WO2018090841A1 - 一种可变多焦点人工晶状体 - Google Patents

一种可变多焦点人工晶状体 Download PDF

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Publication number
WO2018090841A1
WO2018090841A1 PCT/CN2017/109292 CN2017109292W WO2018090841A1 WO 2018090841 A1 WO2018090841 A1 WO 2018090841A1 CN 2017109292 W CN2017109292 W CN 2017109292W WO 2018090841 A1 WO2018090841 A1 WO 2018090841A1
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Prior art keywords
optical body
intraocular lens
grooves
groove
optical
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Ceased
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PCT/CN2017/109292
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English (en)
French (fr)
Inventor
廖秀高
冯振宇
杨勤
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Vision Pro (wuxi) Ltd
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Vision Pro (wuxi) Ltd
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Application filed by Vision Pro (wuxi) Ltd filed Critical Vision Pro (wuxi) Ltd
Priority to JP2018542743A priority Critical patent/JP6588169B2/ja
Priority to ES17870698T priority patent/ES2811399T3/es
Priority to EP17870698.2A priority patent/EP3400905B1/en
Publication of WO2018090841A1 publication Critical patent/WO2018090841A1/zh
Priority to US16/048,354 priority patent/US20180344452A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • 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
    • 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
    • A61F2/1629—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 for changing longitudinal position, i.e. along the visual axis when implanted
    • 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
    • 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
    • A61F2002/1682—Intraocular lenses having supporting structure for lens, e.g. haptics having mechanical force transfer mechanism to the lens, e.g. for accommodating 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
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0019—Angular shapes rectangular
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0091—Additional features; Implant or prostheses properties not otherwise provided for transparent or translucent

Definitions

  • the present invention relates to the technical field of medical supplies, and more particularly to a variable multifocal intraocular lens.
  • the natural lens in the human eye is a colorless, transparent and very soft lens in the newborn baby.
  • the natural lens will change with the increase of age, external conditions, such as ultraviolet radiation. It becomes harder and harder to become a colored lens.
  • a typical intraocular lens consists of an optical crystal and a supporting arm, where the optical lens focuses the light onto the optic nerve so that it can see the object and the arm acts to support its optic zone so that the optic zone is centered in the eye. Focus.
  • the optic zone and the support arm of the intraocular lens can be made of the same material or different materials.
  • the intraocular lens made of the same material which is often called a one-piece lens, is made of different materials.
  • the intraocular lens is a three-piece lens that is commonly referred to, and is described in U.S. Patent No. 4,997,442 and U.S. Patent No. 5,217,491, each of which is incorporated herein by reference. Arm area.
  • All of these designed zoomable intraocular lenses are made of a softer, lower refractive index silicone material. Due to the lower refractive index of the silica gel material, the resulting lens is thicker, and the lens has a limited distance of movement in the intraocular capsule, which limits the variable optical intensity of the zoom. At the same time, the probability of the silica material forming fibers and secondary cataract is also high relative to the hydrophobic polyacrylate. Therefore, when the zoom lens made of silica gel is implanted in the human eye, only some people can have a zoom function, and the percentage of the total number of people in the transplant also decreases with the implantation time. the trend of.
  • the Applicant has provided a variable multifocal intraocular lens.
  • the optical body of the present invention is a multifocal optical zone, and the optical zone moving back and forth can effectively increase the change of the multifocal lens power.
  • a variable multifocal intraocular lens comprising an optical body (1), a bismuth (2) and a silicone connector (3), the silicone connector (3) being located at the optical body (1) and ⁇ (2) Between the optical body (1) and the ⁇ (2) are joined together by a concave-convex groove;
  • the optical body (1) is provided with a groove (4) at both ends; the end of the cymbal (2) combined with the optical body (1) is provided with a groove (5);
  • the optical zone of the optical body (1) is an optical zone having two focal points, a three focus, an infinitely zoomed area or a regional multifocal point;
  • the two ends of the silicone connector (3) in the width direction are respectively provided with convex grooves, which are respectively a convex groove (6) and a convex groove (7).
  • the concave and convex grooves are rectangular or dovetail shaped.
