Glaucoma drainage implant suitable for internal and external implantation and drainage device

Abstract

The invention provides a glaucoma drainage implant suitable for internal and external implantation, the glaucoma drainage implant is used for drainage of aqueous humor of an anterior chamber to reduce intraocular pressure, a schlemm tube can be implanted through an internal approach or an external approach, the glaucoma drainage implant is linear or arc-shaped in a non-implantation state, and the glaucoma drainage implant can adapt to the curvature of the schlemm tube after implantation, the glaucoma drainage implant comprises two tubular bodies and a connecting body, the connecting body is connected with the two tubular bodies, the two tubular bodies are located at the two opposite ends of the glaucoma drainage implant in the axial direction of the glaucoma drainage implant respectively, barb structures are arranged on the outer surfaces of the tubular bodies, the tubular bodies are provided with hollow inner cavities, first open grooves are further formed in the outer surfaces of the tubular bodies in the axial direction of the tubular bodies, and the first open grooves are communicated with the first open grooves. And aqueous humor can flow through the hollow inner cavity, the barb structure and the first open groove. The glaucoma drainage implant can be implanted into the schlemm tube at a time through the inner approach or the outer approach, the implantation efficiency is high, and the operation difficulty is low. The invention further provides a drainage device for guiding the glaucoma drainage implant to be implanted into the schlemm tube.

Description

Technical Field

[0001] The present invention relates to the technical field of ocular implants, and particularly to a glaucoma drainage implant and a drainage device suitable for internal and external implantation. Background Art

[0002] Glaucoma is the world's leading cause of irreversible blindness. Intraocular pressure (IOP) is an independent risk factor for glaucoma, which can lead to further damage to the optic nerve of glaucoma, optic disc atrophy and depression, visual field defect and vision decline. Controlling intraocular pressure mainly requires smooth aqueous humor drainage. Any obstruction in any link of the aqueous humor circulation pathway can lead to increased intraocular pressure and cause pathological changes or exacerbation.

[0003] In existing glaucoma implantation surgeries, a drainage implant is implanted into the interior of the human eye to reconstruct or restore the aqueous humor outflow pathway, and reduce intraocular pressure through external drainage or internal drainage to achieve the treatment purpose. Existing drainage implants mainly include Schlemm's canal drainage implants, suprachoroidal space drainage implants, subconjunctival drainage implants, etc. For Schlemm's canal drainage implants, in the prior art, when a glaucoma internal drainage implant is implanted into Schlemm's canal, the outer wall of Schlemm's canal is cut, and through the formed incision, two independent stent implants are respectively placed into Schlemm's canal on both sides of the incision. Although this type of implant has achieved good intraocular pressure reduction effect clinically and has certain anti-displacement characteristics, due to its extremely small size, there is still a risk of slipping or falling into the anterior chamber after being implanted into Schlemm's canal. Moreover, during the implantation process, it needs to be implanted on both sides of the incision of Schlemm's canal respectively, and its surgical convenience and implantation efficiency need to be further improved.

[0004] In addition, although the existing above-mentioned stent implants can also be implanted through the internal approach, since they need to be implanted on both sides of the trabecular meshwork opening respectively, two implantation incisions need to be created at the corneal limbus during the implantation process, and a stent is implanted into Schlemm's canal of the trabecular meshwork opening from different directions respectively, and the surgery is relatively complex and causes two wounds. Summary of the Invention

[0005] To solve the above technical problems, a technical solution adopted by the present invention is to provide: a glaucoma drainage implant suitable for internal and external implantation, which is used to drain the aqueous humor in the anterior chamber to reduce intraocular pressure. The glaucoma drainage implant is implanted into the Schlemm's canal through an internal approach or an external approach. The glaucoma drainage implant is linear or arc-shaped in the non-implanted state and can adapt to the curvature of the Schlemm's canal after implantation, and includes: two tubular bodies, the two tubular bodies are respectively located at opposite ends of the glaucoma drainage implant in the axial direction of the glaucoma drainage implant. The outer surface of the tubular body is provided with barbed structures for increasing friction that do not protrude from the surface of the tubular body. The tubular body has a hollow inner cavity, and a first slot is further provided on the outer surface of the tubular body along the axial direction of the tubular body. The hollow inner cavity, barbed structures and first slot allow the aqueous humor to flow through; a connecting body, the connecting body connects the two tubular bodies, and the lengths of the two tubular bodies are the same or different.

[0006] In some embodiments, the barbed structure is located on one side of the plane where the central axis of the tubular body is located, and the first slot is located on the other side of the plane where the central axis is located.

[0007] In some embodiments, each of the tubular bodies is provided with one or more of the barbed structures;

[0008] Preferably, the barbed direction of the barbed structure on one of the tubular bodies is opposite to the barbed direction of the barbed structure on the other tubular body;

[0009] In some embodiments, the tubular body is a cylindrical tube. The length of the tubular body is 1-1.5 mm, the inner diameter of the tubular body is 175-185 μm, the outer diameter is 245-315 μm, and the length of the connecting body is 1.6-2.4 mm;

[0010] Preferably, the radius of curvature of the glaucoma drainage implant is 5-6 mm;

[0011] Preferably, the barbed structure is formed by a first opening on the outer surface of the tubular body, and the length of the largest part of the first opening is 0.1-0.3 mm;

[0012] Preferably, the orthographic projection of the first opening is semi-circular, semi-elliptical, triangular, or dovetail groove-shaped;

[0013] Preferably, the length of the first slot is 0.6-1.2 mm, and the width is 30-90 μm.

[0014] In some embodiments, the glaucoma drainage implant is implanted into Schlemm's canal through an internal approach or an external approach. The end face of the tubular body away from the connector is perpendicular to its central axis or has an oblique angle. Preferably, when the glaucoma drainage implant is implanted into Schlemm's canal through the internal approach, the oblique angle between the end face of the tubular body away from the connector and its central axis is 30° to 60°; or, when the glaucoma drainage implant is implanted into Schlemm's canal through the external approach, the oblique angle between the end face of the tubular body away from the connector and its central axis is 120° to 150°.

