WO2014201956A1 - 一种植入性近视眼透镜片及其制备方法 - Google Patents

一种植入性近视眼透镜片及其制备方法 Download PDF

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Publication number
WO2014201956A1
WO2014201956A1 PCT/CN2014/079477 CN2014079477W WO2014201956A1 WO 2014201956 A1 WO2014201956 A1 WO 2014201956A1 CN 2014079477 W CN2014079477 W CN 2014079477W WO 2014201956 A1 WO2014201956 A1 WO 2014201956A1
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WIPO (PCT)
Prior art keywords
lens
implantable
lens body
myopic
support arms
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PCT/CN2014/079477
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English (en)
French (fr)
Inventor
廖秀高
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无锡蕾明视康科技有限公司
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Application filed by 无锡蕾明视康科技有限公司 filed Critical 无锡蕾明视康科技有限公司
Priority to EP14814415.7A priority Critical patent/EP3005981B1/en
Priority to KR1020167001178A priority patent/KR20160024919A/ko
Priority to US14/899,133 priority patent/US20160143727A1/en
Priority to ES14814415.7T priority patent/ES2688587T3/es
Priority to JP2016520256A priority patent/JP6345773B2/ja
Publication of WO2014201956A1 publication Critical patent/WO2014201956A1/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
    • 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
    • A61F2/16—Intraocular lenses
    • A61F2/1601—Lens body having features to facilitate aqueous fluid flow across the intraocular lens, e.g. for pressure equalization or nutrient delivery
    • 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
    • A61F2/15—Implant having one or more holes, e.g. for nutrient transport, for facilitating handling
    • 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
    • A61F2/16—Intraocular lenses
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00—Producing optical elements, e.g. lenses or prisms
    • B29D11/02—Artificial eyes from organic plastic material
    • B29D11/023—Implants for natural eyes
    • 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
    • A61F2/16—Intraocular lenses
    • A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
    • A61F2002/1689—Intraocular lenses having supporting structure for lens, e.g. haptics having plate-haptics
    • 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
    • A61F2/16—Intraocular lenses
    • A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
    • A61F2002/169—Surrounding optic
    • 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
    • A61F2/16—Intraocular lenses
    • A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
    • A61F2002/16901—Supporting structure conforms to shape of capsular bag
    • 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
    • A61F2/16—Intraocular lenses
    • A61F2002/16965—Lens includes ultraviolet absorber
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2033/00—Use of polymers of unsaturated acids or derivatives thereof as moulding material
    • B29K2033/04—Polymers of esters
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0037—Other properties
    • B29K2995/0092—Other properties hydrophilic

