surface of the plate structure.

[0008] Other embodiments of the present invention include a device for reducing intraocular pressure, comprising: a first plate structure comprising an upper surface opposite to a lower surface, the first plate structure being formed by a first multidirectional plate having a plate thickness in a range of about 1 nm to about 1,000 nm; and a second plate structure comprising an upper surface opposite to the lower surface, the second plate structure being formed by a second multidirectional plate having a plate thickness in a range of about 1 nm to about 1,000 nm.

[0009] Other embodiments of the present invention include a device for reducing intraocular pressure, comprising: a plate structure having a first major surface opposite to a second major surface, the plate structure comprising a multidirectional plate having a thickness ranging from about 1 nm to about 1,000 nm; and a penetrating element secured to the first major surface of the plate structure.

[0010] Other embodiments of the present invention include a method of reducing intraocular pressure, the method comprising: implanting a therapeutic device in the front of an eye, the therapeutic device comprising a plate structure formed by multi-directional plates, whereby after implantation, a first end of the plate structure is located between the sclera and conjunctiva of the eye.

[0011] Other embodiments of the present invention include a method of reducing intraocular pressure, comprising: a) securing a therapeutic device to an eye, the therapeutic device comprising: a plate structure comprising an uppermost surface opposite an lowermost surface; a plurality of open channels formed into the lowermost surface; wherein the plate structure has a height, measured as a distance between the uppermost surface and the lowermost surface of the plate structure, in a range of about 5 μm to about 20 μm.

[0012] Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter.It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The present invention will be more fully understood from the detailed description and accompanying drawings, in which:

[0014] Figure 1 is a perspective view of a treatment device according to the present invention;

[0015] Figure 2 yes Figure 1 A top view of a treatment device;

[0016] Figure 3 is based on Figure 1 A close-up view of the treatment device in section A;

[0017] Figure 4 It is along Figure 3 A cross-sectional view of the treatment device shown along line IV-IV in FIG;

[0018] Figure 5 is a front perspective view of an eye including the therapeutic device of the present invention implanted therein;

[0019] Figure 6 is a close-up view of a portion of an eye including a therapeutic device of the present invention implanted therein;

[0020] Figure 7 including a therapeutic device implanted thereon Figure 5 a cross-sectional view of the eye;

[0021] Figure 8 is a device according to the present invention having a therapeutic device implanted thereon Figure 7 A close-up cross-section of the eye;

[0022] Figure 9 is a perspective view of a treatment device according to another embodiment of the present invention;

[0023] Figure 10 yes Figure 9 A top view of a treatment device;

[0024] Figure 11 It includes implanted Figure 9 A front-view stereogram of an eye with a therapeutic device;

[0025] Figure 12 It includes implanted Figure 9 A close-up view of a portion of an eye with a therapeutic device;

[0026] Figure 13 It includes implanted Figure 9 another close-up view of a portion of an eye of a therapeutic device;

[0027] Figure 14 It has an implanted Figure 9 treatment device Figure 11 A close-up cross-section of the eye;

[0028] Figure 15 is a perspective view of a treatment device according to another embodiment of the present invention;

[0029] Figure 16 is based on Figure 15 A close-up view of the treatment device at section X indicated in FIG.

[0030] Figure 17 It is along Figure 16 A cross-sectional view of the treatment device shown along line XVII-XVII in FIG.

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

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

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

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

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

[0036] Figure 18F is a top view of a treatment device according to another embodiment of the present invention;

[0037] Figure 19 is a perspective view of a treatment device according to another embodiment of the present invention;

[0038] Figure 20 yes Figure 19 A side view of a treatment device;

[0039] Figure 21 is a perspective view of a treatment device according to another embodiment of the present invention; and

[0040] Figure 22 yes Figure 21 Side view of the treatment device. DETAILED DESCRIPTION

[0041] The following description of the preferred embodiment is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.

[0042] Throughout the process, ranges are used as shorthand for describing each value within a range. Any value within the range can be selected as the endpoint of the range. In addition, all references cited herein are incorporated herein by reference in their entirety. In the event of a conflict between a definition in the present disclosure and a definition in the cited reference, the present disclosure controls.

[0043] The description of the illustrative embodiments according to the principles of the present invention is intended to be read in conjunction with the accompanying drawings, which are considered a part of the entire written description. In the description of the embodiments of the present invention disclosed herein, any reference to direction or orientation is merely for convenience of description 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 interpreted as referring to the orientation being described at the time or the direction shown in the accompanying drawings in question. These relative terms are for convenience of description only and do not require that the structure be constructed or operated in a specific orientation unless expressly indicated so.

[0044] Unless expressly described otherwise, the terms "attached," "attached," "coupled," "interconnected," and the like refer to relationships in which structures are fixed or attached to one another, directly or indirectly through intervening structures, as well as removable or rigid attachments or relationships. Furthermore, the features and benefits of the present invention are described with reference to exemplary embodiments. Therefore, the present invention should not be limited exclusively to the exemplary embodiments illustrating some possible non-limiting combinations of features that may exist alone or in other combinations of features; the scope of the invention is defined by the appended claims.

[0045] Unless otherwise indicated, all percentages and amounts expressed herein and elsewhere in the specification should be understood to refer to percentages by weight. The amounts given are based on the weight of the material. As used herein, the term "about" refers to + / - 5% of the reference value. As used herein, the term "substantially free" refers to a total amount of less than about 0.1 wt % based on the reference value.

[0046] A "subject" herein can be a human or non-human animal, such as, but not limited to, rodents, such as mice, rats, hamsters, and guinea pigs; rabbits; dogs; cats; sheep; pigs; goats; cows; horses; and non-human primates, such as apes and monkeys.

[0047] refer to Figures 1-4 The present invention comprises a therapeutic device 1 (also referred to as a "device") for reducing intraocular pressure. Additionally, the device 1 of the present invention may provide improvements in the treatment of eye diseases, particularly glaucoma.

[0048] Device 1 may include a plate structure 200 having a first major exposed surface 201 opposite a second major exposed surface 202 and a side surface 203 extending therebetween. Plate structure 200 may include an uppermost surface 206 opposite a lowermost surface 207. First major exposed surface 201 may include uppermost surface 206 of plate structure 200. Second major exposed surface 202 may include lowermost surface 207 of plate structure 200.

[0049] The overall shape of the first and second major exposed surfaces 201, 202 of the plate structure 200 can be defined by the side surfaces 203. The side surfaces 203 can define the perimeter of the first and second major exposed surfaces 201, 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 flanks, a polygon, a circle, a mushroom, an ellipse, an oblong, an egg, or an amoeba.

[0050] Plate structure 200 may have a plate structure height H1, which is the total distance measured between uppermost surface 206 and lowermost surface 207 of plate structure 200. Plate structure height H1 may range from about 5 μm to about 20 μm, including all distances and subranges therebetween.

[0051] The plate structure 200 may be formed at least in part by a multi-directional plate 210 (also referred to as "plate" 210). The plate 210 is a three-dimensional body. The plate 210 may include a first major surface 211 opposite a second major surface 212, and a side surface 213 extending between the first major surface 211 and the second major surface 212. When viewed with the naked eye, the first major surface 211 of the plate 210 may be substantially continuous and appear smooth. When viewed with the naked eye, the second major surface 212 of the plate 210 may be substantially continuous and appear smooth. The plate 210 may be translucent. The plate 210 may be light-transmissive.

[0052] The plate 210 may have a thickness T, which is measured as the distance extending between the nearest adjacent portions of the first major surface 211 and the second major surface 212 of the plate 210 in a direction orthogonal to the first major surface 211 and the second major surface 212. The thickness T may range from about 1 nm to about 1,000 nm, including all thicknesses and subranges therebetween. In some embodiments, the thickness T may range from about 50 nm to about 500 nm, including all thicknesses and subranges therebetween. In some embodiments, the thickness T may range from about 100 nm to about 400 nm, including all thicknesses and subranges therebetween. In some embodiments, the thickness T may range from about 100 nm to about 250 nm, including all thicknesses and subranges therebetween. In some embodiments, the thickness T may range from about 250 nm to about 500 nm, including all thicknesses and subranges therebetween. In some embodiments, the thickness T may range from about 300 nm to about 550 nm, including all thicknesses and subranges therebetween.