[0015] In some embodiments, a second slotted groove and / or a second opening is / are provided on the outer surface of the connector, and the second slotted groove and / or the second opening allows aqueous humor to flow through.

[0016] In some embodiments, a second slotted groove is provided on the outer surface of the connector. There is one or more second slotted grooves, and 1 / 3 of the width of the connector ≤ the width of the second slotted groove ≤ 2 / 3 of the width of the connector, and 1 / 3 of the length of the connector ≤ the sum of the lengths of the second slotted grooves ≤ 2 / 3 of the length of the connector.

[0017] In some embodiments, the connector is circumferentially located in the circumferential direction of the annular surface where the tube wall of the tubular body is located in space;

[0018] Preferably, the connector is circumferentially located in the circumferential direction of the annular surface where the tube wall of the tubular body is located in space and on the side that does not block the radial flow of aqueous humor.

[0019] In some embodiments, the connector and the tubular body are integrally formed or detachably connected;

[0020] Preferably, 0.85 times the length of the connector ≤ the length of any one of the tubular bodies ≤ 1.25 times the length of the connector;

[0021] Preferably, 1 / 12 of the cross-sectional perimeter of the tubular body ≤ the width of the connector ≤ 1 / 3 of the cross-sectional perimeter of the tubular body;

[0022] Preferably, the surface of the tubular body has a color display coating or a drug coating.

[0023] The present invention also provides a drainage device, including an implantor, the implantor includes a pushing mechanism and a guiding tube. A pushing wire and a glaucoma drainage implant suitable for internal and external approach implantation as described above are arranged in the guiding tube. The fixed end of the pushing wire is connected to the pushing mechanism, and the free end of the pushing wire abuts against the glaucoma drainage implant. The pushing mechanism can push the pushing wire to axially move in the guiding tube to guide the glaucoma drainage implant to be implanted into Schlemm's canal.

[0024] The beneficial effects of the present invention are as follows: The present invention provides a glaucoma drainage implant suitable for internal and external implantation, which is used to drain the aqueous humor in the anterior chamber to reduce intraocular pressure. It can be implanted into the Schlemm's canal through an internal approach or an external approach, and is in a linear or arc shape in the non-implanted state, and can adapt to the curvature of the Schlemm's canal after implantation. The implant includes two tubular bodies and a connecting body. The connecting body connects the two tubular bodies. The two tubular bodies are located at opposite ends of the glaucoma drainage implant in the axial direction of the glaucoma drainage implant. The outer surface of the tubular body is provided with barbs, and the tubular body has a hollow inner cavity. A first groove is also provided on the outer surface of the tubular body along the axial direction of the tubular body. The hollow inner cavity, the barb structure and the first groove allow the aqueous humor to flow through. The glaucoma drainage implant in the present invention can be implanted into the Schlemm's canal through an internal approach or an external approach at one time, with high implantation efficiency and low operation difficulty. The present invention also provides a drainage device for guiding the glaucoma drainage implant to be implanted into the Schlemm's canal. Brief Description of the Drawings

[0025] Figure 1A is a top view of the first embodiment of the glaucoma drainage implant of the present invention;

[0026] Figure 1B is a perspective view of the first embodiment of the glaucoma drainage implant of the present invention;

[0027] Figure 1C is a schematic diagram of the first embodiment of the glaucoma drainage implant of the present invention in a bent state;

[0028] Figure 1D is a schematic diagram of the first embodiment of the glaucoma drainage implant of the present invention in a straight state;

[0029] Figure 2A is a top view of the second embodiment of the glaucoma drainage implant of the present invention;

[0030] Figure 2B is a perspective view of the second embodiment of the glaucoma drainage implant of the present invention;

[0031] Figure 2C is a schematic diagram of the second embodiment of the glaucoma drainage implant of the present invention in a bent state;

[0032] Figure 3A is a top view of the third embodiment of the glaucoma drainage implant of the present invention;

[0033] Figure 3B is a perspective view of the third embodiment of the glaucoma drainage implant of the present invention;

[0034] Figure 4A is a top view of the fourth embodiment of the glaucoma drainage implant of the present invention;

[0035] Figure 4B is a perspective view of the fourth embodiment of the glaucoma drainage implant of the present invention;

[0036] Figure 5A is a top view of the fifth embodiment of the glaucoma drainage implant of the present invention;

[0037] Figure 5B is a perspective view of the fifth embodiment of the glaucoma drainage implant of the present invention;

[0038] Figure 5C is a perspective schematic view of another embodiment of the glaucoma drainage implant of the present invention;

[0039] Figure 6A is a top view of the sixth embodiment of the glaucoma drainage implant of the present invention;

[0040] Figure 6B is a perspective view of the sixth embodiment of the glaucoma drainage implant of the present invention;

[0041] Figure 6C is a schematic view of the sixth embodiment of the glaucoma drainage implant of the present invention in a bent state;

[0042] Figure 7A is a top view of the seventh embodiment of the glaucoma drainage implant of the present invention;

[0043] Figure 7B is a perspective view of the seventh embodiment of the glaucoma drainage implant of the present invention;

[0044] Figure 8A is a perspective view of the first embodiment of the drainage device of the present invention;

[0045] Figure 8B is Figure 8A a partial enlarged view of area A in

[0046] Figure 8C is a schematic view of the guide tube and the push wire in the first embodiment of the drainage device of the present invention;

[0047] Figure 9A and Figure 9B is a schematic view of the process of implanting the drainage implant into the Schlemm's canal through the intranasal implantation method;

[0048] Figure 9C is a schematic view of the anatomical structure of the eye tissue, showing the implantation window 400 in the figure;

[0049] Figure 10A is a perspective view of the second embodiment of the drainage device of the present invention;

[0050] Figure 10B isFigure 10A Partial enlarged view of area B;

[0051] Figure 10C Schematic diagram of the guiding tube and the pushing wire in the second embodiment of the drainage device of the present invention;

[0052] Figure 11A and 11B Schematic diagram of the process of implanting the drainage implant into the Schlemm's canal through the external approach implantation method;

[0053] Figure 11C is Figure 11B Partial enlarged schematic diagram. Detailed implementation manners

[0054] For the convenience of understanding the present invention, the present invention will be described in more detail below in conjunction with the drawings and specific embodiments. The preferred embodiments of the present invention are shown in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described in this specification. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure content of the present invention more thorough and comprehensive.

