Glaucoma drainage implant system

Abstract

The utility model provides a glaucoma drainage implant system which comprises a micro-stent and an implanter, the micro-stent is made of nickel-titanium alloy and comprises a tubular body with a hollow cavity, the tubular body is in a straight tube shape, the outer surface of the tubular body is provided with a plurality of holes which are regularly or irregularly arranged, and the implanter is arranged in the tubular body. The open grooves are formed in the surface of the tubular body in the axial direction of the tubular body, aqueous humor can flow through the open grooves and the open holes, the orthographic projection of each open hole is in a dovetail groove shape, and a friction contact part is formed on each dovetail groove; the micro-stent has a good aqueous fluid diversion effect to reduce intraocular pressure, can support the schlemm tube, is good in implantation stability and anti-displacement, has enough strength, and is not easy to deform and collapse; the implanter is used for implanting the micro-stent into the schlemm tube and comprises an implanter body, a guide tube, a push wire and a driving mechanism, the micro-stent is contained in the guide tube, the push wire is arranged in the guide tube, the far end of the push wire abuts against the micro-stent, and the driving mechanism is connected with the push wire and used for pushing out the micro-stent.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a glaucoma drainage implant system. Background Art

[0002] Glaucoma is a group of diseases with common characteristics of optic disc atrophy and depression, visual field defect and decreased vision. Pathological increase in intraocular pressure and insufficient blood supply to the optic nerve are the primary risk factors for the onset of glaucoma. The tolerance of the optic nerve to pressure damage is also related to the occurrence and development of glaucoma. Any obstruction in the aqueous humor circulation pathway can lead to pathological changes caused by increased intraocular pressure. Glaucoma is one of the three major blinding eye diseases that cause blindness in humans. Clinically, glaucoma is divided into three categories: primary, secondary and congenital according to the cause, chamber angle, intraocular pressure recording and other conditions.

[0003] In the existing glaucoma implantation surgery, the drainage implant is implanted into a specific position in the human eye to reconstruct or restore the aqueous humor outflow channel, and through external drainage or internal drainage, the intraocular pressure is reduced to achieve the purpose of treating glaucoma. Among them, internal drainage is discharged through the natural channel for aqueous humor discharge, such as the collection duct on the outer wall of the Schlemm's canal or the suprachoroidal space. Internal drainage relies on the original natural drainage channel of aqueous humor and is not dependent on filtering blebs. It is the main development trend of glaucoma implantation surgery, but traditional internal drainage surgery is generally only suitable for patients with open-angle glaucoma. In recent years, the existing technology has disclosed a stent-assisted internal drainage trabecular surgery (SLITs) for the treatment of glaucoma. This surgery, based on deep scleral flap resection, implants a glaucoma Schlemm's canal drainage stent to support the opening of the Schlemm's canal end, and connects to the anterior chamber through the Dischler membrane window, so as to achieve the effect of continuously draining the inflowing aqueous humor through the Schlemm's canal, thereby reducing the intraocular pressure. This surgery causes less damage to the Schlemm canal tissue and trabecular meshwork, reduces postoperative complications (such as anterior chamber hemorrhage, early increase in intraocular pressure, detachment of the posterior Descemet's membrane, etc.), is independent of the filtering bleb, and has a low incidence of complications such as low intraocular pressure and shallow anterior chamber. It also avoids filtering bleb-related ocular surface discomfort and complications, as well as surgical failure due to long-term posterior filtering bleb scarring. More importantly, this surgery currently uses an external approach, which is not affected by the morphology of the chamber angle and is suitable for the treatment of both open-angle and angle-closure glaucoma.

[0004] Relevant patents such as US11707383B2, CN107981969B, CN111803274B and CN215606822U have been applied for the above-mentioned surgery and the products that implement it, such as implant stents and injectors. The key to the successful implementation and clinical effect of this surgery lies in the implant system (i.e., micro-stent and implanter), but the implant system still needs to be continuously optimized and improved in many aspects such as drainage effect, implant stability, implant physical properties, implant processing and ease of operation of implant surgery. Utility Model Content

[0005] In order to solve the above technical problems, the present application provides a glaucoma drainage implant system, which optimizes the existing glaucoma drainage implant in terms of drainage effect, implantation stability and implant processing, and optimizes the implantation accuracy, implantation effect and ease of use of the implanter. The technical solutions provided by the present application are as follows:

[0006] A glaucoma drainage implant system, the glaucoma drainage implant system comprising a micro-stent and an implanter, the micro-stent being made of nickel-titanium alloy, comprising a tubular body having a hollow cavity, the tubular body being in a straight tube form, the outer surface of the tubular body having a plurality of openings arranged regularly or irregularly, and grooves on the surface of the tubular body along the axial direction of the tubular body, the aqueous humor can flow through the grooves and the openings; the total area of ​​the grooves and the openings accounts for 20-55% of the outer peripheral side area of ​​the tubular body, more preferably, the grooves The total area of ​​the openings accounts for 30-40% of the area of ​​the outer peripheral side surface of the tubular body; the orthographic projection of each opening is in the shape of a dovetail groove, and the multiple dovetail grooves are located within the length L1 of the grooves in the axial direction of the tubular body; the profile of the dovetail groove is formed by a first arc with a first radius R1 and a second arc with a second radius R2 connected by an arc line, the first radius R1 is 0.03-0.05 mm, and the second radius R2 is 0.1-0.14 mm; the second arc forms a friction contact portion on the dovetail groove;

[0007] The implanter is used to implant a micro-stent into a Schlemm's canal, and comprises an implanter body; a guide tube, the guide tube having a guide channel, the micro-stent being accommodated at the distal end of the guide tube, and the implantation end of the micro-stent opening toward the distal end of the guide tube; the proximal end of the guide tube being connected to the implanter body, and the distal end extending in a direction away from the implanter body; a push wire, the push wire being arranged inside the guide tube, the distal end of the push wire being against the micro-stent; and a drive mechanism, the drive mechanism being connected to the proximal end of the push wire and being used to push the micro-stent out of the distal end of the guide tube.

[0008] In some embodiments of the present application, the micro-stent is used for implantation into the broken end port of the Schlemm tube, the plurality of openings are located on one side of the plane where the central axis of the tubular body is located, and the slots are located on the other side of the plane where the central axis of the tubular body is located;

[0009] Preferably, the length L of the tubular body is 1-3 mm, the inner diameter of the tubular body is 175-185 μm, and the wall thickness is 35-65 μm; the size of the slot meets the following restrictions:

[0010] 3 / 4*L<L1<L, wherein L is the length of the tubular body, and L1 is the length of the slot;

[0011] 0<L5<L-L1, wherein L5 is the distance between any end of the slot and the adjacent end surface of the tubular body;

[0012] 3%*C<C2<10%*C, wherein C is the outer diameter circumference of the tubular body, and C2 is the width of the slot;

[0013] Preferably, the inner and outer surfaces of the tubular body are formed with polished surfaces.

[0014] In some embodiments of the present application, the size of the dovetail groove meets the following definition: the width C1 of the dovetail groove at the maximum point along the circumferential direction of the tubular body is 0.4-0.6 mm;

[0015] 10%*L<L3<13%*L, wherein L3 is the distance between the centers of the first arcs of two adjacent dovetail grooves;

[0016] 18%*L<L2<24%*L, L2 is the distance between the center of the first arc in the dovetail groove adjacent to the non-implanted end of the micro-stent and the end surface of the tubular body adjacent thereto;

[0017] 15%*L<L4≤L2, L4 is the distance between the center of the first arc in the dovetail groove adjacent to the implantation end of the micro-stent and the end face of the tubular body adjacent thereto.

[0018] In some embodiments of the present application, a fillet is formed at the dovetail angle of the dovetail groove to prevent turbulent deposition, and the radius R3 of the fillet is 0.005~0.01. Multiple dovetail grooves form bionic fins on the side of the tubular body, and the dovetail angle of the dovetail groove does not exceed the generatrix where the horizontal plane where the central axis of the tubular body is located intersects with the tube wall of the tubular body.

[0019] In some embodiments of the present application, the friction contact portion does not protrude from the tubular body, so that during the process of implanting the tubular body into the Schlemm's tube: when moving in a first moving direction, the surface of the tubular body is not obstructed, and the first moving direction is the implantation direction of the tubular body; when moving in a second moving direction, the friction contact portion contacts the inner wall of the Schlemm's tube to generate friction, and the second moving direction is opposite to the direction of the first moving direction.

[0020] In some embodiments of the present application, the guide tube includes a straight portion and a curved portion in the axial direction, the straight portion is connected to the implant body, the curved portion is arc-shaped, and the angle α between two tangents on the outer side of the curved portion is 70-90°;

[0021] Alternatively, the curved portion is S-shaped, including a first arc tube and a second arc tube with opposite bending directions.

[0022] In some embodiments of the present application, the distal end of the guide tube is provided with an opening, the openings are provided with two openings, and are symmetrically distributed along the circumference of the tube wall of the guide tube, the length of the openings is 0.7-1.3 mm, the width is 0.15-0.25 mm, and the distance between the openings and the end surface of the distal end of the guide tube is 0.1-0.5 mm;

[0023] Alternatively, the opening is formed by partially cutting off the distal end of the guide tube in the axial direction, and the portion of the guide tube opposite to the opening forms a guide portion, and the size of the guide portion meets the following definition:

[0024] 30%*L≤L6≤75%*L, wherein L is the length of the tubular body, and L6 is the length of the guide portion;

[0025] 50%*D<h<75%*D, wherein D is the outer diameter of the guide tube, and h is the height of the guide portion;

[0026] Alternatively, the opening is formed by partially cutting off the distal end of the guide tube along the axial direction and the oblique direction intersecting the axis, the portion of the guide tube opposite to the opening forms a guide portion, the guide portion includes a horizontal portion and an inclined portion, the inclined portion is an end away from the guide tube, and the cross-sectional size gradually decreases, the inclined portion has an inclined surface, and the angle β between the inclined surface and the central axis of the guide tube is 20-45°; the size of the guide portion meets the following restrictions:

[0027] 45%*L≤L6≤75%*L, L6=a+b, wherein L is the length of the tubular body, L6 is the length of the guide portion, a is the length of the horizontal portion, and b is the length of the inclined portion;

[0028] 50%*D<h<75%*D, wherein D is the outer diameter of the guide tube, and h is the height of the guide portion;

[0029] Preferably, the edge contours of the openings are all provided with rounded corners.

