Eye implant

Abstract

The invention discloses an eye implant which comprises an implant body, the implant body is in a strip shape, the outer contour of the upper surface of the implant body is in a protruding arch shape or a semi-arch shape and used for making contact with a sclera, and the lower surface of the implant body is in a plane shape and used for making contact with a choroid; a longitudinal drainage groove is formed in the upper surface of the implant body in the front-back direction of the implant body. The whole implant body is of a structure that the front end and the rear end are gradually thin and the middle is thick or the rear end is gradually thin and the middle is thick to the front end, the implant body can smoothly enter the suprachoroidal space, an originally narrow gap of the suprachoroidal space is expanded, the outflow amount of aqueous humor from the suprachoroidal space is increased through the longitudinal drainage grooves, the drainage effect is good, blocking is not prone to occurring, and the application range is wide. The effect of reducing the intraocular pressure is achieved. The lower surface of the implant body is planar, so that the attachment area of the implant body and the choroid is larger, the implant body can be stably attached to the choroid, the risk of displacement of the anterior chamber and the choroid is reduced, the implant body is prevented from being exposed to the anterior chamber to touch the cornea, and the risk of loss of corneal endothelial cells is reduced to the maximum extent.

Description

Technical Field

[0001] The present invention relates to the technical field of eye implants, and in particular to an eye implant. Background Art

[0002] Glaucoma is the world's leading irreversible blinding eye disease, and with the aging of the population, the prevalence of glaucoma is increasing year by year. Intraocular pressure (IOP) is an independent risk factor for glaucoma, which leads to further damage to the optic nerve. Controlling intraocular pressure is an economical approach. There are many types of surgical treatments for glaucoma, such as laser treatment, trabeculectomy, implantation of various drainage devices and MIGS, but various surgical procedures or equipment have certain limitations. For example, the effective time of laser treatment is short, trabeculectomy has more postoperative complications, drainage devices generally have larger incisions, and MIGS has limited effect on lowering intraocular pressure.

[0003] Suprachoroidal drainage is performed by implanting a drainage device into the suprachoroidal space to expand the originally narrow suprachoroidal space, thereby increasing the outflow of aqueous humor from the suprachoroidal space and reducing intraocular pressure. Current suprachoroidal drainage implants generally protrude from the anterior chamber. If the implant is slightly displaced toward the anterior chamber, its front end contacts the cornea, increasing the risk of corneal endothelial cell loss. If the implant is displaced backward, the risk of choroidal detachment will also increase. In addition, the poor fit between the structure of the implant and the sclera and choroid will also increase the scarring of the implant (causing blockage of the aqueous humor drainage channel) and displacement problems. Therefore, in order to solve the above problems, the existing implants still need to be improved and optimized. Summary of the invention

[0004] In order to solve the above technical problems, a technical solution adopted by the present invention is to provide an ocular implant for integral implantation in the suprachoroidal space, comprising an implant body, the implant body being in the shape of a strip, the outer contour of the upper surface of the implant body being in the shape of a convex arch for contacting the sclera, and the lower surface of the implant body being in the shape of a plane for contacting the choroid; a longitudinal drainage groove is provided on the upper surface of the implant body along the front-to-back direction of the implant body.

[0005] In some embodiments, the portions of the implant body located on both sides of the longitudinal drainage groove form a support wall, and a transverse groove extending toward the lower surface of the implant body is provided on the upper surface of the support wall along the front-to-back direction of the support wall, and the transverse groove is connected to the longitudinal drainage groove. Preferably, the cross-sectional shape of the transverse groove is rectangular, trapezoidal or semicircular.

[0006] In some embodiments, there are multiple transverse grooves, which are arranged regularly or irregularly along the front-to-back direction of the support wall.

[0007] In some embodiments, there is at least one longitudinal drainage groove, which is disposed in the middle position of the upper surface of the implant body.

[0008] In some embodiments, a flow regulator is disposed in the longitudinal drainage groove.

[0009] In some embodiments, the flow regulator includes a transverse baffle that can close the cross-section of the longitudinal drainage groove, and a diversion hole for diverting aqueous humor is arranged on the transverse baffle. The diversion hole is connected to a flow regulating piece that can close or open the diversion hole. When the flow regulating piece is in a closed state, the entire diversion hole is closed, and when the flow regulating piece is in an open state, the diversion hole can allow aqueous humor to pass through.

[0010] In some embodiments, the flow regulator includes at least one transverse baffle that can close the cross-section of the longitudinal drainage groove, and one end or one side of the transverse baffle is connected to the longitudinal drainage groove through an elastic recovery member.

[0011] In some embodiments, the flow regulator is arranged in the longitudinal drainage groove near the middle part of the implant body, and the cross-sectional area of ​​the longitudinal drainage groove gradually decreases from the front end of the implant body to the middle part of the implant body; the cross-sectional area of ​​the longitudinal drainage groove gradually decreases from the rear end of the implant body to the middle part of the implant body.

[0012] In some embodiments, the bottom of the longitudinal drainage groove is slightly inclined downward from front to back.