[0055] It should be noted that unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by those skilled in the technical field to which the present invention belongs. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not used to limit the present invention. The term "and / or" used in this specification includes any and all combinations of one or more of the related listed items.

[0056] As Figures 1A to 7B shown, the present application provides a glaucoma drainage implant applicable to internal and external approach implantations. The glaucoma drainage implant is used for draining the aqueous humor in the anterior chamber to reduce intraocular pressure. The glaucoma drainage implant can be implanted into the Schlemm's canal through the internal approach or the external approach. The glaucoma drainage implant is in a straight or curved shape in the non-implanted state and can adapt to the curvature of the Schlemm's canal after implantation. Specifically, the glaucoma drainage implant includes two tubular bodies 1 and a connecting body 2. The lengths of the two tubular bodies 1 are the same or different. The two tubular bodies 1 are located at opposite ends of the glaucoma drainage implant in the axial direction of the glaucoma drainage implant. The outer surface of the tubular body 1 is provided with a barbed structure (first opening 12) that does not protrude from the surface of the tubular body 1 for increasing friction. The tubular body 1 has a hollow inner cavity. Along the axial direction of the tubular body 1, a first slot 11 is further provided on the outer surface of the tubular body 1. The hollow inner cavity, the barbed structure (first opening 12) and the first slot 11 allow the aqueous humor to flow through; the connecting body 2 is located between the two tubular bodies 1 and connects the two tubular bodies 1.

[0057] In the present application, the glaucoma drainage implant can be implanted on both sides of the Schlemm's canal incision through an internal approach or an external approach at one time, that is, one tubular body 1 is implanted on one side of the Schlemm's canal incision, and the other tubular body 1 is implanted on the other side of the Schlemm's canal incision. This method can improve the implantation efficiency, reduce the difficulty of clinical surgical operation, and the barbed structures on the two tubular bodies can also make the drainage implant resistant to displacement, with better implantation stability.

[0058] In the present application, after the glaucoma drainage implant is implanted into the Schlemm's canal, in addition to the aqueous humor flowing through the hollow inner cavity of the tubular body 1, the above-mentioned barbed structure (the first opening 12) and the first slot 11 can increase the lateral drainage of the aqueous humor (i.e., radial drainage). At the same time, the barbed structure (the first opening 12) and the first slot 11 can also increase the friction between the surface of the glaucoma drainage implant and the eye tissue, making the implantation more stable and resistant to displacement at the incision; in addition, the setting of the first slot 11 can also facilitate the internal cleaning and inner surface treatment of the glaucoma drainage implant during the processing; the area of the barbed structure and the first slot 11 on each tubular body 1 accounts for 20-55% of the outer peripheral side area of the tubular body 1. In this way, on the one hand, the drainage effect of the glaucoma drainage implant can be ensured, and on the other hand, the strength requirements of the glaucoma drainage implant can be met, ensuring that the glaucoma drainage implant is not easily deformed and collapsed, and the inner wall of the tubular body 1 is easy to process and polish, avoiding impurity residues and affecting the polishing effect during the inner wall processing.

[0059] In the present application, in order to better meet the inner wall cleaning and polishing of the tubular body 1, avoid impurity residues and poor polishing effects during the inner wall processing, and affect the clinical implantation effect, the length of the first slot 11 on the surface of the tubular body 1 is greater than half of the length of the tubular body 1, and the area of the first slot 11 on each tubular body 1 accounts for 5-20% of the outer peripheral side area of the tubular body 1.

[0060] In the present application, the length of the tubular body 1 is 1-1.5 mm, the inner diameter is 175-185 μm, and the outer diameter is 245-315 μm. Since the length of the tubular body 1 is short, it will not occupy a large space in the axial direction of the Schlemm's canal, and the overall drainage implant can match and adapt to the curvature of the Schlemm's canal, so it can avoid puncturing the Schlemm's canal after being implanted into the Schlemm's canal.

[0061] In some embodiments of the glaucoma drainage implant, the tubular body 1 is elongated, and the length of the tubular body 1 is greater than its diameter; in some other embodiments of the glaucoma drainage implant, the tubular body 1 is annular, and the diameter of the tubular body 1 is greater than its length.

[0062] In the present application, the connecting body 2 is spatially located in the circumferential direction of the annular surface where the tube wall of the tubular body 1 is located, and is integrally formed with or detachably connected to the tubular body 1, preferably integrally formed. The connecting body 2 has a radial diversion hole or the connecting body 2 is spatially located in the circumferential direction of the annular surface where the tube wall of the tubular body 1 is located and on the side that does not block the radial flow of aqueous humor, so as not to affect the radial circulation of aqueous humor.

[0063] In the present application, the material of the glaucoma drainage implant can be a metal material, such as stainless steel 316L, titanium alloy, nitinol alloy or cobalt-chromium alloy, etc. In some embodiments, a polymer material with good biocompatibility can also be used, such as high molecular polyethylene, polyester, polyether ether ketone peek or polysulfone PS, etc. In some other embodiments, the material of the drainage implant can also be a biodegradable material with good biocompatibility, so that the implant can be stable in the eye for a certain period of time (such as more than half a year), and then gradually degrade and disappear after the intraocular pressure returns to normal.

[0064] In the present application, the sharp edges of the glaucoma drainage implant are all designed with chamfers to be smooth, so as to avoid the deposition and blockage of proteins in the aqueous humor on the implant, and at the same time avoid scratching or cutting the Schlemm's canal due to the sharp outer edge.

[0065] Such as Figure 1A and 1D As shown in [figures], as the first embodiment of the glaucoma drainage implant of the present application, the glaucoma drainage implant can be implanted into the Schlemm's canal through two methods: the internal approach or the external approach. The glaucoma drainage implant is linear or arc-shaped in the non-implanted state, and can adapt to the curvature of the Schlemm's canal after implantation, and is arc-shaped after implantation.

