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WO2023072031A1 - 一种后房型有晶体眼渐进多焦点人工晶状体 - Google Patents

一种后房型有晶体眼渐进多焦点人工晶状体 Download PDF

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Publication number
WO2023072031A1
WO2023072031A1 PCT/CN2022/127253 CN2022127253W WO2023072031A1 WO 2023072031 A1 WO2023072031 A1 WO 2023072031A1 CN 2022127253 W CN2022127253 W CN 2022127253W WO 2023072031 A1 WO2023072031 A1 WO 2023072031A1
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Prior art keywords
intraocular lens
progressive
optical zone
zone
diopter
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PCT/CN2022/127253
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English (en)
French (fr)
Inventor
赵紫微
王明坤
张明瑞
霍胜斌
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Tianjin Shi Ji Kang Tai Biomedical Engineering Co Ltd
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Tianjin Shi Ji Kang Tai Biomedical Engineering Co Ltd
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Priority to GB2407485.8A priority Critical patent/GB2626714A/en
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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
    • A61F2/16—Intraocular lenses
    • 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
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1616—Pseudo-accommodative, e.g. multifocal or enabling monovision
    • A61F2/1618—Multifocal lenses
    • 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
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • 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
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1624—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside
    • 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
    • A61F2/16—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
    • 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

Definitions

  • the invention relates to the technical field of manufacturing phakic intraocular lenses, in particular to a design method for posterior chamber type phakic progressive multifocal intraocular lenses.
  • phakic intraocular lens implantation can treat refractive errors and is widely used clinically. It is a relatively effective and safe operation for correcting moderate to high myopia.
  • the present invention designs an implantable progressive multifocal intraocular lens.
  • the diopter of the intraocular lens gradually increases from top to bottom, and the eyes can see objects at long distances, intermediate distances, and near distances from different areas.
  • the intraocular lens implantation operation is the same as the phakic intraocular lens implantation operation.
  • the operation is relatively simple, the postoperative vision is stable, and the operation is reversible. It does not change the biomechanics of the cornea, but also retains the accommodation. Middle-aged and elderly patients with presbyopia are a great boon.
  • a posterior chamber type phakic progressive multifocal intraocular lens comprising an optical zone, a supporting part at the edge of the optical zone, and supporting haptics, the angle between the plane where the supporting haptics are located and the plane where the main body of the intraocular lens is located is between 10-20 degrees , the intraocular lens optical zone has both the far vision zone and the near vision zone, and the diopter will smoothly transition from the far vision zone to the near vision zone in a step-by-step manner.
  • the front and rear surfaces of the intraocular lens optic zone are generally one One surface is spherical or aspheric, and the other surface is a progressive free-form surface;
  • c is the reciprocal of the radius of curvature of the basic spherical surface of the aspheric surface
  • x is the vertical distance from any point on the curve to the abscissa axis Z
  • a 2i is the coefficient of the high-order term of the aspheric surface
  • m and n are not less than 1 Integer and n>m
  • k is the cone coefficient
  • the diopter of the aspheric surface is obtained by the following formula:
  • n L is the refractive index of the intraocular lens
  • n is the refractive index of the aqueous humor in the human eye
  • r is the basic radius of curvature of the front surface of the intraocular lens
  • c x , cy are respectively the radius of curvature of the basic spherical surface in the x and y directions of the progressive free-form surface, and k x and ky are the conic coefficients in the x and y directions respectively;
  • the diopter of the progressive free-form surface is obtained by the following formula:
  • n L is the refractive index of the intraocular lens
  • n is the refractive index of the aqueous humor in the human eye
  • r 1 and r 2 are the maximum and minimum curvature radii of the progressive free-form surface of the intraocular lens, respectively, where,
  • the astigmatism of the progressive free-form surface is obtained by the following formula:
  • n L is the refractive index of the intraocular lens
  • n is the refractive index of the aqueous humor in the human eye
  • r 1 and r 2 are the maximum and minimum curvature radii of the progressive free-form surface of the intraocular lens, respectively, where,
  • the refractive index n L is in the range of 1.4-1.6, and the dispersion coefficient is 40-55.
  • the optical zone and the support haptics are integrally formed using the same material.
