Ocular implants and their systems

Abstract

The present application relates to an ocular implant comprising a distal port, a proximal port, and at least two hollow channels extending between the distal port and the proximal port and connected in fluid communication, wherein any two adjacent hollow channels of the at least two hollow channels are not coaxial. The present application also relates to a system for treating an ocular disease, and the use of the ocular implant in preparing a system for treating an ocular disease.

Description

Technical Field

[0001] The present invention relates to an ocular implant, and more particularly to a multi-segment ocular implant implanted on the ocular surface and a system comprising the ocular implant. The present invention also relates to a method for implanting the ocular implant and a use of the ocular implant for treating glaucoma. Background Art

[0002] Glaucoma is the second leading cause of blindness worldwide, second only to cataracts, but it is the leading irreversible blinding eye disease.

[0003] In a normal eye, aqueous humor is produced by the ciliary body and enters the posterior chamber, passing through the pupil to the anterior chamber. It then enters the Schlemm's canal from the trabecular meshwork in the anterior chamber, and then flows through the collecting ducts and aqueous humor veins into the anterior ciliary veins on the surface of the sclera, from where it returns to the blood circulation. Any obstruction in the aqueous humor circulation process will lead to increased intraocular pressure. Clinically, the vast majority of glaucoma is caused by increased resistance to aqueous humor outflow, which leads to increased intraocular pressure. High intraocular pressure may then induce optic nerve damage, leading to visual field loss and ultimately blindness. Lowering intraocular pressure is the only effective way to improve visual field loss in glaucoma.

[0004] Currently, glaucoma is treated primarily with medication and surgery. Medication controls intraocular pressure by regulating the rate of aqueous humor production. Surgical treatments, including trabeculectomy, stent implantation, and drainage tube placement, primarily control intraocular pressure by draining excess aqueous humor.

[0005] In recent years, with the advancement of surgical techniques and material technology, minimally invasive glaucoma surgery (MIGS) has become a hot topic in the glaucoma treatment field. Compared with traditional surgical methods, MIGS is relatively simple to perform, has fewer complications, and has a lesser impact on patients' quality of life. Therefore, the minimally invasive procedure of implanting a glaucoma drainage device to drain the aqueous humor and reduce intraocular pressure has become one of the best treatments for glaucoma.

[0006] However, there are still many problems to be solved with the minimally invasive glaucoma drainage implants currently on the market.

[0007] Currently, there are two main designs for glaucoma drainage tubes: traditional drainage valves and minimally invasive drainage tubes. Traditional drainage valves, consisting of a microtube and a drainage valve, are relatively large, resulting in large surgical incisions, extensive scarring, and poor prognosis. Minimally invasive drainage tubes are smaller in size and require a smaller incision, addressing the large scarring and prolonged surgical time associated with traditional drainage valves. Currently, all minimally invasive drainage tubes on the market lack a control valve, which can lead to excessively rapid pressure release and hypotension. Furthermore, these tubes lack effective control over tissue growth within the tube. After implantation, they often become clogged. Once clogged, the drainage tube is unable to drain aqueous humor, causing intraocular pressure to rise again. Existing drainage tubes implanted in the suprachoroidal space (such as the Cypass) or subconjunctival space (such as the Xen Gel Stent) still face challenges such as inaccurate positioning, easy displacement, and loss of the drainage device. Furthermore, current drainage tubes still suffer from poor biocompatibility, potentially leading to adverse reactions such as infection.

[0008] US2020078215A1 discloses a glaucoma drainage device implanted in the cornea. The device is a planar structure (see, for example, US2020078215A1 Figure 1 , Figures 46 and 47), after being implanted into the cornea, the aqueous humor is introduced from the anterior chamber to the ocular surface. The device is still in clinical trials, but it is known that there are several hidden dangers that need to be resolved. First, the device cannot ensure a close fit between the drainage material and the corneal tissue, and there is a great risk of bacterial invasion and infection. For devices implanted on the ocular surface, infection can cause great damage to the eye. In addition, the device has a large risk of displacement and loss. Because it is inserted perpendicular to the cornea and lacks anchoring measures, the device may fall into the anterior chamber or slip out of the ocular surface, resulting in surgical failure and even causing varying degrees of impact on the patient.

