WO2017181836A1 - 一种青光眼内引流替代仿生支架的制备及其使用方法 - Google Patents

一种青光眼内引流替代仿生支架的制备及其使用方法 Download PDF

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Publication number
WO2017181836A1
WO2017181836A1 PCT/CN2017/078966 CN2017078966W WO2017181836A1 WO 2017181836 A1 WO2017181836 A1 WO 2017181836A1 CN 2017078966 W CN2017078966 W CN 2017078966W WO 2017181836 A1 WO2017181836 A1 WO 2017181836A1
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WIPO (PCT)
Prior art keywords
tube
glaucoma
bionic
stent
tube body
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PCT/CN2017/078966
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English (en)
French (fr)
Inventor
梁远波
李星熠
石长灿
胡城
Original Assignee
温州医科大学附属眼视光医院
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Application filed by 温州医科大学附属眼视光医院 filed Critical 温州医科大学附属眼视光医院
Priority to US16/329,707 priority Critical patent/US11707383B2/en
Priority to GB1805030.2A priority patent/GB2558107B/en
Publication of WO2017181836A1 publication Critical patent/WO2017181836A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another

Definitions

  • the present invention relates to the field of medical equipment, and in particular to a preparation of a glaucoma drainage instead of a biomimetic stent and a method of using the same.
  • Glaucoma is a type of optic nerve damaging disease caused by pathological high intraocular pressure. Controlling intraocular pressure becomes the main means of glaucoma treatment.
  • anti-glaucoma drugs and laser technology provide techniques and possibilities for controlling intraocular pressure, a considerable number of glaucoma patients eventually have to undergo surgery because of the specificity of the disease.
  • the main surgical procedure for glaucoma is trabeculectomy, but glaucoma filtration surgery has many uncertainties and relatively high complications, such as postoperative low intraocular pressure, shallow anterior chamber, choroidal detachment, cystoid macular edema, and Surgical failure, filtration bleb scarring and other issues. Seeking a safe and reliable surgical approach has always been the direction of eye care workers.
  • Balloon microstoplasty Canaloplasty is a new glaucoma surgery technique that has emerged in recent years. It is a non-filtering procedure.
  • the suture is implanted into the Schlemm tube through a special microcatheter.
  • the Schlemm tube and the trabecular meshwork are expanded. Reconstruct the natural outflow channel of the aqueous humor to reduce intraocular pressure and treat glaucoma.
  • Non-filtering bleb-dependent surgery is more and more concerned by ophthalmologists because of the absence of conjunctival bleb formation, which avoids a series of complications such as dry eye discomfort, immune structural changes, and infection. Applied to the clinic, it shows that it has a good and safe ocular hypotensive effect.
  • technical problem [0005]
  • due to the need for special equipment and materials for the expansion of the small tube it is expensive, the operation is complicated, and the surgeon has high requirements, and the current research shows that the small tube dilatation is only suitable for the angle glaucoma, the angle-closure glaucoma. Because the iris adhesion at the corner of the occlusion is blocked, it becomes a surgical contraindication and cannot be widely used in clinical practice.
  • the present invention provides a preparation for replacing a bionic stent in glaucoma drainage and a method of using the same.
  • a glaucoma drainage instead of a bionic bracket comprising a cylindrical tube body, the tube body is a hollow structure in the middle, and the hollow structure in the middle of the tube body is provided A plurality of straight tubes, the plurality of straight tubes supporting the tube wall of the tube body.
  • the number of the straight tubes is three, the straight tubes are round holes, and the three circular straight tubes are arranged in a triangular shape in the hollow structure of the tube body.
  • the number of the straight pipes is four, the straight pipes are round holes, and the four circular straight pipes are arranged in a quadrangular shape in the hollow structure of the pipe body.
  • the straight pipe is a polygon, and the straight pipes of the plurality of polygons are closely arranged on the inner wall of the hollow structure of the pipe body.
  • the pipe body has a length of 6-10 mm and a cross-sectional diameter of 300 ⁇ m.
  • the bionic bracket is made of polyurethane.
