WO2014073568A1 - Colored contact lens with thin inner face-side layer, and method for fabricating same - Google Patents

Colored contact lens with thin inner face-side layer, and method for fabricating same Download PDF

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Publication number
WO2014073568A1
WO2014073568A1 PCT/JP2013/080014 JP2013080014W WO2014073568A1 WO 2014073568 A1 WO2014073568 A1 WO 2014073568A1 JP 2013080014 W JP2013080014 W JP 2013080014W WO 2014073568 A1 WO2014073568 A1 WO 2014073568A1
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WIPO (PCT)
Prior art keywords
contact lens
polymer
lens
mold
colored
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PCT/JP2013/080014
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French (fr)
Japanese (ja)
Inventor
岡田 務
麻衣 鈴木
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株式会社メニコンネクト
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Priority to JP2014545732A priority Critical patent/JPWO2014073568A1/en
Publication of WO2014073568A1 publication Critical patent/WO2014073568A1/en

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    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • G02C7/04Contact lenses for the eyes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29DPRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00Producing optical elements, e.g. lenses or prisms
    • B29D11/00009Production of simple or compound lenses
    • B29D11/00038Production of contact lenses
    • B29D11/00048Production of contact lenses composed of parts with dissimilar composition
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29DPRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D11/00Producing optical elements, e.g. lenses or prisms
    • B29D11/0073Optical laminates
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/10Filters, e.g. for facilitating adaptation of the eyes to the dark; Sunglasses

Definitions

  • the present invention relates to a contact lens having a two-layer structure in the thickness direction and a colored portion between the two layers, and a method for producing a laminated colored contact lens by sequentially polymerizing each layer in a mold. Is.
  • a method of polymerizing a contact lens (hereinafter sometimes simply referred to as “lens”) in a mold generally includes a female mold that forms the front side of the lens and a rear surface side.
  • a lens is obtained by filling a polymerizable monomer between the male mold and forming a lens and irradiating with heat or ultraviolet rays. Since the process is simple and short in this way, it has been widely adopted as a manufacturing method for disposable lenses, which has become the mainstream in recent years.
  • the lens can be provided at low cost by the mold manufacturing method.
  • it has been required to increase the added value of the lens by adding new functions by utilizing the characteristics of the mold manufacturing method.
  • An example of increasing the added value of a lens is a colored lens that objectively changes the color or texture of the pupil.
  • These lenses are also called irised lenses, but the manufacturing method for these lenses is to coat the colored monomer component on the part that forms the iris part of the lens molding die surface, form a film, and then fill and polymerize the lens monomer component.
  • a method in which a colored lens is formed when removed from the mold (Patent Document 1), a colored liquid film is deposited in the mold, and the liquid lens-forming mixture is applied to the mold while maintaining the position of the colored film.
  • Patent Document 2 There is a method (Patent Document 2) of filling and forming a molded contact lens in which the film surface and the lens body are integrated.
  • the colored portion does not appear to protrude on the lens surface, and the wearer's eyelid or the like does not cause a sense of incongruity directly.
  • a colored portion may appear on the lens surface.
  • the colored portion may peel off, resulting in irritation to the wearer or the colored portion.
  • the difference in hardness between the surrounding area and the surrounding area is a risk that dirt may adhere to the colored portions appearing on the lens surface.
  • a so-called sandwich sandwiching the colored portion inside the lens that is, a sandwich type lens
  • a sandwich type lens For example, after a colored part is provided between the hydrogel layers of the lens, the hydrogel is joined by polymerization (Patent Document 3), and an iris shielding means is provided between the first lens part and the second lens part.
  • a method of disposing and joining the first lens portion and the second lens portion (Patent Document 4), a transfer material provided with a transfer layer for forming a colored portion is placed in a female mold, A method of injecting a contact lens material between male molds forming a polymer (Patent Document 5), forming a first lens material in a concave mold, that is, a female mold, and forming a functional material serving as a colorant thereon After printing, the lens material is filled, and a convex surface that is paired with the female mold, that is, a method of polymerizing by fitting the male mold (Patent Document 6) or a colored layer having a predetermined thickness by a mold manufacturing method. There are at least two lenses comprising a transparent layer having a predetermined thickness (Patent Document 7) or the like is arranged in. A colored lens in which a colored portion is coated with a coat layer has been proposed (Patent Document 8).
  • the method of Reference 3 does not use a mold, and the method of Reference 4 is supposed to perform processing by a standard method after a manufacturing method using a mold.
  • the manufacturing cost is high and complicated.
  • the method of Document 5 does not make the lens into a two-layer structure, but uses a transfer layer for coloring, etc., so that the handling of the transfer layer causes a problem in coloring quality and the manufacturing cost is high. There is a risk.
  • a functional material such as a light shielding material is applied to a concave mold and transferred to a lens, so that it has a two-layer structure and a colored portion between the two layers.
  • the method of Document 7 can provide a lens having a three-dimensional appearance by using alternately arranged transparent layers and colored layers, and although the thickness of each layer is also described, There is no mention of any issues.
  • Reference 8 describes a lens comprising a lens-forming polymer, a front lens surface, a rear lens surface, a colorant applied to the exterior of the front or rear lens surface, and a colorant coated with a coat layer.
  • a process of forming a coat layer is necessary, and the lens of Document 8 may cause eye irritation due to dropping off of the colorant containing the coat layer.
  • the colored contact lens has a two-layer structure and the colored portion is a sandwich type.
  • a polymer provided with the inner surface of the contact lens that is, the surface in contact with the eyeball when the contact lens is worn on the eyeball, hereinafter simply referred to as “inner surface”.
  • inner surface a polymer provided with the inner surface of the contact lens
  • outer surface a polymer layer provided with an outer surface side surface of the contact lens (that is, a surface contacting the outside when the contact lens is worn on the eyeball, hereinafter simply referred to as “outer surface”).
  • the sandwich type contact lens there are a lens having a thinner polymer layer having an outer surface and a lens having a thicker one than a polymer layer having an inner surface.
  • colored lenses in which the thickness of the polymer layer having the inner surface of the contact lens is thinner than the thickness of the polymer layer having the outer surface of the contact lens are described in Documents 4 and 7 among the documents.
  • these documents do not recognize the problems in the present invention described below, and naturally do not describe the problems to be solved. Therefore, there is no means for solving the problems and problems of the present invention. It can be said that it was still a solution.
  • the object of the present invention is to compare the thickness of the polymer layer having the inner surface with the thickness of the polymer layer having the outer surface in the two-layer colored contact lens by the mold manufacturing method, and the former is not thinner than the latter.
  • the problem is that the colored contact lens is easily displaced from the eyes, the fitting is changed, and the dryness is increased.
  • the inventors of the present invention also found that the stress remaining on the colored contact lens by the mold manufacturing method that was relaxed in the hydrated, equilibrium swollen colored contact lens is not relaxed in the colored contact lens in the dry state.
  • the lens shape is changed so as to cause a change. Furthermore, when the residual stress is strong, the inventors have found that the shape of the hydrated and swollen colored contact lens is remarkably changed, leading to a decrease in the yield rate and cost increase.
  • the possibility of the shape change of the colored contact lens is possessed by the contact lens even if the contact lens is not in a dry state. For example, the contact lens may become apparent when the contact lens that is not in a dry state is cut. In other words, when the contact lens is cut, the contact lens that does not have the possibility of shape change retains the original uneven shape of the contact lens, but the contact lens that may change shape has the original uneven state. The shape may be more distorted. Therefore, the present invention has solved the above-mentioned problems by defining the thickness of a polymer layer having an inner surface to a predetermined thickness, and has completed the invention.
  • a first problem of the present invention is that a sandwich-type colored contact lens having a two-layer structure has a stable shape even when worn for a long time by defining the thickness of a polymer layer having an inner surface to be a predetermined thickness. It is to provide a colored contact lens that can be maintained. More specifically, the shape of the colored contact lens changes due to the dry state of the colored contact lens that is inevitably generated during wearing, which impairs visual stability and makes the colored contact lens easily displaced. Thus, the problem that the feeling of wearing becomes worse, the fitting and appearance change, and the feeling of dryness becomes stronger is solved by maintaining the shape retaining property of the colored contact lens. And the 2nd subject of this invention is to prevent the fall of the yield rate of the colored contact lens which has a 2 layer structure by a mold manufacturing method, and to improve productivity.
  • a first aspect of the present invention is a colored contact lens having a center thickness of 80 ⁇ m or more and 200 ⁇ m or less, the first polymer layer having an inner surface of the contact lens having a center thickness of 5 ⁇ m or more and 40 ⁇ m or less, and an outer surface of the contact lens
  • a colored contact lens comprising: a second polymer layer comprising: a light shielding material pattern portion between the two polymer layers.
  • a second aspect of the present invention is a colored contact lens having a center thickness of 50 ⁇ m or more and less than 80 ⁇ m, wherein the lower limit of the center thickness is 5 ⁇ m and the upper limit is 35% with respect to the center thickness of the contact lens.
  • the colored contact comprising: a first polymer layer having an inner surface; a second polymer layer having an outer surface of a contact lens; and a light shielding pattern portion between the two polymer layers. It is a lens.
  • a contact lens is formed in a space formed by matching a male mold having a convex molding surface and a female mold having a concave molding surface.
  • 1 lens forming material is filled and polymerized to form a first polymer, the male mold and the female mold are opened to fix the first polymer to the male mold, and the first mold fixed to the male mold
  • a light shielding material is applied to the exposed surface of the polymer, and a second die of the contact lens is formed in a space formed by matching the female die paired with the male die to which the first polymer is fixed.
  • 1st or 2nd aspect which fills the lens forming material of this, polymerizes, forms a 2nd polymer, and impregnates the physiological solution in the 2 layer polymer obtained by opening a male type
  • a contact lens in a space formed by matching a male mold having a convex molding surface and a female mold having a concave molding surface.
  • the lens forming material 2 is filled and polymerized to form a second polymer, the male mold and the female mold are opened, the second polymer is fixed to the female mold, and the second mold is fixed to the female mold.
  • a light shielding material is applied to the exposed surface of the polymer, and a first die of the contact lens is formed in a space formed by matching the male die paired with the female die to which the second polymer is fixed.
  • 1st or 2nd aspect which fills the lens formation material of this, polymerizes, forms a 1st polymer, and impregnates the physiological solution in the 2 layer polymer obtained by opening a male type
  • mold This is a method for producing a colored contact lens.
  • the inner surface of the contact lens refers to the surface that contacts the eyeball when the contact lens is worn
  • the outer surface of the contact lens that is, the FC-side outer surface is the opposite side of the BC-side inner surface.
  • a polymer constituting the inner surface layer is referred to as a “first polymer”
  • a polymer constituting the outer surface layer is referred to as a “second polymer”.
  • the colored contact lens of the present invention has a first polymer layer on the inner surface side and a second polymer layer on the outer surface side, and a pattern of light shielding material is provided between these two polymer layers. Has a part.
  • the first and second polymers constituting the colored contact lens of the present invention are generally provided as a soft lens after being impregnated with a physiological solution such as physiological saline and brought into an equilibrium swelling state.
  • a physiological solution such as physiological saline and brought into an equilibrium swelling state.
  • the term “polymer layer” refers to a layer-shaped polymer that has been hydrated and brought into an equilibrium swollen state as a result of impregnating a polymer constituting a colored contact lens with a physiological solution.
  • the “center thickness of the contact lens” means the thickness of the center portion of the contact lens when the polymer is impregnated with a physiological solution and hydrated to be in an equilibrium swollen state.
  • the center thickness of the colored contact lens is adjusted by the refractive index of the contact lens material, the required lens power, and the like, and is generally 50 ⁇ m or more and 200 ⁇ m or less. Therefore, the center thickness of the colored contact lens in the present invention is also preferably 50 ⁇ m or more and 200 ⁇ m or less, more preferably 80 ⁇ m or more and 200 ⁇ m or less, further preferably 80 ⁇ m or more and 140 ⁇ m or less, and most preferably 80 ⁇ m or more and 120 ⁇ m or less.
  • the lower limit of the center thickness of the first polymer layer provided with the inner surface of the colored contact lens is preferably 5 ⁇ m, more preferably 10 ⁇ m.
  • the thickness of the first polymer layer that is in contact with the male mold at the time of manufacturing the colored contact lens is less than 5 ⁇ m, the thinner the first polymer, the more stable quality is maintained in the formation of the first polymer. Difficult to do.
  • the center thickness of the first polymer layer is too thin, the distance between the cornea and the colored material is too small, which may cause an adverse effect on the cornea.
  • the upper limit of the center thickness of the first polymer layer having the inner surface is classified according to the center thickness of the colored contact lens.
  • the upper limit is preferably 40 ⁇ m, more preferably 35 ⁇ m, still more preferably 30 ⁇ m. This is because if the center thickness of the first polymer layer having the inner surface of the colored contact lens exceeds 40 ⁇ m, the problem of the present invention cannot be solved.
  • the upper limit is 35% as a ratio of the center thickness of the first polymer layer including the inner surface of the colored contact lens to the center thickness of the colored contact lens. Preferably, it is 32.5%, more preferably 30%.
  • the preferred range of the center thickness of the first polymer layer provided with the inner surface of the colored contact lens is preferably 5 ⁇ m or more and 40 ⁇ m or less.
  • the center thickness of the colored contact lens is 50 ⁇ m or more and less than 80 ⁇ m
  • the lower limit of the center thickness range of the first polymer layer provided with the inner surface of the colored contact lens is preferably 5 ⁇ m
  • the upper limit of the range is that of the lens.
  • the ratio of the colored contact lens to the center thickness is 35%.
  • a light shield is a substance that functions to color a contact lens by blocking a part of light that reaches the eyes from the outside. After the light shielding material is applied to the exposed surface of the first polymer by printing or the like, the second polymer is formed on the exposed surface of the first polymer, or the light shielding material is the second polymer.
  • the light shielding material can be sandwiched in the contact lens by forming the first polymer on the exposed surface of the second polymer after being applied to the exposed surface of the second polymer by printing or the like.
  • the pattern of the light shielding object is a pattern of the light shielding object.
  • the pattern is formed by printing, or the colored area surrounding the transparent central visual area is a continuous sea part.
  • a sea-island structure composed of the transparent portion and the discontinuous colored opaque portion of the island portion can be formed.
  • the thickness of the light shield is preferably 5 ⁇ m or more and 15 ⁇ m or less, and more preferably 8 ⁇ m or more and 12 ⁇ m or less. If the thickness of the light shielding material is less than 5 ⁇ m, the light shielding is insufficient, and if it exceeds 15 ⁇ m, the two polymer layers sandwiching the light shielding material may peel off, which may cause a problem in the shape retention of the contact lens. It is.
  • the ratio of the thickness of the light shielding layer to the center thickness of the first polymer layer provided with the inner surface of the colored contact lens is such that when the center thickness of the colored contact lens is 80 ⁇ m or more and 200 ⁇ m or less, the inner surface of the colored contact lens is Since the lower limit of the center thickness of the first polymer layer provided is 5 ⁇ m and the upper limit of the thickness of the light shielding layer is 15 ⁇ m, the maximum is 300%, and the center of the first polymer layer provided with the inner surface of the colored contact lens Since the upper limit of the thickness is 40 ⁇ m and the lower limit of the thickness of the light shielding layer is 5 ⁇ m, the minimum is 12.5%.
  • the center thickness of the colored contact lens is 50 ⁇ m or more and less than 80 ⁇ m
  • the lower limit of the center thickness of the first polymer layer including the inner surface of the colored contact lens is 5 ⁇ m
  • the upper limit of the thickness of the light shielding layer is 15 ⁇ m. Therefore, the upper limit of the center thickness of the first polymer layer provided with the inner surface of the colored contact lens is 28 ⁇ m, and the lower limit of the thickness of the light shielding layer is 5 ⁇ m. Therefore, the minimum is 17.9%. Become.
  • the “pair” in the third and fourth embodiments means that a lens forming material is added to a female mold, matched with the male mold, polymerized with the lens forming material, and opened to form both molds.
  • the lens forming material is a flowable polymerizable material that forms a lens after polymerization.
  • the lens forming material includes a first lens forming material and a second lens forming material.
  • the lens forming material that forms the first polymer layer having the inner surface is “first”.
  • the lens forming material that forms the second polymer layer having the outer surface of the contact lens is the “second lens forming material”.
  • the first lens forming material or the second lens forming material is polymerized between the matched male mold and female mold to form a first polymer or a second polymer, respectively.
  • the female mold and the male mold are opened in the next step.
  • the previously formed polymer is fixed to either the male mold or the female mold, and in the subsequent step, a light shielding material is applied to the exposed surface of the fixed polymer.
  • the first polymer is fixed to the male mold, and the light shield is applied to the exposed surface of the first polymer fixed to the male mold.
  • the mold that makes a pair with the male mold to which is fixed is a female mold.
  • the pair of female molds to be used subsequently may be new female molds that are not used, but those that have already been used in consideration of cost reduction may be reused.
  • the second polymer is fixed to the female mold, and the light shield is applied to the exposed surface of the second polymer fixed to the female mold.
  • a mold that makes a pair with a female mold to which an object is fixed becomes a male mold.
  • the pair of male molds to be used subsequently may be new male molds that are not used, but those that have already been used in consideration of cost reduction may be reused.
  • a first polymer is first formed, a light shielding pattern is formed, and then a second polymer is formed.
  • the first polymer is fixed to the male mold, and a light shielding material is formed on the convex portion of the first polymer, and the second polymer is joined along the concave surface.
  • the light shielding material can be applied twice or more, and thus different patterns can be applied to increase the added value.
  • the first polymer and the second polymer may be a transparent layer containing no dye or the like, or a colored transparent layer containing a dye or the like. This is because adding a dye or the like to the transparent layer may increase the added value in combination with the pattern of the light shielding object.
  • a 2nd polymer is formed first, the pattern of a light-shielding material is formed, and then a 1st polymer is formed.
  • the second polymer is fixed to the female mold, and a light shielding material is formed on the concave surface portion of the second polymer, and the second polymer is joined so that the convex surface of the first polymer follows.
  • the light shielding object can be applied two or more times, so that different patterns can be applied and the added value can be increased.
  • the first polymer and the second polymer may be a transparent layer containing no dye or the like, or a colored transparent layer containing a dye or the like.
  • the center thickness of the first polymer is the center of the lens on the male convex molding surface when the molds are matched. Defined by the distance between the point and the lens center point on the female concave mold surface.
  • the center thickness of the first polymer is determined by the center point of the male lens where the polymer is not fixed and the lens center of the exposed surface of the second polymer fixed to the female die. It will be determined by the distance of the points.