[0066] In this embodiment, the glaucoma drainage implant includes two tubular bodies 1 and a connecting body 2 that connects the two tubular bodies 1. The lengths of the two tubular bodies 1 are the same or different. The two tubular bodies 1 are respectively located at opposite ends of the glaucoma drainage implant in the axial direction of the glaucoma drainage implant. The outer surface of the tubular body 1 is provided with a barb structure (the first opening 12) that does not protrude from the surface of the tubular body 1 for increasing friction. The tubular body 1 has a hollow inner cavity. Along the axial direction of the tubular body 1, a first slot 11 is also provided on the outer surface of the tubular body 1. The hollow inner cavity, the barb structure (the first opening 12) and the first slot 11 can allow the aqueous humor to flow through.

[0067] In this embodiment, the glaucoma drainage implant is integrally arc-shaped in the non-implanted state and adapted to the curvature of the Schlemm's canal; in some other embodiments, the glaucoma drainage implant is linear in the non-implanted state, but it has a certain elasticity and flexibility, and presents an arc shape that matches the curvature of the Schlemm's canal after being implanted into the Schlemm's canal.

[0068] In this embodiment, the tubular body 1 is a cylindrical tube as a whole. In some other embodiments, the tubular body 1 may also be non-cylindrical. For example, the tubular body 1 is a regular hexagonal prism as a whole, the outline of its inner cavity is circular, and the outer outline of the tubular body 1 is a regular hexagon.

[0069] In this embodiment, the end surface 3 of the tubular body 1 away from the connector 2 is perpendicular to the central axis Z thereof, and the glaucoma drainage implant can be implanted into the Schlemm's canal through an internal approach or an external approach. In addition, since the end surface 3 of the tubular body 1 is a plane perpendicular to the central axis Z, it is necessary to use a viscoelastic agent to expand the Schlemm's canal before implantation. This is because the incision of the Schlemm's canal is generally flat due to the obstruction of the flow of aqueous humor. After expansion with a viscoelastic agent, the incision of the Schlemm's canal is stretched open to facilitate the implantation of the tubular body 1.

[0070] In this embodiment, the barb structure does not protrude from the surface of the tubular body 1, which can increase the friction force on the surface of the tubular body 1 and prevent the tubular body 1 from being displaced when implanted into the schlemm's tube; and the barb structure allows the tubular body 1 to be implanted only from the incision of the schlemm's tube into the interior of the schlemm's tube during the implantation process of the schlemm's tube, and when the tubular body 1 slides out from the interior of the schlemm's tube toward the incision, it will be stuck by the barb structure and will not cause reverse displacement.

[0071] Furthermore, the barb structure is formed by a first opening 12 on the outer surface of the tubular body 1 , the length of the first opening 12 is 0.1-0.3 mm, and the orthographic projection of the first opening 12 is a semicircular, semi-elliptical, triangular, dovetail groove, or other shape.

[0072] In this embodiment, each tubular body 1 is provided with one or more barb structures (first openings 12), and preferably the barb direction of the barb structure (first opening 12) on one tubular body 1 is opposite to the barb direction of the barb structure (first opening 12) on the other tubular body 1, so that both tubular bodies 1 can be implanted unidirectionally to avoid reverse displacement. Preferably, the number of first openings 12 is 1 to 3, and the length of the first openings 12 is 0.1 to 0.3 mm.

[0073] In this embodiment, the barb structures (first openings 12) on the surface of the tubular body 1 are arranged regularly, and the plurality of barb structures (first openings 12) are located on one side of the plane where the central axis of the tubular body 1 is located, and the first slot 11 is located on the other side of the plane where the central axis is located. In some other embodiments of the present application, the barb structures (first openings 12) on the surface of the tubular body 1 may also be arranged irregularly, and space is reserved for the first slot 11 only at the position of the first slot 11.

[0074] Further, in this embodiment, the projection of the first slotted opening 11 is an elongated rectangle, the length of the first slotted opening 11 is 0.6 - 1.2 mm, and the width is 30 - 90 μm. In some other embodiments of the present application, the projection of the first slotted opening 11 may also be an elongated ellipse or other shapes. In some other embodiments of the present application, there is one or more first slotted openings 11, which are arranged regularly or irregularly on the surface of the tubular body 1.

[0075] In this embodiment, the connecting body 2 is spatially located in the circumferential direction of the annular surface where the wall of the tubular body 1 is located, and it can be on the side that blocks the radial flow of aqueous humor or the side that does not block the radial flow of aqueous humor. When the connecting body 2 is located on the side that blocks the radial flow of aqueous humor, a second slotted opening 21 and / or a second opening 22 need to be provided to enhance the radial diversion of the connecting body 2; when the connecting body 2 is located on the side that does not block the radial flow of aqueous humor, the second slotted opening 21 and / or the second opening 22 do not need to be provided.

[0076] In this embodiment, the connecting body 2 and the tubular body 1 are integrally formed. In other specific feasible embodiments, the connecting body 2 and the tubular body 1 can also be connected by a non-integral design.

[0077] Please refer to Figure 1D , in this embodiment, the length of one of the tubular bodies 1 is a, the length of the other tubular body 1 is c, a and c can be the same or different, preferably a and c are the same, both are 1 - 1.5 mm, and the length of the connecting body 2 is b, b is 1.6 - 2.4 mm.

[0078] Combined with Figure 9A 、 Figure 9B and Figures 11A to 11C , in each embodiment of the present application, regarding the lengths of the tubular body 1 and the connecting body 2, they are respectively related to the opening length of the deep scleral flap 500 during implantation (the length i of the deep scleral flap 500 in the external approach) or the opening length of the trabecular meshwork (i.e., the length h of the implantation window 400 in the internal approach). a, b, and c, and i or h should satisfy the following conditions:

[0079] max(a, c) < h, |h - b| ≤ (10% - 20%) * h, and most preferably a = c and / or b = h.

[0080] max(a, c) < i, |i - b| ≤ (10% - 20%) * i, and most preferably a = c and / or b = i.

[0081] By making such a selection, on the one hand, both tubular bodies 1 of the drainage implant can fall into the opening of the deep scleral flap 500 or the opening of the trabecular meshwork, and after implantation, it is ensured that the two tubular bodies 1 will neither be implanted too deep into the Schlemm's canal and lose the function of propping up the Schlemm's canal incision nor have the unimplanted part exposed to the incision and be prone to displacement.

