Title of invention: Simulated sclera and simulated eyeball
Technical field
[0001]
　The present invention relates to a simulated sclera, a simulated eyeball, and a method for producing the simulated sclera.
Background technology
[0002]
　For example, for eye diseases such as cataract and glaucoma, treatment by eye surgery is adopted. On the other hand, since the eyeball is an organ related to vision, skillful technique is required for eyeball surgery. However, it is difficult to practice eye surgery in clinical practice because the guidance is heard by the patient due to local anesthesia. Therefore, a simulated eyeball is used for practicing eyeball surgery.
[0003]
　Specifically, as a simulated eyeball, a simulated eyeball including a posterior segment having a simulated retinal layer and the like and an anterior segment having a simulated sclera and a cornea have been proposed. It has also been proposed that such a simulated eyeball is fixed to a base portion with, for example, simulated muscles, housed in a housing, and used for practicing eyeball surgery (see, for example, Patent Document 1). ..
Prior art literature
Patent documents
[0004]
Patent Document 1: US Patent Application Publication No. 2016/00638889
Outline of the invention
Problems to be solved by the invention
[0005]
　However, the simulated eyeball is required to have a feel closer to that of a clinical site.
[0006]
　In particular, simulated eyeballs for glaucoma surgery practice are required to have a feeling of incision when making a cut in the sclera with a scalpel or the like, and a feeling of thinning when turning over the incised sclera. ..
[0007]
　The present invention is a simulated sclera having a feeling of cutting and thinning close to that of an actual eyeball (sclera), a simulated eyeball provided with the simulated sclera, and a method for producing the simulated sclera.
Means to solve problems
[0008]
　The present invention [1] includes a plurality of fiber layers (a) and a resin (b) in contact with the fiber layer (a), and the fiber diameter of the fibers constituting the fiber layer (a) is 0. It contains a simulated sclera that is 6 μm or more and 170.0 μm or less.
[0009]
　The present invention [2] includes the simulated sclera according to the above [1], wherein the peel strength between the plurality of fiber layers (a) is 0.20 N / cm or more.
[0010]
　The present invention [3] relates to the above [1] or [2], wherein the asker F hardness of the resin (b) is 45 or more and 95 or less, or the asker C hardness of the resin (b) is 5 or more and 35 or less. Includes the described simulated sclera.
[0011]
　The present invention [4] includes the simulated sclera according to any one of the above [1] to [3], wherein the fiber layer (a) includes a non-woven fabric.
[0012]
　In the present invention [5], the simulated sclera according to any one of the above [1] to [4], wherein the resin (b) contains polyurethane.
[0013]
　The present invention [6] further includes the simulated sclera according to any one of the above [1] to [5], which comprises a surface coating layer (c).
[0014]
　The present invention [7] includes the simulated sclera according to any one of the above [1] to [6], which is a simulated sclera for eye surgery practice.
[0015]
　The present invention [8] includes a simulated eyeball including the simulated sclera according to any one of the above [1] to [7].
[0016]
　The present invention [9] includes a plurality of fiber layers (a) and a resin (b) in contact with the fiber layer (a), and the fiber diameter of the fibers constituting the fiber layer (a) is 0. A method for producing a simulated strong film having a size of 6 μm or more and 170.0 μm or less, which comprises a step of laminating a plurality of fiber layers (a) and a step of impregnating the laminated fiber layers (a) with a resin (b). Includes a method for producing a simulated fiber.
Effect of the invention
[0017]
　The simulated sclera of the present invention includes a plurality of fiber layers (a) and a resin (b) in contact with the fiber layers (a). Therefore, only a part of the plurality of fiber layers (a) can be turned over, and a thin slice feeling close to that of the actual sclera of the eyeball can be obtained.
[0018]
　Further, the simulated sclera of the present invention has a fiber diameter of 0.6 μm or more and 170.0 μm or less of the fibers constituting the fiber layer (a). Therefore, it is possible to obtain a feeling of incision close to the sclera of the actual eyeball.
[0019]
　Further, since the simulated eyeball of the present invention includes the simulated sclera of the present invention, it has an excellent feeling of cutting and a feeling of thinning.
[0020]
　Further, according to the method for producing a simulated sclera of the present invention, it is possible to obtain a simulated sclera having an excellent feeling of cutting and thinning.
A brief description of the drawing
[0021]
FIG. 1 is a cross-sectional view of a main part of an embodiment (a form in which three or more fiber layers are laminated and arranged) of the simulated sclera and the simulated eyeball of the present invention.
FIG. 2 is a process diagram showing a method for producing the simulated sclera shown in FIG. 1, FIG. 2A is a step of laminating a plurality of fiber layers (a), and FIG. 2B is a fiber layer. The steps of arranging (a) in the mold are shown respectively.
FIG. 3 is a process diagram showing a method for producing the simulated sclera shown in FIG. 1, following FIG. 2, and FIG. 3A is a process of impregnating the fiber layer (a) with the resin (b). , And FIG. 3B show the steps of forming the surface coat layer (c), respectively.
FIG. 4 is a cross-sectional view of a main part of the simulated sclera of the present invention and another embodiment of the simulated eyeball (a form in which two fiber layers are laminated and arranged in the central portion in the thickness direction of the simulated sclera). is there.
FIG. 5 is a cross-sectional view of a main part of the simulated sclera of the present invention and another embodiment of the simulated eyeball (a form in which two fiber layers are laminated and arranged on one side in the thickness direction of the simulated sclera). Is.
FIG. 6 is a cross-sectional view of a main part of the simulated sclera of the present invention and another embodiment of the simulated eyeball (a form in which two fiber layers are laminated and arranged on the other side in the thickness direction of the simulated sclera). Is.
[Fig. 7] Fig. 7 shows a cross section of a main part of the simulated sclera of the present invention and another embodiment of the simulated eyeball (a form in which two fiber layers are arranged in the middle of the simulated sclera without being laminated). It is a figure.
FIG. 8 is a cross-sectional view of a main part of the simulated sclera of the present invention and another embodiment of the simulated eyeball (a form in which a fiber layer is arranged on the simulated cornea).
FIG. 9 is a schematic view showing a process of making a notch in the sclera of an eyeball with a knife or a scalpel in glaucoma surgery.
FIG. 10 is a schematic diagram showing a process of confirming the sclera in glaucoma surgery.
FIG. 11 is a schematic view showing a step of exfoliating and incising the sclera of the eyeball, that is, slicing it in glaucoma surgery.
FIG. 12 is a schematic view showing a process of rolling up the sclera of an eyeball in glaucoma surgery.
FIG. 13 is a schematic view showing a step of continuously exfoliating and incising the sclera of the eyeball, that is, slicing it in glaucoma surgery.
FIG. 14 is a schematic view showing a step of suturing an incision site of the sclera of an eyeball in glaucoma surgery.
FIG. 15 is a photograph of the simulated sclera for surgical practice obtained in Example 26, which has been exfoliated and incised and rolled up.
FIG. 16 is a photograph of the incision site of the simulated sclera for surgical practice obtained in Example 26 in a sutured state.
Mode for carrying out the invention
[0022]
　In FIG. 1, the simulated eyeball 1 is an artificial biological model used for various purposes described later (preferably, eyeball surgery practice use), and is continuous or discontinuous with the simulated sclera 2 and the simulated sclera 2. It includes a simulated cornea 3 to be formed.
[0023]
　Examples of the form in which the simulated sclera 2 and the simulated cornea 3 are continuously formed include, for example, a form in which the simulated sclera 2 and the simulated cornea 3 are formed by batch molding a single type of resin, for example. , A form in which the simulated cornea 3 is integrally molded with a mold in which the simulated sclera 2 once formed is set, or a form in which the simulated sclera 2 is integrally molded in a mold in which the simulated sclera 3 once formed is set. Can be mentioned.
[0024]
　Further, as a form in which the simulated sclera 2 and the simulated cornea 3 are formed discontinuously, for example, a form in which the simulated sclera 2 and the simulated cornea 3 separately formed are joined with a known adhesive. Can be mentioned.
[0025]
　Such a simulated sclera 2 is required to have a feeling of cutting (cutting property) and a feeling of thin cutting (thin cutting property) close to those of an actual sclera of the human body.
[0026]
　The feeling of cut is the feeling when a knife or scalpel is used to make a cut in the (simulated) sclera.
[0027]
　Further, the thin slice feeling is a feeling when the (simulated) sclera is exfoliated and incised from the cut portion, that is, thinly sliced.
[0028]
　Further, the simulated sclera 2 preferably has a return feeling (returnability) close to that of the actual sclera of the human body.
[0029]
　The feeling of return is the state of turning back when the (simulated) sclera after slicing is largely turned over.
[0030]
　In addition, the simulated sclera 2 preferably has a tack feeling (tackiness, surface stickiness) close to that of the actual sclera of the human body.
[0031]
　The tack feeling is the stickiness on the surface of the (simulated) sclera.
[0032]
　From these viewpoints, the simulated sclera 2 is configured as follows.
[0033]
　That is, the simulated sclera 2 is a film body that forms a sclera portion in the simulated eyeball 1, and includes a plurality of fiber layers (a) and a resin (b) that contacts the fiber layers (a). ..
[0034]
　The thickness of the simulated sclera 2 is, for example, 0.1 mm or more, preferably 0.3 mm or more, more preferably 0.5 mm or more, still more preferably 0.8 mm or more, for example, 4.0 mm or less. It is preferably 2.0 mm or less, more preferably 1.5 mm or less, and even more preferably 1.2 mm or less. The thickness of the simulated sclera 2 is particularly preferably 1.0 ± 0.2 mm, more preferably 1.0 ± 0.1 mm.
[0035]
　That is, the simulated sclera 2 is provided with a plurality of fiber layers (a) so that the total thickness thereof is within the above range, and the resin (b) is in contact with each fiber layer (a). There is.
[0036]
　The fiber layer (a) is a single layer made of fibers, and examples thereof include woven fabrics, non-woven fabrics, filters, and meshes. These can be used alone or in combination of two or more.
[0037]
　The fiber layer (a) preferably includes a woven fabric, a non-woven fabric, and a mesh, and more preferably a non-woven fabric, from the viewpoint of improving the cut feeling, thinness, and returnability. That is, the fiber layer (a) is more preferably provided with a non-woven fabric, and more preferably made of a non-woven fabric.
[0038]
　In the fiber layer (a), the fiber is not particularly limited as long as it is a material that can be cut with a knife such as a knife, but for example, polyester fiber, polyamide fiber (for example, nylon fiber), polyvinyl alcohol fiber, and polyolefin fiber. (For example, polyethylene fiber, polypropylene fiber, etc.), polyurethane fiber, cellulose-based fiber, wood fiber (for example, wood pulp, etc.) and the like can be mentioned. These can be used alone or in combination of two or more.