  • a method for using glaucoma drainage instead of a bionic stent includes the following steps: conventional eye disinfection, placement of a fistula, irrigation of the conjunctival sac, and taking 0.4 ml of 2% lidocaine after subcutaneous conjunctival anesthesia , the upper rectus muscle traction suture is fixed, according to the direction of the dial of the clock, the cornea is cut at the edge of the 11 o'clock to the 1 o'clock edge, and the size of the corneal margin is 4*4 mm as the center at 12 o'clock.
  • the scleral flap of the scleral thickness under the superficial scleral flap, a deep scleral flap of 3 ⁇ 3 mm in thickness and about 2/3 scleral thickness, and peeled toward the cornea, find the Schlemm tube and cut the Schlemm tube
  • the outer wall using a 30G needle to inject polymer hyaluronic acid into both ends of the tube, so that the bionic stent can easily pass through the fistula, and the deep scleral flap is removed, at 1.0 mm in the corneal limbus at 9 or 3 o'clock, before the flat iris direction Room puncture, lightly press the trailing edge of the puncture, release the aqueous humor to reduce the intraocular pressure, and insert the two bionic brackets into the Schlemm tube after the anterior decompression puncture At the two ends of the fistula, until the stent is fully implanted in the Schlemm tube, then use the scleral bite cutter to bite the deep trabecular tissue between the Schlem
  • the beneficial effects of the present invention are:
  • the present invention provides a glaucoma drainage instead of a bionic stent and a method for using the same, and the tube mouth which is supported by the bionic bracket is smoothly flowed into the Schlemm tube through the proper placement and fixation, and the water is passed through the aqueous solution.
  • the perfusion causes the collapsed Schlemm tube to re-expand, draining the aqueous humor to the collecting tube and the aqueous humor vein, and achieving the purpose of lowering the intraocular pressure to treat glaucoma.
  • the biomimetic scaffold material with expanded Schlemm orifice expansion can effectively solve the problem of scarring of the orifice and achieve the effect of long-term ocular hypotension.
  • trabeculectomy can be performed through the trabeculae.
  • the resection is used to resolve the occlusion of the iris at the anterior chamber angle, so that the aqueous humor flows from the anterior chamber through the trabecular trabeculus into the Schlemm tube end, and the Schlemm tube expanded by the bionic stent flows into the Schlemm tube, and then flows through the collecting tube and the aqueous humor.
  • FIG. 1 is a schematic structural view of the present invention.
  • FIG. 2 is a schematic structural view of the present invention.
  • FIG. 3 is a schematic structural view of the present invention.
  • FIG. 4 is a schematic structural view of the present invention.
  • FIG. 1 The present invention will now be further described in conjunction with FIG. 1, FIG. 2, FIG. 3, and FIG.
  • a glaucoma drainage instead of a biomimetic stent comprising a cylindrical tube body 1, the tube body 1 is empty in the middle
  • the core structure, the hollow structure in the middle of the pipe body 1 is provided with three straight pipes 2, the straight pipe 2 supports the pipe wall 3 of the pipe body 1, and the straight pipe 2 is a circular hole, the third
  • the circular straight tubes 2 are arranged in a triangular shape in the hollow structure of the tube body 1.
  • the pipe body 1 has a pipe length of 6-10 mm and a cross-sectional diameter of 300 ⁇ m.
  • the bionic bracket is made of polyurethane.
  • a glaucoma drainage instead of a biomimetic stent comprises a cylindrical tubular body 1 , wherein the tubular body 1 has a hollow structure in the middle, and the hollow structure in the middle of the tubular body 1 is provided with four straight tubes 2 .
  • the straight pipe 2 supports the pipe wall 3 of the pipe body 1, the straight pipe 2 is a circular hole, and the four circular straight pipes 2 are arranged in a quadrangular shape in the hollow structure of the pipe body 1.
  • the pipe body 1 has a length of 6 mm and a cross-sectional diameter of 300 ⁇ m.
  • the bionic bracket is made of polyurethane.
  • a glaucoma drainage in place of a biomimetic stent comprising a cylindrical tube body 1 having a hollow structure in the middle, and a hollow tube 2 in the hollow structure in the middle of the tube body 1
  • the straight pipe 2 supports the pipe wall 3 of the pipe body 1.
  • the straight pipe 2 is polygonal, and the plurality of polygonal straight pipes 2 are closely arranged on the inner wall of the hollow structure of the pipe body 1.