[0082] In this embodiment, the relationship between the tubular body 1 and the connecting body 2 in terms of length is: 0.85 * the length of the connecting body 2 ≤ the length of any one tubular body 1 ≤ 1.25 * the length of the connecting body 2, that is, 0.85 * b ≤ a ≤ 1.25 * b, 0.85 * b ≤ c ≤ 1.25 * b.

[0083] In this embodiment, the cross-sectional perimeter of the tubular body 1 is d, and the width of the connecting body 2 is e. The relationship between the cross-sectional perimeter d of the tubular body 1 and the width e of the connecting body 2 is: 1 / 12 * the cross-sectional perimeter of the tubular body 1 ≤ the width of the connecting body 2 ≤ 1 / 3 * the cross-sectional perimeter of the tubular body 1, that is, d * 1 / 12 ≤ e ≤ d * 1 / 3. When the width of the connecting body 2 is within this range, the overall strength of the glaucoma drainage implant can be ensured, and it can be avoided that the width of the connecting body 2 is too narrow and the strength is insufficient, resulting in easy breakage.

[0084] In this embodiment, the wall thickness of the tubular body 1 is f, where f is 35 - 65 μm, and the wall thickness of the connecting body 2 is g. The relationship between the wall thickness of the tubular body 1 and the wall thickness of the connecting body 2 is 0 < g ≤ f.

[0085] Furthermore, in this embodiment, a second slot 21 is provided on the outer surface of the connecting body 2. The second slot 21 allows the aqueous humor to flow through, increasing the lateral drainage of the aqueous humor. In some other embodiments of the present application, a second opening 22 is provided on the outer surface of the connecting body 2. The second opening 22 allows the aqueous humor to flow through, increasing the lateral drainage of the aqueous humor; or, in some other embodiments of the present application, both a second slot 21 and a second opening 22 are provided on the outer surface of the connecting body 2. The second slot 21 and the second opening 22 allow the aqueous humor to flow through, further increasing the lateral drainage of the aqueous humor.

[0086] In this embodiment, there is one or more second slots 21. 1 / 3 * the width of the connecting body 2 ≤ the width of the second slot 21 ≤ 2 / 3 * the width of the connecting body 2, that is, e * 1 / 3 ≤ the width of the second slot 21 ≤ e * 2 / 3; 1 / 3 * the length of the connecting body 2 ≤ the sum of the lengths of the second slots 21 ≤ 2 / 3 * the length of the connecting body 2, that is, b * 1 / 3 ≤ the sum of the lengths of the second slots 21 ≤ b * 2 / 3.

[0087] Furthermore, in this embodiment, in order to make the outer surface of the tubular body 1 shiny and the inner surface smooth for the flow of aqueous humor, the inner and outer surfaces can be polished so that polished surfaces are formed on the inner and outer surfaces of the tubular body 1; in some other embodiments, in order to further increase the stability of the glaucoma drainage implant, sandblasting treatment can be performed on the outer surface of the tubular body 1 of the present application.

[0088] In some other embodiments, to further increase the stability and anti-slip property of the glaucoma drainage implant, annular etching grooves with different depths can be laser-etched on the surface of the tubular body 1 at the positions near both ends where there are no openings and slots. In some other embodiments, to make the glaucoma drainage implant easily observable, a color-developing coating can be applied to the outer surface or a part of the outer surface of its tubular body 1, or a color-developing surface can be formed through other surface treatment methods; in some other embodiments, to endow the glaucoma drainage implant with drug efficacy, such as anticoagulant, anti-proliferative, or antibacterial and anti-inflammatory drugs, etc., drugs can be coated on the surface of the tubular body 1 to form a drug coating. For example, in a specific embodiment, heparin, paclitaxel, rapamycin, or mitomycin C, etc. can be coated on the surface of the glaucoma drainage implant of the present application.

[0089] As Figures 2A to 2C shown, as the second embodiment of the glaucoma drainage implant of the present application, different from the first embodiment, in the second embodiment, there is an oblique angle between the end face 3 of the tubular body 1 far from the connecting body 2 and its central axis Z. This oblique angle includes a first included angle α, and the first included angle α is 30 - 60°, preferably the first included angle α is 45°. In addition, it should be noted that if the glaucoma drainage implant is in a curved shape in its natural state, as Figure 2A shown, the length of its tubular body 1, the length of the connecting body 2, and the overall length of the glaucoma drainage implant all refer to the end-to-end distance from one end to the other end.

[0090] In this embodiment, the glaucoma drainage implant is implanted into the Schlemm's canal through an internal approach. Since the end face 3 of the tubular body 1 is an inclined plane, when the tubular body 1 is implanted into the Schlemm's canal, the originally flat incision of the Schlemm's canal can be expanded through the tip of its inclined plane, and there is no need for viscoelastic agent to expand the Schlemm's canal.

[0091] In this embodiment, a second opening 22 is provided on the outer surface of the connecting body 2. The second opening 22 allows the aqueous humor to flow through, increasing the lateral drainage of the aqueous humor. Preferably, there are multiple second openings 22, which are arranged regularly or irregularly on the outer surface along the axial direction of the connecting body 2.

[0092] Other features of the second embodiment of the present application are repeated with the corresponding features of the first embodiment, and will not be repeated here.

[0093] As Figures 3A to 3B shown, as the third embodiment of the glaucoma drainage implant of the present application, different from the third embodiment, in the third embodiment, a second slot 21 is provided on the outer surface of the connecting body 2. The second slot 21 allows the aqueous humor to flow through, increasing the lateral drainage of the aqueous humor. There are multiple second slots 21, which are arranged regularly or irregularly on the outer surface along the axial direction of the connecting body 2.

[0094] Other features of the third embodiment of the present application are repeated with the corresponding features of the first embodiment or the second embodiment, and will not be repeated here.

