WO2021075697A1 - 안구내렌즈 - Google Patents
안구내렌즈 Download PDFInfo
- Publication number
- WO2021075697A1 WO2021075697A1 PCT/KR2020/011051 KR2020011051W WO2021075697A1 WO 2021075697 A1 WO2021075697 A1 WO 2021075697A1 KR 2020011051 W KR2020011051 W KR 2020011051W WO 2021075697 A1 WO2021075697 A1 WO 2021075697A1
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- WO
- WIPO (PCT)
- Prior art keywords
- film
- intraocular lens
- curvature
- front film
- space
- Prior art date
Links
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Classifications
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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- 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
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- A61F2/1635—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 shape
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- 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
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- 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
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- 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
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- 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
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- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/16—Materials or treatment for tissue regeneration for reconstruction of eye parts, e.g. intraocular lens, cornea
Definitions
- An embodiment of the present invention relates to an intraocular lens provided in a capsular sac.
- an intraocular lens artificially manufactured in the space after removing the contents of the lens inside the capsular sac Surgical implantation is currently being performed worldwide.
- the intraocular lens When an intraocular lens is inserted, the intraocular lens can replace the natural lens and provide the patient with a cloud-free vision.
- the problem with the conventional intraocular lens insertion procedure is that the anterior and posterior capsules of the capsular sac are attached to each other after surgery, and the original function of controlling the thickness of the lens by transmitting the relaxation and contraction of the Zonule of Zinn is achieved. You will lose.
- the patient's eye does not secure a field of view by actively performing three-dimensional movement according to an object to be viewed, but has a problem of securing a passive field of view according to the power determined by the intraocular lens.
- the improved adjustable intraocular lens although the thickness of the lens can be adjusted, the degree of change is small, so the effect of correcting vision is not large, and the range of the adjustment force is narrow by reflecting only the two-dimensional movement during the true movement, so the self-adjusting ability of the eyeball is poor. There are limitations that can only be applied to patients over the age of 45.
- An object of the present invention is to provide an intraocular lens that can convert a three-dimensional complex motion transmitted from a haptic unit into a change in refractive power of a lens and has improved controllability.
- the fluid in the internal space is not connected to the outside of the optical part, and the thickness of the optical part is not controlled by applying hydraulic pressure, and a new principle of intraocular that does not have a separate optical part thickness adjusting means. It aims to provide a lens.
- An intraocular lens according to an aspect of the present invention is an intraocular lens including an optical part inserted into the eyeball,
- the optical unit The optical unit,
- the front film facing the outer direction of the eyeball
- a thick film forming an internal space between the front film and the front film
- a junction portion of the front film and the thick film bonded to each other;
- the front film and the thick film are provided with a predetermined thickness and each has an inner surface and an outer surface
- the inner space is a closed space surrounded by the inner surface of the front film and the inner surface of the thick film and filled with a fluid material therein, and the shape of the inner space is changed according to the control state of the front film and the thick film,
- the inner space is a space formed at the center of the front film and the rear film, and a center space that is convexly formed toward the outside;
- a space formed at the periphery of the front film and the rear film may include a peripheral space in which a gap between the front film and the rear film is reduced to form a junction.
- the curvature of the inner surface of the front film is greater than that of the outer surface of the front film, the curvature of the inner surface of the thick film is greater than the curvature of the outer surface of the thick film, and the outer surfaces of the front film and the thick film in a cross-sectional view of the intraocular lens vertically cut It is good to include this sphere,
- the curvature of the inner surface of the front film is greater than or equal to the curvature of the outer surface of the front film
- the curvature of the inner surface of the thick film is greater than or equal to the curvature of the outer surface of the thick film
- the inner surface of the thick film is aspherical
- the front film is the front film
- the outer surface forms a convex curve to the outside, and the curve includes a spherical surface having a first radius of curvature R in the first region, and is formed as an aspherical surface having a larger radius of curvature than the first radius of curvature R in the second region. It is desirable to be,
- the radius of curvature continuously increases toward the junction.
- the curvature of the inner surface of the front film may be 1 to 1.05 times the curvature of the outer surface of the front film
- the curvature of the inner surface of the thick film may be 1 to 1.05 times the curvature of the outer surface of the thick film
- the bonding portion may be integrally formed, and the bonding portion may be bonded by extending the front film and the thick film.
- the haptic part may further include a connector provided in the eye and connected to a fixed support or a connection means.
- the connecting means may be a female groove provided in the connector or support and a male protrusion provided at an end of the haptic part,
- the volume of the internal space is 5 vol% to 50 vol% of the optical part
- the front film and the thick film are made of a material having a refractive index of 1.336 or more, and preferably made of a material having a refractive index of 1.45 or more,
- the fluid material has a refractive index of 1.336 or more, and preferably 1.4 or more.
- the material of the front film and the thick film is silicone, silicone elastomer, silicone polymer, polydimethyl siloxane, polyimide, polybutester, Microplex PMMA, Acrylic, Flexible acrylic, Hydrophobic acrylic, UV absorbing acrylate, Methacrylate copolymer, Butyl Butyl acrylate, polysiloxane elastomer, UV absorbing polysiloxane, collagen copolymer, cellulose acetate butylate (CAB), n-vinyl pyrrolidone (NVP), polyvinyl pyrrolidone (PVP) ), MA (methacrylic acid), GMA (glycerol methacrylate), DMS (dimethyl siloxane), PEGMMA (polyethylenehlycol methacrylate), silicone hydrogels (Silicone hydrogels) may include any one or more,
- the fluid material may be made of silicon fluid, a material having a silicon hardness of 10 or less, or a material including methyl methacrylate (MMA),
- Astigmatism correction may be possible since the haptic part may be transformed in a uniaxial direction by including two or more haptic parts.
