A corneal pathway unidirectional aqueous humor outflow device

Abstract

The application provides a corneal path one-way aqueous humor outflow device, which is internally formed with a Tesla valve unit group outflow channel for draining aqueous humor to an ocular surface, and the outflow channel is one-way outflow. The aqueous humor outflow device provided by the application introduces a Tesla valve as a structure for preventing backflow of aqueous humor, and when liquid flows into the Tesla valve unit group from a liquid outlet, the Tesla valve unit group can block the liquid from flowing to a liquid inlet. The aqueous humor outflow device provided by the application also has the following advantages: it can be used for reducing intraocular pressure of glaucoma patients and can also be used for severe dry eye; it is made of a material with good biocompatibility, has high drainage efficiency in clinical application, has the advantages of compact structure, convenient 3D printing modeling and forming, low cost and convenient use.

Description

Technical Field

[0001] This invention relates to the field of ophthalmic medical device technology, and in particular to a corneal pathway unidirectional aqueous humor drain. Background Technology

[0002] Glaucoma is the second leading cause of irreversible blindness worldwide. Statistics show that there are approximately 60.5 million glaucoma patients globally, with 8.4 million experiencing bilateral blindness. In the United States, the direct cost of glaucoma treatment reaches $2.9 billion annually. While there are currently no statistics on glaucoma treatment costs in my country, given that the number of glaucoma patients in my country is 5-6 times that of the United States, if all glaucoma patients were treated, the direct cost of glaucoma treatment in my country is estimated to reach $15-18 billion. The indirect economic losses caused by glaucoma could be even greater. More seriously, with an aging population, the 2022 policy emphasized strengthening the prevention and control of key eye diseases among key populations, explicitly stating the need to improve the early diagnosis and treatment of glaucoma. With the accelerating aging population and rising public health awareness, the future market potential for glaucoma treatment is enormous. Therefore, research on the prevention and treatment of glaucoma has significant social and economic implications.

[0003] Currently, the main clinical treatments for glaucoma in China are medication and surgery. Early treatment often involves medication (eye drops), while later stages are treated primarily with the "gold standard" surgery, trabeculectomy, which originated in 1968. All current treatments aim to control intraocular pressure and preserve vision throughout the patient's lifespan through rational and effective methods. These two intervention methods have been used for many years. Medication treatment has drawbacks such as drug efficacy drift, poor patient compliance, lifelong medication, and adverse drug reactions. Trabeculectomy, the current "gold standard" for glaucoma surgery, presents numerous problems, including a long learning curve for surgeons, significant surgical trauma, substantial damage to normal eye structures and functions, and complex complications.

[0004] To address these pain points, experts, scholars, and companies in the field have been exploring and experimenting, hoping to find alternative surgical methods with lower complication rates and less trauma. In recent years, the next-generation MIGS surgery, which has become increasingly popular internationally and has been validated in over a million cases, is attracting more and more attention. Its advantages, such as small surgical incisions, short operation time, rapid postoperative recovery, and a low learning curve for doctors, have made it increasingly valued by ophthalmologists. It is understood that the next-generation MIGS, as an emerging and popular method for glaucoma treatment, has been widely applied internationally. In the four years from 2018 to the present, more than one million glaucoma patients worldwide have undergone MIGS intervention and treatment.

[0005] Based on the principle of lowering intraocular pressure (IOP), the mainstream MIGS procedures and products can be divided into three types: ① increasing the trabecular meshwork pathway for aqueous humor outflow; ② suprachoroidal aqueous humor drainage; ③ subconjunctival aqueous humor drainage. Among these, MIGS procedures ① and ② primarily utilize the original physiological aqueous humor outflow pathway, resulting in a smaller IOP reduction compared to traditional trabeculectomy. They are suitable for early to mid-stage open-angle glaucoma patients and have the advantage of minimal impact on the conjunctiva. MIGS procedure ③ has a similar mechanism of action and IOP reduction to traditional trabeculectomy, but its advantage lies in a lower postoperative complication rate compared to trabecular meshwork resection.