[0053] The multi-directional plate 210 may be a single layer patterned in three dimensions to form the multi-directional geometry of the multi-directional plate 210. Although the geometry of the multi-directional plate 210 may 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 a single layer patterned into the multi-directional plate 210) remains within the aforementioned thickness T range of 1 nm to 1000 nm.

[0054] 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 exposed major 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.

[0055] Now refer to Figure 4 In particular, the first major exposed surface 201 of the plate structure 200 can include a first topography 204. The first topography 204 can be formed by the first major surface 211 of the plate 210 due to the multi-directional patterned geometry of the multi-directional plate 210. The first topography 204 can include a surface feature formed into the uppermost surface 206 of the plate structure 200, whereby the surface feature extends from the uppermost surface 206 in a direction toward the lowermost surface 207 of the plate structure 200 and terminates at the bottom plate 224, as discussed in more detail herein.

[0056] The plate structure 200 can further include a second topography 205. Due to the multi-directional patterned geometry of the multi-directional plate 210, the second topography 205 can be formed from the second major surface 212 of the plate 210. The second topography 205 can include a surface feature formed into the lowermost surface 207 of the plate structure 200, whereby the surface feature extends from the lowermost surface 207 in a direction toward the uppermost surface 206 of the plate structure 200 and terminates at the top plate 234, as discussed in more detail herein.

[0057] The surface features of the first topography 204 and / or the second topography 205 can include one or more cells 222. As described in more detail herein, the cells 222 can be open cells. In other embodiments, the surface features of the first topography 204 and / or the second topography 205 can include one or more channels 232. As described in more detail herein, the channels 232 can be open channels.

[0058] The above discussion will refer to, but is not limited to, a first feature 204 including one or more cells 222 and a second feature 205 including one or more channels 232. Although not shown in the figures, other embodiments of the present invention include: a first feature 204 including one or more channels 232, and a second feature 205 including one or more cells 222.

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] Each unit 222 may also include an open end 228 positioned opposite the unit base 224. Unit axis C A -C A 222 may intersect with an open end 228. The open end 228 may be a fluid path that provides access to the open space of the cell 222 between the cell wall surface 226 and the floor surface 224. In other words, each of the cells 222 may be open (also referred to as "open-ended") such that there is no top plate opposite the cell floor 224 that would otherwise close the cell 222 and enclose the open space of the cell 222.

[0064] Each of the cells 222 may be isolated from one another by their respective cell walls 226 such that the open space of each cell 222 is not in fluid communication with other open spaces of other cells 222 .

[0065] The first feature 204 may be formed by the multi-directional nature of the multi-directional plate 210. Thus, the dimensions of the plate structure 200, and in particular, the dimensions of the first feature 204, may be determined relative to the thickness T of the plate 210.

[0066] For each cell 222, the cell bottom plate 224 may be offset from the uppermost surface 206 of the plate structure 200 by a first distance D1 (also referred to herein as a "cell depth"). The offset between the uppermost surface 206 and the bottom plate surface 224 may be referred to as a "vertical offset" or "vertical offset," but is not limited thereto. The first distance D1 is a non-zero value. The first distance D1 may be equal to the difference between the first height H2 of the plate structure 200 and the thickness T of the plate 210, whereby the first distance D1 is calculated according to the following formula:

[0067] D1=H2-T.

[0068] For each cell 222, the cell bottom plate 224 may 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 may be referred to as a "vertical offset" or "vertical offset," but is not limited thereto. The second distance D2 is a non-zero value. The second distance D2 may be substantially equal to the thickness T of the plate 210. The sum of the first distance D1 and the second distance D2 may be substantially equal to the first height H2.

[0069] Now refer to Figure 3 and Figure 4, each cell 222 may have a cell length L2 and a cell width W2 measured as the distance extending between opposing cell walls 226 within each cell chamber 222. In some embodiments, the cell length L2 and the cell width W2 may be equal. In other embodiments, the cell length L2 and the cell width W2 may be different. The cell length L2 may range from about 10 μm to about 110 μm, including all lengths and sub-ranges therebetween. In some embodiments, the cell length L2 may 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 cell width W2 may range from about 10 μm to about 110 μm, including all lengths and sub-ranges therebetween. In some embodiments, the cell width W2 may 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.

[0070] Each channel 232 may be formed by a channel ceiling 234 and at least one channel wall 236. The channel wall 236 may extend downward from the channel ceiling 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 may extend upward from the lowermost surface 207 in a direction toward the channel ceiling 234, whereby the channel wall 236 may terminate at the channel ceiling 234.

[0071] Collectively, the lowermost surface 207, the channel walls 236, and the channel ceiling 234 may 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 may include the second exposed major surface 202 of the plate structure 200. In other words, the second major surface 212 of the plate 210 may include the lower surface 207 and the channel walls 236 and the channel floor 234 formed by the second topography 205.

[0072] Each channel 232 may also include an open end 238 positioned opposite the channel ceiling 234. The open end 238 may be a fluid path that provides access to the open space of the channel 232 between the channel walls 236 and the channel ceiling 234. In other words, each of the channels 232 may be open (also referred to as "open-ended") such that there is no floor opposite the channel ceiling 234 that would otherwise close the channel 232 or enclose the channel space formed by the channel walls 236 and the channel floor 234.

[0073] A plurality of intersecting channels 234 may be present on the second major surface 202 of the plate structure 200, thereby forming a network of channels. Each of the channels in the network may 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.

[0074] The second feature 205 of the present invention may be formed by the multi-directional nature of the multi-directional plate 210. Therefore, the dimensions of the plate structure 200, and in particular, the dimensions of the second feature 205, may be determined relative to the thickness T of the plate 210.

[0075] For each channel 232, the channel top plate 234 may be offset from the lowermost surface 207 of the plate structure 200 by a third distance D3 (also referred to herein as "channel depth"). The offset between the lowermost surface 207 and the channel top plate 234 may be referred to as a "vertical offset" or "vertical offset," but is not limited thereto. The third distance D3 is a non-zero value. The third distance D3 may be equal to the difference between the first height H2 of the plate structure 200 and the thickness T of the plate 210, whereby the third distance D3 is calculated according to the following formula:

[0076] D3=H2-T.

[0077] For each channel 232, the channel ceiling 234 may be offset from the uppermost surface 206 by a fourth distance D4. The offset between the uppermost surface 206 and the channel ceiling 234 may be referred to as a "vertical offset" or "vertical offset," but is not limited thereto. The fourth distance D4 is a non-zero value. The fourth distance D4 may be substantially equal to the thickness T of the plate 210. The sum of the third distance D3 and the fourth distance D4 may be substantially equal to the first height H2.

[0078] 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 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.

[0079] It has been found that a channel depth and channel width W1 of about 10 μm to 15 μm provides 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 subranges therebetween.

[0080] In some embodiments, the plate 210, and the resulting plate structure 200, can be formed from a variety of materials. The material forming the plate is preferably a biocompatible material. As used herein, the term "biocompatible" refers to compatibility with living tissues or systems by being non-toxic, harmless, or physiologically reactive and not causing immune rejection. Non-limiting examples of materials forming the plate 210 include ceramic materials, polymer materials, metal materials, and composites thereof.

[0081] Non-limiting examples of ceramic materials include aluminum oxide (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 comprises aluminum oxide. In another preferred embodiment, the ceramic material comprises silicon nitride. Non-limiting examples of metallic materials include platinum, gold, or tungsten.

