CN118766650A - A one-time implantable artificial cornea imitating human eyes and its use method - Google Patents
A one-time implantable artificial cornea imitating human eyes and its use method Download PDFInfo
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- CN118766650A CN118766650A CN202411034574.0A CN202411034574A CN118766650A CN 118766650 A CN118766650 A CN 118766650A CN 202411034574 A CN202411034574 A CN 202411034574A CN 118766650 A CN118766650 A CN 118766650A
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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 or corneal implants; Artificial eyes
- A61F2/142—Cornea, e.g. artificial corneae, keratoprostheses or corneal implants for repair of defective corneal tissue
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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 or corneal implants; Artificial eyes
- A61F2/148—Implantation instruments specially adapted therefor
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Abstract
本发明公开一种仿人眼一次植入人工角膜,属于体内假体植入技术领域。至少解决现有人工角膜无法模拟真实眼睛外观的问题。人工角膜包括镜柱、支架和美容盘;其中,镜柱包括镜柱本体以及同轴设置在镜柱本体靠近后端面位置的后盘;美容盘同轴设置在镜柱本体的前端;支架同轴且可移动的设置在后盘和美容盘之间的镜柱本体上;使用状态下,支架和后盘一前一后夹持角膜;美容盘中央开孔且具有虹膜纹理区域和巩膜纹理区域;虹膜纹理区域形成有虹膜纹理层,巩膜纹理区域形成有仿球结膜血管纹理层。本发明还提供一种仿人眼一次植入人工角膜的使用方法。
The present invention discloses an artificial cornea that can be implanted once and imitates a human eye, and belongs to the technical field of in vivo prosthesis implantation. At least the problem that the existing artificial cornea cannot simulate the appearance of a real eye is solved. The artificial cornea includes a mirror column, a bracket and a cosmetic tray; wherein the mirror column includes a mirror column body and a rear tray coaxially arranged at a position close to the rear end face of the mirror column body; the cosmetic tray is coaxially arranged at the front end of the mirror column body; the bracket is coaxially and movably arranged on the mirror column body between the rear tray and the cosmetic tray; in the use state, the bracket and the rear tray clamp the cornea one after the other; the cosmetic tray has a hole in the center and has an iris texture area and a sclera texture area; the iris texture area is formed with an iris texture layer, and the sclera texture area is formed with a texture layer that imitates the bulbar conjunctiva blood vessels. The present invention also provides a method for using an artificial cornea that can be implanted once and imitates a human eye.
Description
技术领域Technical Field
本发明属于体内假体植入技术领域,尤其涉及一种仿人眼一次植入人工角膜及其使用方法。The invention belongs to the technical field of in vivo prosthesis implantation, and in particular relates to a one-time implantation artificial cornea imitating a human eye and a use method thereof.
背景技术Background Art
人工角膜,指用人工材料制成的一种特殊屈光装置,用以替代病变后阻碍眼球光学通路的混浊角膜,使患者获得一定视力。An artificial cornea refers to a special refractive device made of artificial materials, which is used to replace the cloudy cornea that blocks the optical pathway of the eye after a disease, so that the patient can regain a certain degree of vision.
虹膜纹理由遗传基因决定,每个人的虹膜纹理都独一无二且生理结构稳定。这些纹理特征包括放射形条纹、斑点、细丝、冠状、隐窝等形状。在患者眼表放置带有虹膜纹理图案的美容片,主要是为了模拟真实眼睛的外观。然而现有技术提供的人工角膜仅具有屈光的功能,并没有模拟真实眼睛的外观。现有技术提供的人工角膜容易产生人工角膜前膜等术后并发症。Iris texture is determined by genetic genes. Each person's iris texture is unique and has a stable physiological structure. These texture features include radial stripes, spots, filaments, coronal shapes, crypts and other shapes. The cosmetic piece with iris texture pattern is placed on the patient's eye surface mainly to simulate the appearance of a real eye. However, the artificial cornea provided by the prior art only has the function of refraction and does not simulate the appearance of a real eye. The artificial cornea provided by the prior art is prone to postoperative complications such as artificial corneal anterior membrane.
鉴于此,亟待提出一种仿人眼一次植入人工角膜及其使用方法。In view of this, it is urgent to propose an artificial cornea that can be implanted once and imitates the human eye and a method of using the same.
发明内容Summary of the invention
本发明的目的在于提供一种仿人眼一次植入人工角膜及其使用方法,以模拟真实眼睛的外观以及降低前膜等术后并发症。The purpose of the present invention is to provide a one-time implantable artificial cornea imitating a human eye and a method of using the same, so as to simulate the appearance of a real eye and reduce postoperative complications such as anterior membrane.
为了实现上述目的,本发明提供如下技术方案:In order to achieve the above object, the present invention provides the following technical solutions:
第一方面,本发明提供一种仿人眼一次植入人工角膜,包括镜柱、支架和美容盘;其中,镜柱包括镜柱本体以及同轴设置在镜柱本体靠近后端面位置的后盘;美容盘同轴设置在镜柱本体的前端;支架同轴且可移动的设置在后盘和美容盘之间的镜柱本体上;使用状态下,支架和后盘一前一后夹持角膜;美容盘中央开孔且具有虹膜纹理区域和巩膜纹理区域;虹膜纹理区域形成有虹膜纹理层,巩膜纹理区域形成有仿球结膜血管纹理层。In a first aspect, the present invention provides a one-time implantable artificial cornea that imitates a human eye, comprising a lens column, a bracket and a cosmetic tray; wherein the lens column comprises a lens column body and a rear tray coaxially arranged at a position near the rear end face of the lens column body; the cosmetic tray is coaxially arranged at the front end of the lens column body; the bracket is coaxially and movably arranged on the lens column body between the rear tray and the cosmetic tray; in a state of use, the bracket and the rear tray clamp the cornea in front and back; the cosmetic tray has a hole in the center and has an iris texture area and a sclera texture area; the iris texture area forms an iris texture layer, and the sclera texture area forms a vascular texture layer that imitates the bulbar conjunctiva.