  • the colored contact lens of the present invention can be obtained by immersing the two-layered polymer obtained in the third and fourth aspects in a physiological solution such as physiological saline to bring it into an equilibrium swelling state.
  • the center thickness of the colored contact lens is finally determined by the center thickness of the two-layered polymer molded and bonded in the mold, swelling during hydration, shrinkage during polymerization, and the like.
  • the “center thickness” of the colored contact lens is a thickness after impregnating a physiological solution into a bilayer polymer to obtain an equilibrium swollen state.
  • the thickness obtained by dividing the thickness of each subsequent polymer layer by the linear expansion coefficient (LSR) of each polymer is the thickness of each polymer before the impregnation treatment, that is, at the time of production.
  • the colored contact lens manufactured by the above-described manufacturing method can add a new function as a colored contact lens having a two-layer structure in the colored thickness direction even if a lens material similar to the conventional lens material is used.
  • a lens material similar to the conventional lens material is used.
  • by superimposing the layer structure it is possible to provide a novel colored contact lens material as a whole by drawing out excellent points of each material and compensating for the defects.
  • the rate of non-defective products at the time of lens production will be improved to reduce costs.
  • the thickness of the first polymer layer provided with the inner surface of the colored contact lens a predetermined thickness, the deformation of the colored contact lens due to the unavoidable occurrence of water evaporation of the colored contact lens is suppressed and stable for a long period of time. Maintain shape.
  • the colored contact lens of the present invention has a two-layer structure, by using an appropriate material for each layer, a problem that cannot be solved by a single material is solved as a whole by combining a plurality of materials. Simple colored contact lenses.
  • FIG. 1 is a diagram for explaining a method for producing a colored contact lens having a two-layer structure.
  • FIG. 2 is a diagram for explaining another method for producing a colored contact lens having a two-layer structure.
  • FIG. 3 is a diagram showing a cross section in the diameter direction of a colored contact lens having a two-layer structure.
  • FIG. 4 is a photograph showing the contact lens shape in Example 4 and Comparative Example 4, wherein (a), (b), and (c) are 0 minutes and 20 minutes after the start of drying of the colored contact lens in Example 4, The lens shape after 45 minutes is shown, and (d), (e), and (f) are photographs showing the contact lens shape after 0 minutes, 20 minutes, and 45 minutes from the start of drying of the colored contact lens in Comparative Example 4. is there.
  • the present invention relates to a colored contact lens having a two-layer structure in the thickness direction in which the center thickness of the first polymer layer provided with the inner surface of the colored contact lens is a predetermined thickness, and a method for manufacturing the same.
  • the lower limit of the center thickness of the first polymer layer having the inner surface is 5 ⁇ m
  • the upper limit is 35% as the ratio of the center thickness of the first polymer layer having the inner surface to the center thickness of the colored contact lens.
  • the colored contact lens is manufactured through at least two polymerization steps so as to have a two-layer structure.
  • FIG. 1 illustrates a process of manufacturing a colored contact lens having a two-layer structure.
  • a female mold (1) having a concave molding surface and a male mold (2) having a convex molding surface are prepared.
  • the male mold or female mold used in the present invention is molded from a general-purpose thermoplastic resin.
  • polypropylene, polyethylene, polystyrene, polycarbonate, polyethylene terephthalate, polyamide, polyacetal, polyvinyl chloride, and nylon 6 can be used. Different resins can be appropriately selected from these resins to form each mold, or the same resin can be selected to form each mold.
  • the mold forming resin polypropylene, polystyrene, polyamide or the like is preferably used for reasons such as excellent price, transparency, and moldability.
  • a known method such as compression molding or vacuum molding can be appropriately employed as a method for forming each mold.
  • the female mold (1) is filled with the first lens forming material (3) of the lens (A-1 in FIG. 1).
  • the first lens forming material is polymerized in the space (4) formed in combination with the male mold (A-2 in FIG. 1).
  • the male mold and the female mold are opened (B in FIG. 1), and a light shielding material (6) is applied on the convex surface of the first polymer (5) fixed to the male mold. (C in FIG. 1).
  • the center thickness of the first polymer is defined by the distance between the male lens center point ( ⁇ ) and the female lens center point ( ⁇ ).
  • a female mold (1 ′) which is a mold that forms a pair with the mold on which the first polymer is fixed, is filled with the second lens forming material (3 ′) (D-1 in FIG. 1) and polymerized (FIG. 1). 1 D-2).
  • the center thickness of the second polymer is such that the lens center point ( ⁇ ′) of the female mold which is a mold in which the polymer is not fixed and the lens center of the exposed surface of the first polymer fixed to the male mold. It is defined by the distance to the point ( ⁇ ).
  • the female mold (1) is filled with the second lens forming material of the lens (A-1 in FIG.
  • the second lens forming material is polymerized in the space formed in combination with the male mold (A-2 in FIG. 2).
  • the male mold and the female mold are opened (B in FIG. 2), and a light shielding material is applied on the concave surface of the second polymer fixed to the female mold (C in FIG. 2).
  • the center thickness of the second polymer is defined by the distance between the male lens center point ( ⁇ ) and the female lens center point ( ⁇ ).
  • the first lens-forming material is filled on the fixed second polymer (D-1 in FIG. 2) and polymerized (D-2 in FIG. 2).
  • the center thickness of the first polymer is determined by the lens center point ( ⁇ ) of the male mold that is a mold in which the polymer is not fixed and the lens center point of the exposed surface of the second polymer fixed to the female mold. It is defined by the distance to ( ⁇ ′).
  • FIG. 1 is an example in which the paired mold is a female mold (third aspect of the present invention)
  • FIG. 2 is an example in which the paired mold is a male mold (fourth aspect of the present invention).
  • the female mold should be a new female mold that is not used if priority is given to the cleanliness of the concave surface of the female mold. In consideration of cost reduction, it is preferable to reuse the already used female mold.
  • the male mold should use a new male mold that is not used if priority is given to the cleanliness of the convex surface of the male mold. In consideration of cost reduction, it is preferable to reuse the already used male mold.
  • the first and second lens forming materials of the present invention are polymerizable compositions, and conventionally known monomers can be used.
  • hydroxyalkyl (meth) Acrylate especially hydroxyalkyl methacrylate: 2-HEMA
  • alkylene glycol mono (meth) acrylate especially hydroxyalkyl methacrylate: 2-HEMA
  • alkylene glycol mono (meth) acrylate alkylaminoalkyl (meth) acrylate, dimethyl (meth) acrylamide (especially dimethylacrylamide: DMAA)
  • glycerol (meth) acrylate especially glycerol
  • Examples include methacrylate: glycerol MA), glycidyl (meth) acrylate, vinyl pyrrolidone, and (meth) acrylic acid.
  • a monomer that gives a polymer having a low glass transition point such as n-butyl (meth) acrylate, decyl (meth) acrylate, or lauryl (meth) acrylate
  • a monomer such as a silicone-containing alkyl (meth) acrylate, a silicone-containing macromer, or the like can be used in combination with the above monomer.
  • None of the polymerizable compositions that are the first and second lens forming materials has an essential monomer, and the type, composition ratio, and the like can be appropriately selected according to the colored contact lens to be obtained.
  • (II) Created with the same mold material for male and female molds, and some kind of treatment (plasma treatment, UV irradiation, corona discharge treatment, laser irradiation or application of a surfactant, etc.) on the surface of one mold To increase the adhesive strength with the first polymer or to facilitate release.
  • a method of opening a mold so as to always be selectively fixed to one mold for example, a mold is opened with a temperature gradient from a male mold to a female mold, and the heat is low.
  • a method in which the first polymer remains selectively may be employed.
  • the adhesive surface between the surface of the first polymer or the second polymer and the male and female surfaces has an antisymmetric relationship (concave with respect to the convex surface, convex with respect to the concave surface).
  • the mold can be opened in a state of being selectively fixed to one of the molds.
  • the control method described above is a technique that enables more reliable control, and whether or not to adopt it may be determined from comprehensive judgment such as cost.
  • the space (4) in FIG. 1 is filled with the first lens forming material (3), but there are separate voids for accommodating an excessive amount of the first lens forming material. It may be formed when these are combined. By accommodating an excessive amount of the first lens forming material as a feeder, shrinkage that may occur during the polymerization process can be suppressed.
  • Other methods for avoiding shrinkage during polymerization include a method in which a non-reactive substance that does not participate in polymerization is added in advance to a polymerizable composition that is a lens-forming material, and male and / or female molds shrink. For example, there is a method of using a material molded with a material having sufficient flexibility to absorb.
  • one surface of the first polymer forms the inner surface of the colored contact lens
  • the other surface is a surface covered with the second polymer (7).
  • the surface to be coated with the second polymer does not necessarily have to have a precisely shaped surface, so the male or female mold that will form this surface has sufficient flexibility. It can be absorbed to absorb shrinkage during polymerization.
  • thermo polymerization by heating, photopolymerization irradiated with light such as ultraviolet rays, and a combination thereof can be mentioned.
  • the temperature is gradually raised from around room temperature, and heat in a temperature range of 30 ° C. to 120 ° C. is applied to the lens forming material within a few minutes to a few hours.
  • the thermal polymerization initiator persulfates, peroxides, azo initiators, and the like can be suitably used.
  • polymerization of the lens forming material proceeds by irradiation with active energy such as ultraviolet rays and electron beams.
  • active energy such as ultraviolet rays and electron beams.
  • an alkylphenone-based or acylphosphine oxide-based initiator can be suitably used.
  • the light shielding object (6) is applied to the exposed surface of the second polymer fixed to the female mold with a desired design to form a pattern by the light shielding object.
  • the design is composed of any one of dots, lines, planes, or a combination thereof, and can also represent characters, figures, symbols, iris patterns, etc. in addition to simply coloring.
  • a method for applying the light shielding pattern a conventional method can be appropriately employed, and screen printing, pad printing, ink jet printing, or the like can be employed.
  • Which coating method is selected is determined in consideration of the physical properties of the light shielding material, the characteristics of the second polymer, the state of the surface to be coated, and the like. After applying the light shield to the second polymer, it is desirable to fix the light shield to the second polymer so that the light shield is not dispersed when filling the first lens forming material. . There are various methods for fixing the light shield (heating, drying, electron beam irradiation, etc.), which can also be selected as appropriate (FIG. 3-i). After opening the male mold and the female mold, the light shielding object (6) is applied to the exposed surface of the first polymer fixed to the male mold with a desired design to form a pattern by the light shielding object. Is done.
  • the design is composed of any one of dots, lines, planes, or a combination thereof, and can also represent characters, figures, symbols, iris patterns, etc. in addition to simply coloring.
  • a method for applying the light shielding pattern a conventional method can be appropriately employed, and screen printing, pad printing, ink jet printing, or the like can be employed. Which coating method is selected is determined in consideration of the physical properties of the light shielding material, the characteristics of the first polymer, the state of the surface to be coated, and the like. After applying the light shield to the first polymer, it is desirable to fix the light shield to the first polymer so that the light shield is not dispersed when filling the second lens forming material. . There are various methods for fixing the light shield (heating, drying, electron beam irradiation, etc.), which can be selected as appropriate (FIG. 3-ii).
  • a pattern of light shielding material (for example, comprising a continuous transparent portion of the sea portion and a discontinuously colored opaque portion of the island portion) masking the color of the iris surrounding the transparent central visual region applied by the above printing method.
  • the pattern having a sea-island structure is a so-called layer having some thickness in the thickness direction of the colored contact lens between the first and second polymers. It is appropriate that the pattern of the light shielding object has a thickness of about 5 to 15 ⁇ m so that it has light shielding properties and can maintain the shape of the colored contact lens.
  • a colored transparent lens containing an opaque material can be manufactured.
  • coloring the entire colored contact lens in the same color it is only necessary to add a coloring component to the first and / or second lens forming material.
  • the production method of the present invention can be used effectively.
  • the first lens forming material and the second lens forming material are not necessarily different compositions as the lens forming material.
  • the same composition as the first lens forming material is applied to the second lens forming material after applying a light shielding material to the exposed surface of the first polymer. It is because it may be used as.
  • An example of combining different polymerizable compositions as lens forming materials is to produce colored contact lenses having different hardnesses of the respective polymer layers.
  • two-material contact lenses have been proposed in which the central portion is a hard contact lens and the peripheral portion is a soft contact lens.
  • the characteristics of these two kinds of contact lenses are that the central part is formed with a hard contact lens with excellent visual acuity correction power, and at the same time, the peripheral part is softened to improve the wearing feeling, and the advantages of the hard contact lens and the soft contact lens are improved. It was to provide a contact lens to have.
  • Various manufacturing methods have been proposed. Basically, the manufacturing method has a material distribution of a central portion and an annular peripheral portion. There are two problems with the two-material contact lens.
  • the wearer removes the worn contact lens
  • two is that the area where the dissimilar materials are joined together is small and the bonding between the dissimilar materials is weak.
  • the hard contact lens is removed by gathering the upper and lower eyelids toward the center. This is possible because the edge portion of the contact lens is hard.
  • the soft contact lens is bent so that the contact lens is sandwiched between the thumb and forefinger and removed from the eye.
  • the hard part does not get in the way to bend like a soft contact lens, and the peripheral part is soft, so the power of the eyelids is like a hard contact lens. It is also difficult to remove.
  • the soft contact lens is inferior in visual acuity correction power than the hard contact lens
  • the color contact lens inner surface side (BC side) layer of the present invention is manufactured as a hard layer
  • the contact lens outer surface side (FC side) layer is manufactured as a soft layer.
  • the hardness on the inner surface side of the contact lens prevents the contact lens from following the irregularities on the corneal surface, and corrects visual acuity by accumulating tear fluid between the inner surface of the contact lens and the cornea.
  • the contact lens outer surface side can be softened to maintain the feeling of wearing the contact lens, and the contact lens as a whole can be made flexible enough to be sandwiched when the contact lens is removed.
  • the colored contact lens of the present invention does not have a narrow joining area of different materials unlike the conventional two-type contact lens, and has a layered structure in the thickness direction.
  • the power is very high. In this way, it is possible to design a contact lens that is comprehensively excellent in terms of visual acuity correction power, wearing feeling, ease of contact lens removal, durability, and the like.
  • FIG. 4 shows a sectional view in the diameter direction of the two-layer colored contact lens.
  • the colored contact lens of the present invention has a colored portion between the first polymer having the inner surface of the contact lens having a predetermined center thickness and the other polymer layer. Recognize.
  • FIG. 3 (i) shows a color on the surface of the second polymer on the FC side
  • FIG. 3 (ii) shows a color on the surface of the first polymer on the BC side.
  • Example 1 The first lens forming material (2-hydroxyethyl methacrylate (HEMA) 59 w / w%, glycerol methacrylate 30 w / w%, ethylene glycol dimethacrylate 0.5 w / w%, glycerin 10 w / w on a female mold having a concave molding surface.
  • a plasma-treated male mold provided, irradiated with light (365 nm, 1 mW / cm 2 ) for 5 minutes from the female mold side in a nitrogen atmosphere, polymerized the lens forming material, and then separated both molds .
  • the obtained first polymer was attached to the male mold and had a shape similar to a colored contact lens.
  • the male mold and the female mold were designed so that a polymer layer having a front curvature radius of 6.6 mm, a rear curvature radius of 6.6 mm, a center thickness of 24 ⁇ m, and an outer diameter of 10.9 mm was obtained.
  • a light shielding material (2-HEMA 30 w / w%, iron oxide 40 w / w%, titanium oxide 20 w / w%, polyvinylpyrrolidone (PVP (K-30)) 10 w / w%) is exposed on the exposed surface of the first polymer.
  • PVP polyvinylpyrrolidone
  • 35 ⁇ l of a second lens forming material having the same composition as the first lens forming material is placed in a female mold that is paired with a male mold on which the first polymer is fixed, and the first polymer is left in a blower.
  • the attached male mold was fitted, and light (365 nm, 3 mW / cm 2 ) was irradiated from the female mold side for 5 minutes in a nitrogen atmosphere to polymerize the second lens forming material.
  • both molds were separated, the two-layer polymer in which the first polymer and the second polymer were joined adhered to the male mold.
  • the two-layer polymer contained water and was removed from the male mold.
  • the colored contact lens which is a two-layered polymer that has been removed from the male mold and softened with water and swelling, was immersed in 5 ml of fresh purified water for 10 minutes at room temperature.
  • the operation of immersing in fresh purified water 5 ml at room temperature for 10 minutes is repeated 5 times to remove the eluting components from the colored contact lens, and 1 colored contact lens is placed in a depression in a PP container containing 1 ml of physiological saline, The hollow of the container was sealed with the multilayer film, and autoclaved at 121 ° C.
  • the measuring method of the center thickness of the colored contact lens and the thickness of the colored part was performed as follows. Two razors with sharp teeth were aligned and fixed. When the fixed razor was pressed and cut at a position where the colored contact lens was divided into two equal parts, a strip-shaped lens piece having a width corresponding to the interval between the razor teeth aligned (about 50 ⁇ m) could be obtained. .
  • the lens piece is immersed in physiological saline in a plastic petri dish, and the thickness direction of the colored contact lens is photographed using a metal microscope (Nikon ECLIPSE ME600) and an illuminator (L-UEP1). In addition, the center thickness of the lens was calculated by comparing with the size of the reference ruled image taken in the same manner. Comparative Example 1 An attempt was made to produce colored contact lenses in the same manner as in Example 1. However, the thickness of the first polymer layer produced by the female mold and the male mold was designed to be 60 ⁇ m. The thickness of the polymer layer on the BC side became too thick, and 2 out of 8 defective products due to shape defects occurred.
  • the center thickness of one polymer layer including the inner surface of the lens was 60 ⁇ m, and the center thickness of the colored contact lens was 110 ⁇ m.
  • the method for measuring the center thickness of the lens was the same as in Example 1.
  • Example 2 23 ⁇ l of the same first lens forming material as in Example 1 was placed in a female mold and fitted with a plasma-treated male mold, and light (365 nm, 1 mW / cm 2 ) was applied for 5 minutes from the female mold side in a nitrogen atmosphere. Irradiated to polymerize the first lens forming material and separate the two molds. The obtained first polymer was attached to the male mold and had a lens-like shape. At this time, the male mold and the female mold were designed so that a polymer layer having a front curvature radius of 6.6 mm, a rear curvature radius of 6.6 mm, a center thickness of 15 ⁇ m, and an outer diameter of 10.9 mm was obtained.
  • a light shielding material (2-HEMA 30 w / w%, iron oxide 40 w / w%, titanium oxide 20 w / w%, PVP (K-30) 10 w / w%) on the exposed surface of the first polymer as in Example 1.
  • the second polymer is designed to have a lens shape with a center thickness of 40 ⁇ m and an outer diameter of 10.9 mm.