[0039]
　Examples of the fiber include polyester fiber, polyamide fiber, and polyolefin fiber, more preferably polyolefin fiber, and particularly preferably polypropylene fiber.
[0040]
　The fiber can be obtained by spinning a resin by a known method.
[0041]
　The fiber diameter of the fibers constituting the fiber layer (a) is 0.6 μm or more, preferably 1.0 μm or more, more preferably 2.0 μm or more, 170.0 μm or less, preferably 150.0 μm or less. , More preferably 100 μm or less, still more preferably 50.0 μm or less, still more preferably 30.0 μm or less, and particularly preferably 25.0 μm or less.
[0042]
　When the fiber diameter is in the above range, excellent cut feeling, thin cut feeling and returnability can be obtained.
[0043]
　The fiber diameter is not the fiber diameter (catalog value) of the fiber layer (a) before being molded as the simulated sclera 2, but the fiber diameter of the fiber layer (a) included in the molded simulated sclera 2. is there.
[0044]
　That is, the fiber diameter of the fiber layer (a) is not the fiber layer (a) prepared as a material, but the fiber layer (a) in the cross section of the simulated sclera 2 or the fiber layer taken out from the simulated sclera 2. Obtained from (a).
[0045]
　Specifically, such a fiber diameter is measured and calculated as an average fiber diameter of 100 fibers by observation using a microscope according to an example described later.
[0046]
　The method for adjusting the fiber diameter within the above range is not particularly limited, and is appropriately set according to the fiber manufacturing method.
[0047]
　The method for obtaining the fiber layer (a) from the above fibers is not particularly limited, and a known woven fabric manufacturing method or a known non-woven fabric manufacturing method can be adopted.
[0048]
　There are various types of non-woven fabrics, such as resin bond, chemical bond, needle punch, thermal bond, spun bond, and melt blown, depending on the production method, and they can be used alone or in combination of two or more. As a method for producing the non-woven fabric, preferably, spunbond is mentioned from the viewpoint of improving the cut feeling of the simulated sclera 2.
[0049]
　The thickness (single layer thickness) of the fiber layer (a) is, for example, 0.01 mm or more, preferably 0.05 mm or more, more preferably 0.1 mm or more, and for example, 0.5 mm or less, preferably. It is 0.4 mm or less, more preferably 0.3 mm or less.
[0050]
　The basis weight of the fiber layer (a) (the basis weight of the single layer) is, for example, 5 g / m 2 or more, preferably 10 g / m 2 or more, and for example, 50 g / m 2 or less, preferably 30 g. 　It is less than / m 2
.
[0051]
　The basis weight (single layer basis weight) is measured in accordance with JIS L1913 (2010).
[0052]
　These fiber layers (a) can be used alone or in combination of two or more.
[0053]
　The number (number of sheets) of the fiber layers (a) varies depending on the thickness (total thickness) of the simulated sclera 2 and the thickness and basis weight of each fiber layer (a), but the feeling of cutting, the feeling of thin cutting, and the return From the viewpoint of sex, it is 2 or more, preferably 3 or more, more preferably 4 or more, still more preferably 5 or more, and for example, 30 or less, preferably 20 or less, more preferably 10 or less.
[0054]
　The plurality of fiber layers (a) may be laminated so as to be in contact with each other inside the simulated sclera 2, or may be arranged at predetermined intervals so as not to be in contact with each other.
[0055]
　Preferably, the plurality of fiber layers (a) are laminated so as to be in contact with each other inside the simulated sclera 2. As a result, a laminated body (hereinafter, referred to as a fiber layer laminated body) 4 in which a plurality of fiber layers (a) are laminated and arranged is obtained.
[0056]
　In the fiber layer laminate 4, each fiber layer (a) in contact with each other may be adhered with a known adhesive (glue or the like), if necessary.
[0057]
　The resin (b) is contact-arranged on the plurality of fiber layers (a).
[0058]
　The resin (b) is not particularly limited as long as it is a material that can be sliced ​​with a knife such as a knife, but for example, polyvinylidene chloride, polyvinyl chloride, polyvinyl alcohol, polyethylene, polypropylene, polymethylpentene, polyethylene terephthalate, and polyamide. , Cellophane, polyurethane, polyethylene and other polymer materials. Further, as the resin (b), rubber and the like can also be mentioned. Examples of the rubber include silicone rubber (polydimethylsiloxane and the like), butadiene rubber, isoprene rubber, butyl rubber, fluororubber, ethylenepropylene rubber, nitrile rubber, natural rubber and the like.
[0059]
　These resins (b) can be used alone or in combination of two or more.
[0060]
　As the resin (b), polyurethane and silicone are preferable, and polyurethane is more preferable, from the viewpoint of improving the thinness feeling and the returnability.
[0061]
　The form of the resin (b) is not particularly limited, and may be, for example, a solid state, a liquid state, or a semi-solid state. The resin (b) is preferably in the form of a semi-solid, more preferably in the form of a gel.
[0062]
　In the present invention, the gel-like resin (b) is an ultra-low hardness elastomer. That is, the Asker F hardness of the resin (b) is relatively low, and / or the Asker C hardness of the resin (b) is relatively low.
[0063]
　The Asker F hardness of the resin (b) (based on JIS K7312 (1996)) is, for example, 40 or more, and 100 or less, for example.
[0064]
　The Asker C hardness of the resin (b) (based on JIS K7312 (1996)) is, for example, 0 or more, and 40 or less, for example.
[0065]
　When the Asker F hardness and / or Asker C hardness of the resin (b) is in the above range, a tactile sensation close to that of the sclera of the eyeball can be obtained.
[0066]
　Further, from the viewpoint of thinness and returnability of the simulated sclera 2, the Asker F hardness of the resin (b) (based on JIS K7312 (1996)) is preferably 45 or more, more preferably 50 or more. It is more preferably 60 or more, particularly preferably 70 or more, and preferably 95 or less, more preferably 90 or less, still more preferably 80 or less.
[0067]
　Further, from the viewpoint of thinness and returnability of the simulated sclera 2, the Asker C hardness of the resin (b) (based on JIS K7312 (1996)) is preferably 3 or more, more preferably 5 or more. Yes, and more preferably 35 or less, more preferably 30 or less, and even more preferably 25 or less.
[0068]
　That is, if the Asker F hardness of the resin (b) is in the above range, or if the Asker C hardness of the resin (b) is in the above range, a simulated sclera 2 having excellent returnability can be obtained.
[0069]
　Further, if the Asker F hardness of the resin (b) is in the above range and the Asker C hardness of the resin (b) is in the above range, a simulated sclera 2 having particularly excellent returnability can be obtained.
[0070]
　Examples of such a gel-like resin (b) include polyurethane gel and silicone gel, and more preferably polyurethane gel.
[0071]
　The method for obtaining the polyurethane gel is not particularly limited, but for example, first, a polyisocyanate component and a polyol component according to desired physical properties are appropriately selected, and they are urethanized in a predetermined mold. That is, the polyurethane gel is a reaction product of a polyisocyanate component and a polyol component.
[0072]
　Examples of the polyisocyanate component include aliphatic polyisocyanates, aromatic polyisocyanates, and aromatic aliphatic polyisocyanates. The polyisocyanate component is preferably an aliphatic polyisocyanate.
[0073]
　Examples of the aliphatic polyisocyanate include chain aliphatic diisocyanates such as hexamethylene diisocyanate (HDI) and pentamethylene diisocyanate (PDI), such as isophorone diisocyanate (IPDI), norbornan diisocyanate (NBDI), and hydrogenated xylylene diisocyanate (hydrogenated xylylene diisocyanate). Examples thereof include alicyclic diisocyanates such as H 6 XDI) and hydrogenated diphenylmethane diisocyanate (H 12 MDI), and derivatives thereof. Examples of the derivative include isocyanurate derivatives (alcohol-unmodified isocyanurate derivatives, alcohol-modified isocyanurate derivatives, etc.), biuret derivatives, allophanate derivatives, carbodiimide derivatives, polyol adducts, and the like.
[0074]
　These aliphatic polyisocyanates can be used alone or in combination of two or more.
[0075]
　Examples of the aliphatic polyisocyanate include a chain aliphatic diisocyanate and a derivative thereof from the viewpoint of obtaining a polyurethane gel having excellent mechanical properties and hardness, and more preferably hexamethylene diisocyanate (HDI) and / or pentamethylene diisocyanate. (PDI) and derivatives thereof, more preferably hexamethylene diisocyanate (HDI) and / or derivatives of pentamethylene diisocyanate (PDI), still more preferably hexamethylene diisocyanate (HDI) and / or pentamethylene. Isocyanurate derivatives of diisocyanate (PDI) are mentioned, and particularly preferably, alcohol-modified isocyanurate derivatives of hexamethylene diisocyanate (HDI) and / or pentamethylene diisocyanate (PDI) are mentioned.
[0076]
　Among hexamethylene diisocyanate (HDI) and pentamethylene diisocyanate (PDI), pentamethylene diisocyanate (PDI) is preferable from the viewpoint of improving transparency.
[0077]
　The average number of isocyanate groups of the polyisocyanate component is 2.3 or more, preferably 2.5 or more, more preferably 2.6 or more, still more preferably 2.7 or more, from the viewpoint of curability and mechanical properties. 3.2 or less, preferably 3.1 or less, more preferably 3.0 or less, still more preferably 2.9 or less.
[0078]
　Examples of the polyol component include a low molecular weight polyol having a molecular weight of less than 400 and a high molecular weight polyol having a molecular weight of 400 or more.
[0079]
　From the viewpoint of obtaining the polyurethane gel having the above-mentioned hardness, the polyol component preferably contains a high molecular weight polyol, and more preferably contains only a high molecular weight polyol.
[0080]
　The high molecular weight polyol is an organic compound having a molecular weight of two or more hydroxyl groups in the molecule (polystyrene-equivalent number average molecular weight measured by GPC) of 400 or more, preferably 500 or more, for example, 10,000 or less, preferably 8000 or less. Yes, for example, polyether polyol, polyester polyol, polycarbonate polyol, polyurethane polyol, epoxy polyol, vegetable oil polyol, polyolefin polyol, acrylic polyol, vinyl monomer modified polyol and the like. These high molecular weight polyols can be used alone or in combination of two or more.
[0081]
　As the high molecular weight polyol, a polyether polyol is preferably used from the viewpoint of the flexibility of the polyurethane gel.