Definitions

  • the invention relates to the technical field of manufacturing and manufacturing of implantable glasses, in particular to an implantable myopic lens sheet and a preparation method thereof.
  • the human eye is colorless and transparent at the time of birth.
  • the crystal ball in the eye is very soft, colorless and transparent. It can effectively achieve its focusing function when it is relaxed and nervous. It can be seen clearly from a distance. . But as the newborn baby grows up, some people's eyes will start to be nearsighted. Especially with the development of computer technology, television technology and network technology, young students need to spend a lot of time using computers and the Internet to learn. Long-term close-sighted display screens have greatly hurt the eyes, making more and more people with myopia, and the degree of myopia is getting higher and higher. Some people have myopias as high as thousands of degrees. If you don’t wear glasses, you can walk and see things. difficult.
  • the materials disclosed in the prior art for developing implantable myopic lens sheets are mainly PMMA materials, silica gel materials and hydrophobic polyacrylate materials.
  • the PMMA material is too hard to be folded, and the side opening required for the implantation operation is large, the cells are lost too much, and the damage to the eye tissue is large.
  • Both silicone materials and hydrophobic polyacrylate materials are hydrophobic materials that are too hard and are implanted in the posterior chamber and are prone to inducible cataracts.
  • the present invention provides an implantable myopic lens sheet and a preparation method thereof, so as to enable the lens to self-adjust the size according to the size of the human eye, enhance the comfort of use, and facilitate the implantation into the human eye. purpose.
  • An implantable myopic lens sheet comprising a lens body and a plurality of sheet-like support arms cut along an edge of the lens body, the support arm comprising a connecting portion and a support portion, the connecting portion and the edge of the lens body Connecting, the plane of the support arm is at an angle of 10-20 degrees with the plane of the lens body, so that the lens is entirely spherical, and the lens body is provided with a transparent light guiding area, the lens body and The support arms are all made of a hydrophilic polyacrylate material.
  • the connecting portion is a thin and short structure.
  • the lens body is provided with a plurality of through holes, and the through holes are not on the transparent light guiding area.
  • the hydrophilic polyacrylate material is formed by copolymerization of 2-hydroxyethyl methacrylate and an alkyl acrylate derivative.
  • the hydrophilic polyacrylate material is formed by copolymerization of an alkyl acrylate, an alkyl methacrylate, and a derivative of styrene or styrene.
  • the hydrophilic polyacrylate material further contains an ultraviolet absorber and a blue light absorber.
  • a method for preparing an implantable myopic lens sheet comprising the steps of:
  • the cut circular lens is placed in an extraction device, and extracted with an alcohol solvent to remove small molecules and medium molecules without polymerization, followed by drying;
  • the implantable myopia lens support arm of the present invention can be bent.
  • the bending angle of the support arm can be adjusted according to the contour of the human eye, and the lens of the same model can be implanted.
  • the support arm is more easily bent, so that the lens is more suitable for the human eye, and the comfort is good, and the refractive index of the lens material is between 1.430 and 1.490.
  • the thickness of the lens is low, the hydrophilic polyacrylate material is elastic, and the recovery time in the human eye is less than 1 second, and the side opening required for the implantation operation is small, which is convenient for implantation into the human eye.
  • FIG. 1 is a front view of an implantable myopic lens sheet disclosed in Embodiment 1 of the present invention.
  • FIG. 2 is a side view showing an implantable myopic lens sheet disclosed in Embodiment 1 of the present invention.
  • FIG. 3 is a front view of an implantable myopic lens sheet disclosed in Embodiment 2 of the present invention.
  • FIG. 4 is a side view of an implantable myopic lens sheet disclosed in Embodiment 2 of the present invention.