作为一种可能的实现方式,虹膜纹理层和仿球结膜血管纹理层应用图像处理和3D打印形成。As a possible implementation method, the iris texture layer and the conjunctiva-like blood vessel texture layer are formed by image processing and 3D printing.
作为一种可能的实现方式,虹膜纹理层和仿球结膜血管纹理层为贴附在美容盘上的角膜接触镜、隐形眼镜、虹膜遮盖片或美瞳中的任意一种。As a possible implementation, the iris texture layer and the conjunctival vascular texture layer are any one of a corneal contact lens, a contact lens, an iris cover lens or a cosmetic contact lens attached to a cosmetic tray.
作为一种可能的实现方式,美容盘为椭圆形,长轴为11mm~26mm,短轴为5.5mm~11mm。As a possible implementation, the beauty tray is oval in shape, with a major axis of 11 mm to 26 mm and a minor axis of 5.5 mm to 11 mm.
作为一种可能的实现方式,美容盘的曲率半径为12mm±3.0mm。As a possible implementation, the curvature radius of the beauty tray is 12 mm ± 3.0 mm.
作为一种可能的实现方式,美容盘为中间厚两边薄的结构,材质为树脂,厚度最大值为0.05~0.5mm。As a possible implementation method, the beauty tray has a structure that is thick in the middle and thin on both sides, is made of resin, and has a maximum thickness of 0.05 to 0.5 mm.
作为一种可能的实现方式,美容盘为树脂美容盘,树脂美容盘的边沿开设有便于夹持的豁口。As a possible implementation, the beauty tray is a resin beauty tray, and a notch is provided on the edge of the resin beauty tray for easy clamping.
作为一种可能的实现方式,美容盘为树脂美容盘,镜柱本体用于安装美容盘的位置处开设有外螺纹,且直径较其他位置的直径小,以形成限位台阶;美容盘的中央孔的内壁开设有与之的内螺纹。As a possible implementation method, the beauty tray is a resin beauty tray, and the position of the mirror column body for installing the beauty tray is provided with an external thread, and the diameter is smaller than the diameter at other positions to form a limiting step; the inner wall of the central hole of the beauty tray is provided with an internal thread therewith.
作为一种可能的实现方式,美容盘为硅水凝胶、水凝胶离子材料、非离子材料,套在镜柱本体的前端。As a possible implementation method, the beauty tray is made of silicone hydrogel, hydrogel ionic material, or non-ionic material, and is sleeved on the front end of the mirror column body.
作为一种可能的实现方式,镜柱本体的前端面与美容盘的中央开孔处齐平或凸出。As a possible implementation manner, the front end surface of the mirror column body is flush with or protrudes from the central opening of the beauty tray.
第二方面,本发明还提供一种仿人眼一次植入人工角膜的使用方法,包括如下步骤:In a second aspect, the present invention further provides a method for using a human eye-like one-time implanted artificial cornea, comprising the following steps:
S10.将人工角膜镜柱后端连同后盘进入前房;S10. Insert the rear end of the artificial cornea column together with the rear disc into the anterior chamber;
S11.将支架的后盘滑行移动至角膜后表面,使镜柱位于角膜钻孔中央;S11. Slide the rear plate of the bracket to the posterior surface of the cornea so that the lens column is located in the center of the corneal hole;
S12.缝合角膜放射状侧切口至水密;S12. Suture the radial lateral corneal incision until it is watertight;
S13.旋转支架,直至支架与角膜前表面贴合;S13. Rotate the bracket until it fits the anterior surface of the cornea;
S14.将支架缝合固定在角膜前表面,此时,后盘和支架前后夹持角膜;S14. Suturing and fixing the stent to the anterior surface of the cornea, at this time, the posterior disc and the stent clamp the cornea front and back;
S15.生物组织或人工合成材料加固支架。S15. Biological tissue or artificial synthetic material reinforced scaffold.
与现有技术相比,本发明具有如下效果:Compared with the prior art, the present invention has the following effects:
1.人工角膜上增加美容盘,且在美容盘中央开孔,美容盘上具有与角膜同等大小的虹膜纹理区域,一方面,不会影响人工角膜必须具备的屈光功能,另外一方面,在虹膜纹理区域形成有虹膜纹理层和巩膜纹理层,能够模拟真实眼睛的外观;1. A beauty tray is added to the artificial cornea, and a hole is opened in the center of the beauty tray. The beauty tray has an iris texture area of the same size as the cornea. On the one hand, it will not affect the refractive function that the artificial cornea must have. On the other hand, an iris texture layer and a sclera texture layer are formed in the iris texture area, which can simulate the appearance of a real eye;
2.本发明的美容盘能够避免生物组织长入镜柱主体的前端面,降低后膜等并发症的发生;2. The cosmetic tray of the present invention can prevent biological tissue from growing into the front end surface of the lens column body, reducing the occurrence of complications such as posterior membrane;
3.减少泪液蒸发,减少术后干眼程度,减少用药;3. Reduce tear evaporation, reduce the degree of postoperative dry eyes, and reduce medication;
4.无需供体角膜,一次植入手术即可完成角膜盲复明的治疗;4. No donor cornea is needed, and a single implantation operation can complete the treatment of corneal blindness and restoration of vision;
5.支架位于角膜外表面,手术难度小、创伤小、愈合周期短且愈合效果好。5. The stent is located on the outer surface of the cornea, which makes the operation less difficult, less traumatic, has a short healing period and good healing effect.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
此处所说明的附图用来提供对本发明的进一步理解,构成本发明的一部分,本发明的示意性实施例及其说明用于解释本发明,并不构成对本发明的不当限定。The drawings described herein are used to provide further understanding of the present invention and constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute improper limitations on the present invention.