[0082] Compared to a planar film, the plate 210, and the resulting plate structure 200, can have a higher bending stiffness. For example, the plate 210 can have the same thickness as a planar structure but have a much higher spring constant when used as a cantilever and / or a clamped-end beam. Similarly, the plate 210 can have the same spring constant as a planar structure but can be significantly thinner. For example, the plate 210 of the present invention can be at least about 20 times, at least about 15 times, at least about 10 times, or at least about 5 times thinner than a planar structure having the same bending stiffness.

[0083] The board 210 of the present invention can be flexible. According to the present invention, the term "flexible" refers to the ability of the board 210 to deform without any or a significant amount of breakage or permanent deformation, also known as having shape recovery. Specifically, the flexibility of the board 210 can be such that the first major surface 211 and the second major surface 212 can be folded at least 90° without breaking the board 210. In some embodiments, the flexibility of the board 210 can be such that the first major surface 211 and the second major surface 212 can be folded up to 180° without breaking the board 210. Similarly, the flexibility of the board 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 breaking the board structure 200. In some embodiments, the flexibility of the board 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 breaking the board structure 200.

[0084] Thus, the present invention enables the panel 210, and the resulting panel structure 200, to be formed entirely from a metal and / or ceramic material that is also flexible (ie, capable of being folded up to 180°, preferably at least 90°, without breaking).

[0085] In some embodiments, the panel structure 200 can be ultralight. The term "ultralight" refers to the panel structure 200, and correspondingly the panel 210, having a weight of approximately 10 -4 The board structure 200 may also have an area density of the order of 100 mg / m2. For example, the board structure 200 may have an area density of about 10 mg / m2. 2 to about 1000 mg / m 2 The surface density between , including all densities and subranges in between.

[0086] Now refer to Figure 1 and Figure 2 , the device 1 may include a plate structure 200 extending along a longitudinal axis AA. The plate structure 200 may also include a proximal end 208 opposite a distal end 209, whereby the longitudinal axis AA intersects both the proximal end 208 and the distal end 209 of the plate structure 200. The plate structure 200 may 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 . Plate structure length L PS The range of L can be from about 10 mm to about 24 mm, including all lengths and subranges therebetween. PS It can be about 17 mm.

[0087] The plate structure 200 may further include a main body portion 240 and an extension portion 250. The main body portion 240 may include a proximal end 241 opposite a distal end 242. The extension portion 250 may include a proximal end 251 opposite a distal end 252. The proximal end 251 of the extension portion 250 may extend from the distal end 242 of the main body portion 240. The proximal end 241 of the main body portion 240 may overlap with the proximal end 208 of the plate structure 200. The distal end 252 of the extension portion 250 may overlap with the distal end 209 of the plate structure 200.

[0088] Body portion 240 may include a first major surface 243 opposite second major surface 244. First major exposed surface 201 of plate structure 200 may include first major surface 243 of body portion 240. Second major exposed surface 202 of plate structure 200 may include second major surface 244 of body portion 240.

[0089] The body portion 240 may extend a body length L spanning the distance from the proximal end 241 to the distal end 242 of the body portion 240. MB . Main body length L MB The range of L can be from about 8 mm to about 16 mm, including all lengths and subranges therebetween. In a preferred embodiment, the body length L MB It can be about 12 mm.

[0090] The body portion 240 may have a body width W measured as a distance across a direction extending perpendicular to the longitudinal axis AA. MB .Main body width W MB The body width W may range from about 4 mm to about 8 mm, including all lengths and subranges therebetween. MB It can be about 6 mm.

[0091] Extension portion 250 may include a first major surface 253 opposite second major surface 254. First major exposed surface 201 of plate structure 200 may include first major surface 253 of extension portion 250. Second major exposed surface 202 of plate structure 200 may include second major surface 254 of extension portion 250.

[0092] The extension portion 250 may extend over an extension length L spanning a distance from a proximal end 251 to a distal end 252 of the extension portion 250. E . Extension length L E The range of L can be from about 1 mm to about 4 mm, including all lengths and sub-ranges therebetween. E It may be about 2 mm.

[0093] The extension portion 250 may have an extension width W measured as a distance across a direction extending perpendicular to the longitudinal axis AA. E . Extension width W E The range of W may be from about 1.0 mm to about 6.0 mm, including all lengths and subranges therebetween. E It can be about 2.6 mm.

[0094] In some embodiments, the body length L MB and extension length L E In other embodiments, the main body length L MB and extension length L E In some embodiments, the body length L MB With extension length L E The ratio of L can range from about 1:1 to about 5:1, including all ratios and subranges therebetween. In some embodiments, the body length L MB With extension length L E The ratio is greater than 1:1. In some embodiments, the body length L MB With extension length L E The ratio can range from about 3:1 to about 5:1, including all ratios and subranges therebetween.

[0095] In some embodiments, the body width W MB and extension width WE In other embodiments, the body width W MB and extension width W E In other embodiments, the body width W MB Can be larger than the extension width W E In some embodiments, the body width W MB With extended width W E The ratio of W can range from about 1:1 to about 4:1, including all ratios and subranges therebetween. In some embodiments, the body width W MB With extended width W E The ratio of can range from about 1.1:1 to about 4:1, including all ratios and subranges therebetween. In some embodiments, the body width W MB With extended width W E The ratio can range from about 1.5:1 to about 3:1, including all ratios and subranges therebetween.

[0096] The first major surface 253 of the extension portion 250 can be substantially coplanar with the first major surface 243 of the body portion 240. The second major surface 254 of the extension portion 250 can be substantially coplanar with the second major surface 244 of the body portion 240.

[0097] The main body portion 240 may have a height substantially equal to the first height H1 of the plate structure 200, as measured between the first major surface 243 and the second major surface 244 of the main body portion 240. The extension portion 250 may have a height substantially equal to the first height H1 of the plate structure 200, as measured between the first major surface 243 and the second major surface 244 of the extension portion 250.

[0098] Now refer to Figures 5 to 8 The therapeutic device 1 of the present invention can be positioned in contact with the eye 900 to treat an ocular disease. Non-limiting examples of such ocular diseases include glaucoma. The eye 900 generally includes outer tissues, including the sclera 913, the cornea 910, the conjunctiva 950, and the limbus. Two chambers exist within the eye 900: a posterior chamber 995 located behind the lens 930 of the eye 900 and an anterior chamber 990 located in front of the lens 930 of the eye 900. The posterior chamber 995 contains the vitreous humor, while the anterior chamber 990 contains the aqueous humor.

[0099] As described herein, the eye 900 includes an anterior region 901 and a posterior region 902, wherein a boundary 903 generally exists between the anterior region 901 and the posterior region 902. The anterior region 901 of the eye 900 includes the cornea 910, the iris 911, the pupil 912, conjunctival tissue 950, the ciliary body 915 and lens 930, a portion of the sclera 913, and an anterior chamber 990 that surrounds the eye 900. The anterior region 901 may also include a limbal region 980, a limbus-limbus region 982, and an anterior scleral region 950.

[0100] The posterior region 902 includes ocular muscle tissue 920 (also referred to as "eye muscles"), a portion of the sclera 913, the optic nerve 942, the retina 941, and a posterior cavity 995 surrounding the eye 900. The eye muscles 920 are present within the orbital cavity of the subject. The eye 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.

[0101] The present invention includes a method for treating an ocular disease, such as glaucoma, by reducing intraocular pressure in a subject using a therapeutic device 1. Specifically, the therapeutic device 1 provides a fluid path for excess fluid present in either the anterior chamber 990 and / or the posterior chamber 995 to exit the eye 900. In a preferred embodiment, the therapeutic device 1 reduces intraocular pressure in a subject by providing a fluid path for excess fluid to exit the anterior chamber 990 to a location external to the sclera 913.

[0102] The term "excess fluid" refers to the extra volume of aqueous humor present in the anterior chamber 990, which raises intraocular pressure above the normal intraocular pressure of a healthy eye. For an eye 900 that is unable to release this excess fluid, increased intraocular pressure is a contributing factor to blindness in glaucoma patients. Therefore, providing a fluid path for draining excess fluid from the anterior chamber 990 of the eye 900 can help reduce intraocular pressure, thereby aiding in the treatment of glaucoma.