  • the intraocular lens has a diameter of 11.5 to 13.5 mm.
  • the optical body (1) is made of a hydrophobic polyacrylate optically transparent material having a refractive index of 1.48 to 1.56; the effective optical zone of the optical body (1) has a diameter of 5.5 to 6.5 mm.
  • the crucible (2) is made of a hydrophobic polyacrylate material or a reinforced silica gel material, the crucible (2) has a thickness of 0.18 to 0.65 mm; and the thickest portion of the silicone connector (3) has a thickness of 0.18. ⁇ 0.65mm.
  • the grooves (4) and (5) have a depth of 0.1 to 0.15 mm; the heights of the convex grooves (6) and (7) are 0.1 to 0.15 mm; and the grooves (4) and (5) The depth of the beam coincides with the height of the convex grooves (6), (7).
  • the width of the convex grooves (6), (7) coincides with the width of the grooves (4), (5).
  • a variable multifocal intraocular lens comprising an optical body (1), a bismuth (2) and a silicone connector (3), the silicone connector (3) being located at the optical body (1) and ⁇ (2) Between the optical body (1) and the ⁇ (2) are joined together by a concave-convex groove;
  • a convex groove (8) is disposed on a cross section of the optical body (1) in the thickness direction of both ends; a groove is formed on a cross section of the one end of the cymbal (2) combined with the optical body (1) in the thickness direction (9) );
  • a groove (10) is provided in a cross section in the thickness direction of both ends in the width direction of the silicone connector (3).
  • the optical zone material of the present invention is an optically transparent hydrophobic polyacrylate material which may also be composed of an acrylate, methacrylate or styrene derivative and a small amount of a hydrophilic monomer such as methacrylic acid 2- Hydroxyethyl ester, 2-hydroxyethyl acrylate, 3-hydroxypropyl methacrylate, 3-hydroxypropyl acrylate, 4-hydroxybutyl methacrylate, 4-hydroxybutyl acrylate, C Dilute acid N,N-dimethyl amide, methyl propyl N,N-dimethyl amide, N,N-diethyl amide ethyl amide, N,N-diethyl methacrylate Amide.
  • a hydrophilic monomer such as methacrylic acid 2- Hydroxyethyl ester, 2-hydroxyethyl acrylate, 3-hydroxypropyl methacrylate, 3-hydroxypropyl acrylate, 4-hydroxybutyl methacrylate, 4-hydroxybutyl
  • variable multifocal intraocular lens can be first made into an artificial lens original film containing a multifocal optical surface, mechanically engraved into a single-piece lens, and then cut into an optical body and two crucibles, and the silicone connector is laminated. Molded
  • the silicone connector used in the present invention is a relatively soft and elastic material, and when the intraocular muscle is relaxed or compressed, the optical zone in the eye can be effectively moved back and forth.
  • the optical zone of the optical body of the present invention is an optical zone having two focal points, a three-focus, an infinitely zoomed region or a region of multiple focus; the original two-focus, three-focus, and infinite zoom regions are moved back and forth when the intraocular muscle contracts and relaxes. , or the regional multifocal lens becomes a new two focus, three focus, infinite zoom area, or regional multifocal lens, and the power range will increase the power change. Since the optical zone of the multifocal lens moves back and forth when the human eye muscle contracts and relaxes, the original two focus, three focus, infinite zoom area, or regional multifocal becomes a new two focus, three focus, and infinite zoom area.
  • the multifocal power range of the region to increase the power of the power will be greater than the range of power of any commercially available multifocal lens. Even after a few years, for a variety of reasons, the lens loses its function of moving back and forth, the crystal will still maintain the original two focus, three focus, infinite zoom area, and regional multifocal function.
  • Figure 1 is a schematic structural view of the present invention
  • FIG. 2 is a schematic structural view of an optical body of the present invention
  • FIG. 3 is a schematic perspective view showing the optical body of the present invention.
  • Figure 4 is a schematic structural view of the crucible of the present invention.
  • Figure 5 is a perspective view showing the structure of the crucible of the present invention.
  • Figure 6 is a schematic structural view of a silicone connector of the present invention.
  • FIG. 7 is a schematic perspective view of a silicone connector of the present invention.