  • the diameter of the effective optical zone of the optical zone is 5.0 mm to 6.0 mm; the thickness of the first support haptic and the second support haptic are both 0.05 mm to 0.2 mm.
  • small circular holes are opened at 2 mm to 6 mm outside the optical zone.
  • the diameter of the small holes is between 0.2 mm and 0.6 mm. The existence of the small holes is conducive to the circulation of aqueous humor and effectively reduces the occurrence of glaucoma. .
  • the optical zone can provide a diopter of -10.0D to +10.0D, and the variation range of the progressive optical power is +0.5D to +5.0D.
  • the optical zone may provide 3D cylinder power.
  • a method for preparing a posterior chamber type phakic progressive multifocal intraocular lens characterized in that the method includes but is not limited to:
  • determine the patient's individual eye use needs determine the distance point and near point position of the intraocular lens, and determine the parameters such as the distance diopter, near vision diopter, and near-use addition.
  • the obtained meridional addition curve is converted into other curves, and the converted curve is evenly distributed on the entire progressive multifocal intraocular lens to determine the distribution of diopter and cylinder power of the progressive multifocal intraocular lens.
  • the single-point diamond ultra-precision machining technology is used to process the progressive free-form surface structure derived by MATLAB on the front and rear surfaces of the substrate.
  • optical inspection using the automatic measurement of the lens meter, measure the diopter of all points on the progressive surface, whether it is consistent with the design value, if it matches, complete the processing, if not, return to the sixth step and reprocess until the eighth step is satisfied requirements.
  • the optical body of the present invention has a progressive free-form surface, and the diopter of the intraocular lens increases gradually from top to bottom, so that the eyes can see objects at long distances, medium distances, and short distances from different areas, and produce asymmetric and personalized imaging effects .
  • the present invention is an implantable progressive multifocal intraocular lens, which combines the design concepts of phakic intraocular lens and progressive multifocal spectacle lens, and is used for intraocular implantation of middle-aged and elderly patients with both myopia and presbyopia. Realize the clearness of far, medium and near vision, and at the same time realize the real removal of the mirror.
  • Fig. 1 is a schematic diagram for illustrating a simulated implantation position of a posterior chamber type phakic progressive multifocal intraocular lens
  • Fig. 2 is a schematic front view of a posterior chamber type phakic progressive multifocal intraocular lens
  • Figure 3 is a schematic side view of the posterior chamber type phakic progressive multifocal intraocular lens
  • Figure 4 is a regional distribution map of the posterior chamber type phakic progressive multifocal intraocular lens
  • Figure 5 is a diagram of the meridian addition curve for the design of the progressive multifocal intraocular lens of the posterior chamber type phakic eye;
  • Fig. 6 is a kind of ellipse adding light curve figure
  • Figure 7 is a contour map of the sphere of the progressive multifocal intraocular lens of the posterior chamber type phakic eye
  • Fig. 8 is a contour map of the cylindricality of the progressive multifocal intraocular lens of the posterior chamber type phakic eye.
  • FIG. 1 is a schematic diagram of a simulated implantation position of a posterior chamber type phakic progressive multifocal intraocular lens (hereinafter referred to as intraocular lens), wherein the intraocular lens can be implanted between the iris 102 and the natural lens 104 .
  • intraocular lens a posterior chamber type phakic progressive multifocal intraocular lens
  • Figure 2 is the front view of the posterior chamber type phakic progressive multifocal intraocular lens
  • Figure 3 is a schematic side view of the posterior chamber type phakic progressive multifocal intraocular lens; as shown in Figure 2 and Figure 3, the intraocular lens includes an optical zone 203 , the supporting portion 202 and the supporting haptics 201 at the edge of the optical zone.
  • the optical zone 203 has a refractive function, and can provide a diopter of -10D to +10D, and the range of progressive refractive power is +0.5D to +5.0D;
  • the front and rear surfaces of the optical zone 203 are generally a spherical surface Or an aspherical surface, while the other surface is a progressive free-form surface;
  • the center of the optical zone 203 has a central hole 206, and the diameter of the central hole 206 is between 0.2 mm and 0.6 mm.
  • the existence of the central hole 206 is conducive to the circulation of aqueous humor, effectively Reduce the occurrence of glaucoma.
  • the support portion 202 on the edge of the optical zone is located at the periphery of the optical zone 203 and is designed in a plate shape.