[0082]
　Examples of the polyether polyol include polyoxyethylene polyol, polyoxypropylene polyol, polyoxyethylene / polyoxypropylene copolymer (random / block), polyoxytrimethylene polyol, and polytetramethylene ether polyol (crystallineity described later). Examples thereof include polyoxyalkylene polyols (such as polytetramethylene ether polyols and amorphous polytetramethylene ether polyols described later). These polyether polyols can be used alone or in combination of two or more.
[0083]
　Examples of the polyether polyol include a polyoxypropylene polyol and a polytetramethylene ether polyol from the viewpoint of moisturizing feeling, dimensional stability, mechanical properties and hardness of the polyurethane gel.
[0084]
　The polyoxypropylene polyol is an addition polymer of propylene oxide using, for example, a low molecular weight polyol or a known low molecular weight polyamine as an initiator.
[0085]
　The low molecular weight polyol is, for example, a compound having two or more hydroxyl groups in the molecule and having a molecular weight of 50 or more and less than 400, and is, for example, ethylene glycol, propylene glycol, 1,3-propanediol, or 1,4-butylene glycol. , 1,3-butylene glycol, 1,2-butylene glycol, 1,5-pentanediol, 1,6-hexanediol, neopentyl glycol, 3-methyl-1,5-pentanediol, 2,2,2- Trimethylpentanediol, 3,3-dimethylolheptan, alcoholic (C7-20) diol, 1,3- or 1,4-cyclohexanedimethanol and mixtures thereof, 1,3- or 1,4-cyclohexanediol and theirs. Divalents such as bisphenol A hydride, 1,4-dihydroxy-2-butene, 2,6-dimethyl-1-octene-3,8-diol, bisphenol A, diethylene glycol, triethylene glycol, dipropylene glycol, etc. Examples of alcohols include trihydric alcohols such as glycerin, trimethylolpropane and triisopropanolamine, and tetrahydric alcohols such as tetramethylolmethane (pentaerythritol) and diglycerin. These low molecular weight polyols can be used alone or in combination of two or more. The low molecular weight polyol preferably includes a dihydric alcohol and a trihydric alcohol, and more preferably a dihydric alcohol.
[0086]
　The polyoxypropylene polyol is obtained as a polyoxypropylene polyol having an average number of functional groups according to the number of functional groups of the initiator. For example, when an initiator having 2 functional groups is used, polyoxypropylene glycol having an average number of functional groups of 2 is obtained, and when an initiator having 3 functional groups is used, polyoxypropylene triol having an average number of functional groups of 3 is obtained. Is obtained.
[0087]
　These polyoxypropylene polyols can be used alone or in combination of two or more.
[0088]
　The polyoxypropylene polyol does not substantially contain polyoxyethylene units. "Substantially" means that it does not contain polyoxyethylene units, except for polyoxyethylene units that are inevitably mixed in. More specifically, the content of the polyoxyethylene unit is less than 1% by mass with respect to the total amount of the polyoxypropylene polyol.
[0089]
　As the polyoxypropylene polyol, preferably, a polyoxypropylene polyol having an average number of functional groups of 2 (polyoxypropylene glycol) can be mentioned.
[0090]
　Examples of the polytetramethylene ether polyol include polytetramethylene ether glycol, and more specifically, for example, a ring-opening polymer (crystalline polytetramethylene ether glycol) obtained by cationic polymerization of tetrahydrofuran and tetrahydrofuran. Examples of the polymerization unit include amorphous polytetramethylene ether glycol obtained by copolymerizing the above dihydric alcohol. In addition, crystalline means solid at room temperature (25 ° C.), and amorphous means liquid at room temperature (25 ° C.).
[0091]
　The amorphous polytetramethylene ether glycol is, for example, a copolymer of tetrahydrofuran and alkyl-substituted tetrahydrofuran (for example, 3-methyltetrahydrofuran) (tetrahydrofuran / alkyl-substituted tetrahydrofuran (molar ratio) = 15/85 to 85/15). ), For example, as a copolymer of tetrahydrofuran and branched glycol (for example, neopentyl glycol) (tetrahydrofuran / branched glycol (molar ratio) = 15/85 to 85/15). ..
[0092]
　Further, as the amorphous polytetramethylene ether glycol, a commercially available product can be used, and such commercially available products include, for example, "PTXG" series manufactured by Asahi Kasei Fibers Co., Ltd. and "PTG-L" manufactured by Hodogaya Chemical Co., Ltd. ”Series and so on.
[0093]
　Further, a plant-derived polytetramethylene ether glycol produced from a plant-based raw material such as furfural and using tetrahydrofuran as a starting material can also be used.
[0094]
　Preferred examples of the polytetramethylene ether polyol include polyoxypropylene glycol and amorphous polytetramethylene ether glycol.
[0095]
　Even in the case of obtaining a polyurethane gel, the polyol component may contain the above-mentioned low molecular weight polyol, if necessary. The content ratio of the low molecular weight polyol is appropriately set as long as the excellent effect of the present invention is not impaired.
[0096]
　Preferably, the polyol component contains only high molecular weight polyols, more preferably only polyether polyols, and even more preferably only polyoxypropylene glycol or amorphous polytetramethylene ether glycols.
[0097]
　The average number of functional groups of the polyol component is usually 2.0 or more from the viewpoint of curability, and from the viewpoint of mechanical properties, for example, 2.3 or less, preferably 2.2 or less, more preferably. It is 2.1 or less. The average number of functional groups of the polyol component is particularly preferably 2.0 from the viewpoint of moisturizing feeling and dimensional stability.
[0098]
　The average hydroxyl value (OH value) of the polyol component is, for example, 30 mgKOH / g or more, preferably 35 mgKOH / g or more, more preferably 37 mgKOH / g or more, still more preferably 40 mgKOH / g or more, for example. , 200 mgKOH / g or less, preferably 160 mgKOH / g or less, more preferably 150 mgKOH / g or less, still more preferably 130 mgKOH / g or less.
[0099]
　The number average molecular weight of the polyol component is, for example, 400 or more, preferably 500 or more, more preferably 600 or more, and for example, 10,000, preferably 7,000 or less, more preferably 5000 or less, still more preferably. It is 3000 or less, particularly preferably 2000 or less.
[0100]
　Then, in order to obtain a polyurethane gel, the polyisocyanate component and the polyol component are preferably subjected to a urethanization reaction (solvent-free reaction, bulk polymerization) in the absence of a solvent.
[0101]
　In the urethanization reaction, for example, a known method such as a one-shot method or a prepolymer method is adopted, and a one-shot method is preferably adopted. In the one-shot method, for example, the equivalent ratio (NCO / hydroxyl group) of the isocyanate group in the polyisocyanate component to the hydroxyl group in the polyol component of the polyisocyanate component and the polyol component is, for example, 0.58 or more, preferably 0.58 or more. 0.60 or more, more preferably 0.62 or more, and for example, 1.2 or less, preferably 1.1 or less, more preferably 1.05 or less, still more preferably less than 1.0, in particular. After being formulated (mixed) so as to be preferably 0.95 or less, it is cured at, for example, room temperature to 120 ° C., preferably room temperature to 100 ° C. for, for example, 5 minutes to 72 hours, preferably 2 to 10 hours. React. The curing temperature may be a constant temperature, or may be raised or cooled stepwise.
[0102]
　Further, in the above reaction, if necessary, known additives such as urethanization catalysts (amines, organic metal compounds, etc.), plasticizers (ester-based plasticizers, etc.), storage stabilizers, antiblocking agents, etc. , Heat-resistant stabilizers, light-resistant stabilizers, ultraviolet absorbers, antioxidants, antifoaming agents, mold release agents, pigments, dyes, lubricants, fillers, hydrolysis inhibitors and the like can be blended at appropriate timings. The blending amount of the additive is appropriately set according to the purpose and application.
[0103]
　As a result, a polyurethane gel can be obtained as the resin (b).
[0104]
　The arrangement of the resin (b) is not particularly limited as long as it is in contact with the fiber layer (a). For example, the resin (b) may be laminated on the fiber layer (a), or the resin (b) may be laminated on the fiber layer (a). The fiber layer (a) may be impregnated with the resin (b).
[0105]
　For example, the resin (b) can be laminated on the surface of the fiber layer (a) by causing the above reaction on the surface of the fiber layer (a) to obtain the resin (b). Further, separately from the fiber layer (a), a layer made of the resin (b) can be obtained by the above reaction, and the obtained resin (b) can be laminated on the fiber layer (a).
[0106]
　Further, the fiber layer (a) can be impregnated with the resin (b) by causing the above reaction inside the fiber layer (a) to obtain the resin (b). Preferably, the fiber layer (a) is impregnated with the resin (b).
[0107]
　As a result, a simulated sclera 2 containing the plurality of fiber layers (a) and the resin (b) in contact with the fiber layers (a) can be obtained.
[0108]
　Further, the simulated sclera 2 can include other layers in addition to the fiber layer (a) and the resin (b).
[0109]
　More specifically, the simulated sclera 2 can be provided with a surface coat layer (c) on its surface (one surface and / or the other surface), for example. If the simulated sclera 2 includes the surface coat layer (c), the stickiness of the surface can be suppressed.
[0110]
　The surface coat layer (c) is not particularly limited, and examples thereof include a resin layer. The resin forming the resin layer is not particularly limited as long as it is a material that can be sliced ​​with a cutting tool such as a knife, as in the resin (b) described above, but for example, polyvinylidene chloride, polyvinyl chloride, polyvinyl alcohol, etc. Examples thereof include polymer materials such as polyethylene, polypropylene, polymethylpentene, polyethylene terephthalate, polyamide, cellophane, polyurethane, and silicone. Further, examples of the resin include rubber and the like. Examples of the rubber include silicone rubber (polydimethylsiloxane and the like), butadiene rubber, isoprene rubber, butyl rubber, fluororubber, ethylenepropylene rubber, nitrile rubber, natural rubber and the like.
[0111]
　These resins can be used alone or in combination of two or more.
[0112]
　As the resin, polyurethane is preferably used from the viewpoint of suppressing the stickiness of the surface. That is, as the surface coat layer (c), a polyurethane layer is preferably mentioned.
[0113]
　The method for forming the surface coat layer (c) is not particularly limited, and a known method is adopted.
[0114]
　For example, a known coating agent is applied to the surface of a composite material (hereinafter, referred to as resin-fiber composite material 5) containing the fiber layer (a) and the resin (b) obtained as described above and cured. ..
[0115]
　As a result, the surface coat layer (c) is obtained.
[0116]
　The surface coat layer (c) can be formed on one surface and / or the other surface of the resin-fiber composite material 5. Preferably, the surface coat layer (c) is formed on one side and the other side (both sides) of the resin-fiber composite material 5.
[0117]
　In such a case, the thickness of the resin-fiber composite material 5 is, for example, 0.5 mm or more, preferably 0.8 mm or more, for example, 1.5 mm or less, preferably 1.2 mm or less.