  • Figure 8 is a schematic structural view of the present invention.
  • a variable multifocal intraocular lens includes an optical body 1, a crucible 2 and a silicone connector 3, and the silicone connector 3 is located between the optical body 1 and the crucible 2, The optical body 1 and the cymbal 2 are plugged together by a concave-convex groove;
  • the optical body 1 is provided with a groove 4 at both ends thereof; the end of the cymbal 2 combined with the optical body 1 is provided with a groove 5; the optical zone of the optical body 1 has two focal points, a three-focus, and a stepless zoom a multi-focus optical zone of a region or region;
  • the two ends of the silicone connector 3 in the width direction are respectively provided with convex grooves, which are respectively a convex groove 6 and a convex groove 7.
  • the concave and convex grooves are rectangular or dovetail shaped.
  • the intraocular lens has a diameter of 11.5 to 13.5 mm.
  • the optical body 1 is made of a hydrophobic polyacrylate optically transparent material having a refractive index of 1.48 to 1.56; the effective optical zone of the optical body 1 has a diameter of 5.5 to 6.5 mm.
  • the crucible 2 is made of a hydrophobic polyacrylate material or a reinforced silica gel material, and the crucible 2 has a thickness of 0.18 to 0.65 mm; and the thickest portion of the silicone connector 3 has a thickness of 0.18 to 0.65 mm.
  • the grooves 4 and 5 have a depth of 0.1 to 0.15 mm; the heights of the grooves 6 and 7 are 0.1 to 0.15 mm; the depths of the grooves 4 and 5 and the grooves 6 and 7 are The height is consistent.
  • the width of the grooves 6, 7 coincides with the width of the grooves 4, 5.
  • the convex grooves of the two silicone connecting members 3 are first coated with medical strong glue, and are loaded on both ends of the optical main body 1.
  • the convex grooves at the two ends of the optical main body 1 are inserted into the grooves of the silicone connecting member 3, and the corresponding optics are used.
  • the groove at the two ends of the main body 1 coincides with the convex groove of the silicone connector 3, and then the convex grooves of the other end of the two silicone connector 3 are loaded into the grooves of the two crucibles 2, thereby completing the integral assembly of the three components. And eventually implanted in the human eye pocket.
  • a variable multifocal intraocular lens includes an optical body 1, a crucible 2 and a silicone connector 3, and the silicone connector 3 is located between the optical body 1 and the crucible 2, and passes through the concavity and convexity.
  • the slot combines the optical body 1 and the cymbal 2 together;
  • the optical body 1 is provided with a convex groove 8 in a cross section in the thickness direction of the both ends; a groove 9 is formed in a cross section of the end of the ⁇ 2 and the optical body 1 in the thickness direction;
  • a groove 10 is provided in a cross section in the thickness direction of both ends of the silicone connector 3 in the width direction.
  • the medical strong glue is first applied to the convex grooves 8 and 9, and then inserted into the grooves 10 in the thickness direction cross section of the both ends of the silicone connector 3 in the width direction, thereby completing the overall assembly of the three components. And eventually implanted in the human eye pocket.
  • variable trifocal intraocular lens is an assembled intraocular lens, and the three focal points are 13.5D, 20D, and 23.5D, respectively, and the preparation method is as follows:
  • the wafer prepared in the step (1) is mechanically engraved into a single-piece lens, and then cut into an optical body and two crucibles, and the silicone connector is formed by compression molding;
  • the material of the optical body is a hydrophobic polyacrylate, and the effective optical zone of the optical body has a diameter of 5.5 mm and a thickness of 0.6 ⁇ 0.2 mm;
  • the material of the crucible is a hydrophobic polyacrylate, and the thickness of the crucible is 0.3 ⁇ 0.1 mm;
  • the overall width of the silicone connector is 1.5 mm, the center thickness is 0.3 mm; the width of the central groove of the silicone connector is 0.3 mm, the width of the convex grooves at both ends is 0.4 mm, and the width of the two grooves in the middle are both It is 0.2mm.
  • the intraocular lens zoom region of the present invention ranges from 13.5D to 15.74D, 20D-22.24D, and 23.5D to 25.74D.