- Another aspect of the present invention is an intermediate manufacturing step of manufacturing an intraocular lens intermediate including an optical unit and a haptic unit;
- the optical unit may include a front film facing the outer direction of the eyeball;
- a thick film forming an internal space between the front film and the front film
- the front film and the thick film are provided with a predetermined thickness and each has an inner surface and an outer surface
- the inner space is a closed space surrounded by the inner surface of the front film and the inner surface of the thick film and filled with a fluid material therein, and the shape of the inner space is changed according to the control state of the front film and the thick film,
- the step of forming the inner space is preferably a step in which a laser is used for processing or shaping the inner space.
- the inner space is a space formed at the center of the front film and the thick film, and the center space is formed to be convex toward the outside, and is formed at the periphery of the front film and the thick film, Forming the surrounding space with a reduced gap,
- the front film includes a spherical surface having a first radius of curvature R in a first area corresponding to the central space, and an aspherical surface having a radius of curvature greater than the first radius of curvature R in a second area corresponding to the peripheral space. I can do it,
- the inner space may be formed from 5 vol% to 50 vol% of the optical part
- the intraocular lens according to an embodiment of the present invention provides an effect of improving the ability to adjust the shape of the optical part by the complex motion generated from the ciliary muscle and transmitted through the true color and capsule color.
- the inner surfaces of the front and rear films of the intraocular lens have a shape having a greater curvature than the outer surface at the center of the optical unit, so that the outer surface at the center of the optical unit has a larger curvature than the inner surface. Excellent ability to gain additional control.
- connection part configuration may not be included, thereby improving the durability of the intraocular lens.
- the intraocular lens which is a preferred embodiment of the present invention, is used as an intraocular lens assembly in combination with a support and a connecting means
- the intraocular lens support transmits the complex motion of the true circumference from the outer circumferential surface, and the intraocular lens is through the connecting means. It produces a change in the power of refraction from compound motion.
- the intraocular lens as an embodiment of the present invention provides a large range of control power, it is not limited to elderly patients with low self-adjusting power of the eye, and can be used in vision correction for all ages, thus expanding the scope of application of the technology. Has the effect of being.
- 1 is a cross-sectional view showing a human eye.
- FIG. 2 is a cross-sectional view illustrating the structure of a natural crystal.
- FIG. 3 is a cross-sectional view of an intraocular lens according to an embodiment of the present invention.
- FIG. 4 is a cross-sectional view of a state in which an intraocular lens, which is an embodiment of the present invention, is inserted into a capsular bag by being combined with a support and a connecting means.
- FIG. 5 is a cross-sectional view illustrating a state in which an intraocular lens, which is an embodiment of the present invention, is inserted into a capsular bag by being combined with a support and a connecting means.
- FIG. 6 is a cross-sectional view of a state in which an intraocular lens, which is another embodiment of the present invention, is inserted into the capsular bag by combining the support and the connecting means.
- FIG. 7 is a state diagram showing the interaction and motion state of the tremor, the lens when looking at a short distance.
- Figure 8 is a state diagram showing the interaction and motion state of the tremor, the lens when looking at a distance.
- FIG. 9 is a perspective view showing a connecting means of an intraocular lens.
- Adjustment state refers to other forms that an adjustable intraocular lens has to adjust the refractive power, and the form in which the refractive power increases when looking at a close place is called a compressed state or an adjustable state, and the refractive power when looking at a distant place. This reduced form is called an uncompressed state or an unregulated state.
- the intraocular lens Before being inserted into the eye, the intraocular lens is in an uncompressed or non-adjustable state.
- the contents representing or describing the shape of the intraocular lens are interpreted according to the situation based on the non-compressed state or the non-adjustable state.
- Diopter is a unit that measures the refractive power of a lens or curved mirror, and is the same as the reciprocal of the focal length specified in meters. It is mainly used for visual acuity and the power of the lens, and generally varies depending on the material of the lens and the relative refractive index, but in the air, it has a positive (+) value for a convex lens and a negative (-) value for a concave lens.
- the optical part is a part that performs an optical function in an intraocular lens, and is a part that collects light that enters the eye like a lens and creates an image on the retina.
- the haptic part is a part that performs a role of preventing movement and tilting by fixing the optical part inside the capsule color so that the optical part can function stably in an intraocular lens in general.
- the intraocular lens when coupled to a connector or a support, it is interpreted as including a structure further including a connecting means coupled to the connector or the support.
- the term'aspherical surface' means a curved surface that is not a spherical surface or a flat surface on any surface of an object, and refers to a shape including a surface whose radius of curvature used when calculating the degree of curvature of a curved surface is not constant. do.
- the shape in which the radius of curvature increases in the aspherical surface means that the radius of curvature corresponding to each section is not spherical, such as a part of a parabola, a hyperbola, or an ellipse, but increases as the radius of curvature proceeds along the arc of the curve.
- first radius of curvature R does not mean a constant as a specific radius of curvature value, but is interpreted as a concept that means an appropriate value of one of the radius of curvature of a certain curved surface.
- the main meridian refers to the meridian in the direction that determines the axis of astigmatism, and the meridian refers to the sexes of the outer surface of the eye that connects the electrode in the front center of the cornea and the posterior pole in the center of the back of the eyeball.
- the intraocular lens is an artificial intraocular lens that is inserted into the capsule color 8, and has a convex lens shape as a part that serves as a lens for the natural lens 5 located at the rear of the pupil.
- the natural crystal has a shape in which the front surface 5a has a smaller curvature than the rear surface 5b in the central part.
- the intraocular lens 30 is composed of an optical portion 31 located at the rear of the pupil, and a haptic portion 32 that is radially protruded from the optical portion 31 and fixed to a connecting means or the like.
- the optical part 31 includes a front film 34, a thick film 35, and an inner space 36.
- the front film and the rear film are divided based on the equator or equator plane of the optics.
- the front film 34 and the thick film 35 may meet at the circumferential surface or the periphery of the optical part 31, and may be directly connected or may be connected by another member or an adhesive material. It is preferable that the front film 34 and the thick film 35 are made of the same material and formed integrally.
- the optical part 31 is a part that performs a function similar to an actual lens by collecting incoming light and causing an image to be formed.
- the haptic part 32 is a means for supporting and fixing the optical part 31 by being located at the periphery of the optical part, preferably providing a part that is coupled with the connecting means, and transmitting the motion of the capsular bag to the optical part 31 You can perform the function that you do.
