CN107874871A - 植入式视网膜支架 - Google Patents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/16—Materials with shape-memory or superelastic properties
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/16—Materials or treatment for tissue regeneration for reconstruction of eye parts, e.g. intraocular lens, cornea
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- Health & Medical Sciences (AREA)
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Abstract
本发明提供了一种植入式视网膜支架,该支架呈一与眼球内腔相匹配的、透明的、且能够弹性变形的镂空球形支撑结构。本发明具有如下的有益效果:视网膜支架的镂空设计可避免房水循环障碍而引起眼压升高,减少了术后并发症的发生。
Description
技术领域
本发明涉及一种植入式视网膜支架,属于医疗器械技术领域。
背景技术
临床上高度近视、外伤、糖尿病等眼病引起的玻璃体视网膜病变往往需要切除玻璃体,术后玻璃体腔内植入填充物以支撑固定视网膜。现况是灌注气体或硅油来充当人工玻璃体,缺点是患者必须趴床数天或数周,等待气体或硅油稳定下来,气体一般在术后数天或几周内完全吸收,而硅油长期植入后会变混浊,且有细胞毒性,一般在术后几周需取出;也有人尝试使用玻尿酸及氧化透明质酸,如中国专利CN104761735公开了一种具有抑制透明质酸酶活性的交联透明质酸钠凝胶的制备方法,该方法是利用不同酸碱条件下,透明质酸钠分子中不同的基团被活化,进而控制不同的酸碱条件在透明质酸钠分子中引入透明质酸酶抑制剂,最终得到具有抑制透明质酸酶活性的交联透明质酸钠凝胶,利用该透明质酸钠凝胶作为人工玻璃体应用于眼科疾病的治疗中。中国专利CN101934089也公开了一种可眼内注射的原位交联水凝胶在制备人工玻璃体中的应用,该方法在眼内可持续填充,无明显毒性反应,并在结构上模拟原始的天然玻璃体结构,具有亲水性。上述方法效果虽然不错,但易被人体吸收,不能持久。人工玻璃体吸收或取出后,由于缺失了玻璃体的支撑可能会引起术后视网膜的再脱离。
发明内容
为了防止无玻璃体支撑的视网膜发生再脱离,相对有效持久地维持视网膜的解剖稳定性,本发明利用丙烯酸酯多聚物(Acrylic)材料制成可折叠植入式玻璃体视网膜支架可有效地解决目前人工玻璃体的有些问题。
本发明是通过以下技术方案实现的:
一种植入式视网膜支架,该支架呈一与眼球内腔相匹配的、透明的、且能够弹性变形的镂空球形支撑结构。
作为优选方案,所述镂空球形支撑结构由数个分别沿经纬线分布的支撑筋相连接构成。
作为优选方案,所述镂空球形支撑结构的球面由数个斜向交叉设置的支撑筋构成的菱形网状结构。
作为优选方案,所述支撑筋的形状为带状或杆状。
作为优选方案,所述支撑筋为带状时,宽度为0.5~1.5mm,厚度为0.25~0.75mm;所述支撑筋为杆状时,直径为1~1.2mm。
作为优选方案,所述支撑筋的材料为丙烯酸酯多聚物或记忆体材料。
作为优选方案,所述丙烯酸酯多聚物由苯乙基丙烯酸甲酯、2-苯乙基丙烯酸酯及交联体聚合而成。
丙烯酸酯多聚物是由苯乙基丙烯酸甲酯、2-苯乙基丙烯酸酯及其他交联体聚合而成的一类多聚物,简称为丙烯酸酯。可被高度纯化,性质稳定,透明性极佳。Acrylic在37℃时屈光指数为1.544,较PMMA为高,因此,同等屈光度人工晶体,Acrylic材料可作得更薄,更适合于小切口植入。Acrylic晶体弹性较小,由折叠状态到完全展开约需3~5秒,因此操作起来比较安全。经过大量的理化及毒理学研究表明,此多聚物有极好的化学稳定性和生物学相容性,无毒性,植入眼内安全。