[0118]
　The thickness of each surface coat layer (c) is, for example, 5 μm or more, preferably 10 μm or more, and for example, 100 μm or less, preferably 50 μm or less.
[0119]
　The ratio of the thickness of the surface coat layer (c) to the thickness of the resin-fiber composite material 5 (thickness of the surface coat layer (c) / thickness of the resin-fiber composite material 5) is, for example, 0.005 or more. It is preferably 0.01 or more, for example, 0.1 or less, preferably 0.05 or less.
[0120]
　The thickness of the simulated sclera 2 is the total thickness of the resin-fiber composite material 5 and the thickness of the surface coat layer (c) formed as needed. As described above, for example, 0.5 mm. The above is preferably 0.8 mm or more, for example, 1.5 mm or less, preferably 1.2 mm or less. The thickness of the simulated sclera 2 is particularly preferably 1.0 ± 0.2 mm, more preferably 1.0 ± 0.1 mm.
[0121]
　The simulated cornea 3 is a membrane body that forms a corneal portion in the simulated eyeball 1, and is, for example, made of the same resin as the resin (b) in the simulated sclera 2 and integrally formed with the simulated sclera 2. Has been done.
[0122]
　The simulated cornea 3 is not limited to the above, and may be formed of, for example, a resin different from the resin (b) of the simulated sclera 2. Further, the simulated cornea 3 may be formed as a separate body from the simulated sclera 2 and may be adhered to the simulated sclera 2 with an adhesive or the like.
[0123]
　The thickness of the simulated cornea 3 is substantially the same as the thickness of the simulated sclera 2, and is, for example, 0.5 mm or more, preferably 0.8 mm or more, for example, 1.5 mm or less, preferably 1.2 mm or less. ..
[0124]
　The simulated sclera 2 includes a plurality of fiber layers (a) and a resin (b) that comes into contact with the fiber layers (a). Therefore, only a part of the plurality of fiber layers (a) can be turned over, and a thin slice feeling close to that of the actual sclera of the eyeball can be obtained.
[0125]
　Further, the simulated sclera 2 has a fiber diameter of 0.6 μm or more and 170.0 μm or less of the fibers constituting the fiber layer (a). Therefore, it is possible to obtain a feeling of incision close to the sclera of the actual eyeball. Further, since the simulated eyeball 1 includes the simulated sclera 2, it has an excellent feeling of cutting and a feeling of thinning.
[0126]
　More specifically, in the simulated sclera 2, the peel strength between the plurality of fiber layers (a) is, for example, 0.15 N / cm or more, preferably 0.20 N / cm or more, more preferably 0. .50 N / cm or more, more preferably 0.80 N / cm or more, for example, 10.00 N / cm or less, preferably 8.00 N / cm or less, more preferably 5.00 N / cm or less. ..
[0127]
　When the peel strength between the fiber layers (a) is within the above range, the cut feeling, the thin cutting feeling, and the returnability are excellent. Therefore, the simulated sclera 2 and the simulated eyeball 1 can be suitably used in various uses described later, particularly in practice of eyeball surgery such as glaucoma surgery.
[0128]
　The peel strength between the fiber layers (a) can be measured in accordance with JIS K6854-2 (1999).
[0129]
　Hereinafter, the method for producing the simulated eyeball 1 and the simulated sclera 2 will be described in detail with reference to FIG.
[0130]
　In this method, first, as shown in FIG. 2A, a plurality of fiber layers (a) are laminated (lamination step).
[0131]
　The method of laminating the fiber layer (a) is not particularly limited, and a known method is adopted.
[0132]
　As described above, the number of fiber layers (a) is 2 or more, preferably 3 or more, more preferably 4 or more, still more preferably 5 or more, and for example, 30 or less, preferably 20 or less. Preferably, it is 10 or less.
[0133]
　Further, if necessary, a known adhesive (glue or the like) can be used to bond the laminated fiber layers (a) to each other.
[0134]
　As a result, the fiber layer laminate 4 is obtained as a laminate of the plurality of fiber layers (a).
[0135]
　Then, in this method, as shown in FIGS. 2B and 3A, the laminated fiber layer (a) is impregnated with the resin (b) (impregnation step).
[0136]
　More specifically, first, as shown in FIG. 2B, a mold 11 for forming a simulated eyeball is prepared.
[0137]
　The mold 11 is a mold formed according to the shapes of the simulated sclera 2 and the simulated cornea 3. Specifically, the mold 11 includes a convex mold M1 and a concave mold M2, and can form a simulated sclera 2 and a simulated cornea 3 in the gap between the convex mold M1 and the concave mold M2.
[0138]
　Then, in this step, the fiber layer laminate 4 obtained above is arranged in the gap between the convex mold M1 and the concave mold M2. For example, the fiber layer laminate 4 is placed on the concave surface of the concave mold M2, and the convex mold M1 is inserted from above (see the broken line in FIG. 2B).
[0139]
　On the other hand, the above-mentioned polyisocyanate component and the above-mentioned polyol component are prepared and mixed to obtain a raw material mixture.
[0140]
　Next, the above raw material mixture is poured into the gap between the convex mold M1 and the concave mold M2. As a result, each fiber layer (a) of the fiber layer laminate 4 is impregnated with the raw material mixture before the reaction of the raw material mixture. Then, the raw material mixture impregnated in each fiber layer (a) is subjected to a urethanization reaction under the above-mentioned conditions.
[0141]
　As a result, as shown in FIG. 3A, as the resin (b) impregnated in each fiber layer (a), a polyurethane gel impregnated in each fiber layer (a) is obtained.
[0142]
　That is, a resin-fiber composite material 5 including the fiber layer laminate 4 and the polyurethane gel (resin (b)) impregnated in each fiber layer (a) is obtained.
[0143]
　Further, in this step, in the portion where the fiber layer laminate 4 is not arranged, the raw material composition is cured without being impregnated with the fiber layer (a), and a simulated cornea 3 is formed.
[0144]
　Then, if necessary, as shown in FIG. 3B, the mold 11 is removed, and the surface (preferably both sides) of the resin-fiber composite material 5 is coated with the above-mentioned known coating agent, if necessary. , Dry and cure.
[0145]
　As a result, the surface coat layer (c) is formed on the surface of the resin-fiber composite material 5.
[0146]
　As a result, it is possible to obtain a simulated sclera 2 containing a plurality of fiber layers (a) and a resin (b) in contact with the fiber layers (a), and optionally having a surface coating layer (c).
[0147]
　Along with this, it is possible to obtain a simulated eyeball 1 including a simulated sclera 2 and a simulated cornea 3.
[0148]
　Then, according to the method for producing the simulated sclera 2 described above, it is possible to obtain a simulated sclera having an excellent feeling of cutting and thinning.
[0149]
　Therefore, the simulated sclera 2 obtained by the method for producing the simulated sclera 2 and the simulated eyeball 1 provided with the simulated sclera 2 are used in various uses described later, particularly in practice of eye surgery such as glaucoma surgery. It can be preferably used.
[0150]
　In the above description, a plurality of (preferably 5 to 10) fiber layers (a) are laminated to form the fiber layer laminate 4, but the number of fiber layers (a) is two or more. If there is, there is no particular limitation. For example, the fiber layer laminate 4 can be formed by laminating two fiber layers (a).
[0151]
　In such a case, the fiber layer laminate 4 composed of the two fiber layers (a) may be arranged substantially in the middle portion in the thickness direction of the simulated sclera 2, as shown in FIG. 4, for example. , As shown in FIG. 5, may be arranged on one side (inside the eyeball) of the simulated sclera 2 in the thickness direction, and as shown in FIG. 6, the other side of the simulated sclera 2 in the thickness direction (inside the eyeball). It may be located on the outside of the eyeball).
[0152]
　Further, the simulated sclera 2 may include a plurality of fiber layers (a) that are not laminated. Specifically, as shown in FIG. 7, a plurality of fiber layers (a) may be arranged in the resin (b) at predetermined intervals from each other. In that case, each fiber layer (a) may be arranged substantially in the middle of the simulated sclera 2 in the thickness direction, or may be arranged on one side (inside the eyeball) of the simulated sclera 2 in the thickness direction. , The simulated sclera 2 may be arranged on the other side (outside the eyeball) in the thickness direction.
[0153]
　Further, in the above description, the fiber layer (a) is arranged on the simulated sclera 2 and not on the simulated cornea 3, but the fiber layer (a) is arranged at least on the simulated sclera 2. Just do it. That is, for example, the fiber layer (a) may be arranged on both the simulated sclera 2 and the simulated cornea 3.
[0154]
　In such a case, the fiber layer (a) may be arranged, for example, on one side of the simulated sclera 2 and the simulated cornea 3 in the thickness direction (inside the eyeball (see FIG. 5)), or the simulated sclera 2 And the simulated cornea 3 may be arranged on the other side in the thickness direction (outside the eyeball (see FIG. 6)).
[0155]
　Preferably, as shown by a thick line in FIG. 8, the fiber layer (a) is arranged on one side (inside the eyeball) in the thickness direction of the simulated sclera 2 and the simulated cornea 3.
[0156]
　In addition, in the above description, the simulated sclera 2 is manufactured as a part of the simulated eyeball 1, but for example, only the simulated sclera 2 may be manufactured. In such a case, the shape of the simulated sclera 2 is not limited to the shape of the simulated eyeball 1 described above, and may be, for example, a flat plate shape.
[0157]
　The simulated sclera 2 and the simulated eyeball 1 can be used for various purposes.
[0158]
　Applications of the simulated sclera 2 and the simulated eyeball 1 include, for example, examination and practice of ophthalmic medical behavior and ophthalmic medical behavior, as shown below.
[0159]
　(1) Eye Surgery Practice
　Examples of the above-mentioned simulated sclera 2 and simulated eyeball 1 are used for eye surgery practice. That is, the simulated sclera 2 and the simulated eyeball 1 can efficiently and effectively improve surgical technique skills, increase the number of doctors with high skills, and provide safety and security to society.
[0160]
　More specifically, for example, the simulated sclera 2 and the simulated eyeball 1 can be used for acquiring an initial stage surgical technique for residents, young doctors, and the like.
[0161]
　Further, for example, the simulated sclera 2 and the simulated eyeball 1 can be used for mastering the surgical technique by repeating the practice and for re-learning the surgical technique acquired in the past.
[0162]
　Further, for example, in preoperative training (patient model) corresponding to each patient and, for example, acquisition of surgical technique for a special symptom (special lesion model), the above-mentioned simulated sclera 2 and simulated eyeball 1 can be used. it can.