  • the pipe body 1 has a length of 6 mm and a cross-sectional diameter of 300 ⁇ m.
  • the bionic bracket is made of polyurethane.
  • the eye is routinely disinfected, the device is placed, and the esophage solution is diluted to wash the conjunctival sac, and 0.4 ml of 2% lidocaine is taken for local anesthesia under the conjunctiva of the operation eye, and the upper rectus traction suture is fixed.
  • the conjunctiva of the global conjunctiva is cut from the 11 o'clock to the 1 o'clock edge, and the shallow scleral flap with a 1/3 scleral thickness of about 4*4 mm, which is based on the limbus, is centered at 12 o'clock.
  • a deep scleral flap with a size of about 3*3 mm and a thickness of about 2/3 scleral thickness was made.
  • the corneal direction was peeled off, the Schlemm tube was found and the outer wall of the Schlemm tube was cut, and a polymer hyaluronic acid (Healon GV) was injected into the both ends of the tube with a 30G needle to allow the stent to easily pass through the fistula and remove the deep scleral flap.
  • Healon GV polymer hyaluronic acid
  • the anterior chamber puncture was performed in the direction of the flat iris, the posterior margin of the puncture was lightly pressed, and the right amount of aqueous humor was released to reduce the intraocular pressure.
  • the two sections of the bionic stent were inserted.
  • the two ends of the Schlemm tube were implanted separately until the stent was fully implanted in the Schlemm tube.
  • use a scleral bite cutter to bite the deep trabecular tissue between the Schlemm tube and the cornea 1.0mmxl.5mm, and cut off the corresponding iris root tissue, and seal the suture with a 10-0 polypropylene thread.
  • the anterior chamber puncture was injected into the balanced salt solution, and the water-tight suture was observed as no leakage.
  • the conjunctival flap was sutured with 10-0 polypropylene thread. Anti-inflammatory drugs were given after operation, and the intraocular pressure and anterior segment reaction were monitored.