[0013] In some embodiments, the width of the longitudinal drainage groove in the transverse direction of the implant body is 0.2 to 0.6 mm, and the depth of the longitudinal drainage groove is 0.1 to 0.4 mm.

[0014] In some embodiments, the cross-sectional shape of the longitudinal drainage groove is rectangular or semicircular; in some embodiments, the cross-sectional shape of the transverse groove is rectangular, trapezoidal or semicircular; in some embodiments, the maximum thickness from the upper surface to the lower surface of the implant body is 0.6±0.1mm; in some embodiments, the minimum thickness from the upper surface to the lower surface of the implant body is 0.3±0.1mm; in some embodiments, the width of the implant body in the transverse direction is 0.8~1.1mm; in some embodiments, the length of the implant body in the anterior-posterior direction is 4~6mm.

[0015] In some embodiments, the front end face and the rear end face of the implant body are both planar and perpendicular to the lower surface of the implant body; or, the rear end face of the implant body is planar, the front end of the implant body further extends away from the rear end of the implant body, and bends downward to form a snap-fitting portion, the bending radius of curvature of the snap-fitting portion is 3 to 6 mm, and the chord length of the snap-fitting portion is 0.5 to 2.5 mm.

[0016] In some embodiments, the implant body is made of a biocompatible material, and the biocompatible material is an elastic biodegradable material, a superhydrophilic material or a superhydrophobic material; preferably, the biocompatible material is a porous biocompatible material with a pore size of 10 to 60 μm and a porosity of 30 to 70%.

[0017] The present invention also discloses an ocular implant for integral implantation in the suprachoroidal space. The ocular implant comprises an implant body, which is strip-shaped. The implant body comprises a proximal portion, a distal portion and a middle portion in the longitudinal direction. The proximal portion is an end of the implant close to the anterior chamber after the implant is implanted in the eye. The lower surface of the implant body is plane, and the upper surface of the implant body comprises a plane portion and a curved portion. The plane portion and the curved portion are tangent to the middle portion of the implant body so that the thickness of the implant body gradually increases from the distal portion to the middle portion.

[0018] In some embodiments, the implant body is made of a porous biocompatible material, the porous biocompatible material has a pore size of 10 to 60 μm and a porosity of 30 to 70%.

[0019] The beneficial effects of the present invention are as follows: the present invention discloses an ocular implant for integral implantation in the suprachoroidal space, including an implant body, the implant body being in a strip shape, the outer contour of the upper surface of the implant body being in a convex arch or semi-arch shape for contacting the sclera, the lower surface of the implant body being in a plane for contacting the choroid; a longitudinal drainage groove is provided on the upper surface of the implant body along the front-back direction of the implant body. The implant body as a whole is in a structure that is gradually thinner at the front and back ends and thicker in the middle or gradually thinner at the rear end and thicker in the middle to the front end, and can smoothly enter the suprachoroidal space in the longitudinal direction, expand the originally narrow suprachoroidal space, and increase the outflow of aqueous humor from the suprachoroidal space by means of the longitudinal drainage groove, and has a good drainage effect, is not easy to be blocked, and plays a role in reducing intraocular pressure. The lower surface of the implant body is in a plane, and the area of ​​​​attachment with the choroid is larger, which is conducive to stable attachment to the choroid, reducing the risk of displacement to the anterior chamber and choroid, avoiding exposure to the anterior chamber to touch the cornea, and minimizing the risk of corneal endothelial cell loss. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1is a stereoscopic view of an embodiment of an ocular implant according to the present invention;

[0021] Figure 2 is a cross-sectional schematic diagram of an embodiment of an ocular implant according to the present invention;

[0022] Figure 3 is a side view of an embodiment of an ocular implant according to the present invention;

[0023] Figure 4 is a front view of an embodiment of an ocular implant according to the present invention;

[0024] Figure 5 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0025] Figure 6 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0026] Figure 7 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0027] Figure 8 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0028] Fig. 9 is a side view of some embodiments of an ocular implant according to the present invention;

[0029] Fig.10 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0030] Fig.11 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0031] Fig.12 is a side view of some embodiments of an ocular implant according to the present invention;

[0032] Fig.13 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0033] Fig.14 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0034] Fig.15 is a side view of some embodiments of an ocular implant according to the present invention;

[0035] Fig.16 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0036] Fig.17 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0037] Fig.18 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0038] Fig.19 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0039] Fig. 20 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0040] Fig.21 is a side view of some embodiments of an ocular implant according to the present invention;

[0041] Fig. 22 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0042] Fig.23 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0043] Fig.24 is a side view of some embodiments of an ocular implant according to the present invention;

[0044] Fig.25 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0045] Fig.26 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0046] Fig. 27 is a side view of some embodiments of an ocular implant according to the present invention;

[0047] Fig.28 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0048] Fig.29 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0049] Fig.30 are stereoscopic views of some embodiments of ocular implants according to the present invention;

[0050] Fig.31 is a side view of some embodiments of an ocular implant according to the present invention;

[0051] Fig.32 Schematic diagram of the implantation position of the ocular implant of the present invention. DETAILED DESCRIPTION

[0052] In order to facilitate the understanding of the present invention, the present invention is described in more detail below in conjunction with the accompanying drawings and specific embodiments. Preferred embodiments of the present invention are provided in the accompanying 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 of the present invention more thorough and comprehensive.