[0030] In some embodiments of the present application, the driving mechanism includes a gear box fixed inside the implant body, and a first gear, a second gear, a push rack and a wire push fixing member arranged in the gear box and transmission-connected, the first gear is at least partially exposed outside the implant body to form a push knob, and the push rack can move axially along the gear box;

[0031] The push wire fixing member comprises: a vertical fixing plate, the vertical fixing plate is connected to the proximal end of the push wire;

[0032] A snap-fit ​​block, the snap-fit ​​block is located on a side of the vertical fixing plate away from the push wire, the snap-fit ​​block can be inserted and fixed in the snap-fit ​​groove of the head of the push rack; the snap-fit ​​block is L-shaped, including a first snap-fit ​​portion perpendicular to the vertical fixing plate and a second snap-fit ​​portion parallel to the vertical fixing plate, the snap-fit ​​groove includes a first snap-fit ​​hole adapted to the first snap-fit ​​portion, and a second snap-fit ​​hole adapted to the second snap-fit ​​portion, the first snap-fit ​​hole is opened along the axial direction of the push rack and communicated with the side wall of the push rack, and the second snap-fit ​​hole is perpendicular to the push rack and communicated with the first snap-fit ​​hole;

[0033] Preferably, the outer contour of the push knob is provided with a rubber layer for enhancing the damping feeling.

[0034] In some embodiments of the present application, the implanter further comprises a protective sleeve disposed on the periphery of the guide tube, wherein the protective sleeve comprises in the axial direction: a tapered portion, the tapered portion extending toward the distal end of the guide tube and having a gradually decreasing cross-sectional size;

[0035] A fixing part, the fixing part is fixed to the first mounting hole of the head of the implant body, one side of the fixing part is connected to the tapered part, and a limiting protrusion is provided on the side of the fixing part away from the tapered part; a limiting groove is provided along the peripheral wall of the first mounting hole to allow the limiting protrusion to slide along the limiting groove and be engaged in the implant body;

[0036] a fixing hole, the fixing hole penetrating the tapered portion and the fixing portion along the axial direction of the protective sleeve, the guide tube passing through and fixed in the fixing hole;

[0037] Preferably, a wall surface of one side of the first mounting hole located inside the implant body is further provided with a limiting column matched with the limiting protrusion, and the limiting column is used to stop the protective sleeve from rotating circumferentially.

[0038] In some embodiments of the present application, the implanter comprises:

[0039] An implanter body, the head of which is fixedly connected to the proximal end of the guide tube, and the interior of the implanter body is provided with a sliding cavity;

[0040] A driving mechanism is connected to the implanter body, and the driving mechanism comprises:

[0041] A push slider, which is arranged in the sliding cavity and connected to the proximal end of the push wire, and a damping ring is sleeved on the outer surface of the push slider, and the damping ring is interference-fitted with the sliding cavity;

[0042] A push button, wherein the push button passes through a push chute provided on the side of the implanter body and is connected to the push slider, so that when the push button moves along the push chute, the push slider provides a thrust to the push wire;

[0043] Preferably, the push button includes a push rod vertically penetrating the push slider and push ears disposed on both sides of the push rod, and the push ears are exposed from the implant body;

[0044] Preferably, the length of the push wire is 45-60 mm, the outer diameter of the push wire is 0.2-0.3 mm, and after the micro-stent is pushed, the length of the push wire exposed from the guide tube is 0.5-1 mm.

[0045] The beneficial effect of the present application is that: in the present application, the micro-stent can be implanted into the two end faces of the cut-off fracture of the Schlemm's canal, that is, one is implanted on each of the two side end faces, and the micro-stent enters the Schlemm's canal to support the originally collapsed Schlemm's canal. In addition to the aqueous humor being diverted through the hollow cavity of the tubular body of the micro-stent, the multiple openings and grooves on the surface of the tubular body can increase the lateral diversion of the aqueous humor. The area of ​​the grooves and openings accounts for 20-55% of the peripheral side area of ​​the tubular body, which can ensure the diversion effect of the micro-stent on the one hand, and can also meet the strength requirements of the micro-stent at the same time, ensuring that the micro-stent is not easy to deform and collapse. The micro-stent has excellent anti-bending properties, and will not cause cracking, deformation, creases, collapse, and other problems when implanted into the Schlemm's canal.

[0046] In the present application, the arrangement of the slots can also facilitate the internal cleaning and inner surface treatment of the micro-stent during the processing, making it easy to process and polish the inner wall of the tubular body, avoiding impurities remaining during the inner wall processing and affecting the polishing effect. The multiple openings are located on one side of the plane where the central axis of the tubular body is located, and the slots are located on the other side of the plane where the central axis of the tubular body is located; the orthographic projection of the openings is in the shape of a dovetail groove, and the multiple dovetail grooves are located as a whole within the length L1 of the slots in the axial direction of the tubular body, which is conducive to the flow of aqueous humor from the openings or slots on one side to the slots or openings on the other side, further enhancing the lateral diversion of aqueous humor.

[0047] The multiple dovetail grooves and slots on the surface of the tubular body can also increase the friction between the surface of the micro-stent and the eye tissue, making the implantation more stable and non-slip. Furthermore, the friction contact portion on the dovetail groove allows the tubular body to be implanted in the Schlemm's canal: when moving in the first moving direction, the surface of the tubular body is not obstructed, and the first moving direction is the implantation direction of the tubular body; when moving in the second moving direction, the friction contact portion contacts the inner wall of the Schlemm's canal to generate friction, and the second moving direction is opposite to the first moving direction, so that the micro-stent will not be displaced after being implanted in the Schlemm's canal, avoiding slipping out of the port of the Schlemm's canal, meeting the one-way implantation, and the micro-stent has excellent fatigue resistance after being implanted in the Schlemm's canal, and can be in the Schlemm's canal for a long time and stably to maintain the drainage effect; the micro-stent also has excellent anti-displacement performance, and the flow of aqueous humor in the Schlemm's canal and the inertial force generated on the micro-stent during human body movement cannot cause axial displacement of the micro-stent.

[0048] The implanter in the present application adopts an external implantation method to implant the micro-stent into the Schlemm's canal. The surgical process is simple, the operation is convenient, the operation time is very short, and the patient's eye pain is reduced. Since the micro-stent is in abutment contact with the distal end of the push wire, the distal end of the push wire can only push the tubular body to expose the guide tube to complete the one-way push; but it cannot drive the tubular body back to the guide tube. When the push wire returns to the inside of the implanter body, the tubular body is in a static state and does not move; therefore, this one-way implantation method guides the operator to drive the driving mechanism in a single push direction (implantation direction) during the implantation process. Even if the push direction is wrong, the tubular body does not move, which can effectively avoid user misoperation. In addition, the distal opening of the guide tube allows the micro-stent to be observed through the opening when the micro-stent is about to be injected into the Schlemm, which is convenient for observing the push position of the micro-stent. At the same time, the opening will not cause the micro-stent to lose the constraint of the guide tube, and it can still be stably pushed in from the broken end of the Schlemm's canal. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] In order to more clearly illustrate the technical solutions in the embodiments of the application, the drawings required for use in the description of the embodiments are briefly introduced below. Obviously, the drawings described below are only some embodiments of the application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work, among which:

[0050] Figure 1A It is a stereoscopic view of a micro-stent in the glaucoma drainage implant system of the utility model;

[0051] Figure 1B It is a stereoscopic view of the micro-stent in the glaucoma drainage implant system of the utility model in another direction;

[0052] Figure 1C It is a cross-sectional view of a micro-stent in the glaucoma drainage implant system of the utility model;

[0053] Figure 1D It is a stereoscopic view of the micro-stent in the glaucoma drainage implant system of the utility model in another direction;

[0054] Figure 1E It is an expanded view of the outer diameter circumference of the micro-stent in the glaucoma drainage implant system of the utility model;

[0055] Figure 1F yes Figure 1E A partial enlarged view of the middle A area;

[0056] Figure 2 It is a schematic diagram of a micro-stent in a glaucoma drainage implant system of the utility model being implanted in a Schlemm's canal;

[0057] Figure 3A It is a stereoscopic view of an embodiment of an implanter in the glaucoma drainage implant system of the utility model;

[0058] Figure 3B It is an exploded view of an embodiment of an implanter in the glaucoma drainage implant system of the utility model;

[0059] Figure 3C This is a view of the assembly of the guide tube and the push wire of an implanter in an embodiment of the glaucoma drainage implant system of the utility model;

[0060] Figure 3D It is an exploded view of a guide tube and a push wire of an implanter in an embodiment of the glaucoma drainage implant system of the utility model;

[0061] Figure 3E is a view of a guide tube of another embodiment of an implanter in a glaucoma drainage implant system of the utility model;

[0062] Figure 3FIt is a stereoscopic view of a driving mechanism of an implanter in a glaucoma drainage implant system of the utility model;

[0063] Figure 3G It is an exploded view of a driving mechanism of an implanter in a glaucoma drainage implant system of the utility model;

[0064] Figure 3H It is a view of a protective cover and a guide tube fixing member of an implanter in a glaucoma drainage implant system of the utility model;

[0065] Fig. 3I It is a three-dimensional view of a second shell of an implanter in a glaucoma drainage implant system of the utility model;

[0066] Figure 4A It is an exploded view of another embodiment of the implanter in the glaucoma drainage implant system of the utility model;

[0067] Figure 4B It is an exploded view of a driving mechanism of another embodiment of an implanter in a glaucoma drainage implant system of the utility model;

[0068] Figure 4C The utility model is a glaucoma drainage implant system Figure 4A or Figure 4B a side view of the protective cover of the implanter shown;

[0069] Figure 4D yes Figure 4C Section view along line AA;

[0070] Figure 4E It is a stereoscopic view of a second shell of another embodiment of the implanter in the glaucoma drainage implant system of the utility model;

[0071] Figure 5 It is a stereoscopic view of a push wire and a push wire fixing member of another embodiment of an implanter in a glaucoma drainage implant system of the utility model;

[0072] Fig. 6A It is a stereoscopic view of another embodiment of the implanter in the glaucoma drainage implant system of the utility model;

[0073] Figure 6B It is an exploded view of another embodiment of the implanter in the glaucoma drainage implant system of the utility model;

[0074] Figure 6C It is a stereoscopic view of a protective cover of another embodiment of the implanter in the glaucoma drainage implant system of the utility model;

[0075] Fig. 7AIt is a stereoscopic view of another embodiment of the implanter in the glaucoma drainage implant system of the utility model;

[0076] Figure 7B yes Fig. 7A A partial magnified view of the middle B area;

[0077] Figure 8 is a view of a guide tube of another embodiment of an implanter in a glaucoma drainage implant system of the utility model;