[0006] Among the MIGS surgeries currently available, the one that utilizes the trabecular meshwork Schlemm's canal pathway is iStent, which was approved by the FDA in 2012 and is suitable for glaucoma patients with mild disease course. Its 1-year efficacy rate is 33.7%, but its disadvantage is that the filtration channel is prone to blockage. Among the drugs utilizing the suprachoroidal pathway of the ciliary body are iStent inject W (FDA approved in 2020, currently without relevant literature reports); Hydrus (FDA approved in 2018, with a 1-year efficacy rate of 37.1%); iStent inject (CE approved in 2010, with a 2-year efficacy rate of 31.0%); CyPass Micro-Stent (discontinued in 2018, its disadvantages include a high risk of low intraocular pressure and filtration channel blockage); SOLX gold shunt (marketed in Canada, with a 5-year efficacy rate of 35.8%); STARflo™ Glaucoma Implant (CE approved in 2012, with a 2-year efficacy rate of 38.5%); and MINIject™ (CE approved in 2020, with a 6-month efficacy rate of 39.1%). For subconjunctival drainage, there's the XEN Gel Stent, approved by the FDA in 2016. Its drawback is conjunctival scarring, with a 1-year efficacy rate of 36.3%. The PRESERFLO™ MicroShunt, approved by the CE in 2012, also suffers from conjunctival scarring, with a 5-year efficacy rate of 46.7%. In summary, common MIGS devices currently available have drawbacks such as filtration channel blockage, fibrosis, drainage device displacement, and conjunctival scarring.

[0007] In summary, different products have their own characteristics and different indications. Recently, foreign literature reported an externally operated glaucoma drain that can directly drain aqueous humor to the cornea, significantly lowering intraocular pressure and showing effectiveness in treating severe dry eye. From the perspective of the approach, external implantation surgery is simple and convenient, directly draining aqueous humor to the ocular surface and effective for severe dry eye. It is an aqueous humor drain with significant comprehensive advantages and broad application prospects. Summary of the Invention

[0008] Embodiments of the present invention provide a corneal pathway unidirectional aqueous humor drainage device to solve the problems existing in the prior art.

[0009] To achieve the above objectives, the present invention adopts the following technical solution.

[0010] A corneal pathway unidirectional aqueous humor drainer has a Tesla valve unit assembly inside, which is configured as a drainage channel; the drainage channel is unidirectional and is used to drain aqueous humor from the eye to the ocular surface.

[0011] Preferably, the system includes a substrate having a first side and a second side connected to each other, and a Tesla valve unit assembly; one end of the first side has a liquid inlet, and one end of the second side has a liquid outlet; the Tesla valve unit assembly passes through the first side and the second side and connects the liquid inlet and the liquid outlet; when liquid flows into the Tesla valve unit assembly from the liquid outlet, the Tesla valve unit assembly can block the liquid from flowing to the liquid inlet.

[0012] Preferably, the Tesla valve unit group includes multiple Tesla valve units connected in series. Each Tesla valve unit includes a first channel and a second channel located on one radial side of the first channel. The second channel includes a second liquid inlet and a second liquid outlet that are interconnected. One end of the second liquid inlet and the second liquid outlet are respectively connected to the first channel. The area of ​​the second liquid inlet connected to the first channel is configured as the liquid inlet end of the Tesla valve unit, and the area of ​​the second liquid outlet connected to the first channel is configured as the liquid outlet end of the Tesla valve unit. The second liquid inlet and the second liquid outlet are respectively angled with the first channel, and the angle between the second liquid inlet and the first channel is greater than the angle between the second liquid outlet and the first channel. When liquid enters the Tesla valve unit from the liquid outlet end, the liquid flowing out from the second liquid inlet can block the flow of liquid in the first channel.