  • the bionic bracket of the present invention is made of a polyurethane material.
  • the research team has applied polyurethane materials to prepare artificial blood vessels in the early stage. After half a year of animal experiments, the material does not produce any inflammatory reaction, which proves that the application of the material is safe; the bionic scaffold is hollow porous design, middle The hollow allows the passage of water, and the porous material ensures sufficient toughness of the material, so that it can support the Schlemm wall and keep the aqueous drainage function from being deformed.

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Abstract

一种青光眼内引流替代仿生支架的制备及其使用方法，该青光眼内引流替代仿生支架包括圆柱形的管体（1），该管体（1）中间为空心结构，该管体（1）中间的空心结构内设有若干直管（2），该若干直管（2）支撑管体（1）的管壁（3）。通过合适安放固定该青光眼内引流替代仿生支架使房水由仿生支架撑起的管口顺利流入Schlemm管，通过房水灌注使塌陷的Schlemm管重新扩张，引流房水至集合管、房水静脉，达到降眼压治疗青光眼的目的，在保留非穿透性青光眼手术优点的同时，大大降低了手术成本，减少患者所需手术费用。同时联合小梁切除术能极大扩大其适应症，为青光眼的治疗提供新的思路与建议。

Description

发明名称：一种青光眼内引流替代仿生支架的制备及其使用方法 技术领域
[0001] 本发明涉及医用器材领域， 具体涉及一种青光眼内引流替代仿生支架的制备及 其使用方法。
背景技术
[0002] 青光眼是一类由病理性高眼压导致的视神经损害性疾病， 控制眼内压成为青光 眼治疗的主要手段。 尽管抗青光眼药物、 激光技术为控制眼内压提供了技术和 可能， 但是由于疾病的特殊性， 相当部分的青光眼患者最终不得不接受手术治 疗。 目前， 青光眼的主流术式是小梁切除术， 但是青光眼滤过手术有许多不确 定因素和相对较高的并发症， 如术后低眼压、 浅前房、 脉络膜脱离、 黄斑囊样 水肿以及手术失败、 滤过泡瘢痕化等问题。 寻求一种安全、 可靠的手术方法一 直是眼科工作者的努力方向。
[0003] 青光眼手术的发展， 从全层巩膜切除术到巩膜瓣保护下的小梁切除术是个飞跃 ， 避免了一些严重的术后并发症； 从传统小梁切除术到现代改良小梁切除术， 包括抗代谢药物的应用及可调节缝线的使用， 进一步降低了手术风险， 提高了 远期疗效。 但是小梁切除术仍然不能有效的控制防水引流量， 所以还不算是一 种理想的手术方式。 在这种情况下， 非穿透性青光眼手术又被重新提出。
[0004] 非穿透性青光眼手术从 20世纪 90年代弓 I入国内之后， 国内的专家学者做了大量 的临床及基础研究工作。 非穿透青光眼手术的技巧及术后处理在不断发展和完 善， 国内外均有较多报道。 粘小管扩张成形术 Canaloplasty是近年来出现的一种 新的抗青光眼手术技术， 是一种非滤过性手术， 通过特殊的微导管将缝线植入 S chlemm管， 扩张 Schlemm管及小梁网， 重建房水自然流出通道， 从而降低眼内 压， 治疗青光眼。 非滤过泡依赖性手术由于没有结膜滤过泡形成， 避免了由此 带来的眼表干涩不适、 免疫结构改变、 易发感染等一系列并发症， 越来越受到 眼科医师的关注， 并且应用于临床， 显示其具有良好、 安全的降眼压作用。 技术问题 [0005] 但是由于粘小管扩张成形术需要特殊设备及材料， 费用昂贵， 手术复杂， 对手 术医生要求高， 并且目前的研究显示粘小管扩张成形术仅适用于幵角型青光眼 ， 闭角型青光眼由于房角处虹膜粘连堵塞， 使其成为手术禁忌症而无法被广泛 应用于临床。
问题的解决方案
技术解决方案
[0006] 为了克服现有技术的缺陷， 本发明提供了一种青光眼内引流替代仿生支架的制 备及其使用方法。