  • the support portion 202 on the edge of the optical zone has two round holes 207 on the upper and lower sides.
  • the diameter of the round holes 207 is between 0.2 mm and 0.6 mm.
  • the size of the positioning groove 205 is 0.2mm*0.5mm, which is used to determine the rotation position of the intraocular lens during eye implantation.
  • the support haptics 201 are located at the four corners of the support portion 202 at the edge of the optical zone, and two of the support haptics 201 have haptic holes 204 with a diameter of 0.2mm-0.6mm for the circulation of aqueous humor.
  • FIG. 4 is a regional distribution map of the posterior chamber type phakic progressive multifocal intraocular lens. As shown in FIG.
  • the distance vision area 401 can provide diopters of -10D to +10D. This area can provide a clear distance vision function for the human eye in a relaxed state of viewing; the near vision area 402 can provide diopters of +0.5D to +5.0D. , this area can provide clear near vision function for the human eye in the state of myopia and downsight.
  • the distance vision zone 401 to the near vision zone 402 realizes a continuous vision range; the peripheral astigmatism zone 403 can provide 3D cylinder power to meet the requirements of astigmatism.
  • the artificial lens designed in the present invention is made of soft transparent hydrophilic or hydrophobic acrylic material, the refractive index n L ranges from 1.4 to 1.6, and the dispersion coefficient is 40 to 55.
  • the artificial lens material designed by the present invention is hydrophilic polymethacrylate, the refractive index of the material is 1.46, and the Abbe number is 45; the refractive index of aqueous humor is 1.336; the design wavelength ⁇ is 0.546um; the diameter of the optical zone is 6.0mm; The surface diopter is -5D.
  • the patient needs -0.24D for distance use, +1.74D for near use, and +1.98D for near use. Since the refractive power of the posterior surface of the intraocular lens is -5D, Then the diopter of the progressive surface is 4.76D ⁇ 6.74D; the distance between the far point of view and the center of the intraocular lens is 1mm, and the addition length is 3mm;
  • the far point of vision is 19.5mm, and the near point of vision is 13.8mm; program through MATLAB, draw the addition curve, and select a curve for far vision and near vision through comparison It is relatively stable, and the change of the curve is relatively smooth (as shown in Figure 5).
  • a is the semi-major axis of the ellipse
  • b is the semi-minor axis of the ellipse
  • c is the half focal length of the ellipse.
  • the semi-major axis a of the ellipse is closer to the half focal length c, and the ellipse addition curve at this time is the line segment between the far point and the near point, that is, the distribution of this elliptic curve can be determined Diopter and cylinder power distribution of progressive multifocal intraocular lens.
  • the single-point diamond ultra-precision machining technology is used to process the progressive free-form surface structure derived by MATLAB on the front and rear surfaces of the substrate.
  • optical inspection using the automatic measurement of the lens meter, measure the diopter of all points on the progressive surface, whether it is consistent with the design value, if it matches, complete the processing, if not, return to the sixth step and reprocess until the eighth step is satisfied requirements.
  • the diopter of the far zone of the intraocular lens is +4.82D
  • the diopter of the near zone is +6.75D
  • the addition of light between the distance reference point and the near reference point is +1.93D.
  • the diopter of the progressive surface satisfies Design requirements +4.76D ⁇ +6.74D.