  • the two-layer polymer in which the first polymer and the second polymer were joined adhered to the male mold.
  • Eight lens-shaped two-layer polymers adhering to the male mold were plasma-treated in an oxygen atmosphere in a low-temperature ashing apparatus for 2 minutes and immersed in 5 ml of purified water, respectively. More off.
  • a colored contact lens which is a two-layered polymer that has been removed from the mold and became soft due to water content and swelling, was immersed in 5 ml of fresh purified water for 10 minutes at room temperature.
  • the operation of immersing in 5 ml of fresh purified water at room temperature for 10 minutes is repeated 5 times to remove the eluting components from the colored contact lens, and the colored contact is formed in the depression in the PP container containing 1 ml of physiological saline as in Example 1.
  • the lens was put in, the hollow of the container was sealed with the multilayer film, and autoclaved at 121 ° C. for 20 minutes. After cooling, the multilayer film was peeled off and the colored contact lens was inspected.
  • the colored contact made of a good silicone hydrogel material and a water-containing material having a power of ⁇ 3.0D, a diameter of 14.2 mm, and a center thickness of 110 ⁇ m. Eight lenses were obtained.
  • the center thickness of the first polymer layer provided with the inner surface of the lens was 15 ⁇ m.
  • the method for measuring the center thickness of the colored contact lens was the same as in Example 1. Comparative Example 2 An attempt was made to produce colored contact lenses in the same manner as in Example 2. However, the thickness of the first polymer layer was designed to be 60 ⁇ m. An attempt was made to produce a colored contact lens of -3.0D, but the size of the finished colored contact lens was unstable, and 3 out of 8 out of specifications occurred.
  • the measuring method of the center thickness of a lens and the center thickness of the 1st polymer layer provided with a lens inner surface was performed similarly to Example 1. FIG.
  • Example 3 Using the same first and second forming materials as in Example 1, a colored contact lens having a center thickness T1 of the colored contact lens and a thickness T2 of the first polymer provided with the inner surface of the colored contact lens was obtained (frequency ⁇ 3.0D, diameter 14.2 mm). The thickness of the colored layer was about 10 ⁇ m. A colored contact lens having a lens center thickness of 50 ⁇ m or more and less than 80 ⁇ m, wherein T1 / T2 which is a ratio of the center thickness of the first polymer layer provided with the inner surface of the colored contact lens to the center thickness of the colored contact lens is 35% or less. The colored contact lenses that were obtained are shown in Table 1 as Example 3-1 and Example 3-2.
  • colored contact lenses having a colored contact lens center thickness of 80 ⁇ m or more and 200 ⁇ m or less and T2 of 40 ⁇ m or less are shown as Example 3-3, Example 3-4 and Example 3-5 in Table 1. It was shown to. Table 1 shows the state of the strip-shaped lens pieces cut out from these hydrated colored contact lenses in the same manner as in Example 1 in physiological saline. When the shape of the strip-shaped lens piece remains the same as that of the colored contact lens before cutting, ⁇ , when it is almost flat, it is warped against the lens shape before cutting. ⁇ when curled, and x when curled.
  • Comparative Example 3 Using the same first and second forming materials as in Example 1, a colored contact lens having a central thickness T1 of the colored contact lens and a thickness T2 of the first polymer layer provided with the colored contact lens inner surface was obtained (frequency) -3.0D, diameter 14.2 mm). The thickness of the colored layer was about 10 ⁇ m. Colored contact lenses having a lens center thickness of 50 ⁇ m or more and less than 80 ⁇ m and having T1 / T2 of more than 35% are shown in Table 1 as Comparative Example 3-1 and Comparative Example 3-2. Further, colored contact lenses having a lens center thickness of 80 ⁇ m or more and 200 ⁇ m or less and T2 exceeding 40 ⁇ m are shown in Table 1 as Comparative Example 3-3 and Comparative Example 3-4.
  • Example 3 The state of the strip-shaped lens pieces cut out from these hydrated colored contact lenses in the same manner as in Example 1 in physiological saline was evaluated in the same manner as in Example 3 and shown in Table 1.
  • the cut-out strip-shaped lens piece maintains an appropriate lens shape, and it is estimated that the stress due to the molding method does not remain in the colored contact lens. It was.
  • the colored contact lens indicated by ⁇ or ⁇ in Comparative Example 3 shows that even if it is in an appropriate lens shape before cutting, the cut-out strip-shaped lens piece cannot retain the lens shape before cutting, and coloring It was estimated that the stress due to the mold manufacturing method remained on the contact lens.
  • Example 4 An experiment was conducted to examine the retention of the contact lens shape when the contact lens was in a dry state.
  • 2 g of cobalt chloride (2) hexahydrate (Nacalai tex) was weighed and dissolved in 8 ml of purified water (Kyoei Pharmaceutical) to prepare a 20 w / v% solution.
  • T1 110 ⁇ m
  • T2 20 ⁇ m
  • the colored contact lens In the colored contact lens, with the discoloration (blue) of the cobalt chloride reagent indicating the dry state, the lens edge bent to the BC side, and the shape of the entire contact lens changed to an irregular shape. On the other hand, the lens shape hardly changed in other cases.
  • the colored contact lens of the present invention is a contact by a mold manufacturing method that is not colored. As with the lens, it was found that even when the dry state progressed, the lens shape retention was excellent.
  • T1 73 ⁇ m
  • T2 62 ⁇ m
  • power ⁇ 9.0D diameter 14.2 mm
  • BC 8.5 mm the thickness of the colored layer in the colored contact lens and the colored (with iris) contact lens was about 10 ⁇ m.
  • the present invention relates to a colored contact lens having a two-layer structure in the thickness direction and a method for producing the same, and the shape of the lens is obtained by setting the center thickness of a first polymer layer provided with the inner surface of the colored contact lens to a predetermined thickness.

Abstract

Provided is a colored contact lens having a center thickness of 80-200µm, comprising: a first polymer layer having an interior surface of the contact lens with a center thickness of 5-40µm; a second polymer layer having an exterior surface of the contact lens; and a light-blocking pattern between the two polymer layers. Also provided is a colored contact lens having a center thickness of 50µm or more and less than 80µm, comprising: a first polymer layer having an interior surface of the contact lens with a lower bound center thickness of 5µm and an upper bound center thickness of 35% of the center thickness of the contact lens; a second polymer layer having an exterior surface of the contact lens; and a light-blocking pattern between the two polymer layers.

Description

内面側層が薄い着色コンタクトレンズ及びその製造方法Colored contact lens with thin inner surface layer and method for producing the same
 本発明は、厚み方向に2層構造及びその2層の間に着色部分を有したコンタクトレンズ及び、成形型内で各層を順次重合して形成することによる積層された着色コンタクトレンズの製造方法に関するものである。 The present invention relates to a contact lens having a two-layer structure in the thickness direction and a colored portion between the two layers, and a method for producing a laminated colored contact lens by sequentially polymerizing each layer in a mold. Is.
 コンタクトレンズ(以下、単に「レンズ」と称することがある。)を成形型内で重合する方法(以下、単に「モールド製法」という)は、一般に、レンズの前面側を形成する雌型と後面側を形成する雄型との間に重合性モノマーを充填して、加熱あるいは紫外線等を照射することによりレンズを得るというものである。このように工程が簡略かつ短時間であるため、近年の主流となっている使い捨てタイプのレンズの製法として広く採用されている。レンズのモールド製法におけるレンズ形成材料の重合収縮、レンズのエッジ部分におけるバリや欠け等の主要な課題が次々と解決されたため、モールド製法によって低価格でレンズが提供できるようになった。そして、現在ではモールド製法の特徴を生かして新しい機能を付与し、レンズの付加価値を高めることが要求されるようになったのである。 A method of polymerizing a contact lens (hereinafter sometimes simply referred to as “lens”) in a mold (hereinafter simply referred to as “molding method”) generally includes a female mold that forms the front side of the lens and a rear surface side. A lens is obtained by filling a polymerizable monomer between the male mold and forming a lens and irradiating with heat or ultraviolet rays. Since the process is simple and short in this way, it has been widely adopted as a manufacturing method for disposable lenses, which has become the mainstream in recent years. Since the main problems such as polymerization shrinkage of the lens forming material in the lens mold manufacturing method and burrs and chips at the edge of the lens have been solved one after another, the lens can be provided at low cost by the mold manufacturing method. Nowadays, it has been required to increase the added value of the lens by adding new functions by utilizing the characteristics of the mold manufacturing method.
 レンズの付加価値を高める例としては、瞳の色又は質感を他覚的に変化させる着色レンズがある。虹彩付きレンズとも呼ばれるが、これらのレンズの製造方法としては、レンズ成形金型表面の虹彩部分を形成する部位に色付きモノマー成分を被覆してフィルム形成後、レンズ用モノマー成分を充填・重合して金型から取り出されたときには着色レンズが形成されている方法(特許文献1)、着色液体フィルムを金型中に堆積し、該着色フィルムの位置を維持しながら液状のレンズ形成混合物を金型に充填して該フィルム表面とレンズ本体とが一体化した成形コンタクトレンズを形成する方法(特許文献2)などがある。これらの製法によって得たレンズは、着色部分がレンズ表面に突出して現れることはなく、装用者のまぶた等に直接違和感を生じさせることはない。しかし、まれにレンズ表面に着色部分が現れることがあり、レンズ本体の素材と着色部分との結合力によっては、着色部分が剥落して結果的に装用者への刺激を生じさせたり、着色部分とその周辺部分との硬さの違いを感じさせたりすることがあった。さらにレンズ表面に現れた着色部分への汚れ付着のおそれもあった。 An example of increasing the added value of a lens is a colored lens that objectively changes the color or texture of the pupil. These lenses are also called irised lenses, but the manufacturing method for these lenses is to coat the colored monomer component on the part that forms the iris part of the lens molding die surface, form a film, and then fill and polymerize the lens monomer component. A method in which a colored lens is formed when removed from the mold (Patent Document 1), a colored liquid film is deposited in the mold, and the liquid lens-forming mixture is applied to the mold while maintaining the position of the colored film. There is a method (Patent Document 2) of filling and forming a molded contact lens in which the film surface and the lens body are integrated. In the lenses obtained by these manufacturing methods, the colored portion does not appear to protrude on the lens surface, and the wearer's eyelid or the like does not cause a sense of incongruity directly. However, in some rare cases, a colored portion may appear on the lens surface. Depending on the bonding strength between the lens body material and the colored portion, the colored portion may peel off, resulting in irritation to the wearer or the colored portion. Sometimes felt the difference in hardness between the surrounding area and the surrounding area. In addition, there is a risk that dirt may adhere to the colored portions appearing on the lens surface.
 そこで、着色部分をレンズ内部で挟み込むいわゆるサンドイッチにするもの、すなわち、サンドイッチ型構造のレンズが提案されている。例えば、着色部分をレンズのヒドロゲル層の間に設けた後、そのヒドロゲル同士を重合により接合する方法(特許文献3)、第1のレンズ部分と第2のレンズ部分との間に虹彩遮蔽手段を配置して、第1レンズ部分と第2レンズ部分とを接合する方法(特許文献4)、着色部分を形成する転写層を配した転写材を雌型モールドに配置し、その雌型モールドと対をなす雄型モールドの間にコンタクトレンズ材料を注入して重合する方法(特許文献5)、凹型すなわち雌型モールドに第1のレンズ材料を形成し、その上に着色剤となる機能性材料をプリントした後、レンズ材料を充填して前記雌型モールドと対となる凸面すなわち雄型モールドを勘合して重合する方法(特許文献6)やモールド製法による少なくとも一つの所定厚みの有色層と交互に並ぶ少なくとも2つの所定厚みの透明層を含むレンズ(特許文献7)等がある。また着色部分がコート層で被覆された着色レンズが提案されている(特許文献8)。 Therefore, a so-called sandwich sandwiching the colored portion inside the lens, that is, a sandwich type lens has been proposed. For example, after a colored part is provided between the hydrogel layers of the lens, the hydrogel is joined by polymerization (Patent Document 3), and an iris shielding means is provided between the first lens part and the second lens part. A method of disposing and joining the first lens portion and the second lens portion (Patent Document 4), a transfer material provided with a transfer layer for forming a colored portion is placed in a female mold, A method of injecting a contact lens material between male molds forming a polymer (Patent Document 5), forming a first lens material in a concave mold, that is, a female mold, and forming a functional material serving as a colorant thereon After printing, the lens material is filled, and a convex surface that is paired with the female mold, that is, a method of polymerizing by fitting the male mold (Patent Document 6) or a colored layer having a predetermined thickness by a mold manufacturing method. There are at least two lenses comprising a transparent layer having a predetermined thickness (Patent Document 7) or the like is arranged in. A colored lens in which a colored portion is coated with a coat layer has been proposed (Patent Document 8).
 しかし、文献3の方法ではモールドを使用しておらず、また文献4の方法ではモールドを用いた製造方法の後に標準的な方法により加工を行うとされているため、通常のモールド製法と比較して製造コストが高く、煩雑になる。文献5の方法はレンズを2層構造にするものではなく、着色等のため転写層を使用しているので、その転写層の製造上の取扱いによって着色の品質に問題を生じ、製造コストが高くなるおそれがある。文献6の方法では凹型モールドに例えば光遮蔽性物などの機能性材料を塗布し、それをレンズに転写する等を行っているので、2層構造であって、その2層の間に着色部分を有する着色コンタクトレンズの製造には適していない。さらに、文献7の方法は交互に並ぶ透明層及び有色層を使用することによって立体的な外観を付与したレンズを提供することができ、各層の厚みについても記載されてはいるが、本発明の課題については一切記載されていない。文献8ではレンズ形成ポリマー、前部レンズ表面、後部レンズ表面を含み、着色剤が前部又は後部レンズ表面外部に塗布され、かつ着色剤がコート層でコーティングされたレンズについて記載されているが、文献8のレンズの製造のためにはコート層を形成する工程が必要であり、また文献8のレンズはコート層を含む着色剤の脱落による目への刺激を引き起こすおそれもある。 However, the method of Reference 3 does not use a mold, and the method of Reference 4 is supposed to perform processing by a standard method after a manufacturing method using a mold. The manufacturing cost is high and complicated. The method of Document 5 does not make the lens into a two-layer structure, but uses a transfer layer for coloring, etc., so that the handling of the transfer layer causes a problem in coloring quality and the manufacturing cost is high. There is a risk. In the method of Document 6, a functional material such as a light shielding material is applied to a concave mold and transferred to a lens, so that it has a two-layer structure and a colored portion between the two layers. It is not suitable for the production of colored contact lenses having Furthermore, the method of Document 7 can provide a lens having a three-dimensional appearance by using alternately arranged transparent layers and colored layers, and although the thickness of each layer is also described, There is no mention of any issues. Reference 8 describes a lens comprising a lens-forming polymer, a front lens surface, a rear lens surface, a colorant applied to the exterior of the front or rear lens surface, and a colorant coated with a coat layer. In order to manufacture the lens of Document 8, a process of forming a coat layer is necessary, and the lens of Document 8 may cause eye irritation due to dropping off of the colorant containing the coat layer.
 ここで着色コンタクトレンズのうち、レンズを2層構造にして着色部分をサンドイッチ型にする場合について説明する。サンドイッチ型コンタクトレンズの着色部分の位置から見て、コンタクトレンズの内面側表面(すなわちコンタクトレンズを眼球に装用した際に眼球に接する側の面、以下、単に「内面」という。)を備える重合物層と、コンタクトレンズの外面側表面(すなわちコンタクトレンズを眼球に装用した際に外界に接する側の面、以下、単に「外面」という。)を備える重合物層の2層が存在する。ここで、サンドイッチ型コンタクトレンズには、内面を備える重合物層の厚みより外面を備える重合物層の厚みの方が薄いものと、厚いものとが存在する。たとえばコンタクトレンズの内面を備える重合物層の厚みが、コンタクトレンズの外面を備える重合物層の厚みより薄い着色レンズは、前記文献のうち文献4及び7等に記載されている。しかし、これらの文献には前述したように、以下に述べる本発明における課題を認識しておらず、当然にその解決課題について記載されていないため、本発明の課題及び課題を解決する手段が未解決のままであったといえる。すなわち本発明の課題はモールド製法による2層の着色コンタクトレンズにおいて内面を備える重合物層の厚みと、外面を備える重合物層の厚みとを比較し、前者が後者より所定の薄さでない場合には、着色コンタクトレンズを装用している際に不可避的に発生する着色コンタクトレンズの乾燥状態に起因して、着色コンタクトレンズの形状が変化し、そのため視力安定性を損ない、装用感の低下をもたらし、着色コンタクトレンズが目からずれやすくなり、フィッティングが変化し、乾燥感を増加させるという課題を見出したことにある。そして、本発明者等は、水和した、平衡膨潤状態の着色コンタクトレンズでは緩和されていたモールド製法による着色コンタクトレンズに残留した応力が、乾燥状態になった着色コンタクトレンズでは緩和されず着色コンタクトレンズの形状に変化を起こさせるように発現することを見出したのである。さらにこの残留応力が強い場合には、水和した、膨潤状態である着色コンタクトレンズの形状を著しく変化させ、良品率の低下を招いてコストアップさせていたことも見出したのである。前記着色コンタクトレンズの形状変化の可能性はコンタクトレンズが乾燥状態になっていなくてもコンタクトレンズが有するものであって、例えば乾燥状態でないコンタクトレンズを切断した場合に顕在化する場合がある。すなわちコンタクトレンズを切断すると、前記形状変化の可能性がないコンタクトレンズでは、コンタクトレンズ本来の凹凸の形状を保持したままであるが、形状変化の可能性があるコンタクトレンズでは、本来の凹凸の状態よりもゆがんだ形状になる場合があるのである。
 そこで本発明は前記課題を、内面を備える重合物層の厚みを所定の薄さに規定することによって解決し、発明を完成するに至った。
Here, a description will be given of the case where the colored contact lens has a two-layer structure and the colored portion is a sandwich type. When viewed from the position of the colored portion of the sandwich-type contact lens, a polymer provided with the inner surface of the contact lens (that is, the surface in contact with the eyeball when the contact lens is worn on the eyeball, hereinafter simply referred to as “inner surface”). There are two layers: a layer and a polymer layer provided with an outer surface side surface of the contact lens (that is, a surface contacting the outside when the contact lens is worn on the eyeball, hereinafter simply referred to as “outer surface”). Here, in the sandwich type contact lens, there are a lens having a thinner polymer layer having an outer surface and a lens having a thicker one than a polymer layer having an inner surface. For example, colored lenses in which the thickness of the polymer layer having the inner surface of the contact lens is thinner than the thickness of the polymer layer having the outer surface of the contact lens are described in Documents 4 and 7 among the documents. However, as described above, these documents do not recognize the problems in the present invention described below, and naturally do not describe the problems to be solved. Therefore, there is no means for solving the problems and problems of the present invention. It can be said that it was still a solution. That is, the object of the present invention is to compare the thickness of the polymer layer having the inner surface with the thickness of the polymer layer having the outer surface in the two-layer colored contact lens by the mold manufacturing method, and the former is not thinner than the latter. Is caused by the dry state of the colored contact lens that is inevitably generated when the colored contact lens is worn, and the shape of the colored contact lens changes, thereby impairing visual stability and reducing the feeling of wearing. The problem is that the colored contact lens is easily displaced from the eyes, the fitting is changed, and the dryness is increased. The inventors of the present invention also found that the stress remaining on the colored contact lens by the mold manufacturing method that was relaxed in the hydrated, equilibrium swollen colored contact lens is not relaxed in the colored contact lens in the dry state. It was found that the lens shape is changed so as to cause a change. Furthermore, when the residual stress is strong, the inventors have found that the shape of the hydrated and swollen colored contact lens is remarkably changed, leading to a decrease in the yield rate and cost increase. The possibility of the shape change of the colored contact lens is possessed by the contact lens even if the contact lens is not in a dry state. For example, the contact lens may become apparent when the contact lens that is not in a dry state is cut. In other words, when the contact lens is cut, the contact lens that does not have the possibility of shape change retains the original uneven shape of the contact lens, but the contact lens that may change shape has the original uneven state. The shape may be more distorted.