[0053] It should be noted that, unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used in this specification includes any and all combinations of one or more related listed items.

[0054] like Figures 1 to 4 As shown, as an embodiment of an ocular implant, the ocular implant includes an implant body 1 for integral implantation in the suprachoroidal space 300 (i.e., the space between the sclera 200 and the choroid 100 of the eye), the implant body 1 is in a strip shape, the outer contour of the upper surface 2 of the implant body 1 is a convex arch, and the upper surface 2 of the implant body 1 is used to contact the sclera 200; the lower surface 3 of the implant body 1 is flat, and the lower surface 3 of the implant body 1 is used to contact the choroid 100; the front end face 5 and the rear end face 6 of the implant body 1 are both flat and perpendicular to the lower surface 3 of the implant body 1; a longitudinal drainage groove 4 is provided on the upper surface 2 of the implant body 1 along the front-to-back direction of the implant body 1.

[0055] In the present invention, the front end (proximal end) of the implant body 1 refers to the end close to the anterior chamber of the eye after the implant is implanted, and the rear end (distal end) of the implant body 1 refers to the end away from the anterior chamber of the eye after the implant is implanted.

[0056] Combination Figures 1 to 4 In this embodiment, the implant body 1 is thin at the front and rear ends and thick in the middle. The implant body 1 can smoothly enter the suprachoroidal space 300 by virtue of its thin rear end (distal end) and expand the originally narrow space of the suprachoroidal space 300. After the implant body 1 is completely implanted in the suprachoroidal space 300, the middle part of the implant body 1 expands the space of the suprachoroidal space 300 to the greatest extent. Secondly, the implant body 1 can increase the outflow of aqueous humor from the suprachoroidal space 300 by virtue of the longitudinal drainage groove 4, has a better drainage effect, is not easy to cause blockage, and plays a role in reducing intraocular pressure.

[0057] The lower surface 3 of the implant body 1 is flat as a whole, which can make the implant body 1 and the choroid 100 fit in a larger area, which is conducive to the stable attachment of the implant to the choroid 100, and the upper surface 2 and the lower surface 3 of the implant body 1 can be stably fixed in the suprachoroidal space 300 under the clamping of the sclera 200 and the choroid 100, respectively, to reduce the risk of displacement of the implant body 1 to the anterior chamber and the choroid 100. It can be seen that in this embodiment, the implant body 1 can be completely implanted in the suprachoroidal space 300, avoiding exposure to the anterior chamber and touching the cornea, and minimizing the risk of corneal endothelial cell loss.

[0058] In this embodiment, the implant body 1 is made of a biocompatible material, and may be an elastic non-degradable material, a super-hydrophilic material, or a super-hydrophobic material.

[0059] The implant body 1 is made of biocompatible materials, so that the implant body 1 has good biocompatibility after being implanted in the suprachoroidal space 300, and can adapt to the intraocular tissue, reduce or avoid adverse reactions to the intraocular tissue. For example, non-degradable materials with good biocompatibility, or superhydrophobic materials or superhydrophilic materials can be used. The use of non-degradable materials can reduce scarring after implantation. The implant body 1 made of superhydrophobic materials and superhydrophilic materials can inhibit excessive tissue growth (scarring) in the suprachoroidal space and the attachment of Staphylococcus aureus.

[0060] Specifically, in this embodiment and some embodiments, the implant body 1 can be made of silicone, acrylic acid, poly(ethylene-vinyl acetate) copolymer, acrylic polymer, polyethylene, polypropylene, polysulfone, poly(methyl methacrylate) (PMMA), fluoropolymer (such as polytetrafluoroethylene), polyethylene phthalate (PET or polyester), polyamide (such as nylon), polyurethane, etc.

[0061] Further, combined with Figure 2 In this embodiment, the length L of the implant body 1 in the front-to-back direction (i.e., from the proximal end to the distal end) is 5±1 mm. If the implant body 1 is too long, it is easy to enter the suprachoroidal space 300 too deeply, causing the choroid 100 to detach; if the implant body 1 is too short, it is easy to be displaced, and the anchoring effect is not good. When the length L of the implant body 1 is set within this range (4 to 6 mm), the implant body 1 is not easy to be displaced and cause the choroid 100 to detach after being implanted in the suprachoroidal space 300.

[0062] The width W1 of the implant body 1 in the transverse direction is preferably 0.8 to 1.1 mm. The width of the implant body 1 within this range is conducive to implanting the implant body 1 through a suitable surgical incision and meeting the size requirements of the longitudinal drainage groove 4. In this embodiment, the width W1 of the implant body 1 is about 1 mm, and in some other embodiments, the width W1 of the implant body 1 is about 0.8 mm, 0.9 mm or 1.1 mm.