  • the maximum cylindricality of the progressive surface of the intraocular lens is less than 0.25D, and the cylindricality is less than 2D in the stable area of the far vision area and the near vision area, and the areas with larger cylindricality are mainly concentrated in areas where people are less
  • the edge areas on both sides used have no significant impact on human eye imaging, which is consistent with the original design requirements.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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Abstract

一种后房型有晶体眼渐进多焦点人工晶状体（103），由软性透明亲水性或疏水性丙烯酸材料制成，包括光学区（203）、光学区（203）边缘的支撑部分（202）以及支撑襻（201），植入位置位于虹膜（102）之后、天然晶状体（104）之前。该人工晶状体（103）光学区（203）同时存在视远区（401）与视近区（402），并且屈光度会以一种循序渐进的方式平稳地从视远区（401）过渡到视近区（402），光学区（203）的前后两个表面一般为一个面为球面或者非球面，而另外一个面为渐进的自由曲面。该人工晶状体（103）在植入后可同时矫正中老年近视及老视眼的视力，让对手机、阅读、娱乐有需求的中老年人真正实现摘掉眼镜。

Description

一种后房型有晶体眼渐进多焦点人工晶状体
本申请要求于2021年10月25日提交中国专利局、申请号为202111238487.3、发明名称为“一种后房型有晶体眼渐进多焦点人工晶状体”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本发明涉及有晶体眼人工晶状体生产制造技术领域，特别涉及一种后房型有晶体眼渐进多焦点人工晶状体设计方法。
背景技术
经常有人认为，近视眼的人不会出现老视眼，这种认识是错误的。近视眼同样会发生老视，发生的时间与正视眼并无区别。但是，由于近视眼的屈光生理特点，表现出来症状的时间会稍晚一些。但是随着老花程度的不断加深，近视眼同样需要一副老视镜，也就是说近视的人看远看近需要两副眼镜，比正常老花更加麻烦。为了实现人眼能够同时视远和视近清晰，先后出现了双光镜、三光镜和渐进多焦点眼镜，但是生活中存在很多不方便戴眼镜或者不推荐戴眼镜情形，比如在寒冷的环境进入常温室内，眼镜表面会起水雾，反复摘戴眼镜会使眼镜变形，影响佩戴效果等。
目前，有晶体眼人工晶状体植入手术可以治疗屈光不正，被广泛应用于临床，对矫正中高度近视是一种相对有效和安全的手术。本发明设计了一款可植入式的渐进多焦点人工晶状体，该人工晶状体从上到下，屈光度逐渐增加，眼睛可以从不同区域看远距离、看中距离、看近距离处的物体，该人工晶状体植入手术与有晶体人工晶状体植入手术方法相同，手术操作相对简便，术后视力稳定，手术可逆等优势，既没有改变角膜的生物力学， 也保留了调节力，对同时存在近视及老视眼的中老年患者是一大福音。
发明内容
一种后房型有晶体眼渐进多焦点人工晶状体，包括光学区、光学区边缘的支撑部分以及支撑襻，所述支撑襻所在的平面与人工晶状体主体所在的平面夹角在10-20度之间，人工晶状体光学区同时存在视远区与视近区，并且屈光度会以一种循序渐进的方式平稳地从视远区过渡到视近区，所述人工晶状体光学区的前后两个表面一般为一个面为球面或者非球面，而另外一个面为渐进的自由曲面；
所述非球面面型表征方程为：
Figure PCTCN2022127253-appb-000001
其中，c为所述非球面的基础球面曲率半径的倒数，x为曲线上任何一点距横坐标轴Z的垂直距离，A 2i为非球面高次项系数，m、n均为不小于1的整数且n＞m，k为圆锥系数；
非球面的屈光度，通过以下公式得到：
Figure PCTCN2022127253-appb-000002