图1为本发明实施例提供的人工角膜的整体结构示意图;FIG1 is a schematic diagram of the overall structure of an artificial cornea provided by an embodiment of the present invention;
图2为本发明实施例提供的镜柱的结构示意图;FIG2 is a schematic diagram of the structure of a mirror column provided in an embodiment of the present invention;
图3为本发明实施例提供的支架的结构示意图;FIG3 is a schematic diagram of the structure of a bracket provided in an embodiment of the present invention;
图4为本发明实施例提供的支架用连接的结构示意图;FIG4 is a schematic structural diagram of a connection for a bracket provided in an embodiment of the present invention;
图5为本发明实施例提供的另外一种支架的结构示意图。FIG. 5 is a schematic diagram of the structure of another bracket provided in an embodiment of the present invention.
附图标记:Reference numerals:
1-镜柱,10-镜柱本体,11-后盘;1-mirror column, 10-mirror column body, 11-rear plate;
2-支架,20-支架本体,21-连接环,210-内螺纹,211-环形凹槽,212-豁口,213-针孔;2-bracket, 20-bracket body, 21-connecting ring, 210-internal thread, 211-annular groove, 212-notch, 213-pinhole;
3-美容盘。3-Beauty tray.
具体实施方式DETAILED DESCRIPTION
为了便于清楚描述本发明实施例的技术方案,在本发明的实施例中,采用了“第一”、“第二”等字样对功能和作用基本相同的相同项或相似项进行区分。例如,第一阈值和第二阈值仅仅是为了区分不同的阈值,并不对其先后顺序进行限定。本领域技术人员可以理解“第一”、“第二”等字样并不对数量和执行次序进行限定,并且“第一”、“第二”等字样也并不限定一定不同。In order to clearly describe the technical solutions of the embodiments of the present invention, in the embodiments of the present invention, words such as "first" and "second" are used to distinguish the same items or similar items with basically the same functions and effects. For example, the first threshold and the second threshold are only used to distinguish different thresholds, and their order is not limited. Those skilled in the art can understand that words such as "first" and "second" do not limit the quantity and execution order, and words such as "first" and "second" do not necessarily limit them to be different.
需要说明的是,本发明中,“示例性的”或者“例如”等词用于表示作例子、例证或说明。本发明中被描述为“示例性的”或者“例如”的任何实施例或设计方案不应被解释为比其他实施例或设计方案更优选或更具优势。确切而言,使用“示例性的”或者“例如”等词旨在以具体方式呈现相关概念。It should be noted that, in the present invention, words such as "exemplary" or "for example" are used to indicate examples, illustrations or descriptions. Any embodiment or design described as "exemplary" or "for example" in the present invention should not be interpreted as being more preferred or more advantageous than other embodiments or designs. Specifically, the use of words such as "exemplary" or "for example" is intended to present related concepts in a specific way.
本发明中,“至少一个”是指一个或者多个,“多个”是指两个或两个以上。“和/或”,描述关联对象的关联关系,表示可以存在三种关系,例如,A和/或B,可以表示:单独存在A,同时存在A和B,单独存在B的情况,其中A,B可以是单数或者复数。字符“/”一般表示前后关联对象是一种“或”的关系。“以下至少一项(个)”或其类似表达,是指的这些项中的任意组合,包括单项(个)或复数项(个)的任意组合。例如,a,b或c中的至少一项(个),可以表示:a,b,c,a和b的结合,a和c的结合,b和c的结合,或a、b和c的结合,其中a,b,c可以是单个,也可以是多个。In the present invention, "at least one" means one or more, and "plurality" means two or more. "And/or" describes the association relationship of associated objects, indicating that three relationships may exist. For example, A and/or B can mean: A exists alone, A and B exist at the same time, and B exists alone, where A and B can be singular or plural. The character "/" generally indicates that the associated objects before and after are in an "or" relationship. "At least one of the following" or similar expressions refers to any combination of these items, including any combination of single or plural items. For example, at least one of a, b or c can mean: a, b, c, the combination of a and b, the combination of a and c, the combination of b and c, or the combination of a, b and c, where a, b, c can be single or multiple.
参见图1和图2,本发明实施例提供一种仿人眼一次植入人工角膜,包括镜柱1、支架2和美容盘3。其中,镜柱1包括镜柱本体10以及同轴设置在镜柱本体10靠近后端面位置的后盘11;美容盘3同轴设置在镜柱本体10的前端;支架2同轴且可移动的设置在后盘11和美容盘3之间的镜柱本体10上;使用状态下,支架2和后盘11一前一后夹持角膜;美容盘3中央开孔且具有虹膜纹理区域和巩膜纹理区域;虹膜纹理区域形成有虹膜纹理层,巩膜纹理区域形成有仿球结膜血管纹理层。Referring to Fig. 1 and Fig. 2, an embodiment of the present invention provides a one-time implantable artificial cornea that simulates a human eye, comprising a lens column 1, a bracket 2 and a cosmetic tray 3. The lens column 1 comprises a lens column body 10 and a rear tray 11 coaxially arranged at a position close to the rear end face of the lens column body 10; the cosmetic tray 3 is coaxially arranged at the front end of the lens column body 10; the bracket 2 is coaxially and movably arranged on the lens column body 10 between the rear tray 11 and the cosmetic tray 3; in the use state, the bracket 2 and the rear tray 11 clamp the cornea in front and back; the cosmetic tray 3 has a central opening and has an iris texture area and a sclera texture area; the iris texture area is formed with an iris texture layer, and the sclera texture area is formed with a bulbar conjunctival vascular texture layer.