[0063] Combination Figure 3 In this embodiment, the maximum thickness H1 from the upper surface 2 to the lower surface 3 of the implant body 1 is 0.6±0.1 mm; the maximum thickness H1 of the implant body 1 is located in the middle part of the implant body 1 (i.e., the top position of the arch). Within the range of the maximum thickness H1, the implant body 1 can both open the gap of the suprachoroidal space 300 and will not cause detachment of the choroid 100.

[0064] The minimum thickness H2 from the upper surface 2 to the lower surface 3 of the implant body 1 is 0.3±0.1mm. The minimum thickness H2 of the implant body 1 is located at the front and rear ends of the implant body 1, and is smoothly transitioned to the middle part of the implant body 1; within the range of the minimum thickness H2, the front end of the implant body 1 can open the connection between the suprachoroidal space 300 and the anterior chamber, allowing the aqueous humor to flow smoothly from the anterior chamber.

[0065] like Figure 4 As shown, in this embodiment, there is at least one longitudinal drainage groove 4, which is arranged in the middle position of the upper surface 2 of the implant body 1. In some embodiments, there are multiple longitudinal drainage grooves 4, which are evenly distributed on the upper surface 2 of the implant body 1; or in some embodiments, the upper surface 2 and the lower surface 3 of the implant body 1 are both provided with longitudinal drainage grooves 4.

[0066] In the present application, the width W2 of the longitudinal drainage groove 4 in the transverse direction of the implant body 1 is 0.2 to 0.6 mm. The specific value of the width W2 of the longitudinal drainage groove 4 can be adjusted according to the implant size and the aqueous humor drainage effect. In some embodiments, the width W2 of the longitudinal drainage groove 4 is 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm or 0.6 mm. Please refer to Figure 2 , Figure 6 , Figure 7 , Fig.10 , Fig.13 , Fig.16 , Fig.19 , Fig. 22 , Fig.25 , Fig.28 , the width W2 of the longitudinal drainage groove 4 is 0.3 mm, referring to Figure 5 , Figure 8 , Fig.11 , Fig.14, Fig.17 , Fig. 20 , Fig.23 , Fig.26 , the width of the longitudinal drainage groove 4 is 0.5 mm.

[0067] Further, such as Figure 1 As shown, in some embodiments, the cross-sectional area of ​​the longitudinal drainage groove 4 gradually increases in the direction from the front end of the implant body 1 to the middle part of the implant body 1, that is, the cross-sectional area of ​​the longitudinal drainage groove 4 tends to gradually increase from the front end to the middle part of the implant body 1; the cross-sectional area of ​​the longitudinal drainage groove 4 gradually increases in the direction from the rear end of the implant body 1 to the middle part of the implant body 1, that is, the cross-sectional area of ​​the longitudinal drainage groove 4 also tends to gradually increase from the rear end to the middle part of the implant body 1.

[0068] In the present application, the depth range of the longitudinal drainage groove 4 in the up and down directions is preferably 0.1 to 0.4 mm. When the bottom of the longitudinal drainage groove 4 is parallel to the lower surface 3 of the implant body 1, since the outer contour of the upper surface of the implant body 1 is a convex arch, it should be understood that the depth of the longitudinal drainage groove 4 gradually increases in the direction from the front end of the implant body 1 to the middle part of the implant body 1, and the depth of the longitudinal drainage groove 4 gradually increases in the direction from the rear end of the implant body 1 to the middle part of the implant body 1, that is, the depth of the longitudinal drainage groove 4 near the middle part of the implant body 1 (that is, the top position of the arch) is the deepest. In the present embodiment, the depth of the longitudinal drainage groove 4 at this location is 0.4 mm.

[0069] Please refer to Figure 4 In this embodiment, the cross-sectional shape of the longitudinal drainage groove 4 is a rectangle. In other embodiments, the cross-sectional shape of the longitudinal drainage groove 4 can also be a semicircle or other shapes, such as referring to Figure 7 As shown, the cross-sectional shape of the longitudinal drainage groove 4 is semicircular.

[0070] Further, in this embodiment, the bottom of the longitudinal drainage groove 4 is parallel to the lower surface 3 of the implant body 1. In some other embodiments, the bottom of the longitudinal drainage groove 4 is slightly inclined downward from front to back, so that the rear end of the longitudinal drainage groove 4 is lower than the front end of the longitudinal drainage groove 4, which is conducive to the diversion of aqueous humor from the suprachoroidal space 300.

[0071] like Figure 6 As shown, in some embodiments, a flow regulator 7 is provided in the longitudinal drainage groove 4. The flow regulator 7 includes a transverse baffle 8 that can close the cross section of the longitudinal drainage groove 4.

[0072] The transverse baffle 8 is permanently fixedly connected to the longitudinal drainage groove 4 or is non-permanently fixedly connected (for example, detachably connected); the location and number of the transverse baffles 8 can be adjusted according to actual needs.