  • variable trifocal intraocular lens is an assembled intraocular lens, and the three focal points are 10D, 20D, and 30D, respectively, and the preparation method is as follows:
  • an intraocular lens (with a diameter of 13 mm) containing a trifocal optical surface is prepared.
  • the wafer prepared in the step (1) is mechanically engraved into a single-piece lens, and then cut into an optical body and two crucibles, and the silicone connector is formed by compression molding;
  • the material of the optical body is a hydrophobic polyacrylate, and the effective optical zone of the optical body has a diameter of 6 mm and a thickness of 0.6 ⁇ 0.2 mm;
  • the material of the crucible is a hydrophobic polyacrylate, and the thickness of the crucible is 0.3 ⁇ 0.1 mm;
  • the overall width of the silicone connector is 1.2 mm, the center thickness is 0.3 mm; the width of the central groove of the silicone connector is 0.1 mm, the width of the convex grooves at both ends is 0.4 mm, and the width of the two grooves in the middle are both It is 0.15mm.
  • the scope of the intraocular lens zoom area For 10D-11.81D, 20D-21.81D, 30D-31.81D;
  • variable trifocal intraocular lens is an assembled intraocular lens, and the three focal points are 10D, 20D, and 30D, respectively, and the preparation method is as follows:
  • an intraocular lens (with a diameter of 13 mm) containing a multifocal optical surface
  • the wafer prepared in the step (1) is mechanically engraved into a single-piece lens, and then cut into an optical body and two crucibles, and the silicone connector is formed by compression molding;
  • the material of the optical body is a hydrophobic polyacrylate, and the effective optical zone of the optical body has a diameter of 6 mm and a thickness of 0.6 ⁇ 0.2 mm;