[0078] Fig.9A This is a view of the implantation direction of another embodiment of the implanter in the glaucoma drainage implant system of the utility model;

[0079] Fig. 9B is a view of a guide tube of another embodiment of an implanter in a glaucoma drainage implant system of the utility model;

[0080] Fig. 9C It is a partial enlarged view of the distal end of the guide tube of another embodiment of the implanter in the glaucoma drainage implant system of the utility model;

[0081] Fig.9D is an enlarged view of a guide portion of another embodiment of an implanter in a glaucoma drainage implant system of the utility model;

[0082] Fig. 10A It is a stereoscopic view of a guide tube of another embodiment of an implanter in a glaucoma drainage implant system of the utility model;

[0083] Fig. 10B yes Fig. 10A A partial magnified view of the middle C area;

[0084] Fig. 10C is an enlarged view of a guide portion of another embodiment of an implanter in a glaucoma drainage implant system of the utility model;

[0085] Fig.11 This is a diagram showing changes in intraocular pressure after the micro-stent in the glaucoma drainage implant system of the utility model is implanted into a glaucoma model;

[0086] Fig.12 a~12d are diagrams showing the micro-stent implantation process under a microscope of the utility model glaucoma drainage implant system in clinical trials;

[0087] Fig.13a It is the strain state diagram of the simulated micro-stent in the Schlemm tube under normal conditions;

[0088] Fig.13b It is the strain state diagram of the simulated micro-stent when the pressure in the Schlemm tube is 34 mmHg;

[0089] Fig.14 is a resistance curve diagram simulating the sliding of the micro-stent in the Schlemm tube;

[0090] Fig.15 It is the internal fluid velocity diagram of the simulated micro-stent at a flow rate of 2.5 μL / min;

[0091] Fig.16 is the axial resultant force curve of the simulated fluid on the micro-stent;

[0092] Fig.17a and Fig.17b This is the result of the micro-stent anti-bending simulation test.

[0093] The reference numerals are as follows: 1a, tubular body; 2a, opening; 3a, slot; 4a, friction contact portion; 21a, top arc surface of the hole; 22a, bottom arc surface of the hole; 200, Schlemm tube; 300, deep scleral flap; 400 / 500 / 600, implanter; 1, implanter body; 2, guide tube; 3, drive mechanism; 4, push wire; 22, straight portion; 21, curved portion; 211, first arc tube; 212, second arc shaped tube; 31, gear box; 32, first gear; 33, second gear; 34, push rack; 301, first fixing rod; 302, second fixing rod; 303, positioning boss; 35, push wire fixing piece; 351, plug-in column; 36, vertical fixing plate; 37, clamping block; 38, first clamping part; 39, second clamping part; 40, clamping groove; 41, first clamping hole; 42, second clamping hole; 43, magnetic piece; 44, fixing groove ; 45, rotating piece; 51, push slider; 52, push button; 521, push ear; 522, push rod; 53, push slide; 54, damping ring; 55, back cover; 56, installation block; 57, positioning hole; 5, limit column; 6, limit pin; 61, pinch plate; 7, protective cover; 71, tapered part; 72, fixed part; 73, limit block; 74, limit protrusion; 75, fixing hole; 101, first shell; 102, first Second shell; 103, rubber ring groove; 104, anti-slip rubber ring; 105, mounting platform; 106, mounting groove; 107, limit slot; 108, reinforcing ribs; 109, flat bottom surface; 8, guide tube fixing piece; 81, plug-in part; 82, stopper part; 9, indicator mark; 10, opening; 11, guide part; 12, horizontal part; 13, inclined part; 14, inclined surface; 15, rounded corner; 311, first box cover; 312, second box cover. DETAILED DESCRIPTION

[0094] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other alternative implementations obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0095] The present application provides a glaucoma drainage implant system, which includes a micro-stent and an implanter. The micro-stent is implanted in the patient's Schlemm's canal through the implanter to drain the aqueous humor of the patient's anterior chamber to reduce intraocular pressure.

[0096] Please refer to Figures 1A-1D As shown, the material of the micro-stent is nickel-titanium alloy, and the micro-stent comprises a tubular body 1a with a hollow cavity, wherein the tubular body 1a is in the form of a straight tube, and the outer surface of the tubular body 1a has a plurality of openings 2a arranged regularly or irregularly, and grooves 3a on the surface of the tubular body along the axial direction of the tubular body 1a, through which aqueous humor can flow through the grooves 3a and the openings 2a, and the areas of the grooves 3a and the openings 2a account for 20-55% of the outer peripheral side area of ​​the tubular body 1a; the plurality of openings 2a are located on one side of the plane where the central axis of the tubular body 1a is located, and the grooves 3a are located on the other side of the plane where the central axis of the tubular body 1a is located; the length L of the tubular body 1a is 1-3 mm, the inner diameter of the tubular body 1a is 175-185 μm, and the wall thickness is 35-65 μm.

[0097] The orthographic projection of each opening 2a on the tubular body 1a is in the shape of a dovetail groove, and the multiple dovetail grooves are located as a whole within the length L1 of the groove in the axial direction of the tubular body 1a; the contour of the dovetail groove is formed by a first arc with a first radius R1 and a second arc with a second radius R2 connected by an arc line, the first radius R1 is 0.03~0.05mm, and the second radius R2 is 0.1~0.14mm; the second arc forms a friction contact portion 4a on the dovetail groove, and the friction contact portion 4a does not protrude from the tubular body 1a.

[0098] In the present application, the micro-stent can be implanted into the two end faces of the cut-off fracture of the Schlemm's canal, that is, one is implanted into each of the two end faces. After the micro-stent enters the Schlemm's canal, it supports the originally collapsed Schlemm's canal; in addition to the aqueous humor being diverted through the hollow cavity of the micro-stent tubular body 1a, the multiple openings 2a and grooves 3a on the surface of the tubular body 1a can increase the lateral diversion of the aqueous humor. Among them, the area of ​​the grooves 3a and the openings 2a accounts for 20-55% of the outer peripheral side area of ​​the tubular body 1a, which can ensure the diversion effect of the micro-stent on the one hand, and can also meet the strength requirements of the micro-stent at the same time, ensuring that the micro-stent is not easily deformed and collapsed.

[0099] The provision of the grooves 3a can also facilitate the internal cleaning and inner surface treatment of the micro-stent during the processing, making the inner wall of the tubular body 1a easy to process and polish, avoiding impurities remaining during the inner wall processing and affecting the polishing effect.

[0100] The orthographic projection of the opening 2a is in the shape of a dovetail groove, and the multiple dovetail grooves are located as a whole within the length L1 of the groove in the axial direction of the tubular body 1a, which is conducive to the flow of aqueous humor from the opening 2a or groove 3a on one side to the groove 3a or opening 2a on the other side, further enhancing the lateral diversion of aqueous humor.

[0101] The multiple dovetail grooves and slots 3a on the surface of the tubular body 1a can also increase the friction between the micro-stent surface and the eye tissue, making the implantation more stable and non-slip. Furthermore, the friction contact portion 4a on the dovetail groove makes the tubular body 1a in the process of implantation into the Schlemm's canal: Figure 2 As shown, taking the right implantation as an example, when moving in the first moving direction y1, the surface of the tubular body 1a is not blocked, and the first moving direction y1 is the implantation direction of the tubular body 1a; when moving in the second moving direction y2, the friction contact portion 4a contacts the inner wall of the Schlemm tube to generate friction, and the second moving direction y2 is opposite to the first moving direction y1, so that the micro-stent will not be displaced after being implanted in the Schlemm tube, and it is avoided to slip out from the end port of the Schlemm tube, and the one-way implantation is satisfied. Figure 1D The first moving direction y1 and the second moving direction y2 are also shown in FIG.

[0102] In addition, in one embodiment, the tubular body 1a is in a straight tube form. Compared with the tubular body 1a in a bent tube form, the straight tube form has a simpler processing technology and lower costs, and can achieve the same effect as the bent tube form. Figure 2 Usually, the average circumference of the Schlemm tube 200 of an adult's eye is 36 mm. When the length of the micro-stent is 1 mm, the corresponding arc length S of the Schlemm tube 200 is about 1.0013 mm. The difference between the two is 0.0013 mm, which is negligible and has basically no effect. Even when the length of the micro-stent is the maximum of 3 mm, the corresponding arc length S of the Schlemm tube 200 is about 3.0353 mm. The difference between the two is 0.0353 mm. This difference is also close to the micron level and has basically no effect. Therefore, changing the micro-stent with a curved tube shape that matches the curvature of the Schlemm tube to a straight tube shape can greatly reduce the process difficulty and machinability, improve production and reduce costs.

[0103] like Figure 1E As shown, in the present application, the length L of the tubular body 1a is 1-3 mm, the inner diameter is 175-185 μm, and the wall thickness is 35-65 μm.

[0104] The size of the slot 3a satisfies the following definition: 3 / 4*L<L1<L, wherein L is the length of the tubular body 1a, and L1 is the length of the slot 3a;

[0105] 0<L5<L-L1, wherein L5 is the distance between any end of the slot 3a and the end surface of the adjacent tubular body 1a;

[0106] 3%*C<C2<10%*C, wherein C is the outer diameter circumference of the tubular body 1a, and C2 is the width of the slot 3a.

[0107] The dimensions of the dovetail groove meet the following requirements: the width C1 of the dovetail groove at the maximum point along the circumferential direction of the tubular body 1a is 0.4-0.6 mm;

[0108] 10%*L<L3<13%*L, where L3 is the distance between the centers of the first arcs of two adjacent dovetail grooves;

[0109] 18%*L<L2<24%*L, L2 is the distance between the center of the first arc in the dovetail groove adjacent to the non-implanted end of the micro-stent and the end surface of the adjacent tubular body 1a;

[0110] 15%*L<L4≤L2, L4 is the distance between the center of the first arc in the dovetail groove adjacent to the implant end of the micro-stent and the end face of the adjacent tubular body 1a. In some embodiments, L4 is equal to L2, and in some embodiments, L2 is designed to be greater than L4. This reduces the radial drainage of aqueous humor at the proximal end after it enters the micro-stent from the broken end of the Schlemm's canal, and increases the axial pressure of aqueous humor in the micro-stent.