[0073] A flow-conducting hole 9 for conducting aqueous humor is arranged on the transverse baffle 8, and a flow-regulating piece 10 which can close or conduct the flow-conducting hole 9 is connected in the flow-conducting hole 9; the flow-regulating piece 10 closes the entire flow-conducting hole 9 when in a closed state; the flow-regulating piece 10 is in an open state, and the flow-conducting hole 9 is conducted, and aqueous humor can flow from one side of the flow-conducting hole 9 to the other side. In this embodiment, the closing or conducting of the flow-regulating piece 10 by the flow-regulating piece 10 is controlled by the pressure of aqueous humor. When the pressure of aqueous humor is low, the flow-regulating piece 10 closes the flow-conducting hole 9, and aqueous humor cannot pass through the flow-conducting hole 9, which can avoid the occurrence of low intraocular pressure caused by continuous discharge of aqueous humor; when the pressure of aqueous humor is high, the flow-regulating piece 10 flips open under the pressure of aqueous humor, and no longer closes the flow-conducting hole 9, and aqueous humor passes through the flow-conducting hole 9.

[0074] In some embodiments, the force required to open the flow regulating plate 10 can be set as a first critical force. When the aqueous humor pressure is lower than the first critical force, the flow regulating plate 10 closes the conduction hole 9; when the aqueous humor pressure is higher than the first critical force, the flow regulating plate 10 opens and conducts the conduction hole 9.

[0075] Furthermore, the flow-conducting hole 9 is adapted to the flow regulating piece 10, and the flow regulating piece 10 and the flow-conducting hole 9 are movably connected or elastically connected, so that the flow regulating piece 10 can be flipped or the flow regulating piece 10 can be switched between an open state and a closed state; in a preferred embodiment, the flow regulating piece 10 is made of a biocompatible elastic material, which has a certain elastic recovery and can be switched between an open state and a closed state according to the pressure of the aqueous humor.

[0076] The shape of the flow-conducting hole 9 is rectangular, circular, semicircular, triangular, or other shapes such as a rectangular upper part and a semicircular lower part.

[0077] In some embodiments, the flow regulator includes at least one transverse baffle (not shown) that can close the cross section of the longitudinal drainage groove 4, and the location and number of the transverse baffle can be adjusted according to actual needs. One end or one side of the transverse baffle is connected to the longitudinal drainage groove 4 through an elastic recovery member. When the pressure of the aqueous humor is relatively low, the transverse baffle automatically closes the longitudinal drainage groove 4 under the action of the elastic recovery member, and the aqueous humor cannot flow in the longitudinal drainage groove 4, which can avoid the occurrence of low intraocular pressure caused by continuous discharge of the aqueous humor; when the pressure of the aqueous humor is relatively high, the transverse baffle rotates under the pressure of the aqueous humor and no longer closes the longitudinal drainage groove 4, and the aqueous humor can flow in the longitudinal drainage groove 4.

[0078] In some embodiments, the force required to open the transverse baffle is the second critical force. When the aqueous humor pressure is lower than the second critical force, the transverse baffle closes the longitudinal drainage groove 4; when the aqueous humor pressure is higher than the second critical force, the transverse baffle opens and connects the longitudinal drainage groove 4.

[0079] The elastic recovery member may be a component with an automatic recovery function such as a micro spring. In some other embodiments, the flow regulator includes a first transverse baffle and a second transverse baffle arranged on the left and right sides of the longitudinal drainage groove, the first transverse baffle and the second transverse baffle are respectively connected to the groove wall of the longitudinal drainage groove through the elastic recovery member, and the first transverse baffle and the second transverse baffle jointly close or conduct the longitudinal drainage groove.

[0080] In some other embodiments, in order to make the flow regulator 7 more responsive to changes in aqueous humor pressure, the flow regulator 7 is disposed at the deepest part of the longitudinal drainage groove 4, that is, in the longitudinal drainage groove 4 near the middle part (that is, the top part of the arch) of the implant body 1, and at the same time, the cross-section of the longitudinal drainage groove 4 tends to gradually decrease from the front end to the middle part of the implant body 1; the cross-sectional area of ​​the longitudinal drainage groove 4 also tends to gradually decrease from the rear end of the implant body 1 to the middle part of the implant body 1, that is, the cross-sectional area of ​​the drainage groove at the position of the flow regulator 7 is the smallest, so that the pressure of the aqueous humor reaching the flow regulator 7 can be increased, and the flow regulator 7 can respond more sensitively to changes in aqueous humor pressure.

[0081] like Figure 8 As shown, the portions of the implant body 1 located on both sides of the longitudinal drainage groove form a support wall 11. In some embodiments, the ocular implant further includes a transverse groove 12 arranged on the upper surface of the support wall 11 along the front-to-back direction of the support wall 11 and extending toward the lower surface 3 of the implant body 1, and the transverse groove 12 is connected to the longitudinal drainage groove 4.

