Epitasis

Abstract

Provide an epithesis that has a more natural and realistic beauty and texture and is excellent in durability. 【Solution means】An epithesis having a multilayer structure, characterized in that at least one layer selected from a short fiber blended layer 2 and a colored layer 3 is laminated on a base material 1, and further, a surface layer 4 is laminated on the uppermost layer. Further, the surface layer 4 is composed of at least one layer selected from a surface protective layer 5 and a surface lubricity layer 6, and further, the surface protective layer 5 is composed of either a silicone resin layer or a urethane resin layer.

Description

Technical Field

[0001] The present invention relates to an epithesis, which is an artificial prosthesis that reproduces a part of the body such as a finger, a limb, a nose, an ear, or a breast in the likeness of a human body.

Background Art

[0002] An epithesis is an artificial prosthesis for compensating for a body part that has been lost due to illness, accident, etc., or is congenitally deformed or missing. Types thereof include epitheses for compensating for facial defects or deformities such as the nose, ear, eye, cheek, etc., epitheses for compensating for defects such as fingers, hands, feet, etc., and epitheses for compensating for the shape of the breast when the breast or nipple is lost due to breast cancer surgery, illness, or accident.

[0003] An epithesis is produced to have a natural finish through processes such as molding, prototype production, coloring, and finishing. Also, epitheses are made to order individually according to the physical condition and desires of each wearer. Therefore, it depends on the knowledge and experience of professional technicians.

[0004] In order to improve the quality and productivity of epitheses, a manufacturing method applying a 3D printer and a method of correcting a trial-produced epithesis by projecting an image onto a model have been proposed (see, for example, Non-Patent Document 1 and Patent Document 1). Also, an epithesis in which a maxillofacial prosthetic material is adhered to a hollow body to improve productivity and comfort during wearing (Patent Document 2), an epithesis in which the fluidity of a silicone resin is increased to improve operability (Non-Patent Document 2), an epithesis suitable for made-to-order consisting of a specific silicone resin (Non-Patent Document 3), and an epithesis in which coloring fibers are blended into a silicone resin to exhibit a texture like that of capillaries (Patent Document 3) have been studied.

[0005] However, even epitheses produced by various methods as described above cannot meet the customer needs for diverse realistic beauty, texture, and durability, and there has been a strong desire for an epithesis with more natural, realistic beauty, texture, and durability.

Prior Art Documents

Non-Patent Documents

[0006]

Non-Patent Document 1

Non-Patent Document 2

Non-Patent Document 3

[0007]

Patent Document 1

Patent Document 2

Patent Document 3

[0008] As described above, various attempts have been made to improve the quality and productivity of epitheses, such as optimizing polymer materials, blending colored fibers, using 3D printers, and digital engineering. However, it has still been unable to meet the customer needs for pursuing beauty and realism. The present invention has been made in view of the above circumstances, and an object thereof is to provide an epithesis having a natural, realistic beauty and a deep texture, and excellent durability. Means for Solving the Problems

[0009] The present inventor aimed to provide an epithesis having a natural, realistic beauty and a deep texture, and excellent durability and reliability during use. Through experiments and the like, the optimal conditions were earnestly studied, and the present invention was completed.

[0010] That is, the first invention is an epitaxial film with a multilayer structure, characterized in that at least one layer selected from a short fiber compound layer and a coloring layer is laminated on a base material, and further, a surface layer is laminated on the uppermost layer.

[0011] The second invention is an epitaxial film with a multilayer structure, characterized in that a short fiber compound layer, a coloring layer, a short fiber compound layer, and a coloring layer are sequentially laminated on a base material, and further, a surface layer is laminated on the uppermost layer.

[0012] The third invention is the epitaxial film according to the first or second invention, characterized in that the surface layer is composed of at least one layer selected from a surface protection layer and a surface lubricity layer.

[0013] The fourth invention is the epitaxial film according to the third invention, characterized in that the surface protection layer is composed of either a silicone resin layer or a urethane resin layer. Effects of the Invention

[0014] According to the first invention, it is possible to provide an epitaxial film having a natural, realistic beauty, a deep texture, and durability.

[0015] According to the second invention, it is possible to further have a more natural and realistic beauty, a deeper texture, and durability.

[0016] According to the third invention, it is possible to provide an epitaxial film having a more natural and realistic beauty, a deep texture, and excellent durability.

[0017] According to the fourth invention, it is possible to provide an epitaxial film with excellent durability in which the lower short fiber compound layer and coloring layer do not peel off or deteriorate.

Brief Description of the Drawings

[0018]

Figure 1

Figure 2

Figure 3

Figure 4

Mode for Carrying Out the Invention

[0019] Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. FIG. 1 is a schematic diagram showing the cross-sectional layer structure of the epidermis 10 of the present invention. On the base material 1, a short fiber blended layer 2, a coloring layer 3, and a surface protective layer 5 as a surface layer 4 are laminated. FIG. 2 is a schematic diagram showing another cross-sectional layer structure of the epidermis 10 of the present invention. In FIG. 1, a coloring layer 3 is further interposed between the base material 1 and the short fiber blended layer 2, and the surface layer 4 is composed of two layers, a surface protective layer 5 and a surface lubricity layer 6.