[0111] As a first specific embodiment of the micro-stent, Figures 1A-1F The micro-stent of the present application is shown in a three-dimensional schematic diagram in different directions and a cross-sectional diagram of a slot 3a. The micro-stent is used for implantation into the Schlemm's canal. Two micro-stents are required for each eye, and are respectively implanted into the two end faces of the cut-off fracture of the Schlemm's canal. The micro-stent is made of nickel-titanium alloy. The micro-stent has a tubular body 1a with a hollow cavity. The tubular body 1a is in the form of a straight tube. A plurality of openings 2a are regularly arranged on one side of the plane where the central axis of the tubular body 1a is located. The openings 2a are arranged along the axial direction of the tubular body 1a. A groove 3a is provided on the surface of the tubular body 1a (parallel to the central axis of the tube body). The tubular body 1a, the opening 2a and the groove 3a are limited by the above-mentioned size range. In this embodiment, the total area of ​​the groove 3a and the plurality of openings 2a accounts for about 31% of the outer peripheral side area of ​​the tubular body. The length of the tubular body 1a is about 2.6 mm, the inner diameter is about 180 μm, the tube wall thickness is about 50 μm, the length of the groove 3a is about 2 mm, and the distances between the two ends of the groove 3a and the two end surfaces of the tubular body 1a are equal; Figure 1C As shown, the groove section of the groove 3a is fan-shaped, that is, the groove cut along the wall thickness has a certain inclination angle, and the width of the groove 3a formed is about 80μm on the side close to the outer surface of the tubular body 1a, and the width of the side close to the inner surface of the tubular body 1a is about 55μm. In this way, the groove of the fan-shaped cross-section is more conducive to the room flowing into or out of the tubular body 1a from the groove 3a; in this embodiment, the orthographic projection of the opening 2a is dovetail groove-shaped, and the distance between the centers of the first arcs of two adjacent dovetail grooves is about 0.3mm. The number of the openings 2a is 6, that is, the surface of the tubular body 1a is provided with 6 openings with orthographic projections in the shape of dovetail grooves The maximum width C1 of each dovetail groove along the circumferential direction of the tubular body 1a is about 0.49mm. The distance L2 between the center of the first arc of the dovetail groove adjacent to the non-implanted end of the micro-stent and the end face of the adjacent tubular body and the distance L4 between the center of the first arc in the dovetail groove adjacent to the implanted end of the micro-stent and the end face of the adjacent tubular body are equal to about 0.55mm. The size of the maximum hollowing out of the dovetail groove-shaped opening 2a, that is, the maximum distance between the top arc surface 21a of the opening 2a and the bottom arc surface 22a can be 0.1-0.15mm, which is about 0.12mm in this embodiment.

[0112] exist Figure 1D In the embodiment, a plurality of dovetail grooves are formed on the side of the tubular body 1a to form a bionic fin, and the dovetail angle of the dovetail groove does not exceed the generatrix m where the horizontal plane where the central axis of the tubular body 1a is located intersects with the wall of the tubular body 1a. Figure 1F In the embodiment, a fillet 15 is formed at the dovetail angle of the dovetail groove to prevent turbulent deposition, and the radius R3 of the fillet 15 is 0.005-0.01; turbulent deposition refers to the phenomenon that sediments are started, suspended or redistributed due to the action of turbulence in fluid flow.

[0113] The above-mentioned micro-stent in this embodiment can well meet the implantation of the broken end of the Schlemm's canal. The size range of the dovetail groove-shaped openings 2a and the grooves 3a on the surface can fully meet the lateral diversion of aqueous humor and the stability after implantation. In particular, the dovetail groove structure plays a good role in increasing the friction of the microstructure. The outer diameter of the stent in this embodiment is about 280 μm, which is slightly larger than the inner diameter of the Schlemm's canal (250 μm on average), so that the surface of the micro-stent is in full contact with the inner wall of the Schlemm's canal. Therefore, the micro-stent is not easy to shift or fall off. While ensuring the diversion effect and stability of the micro-stent, the support requirements of the micro-stent for the broken end face of the Schlemm's canal are met, ensuring that the micro-stent is not easy to deform and collapse, and the inner wall of the micro-stent tube body is easy to handle and polish, avoiding impurities remaining during the inner wall processing and affecting the polishing effect.

[0114] See also Figure 2The surgical method for implanting the micro-stent of the present application into the broken end of the Schlemm's canal is as follows: make a conjunctival flap and a shallow scleral flap along the corneal margin under a microscope, then use a puncture knife to make a deep scleral flap 300, and find the Schlemm's canal 200, then use an implanter to implant the micro-stent at the broken end ports on both sides of the Schlemm's canal, and then remove the trabecular meshwork after implantation, and perform peripheral iridectomy, and finally suture the sclera and conjunctiva, and the operation is completed. This surgical method is not affected by the shape of the chamber angle, and is suitable for the treatment of both open-angle glaucoma and closed-angle glaucoma; and during the operation, a preventive peripheral iridectomy is performed to prevent the iris from blocking the internal opening of the aqueous humor drainage, so that the aqueous humor can be continuously drained through the Schlemm's canal; after the iridectomy is performed, the possibility of increased intraocular pressure due to anterior iris adhesion after the operation is further reduced.

[0115] In some embodiments, in order to prevent damage to the Schlemm's canal during implantation, both end surfaces of the tubular body 1a are rounded, and the radius of the rounded corners is 0.005-0.01 mm.

[0116] In some embodiments, the inner and outer surfaces of the tubular body 1a are formed with polished surfaces, and the polished surface of the inner wall of the tubular body 1a is conducive to preventing deposition and aqueous humor flow. In order to better meet the cleaning and polishing of the inner wall of the tubular body 1a, avoid impurities remaining in the inner wall processing process, which is not clean and the polishing effect is not good, and affect the clinical implantation effect, the length L1 of the groove 3a on the surface of the tubular body 1a of the micro-stent is greater than half of the length L of the tubular body, more preferably greater than 3 / 4 of the length L of the tubular body and less than the length L of the tubular body, and the width of the groove 3a accounts for 3-10% of the outer diameter circumference C of the tubular body 1a. Such a selection can meet the polishing requirements without affecting other physical properties and drainage effects of the micro-stent.

[0117] In some embodiments, the micro-stent is designed as a curved tube, and its structure is different from the above-mentioned micro-stent only in that the tubular body 1a is in a curved shape rather than a straight tube shape, and its curvature is the same as the curvature of the Schlemm tube, so that the micro-stent can better fit and match the inner wall of the Schlemm tube after implantation, and has better stability. However, since the length of the micro-stent in the present application is very small, the curvature of the curved shape and the straight tube shape can even be ignored, so it is preferred to adopt a straight tube shape, which can not only reduce the difficulty of processing and handling the micro-stent, but also facilitate clinical implantation operations.

[0118] In some embodiments, in order to make the microstent easily observable, a color-developing coating may be coated on the outer surface or part of the outer surface of the tubular body 1a thereof, or a color-developing surface may be formed by other surface treatment methods; in other embodiments, in order to make the implant also have drug efficacy, such as anticoagulant, antiproliferative or antibacterial and anti-inflammatory drugs, drugs may be coated on the surface of the tubular body 1a to form a drug coating. For example, in a specific embodiment, heparin, paclitaxel, rapamycin or mitomycin C may be coated on the surface of the implant of the present application.

[0119] The material of the micro-stent is preferably nickel-titanium alloy, which has good biocompatibility and medical safety. After the micro-stent is electrochemically polished, an inactive titanium oxide layer will be formed on the surface of the micro-stent to further improve the biocompatibility of the micro-stent. In some embodiments, other metal materials such as stainless steel 316L, titanium alloy or cobalt-chromium alloy can also be used as the material of the micro-stent. In other embodiments, polymer materials with good biocompatibility can also be used, such as high molecular weight polyethylene, polyester, polyetheretherketone peek or polysulfone PS. In other embodiments, the material of the micro-stent can also be a biodegradable material with good biocompatibility, so that the micro-stent can be stably maintained in the eye for a certain period of time (such as more than half a year), and then gradually degraded and disappeared after the intraocular pressure returns to normal.

[0120] In other embodiments, the tubular body 1a is made of a porous material, thereby improving the biocompatibility of the micro-stent. The porous material can be porous silica gel, porous polyethylene or porous TPU (thermoplastic polyurethane elastomer) or porous metal, etc. The porous material has a porous structure, and the aqueous humor can pass through the porous structure to further improve the diversion effect, and the porous material can also enhance the bonding force with the intraocular tissue, and the micro-stent can avoid displacement; in some embodiments, the periphery of the tubular body 1a is wrapped with a porous material corresponding to the shape of the tubular body 1a, that is, the porous material is also provided with a corresponding slot and opening, and the porous material outside the tubular body 1a is relatively soft, which prevents the tubular body 1a from damaging the Schlemm's canal and can also improve the stability of the tubular body 1a after implantation.

[0121] In the present application, the plurality of openings 2a are located on one side of the plane where the central axis of the tubular body 1a is located, and the slot 3a is located on the other side of the plane where the central axis of the tubular body 1a is located. In some embodiments, the openings 2a on the surface of the tubular body 1a of the micro-stent are preferably regularly arranged, and the plurality of openings 2a are located on one side of the plane where the central axis of the tubular body 1a is located, and the slot 3a is located on the other side of the plane where the central axis of the tubular body 1a is located, and the dovetail grooves of the plurality of openings 2a are completely located within the length L1 of the slot in the axial direction of the tubular body 1a as a whole to improve the lateral diversion effect of the aqueous humor.

[0122] For further information, see FIG. 3A to FIG. 10C The implanter is used to push the micro-stent into the Schlemm's canal. The implanter in the present application comprises an implanter body 1, a guide tube 2, a push wire 4, and a drive mechanism 3. The guide tube 2 has a guide channel. The proximal end of the guide tube 2 is connected to the implanter body 1, and the distal end extends in a direction away from the implanter body 1. In the present application, the distal end refers to the end close to the eyeball, and the proximal end refers to the end close to the operator's hand.

[0123] When loaded, the micro-stent is placed at the distal end of the guide tube 2, and the implantation end of the micro-stent is close to the distal end of the guide tube 2. During the implantation process, the implantation end of the micro-stent is inserted into the broken end of the Schlemm tube port and moves toward the Schlemm tube until the non-implantation end is flush with the edge of the Schlemm port.

[0124] The push wire 4 is arranged inside the guide tube 2 (i.e., inside the guide channel), the distal end of the push wire 4 abuts against the micro-stent, and the proximal end of the push wire 4 is connected to the driving mechanism 3, the driving mechanism 3 provides thrust to the push wire 4 and guides the push wire 4 to move axially along the guide channel; during the micro-stent implantation process, the distal end of the guide tube 2 abuts against the outside of the Schlemm's tube, and the push wire 4 pushes the micro-stent out of the distal end of the guide tube 2 and into the Schlemm's tube.