[0103] In non-limiting embodiments, the methods described herein can be applied to treat any type of ophthalmic condition associated with intraocular pressure. Non-limiting examples of ophthalmic conditions 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 glaucoma. In particular, ophthalmic conditions include glaucoma and all subtypes of glaucoma.

[0104] The therapeutic device 1 of the present invention provides such a fluid path for excess fluid to exit the eye 900. Specifically, the therapeutic device 1 can be implanted in the eye 900 such that it forms a fluid path from the anterior chamber 990 to the exterior of the sclera 913, thereby forming a subconjunctival bleb. The term "subconjunctival bleb" refers to a fluid pocket containing aqueous humor, located between the conjunctival and scleral tissues. Once on the exterior surface of the sclera 913, excess fluid can be removed from the eye 900 by absorption into the subject's surrounding tissues.

[0105] In particular, therapeutic device 1 can be implanted into eye 900 such that plate structure 200 is positioned between the tissues of sclera 913 and conjunctiva 950. Extension portion 250 can extend from body portion 240 through sclera 913 and into anterior chamber 990 of eye 900, such that distal end 209 of plate structure 200 is positioned within anterior chamber 990. In this configuration, plate structure 200 can serve as an external reservoir for excess fluid until it is absorbed by the surrounding tissues of the subject. In certain embodiments, plate structure 200 can be sterilized prior to implantation of therapeutic device 1 to minimize postoperative complications.

[0106] Extension portion 250 can extend from body portion 240 through sclera 913 and into anterior chamber 990 of eye 900 (as shown in the figure), or can extend from body portion 240 through sclera 913 and into posterior cavity 989 of anterior chamber 990 of eye 900. Therapeutic device 1 can be implanted such that extension portion 250 extends through limbal region 980, limbal region 981, or anterior scleral region 982.

[0107] 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 exit the anterior chamber 990 of the eye 900, thereby relieving excess intraocular pressure.

[0108] The therapeutic device 1 can be implanted so that the therapeutic device 1 is fixed to the eye 900. In some embodiments, the therapeutic device 1 can be implanted between the conjunctiva 95 and the sclera 913. In a non-limiting example, a conjunctival incision can be made to allow sufficient exposure for inserting the therapeutic device 1. In a non-limiting example, the therapeutic device 1 can be fixed to any eye 900 by suturing or extending through the plate structure 200 to the sclera 913.

[0109] 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 therapeutic 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.

[0110] In other embodiments, the therapeutic device 1 may 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 exit the eye 900. In such embodiments, excess intraocular fluid can travel along the therapeutic device 1 and exit the eye 900 by capillary action.

[0111] According to the present invention, the plate structure 200 having the thickness T and material properties previously discussed allows for placement of the therapeutic device 1 at least partially within the anterior region 901 of the eye 900. In some embodiments, the therapeutic device 1 can be implanted entirely within the anterior region 901 of the eye 900, referred to herein as "anterior placement." This anterior placement can allow for at least a portion of the therapeutic device 1 to reside within the anterior portion 901 of the eye 900, as discussed further herein. Furthermore, this anterior placement of the therapeutic device 1 can allow for a less invasive implantation procedure than previously used implantable devices. Furthermore, such anterior placement can also provide greater comfort for the subject. Furthermore, the translucent appearance of the plate structure 200 can allow for the therapeutic device 1 to be implanted at least partially within the anterior region 901 of the eye without being readily apparent to the subject's eye 900 when viewed with the naked eye.

[0112] refer to Figure 5 and Figure 6, the therapeutic device 1 can be implanted into the eye 900 such that the therapeutic device 1 is at least partially located between the superior rectus muscle 921 and the lateral rectus muscle 923. In such an embodiment, the therapeutic device 1 can be completely 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 therapeutic device 1 can be implanted into the eye 900 such that the therapeutic device 1 is at least partially located between the inferior rectus muscle 922 and the lateral rectus muscle 923. In such an embodiment, the therapeutic device 1 can be completely 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.

[0113] Now refer to 18A to 18F , shows a plurality of therapeutic devices 1d to 1i according to another embodiment of the present invention. Except as described below, devices 1d, 1e, 1f, 1g, 1h, and 1i are similar to device 1. The above description of device 1 generally applies to the following devices 1d, 1e, 1f, 1g, 1h, and 1i, except for the differences specifically noted below. For devices 1d, 1e, 1f, 1g, 1h, and 1i, a similar numbering scheme as for device 1 will be used, except that the suffixes d, e, f, g, h, and i will be used.

[0114] As described above, the overall shape of the plate structures 200, 200d, 200e, 200f, 200g, 200h, 200i can be selected from a variety of 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 egg shape, or an amoeba shape.

[0115] In non-limiting embodiments, the therapeutic devices 1d to 1i may include polygonal extensions 250d, 250e, 250f, 250g, 250h, 250i. According to these embodiments, the extensions 250d, 250e, 250f, 250g, 250h, 250i may include peripheral portions 255d, 255e, 255f, 255g, 255h, 2551i comprised of substantially straight portions, thereby forming the polygonal shape of the extensions 250d, 250e, 250f, 250g, 250h, 250i. The peripheral portion 255d, 255e, 255f, 255g, 255h, 255i of the extension portion 250d, 250e, 250f, 250g, 250h, 250i forms a part of the peripheral edge 203d, 203e, 203f, 203g, 203h, 203i of the plate structure 200d, 200e, 200f, 200g, 200h, 200i.

[0116] In non-limiting embodiments, the peripheral portions 255d, 255e, 255f, 255g, 255h, 255i of the extension portions 250d, 250e, 250f, 250g, 250h, 250i may form a portion of a rectangle, a square, or a triangle. Figure 18D In particular, extension portion 250g may include a rectangular portion and a triangular tip 256g terminating at an apex 257g, whereby apex 257g coincides with distal end 209g of treatment device 1g. Although not shown, peripheral portions 255d, 255e, 255f, 255g, 255h, 255i of extension portions 250d, 250e, 250f, 250g, 250h, 250i may be curved or non-polygonal. In other embodiments, distal ends 209d, 209e, 209f, 209h, and 209i may include peripheral portions 255d, 255e, 255f, 255h, 255i formed by straight lines.

[0117] In one non-limiting embodiment, the therapeutic devices 1d to 1i may include body portions 240d, 240e, 240f, 240g, 240h, 240i including 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 a portion of the peripheral edge 203d, 203e, 203f, 203g, 203h, 203i of the plate structures 200d, 200e, 200f, 200g, 200h, 200i.

[0118] The peripheral portions 245d, 245e, 245f, 245g, 245h, 245i of the main body portions 240d, 240e, 240f, 240g, 240h, 240i intersect with the peripheral portions 255d, 255e, 255f, 255g, 255h, 255i of the extension portions 250d, 250e, 250f, 250g, 250h, 250i.

[0119] In a non-limiting embodiment, the peripheral portions 245d, 245e, 245f, 245g, 245h, 245i of the main body portions 240d, 240e, 240f, 240g, 240h, 240i may be curved or non-polygonal in shape. Figure 18CThe peripheral portions 245f, 245g of the main body portions 240f, 240g may include both straight and curved sections, whereby the straight sections 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.

[0120] The curved shape of the peripheral portions 245d, 245e, 245f, 245g, 245h, 245i of the main body portions 240d, 240e, 240f, 240g, 240h, 240i may be an ideal circle or an oval.

[0121] Now refer to Figure 18F , the treatment device 1i can have a main body portion 240i having a multi-lobed geometry. Specifically, the main body portion 240i can include two or more lobes 246i that extend outwardly and form a portion of a peripheral portion 245i of the main body portion 240i. Each lobe 246i can include a portion of a circle, i.e., a portion of a circle, a portion of an ellipse. Each lobe can have a symmetrical shape or an asymmetrical shape. Each of the lobes 246i can be symmetrically oriented relative to a center point 249i on the main body portion 240i.

