WO2013016907A1 - 一种人工角膜 - Google Patents

一种人工角膜 Download PDF

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Publication number
WO2013016907A1
WO2013016907A1 PCT/CN2011/082435 CN2011082435W WO2013016907A1 WO 2013016907 A1 WO2013016907 A1 WO 2013016907A1 CN 2011082435 W CN2011082435 W CN 2011082435W WO 2013016907 A1 WO2013016907 A1 WO 2013016907A1
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WIPO (PCT)
Prior art keywords
skirt
optical zone
artificial cornea
cornea according
artificial
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PCT/CN2011/082435
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English (en)
French (fr)
Inventor
姚晓明
于莉
林宝涛
罗仲宽
陈建苏
周莉
肖爱明
Original Assignee
Yao Xiaoming
Yu Li
Lin Baotao
Luo Zhongkuan
Chen Jiansu
Zhou Li
Xiao Aiming
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Application filed by Yao Xiaoming, Yu Li, Lin Baotao, Luo Zhongkuan, Chen Jiansu, Zhou Li, Xiao Aiming filed Critical Yao Xiaoming
Publication of WO2013016907A1 publication Critical patent/WO2013016907A1/zh

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    • 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
    • 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
    • A61F2/142—Cornea, e.g. artificial corneae, keratoprostheses or corneal implants for repair of defective corneal tissue