Therefore, the present invention has solved the above-mentioned problems by defining the thickness of a polymer layer having an inner surface to a predetermined thickness, and has completed the invention.
特開平2-134612号公報Japanese Patent Laid-Open No. 2-134612 特開平3-15020号公報JP-A-3-15020 特公昭54-2856号公報Japanese Patent Publication No.54-2856 特開平2-181723号公報Japanese Patent Laid-Open No. 2-181723 特開平6-258604号公報JP-A-6-258604 特開2009-8848号公報JP 2009-8848 A 特表2010-529505号公報Special table 2010-529505 gazette 特表2005-531810号公報JP 2005-531810 A
 本発明の第1の課題は、2層構造を有するサンドイッチ型着色コンタクトレンズについて、内面を備える重合物層の厚みを所定の薄さに規定することにより、長時間装用しても安定した形状を維持し得る、着色コンタクトレンズを提供することにある。より具体的には、装用している際に不可避的に発生する着色コンタクトレンズの乾燥状態に起因して着色コンタクトレンズの形状が変化し、そのため視力安定性を損ない、着色コンタクトレンズがずれやすくなって装用感が悪くなり、フィッティングや見え方が変化し、乾燥感が強くなるというおそれを、着色コンタクトレンズの形状保持性を保つことによって解決することにある。そして、本発明の第2の課題は、モールド製法による2層構造を有する着色コンタクトレンズの良品率の低下を阻止し、生産性を高めることにある。 A first problem of the present invention is that a sandwich-type colored contact lens having a two-layer structure has a stable shape even when worn for a long time by defining the thickness of a polymer layer having an inner surface to be a predetermined thickness. It is to provide a colored contact lens that can be maintained. More specifically, the shape of the colored contact lens changes due to the dry state of the colored contact lens that is inevitably generated during wearing, which impairs visual stability and makes the colored contact lens easily displaced. Thus, the problem that the feeling of wearing becomes worse, the fitting and appearance change, and the feeling of dryness becomes stronger is solved by maintaining the shape retaining property of the colored contact lens. And the 2nd subject of this invention is to prevent the fall of the yield rate of the colored contact lens which has a 2 layer structure by a mold manufacturing method, and to improve productivity.
 本発明の第1の態様は、中心厚みが80μm以上200μm以下の着色コンタクトレンズであって、中心厚み5μm以上40μm以下の、コンタクトレンズの内面を備える第1の重合物層と、コンタクトレンズの外面を備える第2の重合物層と、前記2層の重合物層の間に光遮蔽物のパターン部分とを含む、着色コンタクトレンズである。
 本発明の第2の態様は、中心厚みが50μm以上80μm未満の着色コンタクトレンズであって、中心厚みの下限が5μm、かつ、上限がコンタクトレンズの中心厚みに対して35%である、コンタクトレンズの内面を備える第1の重合物層と、コンタクトレンズの外面を備える第2の重合物層と、前記2層の重合物層の間に光遮蔽物のパターン部分と、を含む、前記着色コンタクトレンズである。
 本発明の第3の態様は、一対をなす型である凸型成形面を備えた雄型と凹型成形面を備えた雌型とを型合わせして形成される空間内に、コンタクトレンズの第1のレンズ形成材料を充填して重合し第1の重合物を形成し、雄型と雌型を開いて第1の重合物を雄型に固定させ、雄型に固定された前記第1の重合物の露出表面に光遮蔽物を塗布し、前記第1の重合物が固定された雄型と対をなす雌型と型合わせをして形成される空間内に、前記コンタクトレンズの第2のレンズ形成材料を充填して重合し第2の重合物を形成し、雄型と雌型を開いて得られた2層の重合物に生理的溶液を含浸させる、第1または第2の態様の着色コンタクトレンズの製造方法である。
 本発明の第4の態様は、一対をなす型である凸型成形面を備えた雄型と凹型成形面を備えた雌型とを型合わせして形成される空間内に、コンタクトレンズの第2のレンズ形成材料を充填して重合し第2の重合物を形成し、雄型と雌型を開いて第2の重合物を雌型に固定させ、雌型に固定された前記第2の重合物の露出表面に光遮蔽物を塗布し、前記第2の重合物が固定された雌型と対をなす雄型と型合わせをして形成される空間内に、前記コンタクトレンズの第1のレンズ形成材料を充填して重合し第1の重合物を形成し、雄型と雌型を開いて得られた2層の重合物に生理的溶液を含浸させる、第1または第2の態様の着色コンタクトレンズの製造方法である。
A first aspect of the present invention is a colored contact lens having a center thickness of 80 μm or more and 200 μm or less, the first polymer layer having an inner surface of the contact lens having a center thickness of 5 μm or more and 40 μm or less, and an outer surface of the contact lens A colored contact lens comprising: a second polymer layer comprising: a light shielding material pattern portion between the two polymer layers.
A second aspect of the present invention is a colored contact lens having a center thickness of 50 μm or more and less than 80 μm, wherein the lower limit of the center thickness is 5 μm and the upper limit is 35% with respect to the center thickness of the contact lens. The colored contact comprising: a first polymer layer having an inner surface; a second polymer layer having an outer surface of a contact lens; and a light shielding pattern portion between the two polymer layers. It is a lens.
According to a third aspect of the present invention, a contact lens is formed in a space formed by matching a male mold having a convex molding surface and a female mold having a concave molding surface. 1 lens forming material is filled and polymerized to form a first polymer, the male mold and the female mold are opened to fix the first polymer to the male mold, and the first mold fixed to the male mold A light shielding material is applied to the exposed surface of the polymer, and a second die of the contact lens is formed in a space formed by matching the female die paired with the male die to which the first polymer is fixed. 1st or 2nd aspect which fills the lens forming material of this, polymerizes, forms a 2nd polymer, and impregnates the physiological solution in the 2 layer polymer obtained by opening a male type | mold and a female type | mold. This is a method for producing a colored contact lens.
According to a fourth aspect of the present invention, there is provided a contact lens in a space formed by matching a male mold having a convex molding surface and a female mold having a concave molding surface. The lens forming material 2 is filled and polymerized to form a second polymer, the male mold and the female mold are opened, the second polymer is fixed to the female mold, and the second mold is fixed to the female mold. A light shielding material is applied to the exposed surface of the polymer, and a first die of the contact lens is formed in a space formed by matching the male die paired with the female die to which the second polymer is fixed. 1st or 2nd aspect which fills the lens formation material of this, polymerizes, forms a 1st polymer, and impregnates the physiological solution in the 2 layer polymer obtained by opening a male type | mold and a female type | mold This is a method for producing a colored contact lens.
 本明細書においてコンタクトレンズの内面、いわゆるBC側内面とは、コンタクトレンズを装用したときに眼球に接する側の面をいい、コンタクトレンズの外面、すなわちFC側外面とは、BC側内面の反対側の外界に接する側の面をいう。本明細書においては、内面側の層を構成する重合物を「第1の重合物」、外面側の層を構成する重合物を「第2の重合物」と呼ぶこととする。本発明の着色コンタクトレンズは、内面側の第1の重合物層と、外面側の第2の重合物層とを有し、これらの2つの重合物層の間に、光遮蔽物のパターンの部分を有する。 In this specification, the inner surface of the contact lens, the so-called BC-side inner surface, refers to the surface that contacts the eyeball when the contact lens is worn, and the outer surface of the contact lens, that is, the FC-side outer surface is the opposite side of the BC-side inner surface. The surface on the side that touches the outside world. In the present specification, a polymer constituting the inner surface layer is referred to as a “first polymer”, and a polymer constituting the outer surface layer is referred to as a “second polymer”. The colored contact lens of the present invention has a first polymer layer on the inner surface side and a second polymer layer on the outer surface side, and a pattern of light shielding material is provided between these two polymer layers. Has a part.
 本発明の着色コンタクトレンズを構成する第1および第2の重合物は、一般的に生理食塩水等の生理的溶液を含浸させ、平衡膨潤状態にした後にソフトレンズとして提供されるものである。本明細書において「重合物層」とは、着色コンタクトレンズを構成する重合物に生理的溶液を含浸させた結果、水和して平衡膨潤状態になった、層形状の重合物のことである。また本明細書において「コンタクトレンズの中心厚み」とは、重合物に生理的溶液を含浸させ、水和して平衡膨潤状態になったときのコンタクトレンズの中心部分の厚みを意味する。まず、着色コンタクトレンズの内面を備える第1の重合物層の中心厚みの範囲について説明する。着色コンタクトレンズの中心厚みは、コンタクトレンズ材質の屈折率や求めるレンズパワー等によって調整され、一般的には50μm以上200μm以下である。そこで、本発明における着色コンタクトレンズの中心厚みも50μm以上200μm以下が好ましく、より好ましくは80μm以上200μm以下であり、さらに好ましくは80μm以上140μm以下、もっとも好ましくは80μm以上120μm以下である。着色コンタクトレンズの内面を備える第1の重合物層の中心厚みの下限は5μmが好ましく、より好ましくは10μmである。着色コンタクトレンズの製造時に雄型に接することになる第1の重合物層の中心厚みが5μm未満になるほど、第1の重合物を薄くすると、第1の重合物の形成において安定した品質を維持することが困難である。また、第1の重合物層の中心厚みが薄すぎると、角膜と着色物との距離が小さすぎることになるため、角膜に対して悪影響を起こすおそれがある。一方内面を備える第1の重合物層の中心厚みの上限は着色コンタクトレンズの中心厚みによって場合分けされる。すなわち着色コンタクトレンズの中心厚みが80μm以上200μm以下であるときは、前記上限は40μmが好ましく、より好ましくは35μm、さらに好ましくは30μmである。着色コンタクトレンズの内面を備える第1の重合物層の中心厚みが40μmを超えると、前記本発明の課題を解決できなくなるからである。
 また着色コンタクトレンズの中心厚みが50μm以上80μm未満であるときは、前記上限は着色コンタクトレンズの中心厚みに対するその着色コンタクトレンズの内面を備える第1の重合物層の中心厚みの割合として35%が好ましく、より好ましくは32.5%、さらに好ましくは30%である。その割合が35%を超えると、前記本発明の課題を解決できなくなるからである。具体例を挙げれば着色コンタクトレンズの中心厚みが60μmであるときは前記上限の好ましい厚みは60μm×0.35=21μmであり、上限のより好ましい厚みは60μm×0.325=19.5μmであり、上限のさらに好ましい厚みは60μm×0.30=18μmである。以上をまとめると着色コンタクトレンズの中心厚みが80μm以上200μm以下であるときは、着色コンタクトレンズの内面を備える第1の重合物層の中心厚みの好ましい範囲は、5μm以上40μm以下が好ましい。一方着色コンタクトレンズの中心厚みが50μm以上80μm未満であるときは、着色コンタクトレンズの内面を備える第1の重合物層の中心厚みの範囲の下限は、5μmが好ましく、その範囲の上限はレンズの中心厚みによって変化して、着色コンタクトレンズの中心厚みに対する割合としては35%である。
The first and second polymers constituting the colored contact lens of the present invention are generally provided as a soft lens after being impregnated with a physiological solution such as physiological saline and brought into an equilibrium swelling state. As used herein, the term “polymer layer” refers to a layer-shaped polymer that has been hydrated and brought into an equilibrium swollen state as a result of impregnating a polymer constituting a colored contact lens with a physiological solution. . Further, in this specification, the “center thickness of the contact lens” means the thickness of the center portion of the contact lens when the polymer is impregnated with a physiological solution and hydrated to be in an equilibrium swollen state. First, the range of the center thickness of the first polymer layer provided with the inner surface of the colored contact lens will be described. The center thickness of the colored contact lens is adjusted by the refractive index of the contact lens material, the required lens power, and the like, and is generally 50 μm or more and 200 μm or less. Therefore, the center thickness of the colored contact lens in the present invention is also preferably 50 μm or more and 200 μm or less, more preferably 80 μm or more and 200 μm or less, further preferably 80 μm or more and 140 μm or less, and most preferably 80 μm or more and 120 μm or less. The lower limit of the center thickness of the first polymer layer provided with the inner surface of the colored contact lens is preferably 5 μm, more preferably 10 μm. When the thickness of the first polymer layer that is in contact with the male mold at the time of manufacturing the colored contact lens is less than 5 μm, the thinner the first polymer, the more stable quality is maintained in the formation of the first polymer. Difficult to do. Further, if the center thickness of the first polymer layer is too thin, the distance between the cornea and the colored material is too small, which may cause an adverse effect on the cornea. On the other hand, the upper limit of the center thickness of the first polymer layer having the inner surface is classified according to the center thickness of the colored contact lens. That is, when the center thickness of the colored contact lens is 80 μm or more and 200 μm or less, the upper limit is preferably 40 μm, more preferably 35 μm, still more preferably 30 μm. This is because if the center thickness of the first polymer layer having the inner surface of the colored contact lens exceeds 40 μm, the problem of the present invention cannot be solved.
When the center thickness of the colored contact lens is 50 μm or more and less than 80 μm, the upper limit is 35% as a ratio of the center thickness of the first polymer layer including the inner surface of the colored contact lens to the center thickness of the colored contact lens. Preferably, it is 32.5%, more preferably 30%. This is because if the ratio exceeds 35%, the problem of the present invention cannot be solved. As a specific example, when the center thickness of the colored contact lens is 60 μm, the preferable upper limit thickness is 60 μm × 0.35 = 21 μm, and the more preferable upper limit thickness is 60 μm × 0.325 = 19.5 μm. The more preferable upper limit thickness is 60 μm × 0.30 = 18 μm. In summary, when the center thickness of the colored contact lens is 80 μm or more and 200 μm or less, the preferred range of the center thickness of the first polymer layer provided with the inner surface of the colored contact lens is preferably 5 μm or more and 40 μm or less. On the other hand, when the center thickness of the colored contact lens is 50 μm or more and less than 80 μm, the lower limit of the center thickness range of the first polymer layer provided with the inner surface of the colored contact lens is preferably 5 μm, and the upper limit of the range is that of the lens. Depending on the center thickness, the ratio of the colored contact lens to the center thickness is 35%.
 光遮蔽物とは外界より目に届く光の一部を遮蔽することによってコンタクトレンズを着色する働きをする物質のことである。光遮蔽物が第1の重合物の露出表面に印刷等によって塗布された後、第1の重合物の露出表面に第2の重合物を形成する、あるいは、光遮蔽物が第2の重合物の露出表面に印刷等によって塗布された後、第2の重合物の露出表面に第1の重合物を形成することにより、光遮蔽物をコンタクトレンズ内にサンドイッチすることができる。 A light shield is a substance that functions to color a contact lens by blocking a part of light that reaches the eyes from the outside. After the light shielding material is applied to the exposed surface of the first polymer by printing or the like, the second polymer is formed on the exposed surface of the first polymer, or the light shielding material is the second polymer. The light shielding material can be sandwiched in the contact lens by forming the first polymer on the exposed surface of the second polymer after being applied to the exposed surface of the second polymer by printing or the like.
 ここで光遮蔽物のパターンとは、光遮蔽物の模様のことであり、先に記載したように印刷によりパターンを形成したり、あるいは、透明な中央視覚領域を取り巻く着色領域が海部分の連続した透明部と島部分の不連続な着色不透明部とからなる海島構造を形成したりすることができる。光遮蔽物の厚みは5μm以上15μm以下が好ましく、より好ましくは、8μm以上12μm以下である。光遮蔽物の厚みが5μm未満では光の遮蔽が不十分となり、15μmを超えると光遮蔽物を挟む2つの重合物層に剥離が生じてコンタクトレンズの形状保持性に問題を生じるおそれがあるためである。着色コンタクトレンズの内面を備える第1の重合物層の中心厚みに対する光遮蔽物の層の厚みの割合は、着色コンタクトレンズの中心厚みが80μm以上200μm以下であるときでは、着色コンタクトレンズの内面を備える第1の重合物層の中心厚みの下限が5μmで光遮蔽物の層の厚みの上限が15μmであるため最大で300%となり、着色コンタクトレンズの内面を備える第1の重合物層の中心厚みの上限が40μmで光遮蔽物の層の厚みの下限が5μmであるため最小で12.5%となる。一方着色コンタクトレンズの中心厚みが50μm以上80μm未満であるときでは、着色コンタクトレンズの内面を備える第1の重合物層の中心厚みの下限が5μmで光遮蔽物の層の厚みの上限が15μmであるため最大で300%となり、着色コンタクトレンズの内面を備える第1の重合物層の中心厚みの上限が28μmで光遮蔽物の層の厚みの下限が5μmであるため最小で17.9%となる。 Here, the pattern of the light shielding object is a pattern of the light shielding object. As described above, the pattern is formed by printing, or the colored area surrounding the transparent central visual area is a continuous sea part. A sea-island structure composed of the transparent portion and the discontinuous colored opaque portion of the island portion can be formed. The thickness of the light shield is preferably 5 μm or more and 15 μm or less, and more preferably 8 μm or more and 12 μm or less. If the thickness of the light shielding material is less than 5 μm, the light shielding is insufficient, and if it exceeds 15 μm, the two polymer layers sandwiching the light shielding material may peel off, which may cause a problem in the shape retention of the contact lens. It is. The ratio of the thickness of the light shielding layer to the center thickness of the first polymer layer provided with the inner surface of the colored contact lens is such that when the center thickness of the colored contact lens is 80 μm or more and 200 μm or less, the inner surface of the colored contact lens is Since the lower limit of the center thickness of the first polymer layer provided is 5 μm and the upper limit of the thickness of the light shielding layer is 15 μm, the maximum is 300%, and the center of the first polymer layer provided with the inner surface of the colored contact lens Since the upper limit of the thickness is 40 μm and the lower limit of the thickness of the light shielding layer is 5 μm, the minimum is 12.5%. On the other hand, when the center thickness of the colored contact lens is 50 μm or more and less than 80 μm, the lower limit of the center thickness of the first polymer layer including the inner surface of the colored contact lens is 5 μm, and the upper limit of the thickness of the light shielding layer is 15 μm. Therefore, the upper limit of the center thickness of the first polymer layer provided with the inner surface of the colored contact lens is 28 μm, and the lower limit of the thickness of the light shielding layer is 5 μm. Therefore, the minimum is 17.9%. Become.