[0122] In a non-limiting example, the multi-lobed geometry of the main body portion 240i can be a trilobed geometry. The multi-lobed geometry can increase the surface area of ​​the therapeutic device 1i while avoiding the eye muscles, such that two lobes are in front of the eye muscles, while the third lobe extends between the eye muscles to the back of the eye. This increased surface area can be beneficial for fluid absorption to reduce intraocular pressure. In embodiments where the multi-lobed geometry is trilobed, the main body portion 240i can have a generally triangular shape, whereby the corners can be rounded.

[0123] Now refer to Figure 9 and Figure 10 , shows a therapeutic device 1001 according to another embodiment of the present invention. Except as described below, device 1001 is similar to device 1. The above description of devices 1 and 1d to 1i generally applies to device 1001 described below, except for the differences specifically noted below. A similar numbering scheme as for devices 1, 1d to 1i will be used for device 1001, except that the 1000 series numbering will be used.

[0124] Device 1001 may include a body portion 1240, an extension portion 1250, and further include a barb portion 1260. Barb portion 1260 may include a proximal end 1261 opposite a distal end 1262. Proximal end 1261 of barb portion 1260 may extend from distal end 1252 of extension portion 1240. According to this embodiment, distal end 1262 of barb portion 1260 may overlap distal end 1209 of plate structure 1200. Longitudinal axis AA may intersect both proximal end 1261 and distal end 1262 of barb portion 1260.

[0125] Barb portion 1260 may include a first major surface 1263 opposite second major surface 1264. First major exposed surface 1201 of plate structure 1200 may include first major surface 1263 of barb portion 1260. Second major exposed surface 1202 of plate structure 1200 may include second major surface 1264 of barb portion 1260.

[0126] The barb portion 1260 may extend a barb length L spanning the distance from the proximal end 1261 to the distal end 1262 of the barb portion 1260. B . Barb length L B The range of L can be from about 1 mm to about 3 mm, including all lengths and subranges therebetween. In a preferred embodiment, the barb length L B It can be about 2 mm.

[0127] The barb portion 1260 can have a maximum barb width W measured as a maximum distance across a direction extending perpendicular to the longitudinal axis AA. B . Maximum hook width W B The range of W can be from about 1.0 mm to about 54.0 mm, including all lengths and subranges therebetween. In a preferred embodiment, the maximum barb width W B It can be about 3.6 mm.

[0128] Maximum hook width W B Can be larger than the extension width W E In some embodiments, the maximum barb width W B With extended width W E The ratio of W can range from about 1.01:1 to about 3:1, including all ratios and subranges therebetween. In some embodiments, the barb width W B With extended width W E The ratio of can range from about 1.1:1 to about 2:1, including all ratios and subranges therebetween. In a preferred embodiment, the barb width W B With extended width W E The ratio can be about 1.4:1.

[0129] A first major surface 1263 of the barb portion 1260 can be substantially coplanar with the first major surface 1253 of the extension portion 1250. A second major surface 1264 of the barb portion 1260 can be substantially coplanar with the second major surface 1254 of the extension portion 1250.

[0130] The barb portion 1260 can have a height substantially equal to the first height H1 of the plate structure 1200, as measured between the first major surface 1263 and the second major surface 1164 of the barb portion 1260. The barb portion 1260 can include a triangular configuration including an apex 1265. The apex 1265 can overlap with the distal end 1209 of the plate structure 1200.

[0131] Now refer to Figure 11 、 Figure 12 and Figure 14 , therapeutic device 1001 provides such a fluid path for excess fluid to leave the eye 900. Specifically, therapeutic 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 bubble. Once on the exterior surface of the sclera 913, excess fluid can be carried away from the eye 900 by absorption into the surrounding tissues of the subject.

[0132] In particular, therapeutic device 1001 can be implanted in eye 900 such that plate structure 1200 is located between tissue of sclera 913 and conjunctiva 950. Barb portion 1260 can extend from extension portion 1250 through sclera 913 and into anterior chamber 990 of eye 900 such that distal end 1209 of plate structure 200 is positioned within anterior chamber 990.

[0133] Now refer to 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 W of the same as the extension portion. E The barb portion 1260 and the body portion 1240 are of substantially equal width so 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 device 1001 can be implanted by temporarily deforming the barb portion 1260 so that it has a reduced barb width W that is equal to or less than the width of the slit 914. B , thereby allowing the barb portion 1260 to enter the slit 914. Once passing through the slit 914, the barb portion 1260 can recover its deformation so that the barb portion 1260 has a barb portion width W in an undeformed state. B .

[0134] Now refer to Figures 15 to 17 , shows a therapeutic device 2001 according to another embodiment of the present invention. Except as described below, device 2001 is similar to devices 1 and 1001. The above descriptions of devices 1, 1d to 1i, and 1001 are generally applicable to device 2001 described below, except for the differences specifically noted below. A similar numbering scheme as for devices 1, 1d to 1i, and 1001 will be used for device 2001, except that the 2000 series numbering will be used.

[0135] Device 2001 may include multiple plate structures 2200. The foregoing discussion applies to, but is not limited to, a first plate structure 2200a and a second plate structure 2200b. The above description of plate structures 200, 1200 generally applies to the first and second plate structures 2200a, 2200b, except for the differences specifically noted below. A similar numbering scheme as used for plate structures 200, 1200 will be used for first plate structure 2200a, except that 2000 series numbers and suffixes will be used. A similar numbering scheme as used for plate structures 200, 1200 will be used for second plate structure 2200b, except that 2000 series numbers and suffixes will be used.

[0136] The device 2001 may include a first plate structure 2200a and a second plate structure 2200b stacked together. Figure 17 As shown, the second major surface 2202a of the first plate structure 2200a can face the second major surface 2202b of the second plate structure 2200b. The second major surface 2202a of the first plate structure 2200a can be in direct contact with the second major surface 2202b of the second plate structure 2200b. In other embodiments, the device of this embodiment can include one or more intermediate layers positioned 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.

[0137] The second major surface 2202a of the first plate structure 2200a can 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 mirror the open channels 2232b present on the second major surface 2202b of the second plate structure 2200b. The term "mirror image" refers to the open ends of each open channel 2232a, 2232b completely overlapping one another, such that the combination of the open channels 2232a, 2232b of the first and second plate structures 2200a, 2200b together form a common closed channel. In this manner, the therapeutic device 2001 can be a composite structure having insulating properties.

[0138] Although not shown, in other embodiments, the second major surface 2202a of the first plate structure 2200a can 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 horizontally offset from the open channels 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 open channel 2232a, 2232b only partially overlap or the open ends of each open channel 2232a, 2232b do not overlap at all.

[0139] Although not shown, other embodiments provide that 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 channels 2232a present on the second major surface 2202a of the first plate structure 2200a face the open cells 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 cells 2228a present on the first major surface 2201a of the first plate structure 2200a face the open channels 2232b present on the second major surface 2202b of the second plate structure 220b.

[0140] Although not shown, in other embodiments, the first major surface 2201a of the first plate structure 2200a can 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 mirror the open cells 2228b present on the first major surface 2201b of the second plate structure 2200b. The term "mirror image" means that the open cells 2228a and 2228b completely overlap each other, such that the combination of the open cells 2228a and 2228b of the first and second plate structures 2200a and 2200b together form a common closed unit. In this way, the therapeutic device 2001 can be a composite structure with insulating properties.

[0141] Although not shown, in other embodiments, the first major surface 2201a of the first plate structure 2200a can 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 open cell 2228a, 2228b only partially overlap or do not overlap at all.

[0142] 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 and the second plate structure 2200b together. 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 photolithography or etching process to form a stacked plate structure.