[0013] Preferably, the first channels of adjacent Tesla valve units have overlapping sections, and in the adjacent Tesla valve units, the liquid outlet of one Tesla valve unit and the liquid inlet of another Tesla valve unit are located on both sides of the section; the second channels of the adjacent Tesla valve units are opposite to each other.

[0014] Preferably, the first channel of each Tesla valve unit includes a first liquid inlet and a first liquid outlet that are interconnected; the first liquid inlet and the first liquid outlet of each Tesla valve unit have an included angle with each other;

[0015] In adjacent Tesla valve units: the first liquid outlet of one Tesla valve unit coincides with the first liquid inlet of another Tesla valve unit; the tilt angle of the second liquid outlet of one Tesla valve unit is the same as the tilt angle of the first liquid inlet of another Tesla valve unit.

[0016] Preferably, the length of the substrate is 1.0 mm to 6.0 mm, and the thickness is 0.05 mm to 0.5 mm; the diameter of the inlet and outlet is 0.01 mm to 0.09 mm.

[0017] Preferably, the length of the substrate is 3.0 mm to 4.0 mm, and the thickness is 0.15 mm to 0.3 mm; the diameter of the inlet and outlet is 0.02 mm to 0.06 mm.

[0018] Preferably, the diameter of the drainage channel is 0.01mm to 0.09mm.

[0019] Preferably, the outer wall has an auxiliary fixing structure to prevent axial movement of the corneal pathway unidirectional aqueous humor drain.

[0020] Preferably, the auxiliary fixing structure includes: a fixing part with multiple radial protrusions on both radial sides of the second side; the multiple fixing parts are arranged sequentially along the axial direction of the base, and the length of the fixing part located on the side of the base is greater than the length of the fixing part located in the middle of the base, so that the base forms a barbed structure.

[0021] Preferably, biocompatible materials are used.

[0022] Preferably, the biocompatible material is a photocurable biocompatible material.

[0023] Preferably, the photocurable biocompatible material includes any one of epoxy resin (meth)acrylate materials, polyester (meth)acrylate materials, polyurethane (meth)acrylate materials, (meth)acrylate monomers, and (meth)acrylate modified natural biomaterials.

[0024] Preferably, the photocurable biocompatible material includes any one of bisphenol A trioxide dimethacrylate, bisphenol A epoxy methacrylate, polyethylene glycol di(meth)acrylate, (meth)acrylate modified gelatin, and (meth)acrylate modified hyaluronic acid.

[0025] As can be seen from the technical solutions provided by the embodiments of the present invention described above, the corneal pathway unidirectional aqueous humor drainage device provided by the present invention has a Tesla valve unit group drainage channel formed therein, used to drain aqueous humor to the ocular surface, and the drainage channel is unidirectional. The aqueous humor drainage device provided by the present invention introduces a Tesla valve as a structure to prevent backflow of aqueous humor. When liquid flows into the Tesla valve unit group from the outlet, the Tesla valve unit group can block the liquid from flowing towards the inlet. The aqueous humor drainage device provided by the present invention also has the following advantages: it can be used to lower intraocular pressure in glaucoma patients and can also be used for severe dry eye; it is made of biocompatible materials and has high drainage efficiency in clinical practice; it has a compact structure, is easy to model and mold using 3D printing, and is low in cost and easy to use.

[0026] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and will become apparent from the description or may be learned by practice of the invention. Attached Figure Description

[0027] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0028] Figure 1 A front view of a corneal pathway unidirectional aqueous humor drainage device provided by the present invention;

[0029] Figure 2 for Figure 1 A sectional view;

[0030] Figure 3 for Figure 1 A bottom view;

[0031] Figure 4 for Figure 1 The left view;

[0032] Figure 5 for Figure 1 The right view;

[0033] Figure 6 This invention provides a schematic diagram of the Tesla valve unit group structure in a corneal pathway unidirectional aqueous humor drain;

[0034] Figure 7 A schematic diagram of another preferred embodiment of a corneal pathway unidirectional aqueous humor drainage device provided by the present invention;

[0035] Figure 8 A schematic diagram of a corneal pathway unidirectional aqueous humor drain device used in an ex vivo pig eye tissue for drainage, provided by this invention;

[0036] Figure 9 This is a schematic diagram illustrating the safety experiment of a corneal pathway unidirectional aqueous humor drain device in a live rabbit eye tissue, as provided by the present invention.