[0095] As Figures 4A to 4B shown, as the fourth embodiment of the glaucoma drainage implant of the present application, different from the second embodiment, in the fourth embodiment, the glaucoma drainage implant is linear in the non-implanted state and bends after being implanted into the Schlemm's canal under the extrusion of the Schlemm's canal. The outer surface of the connecting body 2 is provided with a second slotted groove 21 and a second opening 22, and the second slotted groove 21 and the second opening 22 allow the aqueous humor to flow through, further increasing the lateral diversion of the aqueous humor. Both the second slotted groove 21 and the second opening 22 have a plurality of them, and are arranged alternately on the outer surface along the axial direction of the connecting body 2.

[0096] Other features of the fourth embodiment of the present application are repeated with the corresponding features of the first embodiment or the second embodiment, and will not be repeated here.

[0097] As Figures 5A to 5B shown, as the fifth embodiment of the glaucoma drainage implant of the present application, different from the second embodiment, in the fifth embodiment, the second slotted groove 21 and / or the second opening 22 are not provided on the outer surface of the connecting body 2, and the connecting body 2 is located in the circumferential direction of the annular surface where the tube wall of the tubular body 1 is located in space and on the side that does not block the radial flow of the aqueous humor, such as the top or bottom in the circumferential direction of the annular surface where the tubular body 1 is located. In this way, the connecting body 2 will not affect the radial flow of the aqueous humor, and there is no need to add the second slotted groove 21 and / or the second opening 22 on the connecting body 2.

[0098] As Figure 5C shown, the outer surface of the tubular body 1 of the glaucoma drainage implant has a plurality of hollow hole structures 13, and the sizes of these hollow hole structures 13 can be the same or different; preferably, these hollow hole structures 13 are evenly arranged on the outer surface of the tubular body 1.

[0099] Other features of the fifth embodiment of the present application are repeated with the corresponding features of the first embodiment or the second embodiment, and will not be repeated here.

[0100] As Figures 6A to 6C shown, as the sixth embodiment of the glaucoma drainage implant of the present application, different from the fifth embodiment, in the sixth embodiment, the end face 3 of the tubular body 1 away from the connecting body 2 has an oblique angle with its central axis Z, and this oblique angle includes a second included angle β, and the second included angle β is 120 to 150°, preferably the second included angle β is 135°.

[0101] In this embodiment, the glaucoma drainage implant is implanted into the Schlemm's canal through an external approach. Since the end face 3 of the tubular body 1 is an inclined plane, when the tubular body 1 is implanted into the Schlemm's canal, the originally flat incision of the Schlemm's canal can be expanded through the tip of its inclined plane, and there is no longer a need for viscoelastic agent to expand the Schlemm's canal.

[0102] Other features of the sixth embodiment of this application are repeated with the corresponding features of the first embodiment or the fifth embodiment, and will not be repeated here.

[0103] As Figures 7A to 7B shown, as the seventh embodiment of the glaucoma drainage implant of this application, different from the sixth embodiment, in the seventh embodiment, the connecting body 2 is spatially located on the circumferential direction of the annular surface where the tube wall of the tubular body 1 is located and on the side that blocks the radial flow of aqueous humor (that is, the front side or the rear side in the circumferential direction of the annular surface where the tubular body 1 is located), and a second slotted opening 21 is provided on the outer surface of the connecting body 2. The second slotted opening 21 allows the aqueous humor to flow through, increasing the lateral drainage of the aqueous humor. There are multiple second slotted openings 21, which are regularly or irregularly arranged on the outer surface along the axial direction of the connecting body 2.

[0104] In some other embodiments, the distal end of the tubular body 1 may also have an incision, which extends along the axial direction of the tubular body 1 and is parallel to the tubular body 1, that is, a part of the tubular body 1 is cut off in the axial direction, exposing the inner cavity of the tubular body 1 in the axial direction. The end face of the tubular body 1 may be perpendicular to this incision or have an oblique angle with this incision.

[0105] The above are the implementation manners and specific embodiments of the glaucoma drainage implant provided by this application. It should be understood that both the internal approach drainage implant and the external approach drainage implant can adopt the drainage implant shown in the first embodiment, or as shown in other embodiments, the difference is that the end oblique incision directions of the two distal ends of the tubular body 1 are different. In the internal approach drainage implant, the end oblique incisions of the two distal ends of the tubular body 1 face away from the trabecular meshwork, while in the external approach drainage implant, the end oblique incisions of the two distal ends of the tubular body 1 face towards the trabecular meshwork. In addition, it should be understood that the surface structure of the two tubular bodies 1 of the external approach drainage implant can also be the surface structure of some other embodiments of the internal approach drainage implant of this application.

[0106] As Figures 8A to 11C shown, the drainage device including the above drainage implant and the implantation method of the drainage implant will be introduced respectively below, where Figures 8A to 8C shows the drainage device for the internal approach drainage implant, Figures 9A to 9C shows the method of implanting the internal approach drainage implant into the Schlemm's canal using the drainage device for the internal approach drainage implant; Figures 10A to 10C shows the drainage device for the external approach drainage implant, Figures 11A to 11CDisclosed is a method for implanting an external access drainage implant into Schlemm's canal using a drainage device with an external access drainage implant.

[0107] Generally, the drainage device provided in the present application includes an inserter 5. The inserter 5 includes a pushing mechanism and a guiding tube 6. A pushing wire 4 is arranged in the guiding tube 6 and the above-mentioned glaucoma drainage implant is accommodated therein. The fixed end of the pushing wire 4 is connected to the pushing mechanism, and the free end of the pushing wire 4 abuts against the glaucoma drainage implant. The pushing mechanism can push the pushing wire 4 to axially move in the guiding tube 6 to guide the glaucoma drainage implant to be implanted into Schlemm's canal.

[0108] In some embodiments of the drainage device of the present application, a visual sensor can be further connected to the distal end of the guiding tube 6 of the inserter 5. The visual sensor is electrically connected to a control circuit board inside the inserter 5. The control circuit board can transmit the image captured by the visual sensor to a display system by means of wired or wireless transmission for the operator to view the implantation image and assist the operator in accurately controlling the implantation process of the glaucoma drainage implant.

[0109] As Figures 8A to 8C shown, as an embodiment of the internal access of the drainage device of the present application, in this embodiment, the inserter 5 can implant the glaucoma drainage implant described in the first to fifth embodiments or other internal access methods into Schlemm's canal through the internal access method.