- the inner space 36 is a closed space located between the front film 34 and the thick film 35.
- the movement of the material existing in the inner space 36 is limited because it exists within a predetermined radius of the optical part.
- the front film 34 is positioned in the visual axis direction (Y direction) of the optical part when the intraocular lens is inserted and is inserted into the eyeball to face the outside of the eyeball, and may be made of a material having a refractive index of 1.336 or more, preferably 1.40 or more. And, more preferably, it may be made of a material of 1.45 or more.
- the front film 34 may have a shape that is thin at the center and thickens or maintains the thickness toward the equator.
- the front film 34 may have a negative diopter value in a partial region including the center.
- the inner surface of the front film includes a region having a greater curvature than the outer surface of the front film.
- the thick film 35 When the intraocular lens is inserted, the thick film 35 is located in a direction opposite to the optical axis direction (Y direction).
- the thick film 35 may be made of a material having a refractive index of 1.336 or more, preferably made of a material having a refractive index of 1.40 or more, more preferably 1.45 or more, and may be selected from the same material as the front film 34 and manufactured integrally.
- Materials for the front film 34 or the thick film 35 include silicone, silicone elastomer, silicone polymer, polydimethyl siloxane, polyimide, and polybutester.
- Microplex PMMA Acrylic, Flexible acrylic, Hydrophobic acrylic, UV absorbing acrylate, Methacrylate copolymer ), butyl acrylate, polysiloxane elastomer, UV absorbing polysiloxane, collagen copolymer, cellulose acetate butylate (CAB), n-vinyl pyrrolidone (NVP), PVP Any one or more of (polyvinyl pyrrolidone), MA (methacrylic acid), GMA (glycerol methacrylate), DMS (dimethyl siloxane), PEGMMA (polyethylenehlycol methacrylate), and silicone hydrogels may be used.
- the thick film 34 may have a negative diopter value in a partial region including the center.
- the inner surface of the thick film includes a region having a greater curvature than the outer surface of the thick film.
- the thick film 35 may be thin in the center due to a difference in curvature between the inner surface and the outer surface, and may have a shape in which the thickness increases or is maintained toward the equator.
- the inner space 36 is an enclosed space surrounded by inner surfaces of the front film 34 and the rear film 35.
- the shape of the inner space matches the shape formed by the inner surfaces of the front film 34 and the thick film 35, and even if the shape changes, the volume may be maintained without accompanying fluid flow with the outside.
- the inner space 36 is filled with a fluid material, and the fluid material may have a refractive index less than or equal to the material of the front film 34 or the thick film 35, and is preferably a material having the same refractive index as the material of the front film and the thick film. .
- the refractive index of the material constituting the front film 34 is A
- the refractive index of the material constituting the thick film 35 is B
- the refractive index of the fluid material filling the inner space 36 is C
- C is not the greater of A or B. It is less than or equal to the value not.
- a and the ratio have the same value, and C may be less than or equal to this.
- the inner space 36 includes a shape that is thicker in the center and thinner or maintained in thickness toward the equator, and even in other shapes, the entire optical portion 31 has a shape that allows the entire optical portion 31 to have the same effect as the effect of the present invention.
- the refractive indexes of the materials of the front film 34, the rear film 35, and the inner space 36 are all the same, the refractive index in the non-adjustable state may not be limited by the shape of the inner space.
- the inner space 36 has a positive diopter value at the center of the intraocular lens 30.
- the inner space 36 may be made of a material having a refractive index of 1.336 or more, preferably 1.4 or more.
- the inner space 36 may be made of a material including silicon fluid, a material having a silicon hardness of 10 or less, or methyl methacrylate (MMA).
- MMA methyl methacrylate
- Sodium hyaluronate, chondroitin sulfate, hydroxypropyl methyl cellulose, polyacrylamide, and the like may be additionally included.
- the outer surface of the front film is an outer surface of the front film 34 in the viewing direction or in the visual axis direction, symmetrical to the central axis and convex in the viewing direction, and has a shape including a spherical surface.
- the outer surface of the anterior membrane may include a spherical surface similar to the curved surface 5a corresponding to the shape of the actual lens shown in FIG. 2 or an aspherical surface having several curvatures in the non-adjustable state.
- the inner surface of the front film is a surface closer to the rear film 35, is symmetrical to the central axis, and includes a convex curved shape in the viewing direction, and includes a spherical surface in a non-adjustable state.
- the inner curvature of the front film 34 may decrease or be maintained from the center of the front film toward the equator of the intraocular lens.
- the outer surface of the thick film 35 includes a convex curve in a direction opposite to the viewing direction, and the outer surface is symmetrical to the central axis and includes a spherical surface and an aspherical surface in a non-adjustable state.
- the outer surface of the thick film 35 may be symmetrical with the outer surface of the front film 34 and may include a spherical surface having a greater curvature than the outer surface of the front film 34.
- the outer surface of the thick film 35 may be a curved surface asymmetrical to the outer surface of the front film 34 or a curved surface similar to the curved surface 5b corresponding to the shape of an actual lens.
- the inner surface of the thick film 35 is a surface close to the front film 34, has a curved shape that is symmetrical to the central axis and is convex in a direction opposite to the viewing direction (Y direction), and includes a spherical surface in the non-adjustable state.
- the inner curvature of the thick film 35 may decrease or be maintained from the center of the thick film toward the equator, and may be symmetrical with the inner surface of the front film 34.
- the internal space 36 preferably occupies 5 vol% to 50 vol% of the volume of the optical part. If the volume of the internal space 36 is less than 5 vol%, the thickness of the internal space 36 becomes too thin, and shape deformation does not easily occur, making it difficult to obtain additional refractive power. If the volume of the internal space 36 is larger than 50 vol%, the thickness of the front layer 34 and the thick layer 35 may become too thin, and the refractive index of the entire optical unit may be lowered.
- the volume ratio occupied by the inner space 36 may be determined differently according to the material and refractive index of the front layer 34 and the thick layer 35.