[0037] In the picture:

[0038] 1. Substrate; 11. First side portion; 12. Second side portion; 13. Liquid inlet; 14. Liquid outlet; 15. Fixing part;

[0039] 2. Tesla valve unit group 21. First channel 211. First liquid inlet 212. First liquid outlet 22. Second channel 221. Second liquid inlet 222. Second liquid outlet 23. Liquid inlet end 24. Liquid outlet end. Detailed Implementation

[0040] Embodiments of the present invention are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0041] Those skilled in the art will understand that, unless specifically stated otherwise, the singular forms “a,” “an,” “the,” and “the” used herein may also include the plural forms. It should be further understood that the term “comprising” as used in this specification means the presence of the stated features, integers, steps, operations, elements, and / or components, but does not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. It should be understood that when we say an element is “connected” or “coupled” to another element, it can be directly connected or coupled to the other element, or there may be intermediate elements. Furthermore, “connected” or “coupled” as used herein can include wireless connections or couplings. The term “and / or” as used herein includes any and all combinations of one or more of the associated listed items.

[0042] It will be understood by those skilled in the art that, unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. It should also be understood that terms such as those defined in general dictionaries should be understood to have the same meaning as in the context of the prior art, and should not be interpreted in an idealized or overly formal sense unless defined as herein.

[0043] To facilitate understanding of the embodiments of the present invention, the following will provide further explanation and description with reference to the accompanying drawings and several specific embodiments. These embodiments do not constitute a limitation on the embodiments of the present invention.

[0044] This invention provides an aqueous humor drainage device for glaucoma treatment, which solves the following technical problems existing in the prior art: some existing aqueous humor drainage devices cannot effectively prevent aqueous humor backflow, affecting the treatment effect; although some other aqueous humor drainage devices are equipped with one-way valves, their backflow prevention effect is limited due to the small size of the device; and some drainage devices rely on external devices for drainage, which is inconvenient to use.

[0045] The present invention provides a corneal pathway unidirectional aqueous humor drainage device, which has a Tesla valve unit group inside. The Tesla valve unit group is constructed as a drainage channel. The drainage channel is unidirectional, that is, it can drain the aqueous humor in the eye to the ocular surface and prevent the aqueous humor from flowing back to the ocular surface.

[0046] In the preferred embodiment provided by the present invention, see Figures 1 to 7 This aqueous humor drainage device includes a base 1, which has a first side 11 and a second side 12 integrally formed and connected to each other, as well as a Tesla valve unit assembly 2. The aqueous humor drainage device is wedged into the eye through the first side 11, one end of which has a liquid inlet 13, and one end of the second side 12 has a liquid outlet 14. The Tesla valve unit assembly 2 passes through the first side 11 and the second side 12, and connects the liquid inlet 13 and the liquid outlet 14. In the embodiment provided by the present invention, the Tesla valve unit assembly 2 is used to prevent aqueous humor backflow (i.e., from the liquid outlet 14 to the liquid inlet 13). When liquid flows into the Tesla valve unit assembly 2 from the liquid outlet 14, the Tesla valve unit assembly 2 can block the liquid from flowing to the liquid inlet 13.