Definitions

  • the invention relates to the field of artificial cornea technology, in particular to the connection structure and function improvement of artificial cornea.
  • the artificial cornea is easily implanted between the human corneal slab layers, which is prone to arc mismatch, which will affect the surgical connection between the two.
  • the front lamellar cornea is in contact with the outer surface of the artificial corneal skirt
  • the posterior lamellar cornea is in contact with the inner surface of the artificial corneal skirt, if the artificial corneal curvature after implantation and the anterior and posterior keratome
  • the inconsistent curvature of the layers causes the adhesion of the two to be inconsistent, affecting the stability of the artificial cornea.
  • the existing artificial cornea transparent body and the skirt are connected to the same plane, or a smooth transition, after surgery, abnormally proliferating eye tissue may migrate from the skirt to the optical zone, obstructing the line of sight, difficult to use drugs or surgery Clear.
  • the main object of the present invention is to solve the above-mentioned prior art artificial cornea, which has poor adaptability and poor stability during connection, and proposes a novel multifunctional artificial cornea.
  • an artificial cornea comprising an optical zone, and a skirt at the periphery of the optical zone, characterized in that: the inner surface of the skirt and The outer surface is provided with a coating of biomaterial compatible with the human eye tissue, the edge of the skirt is serrated, and four or more through holes are provided on the skirt.
  • the inner surface edge of the optical zone protrudes from the skirt and is 90 with the skirt. Degree step structure.
  • the outer surface of the optical zone is provided with a fluoro-heparin surface decorative layer.
  • the optical zone is yellow in color.
  • the optical zone is a central multifocal optical zone.
  • the region of the optical zone having a center diameter of 3.5 mm is a diffraction ring region.
  • the number of through holes on the skirt is 6 to 20, and the diameter of the through hole is 0.5 to 1.0 mm.
  • the through hole closest to the optical zone is spaced from the optical zone by 1.0 to 2.0 mm.
  • the region within the range of 4 mm in the center of the optical zone is slanted by 0.2 to 0.5 mm.
  • the biomaterial coating on the skirt is a hydroxyapatite coating.
  • the skirt is provided with a layer of material that promotes nerve and blood vessel growth.
  • the invention has the beneficial effects that the edge of the skirt is gear-shaped, which makes it easier to adapt to different corneal curvatures, avoiding the skirt bulging, resulting in uneven fitting; the skirt is provided More than 4 through holes not only help the suture fixation, but also strengthen the fusion of the cornea of the anterior and posterior lamina and the artificial cornea, fiber growth and nutrient communication, and enhance the biocompatibility of the artificial cornea.
  • FIG. 1 is a schematic view showing the structure of a front view of the present invention
  • Figure 2 is a schematic view of the cross-sectional structure of A-A in Figure 1.
  • the present invention is mainly composed of two parts, an optical zone 1 and a skirt 2.
  • the skirt 2 is disposed at the periphery of the optical zone 1 for fixing the optical zone 1
  • the skirt is a biomaterial that is compatible with human eye tissue.
  • the biomaterial is preferably hydroxyapatite, but does not exclude or include other biocompatible materials. Hydroxyapatite is a nanometer biomaterial that is porous in other materials. Human corneal tissue can grow into it and has good biocompatibility.
  • hydroxyapatite pores are provided with substances that promote nerve and blood vessel growth substances, such as neuropeptides or fibroblast growth factors or their sustained release microcapsules, to better promote the healing of the cornea and artificial cornea, preventing After the prolapse.
  • the intraocular lens designed by the square edge can inhibit the growth of lens epithelial cells from the peripheral capsule to the center of the visual axis, thereby inhibiting the posterior dysfunction, so the square sharp edge of the artificial lens has a barrier function.
  • Optical zone The inner surface edge of 1 protrudes from the skirt 2, and has a 90-degree step structure with the skirt 2, and the central 4 mm optical zone of the artificial cornea is slanted 0.2-0.5 mm Therefore, the corneal fiber proliferation in the posterior plate layer after the transplantation is reduced, that is, the film formation is inhibited, and the intraocular oozing and fiber proliferation are effectively prevented from moving to the inner surface of the optical zone 1, blocking the line of sight and reducing the effect of re-expanding.
  • the edge of the skirt 2 is gear-shaped, which is easy to adapt to different corneal curvatures, and the skirt does not appear during the surgical implantation 2
  • the edge is raised to avoid the occurrence of a compatible connection between the human cornea and the skirt 2 due to the unevenness of the fit.
  • the diameter of the through hole 23 is 0.5 to 1.0 mm, and the distance between the through hole and the optical zone closest to the optical zone 1 is 1.0 to 2.0 mm.
  • Suture through the through hole during implantation 23 The suture of the anterior and posterior lamellar corneas and the skirt 2 is not only conducive to suture fixation, but also strengthens the fusion of the cornea of the anterior and posterior lamina through the through hole 23, fiber growth and nutrient communication, etc., and strengthens the stability of the artificial cornea. Sex.
  • the outer surface of the optical zone 1 is provided with fluorine - Heparin (other substances that are beneficial for preventing pathological cells and tissues from adsorbing to the optical zone) are not modified.
  • fluorine - Heparin other substances that are beneficial for preventing pathological cells and tissues from adsorbing to the optical zone
  • the artificial corneal optical zone modified by heparin has enhanced hydrophilicity, reduced cell adhesion, reduced granulocyte reaction, and growth of large foreign body cells and fibroblasts, and increased biocompatibility;
  • the increased hydrophobicity of the surface can also reduce inflammatory cell adhesion and reduce cell activation.
  • Fluorine is generally used in two ways by electrostatic adsorption and covalent bonding.
  • - Heparin surface decorative layer and optical zone 1 The outer surfaces are connected.
  • Electrostatic adsorption is based on the characteristics of the negatively charged surface of the heparin molecule, and is bonded to the surface of the material by electrical coupling and physical adsorption.
  • Covalent bond fixation is obtained by chemical bonding or the like using heparin and functional groups on the surface of the polymer.
  • Optical zone 1 It is yellow. Studies have shown that blue light is associated with the development of macular degeneration, which blocks and absorbs blue light and reduces photo damage to the macula. The design of the yellow artificial corneal optic zone will protect the macula in patients with artificial corneal transplants.
  • the optical zone 1 is a central multifocal optical zone with a center diameter of 3.5 mm.
  • the region (which can be appropriately enlarged or reduced) is a diffraction ring region, and the multifocal artificial corneal optical region can be divided into a refractive type and a diffractive type, and both of the light scattered into the eye can achieve the purpose of far and near vision.
  • the diffractive multifocal artificial cornea has the ability of main visual distance and auxiliary visual proximity under the condition of sufficient light and small pupil. When the pupil is enlarged at night, more light enters the pupil to be close to the pupil.
  • the central thin peripheral thick design of the central optic zone can also assist the patient in adjusting the distance and near vision.
  • the multifocal design is mainly located on the anterior surface of the cornea, which is easy to remove even if it is adsorbed by abnormal substances, and the back surface remains smooth to prevent adsorption of abnormal substances.
  • the central optical zone mirror column is designed with different refractive power to suit the choice of patients with aphakic or refractive errors.
  • 'corneal membrane' refers to the cornea of the human eye when used alone.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Transplantation (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

一种人工角膜包括有一个光学区（1）和设在光学区（1）周边的裙边（2）。在所述裙边（2）内表面（22）和外表面（21）上均设有与人眼组织相容的生物材料涂层，所述裙边（2）的边缘为齿轮状，在裙边（2）上设有4个以上的通孔（23）。裙边（2）的边缘为齿轮状，使之更易于适应不同角膜弧度，避免裙边（2）隆起而导致贴合不平整；裙边（2）设有4个以上的通孔（23），不但有利于缝线固定，更可加强前、后板层角膜与人工角膜的融合、纤维生长以及营养沟通等，加强人工角膜的生物相容性。