  • the material of the crucible is a hydrophobic polyacrylate, and the thickness of the crucible is 0.3 ⁇ 0.1 mm;
  • the overall width of the silicone connector is 0.4mm, the intermediate thickness is 0.2mm, and the width is 0.1mm; the connecting members of the two ends of the silica gel are provided with grooves, the width is 0.15mm, the groove thickness is 0.1mm, and the groove is two The end is provided with a boss to realize the plug assembly of the main body and the crucible.
  • the intraocular lens zoom range is 10D-11.81D, 20D-21.81D, 30D-31.81D

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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)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

一种可变多焦点人工晶状体，包括光学主体（1）、襻（2）和硅胶连接件（3）；硅胶连接件（3）位于光学主体（1）和襻（2）之间，通过凹凸槽将光学主体（1）和襻（2）插接组合在一起；光学主体（1）的两端设有凹槽（4）；襻（2）与光学主体（1）相结合的一端设有凹槽（5）；硅胶连接件（3）宽度方向的两端分别设有凸槽，分别为第一凸槽（6）和第二凸槽（7）。光学主体为多焦点的光学区，光学区前后移动可有效的增加多焦点晶状体光焦度的变化。

Description

一种可变多焦点人工晶状体 技术领域
本发明涉及医药用品的技术领域，尤其是涉及一种可变多焦点人工晶状体。
背景技术
人眼内的天然晶状体在刚出生的婴儿时是无色透明且非常软的晶状体，随着年龄的增加，外在条件的改变，如紫外线的辐射等要素的影响下，该天然晶状体将会变得越来越硬和变成有色晶状体，当人们活到五十至六十岁以上时，有百分之三十左右的人眼内晶状体将会变成棕黄色和浑浊，不但失去了可调焦的功能，以至于完全看不见，当这种情况发生时，这种天然晶状体(即白内障晶状体)将不得不用一个人造的晶状体去置换，使之其恢复白内障病人的眼睛视力。
一个典型的人工晶状体由于光学的晶体和支撑的手臂构成，其中光学晶状体聚焦光线到视觉神经上使之能看见物体而手臂的作用在于支撑其光学区，使之光学区位于眼内的中心能够有效的聚焦。
人工晶状体的光学区和支撑手臂可以由同一种材料制成，也可以由不同的材料制成，由同一种材料制成的人工晶状体，即人们常说的单件式晶状体，由不同材料制成的人工晶状体即是人们常说的三件式晶状体，其实例在美国专利4,997,442和美国专利5,217,491中被报道，其中这些专利均是由较软的光学材料制成光学区和较硬的材料制成手臂区。
常规的单聚焦人工晶状体能够提供一个常规距离的视觉矫正，但常规单聚焦人工晶状体不能提供一个有效可变焦的视觉矫正。也就是说，它不能提供一个看远和看近都能提供其视觉矫正的作用。唯一能使单聚焦人工晶状体达到看远看近都能使起作用，就得再带上一副眼镜。其它的选择则是多聚焦的人工晶状体来取代白内障晶状体，来达到其看远看近和中等距离的视觉都能有效。但是每个距离只能有部分光线被聚焦在视觉神经上。且还存在着其它得副作用。因此，人们开始设计新型的可变焦人工晶状体，如美国专利4,409,691，美国专利5,674,282、5,496,366、6,197,059和6,387,126，美国专利6,178,878和美国专利 6,406,494。
所有这些设计的可变焦人工晶状体，都是由材料较软，折射率较低的硅胶材料制作而成。由于硅胶材料的折射率较低，制成的晶状体较厚，其晶状体在眼内囊袋中移动的距离有限，使之可变焦的光学强度变化有限。同时硅胶材料形成纤维和二级白内障的几率也相对于疏水性聚丙烯酸酯为高。因此，由硅胶制成的可变焦晶状体当植入人眼内后，只有部分人能具有可变焦的功能，且这部分人占有移植总人数中的百分比也随着植入时间的增长有所降低的趋势。