[0009] Therefore, there is a need for an ocular implant that can solve one or more of the above problems, especially solve the problem of displacement and loss, and preferably solve the problem of adhesion with the eye tissue, and / or reduce the incidence of infection and other complications. Summary of the Invention

[0010] In one aspect, the present invention provides an ocular implant comprising a distal port, a proximal port, and at least two hollow channels extending between the distal port and the proximal port and connected in a fluid-communicating manner, wherein any two adjacent hollow channels of the at least two hollow channels are not coaxial.

[0011] In another aspect, the present invention provides a system for treating an eye disease, the system comprising:

[0012] incision making device; and

[0013] According to the ocular implant of the present invention,

[0014] The incision making device is used to make multi-plane incisions at the target position according to the shape of the eye implant.

[0015] In yet another aspect, the present invention provides use of an ocular implant according to the present invention for the preparation of a system for treating an ocular disease.

[0016] Therefore, the present invention provides a multi-segment ocular implant, as well as a system, use, and method for treating ocular diseases using the implant. Through a unique structural design, the present invention addresses the issues of ocular implant displacement and loss. In particular, the multi-segment, non-uniaxial design allows for a tight fit with tissue, aligning with the curvature of the implant incision and enhancing implant stability. Furthermore, through specialized material design, the present invention further addresses issues of adhesion to ocular tissue and / or reduces the risk of infection and other complications. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The present invention is explained in detail through the following specific embodiments and drawings, so that those skilled in the art can better understand the present invention. However, it should not be understood as limiting the scope of the present invention in any way.

[0018] Figure 1 a) and b) respectively illustrate three-section ocular implants with normal-section and / or oblique-section ports according to some specific embodiments of the present invention.

[0019] Figure 2 is an ocular implant having an anchor according to a specific embodiment of the present invention.

[0020] Figure 3 is an ocular implant having a flat structure according to a specific embodiment of the present invention.

[0021] Figure 4 is a schematic diagram of implanting an ocular implant according to the present invention at the ocular surface according to one embodiment of the present invention. DETAILED DESCRIPTION

[0022] The ocular implant of the present invention can be used as a drain to guide the aqueous humor of the eye from the anterior chamber to the ocular surface. Traditional minimally invasive glaucoma drainage devices usually introduce aqueous humor into the subconjunctival or suprachoroidal space. Subconjunctival drainage devices may cause adverse events such as choroidal effusion and conjunctival perforation. The suprachoroidal space is relatively narrow, the implantation space is limited, and the volume of aqueous humor that can be accommodated is correspondingly limited. Therefore, the present invention drains the aqueous humor to the ocular surface and discharges it in the form of tears, without causing any changes to the normal physiological structure of the eye, thus avoiding the occurrence of many adverse events. In addition, the aqueous humor introduced into the ocular surface is similar to artificial tears, which has an additional alleviating effect on patients with combined dry eye syndrome.

[0023] In a specific embodiment, an ocular implant according to the present invention comprises a distal port, a proximal port, and at least two hollow channels extending between the distal port and the proximal port and connected in a fluid communication manner, wherein any two adjacent hollow channels of the at least two hollow channels are not coaxial.

[0024] In this article, "coaxial" refers to the axes of two objects being identical or overlapping, and "non-coaxial" refers to the axes of two objects being different or non-overlapping. For the hollow channels of the present invention, this primarily refers to whether the axes are identical or overlapping in the longitudinal direction (i.e., the direction of fluid flow when the fluid passes through the channel, hereinafter referred to as "fluid flow direction").

[0025] In a specific embodiment, the ocular implant includes a first hollow channel and a second hollow channel extending between the distal port and the proximal port, the first hollow channel having a first inlet, a first outlet, and a first axis, the second hollow channel having a second inlet, a second outlet, and a second axis, the first outlet and the second inlet are connected in fluid communication, and the first axis and the second axis do not overlap.