作为优选方案,所述记忆体材料由甲基丙烯酸甲酯、羟乙基甲基丙烯酸甲酯、甲基丙烯酸酯羟基苯酚及乙烯乙二醇二丙烯酸酯交联聚合而成。
记忆体材料,此材料高于25℃时质软。加热使人工晶体变软后,将其卷曲并冷却,使成硬质卷筒形状。通过小切口植入眼内,经体温加热,利用“记忆”效应会缓慢恢复到原有形态。记忆材料为亲水性,可吸水20%,其屈光指数为1.47,可耐高温高压,有极好的生物学相容性。
本发明针对个体化的设计可以使玻璃体视网膜支架完美贴合眼球内壁,有效地固定和支撑视网膜;植入支架后不需要特殊体位即可获得良好的视网膜复位效果;不改变患眼的屈光状态,术后可立即获得较好的视力;采用丙烯酸酯多聚物材料制成的视网膜支架,此前相同的材料广泛应用于白内障手术后的植入的人工晶体材料,具有良好的化学稳定性和生物相容性,无毒性,植入眼内安全,已经得到临床应用的验证;支架可折叠的材质及条带状设计适合小切口植入(例如从玻璃体微创切口的23G进入,23G是微创玻璃体手术的一种主要术式中套管粗细的大小型号,即直径0.61mm,或者20G的切口进入,直径1mm左右),出现严重并发症时或因病情需要进行相应的操作时也方便取出(可以剪断连接处,从切口以条形取出);首次设计了专门应用于视网膜支架的微植入器。
与现有技术相比,本发明还具有如下的有益效果:
1、视网膜支架的镂空设计可避免房水循环障碍而引起眼压升高,减少了术后并发症的发生;(支架的上圈缘以视网膜锯齿缘后界为沿,支架的下界缘以后极部视网膜45度范围为界沿,保证视网膜后极部的主要结构如视神经,黄斑和视网膜颞上下动静脉、鼻上下动静脉解剖学和功能基本不受影响);
2、制作支架的材料丙烯酸酯多聚物(Acrylic)是由苯乙基丙烯酸甲酯、苯乙基丙烯酸酯及其他交联体聚合而成,这种材料已广泛应用于人工晶体的制作,它的性质稳定,透明性好,眼内代谢产物不易吸附,对细菌粘合力小,长期植入眼内安全无毒性;
3、制作支架的材料记忆体材料,通过小切口植入眼内,经体温加热,利用“记忆”效应会缓慢恢复到原有形态;记忆材料为亲水性,可吸水20%,其屈光指数为1.47,可耐高温高压,有极好的生物学相容性;
4、微植入装置结构简单,使用灵巧方便。
附图说明
通过阅读参照以下附图对非限制性实施例所作的详细描述,本发明的其它特征、目的和优点将会变得更明显:
图1为本发明中经纬线式的植入式视网膜支架的结构示意图;
图2为图1在拉伸状态下的示意图;
图3为本发明中网状结构的植入式视网膜支架的剖视图;
图4为本发明的植入式视网膜支架在微创手术中的注入复方生理盐水的原理图;
图5为本发明的植入式视网膜支架在微创手术中的从切口植入的原理图;
图6为本发明的植入式视网膜支架在微创手术中的弹性复位的状态图;
图7为本发明的植入式视网膜支架植入后再眼球中的位置状态图;
图中:1、视网膜支架;11、支撑筋;10、注射器;2、眼球;20、微植入装置;21、角膜;22、锯齿缘;23、黄斑;24、视乳头。
图中:1、视网膜支架;11、支撑筋;10、注射器;2、眼球;20、微植入装置;21、角膜;22、锯齿缘;23、黄斑;24、视乳头。
具体实施方式
下面结合具体实施例对本发明进行详细说明。以下实施例将有助于本领域的技术人员进一步理解本发明,但不以任何形式限制本发明。应当指出的是,对本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进。这些都属于本发明的保护范围。
如图1~3所示,本发明提供的一种植入式视网膜支架1呈一与眼球内腔相匹配的、透明的、且能够弹性变形的镂空球形支撑结构。该支架能够通过采用拉伸、折叠或者卷曲等变形方式,使之形状变长变细,便于通过微型植入装置从玻璃体微创切口植入,再通过该支架的弹性、记忆形变复位,起到对视网膜的内支撑作用。