  • the present invention provides an implantable myopic lens sheet comprising a lens body 1 and four sheet-like support arms 2 cut along the edge of the lens body 1, the support arms 2 comprising a thin and short connection And a flat support portion, the connecting portion is connected to the edge of the lens body 1, and the plane of the support arm 2 is at an angle of 10-20 degrees with the plane of the lens body 1, so that the lens as a whole is spherical-like, and the lens body 1 is
  • the transparent light guiding region 3 is provided with a concave lens sheet having a diameter of 4.5-6.0 mm and a center thickness of 0.05-0.25 mm, and the lens main body 1 and the supporting arm 2 are all made of the same hydrophilic polyacrylate material. .
  • the lens body 1 is provided with two circular through holes 4, and the through holes 4 are not on the transparent light guiding area 3.
  • the present invention provides an implantable myopic lens sheet comprising a lens body 5 and four sheet-like support arms 6 cut along the edge of the lens body 5, the support arms 6 comprising a thin and short connection And a flat support portion, the connecting portion is connected to the edge of the lens body 5, and the distance in the support arm 6 from the edge of the lens body 5 is closer than the distance in the support arm 2 of the first embodiment from the edge of the lens body 1
  • the swinging range of the rear support arm 6 of the human eye is smaller, and the plane of the support arm 6 is at an angle of 10-20 degrees with the plane of the lens main body 5, so that the lens as a whole is spherical-like, and the lens main body 5 is provided with a transparent light guide.
  • the transparent light guiding region 7 is a concave lens sheet having a diameter of 4.5 to 6.0 mm and a center thickness of 0.05 to 0.25 mm, and the lens main body 5 and the supporting arm 6 are made of the same hydrophilic polyacrylate material.
  • the lens body 5 is provided with two circular through holes 8 and four strip-shaped through holes 8 , which are increased by four strip-shaped through holes in the first embodiment, so that the two sides of the lens
  • the human body fluid exchange is smoother, and the through hole 8 is not on the transparent light guiding area 7.
  • the hydrophilic polyacrylate material used in the present invention is obtained by copolymerization of 2-hydroxyethyl methacrylate and an alkyl acrylate derivative, or an alkyl acrylate, an alkyl methacrylate and styrene or A derivative of styrene is copolymerized.
  • the hydrophilic polyacrylate material may also contain a polymerizable medium-sized cross-linkable molecule or a cross-linkable group;
  • the polymerizable cross-linking molecule is: ethylene glycol dimethacrylate, dimethyl Propylene glycol diacrylate, butanediol dimethacrylate, hexanediol dimethacrylate, ethylene glycol diacrylate, propylene glycol diacrylate, butanediol diacrylate, diacrylic acid Hexanediol diester, 1,4-divinylbenzene or 1,3-divinylbenzene;
  • the crosslinkable group is a methacryloyl group, an acryloyl group or a vinylphenyl group.
  • the hydrophilic polyacrylate material further contains an ultraviolet absorber and a blue light absorber, and the ultraviolet absorber contains a benzophenone or a benzotriazole group.
  • the implantable myopic lens sheet provided by the invention is located in the posterior chamber of the eye after implantation.
  • the transparent light guide region is located at the central pupil in the eye, and the outer surface of the transparent light guide region may be a spherical surface.
  • the hydrophilic polyacrylate material has a refractive index in the range of 1.450 to 1.490. Therefore, the thickness of the lens is thin and it is not easy to contact the pouch, thereby guiding the induced cataract.
  • the preparation method of the implantable myopia lens sheet provided by the invention is as follows:
  • a method for preparing an implantable myopic lens sheet comprising the steps of:
  • the cut circular lens is placed in an extraction device, and extracted with an alcohol solvent to remove small molecules and medium molecules without polymerization, followed by drying;
  • the implantable myopia lens support arm of the present invention can be bent.
  • the bending angle of the support arm can be adjusted according to the contour of the human eye.
  • the same type of lens can be implanted into people of different sizes.
  • the refractive index of the lens material is between 1.430 and 1.490, and the lens thickness is low.
  • the water-based polyacrylate material is elastic, and the recovery time in the human eye is less than 1 second, and the side opening required for the implantation operation is small, which is convenient for implantation into the human eye.