[0020] The materials applied to the base material 1 and each layer constituting the epidermis 10 of the present invention are not particularly limited, but silicone resins, urethane resins, thermoplastic elastomers, which have high biocompatibility, excellent flexibility and durability, or acrylic resins with high strength and excellent durability can be preferably used.

[0021] The silicone resin applied as a material is resistant to heat, excellent in transparency, colorability, durability and chemical stability, and has safety for the human body, so it is also preferably used in the medical field and health care related fields. In addition, since the peroxide cross-linked type silicone resin may have decomposition residues after the curing reaction that have an adverse effect on the skin as impurities or cause an unpleasant odor, an addition reaction type in which decomposition products hardly remain using a platinum compound catalyst, a condensation type capable of room temperature curing, or an ultraviolet curable type silicone resin can be used.

[0022] As polymer materials other than silicone resins, curable urethane resins, styrene block copolymers as described in Patent Document 1, olefin polymers, and known thermoplastic elastomers including polyester elastomers, polyurethane elastomers, and polyamide elastomers can also be used to produce the epithesis 10.

[0023] In addition, in order to more naturally imitate the epidermis, dermis, and subcutaneous tissue that make up the skin, natural collagen, gelatin, hyaluronic acid, fibroblasts, fat, artificial blood vessels, artificial capillaries, etc. can be appropriately substituted or combined with the above materials and used. It is also possible to form a fine vascular structure on a scaffold produced by printing or the like using microfluidic technology. Cells that form the basis of blood vessels can be incorporated into the dermis layer to promote the formation of natural capillaries and form a vascular network.

[0024] The base material 1 is located on the innermost side that constitutes the multilayer structure epithesis of the present invention. It can be said that the base material 1 corresponds to a part including subcutaneous tissue or subcutaneous adipose tissue that connects the skin to muscles and bones in a living body.

[0025] The main materials used for the base material 1 are not particularly limited, but silicone resins, urethane resins, thermoplastic elastomers with high biocompatibility, excellent flexibility, transparency, colorability, and durability, or acrylic resins with high strength and excellent durability are suitable. The shape of the base material 1 is determined by the type of the target epithesis, and layered, sheet-like, or three-dimensional shaped ones are applicable. As the three-dimensionally shaped base material 1, it can be a solid body or a hollow body that can be lightened. The thickness of the base material 1 is not particularly limited because it also depends on the type of the epithesis and the desires of the wearer, etc., but it is usually composed of those in the range of about 0.2 mm to a dozen centimeters.

[0026] As the material of the base material 1, various resin materials in natural colors, which are colored or uncolored, can be applied. Also, as the material, a material such as a silicone resin colored in skin tone color can be applied to a part or the whole of it.

[0027] As shown in FIG. 2, the short fiber blended layer 2 formed on the base material 1 or the colored layer 3 can be formed, for example, by curing a composition in which short fibers are blended in a silicone resin. As the short fibers, short fibers colored in purple, red, orange, yellow, green, blue, black, etc. are preferable. By arranging these short fibers inside the short fiber blended layer 2 or near the surface, an epithesis with a natural, realistic beauty and a deep texture can be produced, where blood vessels and capillaries can be seen through under the skin as if they are protruding.

[0028] Here, the fiber of the short fiber is usually a general term for thin and long thread-like substances, meaning natural fibers such as cotton, wool, and silk, and synthetic fibers such as nylon and polyester. On the other hand, usually, a thread means a thing made by twisting or aligning fibers and connecting them long. However, the fiber of the short fiber in the present invention includes those obtained by cutting short the spun yarn obtained by twisting fibers and short fibers, the filament yarn obtained by aligning long fibers, etc.

[0029] The length and diameter of the short fibers used in the present invention can be set in consideration of the type of the target epithesis, the desires of the wearer, etc. For example, the average length of the short fibers is, for example, 0.1 mm to several tens of mm, preferably about 0.2 mm to 5 mm. Also, the fineness (JIS L1015(2010)8.8.1) of the short fibers is preferably, for example, 0.5 dtex to 5.0 dtex, and an epithesis with a more natural, realistic beauty, a deep texture, and a good feel can be provided.

[0030] The amount of short fibers to be blended into a silicone resin or the like can be set in consideration of the intended epithesis and the wearer's preferences. For example, with respect to 100 parts by mass of the silicone resin as the main component, if it is about 0.1 part by mass to 10 parts by mass, preferably about 0.3 part by mass to 5 parts by mass, an epithesis with a natural and realistic texture and feel can be provided.

[0031] The thickness of the short fiber blended layer 2 depends on the type of the intended epithesis and the wearer's preferences, and thus is not particularly limited, but is usually configured in the range from around 0.1 mm to several mm.