[0125] Further, as a first specific embodiment of the implanter, please refer to FIG. 3A to FIG. 3I The implanter comprises an implanter body 1, a guide tube 2, a driving mechanism 3, and a push wire 4; the guide tube 2 has a guide channel, the proximal end of the guide tube 2 is connected to the implanter body 1, and the distal end of the guide tube 2 extends in a direction away from the implanter body 1; the push wire 4 is arranged in the guide channel, the distal end of the push wire 4 abuts against the micro-stent, the proximal end of the push wire 4 is connected to the driving mechanism 3, the driving mechanism 3 is connected to the implanter body 1 and at least partially exposed to the implanter body 1, provides thrust to the push wire 4 and guides the push wire 4 to move axially along the guide channel; during the micro-stent implantation process, the distal end of the guide tube 2 abuts against the outside of the Schlemm's canal, and the distal end of the push wire 4 abuts against the tubular body 1a, that is, the distal end of the push wire 4 can push the tubular body 1a to expose the distal end of the guide tube 2, thereby entering the Schlemm's canal of the human eye; after the micro-stent implantation is completed, the driving mechanism 3 provides a thrust in the opposite direction to the push wire 4, so that the push wire 4 returns to its initial position.

[0126] In the present application, since the tubular body 1a is in abutting contact with the distal end of the push wire 4, the distal end of the push wire 4 can only push the tubular body 1a out of the guide tube 2 to complete the unidirectional pushing; it cannot drive the tubular body 1a to return to the guide tube 2. When the push wire 4 returns to the inside of the implanter body 1, the tubular body 1a is in a stationary state and does not move; therefore, this unidirectional implantation method guides the operator to drive the driving mechanism 3 in a single pushing direction (implantation direction) during the implantation process. Even if the pushing direction is wrong, the tubular body 1a does not move, which can effectively avoid user misoperation.

[0127] In this embodiment, if Figure 3C and 3D As shown, the guide tube 2 includes a curved portion 21 at the distal end and a straight portion 22 connecting the curved portion 21 , the curved portion 21 matches the tubular body 1a and the Schlemm's canal of the human eye, thereby facilitating the ejection of the tubular body 1a , and the straight portion 22 is connected to the implant body 1 .

[0128] The curved portion 21 is S-shaped, including a first arc tube 211 and a second arc tube 212 with opposite bending directions. The curvature range of the first arc tube 211 is 4 mm to 10 mm, and the curvature range of the second arc tube 212 is 3 mm to 8 mm. The second arc tube 212 is connected to the straight portion 22. Figure 3D In the figure, the tubular body 1a is accommodated in the first arc tube 211, and the tubular body 1a abuts against the distal end of the push wire 4; the push wire 4 is partially accommodated in the guide tube 2, and the overall shape of the push wire 4 is consistent with the overall shape of the guide tube 2, which is convenient for pushing.

[0129] See also Figure 3E In some embodiments, the curved portion 21 is arc-shaped, and the curvature of the curved portion 21 matches the curvature of the Schlemm tube, which facilitates the operator's hand to guide the tubular body 1a into the Schlemm tube at a more comfortable angle. The curvature range of the curved portion 21 is 4mm to 10mm.

[0130] In this embodiment, the guide tube 2 has good biocompatibility, and its material can be stainless steel, such as 2Cr13, 1Cr13, 1Cr18Ni9, SUS304(L), SUS316(L), SUS430, etc.; it can also be titanium alloy, such as TC4, etc.; it can also be pure titanium, tungsten steel, platinum, platinum-iridium alloy, polymer material, modified engineering plastics.

[0131] In the present application, the length of the push wire 4 is 45~60mm, and the outer diameter of the push wire 4 is 0.2~0.3mm, which is slightly larger than the inner diameter of the micro-stent, so that it can only abut against the non-implanted end of the micro-stent. The inner diameter of the guide tube is 0.3~0.4mm. After the micro-stent is pushed, the length of the push wire 4 exposed in the guide tube 2 is 0.5~1mm. The push wire 4 can be made of SUS300 series / SUS400 series stainless steel material.

[0132] Combination Figure 3F and Figure 3G In this embodiment, the driving mechanism 3 includes a gear box 31 and a first gear 32, a second gear 33, a push rack 34 and a push wire fixing piece 35 installed on the gear box 31; wherein the gear box 31 is provided with a first fixing rod 301 and a second fixing rod 302, the first gear 32 can rotate around the first fixing rod 301, the first gear 32 is meshed with the second gear 33, so that the second gear 33 can rotate around the second fixing rod 302, the push rack 34 is meshed with the second gear 33, and can move forward and backward along the gear box 31, the front end of the push rack 34 is connected to the push wire fixing piece 35, and the push wire fixing piece 35 is used to fix the push wire 4.

[0133] In this embodiment, at least a portion of the first gear 32 is exposed outside the implant body 1 to form a push knob, so that the operator can push the first gear 32 toward the implant body 1. Figure 3F When the push knob is turned counterclockwise relative to the first gear 32, the push rack 34, under the transmission of the first gear 32 and the second gear 33, can push the push wire and the tubular body 1a forward in the guide tube 2 through the push wire fixing member 35 until the tubular body 1a is pushed out of the guide tube 2 and enters the Schlemm tube; and when the push knob is turned counterclockwise relative to the first gear 32, the push rack 34 can push the push wire and the tubular body 1a forward in the guide tube 2 through the push wire fixing member 35. Figure 3F When the push knob is turned clockwise through the first gear 32, only the push wire 4 moves, while the tubular body 1a is in a stationary state.

[0134] In this embodiment, the push knob portion of the first gear 32 exposed to the implant body 1 may be provided with a protrusion or a depression, so that the operator can feel the pushing distance of the tubular body 1a during the pushing process. The protrusions or depressions are regularly distributed, which can effectively feedback the tactile sense of the travel of the first gear 32; the outer contour of the push knob is provided with a rubber layer (such as silicone, etc.) for enhancing the damping feeling.

[0135] In this embodiment, the transmission ratio of the first gear 32 to the second gear 33 is 1 to 3. Preferably, the transmission ratio of the first gear 32 to the second gear 33 is greater than 1, that is, the rotation speed of the first gear 32 is faster than that of the second gear 33, and the second gear 33 drives the pushing rack 34, thereby pushing the pushing wire 4 to slowly push the micro-stent to move, ensuring that the micro-stent slowly enters the Schlemm's canal from the guide tube 2 during the operation, and also avoiding some surgical risks caused by misoperation.

[0136] In this embodiment, the push wire fixing member 35 is connected to the front end of the push rack 34 by plugging, and a plug-in column 351 is provided on the side of the push wire fixing member 35 close to the push rack 34, and a plug-in hole adapted to the plug-in column 351 is correspondingly provided at the front end of the push rack 34 to allow the plug-in column 351 to be inserted and fixed in the plug-in hole, and the proximal end of the push wire 4 passes through the push wire fixing member 35 and bends downward, and is finally fixedly connected to the push wire fixing member 35.

[0137] In this embodiment, the gear box 31 includes a first box cover 311 and a second box cover 312 that can be covered together. The first fixing rod 301 and the second fixing rod 302 are both vertically arranged on the first box cover 311, and a positioning boss 303 is also arranged on the inner wall of the first box cover 311. The positioning boss 303 is arranged around the circumference of the first fixing rod 301 and the second fixing rod 302, which can improve the stability of the first gear 32 and the second gear 33 during rotation, and ensure that the first gear 32 and the second gear 33 rotate around their axes.

[0138] The material of the gear box 31 can be ABS, POM, PEEK, PVC, PET, nylon, polymer materials, modified engineering plastics, zinc alloy, aluminum alloy, magnesium aluminum alloy, stainless steel, copper, iron, etc.

[0139] In this embodiment, the shape of the implant body 1 is large in the middle and small at both ends, or large at both ends and small in the middle, or a straight rod type, which is suitable for one-handed operation; the length range of the implant body 1 in the axial direction is 10cm to 18cm, and the maximum diameter range of the implant body 1 in the axial direction is 21mm to 27mm to ensure the comfort of holding during operation; the material of the implant body 1 can be ABS, POM, PEEK, PVC, PET, nylon, polymer materials, modified engineering plastics, zinc alloy, aluminum alloy, magnesium-aluminum alloy, stainless steel, copper, iron, etc.

[0140] In this embodiment, the implant body 1 includes a first shell 101 and a second shell 102 that are detachably connected, and the detachable connection includes snap-fitting, clamping, threaded connection and the like; the first shell 101 and the second shell 102 can also be fixedly connected by ultrasonic welding and the like.

[0141] In this embodiment, the head of the implant body 1 is provided with a plurality of anti-slip rubber rings 104, and the first shell 101 and the second shell 102 are also provided with rubber ring grooves 103 for accommodating the anti-slip rubber rings 104; the anti-slip rubber rings 104 facilitate the operator's grip, stimulate the operator's senses, and also play a role in increasing the aesthetics.

[0142] In this embodiment, an indicator mark 9 is provided at a position of the first shell 101 close to the first gear 32 to indicate the pushing direction; the indicator mark 9 may be raised, recessed, silk-screened or pasted with a sticker.

[0143] In this embodiment, the interior of the second shell 102 has a flat bottom surface 109, which is used to fix the gear box 31 of the driving mechanism 3. The gear box 31 can be glued or ultrasonically welded on the flat bottom surface 109; the interior of the second shell 102 is also provided with a plurality of reinforcing ribs 108 along the circumference of the gear box 31, and the reinforcing ribs 108 are used to limit the gear box 31 and increase the strength of the second shell 102 to prevent easy damage; similarly, the interior of the first shell 101 is also provided with a plurality of reinforcing ribs 108 along the circumference of the gear box 31.

[0144] In this embodiment, the implanter is also provided with an anti-trigger mechanism, which is used to limit the movement of the push rack 34 to prevent the implanter from being triggered due to inaction before it is officially used, causing the implanter to fail. After the structure is removed, it indicates that the implanter has been used and cannot be restored, giving the operator a prompt. Figure 3G In the embodiment, the anti-trigger mechanism is a limit pin 6, which passes through the implant body 1 and the push rack 34. A pinch plate 61 is provided at one end of the limit pin 6, and the pinch plate 61 is provided to facilitate the extraction of the limit pin 6. Of course, the anti-trigger mechanism can also be a round rod, a square rod, a metal wire or a thin rope, etc.