 次に本発明の第3ならびに第4の態様である、着色コンタクトレンズの製造方法について説明する。第3および第4の態様における「一対」とは、雌型にレンズの形成材料を加え、雄型と型合わせをし、レンズ形成材料を重合し、両型を開いた際に、所望の形状が得られるように設計・製造された雌型と雄型との組み合わせのことをいう。ここでレンズ形成材料とは流動可能な重合性材料で重合後にレンズを形成する材料のことである。レンズ形成材料には第1のレンズ形成材料と第2のレンズ形成材料とがあり、本発明の着色コンタクトレンズにおいて内面を備える第1の重合物層を形成することになるレンズ形成材料が「第1のレンズ形成材料」であり、コンタクトレンズの外面を備える第2の重合物層を形成することになるレンズ形成材料が「第2のレンズ形成材料」である。第1のレンズ形成材料または第2のレンズ形成材料が型合わせされた雄型と雌型の間で重合され、第1あるいは第2の重合物をそれぞれ形成する。次いで次の工程で雌型と雄型が開かれる。この際、先に形成された重合物は、雄型又は雌型のいずれか一方に固定され、続く工程では、固定された重合物の露出表面に光遮蔽物を塗布する。第3の態様においては、第1の重合物は雄型に固定され、光遮蔽物は雄型に固定された第1の重合物の露出表面に塗布されることになり、第1の重合物が固定された雄型と一対をなす型は雌型になる。続いて用いる一対をなす雌型は、使用されていない新たな雌型であってもよいが、コストダウンを考慮して既に使用したものを再度利用しても良い。一方第4の態様においては、第2の重合物は雌型に固定され、光遮蔽物は雌型に固定された第2の重合物の露出表面に塗布されることになり、第2の重合物が固定された雌型と一対をなす型は雄型になる。続いて用いる一対をなす雄型は、使用されていない新たな雄型であってもよいが、コストダウンを考慮して既に使用したものを再度利用しても良い。 Next, a method for manufacturing a colored contact lens according to the third and fourth aspects of the present invention will be described. The “pair” in the third and fourth embodiments means that a lens forming material is added to a female mold, matched with the male mold, polymerized with the lens forming material, and opened to form both molds. This means a combination of a female mold and a male mold designed and manufactured so that Here, the lens forming material is a flowable polymerizable material that forms a lens after polymerization. The lens forming material includes a first lens forming material and a second lens forming material. In the colored contact lens of the present invention, the lens forming material that forms the first polymer layer having the inner surface is “first”. The lens forming material that forms the second polymer layer having the outer surface of the contact lens is the “second lens forming material”. The first lens forming material or the second lens forming material is polymerized between the matched male mold and female mold to form a first polymer or a second polymer, respectively. Next, the female mold and the male mold are opened in the next step. At this time, the previously formed polymer is fixed to either the male mold or the female mold, and in the subsequent step, a light shielding material is applied to the exposed surface of the fixed polymer. In the third aspect, the first polymer is fixed to the male mold, and the light shield is applied to the exposed surface of the first polymer fixed to the male mold. The mold that makes a pair with the male mold to which is fixed is a female mold. The pair of female molds to be used subsequently may be new female molds that are not used, but those that have already been used in consideration of cost reduction may be reused. On the other hand, in the fourth embodiment, the second polymer is fixed to the female mold, and the light shield is applied to the exposed surface of the second polymer fixed to the female mold. A mold that makes a pair with a female mold to which an object is fixed becomes a male mold. The pair of male molds to be used subsequently may be new male molds that are not used, but those that have already been used in consideration of cost reduction may be reused.
 本発明の第3の態様では、まず第1の重合物を形成し、光遮蔽物のパターンを形成し、次いで第2の重合物を形成する。まず第1の重合物が雄型に固定され、光遮蔽物を第1の重合物の凸面部に形成し、ここに第2の重合物の凹面が沿うように接合されることになる。ここで光遮蔽物を2回以上塗布することもでき、このようにして異なったパターンを塗布することが可能となり付加価値を増すことができる。第1の重合物や第2の重合物は染料等を有しない透明層の他、染料等を含有した有色透明層でもよい。透明層に染料等を含むことにより光遮蔽物のパターンと相まってより付加価値が高まる場合があるからである。
 また、本発明の第4の態様では、まず第2の重合物を形成し、光遮蔽物のパターンを形成し、次いで第1の重合物を形成する。第2の重合物が雌型に固定され、光遮蔽物を第2の重合物の凹面部に形成し、ここに第1の重合物の凸面が沿うように接合されることになる。第3の態様と同様、光遮蔽物を2回以上塗布することができ、異なったパターンを塗布することが可能となり付加価値を増すことができる。第1の重合物や第2の重合物は染料等を有しない透明層の他、染料等を含有した有色透明層でもよい。
In the third aspect of the present invention, a first polymer is first formed, a light shielding pattern is formed, and then a second polymer is formed. First, the first polymer is fixed to the male mold, and a light shielding material is formed on the convex portion of the first polymer, and the second polymer is joined along the concave surface. Here, the light shielding material can be applied twice or more, and thus different patterns can be applied to increase the added value. The first polymer and the second polymer may be a transparent layer containing no dye or the like, or a colored transparent layer containing a dye or the like. This is because adding a dye or the like to the transparent layer may increase the added value in combination with the pattern of the light shielding object.
Moreover, in the 4th aspect of this invention, a 2nd polymer is formed first, the pattern of a light-shielding material is formed, and then a 1st polymer is formed. The second polymer is fixed to the female mold, and a light shielding material is formed on the concave surface portion of the second polymer, and the second polymer is joined so that the convex surface of the first polymer follows. Similar to the third aspect, the light shielding object can be applied two or more times, so that different patterns can be applied and the added value can be increased. The first polymer and the second polymer may be a transparent layer containing no dye or the like, or a colored transparent layer containing a dye or the like.
 第3の態様においては、第1の重合物は雄型成形面に固定されるので、第1の重合物の中心厚みは、型合わせをしたときの雄型の凸型成形面上のレンズ中心点と雌型の凹型成形面上のレンズ中心点との間の距離によって規定される。
 一方、第4の態様においては、第1の重合物の中心厚みは、重合物が固定されていない雄型のレンズ中心点及び雌型に固定された第2の重合物の露出表面のレンズ中心点の距離によって決定されることになる。
 第3ならびに第4の態様において得られた2層の重合物を生理食塩水等の生理的溶液に浸して平衡膨潤状態にして、本発明の着色コンタクトレンズを得ることができる。ここで着色コンタクトレンズの中心厚みは型内で成形されて接合された前記2層の重合物の中心厚みや水和時の膨潤及び重合時の収縮等よって最終的に決定される。先に記載したとおり、本明細書において着色コンタクトレンズの「中心厚み」とは、2層状態の重合物に生理的溶液を含浸させ、平衡膨潤状態にした後の厚みであるから、含浸処理した後の各重合物層の厚みを各重合物が有する線膨張係数(LSR)で除した厚みが、含浸処理前の、すなわち製造時における各重合物の厚みとなる。
In the third aspect, since the first polymer is fixed to the male molding surface, the center thickness of the first polymer is the center of the lens on the male convex molding surface when the molds are matched. Defined by the distance between the point and the lens center point on the female concave mold surface.
On the other hand, in the fourth aspect, the center thickness of the first polymer is determined by the center point of the male lens where the polymer is not fixed and the lens center of the exposed surface of the second polymer fixed to the female die. It will be determined by the distance of the points.
The colored contact lens of the present invention can be obtained by immersing the two-layered polymer obtained in the third and fourth aspects in a physiological solution such as physiological saline to bring it into an equilibrium swelling state. Here, the center thickness of the colored contact lens is finally determined by the center thickness of the two-layered polymer molded and bonded in the mold, swelling during hydration, shrinkage during polymerization, and the like. As described above, in this specification, the “center thickness” of the colored contact lens is a thickness after impregnating a physiological solution into a bilayer polymer to obtain an equilibrium swollen state. The thickness obtained by dividing the thickness of each subsequent polymer layer by the linear expansion coefficient (LSR) of each polymer is the thickness of each polymer before the impregnation treatment, that is, at the time of production.
 前記の製造方法によって製造された着色コンタクトレンズは、着色された厚み方向に2層構造を有する着色コンタクトレンズとして、従来と同様のレンズ素材を使用したとしても新たな機能を付加することができる。また層構造に重ね合わせることで、個々の素材の優れた点を引き出しつつ欠点を補うようにして、全体としては新規な着色コンタクトレンズ素材を提供することができる。また、レンズ製造時の良品率を向上し、コストダウンを図る。 The colored contact lens manufactured by the above-described manufacturing method can add a new function as a colored contact lens having a two-layer structure in the colored thickness direction even if a lens material similar to the conventional lens material is used. In addition, by superimposing the layer structure, it is possible to provide a novel colored contact lens material as a whole by drawing out excellent points of each material and compensating for the defects. In addition, the rate of non-defective products at the time of lens production will be improved to reduce costs.
 着色コンタクトレンズの内面を備える第1の重合物層の厚みを所定の厚みにすることによって、不可避的に発生する着色コンタクトレンズの水分蒸発に起因する着色コンタクトレンズの変形を抑制し長期間安定に形状を維持する。 By making the thickness of the first polymer layer provided with the inner surface of the colored contact lens a predetermined thickness, the deformation of the colored contact lens due to the unavoidable occurrence of water evaporation of the colored contact lens is suppressed and stable for a long period of time. Maintain shape.
 さらに、本発明の着色コンタクトレンズは2層構造を有することから、各層に適切な素材を用いることにより、単一の素材では解決できない課題を、複数の素材を組み合わせることによって全体として解決した、新規な着色コンタクトレンズとすることができる。 Furthermore, since the colored contact lens of the present invention has a two-layer structure, by using an appropriate material for each layer, a problem that cannot be solved by a single material is solved as a whole by combining a plurality of materials. Simple colored contact lenses.
図1は2層構造の着色コンタクトレンズの製造方法を説明する図である。FIG. 1 is a diagram for explaining a method for producing a colored contact lens having a two-layer structure. 図2は2層構造の着色コンタクトレンズの別の製造方法を説明する図である。FIG. 2 is a diagram for explaining another method for producing a colored contact lens having a two-layer structure. 図3は2層構造の着色コンタクトレンズの直径方向の断面を示す図である。FIG. 3 is a diagram showing a cross section in the diameter direction of a colored contact lens having a two-layer structure. 図4は実施例4、比較例4におけるコンタクトレンズ形状を示した写真であって(a)、(b)、(c)は実施例4における着色コンタクトレンズの乾燥開始0分、20分後、45分後のレンズ形状を示し、(d)、(e)、(f)は比較例4における着色コンタクトレンズの乾燥開始0分、20分後、45分後のコンタクトレンズ形状を示した写真である。FIG. 4 is a photograph showing the contact lens shape in Example 4 and Comparative Example 4, wherein (a), (b), and (c) are 0 minutes and 20 minutes after the start of drying of the colored contact lens in Example 4, The lens shape after 45 minutes is shown, and (d), (e), and (f) are photographs showing the contact lens shape after 0 minutes, 20 minutes, and 45 minutes from the start of drying of the colored contact lens in Comparative Example 4. is there.
 本発明は着色コンタクトレンズの内面を備える第1の重合物層の中心厚みが所定の厚みである、厚み方向に2層構造を有する着色コンタクトレンズ及びその製造方法に関するもので、前記所定の中心厚みとは、着色コンタクトレンズの中心厚みが80μm以上200μm以下であるときには、内面を備える第1の重合物層の中心厚みが5μm以上40μm以下であり、着色コンタクトレンズの中心厚みが50μm以上80μm未満であるときは、内面を備える第1の重合物層の中心厚みの下限が5μmでかつ上限が着色コンタクトレンズの中心厚みに対する内面を備える第1の重合物層の中心厚みの割合として35%であることを意味する。以下、図面を参照しつつ具体的に説明する。 The present invention relates to a colored contact lens having a two-layer structure in the thickness direction in which the center thickness of the first polymer layer provided with the inner surface of the colored contact lens is a predetermined thickness, and a method for manufacturing the same. Means that when the center thickness of the colored contact lens is not less than 80 μm and not more than 200 μm, the center thickness of the first polymer layer having the inner surface is not less than 5 μm and not more than 40 μm, and the center thickness of the colored contact lens is not less than 50 μm and less than 80 μm In some cases, the lower limit of the center thickness of the first polymer layer having the inner surface is 5 μm, and the upper limit is 35% as the ratio of the center thickness of the first polymer layer having the inner surface to the center thickness of the colored contact lens. Means that. Hereinafter, it demonstrates concretely, referring drawings.
 本発明では着色コンタクトレンズが2層構造を有するように、少なくとも2段階の重合工程を経て製造される。図1には、2層構造の着色コンタクトレンズを製造する工程が図示されている。初めに凹型成形面を備えた雌型(1)と凸型成形面を備えた雄型(2)を準備する。本発明に使用する雄型あるいは雌型は、汎用の熱可塑性樹脂から成形され、例えば、ポリプロピレン、ポリエチレン、ポリスチレン、ポリカーボネート、ポリエチレンテレフタレート、ポリアミド、ポリアセタール、ポリ塩化ビニル、ナイロン6が使用可能である。これらの樹脂から異なる樹脂を適宜選択し各型を形成することができ、あるいは、同一の樹脂を選択して各型を形成することもできる。型形成用の樹脂としては、ポリプロピレン、ポリスチレン、ポリアミド等が価格、透明性、成形性に優れる等の理由で好ましく用いられる。また各型の形成方法としては射出成形の他、圧縮成形、真空成形など公知の方法が適宜採用可能である。 In the present invention, the colored contact lens is manufactured through at least two polymerization steps so as to have a two-layer structure. FIG. 1 illustrates a process of manufacturing a colored contact lens having a two-layer structure. First, a female mold (1) having a concave molding surface and a male mold (2) having a convex molding surface are prepared. The male mold or female mold used in the present invention is molded from a general-purpose thermoplastic resin. For example, polypropylene, polyethylene, polystyrene, polycarbonate, polyethylene terephthalate, polyamide, polyacetal, polyvinyl chloride, and nylon 6 can be used. Different resins can be appropriately selected from these resins to form each mold, or the same resin can be selected to form each mold. As the mold forming resin, polypropylene, polystyrene, polyamide or the like is preferably used for reasons such as excellent price, transparency, and moldability. In addition to the injection molding, a known method such as compression molding or vacuum molding can be appropriately employed as a method for forming each mold.
 準備された型のうち雌型(1)にレンズの第1のレンズ形成材料(3)を充填する(図1のA-1)。次に雄型と組み合わせて形成された空間内(4)で第1のレンズ形成材料を重合させる(図1のA-2)。第1のレンズ形成材料の重合後に前記雄型と雌型を開き(図1のB)、雄型に固定された第1の重合物(5)の凸面上に光遮蔽物(6)を塗布する(図1のC)。ここで第1の重合物の中心厚みは、雄型のレンズ中心点(α)と雌型のレンズ中心点(β)との距離によって規定される。第1の重合物が固定された型と一対をなす型である雌型(1´)に第2のレンズ形成材料(3´)を充填し(図1のD-1)、重合させる(図1のD-2)。ここで第2の重合物の中心厚みは、重合物が固定されていない型である雌型のレンズ中心点(β´)と雄型に固定された第1の重合物の露出表面のレンズ中心点(γ)との距離によって規定される。
 同様に雌型に第2の重合物が固定された状態で型が開かれる場合について説明する。準備された型のうち雌型(1)にレンズの第2のレンズ形成材料を充填する(図2のA-1)。次に雄型と組み合わせて形成された空間内で第2のレンズ形成材料を重合させる(図2のA-2)。第2のレンズ形成材料の重合後に前記雄型と雌型を開き(図2のB)、雌型に固定された第2の重合物の凹面上に光遮蔽物を塗布する(図2のC)。ここで第2の重合物の中心厚みは、雄型のレンズ中心点(α)と雌型のレンズ中心点(β)との距離によって規定される。固定されている第2の重合物の上に第1のレンズ形成材料を充填し(図2のD-1)、重合させる(図2のD-2)。ここで第1の重合物の中心厚みは、重合物が固定されていない型である雄型のレンズ中心点(α)と雌型に固定された第2の重合物の露出表面のレンズ中心点(γ’)との距離によって規定される。
 ここで図1は、対をなす型が雌型となる例(本発明の第3の態様)であり、図2は、対をなす型が雄型となる例(本発明の第4の態様)を示したものである。なお、対をなす型が雌型である場合において、その雌型は、雌型の凹面の清浄性を優先するならば使用されていない新たな雌型を使用すべきであるが、型成形に要するコストの削減を考慮すると、既に使用された雌型を再度使用することが好ましい。一方、対をなす型が雄型である場合において、その雄型は、雄型の凸面の清浄性を優先するならば使用されていない新たな雄型を使用すべきであるが、型成形に要するコストの削減を考慮すると、既に使用された雄型を再度使用することが好ましい。
Of the prepared molds, the female mold (1) is filled with the first lens forming material (3) of the lens (A-1 in FIG. 1). Next, the first lens forming material is polymerized in the space (4) formed in combination with the male mold (A-2 in FIG. 1). After the polymerization of the first lens forming material, the male mold and the female mold are opened (B in FIG. 1), and a light shielding material (6) is applied on the convex surface of the first polymer (5) fixed to the male mold. (C in FIG. 1). Here, the center thickness of the first polymer is defined by the distance between the male lens center point (α) and the female lens center point (β). A female mold (1 ′), which is a mold that forms a pair with the mold on which the first polymer is fixed, is filled with the second lens forming material (3 ′) (D-1 in FIG. 1) and polymerized (FIG. 1). 1 D-2). Here, the center thickness of the second polymer is such that the lens center point (β ′) of the female mold which is a mold in which the polymer is not fixed and the lens center of the exposed surface of the first polymer fixed to the male mold. It is defined by the distance to the point (γ).