在镜柱1前端同轴设置有美容盘3,且在美容盘3上形成有仿人眼的纹理,使得人工角膜更加接近真实的人眼,美观性提高。而且,不会影响人工角膜必须具备的屈光功能。本发明实施例提供的美容盘3能够避免生物组织长入镜柱主体10的前端面,降低后膜等并发症的发生,即降低对镜柱1屈光度的不利影响。美容盘3相当于眼表的屏障置于眼表外,能够减少泪液蒸发,即能够减少术后干眼程度,减小用药。A cosmetic tray 3 is coaxially arranged at the front end of the lens column 1, and a texture imitating a human eye is formed on the cosmetic tray 3, so that the artificial cornea is closer to a real human eye and the aesthetics are improved. Moreover, the refractive function that the artificial cornea must have will not be affected. The cosmetic tray 3 provided in the embodiment of the present invention can prevent biological tissue from growing into the front end surface of the lens column body 10, reduce the occurrence of complications such as posterior membrane, that is, reduce the adverse effect on the refractive power of the lens column 1. The cosmetic tray 3 is equivalent to a barrier on the ocular surface and is placed outside the ocular surface, which can reduce tear evaporation, that is, it can reduce the degree of postoperative dry eyes and reduce medication.
虹膜纹理层和仿球结膜血管纹理层应用图像处理和3D打印形成。即应用图像处理技术进行特征提取以生成虹膜纹理层和仿球结膜血管纹理层的图像。然后再应用3D打印在美容盘3相对应的区域形成的虹膜纹理层和仿球结膜血管的纹理层。例如,可以将高分子密度树脂通过喷涂或印刷的工艺形成在美容盘3的前表面。The iris texture layer and the imitation bulbar conjunctiva blood vessel texture layer are formed by image processing and 3D printing. That is, the image processing technology is used to extract features to generate images of the iris texture layer and the imitation bulbar conjunctiva blood vessel texture layer. Then, 3D printing is used to form the iris texture layer and the imitation bulbar conjunctiva blood vessel texture layer in the corresponding area of the beauty tray 3. For example, a high molecular density resin can be formed on the front surface of the beauty tray 3 by spraying or printing.
虹膜纹理层和仿球结膜血管纹理层为贴附在美容盘3上的角膜接触镜、隐形眼镜、虹膜遮盖片或美瞳中的任意一种。The iris texture layer and the imitation bulbar conjunctiva blood vessel texture layer are any one of a corneal contact lens, a contact lens, an iris cover lens or a cosmetic contact lens attached to the beauty tray 3 .
美容盘3的大小与结膜囊大小相适应。美容盘3可以是具有一定弧度的椭圆形的片状结构。其长轴为11mm~26mm,短轴为5.5mm~11mm。例如,长轴为11mm、短轴为5.5mm,或长轴为26mm、短轴为11mm。The size of the cosmetic tray 3 is adapted to the size of the conjunctival sac. The cosmetic tray 3 may be an elliptical sheet structure with a certain curvature. Its major axis is 11 mm to 26 mm, and its minor axis is 5.5 mm to 11 mm. For example, the major axis is 11 mm and the minor axis is 5.5 mm, or the major axis is 26 mm and the minor axis is 11 mm.
美容盘3的曲率半径为12mm±3.0mm。例如,具体为9mm、10mm、11mm、12mm、13mm、14mm或15mm。The curvature radius of the beauty tray 3 is 12 mm ± 3.0 mm, for example, specifically 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm or 15 mm.
美容盘3为中间厚两边薄的结构,材质为树脂,厚度为0.05~0.5mm。例如,美容盘3靠近中央孔的位置最厚,其厚度为0.05mm、0.06mm、0.07mm、0.08mm、0.09mm、0.1mm、0.2mm、0.3mm、0.4mm或0.5mm。The beauty tray 3 is thick in the middle and thin at both sides, and is made of resin with a thickness of 0.05 to 0.5 mm. For example, the beauty tray 3 is thickest near the central hole, and its thickness is 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm or 0.5 mm.
为了便于树脂美容盘和镜柱本体10的安装,可以在树脂美容盘的边沿开设有便于夹持的豁口(图中未示出)。豁口可以沿树脂美容盘的圆周间隔且均匀分布。In order to facilitate the installation of the resin beauty tray and the mirror column body 10, a notch (not shown in the figure) for easy clamping can be opened on the edge of the resin beauty tray. The notches can be spaced and evenly distributed along the circumference of the resin beauty tray.
美容盘3为树脂美容盘,镜柱本体10用于安装树脂美容盘的位置处开设有外螺纹,且直径较其他位置的直径小,以形成限位台阶;美容盘3的中央孔的内壁开设有与之的内螺纹。The beauty tray 3 is a resin beauty tray. The mirror column body 10 is provided with an external thread at the position for installing the resin beauty tray, and the diameter is smaller than the diameter at other positions to form a limiting step; the inner wall of the central hole of the beauty tray 3 is provided with an internal thread therewith.
树脂美容盘安装位置的螺纹段的螺距与用于安装支架位置的螺纹段的螺距不同,以使树脂美容盘安装到位后不会继续向下旋。即螺距不同的螺纹段可以起到限位的作用。The pitch of the threaded section at the resin beauty tray installation position is different from the pitch of the threaded section at the bracket installation position, so that the resin beauty tray will not continue to rotate downward after being installed in place. That is, the threaded sections with different pitches can play a role of limiting.