[0163]
　(2) Quantitative Measurement and Evaluation of Surgical Procedures
　Examples of the above-mentioned applications of the simulated sclera 2 and the simulated eyeball 1 include quantitative measurement and evaluation of surgical procedures. By using the simulated sclera 2 and the simulated eyeball 1 in such an application, the surgical technique that relies on the conventional sensibility of a doctor can be quantitatively quantified and widely shared and applied.
[0164]
　More specifically, for example, by using the simulated sclera 2 and the simulated eyeball 1 in combination with a known sensor or the like, the surgical procedure can be converted into quantitative data.
[0165]
　Then, the obtained data can be converted into big data and used for formulating the skill level by machine learning. Further, for example, the simulated sclera 2 and the simulated eyeball 1 can be used for practice based on the surgical technique of a skilled doctor, grasping the proficiency level based on the surgical technique of a skilled doctor, and the like.
[0166]
　Furthermore, the obtained data can be used for a program in operating a surgical robot.
[0167]
　(3) Examination and practice of improvement of surgical method and treatment method The
　uses of the simulated sclera 2 and the simulated eyeball 1 described above include, for example, the use of improving the surgical method, the use of improving the surgical technique, and the use of improving the treatment method. Applications and their practice applications can be mentioned.
[0168]
　More specifically, for example, the above-mentioned simulated sclera 2 and simulated eyeball 1 are used in order to examine improvement of defects in existing surgical methods, surgical techniques, treatment methods (treatment methods other than surgery), and the like. Can be done.
[0169]
　In addition, the simulated sclera 2 and the simulated eyeball 1 can be used in practice for learning improved surgical methods, surgical techniques, treatment methods (treatment methods other than surgery), and the like.
[0170]
　(4) Examination and practice of improvement of instruments and devices used for surgery and treatment
　Examples of the above-mentioned simulated sclera 2 and simulated eyeball 1 include improvement of instruments and devices used for surgery and treatment. Examples include applications for study and applications for practicing the use of improved products.
[0171]
　More specifically, for example, the simulated sclera 2 and the simulated eyeball 1 can be used in order to examine improvement of defects in existing instruments and devices used for eye surgery, treatment, and the like.
[0172]
　In addition, the simulated sclera 2 and the simulated eyeball 1 can be used in practice for learning how to use the improved instruments and devices.
[0173]
　(5) Development and practice of new surgical methods, new surgical techniques, new treatment methods, etc.
　The applications of the simulated sclera 2 and simulated eyeball 1 described above include, for example, the development of new surgical methods, new surgical techniques, new treatment methods, etc. Uses and practice uses for the new method.
[0174]
　More specifically, for example, the simulated sclera 2 and the simulated eyeball 1 can be used in studies for developing a new surgical method, a new surgical technique, and a new treatment method.
[0175]
　Further, for example, the simulated sclera 2 and the simulated eyeball 1 can be used in practice for learning a new surgical method, a new surgical technique, and a new treatment method.
[0176]
　(6) Development and practice of use of new instruments and new devices used for surgery and treatment
　Examples of the above-mentioned simulated sclera 2 and simulated eyeball 1 are new instruments and new devices used in surgical methods and treatment methods. Development applications such as, and usage practice applications of the developed products can be mentioned.
[0177]
　More specifically, for example, the simulated sclera 2 and the simulated eyeball 1 can be used to develop a new surgical method for the eyeball, a new instrument or a new device used for a new eyeball treatment, or the like. it can. In addition, the simulated sclera 2 and the simulated eyeball 1 can be used in order to develop a new instrument or a new device used for an improved eye surgery method, an improved eyeball treatment, or the like. Furthermore, the above-mentioned simulated sclera 2 and simulated eyeball 1 can be used in order to develop a new instrument or a new device used for the current eyeball surgery method, the current eyeball treatment, and the like.
[0178]
　In addition, the simulated sclera 2 and the simulated eyeball 1 can be used in practice for learning how to use these new devices and new devices.
[0179]
　In these various applications, by using the simulated sclera 2 and the simulated eyeball 1, it is possible to clear ethical issues such as not using the human eye, and more efficiently and effectively, improvement of the prior art. You can study the development of new technologies and practice those improved technologies and new technologies.
[0180]
　(7) Utilization in the medical system
　Examples of the use of the simulated sclera 2 and the simulated eyeball 1 in the medical system include utilization in the medical system. By using the simulated sclera 2 and the simulated eyeball 1 in such an application, it is possible to clear ethical issues such as not using the human eye, and further, efficiently and effectively develop medical human resources. Because it can be used, it can be used in various medical systems.
[0181]
　More specifically, the simulated sclera 2 and the simulated eyeball 1 can be used, for example, as standard counterfeit products that contribute to the formulation of a new medical system, and in, for example, in a certified medical system, a specialist system, and the like. It can be used as a test mock product.
[0182]
　(8) Development, improvement and practice of use of medical robots, medical support robots, etc.
　Examples of the above-mentioned simulated strong membrane 2 and simulated eyeball 1 are medical robots (particularly surgical robots) and medical support robots (particularly surgery). Assistance robots) development applications and practice applications for learning their operations can be mentioned.
[0183]
　In other words, the above-mentioned simulated sclera 2 and simulated eyeball 1 were examined for the development and improvement of medical robots and medical support robots that are expected to perform advanced medical practices that are difficult for humans and medical practices by remote control. the use, in a manner to clear the ethical problems, efficiently and effectively can be carried out, further, can be utilized to practice to master such improved products operation
　(9) use of the medical team
　of the Applications of the simulated sclera 2 and the simulated eyeball 1 include, for example, utilization in team medical care.
[0184]
　More specifically, the surgical site requires the support of assistants and nurses and is organized as a team to perform the surgery smoothly and quickly. Therefore, by constructing a system for practicing as a team in advance, the people who participated in the team can take effective organizational actions at an early stage. In this regard, the simulated sclera 2 and the simulated eyeball 1 can be used in the simulated practice of the behaviors and actions of the collaborators during the surgery and in the preliminary examination of the collaborative work before the surgery.
[0185]
　In addition to the above-mentioned examination and practice of ophthalmic medical practice and ophthalmic medical practice, the above-mentioned simulated sclera 2 and simulation are used in various fields where a simulated human body model is required (for example, a human body model for exhibition). Eyeball 1 can be used.
[0186]
　Since the simulated sclera 2 and the simulated eyeball 1 are excellent in the feeling of cutting and thinning, they are preferably used in the above-mentioned examination and practice of ophthalmic medical behavior and ophthalmic medical behavior.
[0187]
　The simulated sclera 2 and the simulated eyeball 1 are more preferably used in eye surgery practice applications, and particularly preferably used in eye glaucoma surgery practice.
[0188]
　In the practice of glaucoma surgery of the eyeball using the simulated eyeball 1, a known surgical method is adopted, and specifically, for example, trabecular incision (travecrotomy) is adopted.
[0189]
　Trabecular incision (travecrotomy) is a physiological incision that improves the inflow of aqueous humor from the anterior chamber into the aqueous humor by incising the para-Schlem canal endothelial reticular tissue, which is said to have high resistance to aqueous humor outflow. This is a technique that attempts to rebuild the aqueous humor outflow channel.
[0190]
　More specifically, in this method, first, as shown in FIG. 9, the sclera (simulated sclera 2 in FIG. 1) of the eyeball (simulated eyeball 1 in FIG. 1) is substantially U-shaped with a knife or a scalpel. Cut into a shape. At this time, one of the more specific processes is to first make a cut in the circumferential direction of the eyeball (horizontal direction of the paper surface), and then make a cut in the radial direction of the eyeball (longitudinal direction of the paper surface) so as to connect to one end of the cut in the circumferential direction. After that, as shown by the virtual line in FIG. 9, the cut is made in the radial direction of the eyeball (longitudinal direction on the paper surface) so as to be connected to the other end of the cut in the circumferential direction.
[0191]
　Then, in this method, as shown in FIG. 10, the sclera (simulated sclera 1 in FIG. 1) grasps the incision angle of the sclera (simulated sclera 2 in FIG. 1) and pulls toward the cornea while pulling the sclera (simulated sclera 2 in FIG. 1). Check the thickness of the simulated sclera 2) in FIG.
[0192]
　Then, as shown in FIG. 11, the sclera (simulated sclera 2 in FIG. 1) is pulled toward the cornea to stretch the sclera fibers (fiber layer (a) of the simulated sclera 2 in FIG. 1). A peel incision, i.e., a thin slice, is made while maintaining the incision depth so as to pay for the site. Then, as shown in FIG. 12, the peeled portion is rolled up, and it is confirmed that the peeled incision, that is, the thin slice has reached the boundary between the cornea (simulated cornea 3 in FIG. 1) and the sclera.
[0193]
　Then, as shown in FIG. 13, a part of the incised portion is grasped and pulled toward the cornea, and the scleral fibers (fiber layer (a) of the simulated sclera 2 in FIG. 1) are further stretched to extend the site. To pay, proceed with a detachment incision, i.e., a slice. Then, although not shown, it is confirmed that the Schlemm's canal has been reached, and the trabecular meshwork is incised. Then, as shown in FIG. 14, the incision site of the sclera (simulated sclera 2 in FIG. 1) is sutured.
[0194]
　In glaucoma surgery by such a method, practice of scleral incision and exfoliation incision (thin incision) is required.
[0195]
　In this regard, since the simulated sclera 2 and the simulated eyeball 1 are excellent in the feeling of incision and thinning, the above-mentioned incision and exfoliation incision (thin cutting) of the sclera are practiced with a feeling close to that of the human eyeball. Can be done (FIGS. 9-11 and 13).
[0196]
　Further, since the simulated sclera 2 and the simulated eyeball 1 can improve the feeling of return, the sclera hoisting (FIG. 12) can be practiced with a feeling close to that of the human eyeball. ..
[0197]
　That is, by using the simulated sclera 2 and the simulated eyeball 1, it is possible to practice glaucoma surgery on the eyeball with a feeling close to that of the human eyeball.
Example
[0198]
　Next, the present invention will be described based on Production Examples, Examples and Comparative Examples, but the present invention is not limited to the following examples. In addition, "part" and "%" are based on mass unless otherwise specified. In addition, specific numerical values ​​such as the compounding ratio (content ratio), physical property values, parameters, etc. used in the following description are described in the above-mentioned "mode for carrying out the invention", and the compounding ratios corresponding to them ( Substitute the upper limit value (value defined as "less than or equal to" or "less than") or the lower limit value (value defined as "greater than or equal to" or "excess") such as content ratio), physical property value, and parameters. be able to.
[0199]
　In addition, the measurement methods adopted in each production example, each example, and each comparative example are described below.