Similarly, a case where the mold is opened in a state where the second polymer is fixed to the female mold will be described. Among the prepared molds, the female mold (1) is filled with the second lens forming material of the lens (A-1 in FIG. 2). Next, the second lens forming material is polymerized in the space formed in combination with the male mold (A-2 in FIG. 2). After the polymerization of the second lens forming material, the male mold and the female mold are opened (B in FIG. 2), and a light shielding material is applied on the concave surface of the second polymer fixed to the female mold (C in FIG. 2). ). Here, the center thickness of the second polymer is defined by the distance between the male lens center point (α) and the female lens center point (β). The first lens-forming material is filled on the fixed second polymer (D-1 in FIG. 2) and polymerized (D-2 in FIG. 2). Here, the center thickness of the first polymer is determined by the lens center point (α) of the male mold that is a mold in which the polymer is not fixed and the lens center point of the exposed surface of the second polymer fixed to the female mold. It is defined by the distance to (γ ′).
Here, FIG. 1 is an example in which the paired mold is a female mold (third aspect of the present invention), and FIG. 2 is an example in which the paired mold is a male mold (fourth aspect of the present invention). ). When the paired mold is a female mold, the female mold should be a new female mold that is not used if priority is given to the cleanliness of the concave surface of the female mold. In consideration of cost reduction, it is preferable to reuse the already used female mold. On the other hand, if the paired mold is a male mold, the male mold should use a new male mold that is not used if priority is given to the cleanliness of the convex surface of the male mold. In consideration of cost reduction, it is preferable to reuse the already used male mold.
 本発明の第1および第2のレンズ形成材料は重合性組成物であり、従来から公知のモノマー等を使用することができ、例えば含水性ソフトコンタクトレンズを得る場合には、ヒドロキシアルキル(メタ)アクリレート(特にヒドロキシアルキルメタアクリレート:2-HEMA)、アルキレングリコールモノ(メタ)アクリレート、アルキルアミノアルキル(メタ)アクリレート、ジメチル(メタ)アクリルアミド(特にジメチルアクリルアミド:DMAA)、グリセロール(メタ)アクリレート(特にグリセロールメタアクリレート:グリセロールMA)、グリシジル(メタ)アクリレート、ビニルピロリドン、(メタ)アクリル酸が挙げられる。また非含水性ソフトコンタクトレンズを得るには、ガラス転移点の低い高分子重合体を与えるモノマー、例えばn-ブチル(メタ)アクリレート、デシル(メタ)アクリレート、ラウリル(メタ)アクリレートが使用できる。酸素透過性レンズを得るためには、シリコーン含有アルキル(メタ)アクリレート等のモノマーやシリコーン含有マクロマー等を前記のモノマーと組み合わせて用いることができる。第1および第2のレンズ形成材料である重合性組成物のいずれも必須のモノマーがあるわけではなく、得ようとする着色コンタクトレンズに応じて種類、組成比などが適宜選択可能である。 The first and second lens forming materials of the present invention are polymerizable compositions, and conventionally known monomers can be used. For example, when obtaining a hydrous soft contact lens, hydroxyalkyl (meth) Acrylate (especially hydroxyalkyl methacrylate: 2-HEMA), alkylene glycol mono (meth) acrylate, alkylaminoalkyl (meth) acrylate, dimethyl (meth) acrylamide (especially dimethylacrylamide: DMAA), glycerol (meth) acrylate (especially glycerol) Examples include methacrylate: glycerol MA), glycidyl (meth) acrylate, vinyl pyrrolidone, and (meth) acrylic acid. In order to obtain a non-hydrous soft contact lens, a monomer that gives a polymer having a low glass transition point, such as n-butyl (meth) acrylate, decyl (meth) acrylate, or lauryl (meth) acrylate, can be used. In order to obtain an oxygen permeable lens, a monomer such as a silicone-containing alkyl (meth) acrylate, a silicone-containing macromer, or the like can be used in combination with the above monomer. None of the polymerizable compositions that are the first and second lens forming materials has an essential monomer, and the type, composition ratio, and the like can be appropriately selected according to the colored contact lens to be obtained.
 本発明の製造方法の雄型と雌型を開く工程において、第1の重合物を雄型側に固定し、あるいは第2の重合物を雌型側に固定することを確実にコントロールする方法としては、(I)第1の重合物との接着力が高い材料を、固定させたい側の型の材料として採用し、他方の型を、第1の重合物との接着力が低い材料で成形する方法(例えば、含水性のレンズを製造する場合には、第1のレンズ形成材料には親水性のモノマーが配合されるので、一方の型の材料をポリアミド等の親水性型材料で作成し、他方の型をポリプロピレン等の疎水性型材料で作成するなど)がある。また、(II)雄型と雌型の同一の型材料で作成し、一方の型の表面に何らかの処理(プラズマ処理、UV照射、コロナ放電処理、レーザー照射或いは、界面活性剤を塗布する等)を施して、第1の重合物との接着力を高めるか、あるいは離型しやすくすることができる。さらに(III)本発明の製造方法において、常に一方の型に選択的に固定するように型を開く方法(たとえば、雄型から雌型へと温度勾配を持たせて型を開き、熱の低い方に選択的に第1の重合物が残るようにする方法)を採用してもよい。 In the process of opening the male mold and the female mold of the manufacturing method of the present invention, as a method for reliably controlling the first polymer fixed on the male mold side or the second polymer fixed on the female mold side. (I) Adopting a material having a high adhesive strength with the first polymer as a material of a mold to be fixed, and molding the other mold with a material having a low adhesive strength with the first polymer (For example, in the case of producing a water-containing lens, a hydrophilic monomer is blended in the first lens forming material. Therefore, one type of material is made of a hydrophilic type material such as polyamide. The other mold is made of a hydrophobic mold material such as polypropylene). (II) Created with the same mold material for male and female molds, and some kind of treatment (plasma treatment, UV irradiation, corona discharge treatment, laser irradiation or application of a surfactant, etc.) on the surface of one mold To increase the adhesive strength with the first polymer or to facilitate release. Further, (III) in the production method of the present invention, a method of opening a mold so as to always be selectively fixed to one mold (for example, a mold is opened with a temperature gradient from a male mold to a female mold, and the heat is low. Alternatively, a method in which the first polymer remains selectively may be employed.
 第1の重合物あるいは第2の重合物の表面と、雄型及び雌型表面との接着面が、反対称(凸面に対して凹面、凹面に対して凸面)の関係にあることから、上記のような処理を特に施さなくても、通常は一方の型に選択的に固定された状態で型を開くことができる。しかしながら前述したコントロールの方法は、より確実に制御することが可能となる技術であり、その採否はコスト等総合的な判断から決定すれば良い。 The adhesive surface between the surface of the first polymer or the second polymer and the male and female surfaces has an antisymmetric relationship (concave with respect to the convex surface, convex with respect to the concave surface). Usually, the mold can be opened in a state of being selectively fixed to one of the molds. However, the control method described above is a technique that enables more reliable control, and whether or not to adopt it may be determined from comprehensive judgment such as cost.
 図1の空間(4)には、第1のレンズ形成材料(3)が充填されているのであるが、過剰量の第1のレンズ形成材料を収容する別の空隙部が雄型と雌型を組み合わせた際に形成されるようにしても良い。過剰量の第1のレンズ形成材料を押湯として収容することにより、重合過程で生じうる収縮を抑制することができる。重合時の収縮の回避方法は他にも、レンズ形成材料である重合性組成物中に予め重合に関与しない非反応性物質を添加しておく方法や、雄型及び/又は雌型が収縮を吸収できる程度の可撓性を有する材料で成形されたものを使用する方法等がある。本発明の製造方法では、第1の重合物の一方の面が着色コンタクトレンズの内面を形成し、他方の面が第2の重合物(7)で被覆される面になる。第2の重合物で被覆される面については、必ずしも正確な形状の表面を形成している必要がないため、この面を形成することになる雄型又は雌型に、十分な可撓性を持たせて重合時の収縮を吸収することができる。 The space (4) in FIG. 1 is filled with the first lens forming material (3), but there are separate voids for accommodating an excessive amount of the first lens forming material. It may be formed when these are combined. By accommodating an excessive amount of the first lens forming material as a feeder, shrinkage that may occur during the polymerization process can be suppressed. Other methods for avoiding shrinkage during polymerization include a method in which a non-reactive substance that does not participate in polymerization is added in advance to a polymerizable composition that is a lens-forming material, and male and / or female molds shrink. For example, there is a method of using a material molded with a material having sufficient flexibility to absorb. In the production method of the present invention, one surface of the first polymer forms the inner surface of the colored contact lens, and the other surface is a surface covered with the second polymer (7). The surface to be coated with the second polymer does not necessarily have to have a precisely shaped surface, so the male or female mold that will form this surface has sufficient flexibility. It can be absorbed to absorb shrinkage during polymerization.
 また、本発明におけるレンズ形成材料である重合性組成物の重合については、公知の方法を採用できる。例えば、加熱による熱重合、紫外線のような光を照射した光重合、これらの併用などが挙げられる。熱重合の場合は、室温付近から徐々に昇温し、数分乃至数時間で30℃~120℃温度範囲の熱をレンズ形成材料にかける。熱重合開始剤として、過硫酸塩や過酸化物、アゾ系開始剤などを好適に用いることができる。一方、光重合の場合には、紫外線、電子線などの活性エネルギー照射によりレンズ形成材料の重合を進行させる。光重合開始剤として、アルキルフェノン系、アシルフォスフィンオキサイド系開始剤等を好適に用いることができる。これらの重合法及び開始剤は、レンズ形成材料である重合性組成物と型材料とのバランス等を考慮して適宜選択することができる。 In addition, a known method can be adopted for the polymerization of the polymerizable composition which is the lens forming material in the present invention. For example, thermal polymerization by heating, photopolymerization irradiated with light such as ultraviolet rays, and a combination thereof can be mentioned. In the case of thermal polymerization, the temperature is gradually raised from around room temperature, and heat in a temperature range of 30 ° C. to 120 ° C. is applied to the lens forming material within a few minutes to a few hours. As the thermal polymerization initiator, persulfates, peroxides, azo initiators, and the like can be suitably used. On the other hand, in the case of photopolymerization, polymerization of the lens forming material proceeds by irradiation with active energy such as ultraviolet rays and electron beams. As the photopolymerization initiator, an alkylphenone-based or acylphosphine oxide-based initiator can be suitably used. These polymerization methods and initiators can be appropriately selected in consideration of the balance between the polymerizable composition as the lens forming material and the mold material.
 次に図3を用いて、型を開いた後、第1の重合物の表面に光遮蔽物を塗布する工程について説明する。
 雄型と雌型とを開いた後に、雌型に固定された第2の重合物の露出した表面に対して所望のデザインで光遮蔽物(6)が塗布されて光遮蔽物によるパターンが形成される。デザインは、ドット、線、平面のいずれか若しくはこれらの組み合わせで構成され、単に着色する他に、文字、図形、記号、虹彩模様などを表すこともできる。光遮蔽物のパターンの塗布方法は、従来の方法が適宜採用でき、スクリーン印刷、パッド印刷、インクジェット印刷等を採用することができる。いずれの塗布方法を選択するかは、光遮蔽物の物性や第2の重合物の特性、塗布する面の状態などを勘案して定められる。光遮蔽物を第2の重合物へ塗布したのちに、第1のレンズ形成材料を充填する際に光遮蔽物が分散しないように、光遮蔽物を第2の重合物に固定することが望ましい。光遮蔽物の固定方法は、種々の方法(加熱、乾燥、電子線照射等)があり、これも適宜選択可能である(図3-i)
 雄型と雌型とを開いた後に、雄型に固定された第1の重合物の露出した表面に対して所望のデザインで光遮蔽物(6)が塗布されて光遮蔽物によるパターンが形成される。デザインは、ドット、線、平面のいずれか若しくはこれらの組み合わせで構成され、単に着色する他に、文字、図形、記号、虹彩模様などを表すこともできる。光遮蔽物のパターンの塗布方法は、従来の方法が適宜採用でき、スクリーン印刷、パッド印刷、インクジェット印刷等を採用することができる。いずれの塗布方法を選択するかは、光遮蔽物の物性や第1の重合物の特性、塗布する面の状態などを勘案して定められる。光遮蔽物を第1の重合物へ塗布したのちに、第2のレンズ形成材料を充填する際に光遮蔽物が分散しないように、光遮蔽物を第1の重合物に固定することが望ましい。光遮蔽物の固定方法は、種々の方法(加熱、乾燥、電子線照射等)があり、これも適宜選択可能である(図3-ii)。
Next, with reference to FIG. 3, a process of applying a light shielding material to the surface of the first polymer after opening the mold will be described.
After opening the male mold and the female mold, the light shielding object (6) is applied to the exposed surface of the second polymer fixed to the female mold with a desired design to form a pattern by the light shielding object. Is done. The design is composed of any one of dots, lines, planes, or a combination thereof, and can also represent characters, figures, symbols, iris patterns, etc. in addition to simply coloring. As a method for applying the light shielding pattern, a conventional method can be appropriately employed, and screen printing, pad printing, ink jet printing, or the like can be employed. Which coating method is selected is determined in consideration of the physical properties of the light shielding material, the characteristics of the second polymer, the state of the surface to be coated, and the like. After applying the light shield to the second polymer, it is desirable to fix the light shield to the second polymer so that the light shield is not dispersed when filling the first lens forming material. . There are various methods for fixing the light shield (heating, drying, electron beam irradiation, etc.), which can also be selected as appropriate (FIG. 3-i).
After opening the male mold and the female mold, the light shielding object (6) is applied to the exposed surface of the first polymer fixed to the male mold with a desired design to form a pattern by the light shielding object. Is done. The design is composed of any one of dots, lines, planes, or a combination thereof, and can also represent characters, figures, symbols, iris patterns, etc. in addition to simply coloring. As a method for applying the light shielding pattern, a conventional method can be appropriately employed, and screen printing, pad printing, ink jet printing, or the like can be employed. Which coating method is selected is determined in consideration of the physical properties of the light shielding material, the characteristics of the first polymer, the state of the surface to be coated, and the like. After applying the light shield to the first polymer, it is desirable to fix the light shield to the first polymer so that the light shield is not dispersed when filling the second lens forming material. . There are various methods for fixing the light shield (heating, drying, electron beam irradiation, etc.), which can be selected as appropriate (FIG. 3-ii).
 前記の印刷方法によって塗布された例えば透明な中央視覚領域を取り巻く虹彩の色をマスキングするような光遮蔽物のパターン(海部分の連続した透明部と島部分の不連続な着色不透明部とからなる海島構造となっているパターン)は、第1と第2の重合物の間で着色コンタクトレンズの厚み方向にいくらかの厚みを有するいわば層になる。光遮蔽物のパターンが、光遮蔽性を有しかつ着色コンタクトレンズの形状を保持することができるように、5~15μm程度の厚みを有することが適切である。 A pattern of light shielding material (for example, comprising a continuous transparent portion of the sea portion and a discontinuously colored opaque portion of the island portion) masking the color of the iris surrounding the transparent central visual region applied by the above printing method. The pattern having a sea-island structure is a so-called layer having some thickness in the thickness direction of the colored contact lens between the first and second polymers. It is appropriate that the pattern of the light shielding object has a thickness of about 5 to 15 μm so that it has light shielding properties and can maintain the shape of the colored contact lens.
 虹彩付きレンズの製造に際しては、レンズ装用者の虹彩を隠蔽して、瞳の色や質感を他覚的に変化させるために、着色成分の他、不透明材料として酸化鉄や酸化チタン等、および流動性を制御するための増粘剤等が光遮蔽物として用いられる。さらに、適切なモノマー等を用いると、光遮蔽物と第1及び第2の重合物とをより強固に結合させることができる。光遮蔽物は第1及び第2の重合物層によって完全にサンドイッチされるので、光遮蔽物の構成成分がレンズの表面に溶出することは効果的に抑制できる。しかし、着色成分を使用することを考慮すると、光遮蔽物の構成成分にモノマー等を添加して、第1及び第2の重合物とをより強固に結合させておくことがより好ましいと云える。 When manufacturing lenses with iris, in order to conceal the lens wearer's iris and objectively change the color and texture of the pupil, in addition to coloring components, opaque materials such as iron oxide and titanium oxide, and fluid A thickener or the like for controlling the property is used as a light shield. Furthermore, when an appropriate monomer or the like is used, the light shielding material and the first and second polymers can be bonded more firmly. Since the light shielding material is completely sandwiched between the first and second polymer layers, it is possible to effectively suppress the components of the light shielding material from eluting to the lens surface. However, in consideration of the use of the coloring component, it can be said that it is more preferable to add a monomer or the like to the constituent component of the light shielding material to bond the first and second polymers more firmly. .
 前記のように、不透明材料を含む着色透明レンズを製造することも可能である。着色コンタクトレンズ全体を同一色に着色する場合は、着色成分を第1及び/又は第2のレンズ形成材料に添加すれば良いが、部分的に異なる色に着色したい場合や、文字、図形などを着色コンタクトレンズ全体に現したい場合には、本発明の製造方法を有効に利用することができる。 As described above, a colored transparent lens containing an opaque material can be manufactured. When coloring the entire colored contact lens in the same color, it is only necessary to add a coloring component to the first and / or second lens forming material. When it is desired to show the entire colored contact lens, the production method of the present invention can be used effectively.
 第1のレンズ形成材料と第2のレンズ形成材料は、レンズ形成材料として異なる組成物であるとは限らない。例えば、後述する虹彩付きレンズを製造するような場合であれば、第1の重合物の露出表面に光遮蔽物を塗布した後に第1のレンズ形成材料と同じ組成物を第2のレンズ形成材料として使用することもあるからである。一方、多焦点着色コンタクトレンズを作成するような場合には、それぞれ異なる屈折率の重合体を形成させる必要があるため、必然的にレンズ形成材料である異種の重合性組成物を使用することになる。 The first lens forming material and the second lens forming material are not necessarily different compositions as the lens forming material. For example, in the case of manufacturing a lens with an iris, which will be described later, the same composition as the first lens forming material is applied to the second lens forming material after applying a light shielding material to the exposed surface of the first polymer. It is because it may be used as. On the other hand, when creating multifocal colored contact lenses, it is necessary to form polymers having different refractive indexes, and therefore it is inevitably necessary to use a different polymerizable composition that is a lens forming material. Become.