[0047] In a preferred embodiment of the present invention, the Tesla valve unit group 2 includes a plurality of Tesla valve units connected in series. Each Tesla valve unit includes a first channel 21 and a second channel 22 located on one radial side of the first channel 21. The second channel 22 includes a second liquid inlet 221 and a second liquid outlet 222 that are interconnected. One end of the second liquid inlet 221 and the second liquid outlet 222 are respectively connected to the first channel 21. The second liquid inlet 221 connects to the region of the first channel 21 (e.g.,...). Figure 6 The ends of the two sections (shown in the diagram) are configured as the inlet end 23 of the Tesla valve unit, and the area where the second outlet 222 connects to the first channel 21 is configured as the outlet end 24 of the Tesla valve unit. The second inlet 221 and the first channel 21 have an angle, and the second outlet 222 and the first channel 21 also have an angle. The angle between the second inlet 221 and the first channel 21 is greater than the angle between the second outlet 222 and the first channel 21. For example, the second inlet 221 and the first channel 21 are nearly perpendicular to each other. In the Tesla valve unit with the above configuration, when liquid flows back into it from the outlet end 24, part of it flows towards the outlet end 24 along the first channel 21, and the other flows towards the outlet end 24 along the second channel 22. When the two liquids converge at the outlet end 24, the angle between the second inlet 221 and the first channel 21 is very steep, so the liquid flowing out of the second inlet 221 can form a large resistance to the liquid flowing out of the first channel 21, thus blocking the flow of liquid in the first channel 21.

[0048] In order to arrange as many Tesla valve units as possible within a limited space, in some improved embodiments, such as Figure 6As shown, the first channels 21 of adjacent Tesla valve units have overlapping sections (i.e., partially overlapping). In each pair of adjacent Tesla valve units: the second channels 22 of the two Tesla valve units are respectively arranged on both radial sides of the first channel 21, forming a mutually opposing arrangement; the liquid outlet 24 of one Tesla valve unit and the liquid inlet 23 of the other Tesla valve unit are respectively located at the two ends of the overlapping section of the first channel 21. Through the above arrangement, a layout is formed in which the second channels 22 are staggered and interconnected, resulting in a compact structure and good space utilization.

[0049] Furthermore, the first channel 21 of each Tesla valve unit includes a first liquid inlet 211 and a first liquid outlet 212 that are interconnected; the first liquid inlet 211 and the first liquid outlet 212 of each Tesla valve unit have an included angle with each other, such as... Figure 2 and 6 As shown, when multiple Tesla valve units are connected in series, the intermediate channel section composed of the first channel 21 is generally zigzag-shaped.

[0050] Based on this, in some improved embodiments, in adjacent Tesla valve units: (with the positive direction of liquid flow from inlet end 23 to outlet end 24 as a reference), the first outlet portion 212 of the Tesla valve unit located in front coincides with the first inlet portion 211 of the Tesla valve unit located behind; the tilt angle of the second outlet portion 222 of one Tesla valve unit is the same as the tilt angle of the first inlet portion 211 of the other Tesla valve unit. For example, in Figure 2 and 6 As shown, the second liquid outlet 222 of a Tesla valve unit located at the front is directly connected to the first liquid outlet 212 of another Tesla valve unit located at the rear, and the two are inclined at the same angle, forming a straight channel as a whole, which can reduce the resistance to the forward flow of liquid and help to drain aqueous humor.

[0051] exist Figure 2 and 6The diagram shows an optimal configuration of a Tesla valve unit group 2: the first inlet section 211 and the first outlet section 212 of each Tesla valve unit have an angle between them, the absolute values ​​of the tilt angles of the first inlet section 211 and the first outlet section 212 of each Tesla valve unit are the same, but the directions are opposite, and the middle channel section composed of the first channel 21 is generally zigzag-shaped; the first outlet section 212 of the Tesla valve unit located in front coincides with the first inlet section 211 of the Tesla valve unit located behind, the second outlet section 222 of the Tesla valve unit located in front is directly connected to the first outlet section 212 of the Tesla valve unit located behind, and the two have the same tilt angle, forming a straight channel; the second inlet section 221 and the second outlet section 222 of the second channel 22 of each Tesla valve unit have the same length and the same tilt angle (direction angle), the second inlet section 221 of each Tesla valve unit is perpendicular to the first inlet section 211, and the connection area between the second inlet section 221 and the second outlet section 222 of each Tesla valve unit is an arc-shaped bending structure. With the above settings, two adjacent Tesla valve units form a mirror-symmetrical configuration with the overlapping first channel 21 as the axis. This facilitates production and processing. For example, when using 3D printing technology, it is more convenient from modeling to printing, which can effectively improve production efficiency.