[0143] Now refer to Figure 19 , shows a therapeutic device 3001 according to another embodiment of the present invention. Except as described below, device 3001 is similar to devices 1, 1d to 1i, 1001, 2001. The above description of devices 1, 1d to 1i, 1001, 2001 generally applies to device 3001 described below, except that the 3000 series numbering will be used. A similar numbering scheme as devices 1, 1d to 1i, 1001, 2001 will be used for device 3001, except that the 3000 series numbering will be used.

[0144] Treatment device 3001 may include a plate structure 3200 and a penetrating element 3100. Penetrating element 3100 and plate structure 3200 may be configured as separate components, whereby penetrating element 3100 is coupled to plate structure 3200. Penetrating element 3100 and plate structure 3200 may be coupled together by any suitable means, such as, but not limited to, adhesives, fasteners, and the like. Non-limiting examples of fasteners include micro-anchors, straps, buckles, strips, or any other restraints. Non-limiting examples of adhesives include cyanoacrylates, epoxies, thermosets, thermoplastics, elastomers, PDMS, epoxy, silicone, polyurethane, and the like.

[0145] The penetrating element 3100 may include an outer surface and an inner surface. The penetrating element may be flexible and include an elongated body 3110 extending along a longitudinal axis. The elongated body 3110 may include a first end 3120 (also referred to as a "distal end") opposite a second end 3130 (also referred to as a "proximal end"), whereby the longitudinal axis intersects both the first end 3120 and the second end 3130 of the elongated body 3110. The elongated body 3110 may extend an extended 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 subranges therebetween.

[0146] The elongated body 3110 can include an outer surface and an inner surface, whereby the inner surface defines a passageway 3140 (also referred to herein as an "inner lumen passageway") extending through the elongated body 3110 along the longitudinal axis. The inner surface can be continuous and form a circular cross-section. The passageway 3140 can intersect the first end 3120 of the elongated body 3110. The passageway 3140 can intersect the second end 3130 of the elongated body 3110. The inner surface of the elongated body 3110 can form an open conduit, serving as the passageway 3140 providing fluid communication between the first end 3120 and the second end 3130 of the elongated body 3110. The outer surface of the penetrating element 3100 can include the outer surface of the elongated body 3110.

[0147] In some embodiments, the coating can be applied to the inner surface of the elongated body 3110 such that the inner surface of the penetrating element comprises the coating. In such embodiments, the coating can form a surface defining the lumen passage 3140. In some embodiments, the coating can be applied to the outer surface of the elongated body 3110 such that the outer surface of the penetrating element 3100 comprises the coating.

[0148] The outer surface of the elongated body 3110 can circumscribe the inner surface of the elongated body 3110, whereby both the inner and outer surfaces are oriented about the longitudinal axis.The outer and inner surfaces of the elongated body 3110 can be concentrically oriented about the longitudinal axis.

[0149] The elongated body 3110 can be formed into a hollow cylindrical shape. The passageway 3140 can have an inner diameter measured in a radial direction from the longitudinal axis to the inner surface of the penetrating element 3100. The inner diameter of the passageway 3140 can range from about 0.01 mm to about 5 mm, including all diameters and subranges therebetween. In a preferred embodiment, the inner diameter of the passageway 3140 can be less than about 1 mm. In non-limiting examples, the inner diameter of the passageway 3140 can 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.

[0150] The elongated body 3110 can have an outer diameter measured radially from the longitudinal axis. The outer diameter is the distance across opposing portions of the outer surface 3111 of the elongated body 3110. The outer diameter can be between about 101% and about 150% of the inner diameter, including all percentages and subranges therebetween. In other words, the inner diameter of the passageway 3140 is smaller than the outer diameter of the channel 3104.

[0151] Penetrating element 3100 (including elongated body 3110) can be formed by polymer material. In some embodiments, elongated body 3110 can be a polymer tube with an inner cavity. As presented herein, the polymer can be a biocompatible polymer. The biocompatible polymer can 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 gel and combinations thereof. In certain embodiments, the biocompatible polymer can include a single type of polymer or a combination of different polymers, for example, as a polymer blend and / or copolymer. In certain embodiments, the polymer matrix can be one or more flexible polymers and / or one or more solid polymers.

[0152] Although not shown, the penetrating element 3100 may further include at least one perforation on the elongated body 3110. Specifically, the perforation may extend radially outward from the longitudinal axis. The perforation may extend continuously from the inner surface of the elongated body 3110 to the outer surface 3110 of the elongated body. The perforation provides a passageway that establishes fluid communication between the inner and outer surfaces of the elongated 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 passageway that establishes fluid communication between the inner and outer surfaces of the penetrating element 3100.

[0153] The perforation can be present on the penetrating element 3100 adjacent the first end 3120 of the elongated body 3110. The perforation can be present on the penetrating element 3100 adjacent the second end 3130 of the elongated body 3110. The perforation can increase the flow rate of fluid (e.g., aqueous humor) through the penetrating element 3100 via the passageway 3140.

[0154] According to some embodiments of the present invention, treatment device 3001 can include a penetrating element 3100 coupled to a plate structure 3200. Specifically, at least a portion of an outer surface of penetrating element 3100 can directly contact first major exposed surface 3201 of plate structure 3200. Direct contact can be maintained by thermally bonding or welding the two surfaces together.

[0155] In other embodiments, at least a portion of the outer surface of the penetrating element 3100 can indirectly contact the first major exposed surface 3201 of the plate structure 3200, whereby the indirect contact is caused by 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 coupling elements can include adhesives or separate fasteners, such as one or more anchors (e.g., silicon anchors formed on a multi-directional plate), straps, buckles, elastic loops, strips, or any other suitable securing features. As further described herein, the penetrating element 3100 can also be coupled to the plate structure through geometric modifications designed to secure the tube to the plate.

[0156] When the penetrating element 3100 is coupled to the plate structure 3200, the penetrating element 3100 can cover at least a portion of the first major exposed surface 3201 of the plate structure 3200, such that the portion of the first major exposed surface 3201 of the plate structure 3200 is no longer exposed (i.e., the portion is covered by the penetrating element 3100). In this configuration, at least one open cell present on the first topography can be closed by the outer surface of the penetrating element 3100.

[0157] 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 the portion of the second major exposed surface 3202 of the plate structure 3200 is no longer exposed (i.e., the portion is covered by the penetrating element 3100). In this configuration, at least one open channel present in the second topography can be closed by the outer surface of the penetrating element 3100.

[0158] 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 cell axis AA 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 AA of the elongated body 3110 is oriented obliquely to the cell axis AA of the plate structure 3200.

[0159] The side surface 3203 of the plate structure 3200 may form a perimeter of the first major exposed surface 3201 of the plate structure 3200 , and similarly, the side exposed surface 3203 forms a perimeter of the second major exposed surface 3202 of the plate structure 3200 .

[0160] The following discussion is made with reference 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 perimeter formed by the side surfaces 3203. R The first major exposed surface 3201 of the plate structure 3200 comprises a peripheral region P R Circumscribed central area C R .

[0161] The perimeter of the plate structure 3200 can form a symmetrical or asymmetrical boundary. In either embodiment, the plate structure 3200 can be approximately centered about the center point 3208. The perimeter area P R and central area C R The peripheral region P may be concentric about the center point 208. In a non-limiting embodiment, the peripheral region P R With the central area C R The transition between the central area C R and the peripheral area P R The dashed boundary 3209 is used to depict the two regions.

[0162] Boundary 3209 may be inset from the perimeter of plate structure 3200 by a perimeter distance D P , so the peripheral distance D Pis a non-zero value. Boundary 3209 may conform to the geometric shape of the perimeter; however, the present invention does not limit the shape of dashed boundary 3209 to any particular shape (eg, polygonal, circular, elliptical, non-geometric, etc.).