[0026] In a specific embodiment, the ocular implant includes a first hollow channel, a second hollow channel, and a third hollow channel extending between the distal port and the proximal port, the first hollow channel having a first inlet, a first outlet, and a first axis, the second hollow channel having a second inlet, a second outlet, and a second axis, the third hollow channel having a third inlet, a third outlet, and a third axis, the first outlet and the second inlet are connected in fluid communication, the second outlet and the third inlet are connected in fluid communication, the first axis and the second axis do not overlap, and the second axis and the third axis do not overlap.

[0027] In a specific embodiment, the ocular implant includes a first hollow channel, a second hollow channel, a third hollow channel, and a fourth hollow channel extending between the distal port and the proximal port, the first hollow channel having a first inlet, a first outlet, and a first axis, the second hollow channel having a second inlet, a second outlet, and a second axis, the third hollow channel having a third inlet, a third outlet, and a third axis, the fourth hollow channel having a fourth inlet, a fourth outlet, and a fourth axis, the first outlet and the second inlet are connected in fluid communication, the second outlet and the third inlet are connected in fluid communication, the third outlet and the fourth inlet are connected in fluid communication, the first axis and the second axis do not overlap, the second axis and the third axis do not overlap, and the third axis and the fourth axis do not overlap.

[0028] Similarly, the ocular implant according to the present invention may also include five or more hollow channels. Thus, the ocular implant according to the present invention may include at least two, at least three, at least four, at least five, at least six, at least seven, at least eight, at least nine, at least ten, or more hollow channels.

[0029] The distal port and the proximal port of the ocular implant according to the present invention can independently have a normal cross-section, an oblique cross-section, or a combination thereof. Herein, a "normal cross-section" refers to a cross-section obtained by cutting along a plane perpendicular to the axis in the longitudinal extension direction or the direction of fluid flow, and an "oblique cross-section" refers to a cross-section obtained by cutting along a plane that is not perpendicular to the axis in the longitudinal extension direction or the direction of fluid flow.

[0030] Figure 1 a) and Figure 1 b) illustrates three-section eye implants with normal cross-section and / or oblique cross-section ports according to some specific embodiments of the present invention. Figure 1 As shown in FIG. 1 , an ocular implant 100 includes a distal port 102 and a proximal port 104, and a first hollow channel 101, a second hollow channel 103, and a third hollow channel 105 extending between the distal port 102 and the proximal port 104 and connected in a fluid communication manner. The first hollow channel 101 has a first inlet 101 a, a first outlet 101 b, and a first axis 101 c. The second hollow channel 103 has a second inlet 103 a, a second outlet 103 b, and a second axis 103 c. The third hollow channel 105 has a third inlet 105 a, a third outlet 105 b, and a third axis 105 c. The first inlet 101a coincides with the proximal port 104, the first outlet 101b is connected to the second inlet 103a in fluid communication, the second outlet 103b is connected to the third inlet 105a in fluid communication, the third outlet 105b coincides with the distal port 102, the first axis 101c and the second axis 103c do not overlap, and the second axis 103c and the third axis 105c do not overlap, that is, the first hollow channel 101 and the second hollow channel 103 are not coaxial, and the second hollow channel 103 and the third hollow channel 105 are not coaxial. The distal port 102 has a normal cross-section perpendicular to the third axis 105c, and the proximal port 104 has a normal cross-section perpendicular to the first axis 101c.