[0200]
　1. 1. Measuring method
< Measuring method of average fiber diameter of fiber layer before simulated sclera molding> The
　fiber layer prepared as a material was observed using a microscope VHX-D510 manufactured by KEYENCE CORPORATION, and the fiber diameter was measured. The average value measured of 100 fibers was taken as the fiber diameter of the fiber layer before molding (that is, the material before molding).
The basis weight of the fiber layer was measured in accordance with JIS L1913 (2010).
The fiber layer thickness was measured under the condition of a load of 100 gf / cm 2 in accordance with JIS L1913 (2010) .
[0201]
　 Using a
　potential differential titrator (manufactured by Kyoto Denshi Kogyo Co., Ltd., model number: AT-510), JIS K-1603-1 ( The isocyanate group concentration (isocyanate group content) was measured by the toluene / dibutylamine / hydrochloric acid method based on (2007), and the conversion rate of the isocyanate group of the measurement sample was calculated by the following formula.
[0202]
　Isocyanate group conversion rate = 100- (Isocyanate group concentration in the reaction mixture after the reaction / Isocyanate group concentration in the reaction solution before the reaction x 100)

　International Publication No. 2012/121291 Pentamethylene diisocyanate or commercially available hexamethylene diisocyanate produced in the same manner as in Example 1 in the specification of the No. pamphlet was used as a standard substance, labeled with dibenzylamine, and chromatograph obtained under the following HPLC measurement conditions. The concentration of unreacted isocyanate monomer (pentamethylene diisocyanate monomer or hexamethylene diisocyanate monomer) was calculated from the calibration line prepared from the area value of gram.
[0203]
　Equipment; Prominence (manufactured by Shimadzu Corporation)
　Pump LC-
　20AT Degassa DGU-20A3
　Auto sampler SIL-20A
　column Constant temperature bath COT-20A
　detector SPD-20A
　column; SHISEIDO SILICA SG-120
　Column temperature; 40 ° C.
　Eluent; n- Hexane / methanol / 1,2-dichloroethane = 　90/5/5 (volume ratio)
　Flow rate; 0.2 mL / min
Detection method; UV225 nm

　E-type viscometer manufactured by Toki Sangyo Co., Ltd. Using a TV-30 (rotor angle: 1 ° 34', rotor radius: 24 cm), measure the viscosity of the sample measured at 25 ° C. in accordance with the JIS K5600-2-3 (2014) cone plate viscometer method. It was measured. The rotation speed of the cone plate at the time of measurement was sequentially changed from 100 rpm to 2.5 rpm as the viscosity increased.
< 1 Mol ratio of allophanate group and isocyanurate group by 1 H-NMR> 1 under
　the following equipment and conditions 1 H-NMR was measured, and the content ratio of allophanate group to 1 mol of isocyanurate group (molar ratio of allophanate group / isocyanurate group) in the aliphatic polyisocyanate was calculated by the following formula. Incidentally, as a reference for the chemical shift ppm, D 6 using tetramethylsilane -DMSO solvent (0 ppm).
[0204]
　Device; JNM-AL400 (manufactured by JEOL)
　conditions; measurement frequency: 400 MHz, solvent: D 6 -DMSO, solute concentration: 5 wt%
　isocyanurate group (methylene group directly bonded to the isocyanurate group (CH 2 protons group)) Attribution peak (6H): 3.8ppm
　allophanate group (NH group in allophanate group) proton attribution peak (1H): 8.3-8.7ppm
　allophanate group / isocyanurate group (molar ratio) = allophanate group Integrated value of proton attribution peak / (Integrated value of proton attribution peak of isocyanurate group / 6)
　Average number of isocyanate groups of aliphatic polyisocyanate, isocyanate group concentration, solid content concentration It was calculated by the following formula from (NV) and the number average molecular weight of gel permeation chromatography measured under the following devices and conditions.
[0205]
　Average number of isocyanate groups = A / B × C / 42.02
　(In the formula, A indicates the isocyanate group concentration, B indicates the solid content concentration, and C indicates the number average molecular weight.)
　Equipment: HLC-8220 GPC (Made by Tosoh)
　Column: TSKgelG1000HXL, TSKgelG2000HXL, and TSKgelG3000HXL (manufactured by Tosoh) are connected in series
　Detector: Differential refractive index meter
　Measurement conditions
　Injection amount: 100 μL
　Eluent: tetrahydrofuran
　Flow rate: 0.8 mL / min
　Temperature: 40 ° C
　Calibration line: Standard polyethylene oxide in the range of 106 to 22450 (manufactured by Toso, trade name: TSK standard polyethylene oxide)
The
　hydroxyl value of potassium hydroxide corresponding to the hydroxyl group in 1 g of polyoxyalkylene polyol. Defined as mg number. Then, the hydroxyl value of the polyol was measured according to JIS K1557 (2007) Section 6.4 “Hydroxylity value”.
[0206]
　2. 2. Raw Material
(1) Fiber Layer (A) The
　following fiber layers were prepared.
[0207]
　Fiber layer (a-1): Average fiber diameter (material before molding) 15.0 μm, grain size 15 g / m 2 , thickness 0.18 mm, obtained by thermal embossing of the spunbond method using polypropylene resin . The non-woven fabric was used as a fiber layer (a-1).
[0208]
　Fiber layer (a-2): Average fiber diameter (material before molding) 20.0 μm, grain size 20 g / m 2 , thickness 0.21 mm, obtained by thermal embossing of the spunbond method using polypropylene resin . The non-woven fabric was used as a fiber layer (a-2).
[0209]
　Fiber layer (a-3): A non-woven fabric having an average fiber diameter (material before molding) of 0.46 μm, a basis weight of 15 g / m 2 , and a thickness of 0.16 mm obtained by calendar processing of the melt blown method using polypropylene resin. , The fiber layer (a-3).
[0210]
　Fiber layer (a-4): A non-woven fabric having an average fiber diameter (material before molding) of 0.60 μm, a basis weight of 15 g / m 2 , and a thickness of 0.16 mm obtained by calendar processing of the melt blown method using polypropylene resin. , Fiber layer (a-4).
[0211]
　Fiber layer (a-5): A non-woven fabric having an average fiber diameter (material before molding) of 0.90 μm, a basis weight of 15 g / m 2 , and a thickness of 0.16 mm obtained by calendar processing of the melt blown method using polypropylene resin. , The fiber layer (a-5).
[0212]
　Fiber layer (a-6): Average fiber diameter (material before molding) 20.1 μm, grain size 16 g / m 2 , thickness 0.18 mm, obtained by thermal embossing of the spunbond method using polypropylene resin . The non-woven fabric was used as a fiber layer (a-6).
[0213]
　Fiber layer (a-7): Average fiber diameter (material before molding) 20.3 μm, grain size 30 g / m 2 , thickness 0.28 mm, obtained by thermal embossing of the spunbond method using polypropylene resin . The non-woven fabric was used as a fiber layer (a-7).
[0214]
　Fiber layer (a-8): Average fiber diameter (material before molding) 33.0 μm, grain size 15 g / m 2 , thickness 0.20 mm, obtained by thermal embossing of the spunbond method using polypropylene resin . The non-woven fabric was used as a fiber layer (a-8).
[0215]
　Fiber layer (a-9): Average fiber diameter (material before molding) 34.9 μm, basis weight 100 g / m 2 , thickness 1 obtained by single-layer needle punching by the spunbond method using polypropylene resin. A .40 mm non-woven fabric was used as a fiber layer (a-9).
[0216]
　Fiber layer (a-10): manufactured by Clever: Trade name: Polypropylene mesh Wire diameter 100 μm, thickness 0.195 mm
　The basis weight of the fiber layer (a-10) was 28.8 g / m 2 .
[0217]
　Fiber layer (a-11): manufactured by Clever: Trade name: Polypropylene mesh Wire diameter 150 μm, thickness 0.315 mm
　The basis weight of the fiber layer (a-11) was 49.0 g / m 2 .
[0218]
　Fiber layer (a-12): manufactured by Clever: Trade name: Polypropylene mesh Wire diameter 200 μm, thickness 0.350 mm
　The basis weight of the fiber layer (a-12) was 67.0 g / m 2 .
[0219]
　Fiber layer (a-13): JIS L0803 compliant dyed white cloth nylon for fastness test, purchased from Japanese Standards Association Webdesk The
　fiber layer (a-13) has an average fiber diameter (material before molding) of 19.3 μm and a grain. The amount was 29.1 g / m 2 and the thickness was 0.106 mm.
[0220]
　Fiber layer (a-14): JIS L0803 compliant dyeing fastness test attached white cloth fiber layer (a-14) has an average fiber diameter (material before molding) of 14.8 μm, a basis weight of 32.1 g / m 2 , The thickness was 0.086 mm.
[0221]
　Fiber layer (a-15): A non-woven fabric having an average fiber diameter (material before molding) of 3.0 μm, a basis weight of 15 g / m 2 , and a thickness of 0.30 mm obtained by calendar processing of the melt blown method using polypropylene resin. , Fiber layer (a-15).
(2) Resin layer (B)
(2-1) Aliphatic polyisocyanate (b-1)
　Preparation example 1 (isocyanate (b-1-1) (alcohol-modified isocyanurate derivative of PDI))
　thermometer, stirrer, Pentamethylene diisocyanate (hereinafter referred to as PDI) produced in the same manner as in Example 1 in the specification of International Publication No. 2012/121291 in a four-necked flask provided with a reflux tube and a nitrogen introduction tube. 500 parts by mass, isocyanate alcohol 6.9 parts by mass, 2,6-di (tert-butyl) -4-methylphenol 0.3 parts by mass, tris (tridecyl) phosphite 0.3 parts by mass, respectively. , Charged and reacted at 80 ° C. for 2 hours.
[0222]
　Next, 0.05 parts by mass of N- (2-hydroxypropyl) -N, N, N-trimethylammonium-2-ethylhexanoate was blended as an isocyanurate-forming catalyst. The isocyanate group concentration was measured, and the reaction was continued until the concentration reached 48.3% by mass (that is, the conversion rate was 10% by mass). When the predetermined conversion rate (conversion rate 10% by mass) was reached after 20 minutes, 0.12 parts by mass of o-toluenesulfonamide was added. The obtained reaction mixture was passed through a thin film distillation apparatus (temperature: 150 ° C., vacuum degree: 0.093 kPa) to remove unreacted pentamethylene diisocyanate monomer, and further, with respect to 100 parts by mass of the obtained filtrate. , O-Toluene Sulfonamide (0.02 parts by mass) and Benzoyl Chloride (0.003 parts by mass) were added to obtain an alcohol-modified isocyanurate derivative of PDI. This was designated as isocyanate (b-1-1).