Description

一种人工角膜
技术领域
本发明涉及到人工角膜技术领域，尤其涉及到人工角膜的连接结构和功能改进。
背景技术
目前，由于不同人的角膜弧度各异，人工角膜在植入人角膜板层之间，容易出现弧度不相配，将影响到二者之间的手术连接。另外，由于人工角膜植入时，前板层角膜与人工角膜裙边外表面相接触，后板层角膜与人工角膜裙边内表面相接触，若植入后的人工角膜曲率与前、后角膜板层的曲率不一致，就造成二者的贴附不紧密，影响到人工角膜的稳定性。还有，现有的人工眼角膜的透明体和裙边间连接为同一平面，或平滑过渡，术后，异常增生的眼组织可能从裙边移行到光学区，遮挡视线，难以用药物或手术清除。
发明内容
综上所述，本发明的主要目的在于解决上述的现有人工角膜存在适应性差，连接时稳定性差的技术缺陷，并提出一种新型多功能人工角膜的构想。
为解决本发明所提出的技术问题，采用的技术方案为：一种人工角膜，包括有一个光学区，在光学区的周边设有裙边，其特征是：所述的在裙边内表面和外表面上均设有与人眼组织相容的生物材料涂层，所述裙边的边缘为锯齿状，在裙边上设有四个以上的通孔。
作为对本发明进行进一步改进的技术方案为：所述的光学区的内表面边缘凸出裙边，与裙边间呈 90 度的台阶结构。
所述的光学区的外表面设有氟 - 肝素表面装饰层。
所述的光学区的为黄色。
所述的光学区为一个中央多焦光学区。
所述的光学区中心直径 3.5mm 的区域为衍射环区。
所述的裙边上的通孔数量为 6 ～ 20 个，通孔直径为 0.5 ～ 1.0mm ，距光学区最近的通孔与光学区间隔在 1.0 ～ 2.0mm 。
所述的光学区中心 4mm 范围内的区域后凸 0.2 ～ 0.5mm 。
所述的裙边上的生物材料涂层为羟基磷灰石涂层。
所述的裙边上设有促进神经及血管生长的材料层。
本发明的有益效果为：裙边的边缘为齿轮状，使之更易于适应不同角膜弧度，避免裙边隆起，导致贴合不平整；裙边设有 4 个以上的通孔，不但有利于缝线固定，更可加强前、后板层角膜与人工角膜的融合、纤维生长以及营养沟通等，加强人工角膜的生物相容性。
附图说明
图 1 为本发明的主视结构示意图；
图 2 为图 1 中 A-A 截面结构示意图。
具体实施方式
以下结合附图和优选的一种具体实施例对本发明的结构作进一步地说明：
参照图 1 和图 2 中所示，本发明主要由光学区 1 和裙边 2 两个部分组成。
所述的裙边 2 设在光学区 1 的周边，用于将固定支撑光学区 1 ，裙边为与人眼组织相容的生物材料，该生物材料最好是羟基磷灰石，但不排除或包括其他具有组织相容性的生物材料。羟基磷灰石为一种纳米的生物材料，掺入其他材料内具有多孔隙，人角膜组织可以长入其内，生物相容性良好。
为了促进神经及血管生长，在裙边 2 上的羟基磷灰石孔隙中设有促进神经及血管生长物质的物质，比如：神经肽或成纤维细胞生长因子或其缓释微囊，以更好促进角膜和人工角膜的相向愈合，防止术后脱出。
近年来对后发障的研究肯定了方形边缘设计的人工晶体能抑制晶状体上皮细胞由周边囊膜向视轴中心生长，从而抑制后发障，故人工晶体的方形锐缘有屏障作用，因而在所述的光学区 1 的内表面边缘凸出裙边 2 ，与裙边 2 间呈 90 度的台阶结构，将人工角膜的中央 4mm 光学区进行后凸 0.2-0.5mm ，从而减少移植后光学区周边后板层角膜纤维增殖即抑制后膜形成，有效地阻止人眼内渗出及纤维增生向光学区 1 内表面移行，阻挡视线，降低复明效果。
所述裙边 2 的边缘为齿轮状，易于适应不同角膜弧度，在手术植入过程中不会出现裙边 2 边缘隆起，避免因贴合不平整，而导致人角膜组织与裙边 2 无法实现相容连接的现象的发生。
在裙边 2 上设有多个的通孔 23 ，可选择手工打孔与激光钻孔，通孔 23 的数量最好 6 ～ 20 个，通孔 23 的直径为 0.5 ～ 1.0mm ，距光学区 1 最近的通孔与光学区间隔在 1.0 ～ 2.0mm 。植入过程中缝线经通孔 23 ，将前、后板层角膜与裙边 2 缝合固定，不但有利于缝线固定，更可加强前、后板层角膜经通孔 23 后融合、纤维生长以及营养沟通等，加强人工角膜的稳定性。
所述的光学区 1 外表面设有氟 - 肝素（不排除其他有利于防止病理性细胞和组织吸附于光学区的物质）表面修饰层。以肝素为例，肝素表面修饰的人工角膜光学区，其亲水性增强，降低细胞粘附，减少粒细胞反应以及异物大细胞沉积和成纤细胞的生长，增加生物相容性；氟表面处理后的表面疏水性增加，同样可以减少炎症细胞黏附，降低细胞激活。一般采用采用静电吸附和共价键固定的两种方法将氟 - 肝素表面装饰层与光学区 1 的外表面相连接。静电吸附是利用肝素分子基负电性表面的特性，通过电性偶合、物理吸附结合到材料表面。共价键固定是利用肝素和聚合物表面的功能基团，经化学键合等方法得到。
所述的光学区 1 的为黄色。研究显示蓝光与黄斑变性的发生相关，黄色光学区可阻挡和吸收蓝光，减少对黄斑的光损伤。黄色人工角膜光学区的设计将使人工角膜移植的患者黄斑受到保护。
所述的光学区 1 为一个中央多焦光学区，在中心直径 3.5mm （可适当扩大或缩小）的区域为衍射环区，多焦点人工角膜光学区可分为折射型和衍射型，均通过分散进入眼内的光线达到视远和视近的目的。其中衍射型多焦点人工角膜，在光线充足小瞳孔条件下有主要视远和辅助视近的能力，在夜间瞳孔放大时，更多的光线进入瞳孔用来视近。另，中央光学区的中央薄周边厚设计也可以辅助患者调节视远和视近。多焦设计主要位于角膜前表面即使有异常物质吸附也容易清除，后表面仍保持光滑，防止异常物质吸附。为满足个性化需求，将中央光学区镜柱进行不同屈光力设计，以适应无晶体眼或屈光不正患者的选择。
注：本文中'角膜'单独使用时指人眼角膜。