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

Abstract

一种植入性近视眼透镜片及其制备方法，所述镜片包括镜片主体（1）和沿镜片主体（1）边缘切割成型的数个片状的支撑臂（2），支撑臂（2）所在的平面与镜片主体（1）所在的平面夹角在10-20度之间，使得所述镜片的整体呈类球面，镜片主体（1）上设有透明光导区（3），镜片主体（1）和支撑臂（2）均为同一种亲水性聚丙烯酸酯材料所制成，该支撑臂（2）可以弯折，所述镜片植入人眼时会根据人眼轮廓自行调整支撑臂（2）的弯折角度，同一型号的所述镜片可以植入到不同大小的人眼中，由于支撑臂（2）与镜片主体（1）的连接处细而短，支撑臂（2）更容易弯折，自动调节所述镜片的尺寸使得所述镜片更贴合人眼，舒适性好，所述镜片材质折射率高，厚度低，亲水性聚丙烯酸酯材料富有弹性，方便植入人眼。

Description

一种植入性近视眼透镜片及其制备方法 技术领域
本发明涉及植入性眼镜生产制造技术领域，特别涉及一种植入性近视眼透镜片及其制备方法。
 背景技术
人的眼睛在刚出生时是无色透明的，眼内晶球很软，无色透明，在松弛和紧张之时都能有效地达到其聚焦的功能，看远看近都能看的很清楚。但随着新生婴儿的逐渐成长，部份人的眼睛会开始近视。尤其是随着计算机技术，电视技术和网路科技的发展，青年学生需要花费大量的时间使用计算机和互联网学习。长期近距离注视显示屏大大的伤害了眼睛，使近视的人越来越多，近视眼的度数也越来越高，有些人近视度数高达上千度，如果不佩戴眼镜，走路看东西都很困难。但是，佩戴外戴的近视眼镜时，无论是吃饭或是吃面，镜片上都常常会有水蒸汽，使用不当还会打坏镜片。高度近视的人，还必须得带上高度近视的近视眼镜片，看上去镜片会是一圈一圈的，直接影响到人的美观。虽然佩戴隐形眼镜看上去很自然，但经常需要把隐形眼镜拿下来清洗。同时，隐形眼镜的材料要求有很好的透气性，在使用一段时间后还必须换新的，极其不方便。为了消除戴眼镜的烦恼，从上世纪九十年代开始，人们开始用雷射技术来处理眼角膜的形状，以到达消除近视的效果。但是使用雷射技术处理过眼角膜后，常常会导致眼睛干涩，更严重的情况会导致术者眼角膜脱落失明。
综合上述技术的不足，人们也开始进行植入性近视眼透镜片的设计和材料的开发。美国专利5,258,025，5,480,428和5,766,245中，Fedorov S等人首先提出植入性近视眼透镜片的设计和植入性近视眼透镜片植入到眼睛里的具体部位。美国专利5,913,898中，Feingold V首先提出了植入性近视眼镜（ICL）。美国专利 6,015,435，6,428,574，6,506,212和6,706,066中，Valunin Igor等人首先提出了后房的漂浮性植入近视眼透镜片的设计。
现有技术所公开的用于开发植入性近视眼透镜片的材料，主要有PMMA材料，硅胶材料和疏水性的聚丙烯酸酯材料。PMMA材料太硬，不能折叠，进行植入手术时所需打开的侧口大，细胞流失太多，对眼组织伤害较大。硅胶材料和疏水性的聚丙烯酸酯材料都是疏水性材料，也太硬，而且植入后房，易于产生诱导式白内障。
 技术问题
为解决上述技术问题，本发明提供了一种植入性近视眼透镜片及其制备方法，以达到使镜片能够根据人眼大小自行调节尺寸，增强使用舒适性，并使其方便植入人眼的目的。
 技术解决方案
为达到上述目的，本发明的技术方案如下：
一种植入性近视眼透镜片，包括镜片主体和沿所述镜片主体边缘切割成型的数个片状支撑臂，所述支撑臂包括连接部和支撑部，所述连接部与所述镜片主体边缘连接，所述支撑臂所在的平面与所述镜片主体所在的平面夹角在10-20度之间，使得镜片整体呈类球面，所述镜片主体上设有透明光导区，所述镜片主体和所述支撑臂均为亲水性聚丙烯酸酯材料所制成。
优选的，所述连接部为细而短的结构。
优选的，所述镜片主体上开设有数个通孔，所述通孔不在所述透明光导区上。
优选的，所述亲水性聚丙烯酸酯材料由甲基丙烯酸-2-羟基乙基酯和丙烯酸烷基酯衍生物共聚而成。
优选的，所述亲水性聚丙烯酸酯材料由丙烯酸烷基酯、甲基丙烯酸烷基酯与苯乙烯或苯乙烯的衍生物共聚而成。
优选的，所述亲水性聚丙烯酸酯材料中还含有紫外线吸收剂和蓝光吸收剂。
一种植入性近视眼透镜片的制备方法，包括以下步骤：
a、向亲水性丙烯酸酯小分子单体混合液中通入氮气以除去溶液中所溶解的空气，60分钟以后，在氮气压下，将该溶液转移到成型模具中，在高温下制成厚度为3毫米左右的片状亲水性聚丙烯酸酯材料，然后将上述片状材料，切割成圆形粗镜片；
b、将切割好的圆形粗镜片放入萃取装置，用醇类溶剂进行萃取，以除去没有聚合的小分子和中型分子，随后进行干燥处理；
c、将粗镜片切割制备为含有透明光导区的镜片主体，抛光以除去刀痕，最后切割出支撑臂即得。
 有益效果