美容盘3为硅水凝胶、水凝胶离子材料、非离子材料,套在镜柱本体10的前端。即美容盘3为非刚性美容盘,换言之,美容盘3具有一定的弹性,美容盘3中央开孔的直径要小于镜柱本体10用于安装美容盘位置的直径,利用其自身的弹性,使美容盘3紧紧的包绕在镜柱本体的前端。如此设置,不仅方便组装,而且,不会影响镜柱本体10屈光的视野。The beauty tray 3 is made of silicone hydrogel, hydrogel ionic material, or non-ionic material, and is sleeved on the front end of the mirror column body 10. That is, the beauty tray 3 is a non-rigid beauty tray, in other words, the beauty tray 3 has a certain elasticity, and the diameter of the central opening of the beauty tray 3 is smaller than the diameter of the mirror column body 10 for installing the beauty tray. By using its own elasticity, the beauty tray 3 is tightly wrapped around the front end of the mirror column body. Such a setting is not only convenient for assembly, but also does not affect the refractive field of the mirror column body 10.
镜柱本体10的前端面与美容盘3的中央开孔处齐平或凸出,以最大程度的降低美容盘3对于镜柱本体10屈光视野的不利影响。The front end surface of the lens column body 10 is flush with or protrudes from the central opening of the beauty tray 3 to minimize the adverse effect of the beauty tray 3 on the refractive field of the lens column body 10.
组装状态下,支架2和镜柱1可以螺纹旋接。In the assembled state, the bracket 2 and the mirror column 1 can be screwed together.
镜柱本体10与后盘11的材质相同,可以一体成型,也可以分别制造完成镜柱本体10和后盘11后,将两者通过任意一种方式同轴紧固连接在一起。The mirror column body 10 and the rear plate 11 are made of the same material and can be integrally formed, or the mirror column body 10 and the rear plate 11 can be manufactured separately and then coaxially fastened together in any manner.
镜柱本体10位于后盘11前方的部分可以是自上而下直径相等的圆柱体结构,与支架2旋接的位置自上而下开设有与支架2的内螺纹210匹配的外螺纹段。The portion of the mirror column body 10 located in front of the rear plate 11 can be a cylindrical structure with equal diameters from top to bottom, and the position screwed to the bracket 2 is provided with an external thread section matching the internal thread 210 of the bracket 2 from top to bottom.
镜柱本体10直径较后盘11直径小。具体的,镜柱本体10直径为2.0~3.5mm。后盘11直径较镜柱本体10直径大2~4mm,即后盘11直径为4~7.5mm。例如,镜柱本体10直径为2mm,后盘11直径为4mm;镜柱本体10直径为3mm,后盘11直径为5mm;镜柱本体10直径为3.5mm,后盘11直径为7.5mm。The diameter of the mirror column body 10 is smaller than that of the rear plate 11. Specifically, the diameter of the mirror column body 10 is 2.0-3.5 mm. The diameter of the rear plate 11 is 2-4 mm larger than that of the mirror column body 10, that is, the diameter of the rear plate 11 is 4-7.5 mm. For example, the diameter of the mirror column body 10 is 2 mm, and the diameter of the rear plate 11 is 4 mm; the diameter of the mirror column body 10 is 3 mm, and the diameter of the rear plate 11 is 5 mm; the diameter of the mirror column body 10 is 3.5 mm, and the diameter of the rear plate 11 is 7.5 mm.
在实际应用中,角膜直径为11mm,钻眼直径为2.5mm。后盘11直径小于或等于角膜半径与镜柱本体10半径的和。In practical applications, the diameter of the cornea is 11 mm, the diameter of the drill hole is 2.5 mm, and the diameter of the rear plate 11 is less than or equal to the sum of the radius of the cornea and the radius of the lens column body 10.
镜柱本体10的总长度为4.5~8.5mm,其中,后盘11至后端面为1~2mm,后盘11至螺纹段段尾的光轴段为0.2~0.5mm,后盘11为0.3~0.5mm,螺纹段为3~5.5mm。The total length of the mirror column body 10 is 4.5-8.5 mm, of which the length from the rear disc 11 to the rear end face is 1-2 mm, the length of the optical axis from the rear disc 11 to the end of the threaded section is 0.2-0.5 mm, the length of the rear disc 11 is 0.3-0.5 mm, and the length of the threaded section is 3-5.5 mm.
镜柱1的屈光度为42~62D,例如,42D、45D、50D、55D、60D或62D。The refractive power of the lens column 1 is 42-62D, for example, 42D, 45D, 50D, 55D, 60D or 62D.
后盘11后方的镜柱本体10的侧面底端至后端面为方边。如此设置,方边周围的生物组织较难越过方边向后端面生长,即能够避免不断生长的生物组织覆盖镜柱1的后端面,从而有效规避镜柱1因被不断生长的生物组织覆盖而无法透光的问题。The side bottom end to the rear end face of the mirror column body 10 behind the rear plate 11 is a square edge. In this way, it is difficult for biological tissues around the square edge to grow over the square edge to the rear end face, that is, it can prevent the growing biological tissues from covering the rear end face of the mirror column 1, thereby effectively avoiding the problem that the mirror column 1 cannot transmit light due to being covered by the growing biological tissues.
方边为直角边、钝角边或锐角边中的一种。后盘11后方的镜柱本体10为等径结构、直径逐渐缩小的结构或直径逐渐增大的结构中的一种。The square edge is one of a right angle edge, an obtuse angle edge or an acute angle edge. The mirror column body 10 behind the rear plate 11 is one of a constant diameter structure, a structure with a gradually decreasing diameter or a structure with a gradually increasing diameter.
后盘11后方的镜柱本体10为等径结构、直径逐渐缩小的结构或直径逐渐增大的结构中的一种。The mirror column body 10 behind the rear plate 11 is one of a structure with a constant diameter, a structure with a gradually decreasing diameter, or a structure with a gradually increasing diameter.
镜柱本体10的非螺纹段上镀羟基磷灰石膜层,利用大气等离子喷涂时,镀膜厚度为30~150微米,粘合强度至少为10Mpa。The non-threaded section of the mirror column body 10 is coated with a hydroxyapatite film. When atmospheric plasma spraying is used, the coating thickness is 30 to 150 microns and the bonding strength is at least 10 MPa.