[0163] The first major exposed surface 3201 of the plate structure 3200 may have a first surface area. P Can be equal to make the peripheral area P R A value equal to about 1% to about 50% of the first surface area. P Can be equal to make the central area C R A value may be equal to about 50% to about 99% of the first surface area.

[0164] The treatment device 1 may include a penetrating element 3100 such that the second end 3130 of the elongated body 3110 is located at 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, Figure 19 As shown, the penetrating element 3100 may not cover the central region C of the plate structure 3200. R 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 may be equal to the peripheral distance D P 1% to about 99%, including all amounts and subranges therebetween.

[0165] According to this embodiment, therapeutic device 3001 can be implanted into eye 900 such that plate structure 3200 is positioned between tissue of sclera 913 and conjunctiva 950. Penetrating element 3100 can extend from plate structure 3200, through sclera 913, and into anterior chamber 990 of eye 900 such that first end 3120 of penetrating element 3100 is positioned within anterior chamber 990. In this configuration, penetrating element 3100 can serve as a pathway for delivering excess fluid from the anterior chamber to plate structure 3200, which serves as an external reservoir for the excess fluid until the excess fluid is absorbed by surrounding tissue of the subject.

[0166] According to an embodiment where the plate structure 3200 comprises a trilobal multi-lobed geometry, the plate structure 3200 may have a generally triangular shape whereby the corners may be rounded. In such an embodiment, the penetrating element 3100 may cover the peripheral region P R (and optionally, the central area C R ) so that the penetrating element 3100 does not intersect any of the lobes.

[0167] In this configuration, the elongated 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 elongated 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 elongated 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.

[0168] Now refer to Figure 21 and Figure 22 , shows a treatment device 4001 according to another embodiment of the present invention. Except as described below, treatment device 4001 is similar to treatment devices 1, 1d to 1i, 2001, 3001. The above description of treatment devices 1, 1d to 1i, 2001, 3001 generally applies to treatment device 4001 described below, except that the 4000 series numbering will be used.

[0169] According to this embodiment, the treatment device 4001 may include a penetrating element 4100 formed as 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 may be coupled to the plate structure 4200 or, alternatively, integrally formed therewith. In such an embodiment, the protruding element 4100 may be formed from the same material as that used to form the plate structure 4200. In other embodiments, the penetrating element 4200 may be the same general type of material (e.g., a ceramic material) as that used to form the plate structure 4200, while each specific material may be different. In a non-limiting example, both the plate structure 4200 and the penetrating element 4200 may be formed from ceramic materials, wherein the multi-directional plate is formed from a first ceramic material (e.g., alumina) and the penetrating element 4200 is formed from a second ceramic material (e.g., silica), the first and second ceramic materials being different.

[0170] The penetrating element 4200 may extend along a longitudinal axis substantially orthogonal to the first and second major exposed surfaces 4201, 4202 of the plate structure 4200. The penetrating element 4200 may extend from a proximal end 4330 to a distal end 4320, whereby the proximal end 4330 is coupled to or integrally formed with the plate structure 4200.

[0171] The penetrating element 4300 can serve as an integrally formed flow channel or path through or along the plate structure 4200. The flow channel 4340 can extend along the longitudinal axis such that it is oriented orthogonal 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 intraocular fluid flows.

[0172] In other embodiments, the therapeutic device 1 of the present invention may be a material suitable for implantation in other areas of the eye 900, including, but not limited to, the cornea 910, the retina 941, the lens 930, and stabilizing structures between various ocular tissues, as well as structures for directing fluids, chemicals, and / or signals between parts of the eye. Additional spaces suitable for implantation of the therapeutic 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 therapeutic device 1 may be implanted in one or more quadrants of the eye 900.

[0173] Example

[0174] This example illustrates the use of a drainage device to reduce intraocular pressure and the tolerability of the device when implanted subconjunctivally in New Zealand white rabbits.

[0175] Materials and methods

[0176] Fabrication of the drainage device: Honeycomb structures were designed and fabricated using 53 nm thick ALD layers of aluminum oxide (Al2O3) and silicon dioxide (SiO2). The honeycomb structures were fabricated into different geometries with lateral dimensions ranging from 0.5 to 10 mm. Three clamping configurations were used: a cantilever, a beam clamped at both ends, and a rectangular plate clamped on all four sides.

[0177] The fabrication starts with a double-side polished silicon wafer. A SiN film with a thickness of 180 nm is deposited on both sides using PECVD. A honeycomb structure with a height of 10 μm is formed in the silicon using photolithography and reactive ion etching (RIE) techniques. The back side is patterned via photolithography and the openings are obtained by RIE etching of the SiN. The SiN mask is removed from the front side and the ALD layer is then deposited. For the aluminum oxide deposition, trimethylaluminum (TMA) and water are used as precursors and two different temperatures are used, 150°C and 250°C. The deposition rate measured using an ellipsometer is At 250℃

[0178] To pattern the ALD layer, a thick layer of SPR 220 resist was spin-coated on 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 photolithography, the aluminum oxide ALD layer was patterned using inductively coupled plasma etching (ICP) using a BCl3-based chemical process. In contrast, RIE was used to pattern the silicon dioxide ALD layer. This was followed by an anisotropic KOH etch. 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. The silicon etch rate was measured to be 75 μm / h in a 30% KOH solution at 80°C. By precisely timing the KOH etch process, the process can be stopped at ~20 μm from the top surface. The exact depth was measured using a Zygo profiler. Afterwards, the ProTek layer was removed and an oxygen plasma was applied 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 the IPG Photonics IX-280-DSF) can be used to partially remove the silicon substrate. XeF2 etching is used for the final release of the structure. For complete release of the structure, approximately 100 cycles of XeF2 etching (30 seconds each) at a ratio of 3.2:2 (XeF2:N2) are required. The silicon tube is coupled to the plate structure via a silicon anchor. The inner diameter of the tube is 0.5 mm. Prior to surgery, the geometry of the plate structure is modified and the tube is perfused with a balanced salt solution to obtain the desired length and shape.

[0179] Surgical Procedures: Three experimental natural New Zealand White rabbits (1 male and 2 females) approximately 5 months old at the start of the study and weighing 2.8 to 3.3 kg for both males and females were assigned to treatment groups as shown in Table 1 below.

[0180] Table 1

[0181]

[0182] To implant the therapeutic device, each rabbit was anesthetized subcutaneously with a combination of ketamine (40 mg / kg) and xylazine (4 mg / kg). Anesthetics were supplemented as needed. All drug use was recorded in the raw data. At this time, a few drops of 1% proparacaine (local anesthesia) were also placed in each eye. Once anesthetized, the rabbit was placed in lateral recumbency and the area around the eye was prepared with a swab (Swapstick) containing 10% povidone-iodine. The eye was then rinsed with 0.9% sterile saline and a few drops of proparacaine were applied. A sterile drape was placed on the rabbit, allowing the eye to be exposed. Sterile instruments (steam autoclaved before the first surgery, then chemically sterilized in a chlorhexidine solution, and rinsed with sterile water / saline between animals) were used. Sterile gloves were worn.

[0183] During surgery, the eyelids are held open manually or with a palpebral speculum. Using Colibri forceps, the eye is rotated centrally, and a small incision is made in the conjunctiva lateral to the iris. A subconjunctival pocket is created ventrally, and the therapeutic device is placed within it. Upon placement, the eye is allowed to rotate back to its normal position, and the placement of the therapeutic device is observed to ensure it is securely positioned within the subconjunctival pocket. The rabbit is then rotated to the other side, and a sham procedure is performed similarly in the contralateral eye without implanting the therapeutic device or other materials. Sterile ophthalmic ointment is applied to both eyes during the recovery period.

[0184] Observations and Measurements: The therapeutic device was implanted in the subject's eye via a conjunctival incision between the sclera and conjunctiva on Day 1. Mortality and clinical observations were assessed daily. Ocular irritation scores were recorded prior to dosing on Day 1 and daily on Days 2 to 5, Day 12, and Day 19. Body weights were recorded weekly. Food consumption was recorded daily. All animals were sacrificed on Day 21. At necropsy, the eye, with the optic nerve, was harvested from all animals and evaluated microscopically.