[0223]
　The average number of isocyanate groups of isocyanate (b-1-1) was 2.8, the isocyanate monomer concentration was 0.4% by mass, the isocyanate group concentration was 23.4% by mass, and the viscosity at 25 ° C. was 950 mPa · s.
[0224]
Also, 1 mol ratio of allophanate groups and isocyanurate groups by H-NMR measurement was allophanate groups / isocyanurate groups = 33.0 / 100.
[0225]
　Preparation Example 2 (Isocyanate (b-1-2) (alcohol-modified isocyanurate derivative of HDI)
　PDI was changed to hexamethylene diisocyanate (manufactured by Mitsui Chemicals, Inc., trade name: Takenate 700 (hereinafter referred to as HDI)). Obtained an alcohol-modified isocyanurate derivative of HDI by the same method as in Preparation Example 1. This was designated as isocyanate (b-1-2).
[0226]
　The average number of isocyanate groups of isocyanate (b-1-2) was 2.9, the isocyanate monomer concentration was 0.5% by mass, the isocyanate group concentration was 22.1% by mass, and the viscosity at 25 ° C. was 840 mPa · s.
[0227]
Also, 1 mol ratio of allophanate groups and isocyanurate groups by H-NMR measurement was allophanate groups / isocyanurate groups = 34.3 / 100.
(2-2) polyol (b-2)
　Preparation Example 1 (polyol (b-2-1))
　Polyoxyalkylene polyol (polyether polyol obtained by addition polymerization of propylene oxide to propylene glycol, number average molecular weight (Mn) = 3000 , Average number of functional groups 2, hydroxyl value 37 mgKOH / g, ethylene oxide concentration in total oxyalkylene = 0% by mass) was used as a polyol (b-2-1).
[0228]
　The polyol (b-2-1) is polyoxypropylene glycol (PPG).
[0229]
　Preparation Example 2 (polyol (b-2-2))
　Polyoxyalkylene polyol (polyether polyol obtained by addition polymerization of propylene oxide to propylene glycol, number average molecular weight (Mn) = 2000, average number of functional groups 2, hydroxyl value 56 mgKOH / g , Ethylene oxide concentration in total oxyalkylene = 0% by mass) was used as a polyol (b-2-2).
[0230]
　The polyol (b-2-2) is polyoxypropylene glycol (PPG).
[0231]
　Preparation Example 3 (polyol (b-2-3))
　Polyoxyalkylene polyol (polyether polyol obtained by addition polymerization of propylene oxide to propylene glycol, number average molecular weight (Mn) = 1000, average number of functional groups 2, hydroxyl value 112 mgKOH / g , Ethylene oxide concentration in total oxyalkylene = 0% by mass) was used as a polyol (b-2-3).
[0232]
　The polyol (b-2-3) is polyoxypropylene glycol (PPG).
[0233]
　Preparation Example 4 (polyol (b-2-4))
　Polyoxyalkylene polyol (polyether polyol obtained by addition polymerization of propylene oxide to propylene glycol, number average molecular weight (Mn) = 700, average number of functional groups 2, hydroxyl value 240 gKOH / g , Ethylene oxide concentration in total oxyalkylene = 0% by mass) was used as a polyol (b-2-4).
[0234]
　The polyol (b-2-4) is polyoxypropylene glycol (PPG).
[0235]
　Preparation Example 5 (Polycarbonate (b-2-5))
　A polyol (b-2-1 ) having a number average molecular weight of 3000 and a polyol (b-2-2) having a number average molecular weight of 2000 were added at 80:20 (b-). 2-1: b-2-2 (mass ratio)) was mixed to obtain a polyol (b-2-5) as a mixture.
[0236]
　The number average molecular weight of the polyol (b-2-5) was about 2130, the average number of functional groups was 2, the hydroxyl value was 53 mgKOH / g, and the ethylene oxide concentration in the total oxyalkylene was 0% by mass.
[0237]
　The polyol (b-2-5) is polyoxypropylene glycol (PPG).
[0238]
　Preparation Example 6 (Polycarbonate (b-2-6))
　A polyol (b-2-2 ) having a number average molecular weight of 2000 and a polyol (b-2-3) having a number average molecular weight of 1000 were added at 75:25 (b-). 2-2: b-2-3 (mass ratio)) was mixed to obtain a polyol (b-2-6) as a mixture.
[0239]
　The number average molecular weight of the polyol (b-2-6) was about 1600, the average number of functional groups was 2, the hydroxyl value was 70 mgKOH / g, and the ethylene oxide concentration in the total oxyalkylene was 0% by mass.
[0240]
　The polyol (b-2-6) is polyoxypropylene glycol (PPG).
[0241]
　Preparation Example 7 (
　Polycarbonate (b-2-7)) Number Average molecular weight 1800 amorphous polytetramethylene ether glycol (manufactured by Asahi Kasei Silicon Co., Ltd., trade name: PTXG, hydroxyl value 60 mgKOH / g, average number of functional groups 2, tetrahydrofuran Copolymer with neopentyl glycol)
(3) Plasticizer (b-3)
　Diisononylcyclohexane-1,2-dicarboxylate (manufactured by BASF, trade name: Hexamol DINCH)
(4) Catalyst (b-4)
　Tokyo Kasei Kogyo Co., Ltd., Reagent Dibutyltin dilaurate (Plasticizer)
(5) Defoamer (b-5)
　Big Chemie Japan Co., Ltd., Trade Name: BYK-088
(6) Silicone Resin (b-6)
　(b- 6-1) Main
　agent; manufactured by Toray Dow Corning Co., Ltd., trade name: Silicone MG7-9800A (b-6-2) Hardener; manufactured by Toray Dow Corning Co., Ltd., trade name: Silicone MG7-9800B
(7) Coating agent (C)
　(C-1) Main agent: Fuji Paint Industry Co., Ltd., Product name: Mold Coat Z UN-750 (
　Polycarbonate component) (c-2) Curing agent: Fuji Paint Industry Co., Ltd., Product name: UB-1300 (Polyisocyanate) Ingredients: hexamethylene diisocyanate derivative)
　(c-3) Diluter: Fuji Paint Industry Co., Ltd., trade name: Mystersinner TM-5510 (petroleum-based organic solvent)
　3. 3. Method for Producing Resin for Hardness Measurement
　Reference Example 1
　Isocyanate (b-1-1) and polyol (b-2-4) were prepared at the mass ratios shown in Table 1.
[0242]
　Next, 100 parts by mass of the polyol (b-2-4) adjusted to 25 ° C. and 15.58 parts by mass of the polyisocyanate (a-1) (equivalent ratio of isocyanate groups to hydroxyl groups (NCO / hydroxyl group = 0.70)). , 0.1 part by mass of dibutyltin dilaurate (b-4) as a catalyst and 0.2 part by mass of antifoaming agent (b-5) in a plastic container, and three-one motor (manufactured by Shinto Kagaku Co., Ltd .: product). Name: HEIDOM FBL3000) was used to stir and mix for 30 seconds under stirring at 800 rpm.
[0243]
　Immediately after that, defoaming under reduced pressure was performed to remove bubbles from the mixture, and then bubbles did not enter the cm x 5 cm x 15 mm height square block mold that had been pre-coated with Teflon (registered trademark) and adjusted to 80 ° C. Carefully, the mixed solution was poured and reacted at 80 ° C. for 1 hour to obtain a polyurethane gel.
[0244]
　The polyurethane gel was allowed to stand in a room at 23 ° C. and a relative humidity of 55% for 1 day, and then the hardness was measured.
[0245]

　A resin layer for hardness measurement was obtained by the same method as in Reference Example 1 except that the formulations shown in 　Reference Examples 2 to 26 and Reference Comparative Examples 1 to 4 Tables 1 to 3 were changed.
[0246]
　4. Production
　Example 1 of Simulated Sclera (Tablet Shape)
　Isocyanate (b-1-1) and polyol (b-2-4) were prepared at the mass ratios shown in Table 1.
[0247]
　Next, 100 parts by mass of the polyol (b-2-4) adjusted to 25 ° C. and 15.58 parts by mass of the polyisocyanate (b-1-1) (equivalent ratio of isocyanate groups to hydroxyl groups (NCO / hydroxyl group = 0.70). )), 0.1 part by mass of dibutyltin dilaurate (b-4) as a catalyst, and 0.2 part by mass of antifoaming agent (b-5) are placed in a plastic container, and three-one motor (manufactured by Shinto Kagaku Co., Ltd.) : Trade name: HEIDOM FBL3000) was used to stir and mix for 30 seconds under stirring at 800 rpm.
[0248]
　Immediately after that, defoaming was performed under reduced pressure to remove bubbles from the mixture.
[0249]
　On the other hand, the number of fiber layers shown in Table 1 was laminated to obtain a fiber layer laminate.
[0250]
　Next, the fiber layer laminate was pre-coated with Teflon (registered trademark) and placed in a sheet mold having a thickness of 1 mm and temperature-controlled at 80 ° C.
[0251]
　Next, the above mixed solution was poured into a sheet mold, being careful not to allow bubbles to enter, and reacted at 80 ° C. for 1 hour to obtain a resin-fiber composite material (flat plate) having a thickness of 1.0 mm. It was.
[0252]
　Next, the main agent (c-1) adjusted to 25 ° C., the curing agent (c-2), and the diluent (c-3) were mixed in the mass ratio shown in Table 1 to obtain a coating agent.
[0253]
　Then, the coating agent was applied to both sides of the resin-fiber composite material (flat plate) by spraying, and then dried at 80 ° C. for 1 hour to form a surface coat layer.
[0254]
　As a result, a simulated sclera (flat plate) was obtained.
[0255]
　This simulated sclera (flat plate) was allowed to stand in a room at 23 ° C. and a relative humidity of 55% for 1 day, and then subjected to various physical property measurements and surgical evaluation by an ophthalmologist.
[0256]
　A
　simulated sclera for surgical practice was obtained in the same manner as in Example 1 except that the formulations shown in Examples 2 to 22, 24 to 25 and Comparative Examples 1 to 4 Tables 1 to 3 were changed.
[0257]
　5. Production
　Example 23 of Simulated Sclera (Eyeball)
　Spray glue (manufactured by 3M, trade name: Spray Glue 55) was sprayed onto each layer of the number of fibers shown in Table 2 and laminated to obtain a fiber layer laminate. .. Next, the obtained fiber layer laminate was heated at 80 ° C. for 1 hour in an eyeball-shaped mold having a thickness of 1.0 mm to shape it into an eyeball shape.
[0258]
　Next, in the fiber layer laminate, the portion corresponding to the cornea was punched out to form only the portion corresponding to the sclera.
[0259]
　Next, isocyanate (b-1-1) and polyol (b-2-4) were prepared at the mass ratios shown in Table 2.