发明内容
针对现有技术存在的上述问题，本申请人提供了一种可变多焦点人工晶状体。本发明光学主体为多焦点的光学区，光学区前后移动可有效的增加了多焦点晶状体光焦度的变化。
本发明的技术方案如下：
一种可变多焦点人工晶状体，所述人工晶状体包括光学主体(1)、襻(2)和硅胶连接件(3)，所述硅胶连接件(3)位于光学主体(1)和襻(2)之间，通过凹凸槽将光学主体(1)和襻(2)插接组合在一起；
所述光学主体(1)的两端设有凹槽(4)；所述襻(2)与光学主体(1)相结合的一端设有凹槽(5)；
所述光学主体(1)的光学区为具有两焦点、三焦点、无极变焦区域或区域多焦点的光学区；
所述硅胶连接件(3)宽度方向的两端分别设有凸槽，分别为凸槽(6)和凸槽(7)。
所述凹凸槽为矩形或燕尾形。
所述人工晶状体的直径为11.5～13.5mm。
所述光学主体(1)由折射率为1.48～1.56的疏水性聚丙烯酸酯光学透明材料制成；所述光学主体(1)的有效光学区的直径为5.5～6.5mm。
所述襻(2)由疏水性聚丙烯酸酯材料或增强的硅胶材料制成，所述襻(2)的厚度为0.18～0.65mm；所述硅胶连接件(3)最厚部分的厚度为0.18～0.65mm。
所述凹槽(4)、(5)的深度均为0.1～0.15mm；所述凸槽(6)、(7)的高度均为0.1～0.15mm；所述凹槽(4)、(5)的深度与所述凸槽(6)、(7)的高度相一致。
所述凸槽(6)、(7)的宽度与凹槽(4)、(5)的宽度相一致。
一种可变多焦点人工晶状体，所述人工晶状体包括光学主体(1)、襻(2)和硅胶连接件(3)，所述硅胶连接件(3)位于光学主体(1)和襻(2)之间，通过凹凸槽将光学主体(1)和襻(2)插接组合在一起；
所述光学主体(1)的两端厚度方向的截面上设有凸槽(8)；所述襻(2)与光学主体(1)相结合的一端厚度方向的截面上设有凸槽(9)；
所述硅胶连接件(3)宽度方向的两端的厚度方向的截面上设有凹槽(10)。
本发明光学区材料是一个光学透明的疏水性聚丙烯酸酯材料，该材料也可能是由丙烯酸酯，甲基丙烯酸酯或苯乙烯衍生物和少量的亲水性单体，如甲基丙烯酸2-羟基乙基酯，丙烯酸2-羟乙基酯，甲基丙烯酸3-羟基丙基酯，丙烯酸3-羟基丙基酯，甲基丙烯酸4-羟基丁基酯，丙烯酸4-羟基丁基酯，丙稀酸N,N-二甲基酰胺，甲基丙稀酸N,N-二甲基酰胺，丙稀酸N,N-二乙基酰胺乙基酰胺，甲基丙烯酸N,N-二乙基酰胺。
所述可变多焦点人工晶状体可先制成含有多焦光学表面的人工晶状体原片，经机械雕刻制成单件式晶状体，而后切割制成光学主体和两个襻，硅胶连接件经压膜成型制成
本发明有益的技术效果在于：
本发明采用的硅胶连接件是相对较软、弹性较好的材料，当眼内肌肉的松弛或压缩时，使其眼内的光学区能够有效的前后移动。
本发明光学主体的光学区为具有两焦点、三焦点、无极变焦区域或区域多焦点的光学区；当眼内肌肉收缩和松弛时前后移动后将原有的两焦点，三焦点，无极变焦区域，或区域多焦点晶状体变成为新的两焦点，三焦点，无极变焦区域，或区域多焦点晶状体，而光焦度范围将增加光焦度变化。由于多焦晶状体的光学区在人眼肌肉收缩和松弛时前后移动后将原有的两焦点，三焦点，无极变焦区域，或区域多焦点变成为新的两焦点，三焦点，无极变焦区域，或区域多焦点的光焦度范围来增加光焦度变化的目的。这样我们新设计的可变多焦晶状体的可调光焦度，将大于任何市面上的多焦点的晶状体的光焦度的范围。即使几年后因多种原因，晶状体失去前后移动功能，晶体将仍然保持原有的两焦点，三焦点，无极变焦区域，区域多焦点的功能。
当变多焦点人工晶状体前后移动时，移动的距离和光焦点度的变化见下表：
Figure PCTCN2017109292-appb-000001
附图说明
图1为本发明结构示意图；
图2为本发明光学主体的结构示意图；
图3为本发明光学主体的立体结构示意图；
图4为本发明襻的结构示意图；
图5为本发明襻的立体结构示意图；
图6为本发明硅胶连接件的结构示意图；
图7为本发明硅胶连接件的立体结构示意图；
图8为本发明的结构示意图；
其中：1、为光学主体，2、为襻，3、为硅胶连接件，4、为凹槽，5、为凹槽，6、为凸槽，7、为凸槽，8、为凸槽，9为凸槽，10为凹槽。