[0031] Figure 1 b) The ocular implant 200 shown with Figure 1The ocular implant 100 shown in a) is generally similar, differing primarily in that its distal port 202 has a normal cross-section perpendicular to the third axis 205c, while its proximal port 204 has an oblique cross-section at a non-perpendicular angle to the first axis 201c. Compared to a normal cross-section, an oblique cross-section facilitates implantation of the ocular implant. For example, it better aligns with the curvature of the implant incision and allows for a tight fit with the tissue, thereby improving implant stability. Furthermore, the forward-facing orientation of the oblique cross-section facilitates insertion of the implant through the wall of the anterior chamber, minimizing the possibility of blockage of the hollow passage opening and facilitating implant penetration. Furthermore, the oblique cross-section of the port provides a larger surface area for aqueous humor flow. By controlling the oblique cross-sectional area of ​​the port, the rate (flow rate) of aqueous humor drawn from the anterior chamber through the hollow passage to the ocular surface can be controlled to achieve a desired intraocular pressure. Therefore, a proximal port with an oblique cross-section not only facilitates implant insertion but also facilitates the flow of aqueous humor from the anterior chamber to the ocular surface.

[0032] In a specific embodiment, the eye implant according to the present invention has an anchoring member, so that the eye implant is better fixed in biological tissue. The anchoring member can be located at any appropriate position of the eye implant. Preferably, the anchoring member is located at the distal port and / or the proximal port, for example, within the range of 0-20mm, preferably 0-15mm, more preferably 0-10mm, even more preferably 0-5mm, most preferably 0-2mm from the distal port and / or the proximal port. The anchoring member can make the eye implant more stable at the implantation site, to further reduce or avoid the displacement and loss problem of the eye implant after implantation. The anchoring member can be an anchoring member with any applicable form, for example, can be annular, snap-on, toothed, barbed or other forms suitable for fixing. Figure 2 An ocular implant 300 is shown having donut-shaped anchors 310 at distal and proximal ports 302 and 304, respectively, in accordance with one embodiment of the present invention.

[0033] The anchor can be manufactured by simply thickening the structural material of the implant, such as a cross-linked polyolefin, at a suitable location within the hollow channel, or by installing the anchor at the suitable location. Furthermore, the anchor can be manufactured by removing excess material. The anchor can extend from the hollow channel in any practical functional shape, extending circumferentially around a portion of the hollow channel, or extending from the hollow channel in one or more directions.

[0034] It should be noted that the anchor can extend in any direction and in any shape and size that facilitates the implantation or anchoring of the ocular implant. Preferably, the anchor is located at the distal port and / or the proximal port to hold the implant in place and prevent it from sliding into the anterior chamber or out of the ocular surface.

[0035] The anchors may be constructed of textured, grooved, or porous materials to facilitate the growth of cells, such as fibroblasts, thereby stabilizing the implant and preventing migration.

[0036] In one embodiment, each hollow channel of the ocular implant can independently have one or more cross-sectional shapes selected from the group consisting of circular, triangular, rectangular, square, trapezoidal, pentagonal, hexagonal, heptagonal, octagonal, star-shaped, and irregular shapes. The cross-sectional shape of each hollow channel along its length or along the direction of fluid flow can vary, for example, in shape or size.

[0037] Adjacent hollow channels can be connected in various suitable forms. For example, adjacent hollow channels can be directly connected end to end, or they can be connected by a bridging member. For example, adjacent hollow channels can be connected by a bridging member having a curved axial section, a flat axial section or any other applicable shape, which is particularly advantageous when the cross-sections of adjacent hollow channels are different and / or the axes of adjacent hollow channels are parallel to each other. That is to say, any two adjacent hollow channels can be connected in a planar manner independently of each other, or they can be connected in a curved manner independently of each other. The planar connection includes connecting by using a bridging member having a single-plane axial section or a multi-plane axial section. The bridging member having a multi-plane axial section includes, for example, a bridging member having a stepped axial section. The curved connection includes connecting by using a bridging member having a curved axial section. The bridging member having a curved axial section includes, for example, a bridging member having an arcuate axial section. In this article, "axial section" refers to the section obtained by cutting the object along the plane where the axis in the length extension direction of the ocular implant or the direction of fluid flow is located, and "cross section" refers to the section obtained by cutting the object perpendicular to the axis in the length extension direction of the ocular implant or the direction of fluid flow.