该镂空球形支撑结构具体可采用但不仅限于以下两种结构:一、由数个分别沿经纬线分布的支撑筋11相连接构成,支撑筋数量可以如本实施方式中的经向的6根、纬向的3根,也可不限于此数量;二、该镂空球形支撑结构的球面由数个斜向交叉设置的支撑筋11构成菱形网状结构。
为了适应不同需求,支撑筋11的形状可采用但不仅限于带状或杆状。
所述支撑筋为带状时,宽度为0.5~1.5mm,优选为1mm,厚度为0.25~0.75mm,优选为0.5mm;所述支撑筋为杆状时,直径为1~1.2mm。
支撑筋11的材料可采用但不仅限于丙烯酸酯多聚物或记忆体材料一次性塑型,其中丙烯酸酯多聚物可由苯乙基丙烯酸甲酯、2-苯乙基丙烯酸酯及交联体聚合而成,丙烯酸酯多聚物是由苯乙基丙烯酸甲酯、2-苯乙基丙烯酸酯及其他交联体聚合而成的一类多聚物,简称为丙烯酸酯。可被高度纯化,性质稳定,透明性极佳。Acrylic在37℃时屈光指数为1.544,较PMMA为高,因此,同等屈光度人工晶体,Acrylic材料可作得更薄,更适合于小切口植入。Acrylic晶体弹性较小,由折叠状态到完全展开约需3~5秒,因此操作起来比较安全。经过大量的理化及毒理学研究表明,此多聚物有极好的化学稳定性和生物学相容性,无毒性,植入眼内安全。
而上述记忆体材料可由甲基丙烯酸甲酯、羟乙基甲基丙烯酸甲酯、甲基丙烯酸酯羟基苯酚及乙烯乙二醇二丙烯酸酯交联聚合而成,此材料高于25℃时质软。加热使采用记忆体材料的视网膜支架变软后,将其卷曲并冷却,使成硬质卷筒形状。通过小切口植入眼内,经体温加热,利用“记忆”效应会缓慢恢复到原有形态。记忆材料为亲水性,可吸水20%,其屈光指数为1.47,可耐高温高压,有极好的生物学相容性。
本发明的视网膜支架1的工作原理如下:
在进行视网膜支架微创手术时,以上述经纬线式的植入式视网膜支架为例,如图4~6所示,第一步先通过注射器10注入复方生理盐水(图4),第二步将视网膜支架1拉伸、卷曲或折叠后装入白内障可折叠式人工晶体的微植入器等类似微植入装置20内,通过在玻璃体上开出的微创口,将视网膜支架1送入玻璃体内(图5),在玻璃体内的视网膜支架1利用自身弹性、记忆恢复原状,在玻璃体内部撑开(图6),对视网膜起到内支撑的作用,最后将微植入装置撤走,缝合微创口,完成微创手术。
手术完成后,如图7所示,玻璃体2由视网膜支架1支撑,角膜21、黄斑23和视乳头24分别外露在视网膜支架外,锯齿缘22包裹于视网膜支架1内。
综上所述,仅为本发明的较佳实施例而已,并非用来限定本发明实施的范围,凡依本发明权利要求范围所述的形状、构造、特征及精神所为的均等变化与修饰,均应包括于本发明的权利要求范围内。
Claims (8)
1.一种植入式视网膜支架,其特征在于,该支架呈一与眼球内腔相匹配的、透明的、且能够弹性变形的镂空球形支撑结构。
2.如权利要求1所述的植入式视网膜支架,其特征在于,所述镂空球形支撑结构由数个分别沿经纬线分布的支撑筋相连接构成。
3.如权利要求1所述的植入式视网膜支架,其特征在于,所述镂空球形支撑结构的球面由数个斜向交叉设置的支撑筋构成菱形网状结构。
4.如权利要求1或2或3所述的植入式视网膜支架,其特征在于,所述支撑筋的形状为带状或杆状。
5.如权利要求4所述的植入式视网膜支架,其特征在于,所述支撑筋为带状时,宽度为0.5~1.5mm,厚度为0.25~0.75mm;所述支撑筋为杆状时,直径为1~1.2mm。
6.如权利要求4所述的植入式视网膜支架,其特征在于,所述支撑筋的材料为丙烯酸酯多聚物或记忆体材料。
7.如权利要求4所述的植入式视网膜支架,其特征在于,所述丙烯酸酯多聚物由苯乙基丙烯酸甲酯、2-苯乙基丙烯酸酯及交联体聚合而成。
8.如权利要求4所述的植入式视网膜支架,其特征在于,所述记忆体材料由甲基丙烯酸甲酯、羟乙基甲基丙烯酸甲酯、甲基丙烯酸酯羟基苯酚及乙烯乙二醇二丙烯酸酯交联聚合而成。
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