镜柱本体10构成用于替代眼睛光路的光学器件,即光线透过镜柱本体10后在视网膜上成像。The mirror column body 10 constitutes an optical device for replacing the optical path of the eye, that is, light is imaged on the retina after passing through the mirror column body 10 .
后盘11的外周向前设置有环形外沿,封闭后盘11与角膜后表面,防止漏水以及感染。The outer periphery of the rear disc 11 is provided with an annular outer edge forwardly, which seals the rear disc 11 and the rear surface of the cornea to prevent water leakage and infection.
镜柱1材质为聚甲基丙烯酸羟乙酯、聚甲基丙烯酸甲酯、生物陶瓷或光学玻璃中的至少一种。The mirror column 1 is made of at least one of poly(hydroxyethyl methacrylate), poly(methyl methacrylate), bioceramics or optical glass.
参见图3至图5,支架2可以是金属支架,例如医用金属钛支架。也可以是PMMA支架,即支架2材质与镜柱1材质相同或相近。3 to 5 , the bracket 2 may be a metal bracket, such as a medical titanium bracket, or a PMMA bracket, that is, the material of the bracket 2 is the same as or similar to that of the mirror column 1 .
当支架2为金属支架时,为了缩短支架2与角膜的愈合周期以及提高愈合效果,可以在支架2表面镀一层羟基磷灰石。When the bracket 2 is a metal bracket, in order to shorten the healing period between the bracket 2 and the cornea and improve the healing effect, a layer of hydroxyapatite can be plated on the surface of the bracket 2.
当支架2为金属支架时,一次植入人工角膜还包括中空阶梯轴状的连接环21,连接环21的材质与镜柱1材质相同或相近。连接环21的内壁开设有内螺纹210,镜柱1的前段开设有与内螺纹210匹配的外螺纹段。中空阶梯轴状的外壁轴肩处开设有环状凹槽211,支架2所具有的中心安装孔的内壁以过盈配合的装配方式卡入环状凹槽211内;且连接环21由前至后卡入支架的中心安装孔。When the bracket 2 is a metal bracket, the one-time implantation of the artificial cornea further includes a hollow stepped shaft-shaped connecting ring 21, the material of which is the same or similar to that of the lens column 1. The inner wall of the connecting ring 21 is provided with an internal thread 210, and the front section of the lens column 1 is provided with an external thread section matching the internal thread 210. An annular groove 211 is provided at the shoulder of the outer wall of the hollow stepped shaft, and the inner wall of the central mounting hole of the bracket 2 is inserted into the annular groove 211 in an interference fit assembly manner; and the connecting ring 21 is inserted into the central mounting hole of the bracket from front to back.
当支架2与镜柱1的材质不同但需要以螺纹连接的方式发生相对运动时,金属材质的支架2会对镜柱1的螺纹造成损伤。材质相同的内螺纹和外螺纹段使得两者发生相对位移变化时,最大程度降低旋转运动对彼此的损伤。而且,连接环21由前至后卡入支架的中心安装孔,术中旋转支架2向眼表靠近时,连接环21不会从中心安装孔脱落至眼内。When the bracket 2 and the lens column 1 are made of different materials but need to move relative to each other in a threaded connection, the metal bracket 2 will damage the threads of the lens column 1. The internal and external thread segments of the same material minimize the damage to each other caused by the rotational movement when the two undergo relative displacement changes. In addition, the connecting ring 21 is inserted into the central mounting hole of the bracket from front to back. When the bracket 2 is rotated to approach the ocular surface during surgery, the connecting ring 21 will not fall off from the central mounting hole into the eye.
当支架2与镜柱1均为PMMA时,可以将支架2与镜柱1直接连接,无需上述连接环21。即可以直接在支架2的中心安装孔的内壁开设与外螺纹段匹配的内螺纹210。When the bracket 2 and the mirror column 1 are both made of PMMA, the bracket 2 and the mirror column 1 can be directly connected without the connecting ring 21. That is, an internal thread 210 matching the external thread segment can be directly provided on the inner wall of the central mounting hole of the bracket 2.
从结构上讲,支架2可以是蝶形支架、单圆环支架、双圆环支架(外圆环和内圆环之间具有栅格连接片)或网状支架。其中,网状支架时便于前后组织的营养交换。Structurally, the support 2 can be a butterfly support, a single ring support, a double ring support (with a grid connecting piece between the outer ring and the inner ring) or a mesh support. Among them, the mesh support is convenient for the nutrient exchange of the front and back tissues.
由于支架2需要与角膜的前表面贴合,因此,需要具有一定的弧度,以确保支架2能够完全贴合在角膜的前表面。而且,支架2需要具有一定的刚性,即支架2贴合到角膜前表面后,不容易受力变形或翘曲。支架2还需要具有一定的柔性,由于不同患者的角膜弧度存在差异,因此,具有一定柔性的支架2可以有一定的变形空间,以适应不同弧度的角膜。Since the bracket 2 needs to fit the front surface of the cornea, it needs to have a certain curvature to ensure that the bracket 2 can completely fit the front surface of the cornea. In addition, the bracket 2 needs to have a certain rigidity, that is, after the bracket 2 is attached to the front surface of the cornea, it is not easy to deform or warp under force. The bracket 2 also needs to have a certain flexibility. Since the curvature of the cornea varies from patient to patient, the bracket 2 with a certain flexibility can have a certain deformation space to adapt to corneas with different curvatures.