- the volume ratio occupied by the internal space 36 may be determined differently according to the refractive index of the fluid material.
- the volume ratio occupied by the internal space 36 may be determined differently according to various conditions including the patient's control power or desired corrective vision.
- the curvature of each inner surface and outer surface is adjusted to obtain a constant diopter value throughout the optical unit without changing the direction.
- the optical unit 31 is divided into a plurality of regions and described.
- the first region 41 is a region including the central portion of the optical unit, and is a region in which inner surfaces of the front and rear films 34 and 35 and outer surfaces of the front and rear films form a spherical surface or an aspherical surface close to the spherical surface.
- the eccentricity of the curved surfaces of the front layer 34 and the thick layer 35 of the first region 41 may be 0.1 or less, and preferably 0.05 or less.
- the first region 41 may include a spherical surface having a first radius of curvature R.
- the second region 42 is a region existing around the central portion of the optical portion 31 and includes the front film 34 and the thick film 35 in regions including up to the maximum diameter region of the inner space 36.
- the curved surfaces of the inner and outer surfaces of the front and rear films of the second region 42 include aspherical surfaces whose radius of curvature increases toward the junction 39.
- the curved surfaces of the inner surface of the front film and the thick film of the second region 42 and the outer surface of the front film and the thick film may include aspherical surfaces in which a reduction rate of curvature increases toward the junction part 39.
- the inner surfaces of the front and rear films of the second region 42 and the outer surfaces of the front and rear films form a continuous curved surface with a spherical or aspherical surface of the adjacent first region 41 or the junction 39.
- the curvature of the inner surface of the front film at the boundary between the junction and the second region is 1 to 1.05 times the curvature of the outer surface of the front film at the boundary between the junction and the second region
- the curvature of the inner surface of the thick film at the boundary between the junction and the second region Silver is 1 to 1.05 times the curvature of the outer surface of the thick film at the boundary between the junction and the second region, and preferably the corresponding inner surface and the outer surface have the same curvature.
- An embodiment of the present invention is an intraocular lens in which a front film and a rear film are symmetrically configured.
- the inner surface of the front membrane has the largest curvature at the center and the smallest curvature at the boundary between the second region and the junction.
- the curvature of the inner surface of the front film increases continuously from the center toward the junction, but the rate of change of the curvature is not constant, the rate of change is small as it approaches the center, and the rate of change tends to increase as it approaches the junction.
- the amount of change in the curvature of the inner surface of the front film in the first region is smaller than that of the inner surface of the front film in the second region, and preferably, the amount of change in curvature in the first region is 0.3 times the amount of change in the curvature in the second region. It may be within 0.5 times.
- the curvature of the outer surface of the front film increases continuously from the center toward the junction, and the curvature at the boundary between the second region and the junction may be 1 to 0.95 times the curvature of the inner surface of the front film at the corresponding position, and preferably the same. I can.
- the outer surface of the front film extends to the junction, it is preferable to maintain the curvature at the boundary between the second region and the junction.
- the eccentricity of the curved surfaces of the inner surface of the front film and the thick film of the second region 42 and the outer surface of the front film and the thick film may be 0.1 or more, and may be 0.05 or more.
- the second region 42 includes an aspherical surface having a larger radius of curvature than the first radius of curvature R. In addition, the second region 42 may not exist depending on the shape of the inner space 36.
- the first region 41 and the second region 42 include front and rear surfaces corresponding to regions in which the internal space 36 of the optical unit exists.
- the outer surfaces of the front layer 34 and the rear layer 35 may have a smaller curvature than the inner surface to have a negative diopter value.
- This difference in curvature between the inner and outer surfaces causes the front film 34 and the rear film 35 to have a negative diopter in the region including the center, and promotes shape change in the controlled state to obtain additional control force.
- the direction of curvature does not change, but only the size of the curvature changes, thereby having a convex curved shape toward the outside.
- the additional adjustment force varies according to the difference between the curvature of the outer surface and the inner surface, and by adjusting this, an intraocular lens having a desired power and adjustment force can be obtained.
- the diopter value which is the frequency of the lens in the section formed by changing the direction of curvature due to the high refractive index of the material forming the front and rear films, may not naturally lead .
- the junction part 39 is a peripheral region located outside the second region 42, and the front film 34 and the rear film 35 extend to form an integral or bonded part, and the inner space 36 does not exist.
- the outer surface of the joint 39 includes a spherical surface. An aspherical surface may be included at an end of the junction part 39 or a curvature direction of the curved surface may be changed.
- the optics 31 may be implemented to have a uniform diopter value in the first region 41, the second region 42, and the junction 39, and the first region 41 and the second region 42 It can be implemented to have a constant diopter value and to have a low diopter value at the junction 39.
- the inner space 36 is a closed space formed by the inner surfaces of the front film 34 and the thick film 35, and is located in the vicinity of the central space 37, which includes a central portion and a convex front and rear surface. It includes a peripheral space 38 in which the distance between the front film 34 and the rear film 35 is reduced.
- the central space 36 is a region corresponding to the first region 41 of the front film 34 and the rear film 35, and has a convex curved surface toward the outside in the front and the rear, and the front film 34 and the rear film 35 It has an additional control force due to the shape that becomes thicker toward the peripheral space 38.
- the central space 37 has a curved shape including a spherical surface in a partial area.
- the peripheral space 38 corresponds to the second region 42 of the front film 34 and the rear film 35 and includes curved surfaces that are convex forward and backward, respectively, and the periphery of the front film 34 and the rear film 35 It is a space in which the gap between the front film 34 and the thick film 35 is reduced in order to form the junction part 39 where the front film and the thick film meet.
- the peripheral space 38 may not exist depending on the shape of the inner space 36.
- the bonding portion 39 refers to a portion in which the front film 34 and the thick film 35 are bonded or integrally formed, and is a region in which the inner space 36 and the inner surface do not exist.
- the front film 34 and the thick film 35 corresponding to the junction part 39 have only an outer surface.
- the bonding portion 39 may be formed by an adhesive suitable for the material of the front film and the thick film.