通过上述技术方案，本发明提供的一种植入性近视眼透镜片支撑臂可以弯折，镜片植入人眼时会根据人眼轮廓自行调整支撑臂的弯折角度，同一型号的镜片可以植入到不同大小的人眼中，由于支撑臂与镜片主体的连接处细而短，支撑臂更容易弯折，使得镜片更贴合人眼，舒适性好，镜片材质折射率在1.430-1.490之间，镜片厚度低，亲水性聚丙烯酸酯材料富有弹性，在人眼内的复原时间小于1秒，进行植入手术时所需打开的侧口小，方便植入人眼。
 附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍。
图1为本发明实施例1所公开的一种植入性近视眼透镜片主视示意图；
图2为本发明实施例1所公开的一种植入性近视眼透镜片侧视示意图；
图3为本发明实施例2所公开的一种植入性近视眼透镜片主视示意图；
图4为本发明实施例2所公开的一种植入性近视眼透镜片侧视示意图。
 本发明的实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述。
实施例1
根据图1至2，本发明提供了一种植入性近视眼透镜片，包括镜片主体1和沿镜片主体1边缘切割成型的4个片状的支撑臂2，支撑臂2包括细而短的连接部和扁平的支撑部，连接部与镜片主体1边缘连接，支撑臂2所在的平面与镜片主体1所在的平面夹角在10-20度之间，使得镜片整体呈类球面，镜片主体1上设有透明光导区3，透明光导区3为直径4.5-6.0毫米、中心厚度为0.05-0.25毫米的凹透镜片，镜片主体1和支撑臂2均为同一种亲水性聚丙烯酸酯材料所制成。
为了方便镜片两侧的人体体液交换，镜片主体1上开设有两个圆形通孔4，通孔4不在透明光导区3上。
实施例2
根据图3至4，本发明提供了一种植入性近视眼透镜片，包括镜片主体5和沿镜片主体5边缘切割成型的4个片状的支撑臂6，支撑臂6包括细而短的连接部和扁平的支撑部，连接部与镜片主体5边缘连接，支撑臂6内沿距离镜片主体5边缘的距离较实施例1中支撑臂2内沿距离镜片主体1边缘的距离更近，植入人眼后支撑臂6的摆动范围更小，支撑臂6所在的平面与镜片主体5所在的平面夹角在10-20度之间，使得镜片整体呈类球面，镜片主体5上设有透明光导区7，透明光导区7为直径4.5-6.0毫米、中心厚度为0.05-0.25毫米的凹透镜片，镜片主体5和支撑臂6均为同一种亲水性聚丙烯酸酯材料所制成。
为了方便镜片两侧的人体体液交换，镜片主体5上开设有两个圆形通孔8和4个条形通孔8，较实施例1增加的4个条形通孔，使镜片两侧的人体体液交换更加流畅，通孔8不在透明光导区7上。
本发明使用的亲水性聚丙烯酸酯材料由甲基丙烯酸-2-羟基乙基酯和丙烯酸烷基酯衍生物共聚而成，或者由丙烯酸烷基酯、甲基丙烯酸烷基酯与苯乙烯或苯乙烯的衍生物共聚而成。
其中，所述亲水性聚丙烯酸酯材料中也可含有可聚合的中型可交链分子或者可交链基团；可聚合的交链分子为：二甲基丙烯酸乙二醇二酯、二甲基丙烯酸丙二醇二酯、二甲基丙烯酸丁二醇二酯、二甲基丙烯酸己二醇二酯、二丙烯酸乙二醇二酯、二丙烯酸丙二醇二酯、二丙烯酸丁二醇二酯、二丙烯酸己二醇二酯、1,4-二乙烯基苯或者1,3-二乙烯基苯；可交链基团为：甲基丙烯酰基团、丙烯酰基团或者乙烯基苯基基团。
亲水性聚丙烯酸酯材料中还含有紫外线吸收剂和蓝光吸收剂，紫外线吸收剂中含有二苯酮或者苯并三唑基团。
本发明提供的植入性近视眼透镜片，植入后位于眼内后房中，在支撑臂的支撑作用下，透明光导区位于眼内的中心瞳孔处，透明光导区外表面可以为球面、非球面或者托内克(Toric)光学表面，亲水性聚丙烯酸酯材料折射率的范围为1.450-1.490，因此，镜片的厚度较薄，不易于与囊袋接触,导制其诱导式白内障。
本发明提供的植入性近视眼透镜片的制备方法如下：
一种植入性近视眼透镜片的制备方法，包括以下步骤：
a、在一个3升的三颈玻璃瓶中，放入预先制备好的亲水性丙烯酸酯小分子单体混合液，通入氮气以除去溶液中所溶解的空气，约60分钟以后，在氮气压下，将该小分子单体混合溶液转移到成型模具中，在高温下制成厚度为3毫米左右，长为10.5英寸，宽为9.5英寸的片状亲水性聚丙烯酸酯材料，然后将上述片状材料，切割成圆形粗镜片；
b、将切割好的圆形粗镜片放入萃取装置，用醇类溶剂进行萃取，以除去没有聚合的小分子和中型分子，随后进行干燥处理；
c、用DAC或是Optoform切割机将粗镜片切割制备为含有透明光导区的镜片主体，抛光以除去刀痕，最后切割出支撑臂即得。
本发明提供的一种植入性近视眼透镜片支撑臂可以弯折，镜片植入人眼时会根据人眼轮廓自行调整支撑臂的弯折角度，同一型号的镜片可以植入到不同大小的人眼中，由于支撑臂与镜片主体的连接处细而短，支撑臂更容易弯折，使得镜片更贴合人眼，舒适性好，镜片材质折射率在1.430-1.490之间，镜片厚度低，亲水性聚丙烯酸酯材料富有弹性，在人眼内的复原时间小于1秒，进行植入手术时所需打开的侧口小，方便植入人眼。
对所公开的实施例的上述说明，使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明将不会被限制于本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。