 レンズ形成材料として異種の重合性組成物を組み合わせる例として、それぞれの重合物層の硬さが異なる着色コンタクトレンズを製造することが挙げられる。従来から、中心部分がハードコンタクトレンズで、周辺部分をソフトコンタクトレンズにするという2種材コンタクトレンズが提案されている。このような2種材コンタクトレンズの特徴は、視力矯正力に優れるハードコンタクトレンズで中心部を形成すると同時に、周辺部分をソフトにして装用感を向上させ、ハードコンタクトレンズとソフトコンタクトレンズの長所を併せ持つコンタクトレンズが提供されることにあった。その製造方法は種々が提案されているが、基本的には中心部と環状周辺部という材料の分布を有するものを製造する方法であった。2種材コンタクトレンズには2つの課題がある。一つには、装用したコンタクトレンズを装用者がいかにして外すのか、二つには、異種の材料同士を接合する面積が小さく、両異種材料の結合自体が弱い、ということである。コンタクトレンズの外し方として、一般にハードコンタクトレンズは上下のまぶたを中心に向けて寄せ集めるようにして外すが、これはコンタクトレンズのエッジ部が硬いから可能なのである。一方、ソフトコンタクトレンズはコンタクトレンズを親指と人差し指で挟むように折り曲げて、眼から外す。しかし、2種材コンタクトレンズを外す際は、ソフトコンタクトレンズのように折り曲げるにはハード部分が邪魔をして思うように挟めず、周辺部がソフトのためハードコンタクトレンズのようにまぶたの力で外すことも困難である。 An example of combining different polymerizable compositions as lens forming materials is to produce colored contact lenses having different hardnesses of the respective polymer layers. Conventionally, two-material contact lenses have been proposed in which the central portion is a hard contact lens and the peripheral portion is a soft contact lens. The characteristics of these two kinds of contact lenses are that the central part is formed with a hard contact lens with excellent visual acuity correction power, and at the same time, the peripheral part is softened to improve the wearing feeling, and the advantages of the hard contact lens and the soft contact lens are improved. It was to provide a contact lens to have. Various manufacturing methods have been proposed. Basically, the manufacturing method has a material distribution of a central portion and an annular peripheral portion. There are two problems with the two-material contact lens. One is how the wearer removes the worn contact lens, and two is that the area where the dissimilar materials are joined together is small and the bonding between the dissimilar materials is weak. As a method of removing the contact lens, generally, the hard contact lens is removed by gathering the upper and lower eyelids toward the center. This is possible because the edge portion of the contact lens is hard. On the other hand, the soft contact lens is bent so that the contact lens is sandwiched between the thumb and forefinger and removed from the eye. However, when removing the two-type contact lens, the hard part does not get in the way to bend like a soft contact lens, and the peripheral part is soft, so the power of the eyelids is like a hard contact lens. It is also difficult to remove.
 それに対して、本発明の製造方法によって得られる、各層の硬さが異なるコンタクトレンズを製造した場合について説明する。ソフトコンタクトレンズがハードコンタクトレンズよりも視力矯正力に劣るのは、ソフトコンタクトレンズの表面が装用者の角膜表面の凹凸に倣ってしまうからである。これはすなわち乱視の矯正力に劣ることを意味する。そこで、本発明の着色コンタクトレンズ内面側(BC側)の層を硬めの層とし、コンタクトレンズ外面側(FC側)の層を柔らかい層とするように製造する。コンタクトレンズ内面側の硬さによって、コンタクトレンズが角膜表面の凹凸に倣うことが防止され、コンタクトレンズ内面と角膜の間に涙液を溜めて視力を矯正することができる。一方、コンタクトレンズ外面側を柔らかくすることでコンタクトレンズの装用感を維持し、かつコンタクトレンズを外す際に挟める程度に、コンタクトレンズ全体としては柔軟性を示すようにすることができる。 On the other hand, a case where contact lenses obtained by the manufacturing method of the present invention having different hardnesses are manufactured will be described. The reason why the soft contact lens is inferior in visual acuity correction power than the hard contact lens is because the surface of the soft contact lens follows the unevenness of the wearer's cornea surface. This means that the correction power of astigmatism is inferior. Therefore, the colored contact lens inner surface side (BC side) layer of the present invention is manufactured as a hard layer, and the contact lens outer surface side (FC side) layer is manufactured as a soft layer. The hardness on the inner surface side of the contact lens prevents the contact lens from following the irregularities on the corneal surface, and corrects visual acuity by accumulating tear fluid between the inner surface of the contact lens and the cornea. On the other hand, the contact lens outer surface side can be softened to maintain the feeling of wearing the contact lens, and the contact lens as a whole can be made flexible enough to be sandwiched when the contact lens is removed.
 しかも、本発明の着色コンタクトレンズは、従来の2種材コンタクトレンズのように異種素材の接合面積が狭いわけではなく、厚み方向に層状構造を有する構造となっているために、両材料の接合力は非常に高い。このように視力矯正力、装用感、コンタクトレンズの外し易さ、耐久性など、総合的に優れたコンタクトレンズを設計することが可能となる。 Moreover, the colored contact lens of the present invention does not have a narrow joining area of different materials unlike the conventional two-type contact lens, and has a layered structure in the thickness direction. The power is very high. In this way, it is possible to design a contact lens that is comprehensively excellent in terms of visual acuity correction power, wearing feeling, ease of contact lens removal, durability, and the like.
 2層の着色コンタクトレンズの直径方向の断面図を図4に示す。この図から明らかなように本発明の着色コンタクトレンズは、所定の中心厚みであるコンタクトレンズの内面を備える第1の重合物とその他の重合物層の間に着色部分を有するものであることがわかる。図3(i)はFC側の第2の重合物の表面上に着色したものであり、図3(ii)はBC側の第1の重合物の表面上に着色したものである。 FIG. 4 shows a sectional view in the diameter direction of the two-layer colored contact lens. As is apparent from this figure, the colored contact lens of the present invention has a colored portion between the first polymer having the inner surface of the contact lens having a predetermined center thickness and the other polymer layer. Recognize. FIG. 3 (i) shows a color on the surface of the second polymer on the FC side, and FIG. 3 (ii) shows a color on the surface of the first polymer on the BC side.
 実施例1
 凹型成形面を備えた雌型に第1のレンズ形成材料(2-ヒドロキシエチルメタクリレート(HEMA)59w/w%、グリセロールメタクリレート30w/w%、エチレングリコールジメタクリレート0.5w/w%、グリセリン10w/w%、2-ヒドロキシ-2-メチル-1-フェニル-プロパン-1-オン(HMPPO)0.5w/w%(光重合開始剤)、LSR=1.3)を23μl入れ凸型成形面を備えたプラズマ処理した雄型にて嵌合し、窒素雰囲気下で、雌型側から光(365nm、1mW/cm)を5分間照射し、レンズ形成材料を重合させ、次いで両型を分離した。得られた第1の重合物は雄型に付着されており、着色コンタクトレンズ類似形状であった。このとき雄型と雌型は、前面曲率半径6.6mm、後面曲率半径6.6mm、中心厚み24μm、外径10.9mmの重合物層が得られるように設計されていた。第1の重合物の露出表面に光遮蔽物(2-HEMA30w/w%、酸化鉄40w/w%、酸化チタン20w/w%、ポリビニルピロリドン(PVP(K-30))10w/w%)を、光遮蔽物層である着色層の厚みが10μmになるように雄型に付着しているレンズ類似形状の第1の重合物の表面に印刷し、送風器中で10分間約25℃にて放置した。塗布した光遮蔽物の表面は乾燥したように観察された。第1の重合物が固定された雄型と一対をなす雌型に第1のレンズ形成材料と同じ組成の第2のレンズ形成材料を35μl入れ、送風器中で放置した第1の重合物の付着した雄型に嵌合し、窒素雰囲気下で、雌型側から光(365nm、3mW/cm)を5分間照射し、第2のレンズ形成材料を重合させた。両型を分離したところ、第1の重合物と第2の重合物が接合した2層の重合物は雄型に付着した。雄型に付着したレンズ形状の2層の重合物8個をそれぞれ精製水5mlに浸漬すると、2層の重合物は含水して雄型より外れた。雄型より外れ、含水・膨潤して軟らかくなった2層の重合物である着色コンタクトレンズを新たな精製水5mlに10分間室温で浸漬した。新たな精製水5mlに10分間室温で浸漬する操作を5回繰り返し、着色コンタクトレンズからの溶出性成分を除去し、生理食塩水1ml入りPP製容器内の窪みに着色コンタクトレンズ1枚を入れ、多層フィルムで容器の窪みをシールし、121℃で20分間オートクレーブ滅菌した。冷却後、多層フィルムを剥がし、水和した平衡膨潤状態の着色コンタクトレンズを検査したが、設計通り度数-3.0D、直径14.2mm、中心厚み110μmの歪のない良品の着色コンタクトレンズが8枚得られた。
 着色コンタクトレンズの中心厚みや着色部分の厚みの測定方法は以下のように行った。鋭利な歯を持つ2枚のカミソリを歯を揃えて固定した。その固定されたカミソリを着色コンタクトレンズが2等分割される位置に押し当てて切断すると、揃えたカミソリの歯の間隔(約50μm)に応じた幅の短冊状のレンズ片を得ことができた。そのレンズ片をプラスチック製のシャーレに入れた生理食塩水中に浸漬し、金属顕微鏡(ニコン製ECLIPSE ME600)、照明装置(L-UEP1)を用いて着色コンタクトレンズの厚み方向を撮影し画像としてコンピュータにとり込み、同様にして撮影した基準となる物差しの画像の大きさと比較することによってレンズの中心厚み等を計算した。
 比較例1 
 実施例1と同様に着色コンタクトレンズ製作を試みた。但し、雌型と雄型によって製作される第1の重合物層の厚みが60μmとなるよう設計した。BC側の重合物層の厚みが厚くなり過ぎ、形状不良による不良品が8枚中、2枚発生した。このとき設計どおりの良品レンズについては、レンズの内面を備える1層の重合物層の中心厚みは60μm、着色コンタクトレンズの中心厚みは110μmであった。なおレンズの中心厚みの測定方法は実施例1と同様に行った。
Example 1
The first lens forming material (2-hydroxyethyl methacrylate (HEMA) 59 w / w%, glycerol methacrylate 30 w / w%, ethylene glycol dimethacrylate 0.5 w / w%, glycerin 10 w / w on a female mold having a concave molding surface. The convex molding surface was filled with 23 μl of w%, 2-hydroxy-2-methyl-1-phenyl-propan-1-one (HMPPO) 0.5 w / w% (photopolymerization initiator), LSR = 1.3). Fitted with a plasma-treated male mold provided, irradiated with light (365 nm, 1 mW / cm 2 ) for 5 minutes from the female mold side in a nitrogen atmosphere, polymerized the lens forming material, and then separated both molds . The obtained first polymer was attached to the male mold and had a shape similar to a colored contact lens. At this time, the male mold and the female mold were designed so that a polymer layer having a front curvature radius of 6.6 mm, a rear curvature radius of 6.6 mm, a center thickness of 24 μm, and an outer diameter of 10.9 mm was obtained. A light shielding material (2-HEMA 30 w / w%, iron oxide 40 w / w%, titanium oxide 20 w / w%, polyvinylpyrrolidone (PVP (K-30)) 10 w / w%) is exposed on the exposed surface of the first polymer. , Printed on the surface of the first polymer of the lens-like shape attached to the male mold so that the thickness of the colored layer as the light shielding layer is 10 μm, in a blower at about 25 ° C. for 10 minutes I left it alone. The surface of the applied light shield was observed to be dry. 35 μl of a second lens forming material having the same composition as the first lens forming material is placed in a female mold that is paired with a male mold on which the first polymer is fixed, and the first polymer is left in a blower. The attached male mold was fitted, and light (365 nm, 3 mW / cm 2 ) was irradiated from the female mold side for 5 minutes in a nitrogen atmosphere to polymerize the second lens forming material. When both molds were separated, the two-layer polymer in which the first polymer and the second polymer were joined adhered to the male mold. When eight lens-shaped two-layer polymers adhering to the male mold were each immersed in 5 ml of purified water, the two-layer polymer contained water and was removed from the male mold. The colored contact lens, which is a two-layered polymer that has been removed from the male mold and softened with water and swelling, was immersed in 5 ml of fresh purified water for 10 minutes at room temperature. The operation of immersing in fresh purified water 5 ml at room temperature for 10 minutes is repeated 5 times to remove the eluting components from the colored contact lens, and 1 colored contact lens is placed in a depression in a PP container containing 1 ml of physiological saline, The hollow of the container was sealed with the multilayer film, and autoclaved at 121 ° C. for 20 minutes. After cooling, the multilayer film was peeled off and the hydrated equilibrium swollen colored contact lens was inspected. As a result, 8 non-strained colored contact lenses having a power of −3.0D, a diameter of 14.2 mm and a center thickness of 110 μm were obtained. A sheet was obtained.
The measuring method of the center thickness of the colored contact lens and the thickness of the colored part was performed as follows. Two razors with sharp teeth were aligned and fixed. When the fixed razor was pressed and cut at a position where the colored contact lens was divided into two equal parts, a strip-shaped lens piece having a width corresponding to the interval between the razor teeth aligned (about 50 μm) could be obtained. . The lens piece is immersed in physiological saline in a plastic petri dish, and the thickness direction of the colored contact lens is photographed using a metal microscope (Nikon ECLIPSE ME600) and an illuminator (L-UEP1). In addition, the center thickness of the lens was calculated by comparing with the size of the reference ruled image taken in the same manner.
Comparative Example 1
An attempt was made to produce colored contact lenses in the same manner as in Example 1. However, the thickness of the first polymer layer produced by the female mold and the male mold was designed to be 60 μm. The thickness of the polymer layer on the BC side became too thick, and 2 out of 8 defective products due to shape defects occurred. At this time, with respect to the non-defective lens as designed, the center thickness of one polymer layer including the inner surface of the lens was 60 μm, and the center thickness of the colored contact lens was 110 μm. The method for measuring the center thickness of the lens was the same as in Example 1.
 実施例2 
 雌型に実施例1と同じ第1のレンズ形成材料を23μl入れ、プラズマ処理した雄型にて嵌合し、窒素雰囲気下で、雌型側から光(365nm、1mW/cm)を5分間照射し、第1のレンズ形成材料を重合し、両型を分離した。得られた第1の重合物は雄型に付着されており、レンズ類似形状であった。このとき、雄型と雌型は、前面曲率半径6.6mm,後面曲率半径6.6mm,中心厚み15μm,外径10.9mmの重合物層が得られるように設計されていた。第1の重合物の露出表面に実施例1と同じく光遮蔽物(2-HEMA30w/w%、酸化鉄40w/w%、酸化チタン20w/w%、PVP(K-30)10w/w%)を、光遮蔽物層である着色層の厚みが10μmになるように雄型に付着しているレンズ類似形状の第1の重合物の表面に印刷し、送風器中で10分間約25℃にて放置した。塗布した光遮蔽物の表面は乾燥したように観察された。第1の重合物が固定された雄型と一対をなす雌型に、第2のレンズ形成材料(ポリジメチルシロキサンメタクリレート30w/w%,トリスメタクリレート30w/w%、エチレングリコールジメタクリレート39w/w%、0.5w/w%、2-ヒドロキシ-2-メチル-1-フェニル-プロパン-1-オン0.5%、LSR=1.3)を30μl入れ、第1の重合物の付着した雄型にて嵌合し、窒素雰囲気下で、雌型側から光(365nm、3mW/cm)を5分間照射し、第2のレンズ形成材料を重合させた。第2の重合物は中心厚み40μm,外径10.9mmのレンズ形状となるように設計されている。両型を分離したところ、第1の重合物と第2の重合物とが接合した2層の重合物は雄型に付着した。雄型に付着したレンズ形状の2層の重合物8個を低温灰化装置内の酸素雰囲気下で2分間プラズマ処理し、それぞれ精製水5mlに浸漬すると、2層の重合物は含水して型より外れた。型より外れ、含水・膨潤して軟らかくなった2層の重合物である着色コンタクトレンズを新たな精製水5mlに10分間室温で浸漬した。新たな精製水5mlに10分間室温で浸漬する操作を5回繰り返し、着色コンタクトレンズからの溶出性成分を除去し、実施例1と同様に生理食塩水1ml入りPP製容器内の窪みに着色コンタクトレンズを入れ、前記多層フィルムで容器の窪みをシールし、121℃で20分間オートクレーブ滅菌した。冷却後、前記多層フィルムを剥がし、着色コンタクトレンズを検査したが、設計通り度数-3.0D、直径14.2mm、中心厚み110μmレンズの歪のない良品のシリコーンヒドロゲル材と含水材からなる着色コンタクトレンズが8枚得られた。またレンズの内面を備える第1の重合物層の中心厚みは15μmであった。なお着色コンタクトレンズの中心厚みの測定方法は実施例1と同様であった。
 比較例2
 実施例2と同様に着色コンタクトレンズ製作を試みた。但し、第1の重合物層の厚みは60μmとなるよう設計した。-3.0Dの着色コンタクトレンズ製作を試みたが、完成着色コンタクトレンズのサイズが不安定で、規格外れが8枚中、3枚発生した。なお、レンズの中心厚み、レンズ内面を備える第1の重合物層の中心厚みの測定方法は実施例1と同様に行った。
Example 2
23 μl of the same first lens forming material as in Example 1 was placed in a female mold and fitted with a plasma-treated male mold, and light (365 nm, 1 mW / cm 2 ) was applied for 5 minutes from the female mold side in a nitrogen atmosphere. Irradiated to polymerize the first lens forming material and separate the two molds. The obtained first polymer was attached to the male mold and had a lens-like shape. At this time, the male mold and the female mold were designed so that a polymer layer having a front curvature radius of 6.6 mm, a rear curvature radius of 6.6 mm, a center thickness of 15 μm, and an outer diameter of 10.9 mm was obtained. A light shielding material (2-HEMA 30 w / w%, iron oxide 40 w / w%, titanium oxide 20 w / w%, PVP (K-30) 10 w / w%) on the exposed surface of the first polymer as in Example 1. Is printed on the surface of the first polymer having a lens-like shape attached to the male mold so that the thickness of the colored layer, which is a light shielding layer, is 10 μm, and is kept at about 25 ° C. for 10 minutes in a blower. Left unattended. The surface of the applied light shield was observed to be dry. The second lens forming material (polydimethylsiloxane methacrylate 30 w / w%, tris methacrylate 30 w / w%, ethylene glycol dimethacrylate 39 w / w%) is formed into a female mold that makes a pair with the male mold on which the first polymer is fixed. , 0.5 w / w%, 2-hydroxy-2-methyl-1-phenyl-propan-1-one 0.5%, LSR = 1.3) was added to the male mold with the first polymer attached thereto And was irradiated with light (365 nm, 3 mW / cm 2 ) from the female mold side for 5 minutes in a nitrogen atmosphere to polymerize the second lens forming material. The second polymer is designed to have a lens shape with a center thickness of 40 μm and an outer diameter of 10.9 mm. When the two molds were separated, the two-layer polymer in which the first polymer and the second polymer were joined adhered to the male mold. Eight lens-shaped two-layer polymers adhering to the male mold were plasma-treated in an oxygen atmosphere in a low-temperature ashing apparatus for 2 minutes and immersed in 5 ml of purified water, respectively. More off. A colored contact lens, which is a two-layered polymer that has been removed from the mold and became soft due to water content and swelling, was immersed in 5 ml of fresh purified water for 10 minutes at room temperature. The operation of immersing in 5 ml of fresh purified water at room temperature for 10 minutes is repeated 5 times to remove the eluting components from the colored contact lens, and the colored contact is formed in the depression in the PP container containing 1 ml of physiological saline as in Example 1. The lens was put in, the hollow of the container was sealed with the multilayer film, and autoclaved at 121 ° C. for 20 minutes. After cooling, the multilayer film was peeled off and the colored contact lens was inspected. As designed, the colored contact made of a good silicone hydrogel material and a water-containing material having a power of −3.0D, a diameter of 14.2 mm, and a center thickness of 110 μm. Eight lenses were obtained. The center thickness of the first polymer layer provided with the inner surface of the lens was 15 μm. The method for measuring the center thickness of the colored contact lens was the same as in Example 1.