[0038] Figure 3 An overall flat ocular implant 400 according to a specific embodiment of the present invention is shown, wherein a first hollow channel 401 and a second hollow channel 403 are connected by a first bridge member 413 having an arcuate axial cross-section, and a second bridge member 435 having an arcuate axial cross-section connects the second hollow channel 403 and the third hollow channel 405. The shapes and sizes of the first bridge member 413 and the second bridge member 435 can be identical or different. The bridge member can be integrally formed with one or both of the adjacent hollow channels, or it can be separately formed and then assembled with the adjacent hollow channels.

[0039] The surface of the ocular implant according to the present invention may have a porous structure. The porous structure may be in a form that is conducive to cell adhesion, proliferation, and differentiation, so that after the ocular implant is implanted in the body, it is conducive to the ingrowth of tissue cells around the implant site, thereby solving the problem that existing implants (such as ocular surface drainage tubes) are prone to bacterial infection. In one embodiment, the porous structure is a honeycomb structure or a honeycomb-like structure. In one embodiment, the porous structure is a randomly distributed irregular porous structure. In one embodiment, the inner diameter of the pores or the equivalent inner diameter of the pores in the porous structure may be 1-1000 nm, for example, 2-800 nm, 5-600 nm, 10-500 nm, 50-400 nm, 100-300 nm, or 80-200 nm. In a specific embodiment, the pore inner diameter or equivalent pore inner diameter in the porous structure may be 1-20 μm, such as 2-18 μm, 3-15 μm, 5-12 μm, 6-10 μm, 8-16 μm or 11-14 μm.

[0040] The ocular implant according to the present invention can be made of any material suitable for implantation into the eye. Suitable materials for implantation into the eye include, but are not limited to, metallic materials, polymeric materials, ceramic materials, and combinations thereof. In some embodiments, the ocular implant according to the present invention is made of one or more materials selected from the group consisting of cross-linked polyolefins, polysiloxanes, polytetrafluoroethylene, polycarbonate, polyethylene, polypropylene, polyacrylic acid, polymethyl methacrylate, polyethylene terephthalate, polyethylene glycol, polyurethane, polysulfone, polyvinylidene fluoride, polyhexafluoropropylene, perfluoroalkoxy polymers, fluorinated ethylene propylene, acrylic acid copolymers, parylene, polyimide, and composites thereof. Preferably, the ocular implant according to the present invention is made of a biocompatible material. Here, "biocompatible material" refers to a material that, upon implantation into a living organism, exhibits favorable effects and interactions with a specific biological tissue environment while minimizing adverse effects and interactions. In one specific embodiment, the ocular implant according to the present invention is made of a cross-linked polyolefin. Cross-linked polyolefins have excellent biocompatibility and do not induce rejection reactions such as inflammation upon implantation. Furthermore, the one or more materials forming the ocular implant can be elastic or inelastic.

[0041] The size of the ocular implant according to the present invention depends on the size of the implantation site. Generally speaking, the total length of the ocular implant can be 0.5-20 mm. For example, the total length of the ocular implant can be within the range defined by any two of 0.5 mm, 0.8 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 5.5 mm, 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, 11 mm, 11.5 mm, 12 mm, 12.5 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm. In a specific embodiment, the total length of the ocular implant can be 3-10 mm, for example, 4-9 mm, 5-8 mm, 6-7 mm, 4.5-6.5 mm, or 7.5-9.5 mm. The length of the ocular implant may exceed the actual length of the patient's anatomy, in which case the physician may trim the ocular implant to the desired / required length before or during the implantation procedure.

[0042] The lengths of the hollow channels of the ocular implant according to the present invention may be the same or different and may be adjusted independently of each other according to the size of the implantation site.

[0043] In some embodiments, the proximal and distal ports of the ocular implant are configured to prevent the attraction of new tissue (e.g., fibroblasts) that can grow at the surgical site and block the flow of aqueous humor. Thus, the distal port of the ocular implant can be configured to extend 0.1 to 3 mm into the anterior chamber, or preferably within a range defined by any two of 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, or 3.0 mm. The proximal port will also extend beyond the surgical site to prevent subsequent fibroblast proliferation. Therefore, the length of the distal portion can be 4mm to 6mm, or preferably within the range defined by any two values ​​of 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm, 5.0mm, 5.1mm, 5.2mm, 5.3mm, 5.4mm, 5.5mm, 5.6mm, 5.7mm, 5.8mm, 5.9mm, and 6.0mm.