[0110] In this embodiment, the guiding tube 6 includes a straight portion 63 and a bent portion 62. The curvature of the bent portion 62 matches the curvature of the glaucoma drainage implant and Schlemm's canal. The glaucoma drainage implant is located in the bent portion 62 of the guiding tube 6, thereby facilitating the pushing of the glaucoma drainage implant into Schlemm's canal. And the end face 61 of the bent portion 62 is an inclined plane and is parallel to the end face 3 of the tubular body 1 in the second to fifth embodiments.

[0111] Combined with Figures 9A to 9C , the inserter 5 implants the glaucoma drainage implant into Schlemm's canal 200 through the internal access method, where Figure 9C is a schematic diagram of the anatomical structure of eye tissues, which shows Schlemm's canal 200, trabecular meshwork 300, implantation window 400, cornea 500, inner wall of the anterior chamber 600, iris 700 and pupil 800. The specific method for implanting the glaucoma drainage implant of the present application into Schlemm's canal through the inserter 5 by the internal access method is as follows:

[0112] Step 1: Under a microscope and a gonioscope, first cut an implantation window 400 with a length dimension of h on the trabecular meshwork 300 using a trabeculectomy instrument;

[0113] Step 2: Create a surgical incision at the edge of the cornea 500;

[0114] Step 3: Insert the tip of the bevel (end face 61) at the distal end of the guiding tube 6 of the inserter 5 loaded with the glaucoma drainage implant through the surgical incision into the implantation window 400, and then slowly rotate the roller of the inserter 5 so that the pusher wire 4 releases and pushes the glaucoma drainage implant into the Schlemm's canal 200 (as Figure 9A shown in the process of the tubular body 1 just about to enter the Schlemm's canal from one end of the implantation window 400); when any one of the tubular bodies 1 completely enters the Schlemm's canal 200 and at least part of the connecting body 2 also enters the Schlemm's canal 200, stop the injection when the other tubular body 1 also enters the implantation window 400;

[0115] Step 4: Rotate the inserter 5 by 180°, and use the bevel (end face 61) at the distal end of the guiding tube 6 to dial the proximal end of the other tubular body 1 in the opposite direction of the initial implantation direction so that it inserts into the Schlemm's canal 200. When the other tubular body 1 is also completely implanted into the Schlemm's canal, withdraw the guiding tube 6 of the inserter 5 (as Figure 9B shown in the process that the other tubular body 1 has been completely dialed into the other end of the implantation window);

[0116] Step 5: Suture the surgical incision at the corneal edge, and the internal approach implantation is completed.

[0117] It should be noted that in the glaucoma drainage implant applicable to be implanted into the Schlemm's canal 200 through the internal approach, when the end face 3 of the tubular body 1 of the glaucoma drainage implant is a bevel, the end of its bevel port faces the side of the Schlemm's canal wall with the collecting tube (i.e., the side away from the trabecular meshwork).

[0118] Preferably, the relationship between the above-mentioned implantation window h and the length b of the connecting body 2 is: |h - b| ≤ (10% - 20%) * h. Exemplarily, if h = 2 mm, then the range of b is 1.6 mm - 2.4 mm, that is, the opening length dimension of the implantation window h in clinical practice affects the determination of the length of the connecting body 2 of the drainage inserter.

[0119] Further, in Figure 9C 600 is the anterior chamber, 700 is the iris, and 800 is the pupil.

[0120] As Figures 10A to 10C shown, as an embodiment of the external approach of the application drainage device, in this embodiment, the inserter 5 implants the aforementioned glaucoma drainage implant of the first embodiment, the sixth embodiment, the seventh embodiment or other external approaches into the Schlemm's canal through the external approach.

[0121] In this embodiment, the guiding tube 6 includes a straight portion 63 and a bent portion 62. The bent portion 62 is integrally S-shaped and includes a first arc portion 621 and a second arc portion 622. The curvature of the second arc portion 622 matches the curvature of the glaucoma drainage implant and the Schlemm's canal. The glaucoma drainage implant is located within the second arc portion 622, thereby facilitating the pushing of the glaucoma drainage implant into the Schlemm's canal. The end face 61 of the second arc portion 622 is an inclined plane and is parallel to the end face 3 of the tubular body 1 in the sixth and seventh embodiments described above.

[0122] Combined with Figures 11A to 11C , the method for implanting a glaucoma drainage implant into the Schlemm's canal by the inserter 5 through an external approach is as follows:

[0123] Step 1: Make a conjunctival flap and a superficial scleral flap along the corneal limbus under a microscope, and then use a puncture knife to make a deep scleral flap 500 with a length dimension i and expose the Schlemm's canal 200;

[0124] Step 2: Use the inserter 5 to implant the glaucoma drainage implant towards the incision side of the Schlemm's canal 200 (as Figure 11A shows the process of a tubular body 1 of the drainage implant just about to enter the Schlemm's canal). Slowly rotate the roller of the inserter 5. After one tubular body 1 is implanted into the Schlemm's canal 200, the inserter 5 continues to inject so that the other tubular body 1 of the glaucoma drainage implant can be received into the opening of the deep scleral flap 500;

[0125] Step 3: Rotate the inserter 5 by 180°. Use the inclined plane (end face 61) of the guiding tube 6 to deflect the proximal end of the other tubular body 1 in the opposite direction (as Figure 11B and 11C show the process of the other tubular body 1 being about to be deflected into the other side of the cut end of the Schlemm's canal incision) so that it is inserted into the Schlemm's canal 200. When the other tubular body 1 is also completely implanted into the Schlemm's canal 200, the guiding tube 6 of the inserter 5 is withdrawn;

[0126] Step 4: Resect the trabecular meshwork and perform peripheral iridectomy, and finally suture the sclera and conjunctiva to complete the operation.

[0127] It should be noted that in the glaucoma drainage implant suitable for being implanted into the Schlemm's canal through an external approach, when the end face 3 of the tubular body 1 of the glaucoma drainage implant is an inclined plane, the end of the inclined plane port faces the side close to the trabecular meshwork of the Schlemm's canal wall.