[0052] The applicant found in the experiment that when the axial length of the substrate 1 is 1.0mm to 6.0mm, preferably 3.0mm to 4.0mm, the thickness is 0.05mm to 0.5mm, preferably 0.15mm to 0.3mm, and the diameter of the inlet 13 and outlet 14 is 0.01mm to 0.09mm, preferably 0.02mm to 0.06mm, the finished product of the water drainage device formed by 3D printing process can simultaneously meet the requirements of structural strength and printing accuracy.

[0053] In a preferred embodiment of the present invention, the diameter of the drainage channel ranges from 0.01 mm to 0.09 mm, preferably from 0.02 mm to 0.06 mm.

[0054] In addition, the difference between the thickness of the inlet 13, outlet 14, drainage channel and the substrate 1 is at least 0.04 mm. For example, when the thickness of the inlet 13, outlet 14 and drainage channel is 0.09 mm, the thickness of the substrate 1 is at least 0.13 mm.

[0055] In a preferred embodiment of the present invention, the aqueous humor drainage device adopts an approximately hook-shaped shape, with one side having an approximately trapezoidal structure whose diameter gradually decreases towards its end, and the end face of this side being an arc-shaped surface. The other side has a radially protruding auxiliary fixing structure to prevent axial movement of the corneal pathway unidirectional aqueous humor drainage device.

[0056] Specifically, such as Figure 1 and2 As shown, in a preferred embodiment, the first side portion 11 has an approximately trapezoidal structure, and the end face of the inlet 13 is arc-shaped to facilitate the insertion of the drainage device into the eye. The auxiliary fixing structure includes: the second side portion 12 has multiple radially protruding fixing portions 15 on its radial sides to prevent the drainage device from sliding in the eye. These multiple fixing portions 15 are arranged sequentially along the axial direction of the base, and the length of the fixing portion 15 located on the side of the base 1 (i.e., adjacent to the outlet 14 of the second side portion 12) is greater than the length of the fixing portion 15 located in the middle of the base 1 (the area where the first side portion 11 and the second side portion 12 connect). The first side portion 11 and the second side portion 12, with the above-described configuration, give the aqueous humor drainage device an approximately hook-shaped structure.

[0057] In another preferred embodiment, the auxiliary fixing structure is a recess (not shown in the figure), and the specific arrangement is similar to that of the fixing part 15 described above. A protrusion with anchoring effect is formed between adjacent recesses.

[0058] The aforementioned fixing part 15 is preferably a convex ring, convex dot, convex ridge, convex piece or threaded protrusion, and the recessed part is preferably a concave dot, groove or recessed thread structure.

[0059] like Figure 1 As shown, this water drainage device adopts a configuration with an arc-shaped end face on one end and a flat surface on the other end. It can also be configured as follows: Figure 7 As shown, it adopts a configuration with arc-shaped end faces at both ends.

[0060] In a preferred embodiment of the present invention, the aqueous humor drainage device uses a biocompatible material, preferably a photocurable biocompatible material suitable for 3D printing. Specifically, it is any one of epoxy resin (meth)acrylate materials, polyester (meth)acrylate materials, polyurethane (meth)acrylate materials, (meth)acrylate monomers, and (meth)acrylate-modified natural biomaterials. Preferably, it is any one of bisphenol A trioxide dimethacrylate, bisphenol A epoxy methacrylate, polyethylene glycol di(meth)acrylate, (meth)acrylate-modified gelatin, and (meth)acrylate-modified hyaluronic acid.