P 1为人工晶状体非球面的屈光度，n L为人工晶状体的折射率，n为人眼内房水折射率，r为人工晶状体前表面的基础曲率半径，其中
Figure PCTCN2022127253-appb-000003
所述渐进的自由曲面面型表征方程为：
Figure PCTCN2022127253-appb-000004
其中，c x、c y分别为所述渐进的自由曲面x、y方向上的基础球 面曲率半径，k x、k y分别为x、y方向上的圆锥系数；
渐进的自由曲面的屈光度，通过以下公式得到：
Figure PCTCN2022127253-appb-000005
P 2为人工晶状体的渐进自由曲面的屈光度，n L为人工晶状体的折射率，n为人眼内房水折射率，r 1、r 2分别为人工晶状体渐进自由曲面的最大和最小曲率半径，其中，
Figure PCTCN2022127253-appb-000006
渐进的自由曲面的散光度，通过以下公式得到：
Figure PCTCN2022127253-appb-000007
C为人工晶状体的渐进自由曲面的散光度，n L为人工晶状体的折射率，n为人眼内房水折射率，r 1、r 2分别为人工晶状体渐进自由曲面的最大和最小曲率半径，其中，
Figure PCTCN2022127253-appb-000008
可选地，采用软性透明亲水性或疏水性丙烯酸材料制成，折射率为n L范围为1.4～1.6，色散系数为40～55。
可选地，所述光学区和支撑襻采用同一种材料，整体成型。
可选地，所述光学区的有效光学区直径为5.0mm～6.0mm；第一支撑襻、第二支撑襻的厚度均为0.05mm～0.2mm。
可选地，所述光学区外围2mm～6mm处开设有数个圆形小孔，小孔的直径为0.2mm～0.6mm之间，小孔的存在有利于房水的流通，有效减少青光眼的产生。
可选地，所述光学区可以提供-10.0D～+10.0D的屈光度，渐进光焦度的变化范围为+0.5D～+5.0D。
可选地，所述光学区可以提供3D的柱镜度。
一种后房型有晶体眼渐进多焦点人工晶状体的制备方法，其特征在于，该方法包括但不限于：
第一，确定患者个性化用眼需求，确定人工晶状体视远点、视近点位置，确定视远屈光度、视近屈光度和近用下的加光度等参数。
第二，根据视远屈光度、视近屈光度，确定视远点与视近点曲率半径，根据曲率半径参数设计渐进多焦点人工晶状体子午加光曲线。
第三，把得到的子午加光曲线转换为其他曲线，将变换后的曲线均匀的分布在整个渐进多焦点人工晶状体上，以确定渐进多焦点人工晶状体的屈光度、柱镜度的分布。
第四，通过加光曲线，求出渐进面的表面矢高分布。
第五，通过MATLAB进行编程，运算获得渐进面的球面度与柱面度。
第六，采用单点金刚石超精密加工技术，在片基的前后表面，加工出MATLAB推导得出的渐进自由曲面结构。
第七，初步检测，首先通过非球面轮廓仪检测镜片面型与设计值是否相符，相符则进行下一步检测，不符则返回第六步，重新加工，直到满足第七步中的要求。
第八，光学检测，使用焦度计的自动化测量，测量渐进面上所有点的屈光度，与设计值是否相符，相符则完成加工，不符则返回第六步，重新加工，直到满足第八步中的要求。
本发明有益的技术效果在于：
本发明光学主体具有渐进的自由曲面，人工晶状体从上到下，屈光度逐渐增加，实现眼睛可以从不同区域看远距离、看中距离、看近距离处的物体，产生非对称、个性化成像效果。
本发明为可植入式的渐进多焦点人工晶状体，结合有晶体眼人工晶状体与渐进多焦点眼镜片的设计理念，用于同时存在近视及老视眼的中老年患者眼内植入，让患者实现远、中、近视物清晰的同时，实现真正的摘镜。
说明书附图
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是用于说明后房型有晶体眼渐进多焦点人工晶状体的模拟植入位置的示意图；
图2是后房型有晶体眼渐进多焦点人工晶状体的主视示意图；
图3是后房型有晶体眼渐进多焦点人工晶状体的侧视示意图；
图4是后房型有晶体眼渐进多焦点人工晶状体的区域分布图；
图5是后房型有晶体眼渐进多焦点人工晶状体设计的子午加光曲线图；
图6是一种椭圆加光曲线图；
图7是后房型有晶体眼渐进多焦点人工晶状体球面度的等高线图；
图8是后房型有晶体眼渐进多焦点人工晶状体柱面度的等高线图。
附图标记说明
101-角膜；102-虹膜；103-后房型有晶体眼渐进多焦点人工晶状体；104-天然晶状体；105-睫状沟；201-支撑襻；202-光学区边缘的支撑部分；203-光学区；204-襻孔；205-定位槽；206-中心孔；207-圆孔；401-视远区；402-视近区；403-周边散光区；404-中间过渡区。
具体实施方式