具体实施方式
下面结合附图和实施例，对本发明进行具体描述。
如图1～7所示，一种可变多焦点人工晶状体，所述人工晶状体包括光学主体1、襻2和硅胶连接件3，所述硅胶连接件3位于光学主体1和襻2之间，通过凹凸槽将光学主体1和襻2插接组合在一起；
所述光学主体1的两端设有凹槽4；所述襻2与光学主体1相结合的一端设有凹槽5；所述光学主体1的光学区为具有两焦点、三焦点、无极变焦区域或区域多焦点的光学区；
所述硅胶连接件3宽度方向的两端分别设有凸槽，分别为凸槽6和凸槽7。
所述凹凸槽为矩形或燕尾形。
所述人工晶状体的直径为11.5～13.5mm。
所述光学主体1由折射率为1.48～1.56的疏水性聚丙烯酸酯光学透明材料制成；所述光学主体1的有效光学区的直径为5.5～6.5mm。
所述襻2由疏水性聚丙烯酸酯材料或增强的硅胶材料制成，所述襻2的厚度为0.18～0.65mm；所述硅胶连接件3最厚部分的厚度为0.18～0.65mm。
所述凹槽4、5的深度均为0.1～0.15mm；所述凸槽6、7的高度均为0.1～0.15mm；所述凹槽4、5的深度与所述凸槽6、7的高度相一致。
所述凸槽6、7的宽度与凹槽4、5的宽度相一致。
使用时先将两个硅胶连接件3的凸凹槽涂上医用强胶，装填于光学主体1的两端，光学主体1两端的凸槽插接到硅胶连接件3的凹槽中，相应的光学主体1两端的凹槽与硅胶连接件3的凸槽重合，然后将两个硅胶连接件3的另外一端的凸槽，装填于两个襻2的凹槽内，这样完成三个部件的整体组装，并最终植入人眼内囊袋中。
如图8所示，一种可变多焦点人工晶状体，所述人工晶状体包括光学主体1、襻2和硅胶连接件3，所述硅胶连接件3位于光学主体1和襻2之间，通过凹凸槽将光学主体1和襻2插接组合在一起；
所述光学主体1的两端厚度方向的截面上设有凸槽8；所述襻2与光学主体1相结合的一端厚度方向的截面上设有凸槽9；
所述硅胶连接件3宽度方向的两端的厚度方向的截面上设有凹槽10。
使用时，先在凸槽8、9上涂上医用强胶，然后将其分别插入硅胶连接件3宽度方向的两端的厚度方向的截面上的凹槽10内，这样完成三个部件的整体组装，并最终植入人眼内囊袋中。
实施例1
参照图1～7，可变三焦点人工晶状体为组装式人工晶状体，三焦点分别为13.5D、20D、23.5D，其制备方法为：
(1)先制成含有三焦点光学表面的人工晶状体圆片(直径为13mm)，；
(2)将步骤(1)制成的圆片经机械雕刻制成单件式晶状体，而后切割制成光学主体和两个襻，硅胶连接件经压模成型制成；
(3)将两个硅胶连接件的凸凹槽涂上医用强胶，装填于光学主体的两端，光学主体两端的凸槽插接到硅胶连接件的凹槽中，相应的光学主体两端的凹槽与硅胶连接件的凸槽重合，然后将两个硅胶连接件的另外一端的凸槽，装填于两个襻的凹槽内，这样完成三个部件的整体组装，并最终植入人眼内囊袋中；
所述光学主体的材料为疏水性聚丙烯酸酯，光学主体有效光学区的直径为5.5mm、厚度为0.6±0.2mm；
所述襻的材料为疏水性聚丙烯酸酯，襻的厚度为0.3±0.1mm；
所述硅胶连接件的整体宽度为1.5mm，中心厚度为0.3mm；所述硅胶连接件中间凸槽的宽度为0.3mm，两端凸槽的宽度均为0.4mm，中间两凹槽的宽度均为0.2mm。
当眼睛肌肉收缩和松弛前后移动距离为1.5mm，本发明人工晶状体变焦区域范围为13.5D-15.74D，20D-22.24D，23.5D-25.74D。
实施例2
参照图1～7，可变三焦点人工晶状体为组装式人工晶状体，三焦点分别为10D、20D、30D，其制备方法为：
(1)先制成含有三焦光学表面的人工晶状体圆片(直径为13mm)，
(2)将步骤(1)制成的圆片经机械雕刻制成单件式晶状体，而后切割制成光学主体和两个襻，硅胶连接件经压模成型制成；
(3)将两个硅胶连接件的凸凹槽涂上医用强胶，装填于光学主体的两端，光学主体两端的凸槽插接到硅胶连接件的凹槽中，相应的光学主体两端的凹槽与硅胶连接件的凸槽重合，然后将两个硅胶连接件的另外一端的凸槽，装填于两个襻的凹槽内，这样完成三个部件的整体组装，并最终植入人眼内囊袋中；
所述光学主体的材料为疏水性聚丙烯酸酯，光学主体有效光学区的直径为6mm、厚度为0.6±0.2mm；
所述襻的材料为疏水性聚丙烯酸酯，襻的厚度为0.3±0.1mm；