[0061] Figure 8 The schematic diagram of the drainage experiment of the corneal pathway unidirectional aqueous humor drain provided by the present invention in isolated pig eye tissue shows that when the staining liquid is dripped on the second side 12 of the aqueous humor drain that is wedged into the eye tissue, the Tesla valve unit group in the aqueous humor drain can effectively prevent the staining liquid from flowing from the second side to the first side 11.

[0062] Figure 9This is a schematic diagram of the safety experiment of the corneal pathway unidirectional aqueous humor drainage device provided by the present invention in live rabbit eye tissue. The figure shows the state of the aqueous humor drainage device on the 4th day after implantation into the rabbit eye tissue. Figure a shows the state of rabbit No. 1 and Figure b shows the state of rabbit No. 2. As can be seen from the figure, no allergic or inflammatory reaction was observed in the eye tissue of either rabbit, and the aqueous humor drainage device has good safety.

[0063] In summary, this invention provides a unidirectional aqueous humor drainage device with a Tesla valve unit assembly forming a drainage channel for draining aqueous humor to the ocular surface. The drainage channel is unidirectional. The aqueous humor drainage device provided by this invention incorporates a Tesla valve as a structure to prevent backflow of aqueous humor. When liquid flows into the Tesla valve unit assembly from the outlet, the Tesla valve unit assembly can block the liquid from flowing towards the inlet. The aqueous humor drainage device provided by this invention also has the following advantages: it can be used to lower intraocular pressure in glaucoma patients and for severe dry eye; it is made of biocompatible materials, resulting in high drainage efficiency in clinical practice; it has a compact structure, is easy to model and mold using 3D printing, and is low in cost and easy to use.

[0064] Those skilled in the art will understand that the accompanying drawings are merely schematic diagrams of one embodiment, and the modules or processes shown in the drawings are not necessarily essential for implementing the present invention.

[0065] As can be seen from the above description of the embodiments, those skilled in the art can clearly understand that the present invention can be implemented by means of software plus necessary general-purpose hardware platforms. Based on this understanding, the technical solution of the present invention, or the part that contributes to the prior art, can be embodied in the form of a software product. This computer software product can be stored in a storage medium, such as ROM / RAM, magnetic disk, optical disk, etc., and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute the methods described in various embodiments or some parts of the embodiments of the present invention.

[0066] The various embodiments in this specification are described in a progressive manner. Similar or identical parts between embodiments can be referred to mutually. Each embodiment focuses on describing the differences from other embodiments. In particular, for apparatus or system embodiments, since they are basically similar to method embodiments, the description is relatively simple; relevant parts can be referred to the descriptions in the method embodiments. The apparatus and system embodiments described above are merely illustrative. The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the modules can be selected to achieve the purpose of this embodiment according to actual needs. Those skilled in the art can understand and implement this without creative effort.

[0067] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A corneal pathway unidirectional aqueous humor drainage device, characterized in that, The corneal pathway unidirectional aqueous humor drainer has a Tesla valve unit group inside, which is configured as a drainage channel; the drainage channel is unidirectional and is used to drain the aqueous humor in the eye to the ocular surface; The device includes a substrate having a first side and a second side connected to each other, and the Tesla valve unit assembly. One end of the first side has a liquid inlet, and one end of the second side has a liquid outlet. The Tesla valve unit assembly passes through the first side and the second side and connects the liquid inlet and the liquid outlet. When liquid flows into the Tesla valve unit assembly from the liquid outlet, the Tesla valve unit assembly can block the liquid from flowing towards the liquid inlet. The Tesla valve unit group includes multiple Tesla valve units connected in series. Each Tesla valve unit includes a first channel and a second channel located on one radial side of the first channel. The second channel includes a second liquid inlet and a second liquid outlet that are interconnected. One end of the second liquid inlet and the second liquid outlet are respectively connected to the first channel. The area of ​​the second liquid inlet connected to the first channel is configured as the liquid inlet end of the Tesla valve unit, and the area of ​​the second liquid outlet connected to the first channel is configured as the liquid outlet end of the Tesla valve unit. The second liquid inlet and the second liquid outlet are respectively angled with the first channel, and the angle between the second liquid inlet and the first channel is greater than the angle between the second liquid outlet and the first channel. When liquid enters the Tesla valve unit from the liquid outlet end, the liquid flowing out from the second liquid inlet can block the flow of liquid in the first channel. The first channel of each Tesla valve unit includes a first liquid inlet and a first liquid outlet that are interconnected; the first liquid inlet and the first liquid outlet of each Tesla valve unit have an included angle with each other.