[0185] Histological analysis: Animals were sacrificed on day 21 by an overdose of intravenous barbiturates. All animals were subjected to necropsy. The eyes with the optic nerves were collected and immediately fixed in Davidson's fixative for 24 to 48 hours. After the nerve samples were dehydrated by higher concentrations of ethanol (30-100%), the nerves were sectioned by a sharp blade. The sections were then embedded in paraffin in descending order and sectioned at 3 mm thickness. The sections were stained with hematoxylin and eosin. Two sections (hemispheres) with pupil-optic disc orientation were trimmed from each eye, and two levels were sectioned per paraffin block so that four slides per eye could be used for microphonics examination.

[0186] Conclusion Discussion

[0187] One male and two female New Zealand White rabbits were dosed once on day 1 with the treatment device through a conjunctival incision between the sclera and conjunctiva.

[0188] Mortality / Morbidity: There were no early deaths during the study. All animals survived until their scheduled sacrifice on day 21.

[0189] Clinical Observations: On Day 1, mild to moderate decreases in post-operative behavioral activity were noted, and all animals had closed or partially closed eyes 2 to 4 hours after dosing. These findings were considered unrelated to the test article and occurred after anesthesia and surgery. From Study Days 2 to 21, all animals appeared normal, and no clinical signs were noted.

[0190] Ocular Observations: Prior to dosing on Day 1, all animals had an ocular irritation score of 0 in both eyes (left and right). The lowest overall ocular irritation scores were recorded on Study Days 2 and 3. Scores were recorded in both the left and right eyes (drainage device implanted and sham operated, respectively). By Day 4, no ocular scores were noted. Table 2 below summarizes the overall ocular irritation scores recorded during the study.

[0191] Table 2

[0192]

[0193]

[0194] Body Weight: No significant test sample-related effects on body weight or weight gain were noted.

[0195] Food Consumption: There were no test article-related effects on food consumption. Animals consumed essentially all of their food throughout the day.

[0196] Postmortem observation

[0197] Gross Autopsy Findings: No gross autopsy findings were noted at the planned sacrifice on day 21.

[0198] Histopathology: The therapeutic device was not visible microscopically in any animal. Localized scleral [defects] (or "changes," as "defect" can imply a problem) were noted near the limbus of several eyes, consisting of bulging and separation of conjunctival and superficial collagen fibers from the deeper collagen fibers of the sclera, forming empty spaces. No tissue reactions were apparent other than collagen debris. While defects of minimal severity (Grade 1) were noted in two control (right) eyes, defects of mild (Grade 2) to moderate (Grade 3) severity were evident in two of the three treated (left) eyes, raising the suspicion that tissue defects in eyes receiving the therapeutic device may, at least in part, represent implant sites where the implant was broken or washed out during handling. Conjunctival hyperplasia, lymphoplasmacytic intrusions, and / or minimal fibrosis were noted near the limbus in both the right and left eyes of all three animals. These lesions could be interpreted as spontaneous background findings and / or related to the surgical procedure.

[0199] Overall, no clinical observations related to the testing, effects on body weight or weight gain, or effects on food consumption were found. Following surgery, overall eye irritation scores were minimal, and all eyes appeared normal by day 4. No naked eye necropsy findings were noted at the scheduled sacrifice on day 21. Following tissue processing, the therapeutic device was not visible, and no tissue reactions were noted at the implantation site. Overall, the therapeutic device was well tolerated when implanted subconjunctivally in New Zealand White rabbits.

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

Claims

1. A device for reducing intraocular pressure, 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 body portion having a proximal end opposite the distal end, the body portion having a first length measured from the proximal end to the distal end of the body portion; and an extension portion having a proximal end opposite the distal end, the extension portion having a second length measured from the proximal end to the distal end of the extension portion, wherein the longitudinal axis intersects the proximal and distal ends of both the main body portion and the extension portion, and the proximal end of the extension portion extends from the distal end of the main body portion, wherein the surfaces on the main portion and the extension portion include a fluid path, the fluid path including a plurality of open channels arranged in a cross-grid pattern extending from a first end to a second end of the continuous plate structure, wherein the continuous plate structure enables aqueous humor to flow along the fluid path, thereby reducing 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 A ratio of the first length to the second length ranges from 1:1 to 5:

1.

3. The device according to claim 1, wherein The first length is greater than the second length.

4. The device according to claim 1 or 3, wherein The main body portion has a first width measured in a direction normal to the longitudinal axis, and the extension portion has a second width measured in a direction normal to the longitudinal axis.

5. The device according to claim 4, wherein The first width is greater than the second width.

6. The device according to claim 4, wherein A ratio of the first width to the second width ranges from 1.1:1 to 4:

1.

7. The device according to claim 1 or 4, wherein: Each of the plurality of open channels includes a channel ceiling, at least one channel wall, and an open end positioned opposite to the corresponding channel ceiling, thereby forming an open space between the corresponding channel wall and the corresponding channel ceiling that is accessible through the corresponding open end.

8. The device according to claim 1 or 7, wherein: The surface is a first surface, and the continuous plate structure includes a second surface opposite to the first surface, the second 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 accessed through the corresponding open end.

9. The device according to claim 1, wherein A surface of the main body portion and a surface of the extension portion are substantially coplanar.

10. The device according to claim 1, wherein The continuous plate structure is flexible.

11. The device according to claim 1 or 10, wherein: The cross grid pattern includes a hexagonal grid pattern.

12. The device according to claim 1, wherein The continuous plate structure is formed of a ceramic material, and Wherein, the ceramic material is selected from the group consisting of aluminum oxide, silicon nitride, silicon dioxide, hafnium oxide, titanium nitride and titanium carbide.

13. The device according to claim 1, wherein The second end of the continuous plate structure is sized and configured to be inserted into: in at least one of the uveoscleral outflow pathway, Schlemm's canal, collector channel, trabecular meshwork, subconjunctival space, or suprachoroidal space of the eye, or Between the superior and inferior rectus muscles.

14. The device according to claim 1, wherein The continuous plate structure has a thickness between 1 nanometer (nm) and 1000 nm.

15. 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 surface comprising a fluid path, the fluid path comprising a plurality of open channels arranged in a cross-grid pattern extending from a first end to a second end of the continuous plate structure, each of the plurality of open channels comprising a channel ceiling, at least one channel wall, and an open end positioned opposite the corresponding channel ceiling to form an open space between the corresponding channel wall and the corresponding channel ceiling that is accessible through the corresponding open end, wherein the continuous plate structure enables aqueous humor to flow along the fluid path, thereby reducing intraocular pressure within the eye, and Wherein, the first end of the continuous plate structure is inserted into the anterior chamber of the eye.

16. The device according to claim 15, wherein The surface is formed on: a body portion having a proximal end opposite a distal end, the body portion having a first length measured from the proximal end to the distal end of the body portion; and an extension portion having a proximal end opposite the 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 the proximal and distal ends of both the main portion and the extension portion, and the proximal end of the extension portion extends from the distal end of the main portion.

17. The device according to claim 16, wherein A ratio of the first length to the second length ranges from 1:1 to 5:

1.

18. The device according to claim 15, wherein The cross grid pattern includes a hexagonal grid pattern.

19. The device according to claim 15, wherein The continuous plate structure is flexible, and Wherein, the continuous plate structure is formed of a ceramic material selected from the group consisting of aluminum oxide, silicon nitride, silicon dioxide, hafnium oxide, titanium nitride and titanium carbide.

20. The apparatus according to claim 15, wherein The second end of the continuous plate structure is sized and configured to be inserted into: in at least one of the uveoscleral outflow pathway, Schlemm's canal, collector channel, trabecular meshwork, subconjunctival space, or suprachoroidal space of the eye, or Between the superior and inferior rectus muscles.

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