[0260]
　Next, 100 parts by mass of the polyol (b-2-4) adjusted to 25 ° C. and 15.68 parts by mass of the polyisocyanate (ba-1) (equivalent ratio of isocyanate groups to hydroxyl groups (NCO / hydroxyl group = 0.70). )), 0.5 part by mass of dibutyltin dilaurate (b-4) as a catalyst, and 0.2 part by mass of antifoaming agent (b-5) are placed in a plastic container, and three-one motor (manufactured by Shinto Kagaku Co., Ltd.) : Trade name: HEIDOM FBL3000) was used to stir and mix for 30 seconds under stirring at 800 rpm.
[0261]
　Immediately after that, defoaming was performed under reduced pressure to remove bubbles from the mixture.
[0262]
　Next, the above-mentioned fiber layer laminate was preheated to 80 ° C. and placed in a simulated eyeball mold having a thickness of 1.0 mm coated with a mold release agent (Fu Release 310 manufactured by Neos Co., Ltd.).
[0263]
　Next, the above mixed solution was poured into a simulated eyeball mold, being careful not to allow bubbles to enter, and reacted at 80 ° C. for 2 hours to form a resin-fiber composite material (eyeball shape) having a thickness of 1.0 mm. Obtained.
[0264]
　Next, the main agent (c-1) adjusted to 25 ° C., the curing agent (c-2), and the diluent (c-3) were mixed in the mass ratios shown in Table 2 to obtain a coating agent.
[0265]
　Then, the coating agent was applied to both sides of the resin-fiber composite material (eyeball shape) by spraying, and then dried at 80 ° C. for 1 hour to form a surface coat layer.
[0266]
　As a result, a simulated sclera (eyeball shape) was obtained.
[0267]
　This simulated sclera (eyeball shape) was allowed to stand in a room at 23 ° C. and 55% relative humidity for 1 day, and then subjected to various physical property measurements and surgical evaluation by an ophthalmologist.
[0268]
　Example 26 A
　simulated sclera (eyeball shape) for surgical practice was obtained by the same method as in Example 23 except that the prescription was changed to that shown in Table 3.
[0269]
　5. Evaluation The
　polyurethane gel and simulated sclera were evaluated by the following procedure. The results are shown in Tables 3 to 4.
The
　fiber layer is taken out from the simulated sclera (flat plate shape and eyeball shape), and the fiber layer is observed using a KEYENCE microscope VHX-D510. Then, the fiber diameter was measured. The average value measured by 100 fibers was taken as the fiber diameter of the fiber layer (after molding) in the simulated sclera.
A flat plate-shaped simulated sclera was cut into a width of 5 mm and a length of 50 mm to prepare a test piece. The second layer or the first layer at the fiber layer interface was peeled off by 20 mm in advance, and the peeling strength was measured using a tensile compression tester (Model 205N, manufactured by Intesco) in accordance with JIS K6854-2 (1999).
[0270]
　Further, an eyeball-shaped simulated sclera was cut out to a width of 5 mm and a length of 10 mm to obtain a test piece. The second layer at the fiber layer interface was peeled off by 3 mm in advance. Next, a simulated strong film having a width of 5 mm and a length of 50 mm was adhered to the surface side of the peeled portion with a cyanoacrylate adhesive (manufactured by Konishi Co., Ltd., trade name: Aron Alpha) to extend the portion to be gripped by the chuck of the tensile tester. , JISK6854-2 (1999), and the peel strength was measured.
The Asker C hardness of
　the polyurethane gel obtained in each reference example and each reference comparative example was measured by a type C hardness test of JIS K7312 (1996).
The Asker F hardness of
　the polyurethane gel obtained in each reference example and each reference comparative example was measured by the same method as the type C hardness test of JIS K7312 (1996).
Using simulated sclera (plate-shaped and eyeball-shaped), glaucoma surgery was performed by an ophthalmologist. The feel of making a cut in the simulated sclera with a scalpel was evaluated and classified into the following four stages.
[0271]
　1: The feeling when cutting with a scalpel is the same as when cutting the actual collagen fiber of the sclera. There is a moderate sense of resistance, and the feeling is the same as when cutting the actual sclera. ..
[0272]
　2: The feel when cut with a scalpel is the same as when cutting the actual collagen fibers of the sclera. There is a feeling of resistance, but the resistance is weak or strong, similar to the actual sclera. However, there is a slight sense of discomfort.
[0273]
　3: The feel when cut with a scalpel is the same as when cutting the actual collagen fibers of the sclera. There is a feeling of resistance, but the resistance is weak or strong, similar to the actual sclera. Feeling that is not the same.
[0274]
　4: Feeling that the resistance of the fiber is not felt at all when cut with a scalpel, or it is too strong and feels completely different from the actual sclera.
Using simulated sclera (plate-shaped and eyeball-shaped), glaucoma surgery was performed by an ophthalmologist. The feel of the simulated sclera when sliced ​​with a scalpel was evaluated and classified into the following five stages.
[0275]
　1: As the peeling progresses, if you lightly press the scalpel while pinching the flap with tweezers, the peeling will expand and the feeling will be the same as when the actual sclera is sliced.
[0276]
　2: As the peeling progresses, if you lightly press the scalpel while pinching the flap with tweezers, the peeling will expand, but even if the pressing force is weak, the peeling will expand and the tactile sensation is close to that of a real sclera. However, it feels a little strange.
[0277]
　3: As the peeling progresses, if you lightly press the scalpel while pinching the flap with tweezers, the peeling will expand, but if you pull the pinched tweezers strongly, the peeling will expand, and what is the actual sclera? Similar but different feel.
[0278]
　4: When the peeling progresses, the peeling easily expands just by pinching the flap with tweezers, which is completely different from the actual sclera.
[0279]
　5: can not be delaminated, quite different from the real sclera

　using simulated sclera (tabular and eye shape), it was carried glaucoma surgery ophthalmologist. The flaps prepared by slicing the simulated sclera with a scalpel were turned over to 90 ° or more to evaluate the subsequent return, and classified into the following four stages.
[0280]
　1: After flipping the flap to 90 ° or more, it keeps the flipped state while slightly deforming in the return direction, and becomes the same state as the actual scleral flap.
[0281]
　2: After flipping the flap to 90 ° or more, the flap's return force is too weak to partially stick to the sclera, or the return strength is too strong to maintain the flipped state, and the actual sclera Similar to, but slightly uncomfortable.
[0282]
　3: After flipping the flap to 90 ° or more, the force that the flap returns is weak, it sticks to the sclera about half, or the strength to return is strong, and the flap gradually returns to its original state, so the real thing It is similar to the sclera of, but it feels strange.
[0283]
　4: After flipping the flap over 90 °, the flap's return force is very weak and sticks to the sclera, or the return strength is very strong, and as soon as you speak the picked tweezers It returns to its original state and is completely different from the actual sclera.
Using the
　simulated sclera (flat and eyeball shape), glaucoma surgery was performed by an ophthalmologist. The feel when touching the surface of the simulated sclera was classified into the following three stages.
[0284]
　1. 1. The surface is not sticky, and there is no discomfort with the handling of the actual sclera.
[0285]
　2. 2. The surface is sticky and resembles an actual sclera, but it feels strange.
[0286]
　3. 3. The surface is too sticky and clings to what you touch, which is completely different from the actual sclera.
The
　simulated sclera (eyeball shape) for surgery practice obtained in Example 23 and Example 26 was used for practice of trabecular incision (travecrotomy).
[0287]
　Specifically, first, an incision was made in the obtained simulated sclera for surgical practice (see FIG. 9), and the thickness of the sclera was confirmed while grasping the incision angle and pulling it toward the cornea (see FIG. 10). .. Then, while pulling the sclera toward the cornea, a detachment incision was made, that is, a thin slice was made (see FIG. 11). Then, the peeled portion was rolled up, and it was confirmed that the peeled incision, that is, the thin slice, reached the boundary between the cornea and the sclera (see FIG. 12). After that, a part of the incised portion was grasped and pulled toward the cornea, and a detachment incision, that is, a thin slice was performed so as to dispel the scleral fibers (see FIG. 13).
[0288]
　In the above exercises, both of the simulated sclera for surgical practice obtained in Example 23 and Example 26 obtained a sensation close to that of the human eyeball.
[0289]
　FIG. 15 shows a photograph of the process of peeling and incising the simulated sclera for surgical practice obtained in Example 26 and rolling it up (corresponding to FIG. 13). After that, a photograph of the process of suturing the incision site of the simulated sclera for surgical practice (corresponding to FIG. 14) is shown in FIG.
[0290]
[table 1]

[0291]
[Table 2]

[0292]
[Table 3]

[0293]
[Table 4]

[0294]
[Table 5]

[0295]
[Table 6]

[0296]
　Although the above invention has been provided as an exemplary embodiment of the present invention, this is merely an example and should not be construed in a limited manner. Modifications of the present invention that will be apparent to those skilled in the art are included in the claims below.
Industrial applicability
[0297]
　The simulated sclera, the simulated eyeball, and the method for producing the simulated sclera of the present invention are preferably used in the practice of glaucoma surgery of the eyeball.
The scope of the claims
[Claim 1]
　When
　the fiber diameter of the fiber containing the plurality of fiber layers (a) and the resin (b) in contact with the fiber layer (a) and constituting the fiber layer (a) is 0.6 μm or more and 170.0 μm or less. A simulated sclera characterized by being present.
[Claim 2]
　The simulated sclera according to claim 1, wherein the peel strength between the plurality of fiber layers (a) is 0.20 N / cm or more.
[Claim 3]
　The simulated sclera according to claim 1, wherein the asker F hardness of the resin (b) is 45 or more and 95 or less, or the asker C hardness of the resin (b) is 5 or more and 35 or less.
[Claim 4]
　The simulated sclera according to claim 1, wherein the fiber layer (a) includes a non-woven fabric.
[Claim 5]
　The simulated sclera according to claim 1, wherein the resin (b) contains polyurethane.
[Claim 6]
　The simulated sclera according to claim 1, further comprising a surface coat layer (c).
[Claim 7]
　The simulated sclera according to claim 1, wherein the simulated sclera is for practicing eye surgery.
[Claim 8]
　A simulated eyeball comprising the simulated sclera according to claim 1.
[Claim 9]
　When
　the fiber diameter of the fiber containing the plurality of fiber layers (a) and the resin (b) in contact with the fiber layer (a) and constituting the fiber layer (a) is 0.6 μm or more and 170.0 μm or less. A method for producing a simulated strong film, 　which comprises
　a step of laminating a plurality of fiber layers (a) and a step
of impregnating the laminated fiber layers (a) with a resin (b). , A method for manufacturing a simulated fiber.