支架2上开设有便于缝合固定的豁口212或针孔213。如此设置,便于将支架2缝合固定在眼表。角膜放射状侧切口缝合后,将人角膜固定在角膜后表面,待支架2移动至与角膜前表面贴合后,再利用豁口212或者是针孔213将支架2与角膜缝合。The bracket 2 is provided with a notch 212 or a pinhole 213 for suturing and fixing. This arrangement facilitates the bracket 2 to be sutured and fixed to the ocular surface. After the radial side incision of the cornea is sutured, the human cornea is fixed to the posterior surface of the cornea, and after the bracket 2 is moved to fit the anterior surface of the cornea, the notch 212 or the pinhole 213 is used to suture the bracket 2 and the cornea.
角膜外还缝合有用于加固支架2的生物组织或人工合成材料。生物组织覆盖支架2且包绕镜柱1。起到同时加固支架2和镜柱1的作用。组织由后向前依次耳软骨、Tenon's囊和上皮组织。人工合成材料可以是羟基磷灰石、人工骨。Biological tissue or artificial synthetic material for reinforcing the bracket 2 is also sutured outside the cornea. The biological tissue covers the bracket 2 and surrounds the lens column 1. It plays the role of reinforcing the bracket 2 and the lens column 1 at the same time. The tissues are ear cartilage, Tenon's capsule and epithelial tissue from back to front. The artificial synthetic material can be hydroxyapatite or artificial bone.
在具体应用时,可以取患者自身的耳软骨,耳软骨对应镜柱1的位置钻孔,将耳软骨与角膜缝合,包绕镜柱1且覆盖支架2。实现对人工角膜的二次加固,使得人工角膜更加稳固,不易脱位。另外,角膜被耳软骨覆盖后,相当于其上覆盖有屏障,不仅起到保护的作用,而且能够避免角膜溶解。In specific applications, the patient's own ear cartilage can be taken, a hole is drilled in the ear cartilage corresponding to the position of the mirror column 1, and the ear cartilage is sutured to the cornea, wrapping around the mirror column 1 and covering the bracket 2. The secondary reinforcement of the artificial cornea is achieved, making the artificial cornea more stable and not easy to dislocate. In addition, after the cornea is covered with ear cartilage, it is equivalent to covering it with a barrier, which not only plays a protective role, but also can prevent the cornea from dissolving.
在耳软骨的前表面,还进一步的覆盖有Tenon's囊,其属于眼表的生物质囊,具有一定的柔性和弹性,利用Tenon's囊能够实现对人工角膜的三次加固。The front surface of the ear cartilage is further covered with a Tenon's capsule, which is a biomass capsule on the surface of the eye and has a certain degree of flexibility and elasticity. The Tenon's capsule can be used to achieve three reinforcements of the artificial cornea.
支架2外周尺寸8.5mm~10mm,例如,支架2外周尺寸为8.5mm、9.0mm、9.5mm或10mm。The outer circumference size of the bracket 2 is 8.5 mm to 10 mm. For example, the outer circumference size of the bracket 2 is 8.5 mm, 9.0 mm, 9.5 mm or 10 mm.
支架2的曲率半径为7.8mm±2.0mm。例如,支架2的曲率半径为5.8mm、6.8mm、7.8mm、8.8mm或9.8mm。The curvature radius of the bracket 2 is 7.8 mm ± 2.0 mm. For example, the curvature radius of the bracket 2 is 5.8 mm, 6.8 mm, 7.8 mm, 8.8 mm or 9.8 mm.
通过如下方式将本发明提供的人工角膜植入严重角膜盲患者的眼内,达到复明的目的。即在患者角膜中央利用环钻打孔,并在孔的一侧侧切以形成角膜放射状侧切口,改善手术视野,便于晶体完整取出,或解决了现有技术存在的晶体皮质残留的问题。The artificial cornea provided by the present invention is implanted into the eyes of patients with severe corneal blindness in the following manner to achieve the purpose of restoring sight: a hole is drilled in the center of the patient's cornea, and a side cut is made on one side of the hole to form a radial side incision of the cornea, thereby improving the surgical field of view, facilitating the complete removal of the lens, or solving the problem of residual lens cortex in the prior art.
取出晶状体以及切除前部玻璃体后,将人工角膜所包括得后盘11植入上述钻孔内,即后盘11通过角膜放射状侧切口进入角膜后与其后表面贴合。此时,可以将角膜放射状侧切口缝合,以使镜柱1初步固定。在此基础上,旋转支架2,以使支架2向后移动,当支架2与角膜前表面贴合时,支架2和后盘11一前一后夹持在角膜上,将支架2与角膜缝合在一起,以实现支架2在眼表的固定。After the lens is removed and the anterior vitreous body is removed, the posterior disc 11 included in the artificial cornea is implanted into the above-mentioned drilled hole, that is, the posterior disc 11 enters the cornea through the radial side incision of the cornea and fits with its rear surface. At this time, the radial side incision of the cornea can be sutured to preliminarily fix the lens column 1. On this basis, the bracket 2 is rotated to move the bracket 2 backward. When the bracket 2 fits with the front surface of the cornea, the bracket 2 and the posterior disc 11 are clamped on the cornea one after the other, and the bracket 2 and the cornea are sutured together to achieve the fixation of the bracket 2 on the ocular surface.
从上述应用过程可知,本发明提供的人工角膜仅需要一次手术即可完成角膜盲复明的治疗,缩短手术期,能够降低患者等待的焦虑和多次手术的痛苦。而且,利用患者自体角膜实现对支架2的初步固定,无需供体角膜,可以完全避免供体角膜缺乏及异体角膜移植排斥。另外,支架2位于角膜前表面,相对于现有技术提供的支架植入角膜板层内,手术难度和风险大大降低、创伤小以及愈合周期短且愈合效果好。From the above application process, it can be known that the artificial cornea provided by the present invention only requires one operation to complete the treatment of corneal blindness and restoration of vision, shortening the operation period, and reducing the patient's anxiety of waiting and the pain of multiple operations. Moreover, the initial fixation of the bracket 2 is achieved by using the patient's own cornea, without the need for a donor cornea, which can completely avoid the lack of donor corneas and rejection of allogeneic corneal transplants. In addition, the bracket 2 is located on the front surface of the cornea. Compared with the bracket provided by the prior art that is implanted in the corneal lamella, the difficulty and risk of the operation are greatly reduced, the trauma is small, the healing period is short, and the healing effect is good.