- an embodiment of the present invention has an inner space 36 having a maximum diameter of 3.6 mm, so that the section having a diameter of 2.4 mm or less is the first region 41, and the diameter is 2.4 mm to 3.6 mm. It has two areas 42.
- the outer and inner surfaces of the front film 34 form a spherical surface in a section with a diameter of 2.4 mm from the center, and form an aspherical surface in which the degree of asphericity increases in a section with a diameter of 2.4 mm to 3.6 mm, and the curvature decreases toward the outside.
- the outer surface of the front film 34 includes a spherical surface in a section having a diameter of 3.6 mm or more.
- the second region 42 connects the spherical region of the first region 41 and the spherical region of the junction 39, and the curvature of both regions continuously changes.
- FIG. 4 is a cross-sectional view of an intraocular lens according to another embodiment of the present invention.
- the radius of curvature of each surface of the front film 34 and the rear film 35 of the intraocular lens is indicated in the figure in mm.
- the radius of curvature of the outer surface of the front film is 4.5 mm
- the radius of curvature of the inner surface of the front film is 3.6 mm.
- the radius of curvature of the outer surface of the thick film at the center of the first region 41 is 3.75 mm
- the radius of curvature of the inner surface of the thick film is 3.0 mm.
- the radius of curvature of the inner surface is smaller than that of the outer surface, and the curvature of the curved surface is greater on the inner surface.
- the radius of curvature in the thick film is smaller and the curvature is large.
- FIG. 5 is a cross-sectional view of an intraocular lens according to another embodiment of the present invention.
- the radius of curvature of the outer surface of the front film is 3.79 mm
- the radius of curvature of the inner surface of the front film is 3.13 mm
- the radius of curvature of the outer surface of the thick film is 3.16 mm
- the radius of curvature of the inner surface of the thick film is 2.61 mm.
- the first area 41 is an area having a diameter of 3.0 mm or less
- the joint portion is an area having a diameter of 3.0 mm to 5.0 mm or less.
- the radius of curvature of the outer surface of the front film is 3.24 mm
- the radius of curvature of the inner surface of the front film is 3.43 mm
- the radius of curvature of the outer surface of the thick film at the center of the first region 41 is 3.53
- the radius of curvature of the inner surface of the thick film is 2.9 mm.
- the intraocular lens has an internal space having a maximum diameter of 3.0 mm, so that a section having a diameter of 3.0 mm or less is the first region 41 and does not include the second region.
- the outer and inner surfaces of the front film 34 form a spherical surface or an aspherical surface close to the spherical surface in a section having a diameter of 3.0 mm from the center, and the outer surface of the front film 34 includes a spherical surface or an aspherical surface in a section having a diameter of 3.0 mm to 5.0 mm.
- the inner surface of the front film or the inner surface of the thick film increases as the distance from the center increases.
- the amount of change in curvature from the outer end of the second region 42 to the middle of the second region 42 is from the middle end of the second region 42 to the middle of the second region 42. It may be more than three times the amount of change in curvature.
- An embodiment of the present invention determines the relationship between the width of the central space 37, the peripheral space 38, and the junction 39 in the intraocular lens.
- the haptic part 32 includes a structure protruding outward from the circumferential surface of the optical part 31.
- the shape of the haptic part is not limited.
- the haptic unit may be radially directed outward from the circumferential surface of the optical unit, may include one or two or more protruding structures, and may be in the form of a disk, a ring, a tube, or a torus.
- three structures may be formed at intervals of 120 degrees.
- haptic parts When there are three or less haptic parts, it is easy to connect to the connecting means when the intraocular lens is inserted. Even if there are four or more haptic parts, insertion may be facilitated when the spacing between the haptic parts is not uniformly arranged.
- the optical part is an elliptical or rugby ball whose axis is shortened by the transmitted force. It can be transformed into a shape to form a main meridian with maximum refractive power, so that astigmatism correction effect can be obtained.
- the two haptic parts When the two haptic parts are inserted into the eyeball, they can be disposed in a horizontal direction, so that the adjusting force of the capsular bag is transmitted to the intraocular lens in one axial direction, causing asymmetric shape deformation. Even if there are four or more haptic parts, the distance formed by each haptic part is not uniformly arranged, but may be deflected in the horizontal direction, and in this case, it is possible to induce asymmetric shape change similar to the case of two haptic parts, thereby correcting astigmatism. You can get the effect.
- the end of the haptic part 32 may be coupled to an intraocular lens support or connector provided in the eyeball to fix and support the intraocular lens and receive the motion of the capsular bag, and at this time, it may be connected by a connecting means.
- the manner and form of the connecting means are not limited.
- a connector and a support having a female groove in which the end or part of the haptic part 32 has a male protrusion and is coupled to the male protrusion are coupled.
- the end of the haptic part 32 has one or more grooves
- the connector or support has a connecting means having a shape that can be coupled to the groove of the haptic part.
- the force that transmits the movement of the true band may be more effectively transmitted to the intraocular lens 30 through the support and the haptic part 32.
- the haptic part 32 has a larger protruding width than the protruding length from the periphery of the optical part 31. If the protruding width is smaller than the protruding length, the force such as torsion acting in the three-axis direction may not be properly transmitted, so that the width larger than the protruding length is an important factor in improving the motion transmission performance. In addition, it is preferable that the width of the haptic part 32 increases as it protrudes.
- a fixing part 33 is provided at the end of the haptic part 32 as a connecting means.
- the fixing portion 33 is sequentially provided with a plurality of concave portions and convex portions at the protruding end.
- Convex portions 33b are provided on both sides of the fixing portion in the center of the concave portion 33a, respectively. Both side portions 33c in contact with the convex portion 33b form a curved shape.
- the fixing part 33 is fixed in engagement with the shape of the groove of the connector 50 to support the optical part 31 and the haptic part 32.
- a concave portion and a convex portion may be formed in the side portion 33c.
- a fixing part 33 having a concave part and a convex part is provided at the end of the haptic part 32, so that it is combined with the connecting means of the connector 50 to transmit a force acting in the Z-axis as well as the X-axis and Y-axis. It is to improve the ability to transmit the exercise.