[0082] like Figure 7 , Figure 8 , Fig.10 , Fig.11 , Fig.13 , Fig.14 , Fig.16 , Fig.17 , Fig.19 , Fig. 20 , Fig. 22 , Fig.23 , Fig.24 , Fig.25 , Fig.26 , Fig.28As shown, there are two support walls 11, and a plurality of transverse grooves 12 are arranged on each support wall 11, and the plurality of transverse grooves 12 are arranged regularly or irregularly along the front-back direction of the support wall 11. By providing the transverse grooves 12, the friction between the upper surface 2 of the implant body 1 and the sclera 200 can be increased, the displacement of the implant body 1 can be avoided, and the stability of the implant body 1 can be enhanced; at the same time, these transverse grooves 12 are also connected to the longitudinal drainage grooves 4, which have the function of diverting aqueous humor; the transverse grooves 12 can also reduce the stress on the upper surface of the implant body 1, so that the implant body 1 is easier to bend and fits the sclera 200 more closely.

[0083] like Figure 8 to Figure 13 , Figure 20 to Figure 25 As shown, in some embodiments, the cross-sectional shape of the transverse groove 12 is a trapezoid, such as Figure 7 As shown, in other embodiments, the cross-sectional shape of the transverse groove 12 is semicircular; Fig.14 , Fig.15 , Fig.16 , Fig.26 , Fig. 27 , Fig.28 As shown, in some other embodiments, the cross-sectional shape of the transverse groove 12 can also be a rectangle or other shapes.

[0084] Furthermore, the width of the transverse groove 12 is 0.1-0.4 mm. In some embodiments, the widths of the plurality of transverse grooves 12 may be the same or different.

[0085] The depth of the transverse groove 12 is 0.1 to 0.4 mm. In some embodiments, the depths of multiple transverse grooves 12 may be the same or different. For example, the depth of the transverse groove 12 tends to gradually increase from the front and rear sides of the implant body 1 to the middle part of the implant body 1.

[0086] The number of transverse grooves 12 can be multiple on the supporting walls 11 on both sides of the implant body 1, such as Figure 8 , Fig. 9 , Fig.10 , Fig. 20 , Fig.21 , Fig. 22 As shown, in some embodiments, the number of transverse grooves 12 of the same support wall 11 is 3; Figure 7 , Figures 11 to 16 , Fig.23 , Fig.24 , Figure 25 to Figure 28 As shown, in some other embodiments, the number of the transverse grooves 12 of the same supporting wall 11 is 5. In other embodiments, the number of corresponding transverse grooves 12 can be set according to the longitudinal length of the upper surface 2 of the implant body 1, and is not limited to 3 or 5.

[0087] In some preferred embodiments, the transverse grooves 12 on the supporting walls 11 on both sides of the implant body 1 are symmetrically arranged, and the bottom of the transverse groove 12 is flush with the bottom of the longitudinal drainage groove 4, which is more conducive to lateral diversion of aqueous humor.

[0088] like Figures 17 to 28 As shown, in some embodiments, the front end of the implant body 1 further extends in a direction away from the rear end of the implant body 1 and bends downward to form a snap-fit ​​portion 13.

[0089] In these embodiments, the rear end face 6 of the implant body 1 is perpendicular to the lower surface 3 of the implant body 1, the front end face 5 of the implant body 1 is parallel to the lower surface 3 of the implant body 1 or there is an angle between the front end face 5 of the implant body 1 and the lower surface 3 of the implant body 1.

[0090] The front end (proximal end) of the implant body 1 is gradually bent downward to form a snap-fitting portion 13. The snap-fitting portion 13 can further avoid the risk of the front end (proximal end) of the implant body 1 contacting the cornea 500 even when the anterior chamber is exposed. At the same time, the arc-shaped snap-fitting portion 13 can be tightly fastened to the root of the iris 400 to prevent the implant body 1 from moving in the distal direction and affecting the choroid 100, thereby avoiding detachment of the choroid 100. At the same time, even if the implant body 1 moves in the proximal direction, it will not cause damage to the corneal endothelial cells. More specifically, in order to make the snap-fitting portion 13 better conform to the physiological curvature of the iris and facilitate anchoring, the snap-fitting portion 13 has a bending radius of curvature of 3 to 6 mm and a chord length of 0.5 to 2.5 mm.

[0091] In addition, in order to increase the bonding force between the implant body 1 and the suprachoroidal ocular tissue and further stabilize the implant after implantation, in the above-mentioned embodiment of the present application or some other embodiments, longitudinal and transverse microgrooves are provided on the surface of the support wall 11 and the lower surface 3 of the implant body 1, so that the sclera and the choroid can further fix the implant body 1 through these microgrooves. Alternatively, in some other embodiments, the implant body 1 of the above-mentioned implant of the present application can be made of porous silica gel, porous polyethylene or porous TPU, with a pore size of 10 to 60 μm and a porosity of 30 to 70%. The use of porous materials can enhance the bonding force between the implant and the ocular tissue on the one hand, and on the other hand, part of the aqueous humor can also flow through its porous structure to enhance the diversion effect.