下面参照附图对本发明进行详细的说明。
图1为后房型有晶体眼渐进多焦点人工晶状体(以下简称人工晶状体)的模拟植入位置的示意图，其中人工晶状体可被植入虹膜102与天然晶状体104之间。
图2为后房型有晶体眼渐进多焦点人工晶状体的主视图，图3是后房型有晶体眼渐进多焦点人工晶状体的侧视示意图；如图2和图3所示，人工晶状体包括含光学区203、光学区边缘的支撑部分202以及支撑襻201。
其中，光学区203具有屈光功能，可以提供-10D～+10D的屈光度，渐进光焦度的变化范围为+0.5D～+5.0D；光学区203的前后两个表面一般为一个面为球面或者非球面，而另外一个面为渐进的自由曲面；光学区203中心有中心孔206，中心孔206的直径为0.2mm～0.6mm之间，中心孔206的存在有利于房水的流通，有效减少青光眼的产生。
光学区边缘的支撑部分202位于光学区203外围，为板状设计，光学区边缘的支撑部分202上下各有两个圆孔207，圆孔207的直径为0.2mm～0.6mm之间，用于房水的流通；光学区边缘的支撑部分202上下各有一个长方形的定位槽205，定位槽205的尺寸为0.2mm*0.5mm，用于眼植入时确定人工晶状体的旋转位置。
支撑襻201位于光学区边缘的支撑部分202外围四角，其中两个支撑襻201带有襻孔204，襻孔204的直径为0.2mm～0.6mm之间，用于房水的流通。
图4为后房型有晶体眼渐进多焦点人工晶状体的区域分布图，如图4所示，人工晶状体包括视远区401、视近区402、周边散光区403、中间过渡区404。
其中，视远区401可以提供-10D～+10D的屈光度，此区域可以为人眼在放松平视的状态下，提供清晰的视远功能；视近区402可以提供+0.5D～+5.0D的屈光度，此区域可以为人眼在视近下视的状态下，提供清晰的视近功能；中间过渡区404是视远区401到视近区402的过渡区域，此区域的屈光度是循序渐进的，可以使视远区401到视近区402实现连续视程；周边散光区403可以提供3D的柱镜度，满足散光要求。
本发明设计人工晶状体采用软性透明亲水性或疏水性丙烯酸材料制成，折射率为n L范围为1.4～1.6，色散系数为40～55。
所述的渐进多焦点人工晶状体的制备方法：
本发明设计人工晶状体材料为亲水性聚甲基丙烯酸酯，材料折射率为1.46，阿贝数为45；房水折射率为1.336；设计波长λ为0.546um；光学区直径为6.0mm；后表面屈光度为-5D。
第一，确定患者个性化用眼需求，通过检测，患者需求远用度数-0.24D，近用度数+1.74D和近用下的加光度+1.98D，由于人工晶状体后表面屈光度为-5D，则得到渐进面的屈光度为4.76D～6.74D；视远点与人工晶状体中心之间的距离为1mm，加光长度为3mm；
第二，根据确定的屈光度范围求得视远点为19.5mm，视近点为13.8mm；通过MATLAB进行编程，绘出加光曲线图，通过对比，选出一条曲线视远区与视近区较为稳定，而且曲线的变化较为平稳的加光曲线(如图5所示)。
第三，把得到的子午加光曲线转换为椭圆曲线(如图6所示)，椭圆曲线的公式为：
Figure PCTCN2022127253-appb-000009
其中，a为椭圆的长半轴；b为椭圆的短半轴；c为椭圆的半焦距。
当y坐标值越接近于0时，椭圆的长半轴a越接近于半焦距c，此时的椭圆加光曲线即为视远点与视近点的线段，即此椭圆曲线的分布可以确定渐进多焦点人工晶状体的屈光度、柱镜度的分布。
第四，通过加光曲线，求出渐进面的表面矢高分布。
第五，根据求出的人工晶状体渐进面的矢高分布方程，通过MATLAB进行编程，选取间隔为0.1mm的点运算获得渐进面的球面度与柱面度，进行绘图，图7为球面度的等高线图，图8为柱面度的等高线图。
第六，采用单点金刚石超精密加工技术，在片基的前后表面，加工出MATLAB推导得出的渐进自由曲面结构。
第七，初步检测，首先通过非球面轮廓仪检测镜片面型与设计值是否相符，相符则进行下一步检测，不符则返回第六步，重新加工，直到满足第七步中的要求。
第八，光学检测，使用焦度计的自动化测量，测量渐进面上所有点的屈光度，与设计值是否相符，相符则完成加工，不符则返回第六步，重新 加工，直到满足第八步中的要求。
结果分析与讨论：
由图7可以看出人工晶状体视远区屈光度为+4.82D，视近区屈光度为+6.75D，视远参考点与视近参考点之间加光为+1.93D，可知渐进面的屈光度满足设计要求+4.76D～+6.74D。结合图8可以看出人工晶状体渐进面最大柱面度小于0.25D，在视远区与视近区的稳定区域内柱面度小于2D，而柱面度较大的区域主要集中在人们较少使用的两侧边缘区域，对人眼成像并无较大影响，这与最初的设计要求一致。