- a process in which the intraocular lens, which is a preferred embodiment of the present invention configured as described above, is used is as follows.
- the state of each component is as follows.
- the first platoon 7a of the capsuler color 8 becomes taut, and the second platoon 7b becomes loose.
- the equatorial part of the capsule color 8 receives a force that increases in the X direction, and the elastic intraocular lens 30 located inside the capsule color 8 also extends in the same direction, so that its thickness is reduced or its position is reduced. Move.
- the force exerted by the Jindae 7 does not act only in one direction of the X-axis, but substantially forms a compound motion in which vectors in the X, Y, and Z triaxial directions are combined.
- the first platoon 7a of the capsuler color 8 becomes loose, and the second platoon 7b becomes taut.
- the equatorial part of the capsule color 8 receives a force that increases in the Y direction, and the elastic intraocular lens 30 located inside the capsule color 8 also increases in the same direction, increasing its thickness or increasing its position. Move.
- the force exerted by the Jindae (7) does not simply act in one direction of the Y-axis, but actually constitutes a complex motion in which vectors in the X, Y, and Z triaxial directions are combined, and such a complex motion (including torsion) Is transmitted to the optical unit 31 of the intraocular lens 30 via the haptic unit 32.
- the equatorial part of the optical part 31 is compressed inward, and the shape of the front film 34 and the thick film 35 made of a flexible material is deformed.
- the front film 34 has a structure that is thinner than the periphery at the center and is displaced forward and has a larger curvature than before.
- the thick film 35 has a structure that is thinner than the periphery at the center and is displaced rearward and has a larger curvature than before.
- the front film 34 and the rear film 35 are deformed to move away from each other, so that the thickness increases at the center of the inner space.
- the optical part 31 is deformed into a shape having a larger positive diopter value than before the force is applied.
- the intraocular lens which is an embodiment of the present invention, is different from the conventional hydraulically controlled intraocular lens because the fluid is not connected to the outside of the optical unit or actively moves to adjust the thickness of the optical unit by applying hydraulic pressure. Or, the means for changing the distance is not an essential component.
- the front film 34 and the rear film 35 of an intraocular lens have a structure in which the center is thinner than the periphery, which is made due to the difference in curvature between the inner and outer surfaces at the center.
- the shape change of the thick film 35 is well caused to provide an added control force.
- the deformation of the curvature of the optical portion may occur more easily. Since the change in the thickness of the lens occurs largely at the center of the optical part 31, a larger change in curvature can be expected in a structure having a thinner thickness than the surrounding due to the difference in curvature between the inner and outer surfaces of the center part, thereby obtaining additional control power.
- One embodiment of the present invention is an intraocular lens in which the front and rear films have a symmetrical shape with respect to the equator, and another embodiment is an intraocular lens in which the front and rear films have an asymmetrical shape similar to that of the natural lens.
- the manufacturing method which is an embodiment of this aspect, includes an intermediate manufacturing step of manufacturing an intraocular lens intermediate having an optical part and a haptic part, an inner space forming step of forming an inner space in the intraocular lens intermediate, and an injection of injecting a fluid material into the inner space. Includes steps.
- the optics includes a front film facing the outer direction of the eyeball, a thick film forming an internal space between the front film, and a junction 39 in which the edges of the front film and the front film are joined, and the front film and the rear film have an inner surface and an outer surface, respectively.
- the inner space is surrounded by the inner surface of the front film and the inner surface of the thick film, and the shape of the inner space is changed according to the control state of the front film and the rear film.
- the intermediate manufacturing step is a step of manufacturing an intraocular lens intermediate including an optical unit and a haptic unit.
- the intermediate manufacturing step is processed with a preselected material and includes a front film and a thick film divided based on the equatorial plane of the optics.
- the material of the front film and the thick film may be selected identically and formed integrally, and other materials may be selected and manufactured and then bonded.
- an intraocular lens intermediate including an aspherical section in which the curvature decreases as the outer surface of the front film of the optical part goes toward the periphery, and a spherical section continuously connected to the aspherical section may be manufactured.
- the outer surface of the front film forms a convex curve to the outside, and the curve includes a spherical surface with a first radius of curvature R and the outer surface of the front film is removed from the periphery of the area formed in the center.
- An intraocular lens intermediate comprising an aspherical surface having a radius of curvature greater than one radius of curvature R can be manufactured.
- the intraocular lens intermediate is preferably made of a material having a refractive index of 1.336 or more and a material having a refractive index of 1.45 or more.
- the intraocular lens intermediate is silicone, silicone elastomer, silicone polymer, polydimethyl siloxane, polyimide, polybutester, microflex PMMA ( Microplex PMMA), Acrylic, Flexible acrylic, Hydrophobic acrylic, UV absorbing acrylate, Methacrylate copolymer, Butyl acrylate acrylate), polysiloxane elastomer, UV absorbing polysiloxane, collagen copolymer, cellulose acetate butylate (CAB), n-vinyl pyrrolidone (NVP), polyvinyl pyrrolidone (PVP), MA ( methacrylic acid), glycerol methacrylate (GMA), dimethyl siloxane (DMS), polyethylenehlycol methacrylate (PEGMMA), and silicone hydrogels.
- silicone silicone elastomer
- silicone polymer polymer
- polydimethyl siloxane polyimide
- polybutester microflex PMMA ( Microplex PMMA)
- Acrylic Flexible
- the inner space forming step is a step of forming a closed space formed with the inner surfaces of the front film and the thick film therein.
- the optical part as a whole is formed integrally, so that the inside of the optical part can be directly processed without destroying the outside of the optical part by using a laser.
- the inner space is a space formed at the center of the front and rear films, and is a central space formed convexly toward the outside, and a space formed at the periphery of the front and rear films.
- the space between the front and rear films is reduced to form a junction. Includes.
- the entire film may be manufactured to form an aspherical surface including a spherical surface in a first region corresponding to the central space, and having a radius of curvature larger than a radius of curvature of the spherical surface in a second region corresponding to the peripheral space.