[0044] The diameter of the hollow channel of the ocular implant should be of sufficient size to facilitate the flow of aqueous humor (a type of intraocular fluid) through the ocular drainage system while avoiding an outer diameter that significantly interferes with or impairs normal ocular function (e.g., does not interfere with blinking or normal eye movement). In some embodiments, the outer diameter or equivalent outer diameter of the hollow channel of the ocular implant can be in the range of 10 to 1000 μm, for example, in the range of 10 μm, 12 μm, 15 μm, 20 μm, 30 μm, 40 μm, 50 μm, 60 μm, 70 μm, 80 μm, 90 μm, 100 μm, 110 μm, 120 μm, 130 μm, 140 μm, 150 μm, 160 μm, 170 μm, 180 μm, 190 μm, 200 μm, 210 μm, 220 μm, 230 μm, 240 μm, 250 μm, 260 μm, 270 μm, 280 μm, 290 μm, 300 μm, 310 μm, 320 μm, 330 μm, 340 μm, 350 μm, 360 μm, 370 μm, 380 μm, 390 μm, 400 μm, 410 μm, 420 μm, 430 μm, 440 μm, 450 μm, 460 μm, 470 μm, 480 μm, 490 μm, 500 μm, 510 μm, 520 μm, 530 μm, 540 μm, 550 μm, 560 μ Various size combinations can be considered within the range defined by any two values ​​of 0μm, 180μm, 190μm, 200μm, 250μm, 300μm, 350μm, 400μm, 450μm, 500μm, 550μm, 600μm, 650μm, 700μm, 750μm, 800μm, 850μm, 900μm, 950μm, and 1000μm.

[0045] The inner diameter of the hollow channel can be constant or can vary along the length of the ocular implant. For example, the ocular implant can have a first inner diameter at its proximal port, a second inner diameter at its distal port, and a third inner diameter at a position between the proximal port and the distal port along the length of the ocular implant. In this embodiment, it should be understood that the second inner diameter can be greater than the first inner diameter and the third inner diameter, wherein the third inner diameter can be greater than (or alternatively less than) the first inner diameter. Therefore, in some embodiments, the first inner diameter and the second inner diameter can be greater than the third inner diameter. Alternatively, the third inner diameter can be greater than each of the first inner diameter and the second inner diameter. In the case where the inner diameter of the ocular implant varies along the length of the ocular implant, the inner diameter can vary in a continuous manner or in a discrete (e.g., stepped) manner. Additionally or alternatively, the wall thickness of the ocular implant can be constant or can vary along the length of the ocular implant. Thus, in some embodiments, the inner diameter of the ocular implant can vary along the length of the ocular implant, and the wall thickness of the ocular implant can vary along the length of the ocular implant, such that the ocular implant maintains a constant outer diameter along its length. Alternatively, in some embodiments, the outer diameter of the ocular implant can vary along the length of the ocular implant, and the wall thickness of the ocular implant can vary along the length of the ocular implant, such that the ocular implant maintains a constant inner diameter along its length. In a specific embodiment, each hollow channel in the ocular implant independently has an inner diameter or an equivalent inner diameter of 10-500 μm, for example, an inner diameter or an equivalent inner diameter within the range defined by any two of 10 μm, 12 μm, 15 μm, 20 μm, 25 μm, 30 μm, 35 μm, 40 μm, 50 μm, 60 μm, 70 μm, 80 μm, 90 μm, 100 μm, 110 μm, 120 μm, 130 μm, 140 μm, 150 μm, 160 μm, 170 μm, 180 μm, 190 μm, 200 μm, 250 μm, 300 μm, 350 μm, 400 μm, 450 μm, or 500 μm. In a specific embodiment, each hollow channel in the ocular implant independently has an inner diameter or equivalent inner diameter of 60-180 μm, 70-160 μm, 80-140 μm, 100-120 μm, 65-95 μm, 75-110 μm, 90-150 μm, or 130-170 μm. Although examples of outer diameters, inner diameters, and wall thicknesses have been provided, various sizes and variations are contemplated and are included within the scope of the present invention.