[0145] Further, combined with Figure 3H and Fig. 3I , a protective sleeve 7 is provided at the front end of the implant body 1, the guide tube 2 passes through the protective sleeve 7, and the fixing portion 72 of the protective sleeve 7 is installed in the implant body 1. The protective sleeve 7 includes a tapered portion 71 and a fixing portion 72 in the axial direction, the tapered portion 71 extends toward the distal end of the guide tube 2 and the cross section gradually decreases; the fixing portion 72 is fixed in the first mounting hole (not shown) of the head of the implant body 1, and a limiting card block 73 is provided along the circumferential wall of one of the fixing portion 72 and the first mounting hole, and a limiting card groove 107 adapted to the limiting card block 73 is provided along the circumferential wall of the other of the fixing portion 72 and the first mounting hole.

[0146] In this embodiment, the tip of the conical portion 71 can be fixed to the guide tube 2 by colloid to prevent the guide tube 2 from shaking; the fixing portion 72 is cylindrical, and a limit block 73 is provided on the fixing portion 72 of the protective sleeve 7; Fig. 3I In the figure, a mounting platform 105 is provided at the front end of the second shell 102, and a mounting groove 106 for placing the fixing portion 72 is provided on the mounting platform 105, and a limiting card groove 107 adapted to the limiting card block 73 is also correspondingly provided on the groove wall of the mounting groove 106; similarly, a mounting platform 105, a mounting groove 106, and a limiting card groove 107 are also correspondingly provided on the first shell 101, and the mounting groove 106 on the first shell 101 and the mounting groove 106 on the second shell 102 together constitute the above-mentioned first mounting hole.

[0147] In this embodiment, the implanter also includes a guide tube fixing member 8, which includes a plug-in portion 81, a stop portion 82 and a fixing hole 75 in the axial direction. The plug-in portion 81 is inserted into and fixed in the fixing portion 72, and the stop portion 82 is located on the side that stops at the first mounting hole, that is, the stop portion 82 is engaged with the side wall of the mounting platform 105; the fixing hole 75 passes through the plug-in portion 81 and the stop portion 82 along the axial direction of the guide tube fixing member 8, and the proximal end of the guide tube 2 is inserted into and fixed in the fixing hole 75, and the guide tube 2 and the fixing hole 75 can be fixed by using a colloid.

[0148] like FIG. 4A to FIG. 4D Different from the above-mentioned implanter, in one embodiment, the push wire fixing member 35 in the implanter includes a vertical fixing plate 36 and a clamping block 37. The vertical fixing plate 36 is connected to the proximal end of the push wire 4. The clamping block 37 is located on the side of the vertical fixing plate 36 away from the push wire 4. The clamping block 37 can be inserted and fixed in the clamping groove 40 at the head of the push rack 34; the clamping block 37 is L-shaped, including a first clamping portion 38 perpendicular to the vertical fixing plate 36 and a second clamping portion 39 parallel to the vertical fixing plate 36. The engaging groove 40 includes a first engaging hole 41 adapted to the first engaging portion 38 and a second engaging hole 42 adapted to the second engaging portion 39. The first engaging hole 41 is opened along the axial direction of the pushing rack 34 and is connected to the side wall of the pushing rack 34. The second engaging hole 42 is perpendicular to the pushing rack 34 and is connected to the first engaging hole 41. The push wire fixing member 35 and the pushing rack 34 can be connected through the engaging block 37 and the engaging groove 40 to enhance the stability of the connection and facilitate installation and disassembly.

[0149] In this embodiment, the protective sleeve 7 includes a tapered portion 71 and a fixed portion 72 in the axial direction, the tapered portion 71 extends toward the distal end of the guide tube 2 and the cross-sectional size gradually decreases; the fixed portion 72 is fixed to the first mounting hole at the head of the implant body 1, one side of the fixed portion 72 is connected to the tapered portion 71, and a limiting protrusion 74 is provided on the side of the fixed portion 72 away from the tapered portion 71; a limiting groove 107 is provided along the peripheral wall of the first mounting hole to allow the limiting protrusion 74 to slide along the limiting groove 107 and snap into the implant body 1; the protective sleeve 7 also has a fixing hole 75, which passes through the tapered portion 71 and the fixed portion 72 along the axial direction of the protective sleeve 7, and the guide The tube 2 is inserted into and fixed in the fixing hole 75, so that the protective sleeve 7 and the guide tube 2 form an integrated structure; during manufacturing, the protective sleeve 7 and the guide tube 2 are integrally injected to make the protective sleeve 7 and the guide tube 2 more tightly connected to avoid slipping; during assembly, the integrally injected protective sleeve 7 can be slid into the implant body 1 along the limiting groove 107 through the limiting protrusion 74, and then the protective sleeve 7 is rotated so that the limiting protrusion 74 is engaged with the wall surface of the mounting platform 105 in the implant body 1, so that the protective sleeve 7 and the guide tube 2 are integrally assembled in the implant body 1, reducing the difficulty of assembly and the protective sleeve 7 and the guide tube 2 can also be easily removed from the implant body 1 and replaced as a whole.

[0150] In this embodiment, the wall surface (i.e., the wall surface of the mounting platform 105) where the first mounting hole is located on one side of the implant body 1 is also provided with a limiting column 5 adapted to the limiting protrusion 74, and the limiting column 5 is used to stop the protective cover 7 from rotating in the circumferential direction; when the limiting protrusion 74 stops at the limiting column 5, it indicates that the protective cover 7 is assembled in place. There are two limiting protrusions 74, which are located at the end of the fixing portion 72 away from the conical portion 71 and are symmetrically distributed, and there are two corresponding limiting columns 5, which are respectively located in the first shell 101 and the second shell 102.

[0151] In some embodiments, Figure 5 As shown, a magnetic member 43 is provided at the proximal end of the push wire 4, and a fixing groove 44 adapted to the magnetic member 43 is provided on one side of the vertical fixing plate 36 close to the magnetic member 43, and a rotating piece 45 is rotatably connected in the fixing groove 44, which can rotate in the fixing groove 44 and be magnetically attracted to the magnetic member 43; when the protective cover 7, the guide tube 2 and the push wire 4 are installed, the protective cover 7 and the guide tube 2 together with the push wire 4 slide into the implant body 1 along the limiting groove 107 through the limiting protrusion 74, and the push wire 4 is pushed. The magnetic part 43 at the proximal end of the wire 4 enters the fixed groove 44 and is attracted by the magnetic part 43, and then the protective sleeve 7 is rotated, and the magnetic part 43 rotates coaxially with the rotating plate 45 until the limiting protrusion 74 stops at the limiting column 5; when replacing the protective sleeve 7, the guide tube 2 and the push wire 4, the protective sleeve 7 is rotated in the opposite direction until the limiting protrusion 74 rotates to the position of the limiting slot 107, and then the protective sleeve 7 is pulled outward, and the magnetic part 43 is disengaged from the rotating plate 45 and the fixed groove 44 until it is completely removed.

[0152] like FIG. 6A to FIG. 6C As shown, in some embodiments, the implanter includes an implanter body 1, a guide tube 2, a drive mechanism 3 and a push wire 4. The head of the implanter body 1 is fixedly connected to the proximal end of the guide tube 2. The interior of the implanter body 1 has a sliding cavity. The drive mechanism 3 is arranged in the sliding cavity and is partially exposed from the implanter body 1.

[0153] In this embodiment, the driving mechanism 3 includes a pushing slider 51 and a pushing button 52. The pushing slider 51 is columnar, arranged in the sliding cavity, and connected to the proximal end of the push wire 4; the pushing button 52 passes through a pushing groove 53 arranged on the side of the implanter body 1 and is connected to the pushing slider 51, so that when the push button 52 moves along the pushing groove 53, the pushing slider 51 provides a thrust to the push wire 4, and the distal end of the push wire 4 contacts the micro-stent, thereby pushing the micro-stent out from the distal end of the guide tube 2.

[0154] In this embodiment, a damping ring 54 is sleeved on the outer surface of the pushing slider 51 , and the damping ring 54 is interference fit with the sliding cavity, thereby improving the damping feeling of the pushing slider 51 during the movement.

[0155] In this embodiment, the push button 52 includes a push rod 522 vertically penetrating the push slider 51 and push ears 521 disposed on both sides of the push rod 522, and the push ears 521 are exposed from the implanter body 1. It can be seen that there are two push ears 521 and they are located on both sides of the implanter body 1, so that it is convenient for the operator to implant the micro-stent in different implantation directions with the left and right hands respectively.

[0156] In this embodiment, the implanter further includes a rear cover 55 , which is inserted through and fixed in the opening of the rear portion of the implanter body 1 .

[0157] like Figure 6C As shown, in the present embodiment, the implanter further comprises a protective sleeve 7, which is arranged at the periphery of the guide tube 2 and fixed in the first mounting hole at the head of the implanter body 1; the protective sleeve 7 comprises a tapered portion 71, a fixing portion 72, and a stop portion 82 in the axial direction, the tapered portion 71 extends toward the distal end of the guide tube 2 and the cross-sectional size gradually decreases; one side of the fixing portion 72 is connected to the tapered portion 71, and the fixing portion 72 is fixed in the first mounting hole, a limiting block 73 is arranged along the circumferential wall between the fixing portion 72 and one of the first mounting holes, and a limiting groove 107 matched with the limiting block 73 is arranged along the circumferential wall between the fixing portion 72 and the other of the first mounting holes; the stop portion 82 is located on the other side of the fixing portion 72 and stops at one side of the first mounting hole.

[0158] In this embodiment, the protective sleeve 7 further has a fixing hole 75 , which penetrates the tapered portion 71 , the fixing portion 72 and the stopper 82 along the axial direction of the protective sleeve 7 , and the guide tube 2 is inserted through and fixed in the fixing hole 75 .

[0159] In this embodiment, the implant body 1 includes a first shell 101 and a second shell 102 that are detachably connected, one of the first shell 101 and the second shell 102 is provided with a plurality of mounting blocks 56 on the edge profile, and the other of the first shell 101 and the second shell 102 is provided with a plurality of first mounting grooves on the edge profile, so that the first shell 101 and the second shell 102 can be snapped together.

[0160] In this embodiment, one of the first shell 101 and the second shell 102 is provided with a positioning hole 57 on the inner wall, and the other of the first shell 101 and the second shell 102 is provided with a first positioning column adapted to the positioning hole 57 on the inner wall. The first positioning column can be inserted and fixed in the positioning hole 57 to enhance the stability of the connection between the first shell 101 and the second shell 102.

[0161] In this embodiment, the front ends of the first shell 101 and the second shell 102 are both provided with an installation groove 106 for placing the fixing portion 72, and the groove wall of the installation groove 106 is also correspondingly provided with a limit card groove 107 adapted to the limit card block 73. The installation groove 106 on the first shell 101 and the installation groove 106 on the second shell 102 together constitute the above-mentioned first installation hole.