Claims (7)

  1. 一种后房型有晶体眼渐进多焦点人工晶状体，包括光学区、光学区边缘的支撑部分以及支撑襻，所述支撑襻所在的平面与人工晶状体主体所在的平面夹角在10-20度之间，人工晶状体光学区同时存在视远区与视近区，并且屈光度会以一种循序渐进的方式平稳地从视远区过渡到视近区，所述人工晶状体光学区的前后两个表面一般为一个面为球面或者非球面，而另外一个面为渐进的自由曲面；
    所述非球面面型表征方程为：
    Figure PCTCN2022127253-appb-100001
    其中，c为所述非球面的基础球面曲率半径的倒数，x为曲线上任何一点距横坐标轴Z的垂直距离，A 2i为非球面高次项系数，m、n均为不小于1的整数且n>m，k为圆锥系数；
    非球面的屈光度，通过以下公式得到：
    Figure PCTCN2022127253-appb-100002
    P 1为人工晶状体非球面的屈光度，n L为人工晶状体的折射率，n为人眼内房水折射率，r为人工晶状体前表面的基础曲率半径，其中
    Figure PCTCN2022127253-appb-100003
    所述渐进的自由曲面面型表征方程为：
    Figure PCTCN2022127253-appb-100004
    其中，c x、c y分别为所述渐进的自由曲面x、y方向上的基础球面曲率半径，k x、k y分别为x、y方向上的圆锥系数；
    渐进的自由曲面的屈光度，通过以下公式得到：
    Figure PCTCN2022127253-appb-100005
    P 2为人工晶状体的渐进自由曲面的屈光度，n L为人工晶状体的折射率，n为人眼内房水折射率，r 1、r 2分别为人工晶状体渐进自由曲面的最大和最小曲率半径，其中，
    Figure PCTCN2022127253-appb-100006
    渐进的自由曲面的散光度，通过以下公式得到：
    Figure PCTCN2022127253-appb-100007
    C为人工晶状体的渐进自由曲面的散光度，n L为人工晶状体的折射率，n为人眼内房水折射率，r 1、r 2分别为人工晶状体渐进自由曲面的最大和最小曲率半径，其中，
    Figure PCTCN2022127253-appb-100008
  2. 根据权利要求1所述的渐进多焦点人工晶状体，其特征在于，采用软性透明亲水性或疏水性丙烯酸材料制成，折射率n L范围为1.4～1.6，色散系数为40～55。
  3. 根据权利要求1所述的渐进多焦点人工晶状体，其特征在于，所述光学区和支撑襻采用同一种材料，整体成型。
  4. 根据权利要求1所述的渐进多焦点人工晶状体，其特征在于，所述光学区的有效光学区直径为5.0mm～6.0mm；第一支撑襻、第二支撑襻的厚度均为0.05mm～0.2mm。
  5. 根据权利要求1所述的渐进多焦点人工晶状体，其特征在于，所述光学区外围2mm～6mm处开设有数个圆形小孔，小孔的直径为0.2mm～0.6mm之间，小孔的存在有利于房水的流通，有效减少青光眼的产生。
  6. 根据权利要求1所述的渐进多焦点人工晶状体，其特征在于，所述 光学区可以提供-10.0D～+10.0D的屈光度，渐进光焦度的变化范围为+0.5D～+5.0D。
  7. 根据权利要求1所述的渐进多焦点人工晶状体，其特征在于，所述光学区可以提供3D的柱镜度。
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CN114010371A (zh) * 2021-10-25 2022-02-08 天津世纪康泰生物医学工程有限公司 一种后房型有晶体眼渐进多焦点人工晶状体

Cited By (2)

* Cited by examiner, † Cited by third party
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CN116819799A (zh) * 2023-06-15 2023-09-29 深圳盛达同泽科技有限公司 渐进多焦点镜片和渐进多焦点眼镜
CN119908876A (zh) * 2025-04-02 2025-05-02 晶天医疗科技有限公司 一种波前调控的连续视程人工晶状体

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