[0007] 本发明采用的技术解决方案是： 一种青光眼内引流替代仿生支架， 包括圆柱形 的管体， 所述的管体中间为空心结构， 所述的管体中间的空心结构内设有若干 直管， 所述的若干直管支撑管体的管壁。
[0008] 所述的直管的数量为三个， 所述的直管为圆孔， 所述的三个圆形的直管按三角 形排列在管体的空心结构内。
[0009] 所述的直管的数量为四个， 所述的直管为圆孔， 所述的四个圆形的直管按四边 形排列在管体的空心结构内。
[0010] 所述的直管为多边形， 所述的若干个多边形的直管紧密排列在管体的空心结构 的内壁上。
[0011] 所述的管体管长为 6-10mm， 截面直径为 300μηι。
[0012] 所述的仿生支架采用聚氨酯制成。
[0013] 一种青光眼内引流替代仿生支架的使用方法， 包括以下步骤： 术眼常规消毒， 置幵睑器， 冲洗结膜囊， 取 0.4ml 2%利多卡因于术眼结膜下局部润麻醉后， 做上 直肌牵引缝线固定， 按钟表表盘方向计， 于 11点位至 1点位边缘环球结膜切幵， 以 12点位为中心处作以角膜缘为基底的大小 4*4mm的 1/3巩膜厚度的浅层巩膜瓣 ， 在浅层巩膜瓣下方再做一个大小 3*3mm， 厚度约 2/3巩膜厚度的深层巩膜瓣， 并向角膜方向剥离， 找到 Schlemm管并切幵 Schlemm管外壁， 用 30G针头向两端 管内注入高分子透明质酸， 使仿生支架能够容易通过幵口， 并切除深层巩膜瓣 ， 于 9或 3点钟方位角膜缘内 1.0 mm处， 平虹膜方向行前房穿刺， 轻压穿刺口后 缘， 放出房水降低眼压， 前房减压穿刺后将两段仿生支架分别插入 Schlemm管的 两断端幵口处， 直至支架全部植入 Schlemm管中， 然后用巩膜咬切器咬除 Schlem m管与角膜之间的深层小梁组织 1.0mmxl.5mm， 并剪除相应的虹膜根部组织， 密 闭缝合巩膜瓣， 前房穿刺口注入平衡盐溶液观察， 待眼压恢复至正常后， 缝合 结膜瓣。
发明的有益效果
有益效果
[0014] 本发明的有益效果是： 本发明提供了一种青光眼内引流替代仿生支架及其使用 方法， 通过合适安放固定使房水由仿生支架撑起的管口顺利流入 Schlemm管， 通 过房水灌注使塌陷的 Schlemm管重新扩张， 引流房水至集合管、 房水静脉， 达到 降眼压治疗青光眼的目的。 植入扩张 Schlemm管口扩张的仿生支架材料能有效解 决管口瘢痕化问题， 达到长期降眼压的效果， 同吋， 对于闭角型青光眼患者， 可以局部联和小梁切除术， 通过小梁切除术解决前房角处虹膜粘连堵塞， 使房 水由前房经虹膜小梁周切口流入 Schlemm管断端， 经仿生支架扩张的 Schlemm管 口流入 Schlemm管， 再经集合管、 房水静脉流出， 达到降眼压治疗青光眼的目的 对附图的简要说明
附图说明
[0015] 图 1为本发明结构示意图。
[0016] 图 2为本发明结构示意图。
[0017] 图 3为本发明结构示意图。
[0018] 图 4为本发明结构示意图。
[0019] 图中 1-管体， 2-直管， 3-管壁。
本发明的实施方式
[0020] 现结合图 1、 图 2、 图 3、 图 4对本发明进行进一步说明：
[0021] 实施例 1
[0022] 一种青光眼内引流替代仿生支架， 包括圆柱形的管体 1， 所述的管体 1中间为空 心结构， 所述的管体 1中间的空心结构内设有三个直管 2， 所述的直管 2支撑管体 1的管壁 3， 所述的直管 2为圆孔， 所述的三个圆形的直管 2按三角形排列在管体 1 的空心结构内。 所述的管体 1管长为 6-10mm， 截面直径为 300μηι。 所述的仿生支 架采用聚氨酯制成。
[0023] 实施例 2
[0024] 一种青光眼内引流替代仿生支架， 包括圆柱形的管体 1， 所述的管体 1中间为空 心结构， 所述的管体 1中间的空心结构内设有四个直管 2， 所述的直管 2支撑管体 1的管壁 3， 所述的直管 2为圆孔， 所述的四个圆形的直管 2按四边形排列在管体 1 的空心结构内。 所述的管体 1管长为 6mm， 截面直径为 300μηι。 所述的仿生支架 采用聚氨酯制成。
[0025] 实施例 3
[0026] 一种青光眼内引流替代仿生支架， 包括圆柱形的管体 1， 所述的管体 1中间为空 心结构， 所述的管体 1中间的空心结构内设有六个直管 2， 所述的直管 2支撑管体 1的管壁 3， 所述的直管 2为多边形， 所述的若干个多边形的直管 2紧密排列在管 体 1的空心结构的内壁上。 所述的管体 1管长为 6mm， 截面直径为 300μηι。 所述的 仿生支架采用聚氨酯制成。
[0027] 仿生支架放置过程：