[0092] Combination Figure 29 to Figure 31In some embodiments, the ocular implant includes an implant body 1 and a drainage portion located on the implant body 1, and the drainage portion is used to drain the aqueous humor from the anterior chamber to reduce intraocular pressure. In these embodiments, the implant body 1 has a porous structure, the drainage portion includes a porous structure, the aqueous humor can flow through the pores of the porous structure, so that the aqueous humor in the anterior chamber is drained to reduce intraocular pressure, and the pore size of the porous structure is 10 to 60 μm, and the porosity is 30 to 70%.

[0093] The guide part also includes a longitudinal drainage groove 4 arranged on the upper surface 2 of the implant body 1 along the longitudinal direction of the implant body 1. The implant body 1 can increase the outflow of aqueous humor from the suprachoroidal space 300 through the longitudinal drainage groove 4, has a better drainage effect, is not easy to cause blockage, and further plays a role in reducing intraocular pressure.

[0094] In these embodiments, the implant body 1 is in the shape of a strip, and is implanted as a whole and in the suprachoroidal space along its longitudinal direction. The implant body 1 includes a proximal portion 101, a distal portion 103 and a middle portion 102 in the longitudinal direction. The proximal portion 101 is the end of the implant close to the anterior chamber after the implant is implanted in the eye, and the distal portion 103 is the other end of the implant away from the anterior chamber after the implant is implanted in the eye; the lower surface 3 of the implant body 1 is flat, the upper surface 2 of the implant body 1 is at least partially curved, and the thickness of at least the distal portion 103 to the middle portion 102 of the implant body 1 gradually increases.

[0095] exist Figure 29 to Figure 31 In the embodiment, the upper surface 2 of the implant body 1 includes a plane portion and a curved surface portion, the plane portion and the curved surface portion are tangent to the middle portion 102 of the implant body 1, and the curved surface portion forms a semi-arched shape, so that the thickness from the distal end portion 103 to the middle portion 102 of the implant body 1 gradually increases. The upper surface of the proximal portion 101 belongs to the plane portion, which is parallel to the lower surface 3 of the implant body 1, while the upper surface of the distal portion 103 belongs to the curved surface portion. It can be seen that the proximal portion 101 is larger in volume in the longitudinal direction of the implant body 1 relative to the distal portion 103. After implantation in the suprachoroidal space, the anterior chamber angle of the eye will be more open, which is more conducive to the circulation of aqueous humor. And because the thickness from the distal portion 103 to the middle portion 102 of the present implant is gradually increased, it can also prevent the implant from moving in the distal direction and avoid affecting the choroid 100.

[0096] Recombination Figures 1 to 16 In these embodiments, the implant body 1 is also divided into three parts in the longitudinal direction: the proximal part, the distal part and the middle part. However, the thickness of the distal part and the proximal part to the middle part of the implant body 1 gradually increases, and the upper surface 2 of the implant body is generally convex. Figure 29 to Figure 31 The difference of this embodiment.

[0097] In addition to the above differences, Figure 29 to Figure 31 The implant structure, structural dimensions, materials, etc. of the present implant and other embodiments of the present invention can be completely the same. For example, in some embodiments, the upper surface of the body of the present implant is also provided with a plurality of transverse grooves 12 as described in other embodiments of the present application, in some embodiments, the longitudinal drainage groove 4 of the present implant is also provided with a flow regulator as described in other embodiments of the present application, in some embodiments, the surface of the support wall 11 and the lower surface 3 of the body 1 of the present implant are provided with longitudinal and transverse microgrooves as described in other embodiments of the present application, and in some preferred embodiments, the above-mentioned transverse grooves, flow regulators or two or more of the above-mentioned microgrooves can also be provided simultaneously in the present implant.

[0098] Combination Figures 1 to 32 The present invention provides an ocular implant, which is used to be implanted in the suprachoroidal space 300 to increase the outflow of aqueous humor from the suprachoroidal space 300 and reduce intraocular pressure. The process of implanting the ocular implant in the suprachoroidal space 300 is as follows:

[0099] Step 1: Making a surgical incision at the edge of the cornea 500;

[0100] Step 2: Inject a certain amount of viscoelastic into the anterior chamber to open the chamber angle;

[0101] Step 3: inserting a delivery device loaded with the ocular implant from the surgical incision, and inserting the head end of the delivery device into the suprachoroidal space 300;

[0102] Step 4: Operate the handle of the conveyor to release the eye implant;

[0103] Step 5: withdraw the conveyor and extract the viscoelastic agent;

[0104] Step 6: Suturing the surgical incision at the edge of the cornea 500.

[0105] After the ocular implant of the present invention is implanted in the suprachoroidal space 300, it can expand the originally narrow space of the suprachoroidal space 300, increase the outflow of aqueous humor from the suprachoroidal space 300, have a good drainage effect, not easy to be blocked, and play a role in reducing intraocular pressure. The ocular implant can be stably attached to the choroid 100, reduce the risk of displacement to the anterior chamber and the choroid 100, avoid exposure to the anterior chamber to touch the cornea, and minimize the risk of corneal endothelial cell loss. In addition, the ocular implant of the present invention can be performed simultaneously with cataract surgery during the implantation process, sharing the same surgical incision, and reducing the complexity of the surgical process.