所述硅胶连接件的整体宽度为1.2mm，中心厚度为0.3mm；所述硅胶连接件中间凸槽的宽度为0.1mm，两端凸槽的宽度均为0.4mm，中间两凹槽的宽度均为0.15mm。
当眼睛肌肉收缩和松弛前后移动距离为1.25mm，人工晶状体变焦区域范围 为10D-11.81D，20D-21.81D，30D-31.81D；
实施例3
参照图8，可变三焦点人工晶状体为组装式人工晶状体，三焦点分别为10D、20D、30D，其制备方法为：
(1)先制成含有多焦光学表面的人工晶状体圆片(直径为13mm)；
(2)将步骤(1)制成的圆片经机械雕刻制成单件式晶状体，而后切割制成光学主体和两个襻，硅胶连接件经压模成型制成；
(3)将光学主体两端的凸槽和两个襻的凸槽涂上医用胶，然后将其分别插入硅胶连接件两端的凹槽内，这样完成三个部件的整体组装，并最终植入人眼内囊袋中；
所述光学主体的材料为疏水性聚丙烯酸酯，光学主体有效光学区的直径为6mm、厚度为0.6±0.2mm；
所述襻的材料为疏水性聚丙烯酸酯，襻的厚度均为0.3±0.1mm；
所述硅胶连接件的整体宽度为0.4mm，中间厚度为0.2mm，宽度为0.1mm；硅胶两端连接件设有凹槽，其宽度均为0.15mm，凹槽厚度为0.1mm，凹槽两端设有凸台以便实现主体、襻的插接组装。
当眼睛肌肉收缩和松弛前后移动距离为1.25mm，人工晶状体变焦区域范围为10D-11.81D，20D-21.81D，30D-31.81D

Claims (8)

  1. 一种可变多焦点人工晶状体，其特征在于所述人工晶状体包括光学主体(1)、襻(2)和硅胶连接件(3)，所述硅胶连接件(3)位于光学主体(1)和襻(2)之间，通过凹凸槽将光学主体(1)和襻(2)插接组合在一起；
    所述光学主体(1)的两端设有凹槽(4)；所述襻(2)与光学主体(1)相结合的一端设有凹槽(5)；
    所述光学主体(1)的光学区为具有两焦点、三焦点、无极变焦区域或区域多焦点的光学区；
    所述硅胶连接件(3)宽度方向的两端分别设有凸槽，分别为凸槽(6)和凸槽(7)。
  2. 根据权利要求1所述的可变多焦点人工晶状体，其特征在于所述凹凸槽为矩形或燕尾形。
  3. 根据权利要求1所述的可变多焦点人工晶状体，其特征在于所述人工晶状体的直径为11.5～13.5mm。
  4. 根据权利要求1所述的可变多焦点人工晶状体，其特征在于所述光学主体(1)由折射率为1.48～1.56的疏水性聚丙烯酸酯光学透明材料制成；所述光学主体(1)的有效光学区的直径为5.5～6.5mm。
  5. 根据权利要求1所述的可变多焦点人工晶状体，其特征在于所述襻(2)由疏水性聚丙烯酸酯材料或增强的硅胶材料制成，所述襻(2)的厚度为0.18～0.65mm；所述硅胶连接件(3)最厚部分的厚度为0.18～0.65mm。
  6. 根据权利要求1所述的可变多焦点人工晶状体，其特征在于所述凹槽(4)、(5)的深度均为0.1～0.15mm；所述凸槽(6)、(7)的高度均为0.1～0.15mm；所述凹槽(4)、(5)的深度与所述凸槽(6)、(7)的高度相一致。
  7. 根据权利要求1所述的可变多焦点人工晶状体，其特征在于所述凸槽(6)、(7)的宽度与凹槽(4)、(5)的宽度相一致。
  8. 一种可变多焦点人工晶状体，其特征在于所述人工晶状体包括光学主体(1)、襻(2)和硅胶连接件(3)，所述硅胶连接件(3)位于光学主体(1)和襻(2)之间，通过凹凸槽将光学主体(1)和襻(2)插接组合在一起；
    所述光学主体(1)的两端厚度方向的截面上设有凸槽(8)；所述襻(2)与 光学主体(1)相结合的一端厚度方向的截面上设有凸槽(9)；
    所述硅胶连接件(3)宽度方向的两端的厚度方向的截面上设有凹槽(10)。
PCT/CN2017/109292 2016-11-16 2017-11-03 一种可变多焦点人工晶状体 Ceased WO2018090841A1 (zh)

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EP17870698.2A EP3400905B1 (en) 2016-11-16 2017-11-03 Variable multifocal artificial lens
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