[0162] like Fig. 7A and 7B As shown, in some embodiments, the curved portion of the guide tube 2 in the implanter 400 is S-shaped, including a first arc tube and a second arc tube with opposite bending directions, and an opening 10 is provided at the distal end of the guide tube 2. The openings 10 have two openings, which are symmetrically distributed along the tube wall of the guide tube 2. The length of the opening 10 is 0.7-1.3 mm, the width is 0.15-0.25 mm, and the distance L7 between the opening 10 and the end face of the distal end of the guide tube 2 is 0.1-0.5 mm. In this embodiment, when the implanter 400 pushes the microstent, the microstent can be observed through the opening 10, which facilitates the understanding of the pushing process of the microstent; at the same time, there are two openings 10, which are symmetrical to each other, and when the microstent is implanted on both sides of the broken end port of the Schlemm tube, the same implanter can be used, and there is no need to distinguish between the left and right implanters.

[0163] like Figure 8As shown, in some embodiments, the curved portion 21 of the guide tube 2 in the implanter is arc-shaped, and the angle α between the two tangent lines Z1 and Z2 outside the curved portion 21 is 70-90°. Within this range, it is convenient for the operator to implant the micro-stent at a comfortable angle. In this embodiment, the distal end of the guide tube 2 is provided with an opening 10, and the opening 10 has two openings, which are symmetrically distributed along the circumferential direction of the tube wall of the guide tube 2.

[0164] like 9A to 9C As shown, in some embodiments, the implanter 500 is used to implant the micro-stent into the right port of the end port of the Schlemm tube 200, and the implanter 600 is used to implant the micro-stent into the left port of the end port of the Schlemm tube 200. In this embodiment, the left and right implanters need to be distinguished. Fig. 9B The distal end of the guide tube 2 in the implanter 500 and the implanter 600 is provided with an opening 10, and the opening 10 is formed by partially cutting off the distal end of the guide tube 2 along the axial direction. The guide tube 2 is divided into two types due to the different directions of the opening 10, and the two guide tubes 2 are mirror images of each other.

[0165] See also Fig. 9C and Fig.9D The portion of the guide tube 2 opposite to the opening 10 forms a guide portion 11, and the size of the guide portion 11 satisfies the following limitations: 30%*L≤L6≤75%*L, wherein L is the length of the tubular body 1a, and L6 is the length of the guide portion 11; 50%*D<h<75%*D, wherein D is the outer diameter of the guide tube 2, and h is the height of the guide portion 11; the relevant parameters of the tubular body 1a and the guide tube 2 have been recorded in other embodiments of the present application and will not be repeated here.

[0166] In this embodiment, an opening of the above-mentioned size is provided at the distal end of the guide tube 2 of the implanter 500 / 600, so that when the microstent is about to be injected into the Schlemm, the microstent can be observed through the opening 10, and the pushing position of the microstent can be observed conveniently. At the same time, the opening 10 does not cause the microstent to lose the constraint of the guide tube 2, and the microstent can still be stably pushed in from the broken end of the Schlemm tube. The edge contours of the opening 10 are all provided with rounded corners to prevent the guide portion 11 from being too sharp and scratching the Schlemm tube.

[0167] like FIG. 10A to FIG. 10CAs shown, in some embodiments, the opening 10 is formed by partially cutting off the distal end of the guide tube 2 along the axial direction and the oblique direction intersecting the axis, and the portion of the guide tube 2 opposite to the opening 10 forms a guide portion 11, the guide portion 11 includes a horizontal portion 12 and an inclined portion 13, the inclined portion 13 is an end away from the guide tube 2, and the cross-sectional size gradually decreases, the inclined portion 13 has an inclined surface 14, and the angle β between the inclined surface 14 and the central axis of the guide tube 2 is 20~45°; the size of the guide portion 11 meets the following restrictions: 45%*L≤L6≤75%*L, L6=a+b, wherein L is the length of the tubular body 1a, L6 is the length of the guide portion 11, a is the length of the horizontal portion 12, and b is the length of the inclined portion 13; 50%*D<h<75%*D, wherein D is the outer diameter of the guide tube 2, and h is the height of the guide portion 11.

[0168] In this embodiment, the above-mentioned opening 10 is opened at the distal end of the guide tube 2. In addition to observing the micro-stent through the opening 10 and simultaneously allowing the micro-stent to be pushed to the opening 10 without losing the constraint of the guide tube 2, the inclined portion 13 at the distal end of the guide tube 2 can also be inserted into the port of the broken end of the Schlemm tube, which is more conducive to implanting the implant into the port of the broken end of the Schlemm tube.

[0169] In this application, 7A to 10C The types of guide tubes 2 involved can be applied to the embodiments of the various implanters described above.

[0170] In the first specific embodiment of the microstent of the present application, by establishing glaucoma models of different degrees, the microstent implanted in the Schlemm's canal is added to the model, and simulations are performed to calculate the changes in intraocular pressure before and after the microstent implantation and the distribution of aqueous humor streamlines to evaluate the intraocular pressure-lowering effect of the Schlemm's canal drainage stent implanted in glaucoma.

[0171] See also Fig.11 At least four glaucoma models with different intraocular pressures were established, including normal intraocular pressure and mild, moderate, and severe glaucoma intraocular pressure models. In the preoperative intraocular pressure curve, the normal intraocular pressure was 12 mmHg, the mild glaucoma intraocular pressure was 20 mmHg, the moderate glaucoma intraocular pressure was 30 mmHg, and the severe glaucoma intraocular pressure was 37 mmHg. After implantation of the micro-stent, see Fig.11The intraocular pressure curves after surgery show that the intraocular pressure of the above four glaucoma models with different intraocular pressures all dropped below 10 mmHg. It was analyzed that the postoperative intraocular pressure in all the above models was significantly reduced after the micro-stent was implanted. During the process of reducing intraocular pressure, most of the aqueous humor flowed away through the stent channel. The micro-stent has a significant effect in reducing intraocular pressure. In actual clinical effects, this micro-stent product has completed dozens of clinical trials, including open-angle and angle-closure glaucoma. According to the clinical data of three months of postoperative follow-up, the postoperative intraocular pressure of patients decreased by an average of 41.16% compared with the preoperative intraocular pressure, and the average reduction of the intraocular pressure-lowering drugs used was 58.33%. There were no serious complications, and the safety and effectiveness were excellent.

[0172] like Fig.12 The figure is an actual picture taken under a microscope during a micro-stent implantation operation for a patient using the implanter of the glaucoma drainage implant system in a clinical trial. Fig.12 a and Fig.12 b shows a micro stent being implanted into the left end port of Schlemm's canal through the guide tube 2 of the implanter. Fig.12 c and Fig.12 d shows that another microstent is implanted into the right end port of Schlemm's canal through the guide tube 2 of the implanter.

[0173] This application also conducts fatigue analysis and stability analysis on the micro-bracket by finite element analysis, such as Fig.13a As shown, the stress state of the micro-stent when it is located in the Schlemm tube is low, about 15.62 mPa; Fig.13b is the strain state of the micro-stent when the pressure in the Schlemm tube is 34 mmHg. The maximum strain value of the micro-stent is 2.525×10 -4 mpa.

[0174] In this application, the material of the micro-stent is nickel-titanium alloy, and its strain amplitude The effect on fatigue is nonlinear, and the fatigue safety factor [n] of nickel-titanium alloy material can be expressed as: ( is the fatigue limit; Expressed as half the difference between the maximum and minimum strains: ).

[0175] The micro-stent in the present application has a large rigidity, and the hollow area (i.e., the sum of the areas of the slots and all the openings) accounts for 20% to 55% of the outer peripheral side area of ​​the tubular body. In addition, since the tissue at the implantation site is relatively soft and the pressure differential load is relatively low, with a high theoretical safety factor, an infinite fatigue life can theoretically be achieved.

[0176] Furthermore, if the micro-stent is to be moved in the Schlemm's canal, it is necessary to overcome the friction resistance and the structural resistance of the surrounding tissue (the outer diameter of the micro-stent is much larger than the inner diameter of the implantation site). The axial resistance to the movement of the micro-stent in the Schlemm's canal was tested. Fig.14 The maximum axial resistance of the micro-stent was 4.97×10 -3 N.

[0177] After the micro-stent is implanted into Schlemm's canal, the inner wall of the micro-stent will generate an axial force under the impact of the flow of aqueous humor. Fig.15 and Fig.16 As shown in the fluid calculation, the flow field inside the micro-stent at a flow rate of 2.5 μL / min is as follows: Fig.15 As shown in the figure, the viscous effect of the fluid on the micro-stent and the axial resultant force curve of the impact force are as follows Fig.16 As shown, the maximum axial force is 1.69×10 -7 N, which is much smaller than the maximum axial resistance of the biological tissue at the implantation site to the stent, which is 4.97×10 -3 N, so it can be considered that the flow of aqueous humor cannot cause axial displacement of the microstent.

[0178] In addition, the acceleration of human body movement can generate inertial force on the micro-stent, where the formula of axial inertial force is: , where the volume of the micro-stent is shown as 0.0816mm according to the modeling software 3 , the density of nickel-titanium alloy is about 6450kg / m 3 , so the mass m of the micro-scaffold is 5.26×10 -7 kg, based on the maximum axial resistance of 4.97×10 -3 N calculates the maximum acceleration a that the micro-bracket can withstand, which is about 9443 m / s 2 This acceleration is completely impossible to achieve in human life, so it can be considered that neither the axial force of aqueous humor on the micro-stent nor the axial inertial force generated by acceleration can cause axial displacement after the micro-stent is implanted in Schlemm's canal.

[0179] In fatigue analysis, the micro-stent can be considered to have infinite fatigue life; in displacement analysis, the maximum axial resistance of the micro-stent to the surrounding tissue is N, much larger than the axial force exerted by the aqueous humor flow on the stent N, and this resistance can theoretically allow the bracket to withstand 9443m / s 2 Without sliding. In summary, the micro-stent has excellent anti-fatigue and anti-displacement performance.

[0180] In this application, due to its structural characteristics, the micro-stent has different loads when bent in different directions. In order to conduct the bending test under the worst conditions, the finite element analysis method is used to find the worst bending direction before the actual bending test. The bending analysis is performed on the micro-stent at different angles, and the finite element analysis is performed on the micro-stent at 15 degrees in turn to determine the direction with the largest load. Fig.17a and 17b As shown in the figure, the simulation analysis shows that the maximum load of the micro-stent is 8.660×10 10 N / m 2 The minimum load of the micro-stent is 4.172×10 10 N / m 2 Based on this, all micro-stent samples passed the bending test and qualified in the actual test according to the maximum stress direction. Under the most stringent conditions, the micro-stent samples did not crack, deform, or crease, and the inner hole did not collapse.