[0106] The above descriptions are merely embodiments of the present invention and are not intended to limit the patent scope of the present invention. Any equivalent structural transformations made using the contents of the present invention's specification and drawings, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present invention.

Claims

1. An ocular implant for integral implantation in the suprachoroidal space, characterized in that: The implant body includes an implant body which is strip-shaped, the outer contour of the upper surface of the implant body is a convex arch for contacting the sclera, and the lower surface of the implant body is a plane for contacting the choroid; a longitudinal drainage groove is arranged on the upper surface of the implant body along the front-to-back direction of the implant body.

2. The ocular implant according to claim 1, characterized in that: The parts of the implant body located on both sides of the longitudinal drainage groove form a support wall, and a transverse groove extending toward the lower surface of the implant body is arranged on the upper surface of the support wall along the front-to-back direction of the support wall, and the transverse groove is connected with the longitudinal drainage groove. Preferably, the cross-sectional shape of the transverse groove is rectangular, trapezoidal or semicircular.

3. The ocular implant according to claim 2, characterized in that: There are multiple transverse grooves, which are arranged regularly or irregularly along the front-to-back direction of the support wall.

4. The ocular implant according to claim 1, characterized in that: There is at least one longitudinal drainage groove, which is arranged at the middle position of the upper surface of the implant body.

5. The ocular implant according to claim 1, characterized in that: A flow regulator is arranged in the longitudinal drainage groove.

6. The ocular implant according to claim 5, characterized in that: The flow regulator includes a transverse baffle that can close the cross-section of the longitudinal drainage groove, and a diversion hole for diverting aqueous humor is arranged on the transverse baffle. The diversion hole is connected with a flow regulating piece that can close or open the diversion hole. When the flow regulating piece is in a closed state, the entire diversion hole is closed, and when the flow regulating piece is in an open state, the diversion hole can allow aqueous humor to pass through.

7. The ocular implant according to claim 5, characterized in that: The flow regulator comprises at least one transverse baffle which can close the cross section of the longitudinal drainage groove, and one end or one side of the transverse baffle is connected to the longitudinal drainage groove through an elastic recovery member.

8. The ocular implant according to any one of claims 5 to 7, characterized in that: The flow regulator is arranged in the longitudinal drainage groove near the middle part of the implant body, and the cross-sectional area of ​​the longitudinal drainage groove gradually decreases from the front end of the implant body to the middle part of the implant body; the cross-sectional area of ​​the longitudinal drainage groove gradually decreases from the rear end of the implant body to the middle part of the implant body.

9. The ocular implant according to claim 1, characterized in that: The bottom of the longitudinal drainage groove is slightly inclined downward from front to back.

10. The ocular implant according to claim 1, characterized in that: Preferably, the width of the longitudinal drainage groove in the transverse direction of the implant body is 0.2 to 0.6 mm, and the depth of the longitudinal drainage groove is 0.1 to 0.4 mm; Preferably, the cross-sectional shape of the longitudinal drainage groove is rectangular or semicircular; Preferably, the maximum thickness from the upper surface to the lower surface of the implant body is 0.6±0.1 mm; Preferably, the minimum thickness from the upper surface to the lower surface of the implant body is 0.3±0.1 mm; Preferably, the width of the implant body in the transverse direction is 0.8 to 1.1 mm; Preferably, the length of the implant body in the anterior-posterior direction is 4 to 6 mm; Preferably, the front end face and the rear end face of the implant body are both plane and perpendicular to the lower surface of the implant body; or, the rear end face of the implant body is plane, the front end of the implant body further extends in a direction away from the rear end of the implant body, and bends downward to form a buckle portion, the bending radius of the buckle portion is 3 to 6 mm, and the chord length of the buckle portion is 0.5 to 2.5 mm; Preferably, the implant body is made of a biocompatible material, and the biocompatible material is an elastic bio-non-degradable material, a super-hydrophilic material or a super-hydrophobic material; preferably, the biocompatible material is a porous biocompatible material with a pore size of 10 to 60 μm and a porosity of 30 to 70%.

11. An ocular implant for integral implantation in the suprachoroidal space, characterized in that: The invention comprises an implant body, which is in the shape of a strip and includes a proximal portion, a distal portion and a middle portion in the longitudinal direction, wherein the proximal portion is an end of the implant close to the anterior chamber after being implanted in the eye, the lower surface of the implant body is plane, and the upper surface of the implant body includes a plane portion and a curved portion, wherein the plane portion and the curved portion are tangent to the middle portion of the implant body so that the thickness of the implant body gradually increases from the distal portion to the middle portion.

12. The ocular implant according to claim 11, characterized in that The implant body is made of porous biocompatible material, the pore size of the porous biocompatible material is 10-60 μm, and the porosity is 30-70%.

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