Claims (10)

  1. 一种人工角膜，包括有一个光学区，在光学区的周边设有裙边，其特征是：所述的裙边为含空隙的人眼组织相容性生物材料，其边缘为齿轮状，其上设有4个以上的通孔。
  2. 根据权利要求1所述的一种人工角膜，其特征是：所述的光学区的内表面边缘凸出于裙边，与裙边间呈90度的台阶结构。
  3. 根据权利要求1所述的一种人工角膜，其特征是：所述的光学区的内外表面设有有利于防止病理性细胞和组织吸附材料的表面修饰层。
  4. 根据权利要求1所述的一种人工角膜，其特征是：所述的光学区为可吸收或阻止紫外线透过的黄色。
  5. 根据权利要求1所述的一种人工角膜，其特征是：所述的光学区为一个中央多焦光学区。
  6. 根据权利要求5所述的一种人工角膜，其特征是：所述的光学区中心直径3.5mm的区域为衍射环区。
  7. 根据权利要求1所述的一种人工角膜，其特征是：所述的裙边上的通孔数量6～20个，通孔直径为0.5～1.0mm，距光学区最近的通孔与光学区间隔在1.0～2.0mm。
  8. 根据权利要求1所述的一种人工角膜，其特征是：所述的光学区中心4mm范围内的区域后凸0.2～0.5mm。
  9. 根据权利要求1所述的一种人工角膜，其特征是：所述的裙边为羟基磷灰石的材料。
  10. 根据权利要求9所述的一种人工角膜，其特征是：所述的裙边含有促进神经及血管生长的成分或材料。
PCT/CN2011/082435 2011-08-01 2011-11-18 一种人工角膜 WO2013016907A1 (zh)

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CN104436302B (zh) * 2014-12-02 2016-03-30 浙江大学 一种纳米超薄生物膜差异修饰前后表面的人工角膜及制作方法
JP6581218B2 (ja) 2015-06-08 2019-09-25 コーニート ビジョン リミテッド 人工角膜
US10939993B2 (en) 2016-04-08 2021-03-09 Massachusetts Eye And Ear Infirmary Keratoprosthesis apparatuses, systems, and methods
CN107007879A (zh) * 2017-03-14 2017-08-04 暨南大学 一种活性人工角膜及其制备方法
CN107496981B (zh) * 2017-09-22 2020-07-31 陈小鸟 一种新型材料的人工角膜支架及其应用
KR102190257B1 (ko) * 2017-12-20 2020-12-16 주식회사 마이크로트 안압의 조절을 위한 안질환용 임플란트 장치
EP3806775A1 (en) * 2018-06-14 2021-04-21 W.L. Gore & Associates, Inc. Artificial cornea
CN111419471A (zh) * 2020-03-05 2020-07-17 姚晓明 一种人工角膜
CN111714249A (zh) * 2020-05-28 2020-09-29 广州新诚生物科技有限公司 一种人工角膜及其制备方法
CN113952076A (zh) * 2021-12-02 2022-01-21 北京米赫医疗器械有限责任公司 一种多焦点人工角膜及其制备工艺

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