[0028] 术眼常规消毒铺巾， 置幵睑器， 稀释碘伏溶液冲洗结膜囊， 取 0.4ml 2%利多卡 因于术眼结膜下局部润麻醉后， 做上直肌牵引缝线固定， 按钟表表盘方向计， 于 11点位至 1点位边缘环球结膜切幵， 以 12点位为中心处作以角膜缘为基底的大 小约 4*4mm的 1/3巩膜厚度的浅层巩膜瓣， 在浅层巩膜瓣下方再做一个大小约 3*3 mm, 厚度约 2/3巩膜厚度的深层巩膜瓣。 并向角膜方向剥离， 找到 Schlemm管并 切幵 Schlemm管外壁， 用 30G针头向两端管内注入高分子透明质酸 （Healon GV ) ， 使支架能够容易通过幵口， 并切除深层巩膜瓣。 于 9或 3点钟方位角膜缘内 1. 0 mm处， 平虹膜方向行前房穿刺， 轻压穿刺口后缘， 放出适量房水降低眼压， 前房减压穿刺后将两段仿生支架分别植入 Schlemm管的两断端幵口处， 直至支架 全部植入 Schlemm管中。 然后用巩膜咬切器咬除 Schlemm管与角膜之间的深层小 梁组织 1.0mmxl.5mm， 并剪除相应的虹膜根部组织， 用 10-0聚丙烯线密闭缝合巩 膜瓣 4针， 前房穿刺口注入平衡盐溶液观察， 以不渗漏视为水密缝合， 在眼压恢 复至正常后， 用 10-0聚丙烯线缝合结膜瓣 2针。 术后给予抗炎药物， 监测眼压、 眼前节反应情况， 术毕单眼加压包扎。
[0029] 本发明的仿生支架由聚氨酯材料制作而成。 关于材料的安全性， 本研究团队前 期已经应用聚氨酯材料制备成人工血管， 经过半年的动物实验观察， 该材料不 产生任何炎症反应， 证明材料的应用安全性好； 仿生支架为中空多孔设计， 中 间空心允许房水通过， 多孔又能保证材料的足够韧性， 使其能够撑幵 Schlemm管 壁而长吋间保持房水引流功能不变形。
[0030] 以上所述仅是本发明的优选实施方式， 本发明的保护范围并不仅局限于上述实 施例， 凡属于本发明思路下的技术方案均属于本发明的保护范围。 应当指出， 对于本技术领域的普通技术人员来说， 在不脱离本发明原理前提下的若干改进 和润饰， 这些改进和润饰也应视为本发明的保护范围。

Claims

权利要求书
一种青光眼内引流替代仿生支架， 其特征在于， 包括圆柱形的管体 （ 1) ， 所述的管体 （1) 中间为空心结构， 所述的管体 （1) 中间的空 心结构内设有若干直管 （2) ， 所述的若干直管 （2) 支撑管体 （1) 的管壁 (3) 。
根据权利要求 1所述的一种青光眼内引流替代仿生支架， 其特征在于 ， 所述的直管 （2) 的数量为三个， 所述的直管 （2) 为圆孔， 所述的 三个圆形的直管 （2) 按三角形排列在管体 （1) 的空心结构内。
根据权利要求 1所述的一种青光眼内引流替代仿生支架， 其特征在于 ， 所述的直管 （2) 的数量为四个， 所述的直管 （2) 为圆孔， 所述的 四个圆形的直管 （2) 按四边形排列在管体 （1) 的空心结构内。
根据权利要求 1所述的一种青光眼内引流替代仿生支架， 其特征在于 ， 所述的直管 （2) 为多边形， 所述的若干个多边形的直管 （2) 紧密 排列在管体 （1) 的空心结构的内壁上。
根据权利要求 1所述的一种青光眼内引流替代仿生支架， 其特征在于 ， 所述的管体 （1) 管长为 6mm， 截面直径为 300μηι。
根据权利要求 1所述的一种青光眼内引流替代仿生支架， 其特征在于 ， 所述的仿生支架采用聚氨酯制成。
一种权利要求 1所述的青光眼内引流替代仿生支架的使用方法， 其特 征在于， 包括以下步骤： 术眼常规消毒， 置幵睑器， 冲洗结膜囊， 取 0.4ml 2%利多卡因于术眼结膜下局部润麻醉后， 做上直肌牵引缝线固 定， 按钟表表盘方向计， 于 11点位至 1点位边缘环球结膜切幵， 以 12 点位为中心处作以角膜缘为基底的大小 4*4mm的 1/3巩膜厚度的浅层 巩膜瓣， 在浅层巩膜瓣下方再做一个大小 3*3mm， 厚度约 2/3巩膜厚 度的深层巩膜瓣， 并向角膜方向剥离， 找到
Schlemm管并切幵 Schlemm管外壁， 用 30G针头向两端管内注入高分 子透明质酸， 使仿生支架能够容易通过幵口， 并切除深层巩膜瓣， 于 9或 3点钟方位角膜缘内 1.0 mm处， 平虹膜方向行前房穿刺， 轻压穿刺 口后缘， 放出房水降低眼压， 前房减压穿刺后将两段仿生支架分别植 入 Schlemm管的两断端幵口处， 直至支架全部植入 Schlemm管中， 然 后用巩膜咬切器咬除 Schlemm管与角膜之间的深层小梁组织 l.Ommxl. 5mm, 并剪除相应的虹膜根部组织， 密闭缝合巩膜瓣， 前房穿刺口注 入平衡盐溶液观察， 待眼压恢复至正常后， 缝合结膜瓣。
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