[0046] The present invention also relates to a system for treating eye diseases, the system comprising: an incision making device and an eye implant according to the present invention, wherein the incision making device is used to make a multi-plane incision at a target position according to the shape of the eye implant. Here, "multi-plane incision" refers to an incision comprising two or more different planes. The multi-plane incision can be a double-plane incision, a three-plane incision, a four-plane incision, a five-plane incision, and so on. This multi-plane incision structure is easy to seal, bacteria are not easy to invade, and the overall stability and safety of the implant after implantation are good. In a specific embodiment, the multi-plane incision is a three-plane incision.

[0047] The multi-plane incision can be made in any medically appropriate manner. For example, in a specific embodiment, the multi-plane incision can be made by a puncture knife and / or a femtosecond laser.

[0048] The target location can be one or more selected from the group consisting of the ocular surface, cornea, conjunctiva, sclera, iris, and choroid. In a specific embodiment, the incision can be located in front of the limbus boundary, and the portion where the blood vessels are nearly transparent is made through a clear corneal incision.

[0049] In one embodiment, the target location is located on the ocular surface, such that aqueous humor flows from the anterior chamber of the eye to the tear film. In one embodiment, the target location is located on the cornea. In one embodiment, the target location is located on the sclera. In some embodiments, the ocular implant according to the present invention drains aqueous humor into the tear film, rather than into the subconjuctival space. Thus, conjunctival blisters are not formed, and thus, there is no possibility of scarring. The aqueous humor can drain into the tear film, thereby providing moistening and lubrication to the surface of the eye. The drainage of aqueous humor from the ocular implant of the present invention into the tear film can alleviate the symptoms of dry eye in glaucoma patients in whom the implant is implanted.

[0050] Figure 4A schematic diagram illustrates the implantation of an ocular implant according to one embodiment of the present invention on the ocular surface, wherein the oval circled portion represents the implantation site of the multi-segment drainage tube according to the present invention. An exemplary implant 500 is shown implanted in a diseased eye 550 and can be used to treat glaucoma in the diseased eye 550. The anatomical features of eye 550 are shown, including an anterior chamber 520, cornea 522, sclera 524, conjunctiva 526, iris 528, lens 530, and ocular surface 532. Implant 500 is positioned on cornea 522 so that distal port 502 is located in anterior chamber 520 and proximal port 504 is located on ocular surface 532. This allows aqueous humor to flow from anterior chamber 520 to ocular surface 532, where it can be drained in a tear-like manner, without altering the normal physiological structure of the eye and thus avoiding the occurrence of numerous adverse events. Furthermore, the aqueous humor introduced into the ocular surface acts like artificial tears, providing additional relief for patients with concurrent dry eye.

[0051] Although the word "about" is not used to describe the numerical values ​​and numerical ranges mentioned in this application, it should be understood that these numerical values ​​and numerical ranges can vary within the range of ±5% without departing from the scope of the present invention.

[0052] Unless otherwise expressly provided, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the invention pertains. Although some methods and materials are described in detail herein, methods and materials similar or equivalent to those described herein may also be used in practicing the present invention even if not specifically mentioned herein. For example, the various specific hollow channel structures described herein are not an exhaustive list of the various structures that can be used to construct the ocular implants provided herein. In addition, the features of one or more of the illustrated hollow channel structures may be combined with the features of one or more other illustrated hollow channel structures to produce many different combinations, which are within the scope of this application. All publications, patent applications, patents, and other references mentioned herein are incorporated herein by reference in their entirety. In the event of a conflict, the definitions in this application shall prevail. In addition, these materials, methods, and examples are illustrative only and should not be construed as limiting the scope of protection claimed in this application.