- the front film and the thick film processed in the intermediate manufacturing step may be bonded to form an inner space.
- the front film and the thick film in a state in which the inner surface is not processed may be combined, and an inner space may be formed thereafter through a laser.
- a step of introducing a removing means capable of discharging smoke and by-products generated inside the optical part outside the optical part may be additionally included.
- the front film and the thick film are selected from the same material, and in the step of forming the inner space, the inner space of a predetermined thickness and curvature is processed by a femtosecond laser, and at this time, a needle is used as a removal means to smoke. Discharge.
- the inner space is preferably formed from 5 vol% to 50 vol% of the optical part.
- the inner surface of the front film and the thick film may be processed so that the inner surface of the first region has a greater curvature than the corresponding outer surface, and forms a curved surface including a spherical surface.
- the front film and the thick film may be processed so that the inner surface of the second region 42 forms a curved surface including an aspherical surface having a curvature equal to or greater than the corresponding outer surface.
- the injection step is a step in which a fluid material is filled in the formed inner space to have refractive power.
- the flowable material is preferably a material that has a refractive index less than or equal to the refractive index of the material constituting the intraocular lens intermediate, and contains silicon fluid, a silicon hardness of 10 or less, or MMA (methyl methacrylate).
- the flowable material may additionally include sodium hyaluronate, chondroitin sulfate, hydroxypropyl methylcellulose, and polyacrylamide.
- a material having a refractive index of 1.336 or more, and preferably 1.4 or more may be used as the flowable material.
- an intraocular lens that satisfies the following equations for x, y, and z can be manufactured.
- the injection step may be manufactured using an injection means, and the removal means of the inner space forming step may be used as the injection means.
- a separation step of removing the injection means used after the injection step is included.
- a finishing step in which tracks left by the injection means after the separation step are naturally blocked or removed may be included.
- the finishing step may include the step of removing the track by injecting an adhesive member into the track after the injection means is moved to a position between the inner surface and the outer surface of the front film or the thick film.
- the adhesive member used is selected according to the material of the front film and the thick film, and when an acrylic material is selected, an acrylic bond is preferably used.
- a new injection means is used to proceed with the injection step, and after the injection step, a separation step of removing the injection means is performed.
- the track was fine, so the finishing step was carried out without the use of adhesive.
- capsular sac 30 intraocular lens
- optical unit 32 haptic unit
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Abstract
Description
Claims (24)
- 안구내부에 삽입되는 옵틱부를 포함하는 안구내렌즈로서,상기 옵틱부는,상기 안구의 시선의 외부방향을 향하는 전막;상기 전막과의 사이에 내부공간을 형성하는 후막; 및상기 전막과 상기 후막의 가장자리가 접합된 접합부;를 포함하며,상기 전막 및 상기 후막은 미리 정해진 두께로 구비되어 각각 내면과 외면을 가지고,상기 내부공간은 상기 전막의 내면과 상기 후막의 내면으로 둘러싸여 내부에 유동성소재가 채워지는 밀폐공간이며, 상기 전막 및 상기 후막의 조절상태에 따라 상기 내부공간의 형상이 변경되는 안구내렌즈.
- 제1항에 있어서,상기 내부공간은 상기 전막과 상기 후막의 중앙부에 형성되는 공간으로서 외부를 향해 볼록하게 형성되는 중심공간과,상기 전막과 후막의 주변부에 형성되는 공간으로 접합부를 형성하기 위해 상기 전막과 상기 후막 사이의 간격이 줄어드는 주변공간을 포함하는 안구내 렌즈.
- 제2항에 있어서,상기 중심공간에 대응하는 위치에 형성되는 상기 전막 및 상기 후막의 제1영역은,상기 전막의 내면의 곡률이 상기 전막의 외면의 곡률보다 크고, 상기 후막의 내면의 곡률이 상기 후막의 외면의 곡률보다 크며, 상기 안구내렌즈를 수직으로 절단한 단면도에서 상기 전막 및 상기 후막의 외면이 구면을 포함하는 안구내렌즈.
- 제3항에 있어서,상기 주변공간에 대응하는 위치에 형성되는 상기 전막 및 상기 후막의 제2영역은,상기 전막의 내면의 곡률이 상기 전막의 외면의 곡률보다 크거나 같고, 상기 후막의 내면의 곡률이 상기 후막의 외면의 곡률보다 크거나 같으며, 상기 안구내렌즈를 수직으로 절단한 단면도에서 상기 전막 및 후막의 내면이 비구면인 안구내렌즈.
- 제4항에 있어서,상기 전막은,상기 안구내렌즈를 수직으로 절단한 수직단면도에서,외면이 외부로 볼록한 곡선을 형성하며, 상기 곡선은 상기 제1영역에서 제1곡률반경 R을 가지는 구면을 포함하고, 상기 제2영역에서 상기 제1곡률반경 R보다 큰 곡률반경을 가지는 비구면으로 형성되는 안구내렌즈.
- 제5항에 있어서,상기 제1곡률반경 R보다 큰 곡률반경을 가지는 비구면은 접합부 쪽으로 갈수록 곡률반경이 연속적으로 증가하는 안구내렌즈.
- 제6항에 있어서,상기 접합부와 상기 제2영역의 경계에서,상기 전막의 내면의 곡률은 상기 전막의 외면의 곡률의 1배 내지 1.05배 이고, 상기 후막의 내면의 곡률은 상기 후막의 외면의 곡률의 1배 내지 1.05배인 안구내렌즈.
- 제7항에 있어서,상기 접합부는 일체로 형성되는 안구내렌즈.
- 제7항에 있어서,상기 접합부는 상기 전막 및 상기 후막이 연장되어 접착되는 안구내렌즈.
- 제8항 또는 제9항에 있어서,상기 옵틱부의 둘레면에 구비되는 1개 이상의 햅틱부를 더 포함하는 안구내렌즈.
- 제10항에 있어서,상기 햅틱부는 안구 내에 구비되어 고정되는 커넥터 또는 지지체에 연결되기 위한 연결수단을 더 구비하는 안구내렌즈.