[0128] Further, during the process of implanting the glaucoma drainage implant into the Schlemm's canal through the external approach, the relationship between the length i of the above-mentioned deep scleral flap and the length b of the connector 2 is: |i - b| ≤ (10% - 20%) * i. Assuming i = 2 mm, then the range of b is 1.6 mm to 2.4 mm, that is, the length i of the deep scleral flap and the length b of the connector 2 are mutually adapted and restricted, that is, the length dimension of the deep scleral flap opened in clinical practice affects the determination of the length of the connector 2 of the drainage implant.

[0129] In summary, the glaucoma drainage implant in the present application can be implanted into the Schlemm's canal through the internal approach or the external approach in one-time, but it is more suitable to be implanted into the Schlemm's canal through the internal approach. It is completed in one-time during the implantation process, without the need to create two implantation incisions at the corneal limbus, only one implantation incision needs to be created, and the area of trauma to the eye caused by a single implantation incision is smaller, and the surgery is relatively less invasive.

[0130] The above are only the embodiments of the present invention, and do not limit the patent scope of the present invention accordingly. All equivalent structural transformations made by using the content of the specification and drawings of the present invention, or directly or indirectly applied in other related technical fields, are similarly included in the patent protection scope of the present invention.

Claims

1. A glaucoma drainage implant suitable for both internal and external implantation, which is used to drain the aqueous humor in the anterior chamber to reduce intraocular pressure, and is characterized in that The glaucoma drainage implant is implanted into Schlemm's canal through an internal approach or an external approach. The glaucoma drainage implant is linear or arcuate in the non-implanted state and can adapt to the curvature of Schlemm's canal after implantation, including: Two tubular bodies, which are respectively located at opposite ends of the glaucoma drainage implant in the axial direction of the glaucoma drainage implant. The outer surface of the tubular body is provided with barbed structures for increasing friction that do not protrude from the surface of the tubular body. The tubular body has a hollow inner cavity. Along the axial direction of the tubular body, a first slotted groove is further provided on the outer surface of the tubular body. The hollow inner cavity, barbed structures and first slotted groove allow aqueous humor to flow through; A connecting body that connects the two tubular bodies, and the lengths of the two tubular bodies are the same or different.

2. The glaucoma drainage implant applicable to internal and external implantation according to claim 1, characterized in that, The barbed structures are located on one side of the plane where the central axis of the tubular body is located, and the first slotted groove is located on the other side of the plane where the central axis is located.

3. The glaucoma drainage implant applicable to internal and external implantation according to claim 2, characterized in that, Each of the tubular bodies is provided with one or more of the barbed structures; Preferably, the barbed directions of the barbed structures on one of the tubular bodies are opposite to the barbed directions of the barbed structures on the other tubular body.

4. The glaucoma drainage implant suitable for internal and external implantation according to claim 3, characterized in that, The tubular body is a cylindrical tube. The length of the tubular body is 1-1.5 mm, the inner diameter of the tubular body is 175-185 μm, the outer diameter is 245-315 μm, and the length of the connecting body is 1.6-2.4 mm; Preferably, the radius of curvature of the glaucoma drainage implant is 5-6 mm; Preferably, the barbed structure is formed by a first opening on the outer surface of the tubular body, and the length of the largest part of the first opening is 0.1-0.3 mm; Preferably, the orthographic projection of the first opening is semicircular, semi-elliptical, triangular, or dovetail groove-shaped; Preferably, the length of the first slotted groove is 0.6-1.2 mm, and the width is 30-90 μm.

5. The glaucoma drainage implant suitable for internal and external approach implantation according to any one of claims 1 to 4. The glaucoma drainage implant is implanted into Schlemm's canal through an internal approach or an external approach. The end face of the tubular body away from the connecting body is perpendicular to its central axis or has an oblique angle; Preferably, when the glaucoma drainage implant is implanted into Schlemm's canal through an internal approach, the oblique angle between the end face of the tubular body away from the connecting body and its central axis is 30-60°; Or, when the glaucoma drainage implant is implanted into Schlemm's canal through an external approach, the oblique angle between the end face of the tubular body away from the connecting body and its central axis is 120-150°.

6. The glaucoma drainage implant suitable for internal and external implantation according to claim 5, characterized in that, The outer surface of the connecting body is provided with a second slotted groove and / or a second opening, and the second slotted groove and / or the second opening allow aqueous humor to flow through.

7. The glaucoma drainage implant applicable to internal and external implantation according to claim 6, characterized in that, The outer surface of the connecting body is provided with a second slotted groove. There are one or more second slotted grooves. 1 / 3 of the width of the connecting body ≤ the width of the second slotted groove ≤ 2 / 3 of the width of the connecting body, and 1 / 3 of the length of the connecting body ≤ the sum of the lengths of the second slotted grooves ≤ 2 / 3 of the length of the connecting body.

8. The glaucoma drainage implant applicable to internal and external implantation according to claim 5, characterized in that The connecting body is spatially located in the circumferential direction of the annular surface where the tube wall of the tubular body is located; Preferably, the connecting body is spatially located on the circumferential side of the annular surface where the tube wall of the tubular body is located and does not block the radial flow of aqueous humor.

9. The glaucoma drainage implant applicable to both internal and external implantation according to any one of claims 1 to 4, characterized in that, The connecting body is integrally formed with or detachably connected to the tubular body; Preferably, 0.85 × the length of the connecting body ≤ the length of any one of the tubular bodies ≤ 1.25 × the length of the connecting body; Preferably, 1 / 12 × the cross-sectional perimeter of the tubular body ≤ the width of the connecting body ≤ 1 / 3 × the cross-sectional perimeter of the tubular body; Preferably, the surface of the tubular body has a color display coating or a drug coating.

10. A drainage device, characterized in that, An inserter is included, and the inserter includes a pushing mechanism and a guiding tube. A pushing wire and a glaucoma drainage implant applicable to internal and external route implantation as described in any one of claims 1 to 9 are accommodated in the guiding tube. The fixed end of the pushing wire is connected to the pushing mechanism, and the free end of the pushing wire abuts against the glaucoma drainage implant. The pushing mechanism can push the pushing wire to axially move in the guiding tube to guide the glaucoma drainage implant to be implanted into the Schlemm's canal.

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