[0053] Although this specification contains many details of specific embodiments, these details should not be construed as limitations on the scope of any invention or of what may be claimed, but rather as detailed descriptions of features that may be features of particular embodiments of particular inventions. Certain features described in this specification in the context of separate embodiments may also be implemented in combination in a single embodiment, and various features described in the context of a single embodiment may also be implemented in multiple embodiments, either separately or in any suitable subcombination.

Claims

1. An ocular implant comprising a distal port, a proximal port, and at least two hollow channels extending between the distal port and the proximal port and connected in a fluid communication manner, characterized in that Any two adjacent hollow channels among the at least two hollow channels are not coaxial; wherein the ocular implant comprises a first hollow channel and a second hollow channel extending between the distal port and the proximal port, the first hollow channel having a first inlet, a first outlet, and a first axis, the second hollow channel having a second inlet, a second outlet, and a second axis, the first outlet and the second inlet being connected in fluid communication, and the first axis and the second axis not overlapping; The ocular implant further includes a third hollow channel having a third inlet, a third outlet, and a third axis, the second outlet and the third inlet are connected in fluid communication, and the second axis and the third axis do not overlap.

2. The ocular implant according to claim 1, characterized in that Any two adjacent hollow channels are independently connected to each other directly or through a bridge.

3. The ocular implant according to claim 1, characterized in that Any two adjacent hollow channels are independently connected to each other via a bridging member, wherein the bridging member is a bridging member having a curved axial cross-section.

4. The ocular implant according to any one of claims 1 to 3, characterized in that The ocular implant has an anchor.

5. The ocular implant according to claim 4, wherein The anchor is located at the distal port and / or the proximal port.

6. The ocular implant according to any one of claims 1 to 3, characterized in that The outer surface of the ocular implant has a porous structure.

7. The ocular implant according to any one of claims 1 to 3, characterized in that Each hollow channel independently has one or more cross-sectional shapes selected from the group consisting of circle, triangle, rectangle, square, trapezoid, pentagon, hexagon, heptagon, octagon, and star.

8. The ocular implant according to any one of claims 1 to 3, characterized in that The distal port and the proximal port independently have a normal cross section, an oblique cross section or a combination thereof.

9. The ocular implant according to any one of claims 1 to 3, characterized in that The ocular implant is made of one or more materials selected from the group consisting of cross-linked polyolefins, polysiloxanes, polytetrafluoroethylene, polycarbonate, polyethylene, polypropylene, polyacrylic acid, polymethyl methacrylate, polyethylene terephthalate, polyethylene glycol, polyurethane, polysulfone, polyvinylidene fluoride, polyhexafluoropropylene, perfluoroalkoxy polymers, fluorinated ethylene propylene, acrylic copolymers, parylene, polyimide, and composites thereof.

10. The ocular implant according to any one of claims 1 to 3, characterized in that The ocular implant is made of a cross-linked polyolefin.

11. The ocular implant according to any one of claims 1 to 3, wherein The ocular implant has an overall length of 0.5-20 mm.

12. The ocular implant of claim 1, wherein: Each hollow channel independently has an inner diameter or an equivalent inner diameter of 10-500 μm.

13. A system for treating an eye disease, the system comprising: incision making device, and The ocular implant according to any one of claims 1 to 12, The incision making device is used to make multi-plane incisions at the target position according to the shape of the eye implant.

14. The system of claim 13, wherein the target location is one or more selected from the group consisting of an ocular surface, a cornea, a conjunctiva, a sclera, an iris, and a choroid.

15. The system of claim 13 or 14, wherein the multi-plane incision is a tri-plane incision.

16. Use of the ocular implant according to any one of claims 1 to 12 for preparing a system for treating an ocular disease.

17. The use according to claim 16, wherein the eye disease is one or more selected from glaucoma, dry eye, increased intraocular pressure, increased aqueous humor, cataract, impaired visual function, visual fatigue, optic atrophy, visual field defect, myopia, and maculopathy.

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