- 제11항에 있어서,상기 연결수단은 상기 커넥터 또는 지지체에 구비되는 암형홈과 상기 햅틱부의 단부에 구비되는 수형돌부인 안구내렌즈.
- 제12항에 있어서,상기 내부공간의 부피는 상기 옵틱부의 5 vol% 내지 50 vol%인 안구내렌즈.
- 제13항에 있어서,상기 전막 및 상기 후막은 굴절률이 1.336 이상인 소재로 이루어지고, 바람직하게는 굴절율이 1.45 이상인 소재로 이루어지는 안구내렌즈.
- 제14항에 있어서,상기 유동성소재는 굴절률이 1.336 이상이고, 바람직하게는 1.4 이상인 안구내렌즈.
- 제15항에 있어서,상기 전막 및 상기 후막의 소재는 실리콘(Silicone), 실리콘 엘라스토머(Silicone elastomer), 실리콘 폴리머(Silicone polymer), 폴리디메틸 실록산(Polydimethyl siloxane), 폴리이미드(Polyimide), 폴리부테스터(Polybutester), 마이크로플렉스 PMMA(Microplex PMMA), 아크릴수지(Acrylic), 유연성 아크릴(Flexible acrylic), 혐수성 아크릴(Hydrophobic acrylic), 자외선 흡수 아크릴레이트(UV absorbing acrylate), 메타크릴레이트 코폴리머(Methacrylate copolymer), 부틸 아크릴레이트(Butyl acrylate), 폴리실록산 엘라스토머(Polysiloxane elastomer), 자외선 흡수 폴리실록산(UV absorbing polysiloxane), 콜라겐 코폴리머(Collagen copolymer), CAB(cellulose acetate butylate), NVP(n-vinyl pyrrolidone), PVP(polyvinyl pyrrolidone), MA(methacrylic acid), GMA(glycerol methacrylate), DMS(dimethyl siloxane), PEGMMA(polyethylenehlycol methacrylate), 실리콘 히드로겔(Silicone hydrogels) 중 어느 하나 이상을 포함하는 안구내렌즈.
- 제16항에 있어서,상기 유동성소재는 실리콘수(Silicon fluid), 실리콘경도가 10 이하인 물질 또는 MMA( Methyl methacrylate)를 포함하는 소재로 이루어지는 안구내렌즈.
- 제17항에 있어서,상기 햅틱부를 2개 이상 포함하여 단일축방향으로 형태변형될 수 있어 난시교정이 가능한 안구내렌즈.
- 옵틱부 및 햅틱부를 포함하는 안구내렌즈중간체를 제조하는 중간체제조단계;상기 옵틱부의 중앙부에 내부공간을 형성하는 내부공간형성단계; 및상기 내부공간에 유동성소재를 주입하는 주입단계;를 포함하는 안구내렌즈 제조방법.
- 제19항에 있어서,상기 옵틱부는안구의 시선의 외부방향을 향하는 전막;상기 전막과의 사이에 내부공간을 형성하는 후막; 및상기 전막과 상기 전막의 가장자리가 접합된 접합부;를 포함하며,상기 전막 및 상기 후막은 미리 정해진 두께로 구비되어 각각 내면과 외면을 가지고,상기 내부공간은 상기 전막의 내면과 상기 후막의 내면으로 둘러싸여 내부에 유동성소재가 채워지는 밀폐공간이고, 상기 전막 및 상기 후막의 조절상태에 따라 상기 내부공간의 형상이 변경되는 안구내렌즈 제조방법.
- 제20항에 있어서,상기 내부공간형성단계는 상기 내부공간의 가공 또는 성형에 레이저가 사용되는 단계인 안구내렌즈 제조방법.
- 제21항에 있어서,상기 내부공간형성단계는 상기 내부공간이 상기 전막과 후막의 중앙부에 형성되는 공간으로서 외부를 향해 볼록하게 형성되는 중심공간과, 상기 전막과 후막의 주변부에 형성되어 상기 전막과 상기 후막 사이의 간격이 줄어드는 주변공간을 형성하고,상기 전막은 상기 중심공간에 대응하는 제1영역에서 제1곡률반경 R을 가지는 구면을 포함하고, 상기 주변공간에 대응하는 제2영역에서 상기 제1곡률반경 R보다 큰 곡률반경을 가지는 비구면을 포함하는 안구내렌즈 제조방법.
- 제22항에 있어서,상기 내부공간형성단계에서 상기 내부공간은 상기 옵틱부의 5vol% 내지 50vol%로 형성되는 안구내렌즈 제조방법.
- 제23항에 있어서,상기 주입단계 이후에 사용한 주입수단을 제거하고, 상기 주입수단이 남긴 트랙을 처리하는 마무리단계를 추가적으로 포함하는 안구내렌즈 제조방법.
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AU2020367644A AU2020367644B2 (en) | 2019-10-18 | 2020-08-19 | Intraocular lens |
JP2022517178A JP7364790B2 (ja) | 2019-10-18 | 2020-08-19 | 眼内レンズ |
EP20877644.3A EP4046599A4 (en) | 2019-10-18 | 2020-08-19 | INTRAOCULAR LENS |
CA3150647A CA3150647A1 (en) | 2019-10-18 | 2020-08-19 | INTRAOCULAR LENS |
CN202080063586.XA CN114423380A (zh) | 2019-10-18 | 2020-08-19 | 人工晶状体 |
US17/761,441 US20220241067A1 (en) | 2019-10-18 | 2020-08-19 | Intraocular lens |
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AU2020367644B2 (en) | 2024-02-15 |
CN114423380A (zh) | 2022-04-29 |
JP7364790B2 (ja) | 2023-10-18 |
KR102306886B1 (ko) | 2021-09-30 |
CA3150647A1 (en) | 2021-04-22 |
EP4046599A1 (en) | 2022-08-24 |
EP4046599A4 (en) | 2023-12-06 |
US20220241067A1 (en) | 2022-08-04 |
AU2020367644A1 (en) | 2022-03-31 |
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JP2022548156A (ja) | 2022-11-16 |
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