[0181] Finally, it should be noted that if the embodiments of the present application involve directional indications (such as up, down, left, right, front, back...), the directional indications are only used to explain the relative position relationship, movement status, etc. between the components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly.

[0182] In addition, if there are descriptions involving "first", "second", etc. in the embodiments of the present application, the descriptions of "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or suggesting their relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In addition, the technical solutions between the various embodiments can be combined with each other, but they must be based on the ability of ordinary technicians in the field to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such combination of technical solutions does not exist and is not within the scope of protection required by this application.

[0183] The above are only implementation methods of the present application, and are not intended to limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made using the contents of the present application specification and drawings, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. A glaucoma drainage implant system, characterized in that: include: A micro-stent, wherein the micro-stent is made of nickel-titanium alloy, comprises a tubular body having a hollow cavity, the tubular body being in the form of a straight tube, the outer surface of the tubular body having a plurality of openings arranged regularly or irregularly, and grooves on the surface of the tubular body along the axial direction of the tubular body, and aqueous humor can flow through the grooves and the openings; the total area of ​​the grooves and the openings accounts for 20-55% of the outer peripheral side area of ​​the tubular body; The orthographic projection of each opening is in the shape of a dovetail groove, and the plurality of dovetail grooves are integrally located within the length L1 of the groove in the axial direction of the tubular body; the profile of the dovetail groove is formed by a first arc with a first radius R1 and a second arc with a second radius R2 connected by an arc line, the first radius R1 is 0.03-0.05 mm, and the second radius R2 is 0.1-0.14 mm; the second arc forms a friction contact portion on the dovetail groove; An implanter, used for implanting the micro-stent into the Schlemm's canal, the implanter comprising: implant body; A guide tube, wherein the guide tube has a guide channel, the micro-stent is accommodated at the distal end of the guide tube, and the implantation end of the micro-stent opens toward the distal end of the guide tube; the proximal end of the guide tube is connected to the implanter body, and the distal end extends in a direction away from the implanter body; A push wire, the push wire is arranged inside the guide tube, and the distal end of the push wire abuts against the micro-stent; A driving mechanism is connected to the proximal end of the push wire and is used to push the micro-stent out from the distal end of the guide tube.

2. The glaucoma drainage implant system according to claim 1, characterized in that: The micro-stent is used for implanting into the broken end port of the Schlemm tube, the plurality of openings are located on one side of the plane where the central axis of the tubular body is located, and the slots are located on the other side of the plane where the central axis of the tubular body is located.

3. The glaucoma drainage implant system according to claim 2, characterized in that: The length L of the tubular body is 1-3 mm, the inner diameter of the tubular body is 175-185 μm, and the wall thickness is 35-65 μm; The size of the slot meets the following requirements: 3 / 4*L<L1<L, wherein L is the length of the tubular body, and L1 is the length of the slot; 0<L5<L-L1, wherein L5 is the distance between any end of the slot and the adjacent end surface of the tubular body; 3%*C<C2<10%*C, wherein C is the outer diameter circumference of the tubular body, and C2 is the width of the slot.

4. The glaucoma drainage implant system according to claim 3, characterized in that: The inner and outer surfaces of the tubular body are formed with polished surfaces.

5. The glaucoma drainage implant system according to claim 4, characterized in that: The size of the dovetail groove meets the following definition: the width C1 of the dovetail groove at the maximum point along the circumferential direction of the tubular body is 0.4-0.6 mm; 10%*L<L3<13%*L, wherein L3 is the distance between the centers of the first arcs of two adjacent dovetail grooves; 18%*L<L2<24%*L, L2 is the distance between the center of the first arc in the dovetail groove adjacent to the non-implanted end of the micro-stent and the end surface of the tubular body adjacent thereto; 15%*L<L4≤L2, L4 is the distance between the center of the first arc in the dovetail groove adjacent to the implantation end of the micro-stent and the end face of the tubular body adjacent thereto.

6. The glaucoma drainage implant system according to claim 5, characterized in that: A fillet is formed at the dovetail angle of the dovetail groove to prevent turbulent deposition, and the radius R3 of the fillet is 0.005~0.

01. Multiple dovetail grooves form bionic fins on the side of the tubular body, and the dovetail angle of the dovetail groove does not exceed the generatrix where the horizontal plane where the central axis of the tubular body is located intersects with the tube wall of the tubular body.

7. The glaucoma drainage implant system according to claim 6, characterized in that: The friction contact portion does not protrude from the tubular body, so that during the process of implanting the tubular body into the Schlemm's tube: when moving in a first moving direction, the surface of the tubular body is not obstructed, and the first moving direction is the implantation direction of the tubular body; when moving in a second moving direction, the friction contact portion contacts the inner wall of the Schlemm's tube to generate friction, and the second moving direction is opposite to the direction of the first moving direction.

8. The glaucoma drainage implant system according to claim 1, wherein: The guide tube includes a straight portion and a curved portion in the axial direction, the straight portion is connected to the implant body, the curved portion is in an arc shape, and the angle α between two tangent lines outside the curved portion is 70-90°; Alternatively, the curved portion is S-shaped, including a first arc tube and a second arc tube with opposite bending directions.

9. The glaucoma drainage implant system according to claim 1, wherein: The distal end of the guide tube is provided with an opening, and the openings are provided with two openings, which are symmetrically distributed along the circumference of the tube wall of the guide tube, the length of the openings is 0.7-1.3 mm, the width is 0.15-0.25 mm, and the distance between the openings and the end surface of the distal end of the guide tube is 0.1-0.5 mm; Alternatively, the opening is formed by partially cutting off the distal end of the guide tube in the axial direction, and the portion of the guide tube opposite to the opening forms a guide portion, and the size of the guide portion meets the following definition: 30%*L≤L6≤75%*L, wherein L is the length of the tubular body, and L6 is the length of the guide portion; 50%*D<h<75%*D, wherein D is the outer diameter of the guide tube, and h is the height of the guide portion; Alternatively, the opening is formed by partially cutting off the distal end of the guide tube along the axial direction and the oblique direction intersecting the axis, the portion of the guide tube opposite to the opening forms a guide portion, the guide portion includes a horizontal portion and an inclined portion, the inclined portion is an end away from the guide tube, and the cross-sectional size gradually decreases, the inclined portion has an inclined surface, and the angle β between the inclined surface and the central axis of the guide tube is 20-45°; the size of the guide portion meets the following restrictions: 45%*L≤L6≤75%*L, L6=a+b, wherein L is the length of the tubular body, L6 is the length of the guide portion, a is the length of the horizontal portion, and b is the length of the inclined portion; 50%*D<h<75%*D, wherein D is the outer diameter of the guide tube, and h is the height of the guide portion.

10. The glaucoma drainage implant system according to claim 9, characterized in that: The edge contours of the openings are all provided with rounded corners.

11. The glaucoma drainage implant system according to any one of claims 1 to 10, characterized in that: The driving mechanism includes a gear box fixed inside the implant body, and a first gear, a second gear, a push rack and a wire pushing fixing member arranged in the gear box and transmission-connected, the first gear is at least partially exposed outside the implant body to form a push knob, and the push rack can move axially along the gear box; The push wire fixing member comprises: a vertical fixing plate, the vertical fixing plate is connected to the proximal end of the push wire; A snap-fit ​​block, wherein the snap-fit ​​block is located on a side of the vertical fixed plate away from the push wire, and the snap-fit ​​block can be inserted and fixed in the snap-fit ​​groove of the head of the push rack; the snap-fit ​​block is L-shaped, and comprises a first snap-fit ​​portion perpendicular to the vertical fixed plate and a second snap-fit ​​portion parallel to the vertical fixed plate, and the snap-fit ​​groove comprises a first snap-fit ​​hole adapted to the first snap-fit ​​portion, and a second snap-fit ​​hole adapted to the second snap-fit ​​portion, the first snap-fit ​​hole is opened along the axial direction of the push rack and is connected to the side wall of the push rack, and the second snap-fit ​​hole is perpendicular to the push rack and is connected to the first snap-fit ​​hole.

12. The glaucoma drainage implant system according to claim 11, wherein: The outer contour of the push knob is provided with a rubber layer for enhancing the damping feeling.

13. The glaucoma drainage implant system of claim 11, wherein: The implanter further comprises a protective sleeve disposed on the periphery of the guide tube, wherein the protective sleeve comprises, in the axial direction: a tapered portion, the tapered portion extending toward the distal end of the guide tube and having a gradually decreasing cross-sectional size; A fixing part, the fixing part is fixed to the first mounting hole of the head of the implant body, one side of the fixing part is connected to the tapered part, and a limiting protrusion is provided on the side of the fixing part away from the tapered part; a limiting groove is provided along the peripheral wall of the first mounting hole to allow the limiting protrusion to slide along the limiting groove and be engaged in the implant body; A fixing hole, wherein the fixing hole penetrates the tapered portion and the fixing portion along the axial direction of the protective sleeve, and the guide tube is passed through and fixed in the fixing hole.

14. The glaucoma drainage implant system of claim 13, wherein: A limiting column matched with the limiting protrusion is also provided on the wall surface of one side of the first mounting hole located inside the implanter body, and the limiting column is used to stop the protective sleeve from rotating circumferentially.

15. The glaucoma drainage implant system according to any one of claims 1 to 10, characterized in that: The implanter comprises: An implanter body, the head of which is fixedly connected to the proximal end of the guide tube, and the interior of the implanter body is provided with a sliding cavity; A driving mechanism is connected to the implanter body, and the driving mechanism comprises: A push slider, which is arranged in the sliding cavity and connected to the proximal end of the push wire, and a damping ring is sleeved on the outer surface of the push slider, and the damping ring is interference-fitted with the sliding cavity; A push button is connected to the push slider through a push slide groove provided on the side of the implanter body, so that when the push button moves along the push slide groove, the push slider provides a thrust to the push wire.

16. The glaucoma drainage implant system of claim 15, wherein: The push button includes a push rod vertically penetrating the push slider and push ears disposed on both sides of the push rod, and the push ears are exposed from the implanter body.

17. The glaucoma drainage implant system of claim 15, wherein: The length of the push wire is 45-60 mm, the outer diameter of the push wire is 0.2-0.3 mm, and after the micro-stent is pushed, the length of the push wire exposed from the guide tube is 0.5-1 mm.

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