在实际应用中,当后盘11与镜柱本体10一体成型时,通过如下方式组装在一起:In practical applications, when the rear disc 11 and the mirror column body 10 are integrally formed, they are assembled together in the following manner:
a.将连接环21自上而下卡入支架2的中心安装孔;a. Insert the connecting ring 21 into the center mounting hole of the bracket 2 from top to bottom;
b.镜柱本体10的前端贯穿连接环21(或中心安装孔具有的内螺纹孔)的内螺纹210,以相反的方向旋转镜柱本体20和支架2,以使支架2沿镜柱本体10的轴向向靠近后盘11的方向移动;b. The front end of the mirror column body 10 penetrates the internal thread 210 of the connecting ring 21 (or the internal thread hole of the central mounting hole), and the mirror column body 20 and the bracket 2 are rotated in opposite directions to move the bracket 2 along the axial direction of the mirror column body 10 toward the direction close to the rear plate 11;
c.在镜柱本体10的前端同轴安装美容盘。c. A beauty tray is coaxially mounted at the front end of the mirror column body 10.
当采用的支架材质与镜柱材质相同时,省略连接环,直接将带有内螺纹的支架与镜柱本体连接在一起。When the material of the bracket is the same as that of the mirror column, the connecting ring is omitted, and the bracket with internal threads is directly connected to the mirror column body.
第二方面,本发明实施例还提供一种一次植入人工角膜的使用方法,应用本发明实施例提供的人工角膜前,首先需要确定植入位置位居角膜中央,在角膜中央用环钻打孔,并做一个角膜放射状侧切口。使用方法包括如下步骤:In a second aspect, the embodiment of the present invention also provides a method for using an artificial cornea that is implanted once. Before using the artificial cornea provided by the embodiment of the present invention, it is first necessary to determine that the implantation position is located in the center of the cornea, drill a hole in the center of the cornea with a trephine, and make a radial side incision of the cornea. The method of use comprises the following steps:
S10.将人工角膜镜柱后端连同后盘植入前房;S10. Implant the rear end of the artificial cornea column together with the posterior disc into the anterior chamber;
S11.将支架的后盘滑行移动至角膜中央的后表面;S11. Slide the rear disc of the bracket to the rear surface of the center of the cornea;
S12.缝合角膜放射状侧切口至水密;S12. Suture the radial lateral corneal incision until it is watertight;
S13.旋转支架,直至支架与角膜前表面贴合;S13. Rotate the bracket until it fits against the anterior surface of the cornea;
S14.将支架缝合固定在眼球前表面,此时,后盘和支架前后夹持角膜;S14. Suture and fix the stent to the anterior surface of the eyeball. At this time, the posterior disc and the stent clamp the cornea front and back;
S15.生物组织或人工材料加固支架。S15. Biological tissue or artificial material reinforced scaffold.
作为一种示例,S15具体包括:As an example, S15 specifically includes:
S150.取患者的耳软骨,并在耳软骨对应镜柱本体的钻孔。将耳软骨通过孔包绕镜柱本体且覆盖支架,同时缝合耳软骨和角膜。S150. Take the patient's ear cartilage, and drill a hole in the ear cartilage corresponding to the mirror column body. Pass the ear cartilage through the hole to wrap around the mirror column body and cover the bracket, and suture the ear cartilage and cornea at the same time.
S151.将Tenon's囊扯平整覆盖在耳软骨的表面,并与耳软骨缝合在一起。S151. Flatten the Tenon's capsule and cover it on the surface of the ear cartilage, and sew it together with the ear cartilage.
尽管在此结合各实施例对本发明进行了描述,然而,在实施所要求保护的本发明过程中,本领域技术人员通过查看附图、公开内容、以及附图等,可理解并实现公开实施例的其他变化。在说明书中,“包括”(comprising)一词不排除其他组成部分或步骤,“一”或“一个”不排除多个的情况。单个处理器或其他单元可以实现说明书中列举的若干项功能。相互不同的实施例中记载了某些措施,但这并不表示这些措施不能组合起来产生良好的效果。Although the present invention is described herein in conjunction with various embodiments, in the process of implementing the claimed invention, those skilled in the art may understand and implement other variations of the disclosed embodiments by viewing the drawings, the disclosure, and the drawings, etc. In the specification, the word "comprising" does not exclude other components or steps, and "one" or "an" does not exclude multiple situations. A single processor or other unit can implement several functions listed in the specification. Certain measures are recorded in different embodiments, but this does not mean that these measures cannot be combined to produce good results.
尽管结合具体特征及其实施例对本发明进行了描述,显而易见的,在不脱离本发明的精神和范围的情况下,可对其进行各种修改和组合。相应地,本说明书和附图仅仅是本发明的示例性说明,且视为已覆盖本发明范围内的任意和所有修改、变化、组合或等同物。显然,本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样,倘若本发明的这些修改和变型属于本发明及其等同技术的范围之内,则本发明也意图包括这些改动和变型在内。Although the present invention has been described in conjunction with specific features and embodiments thereof, it is apparent that various modifications and combinations may be made thereto without departing from the spirit and scope of the present invention. Accordingly, this specification and the accompanying drawings are merely exemplary illustrations of the present invention and are deemed to cover any and all modifications, variations, combinations or equivalents within the scope of the present invention. Obviously, those skilled in the art may make various modifications and variations to the present invention without departing from the spirit and scope of the present invention. Thus, the present invention is intended to include such modifications and variations if they fall within the scope of the present invention and its equivalents.
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