2. The corneal pathway unidirectional aqueous humor drainage device according to claim 1, characterized in that, The first channels of adjacent Tesla valve units have overlapping sections, and the outlet end of one Tesla valve unit and the inlet end of another Tesla valve unit are located on opposite sides of the section; the second channels of the adjacent Tesla valve units are opposite to each other.

3. The corneal pathway unidirectional aqueous humor drainage device according to claim 1, characterized in that, In adjacent Tesla valve units: the first liquid outlet of one Tesla valve unit coincides with the first liquid inlet of another Tesla valve unit; the tilt angle of the second liquid outlet of one Tesla valve unit is the same as the tilt angle of the first liquid inlet of another Tesla valve unit.

4. The corneal pathway unidirectional aqueous humor drainage device according to any one of claims 1 to 3, characterized in that, The length of the substrate is 1.0mm to 6.0mm and the thickness is 0.05mm to 0.5mm; the diameter of the inlet and outlet is 0.01mm to 0.09mm.

5. The corneal pathway unidirectional aqueous humor drainage device according to claim 4, characterized in that, The length of the substrate is 3.0mm~4.0mm and the thickness is 0.15mm~0.3mm; the diameter of the inlet and outlet is 0.02mm~0.06mm.

6. The corneal pathway unidirectional aqueous humor drainage device according to any one of claims 1 to 3, characterized in that, The diameter of the drainage channel is 0.01mm to 0.09mm.

7. The corneal pathway unidirectional aqueous humor drainage device according to any one of claims 1 to 3, characterized in that, The outer wall has an auxiliary fixing structure to prevent axial movement of the corneal pathway unidirectional aqueous humor drain.

8. The corneal pathway unidirectional aqueous humor drainage device according to claim 7, characterized in that, The auxiliary fixing structure includes: a plurality of fixing parts with radial protrusions on both radial sides of the second side; the plurality of fixing parts are arranged sequentially along the axial direction of the base, and the length of the fixing part located on the side of the base is greater than the length of the fixing part located in the middle of the base, so that the base forms a barbed structure.

9. The corneal pathway unidirectional aqueous humor drainage device according to any one of claims 1 to 3, characterized in that, Biocompatible materials are used.

10. The corneal pathway unidirectional aqueous humor drainage device according to claim 9, characterized in that, The biocompatible material is a photocurable biocompatible material.

11. The corneal pathway unidirectional aqueous humor drainage device according to claim 10, characterized in that, The photocurable biocompatible material includes any one of epoxy resin (meth)acrylate materials, polyester (meth)acrylate materials, polyurethane (meth)acrylate materials, (meth)acrylate monomers, and (meth)acrylate modified natural biomaterials.

12. The corneal pathway unidirectional aqueous humor drainage device according to claim 11, characterized in that, The photocurable biocompatible material includes any one of bisphenol A trioxide dimethacrylate, bisphenol A epoxy methacrylate, polyethylene glycol di(meth)acrylate, (meth)acrylate modified gelatin, and (meth)acrylate modified hyaluronic acid.

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