Claims (7)

  1. 一种植入性近视眼透镜片，其特征在于，包括镜片主体和沿所述镜片主体边缘切割成型的数个片状支撑臂，所述支撑臂包括连接部和支撑部，所述连接部与所述镜片主体边缘连接，所述支撑臂所在的平面与所述镜片主体所在的平面夹角在10-20度之间，使得镜片整体呈类球面，所述镜片主体上设有透明光导区，所述镜片主体和所述支撑臂均为亲水性聚丙烯酸酯材料所制成。
  2. 根据权利要求1所述的一种植入性近视眼透镜片，其特征在于，所述连接部为细而短的结构。
  3. 根据权利要求1所述的一种植入性近视眼透镜片，其特征在于，所述镜片主体上开设有数个通孔，所述通孔不在所述透明光导区上。
  4. 根据权利要求1所述的一种植入性近视眼透镜片，其特征在于，所述亲水性聚丙烯酸酯材料由甲基丙烯酸-2-羟基乙基酯和丙烯酸烷基酯衍生物共聚而成。
  5. 根据权利要求1所述的一种植入性近视眼透镜片，其特征在于，所述亲水性聚丙烯酸酯材料由丙烯酸烷基酯、甲基丙烯酸烷基酯和苯乙烯共聚而成。
  6. 根据权利要求1或4或5所述的一种植入性近视眼透镜片，其特征在于，所述亲水性聚丙烯酸酯材料中还含有紫外线吸收剂和蓝光吸收剂。
  7. 一种基于权利要求1所述的植入性近视眼透镜片的制备方法，其特征在于，包括以下步骤：
    a、向亲水性丙烯酸酯小分子单体混合液中通入氮气以除去溶液中所溶解的空气，60分钟以后，在氮气压下，将该溶液转移到成型模具中，在高温下制成厚度为3毫米左右的片状亲水性聚丙烯酸酯材料，然后将上述片状材料，切割成圆形粗镜片；
    b、将切割好的圆形粗镜片放入萃取装置，用醇类溶剂进行萃取，以除去没有聚合的小分子和中型分子，随后进行干燥处理；
    c、将粗镜片切割制备为含有透明光导区的镜片主体，抛光以除去刀痕，最后切割出支撑臂即得。
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JP2016524729A (ja) 2016-08-18
KR20160024919A (ko) 2016-03-07
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