Comparative Example 2
An attempt was made to produce colored contact lenses in the same manner as in Example 2. However, the thickness of the first polymer layer was designed to be 60 μm. An attempt was made to produce a colored contact lens of -3.0D, but the size of the finished colored contact lens was unstable, and 3 out of 8 out of specifications occurred. In addition, the measuring method of the center thickness of a lens and the center thickness of the 1st polymer layer provided with a lens inner surface was performed similarly to Example 1. FIG.
 実施例3
 実施例1と同様の第1及び第2の形成材料を使用し、着色コンタクトレンズの中心厚みT1、着色コンタクトレンズ内面を備える第1の重合物の厚みT2の着色コンタクトレンズを得た(度数-3.0D、直径14.2mm)。着色層の厚みは約10μmであった。レンズの中心厚みが50μm以上80μm未満の着色コンタクトレンズであって、着色コンタクトレンズの中心厚みに対する着色コンタクトレンズ内面を備える第1の重合物層の中心厚みの割合であるT1/T2が35%以下であった着色コンタクトレンズを実施例3-1及び実施例3-2として表1に示した。
 また着色コンタクトレンズ中心厚みが80μm以上200μm以下の着色コンタクトレンズであって、T2が40μm以下であった着色コンタクトレンズを実施例3-3、実施例3-4及び実施例3-5として表1に示した。それらの水和した着色コンタクトレンズから実施例1と同様にして切り出した短冊状のレンズ片の生理食塩水中における状態を表1に示した。その短冊状のレンズ片の形状が切断前の着色コンタクトレンズと同様な形状のままであった場合には◎、ほぼフラットな状態になった場合には○、切断前のレンズ形状に対して反り返った場合には△、カールした場合には×とした。
 比較例3
 実施例1と同様な第1及び第2の形成材料を使用し、着色コンタクトレンズの中心厚みT1、着色コンタクトレンズ内面を備える第1の重合物層の厚みT2の着色コンタクトレンズを得た(度数-3.0D、直径14.2mm)。着色層の厚みは約10μmであった。レンズの中心厚みが50μm以上80μm未満の着色コンタクトレンズであって、T1/T2が35%を超えた着色コンタクトレンズを比較例3-1及び比較例3-2として表1に示した。またレンズ中心厚みが80μm以上200μm以下の着色コンタクトレンズであって、T2が40μmを超えた着色コンタクトレンズを比較例3-3及び比較例3-4として表1に示した。それらの水和した着色コンタクトレンズから実施例1と同様にして切り出した短冊状のレンズ片の生理食塩水中における状態を実施例3と同様に評価して表1に示した。
 実施例3における◎又は○で示した着色コンタクトレンズは切り出した短冊状のレンズ片が適切なレンズ形状を維持しており、着色コンタクトレンズにモールド製法による応力が残留していなかったことが推定された。一方、比較例3における△又は×で示した着色コンタクトレンズは、切断前には適切なレンズ形状であっても切り出した短冊状のレンズ片が切断前のレンズ形状を保持できないことが分かり、着色コンタクトレンズにモールド製法による応力が残留していたことが推定された。
Figure JPOXMLDOC01-appb-T000001
 
Example 3
Using the same first and second forming materials as in Example 1, a colored contact lens having a center thickness T1 of the colored contact lens and a thickness T2 of the first polymer provided with the inner surface of the colored contact lens was obtained (frequency − 3.0D, diameter 14.2 mm). The thickness of the colored layer was about 10 μm. A colored contact lens having a lens center thickness of 50 μm or more and less than 80 μm, wherein T1 / T2 which is a ratio of the center thickness of the first polymer layer provided with the inner surface of the colored contact lens to the center thickness of the colored contact lens is 35% or less. The colored contact lenses that were obtained are shown in Table 1 as Example 3-1 and Example 3-2.
Further, colored contact lenses having a colored contact lens center thickness of 80 μm or more and 200 μm or less and T2 of 40 μm or less are shown as Example 3-3, Example 3-4 and Example 3-5 in Table 1. It was shown to. Table 1 shows the state of the strip-shaped lens pieces cut out from these hydrated colored contact lenses in the same manner as in Example 1 in physiological saline. When the shape of the strip-shaped lens piece remains the same as that of the colored contact lens before cutting, ◎, when it is almost flat, it is warped against the lens shape before cutting. △ when curled, and x when curled.
Comparative Example 3
Using the same first and second forming materials as in Example 1, a colored contact lens having a central thickness T1 of the colored contact lens and a thickness T2 of the first polymer layer provided with the colored contact lens inner surface was obtained (frequency) -3.0D, diameter 14.2 mm). The thickness of the colored layer was about 10 μm. Colored contact lenses having a lens center thickness of 50 μm or more and less than 80 μm and having T1 / T2 of more than 35% are shown in Table 1 as Comparative Example 3-1 and Comparative Example 3-2. Further, colored contact lenses having a lens center thickness of 80 μm or more and 200 μm or less and T2 exceeding 40 μm are shown in Table 1 as Comparative Example 3-3 and Comparative Example 3-4. The state of the strip-shaped lens pieces cut out from these hydrated colored contact lenses in the same manner as in Example 1 in physiological saline was evaluated in the same manner as in Example 3 and shown in Table 1.
In the colored contact lens indicated by ◎ or ◯ in Example 3, the cut-out strip-shaped lens piece maintains an appropriate lens shape, and it is estimated that the stress due to the molding method does not remain in the colored contact lens. It was. On the other hand, the colored contact lens indicated by Δ or × in Comparative Example 3 shows that even if it is in an appropriate lens shape before cutting, the cut-out strip-shaped lens piece cannot retain the lens shape before cutting, and coloring It was estimated that the stress due to the mold manufacturing method remained on the contact lens.
Figure JPOXMLDOC01-appb-T000001
 実施例4
 コンタクトレンズが乾燥状態になったときのコンタクトレンズ形状の保持性を調べる実験を行った。
 塩化コバルト(2)六水和物(ナカライテクス)2gを秤取り、8mlの精製水(共栄製薬)で溶解し、その20w/v%溶液を調製した。水和状態になった着色コンタクトレンズ(T1=110μm、T2=20μm、ベースカーブ(BC)8.6mm、度数-3.0D)の水分をキムワイプで十分に 拭き取った後、1mlの20w/v%塩化コバルト溶液に1時間以上浸漬させた。25℃でさらに1時間以上静置させた後、コンタクトレンズを取り出し、水分をキムワイプ(クレシア)で十分に拭き取った後、コンタクトレンズを金網の上に置き、デジタルカメラでコンタクトレンズの乾燥状態を撮影した。この時の時間を0分とした。コンタクトレンズを25℃で放置し、コンタクトレンズの経時変化を撮影した。乾燥開始5、10、15、20、25、30分、35分、40分、45分後に撮影した。コンタクトレンズに取り込まれた塩化コバルト試薬の変色(青色)によってコンタクトレンズが乾燥状態になっていくことが分かった。乾燥開始と共にコンタクトレンズの乾燥状態が進んでもコンタクトレンズの形状はほとんど変化せず、コンタクトレンズの形状安定性が維持できていることが分かった(図4)。
 比較例4
 着色コンタクトレンズ(T1=140μm,T2=100μm,BC8.6、度数-3.0D)、着色部分を持たない本発明のモールド製法による一層コンタクトレンズ(中心厚み110μm、度数-3.0D、直径14.2mm、BC8.6mm)、2WEEKメニコンデュオ(メニコン社製、中心厚み160μm、度数S-0.25D/ADD+0.50D、直径14.5mm、BC8.6mm)を用いて同様な試験を行った。着色コンタクトレンズでは乾燥状態を示す塩化コバルト試薬の変色(青色)にともなってレンズエッジがBC側に曲がり込んでコンタクトレンズ全体の形状がいびつなものに変化した。一方それら以外ではレンズ形状はほとんど変化しなかった。水和状態では適正なレンズ形状を持つものであっても、乾燥状態が進むにつれてレンズ形状が変化する着色コンタクトレンズに比較して、本発明の着色コンタクトレンズは、着色していないモールド製法によるコンタクトレンズと同様に乾燥状態が進行してもレンズの形状保持性に優れていることが分かった。また図示はしないが、着色(虹彩付き)コンタクトレンズ(1Dayアキュビューディファインvivid(ジョンソン&ジョンソン社製)、T1=73μm、T2=62μm、度数-9.0D、直径14.2mm、BC8.5mm)を用いて同様な試験を行ったところ乾燥開始30分後には乾燥状態を示す塩化コバルト試薬の変色(青色)にともなってレンズエッジがBC側に曲がり込んでコンタクトレンズ全体の形状がいびつなものに変化した。なお着色コンタクトレンズ及び着色(虹彩付き)コンタクトレンズでの着色層の厚みは約10μmであった。
Example 4
An experiment was conducted to examine the retention of the contact lens shape when the contact lens was in a dry state.
2 g of cobalt chloride (2) hexahydrate (Nacalai tex) was weighed and dissolved in 8 ml of purified water (Kyoei Pharmaceutical) to prepare a 20 w / v% solution. After thoroughly wiping off the water of the hydrated colored contact lens (T1 = 110 μm, T2 = 20 μm, base curve (BC) 8.6 mm, frequency −3.0D) with Kimwipe, 1 ml of 20 w / v% It was immersed in the cobalt chloride solution for 1 hour or more. After leaving it to stand at 25 ° C. for an additional hour or longer, remove the contact lens, thoroughly wipe off the moisture with Kimwipe (Cresia), place the contact lens on a wire mesh, and take a picture of the dry state of the contact lens with a digital camera. did. The time at this time was 0 minute. The contact lens was left at 25 ° C., and changes with time of the contact lens were photographed. Images were taken at 5, 10, 15, 20, 25, 30 minutes, 35 minutes, 40 minutes, and 45 minutes after the start of drying. It was found that the contact lens became dry due to the discoloration (blue) of the cobalt chloride reagent incorporated into the contact lens. Even when the dry state of the contact lens progressed with the start of drying, the shape of the contact lens hardly changed, and it was found that the shape stability of the contact lens could be maintained (FIG. 4).
Comparative Example 4
Colored contact lens (T1 = 140 μm, T2 = 100 μm, BC8.6, power −3.0D), single contact lens (center thickness 110 μm, power −3.0D, diameter 14) by the mold manufacturing method of the present invention having no colored portion .2 mm, BC 8.6 mm) and 2WEEK Menicon Duo (manicon, center thickness 160 μm, frequency S-0.25 D / ADD + 0.50 D, diameter 14.5 mm, BC 8.6 mm). In the colored contact lens, with the discoloration (blue) of the cobalt chloride reagent indicating the dry state, the lens edge bent to the BC side, and the shape of the entire contact lens changed to an irregular shape. On the other hand, the lens shape hardly changed in other cases. Compared to a colored contact lens that changes its shape as the drying state progresses even if it has an appropriate lens shape in the hydrated state, the colored contact lens of the present invention is a contact by a mold manufacturing method that is not colored. As with the lens, it was found that even when the dry state progressed, the lens shape retention was excellent. Although not shown, a colored (with iris) contact lens (1 Day Accuview Fine vivid (manufactured by Johnson & Johnson), T1 = 73 μm, T2 = 62 μm, power −9.0D, diameter 14.2 mm, BC 8.5 mm) When the same test was performed using 30 minutes after the start of drying, the lens edge bent to the BC side due to the discoloration (blue) of the cobalt chloride reagent indicating the dry state, and the shape of the entire contact lens became irregular. changed. In addition, the thickness of the colored layer in the colored contact lens and the colored (with iris) contact lens was about 10 μm.
 本発明は、厚み方向に2層構造を有する着色コンタクトレンズ及びその製造方法に関するもので、着色コンタクトレンズの内面を備える第1の重合物層の中心厚みを所定の厚みにすることによってレンズの形状安定性を維持し、各層に適切な素材を採用することにより、単一の素材では解決できない課題を、複数の素材を組み合わせることによって全体として解決した、有用なコンタクトレンズを提供することができる。 The present invention relates to a colored contact lens having a two-layer structure in the thickness direction and a method for producing the same, and the shape of the lens is obtained by setting the center thickness of a first polymer layer provided with the inner surface of the colored contact lens to a predetermined thickness. By maintaining stability and employing an appropriate material for each layer, it is possible to provide a useful contact lens that solves a problem that cannot be solved by a single material as a whole by combining a plurality of materials.
1、1´ 雌型
2    雄型
3、3´ 形成材料
4    空間
5    第1の重合物
6    光遮蔽物
7    第2の重合物
8    2層の重合物
α、β  レンズ中心点
1, 1 'female mold 2 male mold 3, 3' forming material 4 space 5 first polymer 6 light shield 7 second polymer 8 two-layer polymer α, β lens center point

Claims (4)

  1.  中心厚みが80μm以上200μm以下の着色コンタクトレンズであって、
      中心厚み5μm以上40μm以下の、コンタクトレンズの内面を備える第1の重合物層と、
      コンタクトレンズの外面を備える第2の重合物層と、
      前記2層の重合物層の間に光遮蔽物のパターン部分と
    を含む、前記着色コンタクトレンズ。
    A colored contact lens having a center thickness of 80 μm to 200 μm,
    A first polymer layer having an inner surface of a contact lens having a center thickness of 5 μm or more and 40 μm or less;
    A second polymer layer comprising the outer surface of the contact lens;
    The colored contact lens comprising a light shielding pattern portion between the two polymer layers.
  2.  中心厚みが50μm以上80μm未満の着色コンタクトレンズであって、
      中心厚みの下限が5μm、かつ、上限がコンタクトレンズの中心厚みに対して35%である、コンタクトレンズの内面を備える第1の重合物層と、
      コンタクトレンズの外面を備える第2の重合物層と、
      前記2層の重合物層の間に光遮蔽物のパターン部分と、
    を含む、前記着色コンタクトレンズ。
    A colored contact lens having a center thickness of 50 μm or more and less than 80 μm,
    A first polymer layer comprising the inner surface of the contact lens, wherein the lower limit of the center thickness is 5 μm and the upper limit is 35% with respect to the center thickness of the contact lens;
    A second polymer layer comprising the outer surface of the contact lens;
    A pattern portion of a light shielding material between the two polymer layers;
    The colored contact lens comprising:
  3.  一対をなす型である凸型成形面を備えた雄型と凹型成形面を備えた雌型とを型合わせして形成される空間内に、コンタクトレンズの第1のレンズ形成材料を充填して重合し第1の重合物を形成し、
     雄型と雌型を開いて第1の重合物を雄型に固定させ、
     雄型に固定された前記第1の重合物の露出表面に光遮蔽物を塗布し、
     前記第1の重合物が固定された雄型と対をなす雌型と型合わせをして形成される空間内に、前記コンタクトレンズの第2のレンズ形成材料を充填して重合し第2の重合物を形成し、
     雄型と雌型を開いて得られた2層の重合物に生理的溶液を含浸させる、
    請求項1または2に記載の着色コンタクトレンズの製造方法。
    A space formed by matching a male mold having a convex molding surface and a female mold having a concave molding surface, which are a pair of molds, is filled with the first lens forming material of the contact lens. Polymerize to form a first polymer,
    Open the male and female molds to fix the first polymer to the male mold,
    Applying a light shielding material to the exposed surface of the first polymer fixed to the male mold;
    A second lens forming material of the contact lens is filled into a space formed by matching with a female mold that forms a pair with the male mold on which the first polymer is fixed, and then polymerized. Forming a polymer,
    Impregnating a physiological solution into a two-layer polymer obtained by opening a male mold and a female mold;
    The manufacturing method of the colored contact lens of Claim 1 or 2.
  4.  一対をなす型である凸型成形面を備えた雄型と凹型成形面を備えた雌型とを型合わせして形成される空間内に、コンタクトレンズの第2のレンズ形成材料を充填して重合し第2の重合物を形成し、
     雄型と雌型を開いて第2の重合物を雌型に固定させ、
     雌型に固定された前記第2の重合物の露出表面に光遮蔽物を塗布し、
     前記第2の重合物が固定された雌型と対をなす雄型と型合わせをして形成される空間内に、前記コンタクトレンズの第1のレンズ形成材料を充填して重合し第1の重合物を形成し、
     雄型と雌型を開いて得られた2層の重合物に生理的溶液を含浸させる、
    請求項1または2に記載の着色コンタクトレンズの製造方法。
    A space formed by mating a male mold having a convex molding surface and a female mold having a concave molding surface, which are a pair of molds, is filled with a second lens forming material of a contact lens. Polymerize to form a second polymer,
    Open the male and female molds to fix the second polymer to the female mold,
    Applying a light shielding material to the exposed surface of the second polymer fixed to the female mold;
    The first lens forming material of the contact lens is filled and polymerized in a space formed by matching with the male mold that is paired with the female mold on which the second polymer is fixed. Forming a polymer,
    Impregnating a physiological solution into a two-layer polymer obtained by opening a male mold and a female mold;
    The manufacturing method of the colored contact lens of Claim 1 or 2.
PCT/JP2013/080014 2012-11-09 2013-11-06 Colored contact lens with thin inner face-side layer, and method for fabricating same WO2014073568A1 (en)

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JP2018103600A (en) * 2016-07-28 2018-07-05 株式会社キヨシ・ネットワーク Anilox roll washing equipment
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