[0032] On the base material 1 or on the short fiber blended layer 2, a paint or ink colored in a skin tone color or the like can be applied or printed to form a colored layer 3. Further, in order to produce an epithesis with a more natural and realistic texture, multi-color inks or paints can be used, and a plurality of colored layers 3 composed of patterns or patterns such as wrinkles, moles, various blood vessels, and fat cells can be formed on the base material 1. Also, moles and the like can be embedded near the surface at a stage when the silicone resin is in the middle of curing. The paint or ink used for the colored layer 3 is usually composed of components such as a pigment as a colorant, a binder resin such as a silicone resin, an additive, a solvent or water. The above-mentioned patterns or patterns may be hand-drawn with a pen, or printed by screen printing, pad printing, a 3D printer, or spray-coated, and the volatile components contained therein are dried and removed to be cured to form the colored layer 3. The thickness of the colored layer 3 depends on the type of epithesis and the wearer's preferences, etc., and is not particularly limited, but is usually configured in the range from around 20 μm to several hundred μm.

[0033] The multilayer-structured epithesis of the present invention is characterized in that at least one layer selected from the short fiber blended layer 2 and the colored layer 3 is laminated on the base material 1, and further, a surface layer 4 is laminated on the uppermost layer. Therefore, only the short fiber blended layer 2 or only the colored layer 3 may be formed between the base material 1 and the surface layer 4.

[0034] The epitaxy of the multilayer structure of the present invention is characterized in that a short fiber compound layer 2, a coloring layer 3, a short fiber compound layer 2, and a coloring layer 3 are sequentially laminated on a base material 1, and a surface layer is further laminated on the uppermost layer. Further, the single-layer or multiple-layer short fiber compound layer 2 and the single-layer or multiple-layer coloring layer 3 may be combined in an arbitrary layer configuration.

[0035] The surface layer 4 formed on the uppermost layer of the epitaxy of the multilayer structure of the present invention is configured to protect the short fiber compound layer 2, the coloring layer 3, etc. formed on the lower layer. Further, the surface layer 4 is composed of at least one layer selected from a surface protection layer 5 and a surface lubricity layer 6. Further, by directly forming fingerprints or the shape of the skin surface on the surface layer 4 or its lower layer, or by transferring and forming from an actual object or the like, an epitaxy excellent in a more natural, realistic beauty and a deep texture can be created.

[0036] It is preferable that the surface protection layer 5 is composed of either a silicone resin layer or a urethane resin layer because it can exhibit the effect as a protection layer. Further, for example, when the main materials of the lower short fiber compound layer 2 and the coloring layer 3 are silicone resin and the surface protection layer 5 is composed of a urethane resin layer, in order to enhance the adhesion between the two layers, for example, the surface of the silicone resin layer is degreased and washed, and plasma treatment, corona treatment, etc. are performed to increase the surface energy, improve the wettability of the paint, and treat with a primer such as a silane coupling agent, and then the urethane resin paint is coated and reaction-cured to form the surface protection layer 5. Further, the surface protection layer 5 may be colorless and transparent or colored.

[0037] The thickness of the surface protection layer 5 is not particularly limited because it depends on the type of epitaxy, the state of the lower layer, the properties of the urethane resin paint or silicone resin layer paint used, etc. However, for example, when it is configured in the range of 10 μm to about 100 μm, preferably 20 μm to 80 μm, a high level of durability as the target protection layer can be exhibited.

[0038] The surface smoothness layer 6 is a layer formed to cover the short fiber compound layer 2, the coloring layer 3, or the surface protection layer 5 formed on the lower layer, and is composed of a layer mainly containing powders such as silica, talc, steatite, calcium carbonate, starch of plants such as corn starch, trichosanthis root powder, and tienkuafu powder. The surface smoothness layer 6 can be formed by ordinary coating methods and printing methods. It can achieve effects such as matting the surface of the epithesis, forming fine unevenness, creating a smooth touch, reducing the coefficient of friction, eliminating stickiness, and preventing blocking.

Example

[0039] Next, the present invention will be described in more detail with reference to examples. However, the present invention is not limited to these examples, and many modifications can be made by those with ordinary knowledge in the art within the technical idea of the present invention.

Example

[0040] The epithesis 11 of the index finger in Example 1 will be described. Using natural silicone resin, a base material 1 with a thickness of about 0.1 mm was formed by the molding method.

[0041] On the base material 1, a short fiber compound layer 2 with a thickness of about 0.4 mm was formed. The short fiber compound layer 2 is obtained by applying and curing a composition in which 0.5 parts by mass of polyester short fibers of red, yellow, and orange with an average length of 0.5 mm and a fineness of 0.6 dtex are blended in a silicone resin adjusted to skin tone color.

[0042] On the short fiber compound layer 2, a coloring layer 3 with a thickness of about 0.1 mm was formed by hand-drawing blood vessels, capillaries, etc. using multi-color silicone resin ink.

[0043] On the coloring layer 3, a short fiber compound layer 2 with a thickness of about 0.4 mm similar to the above was further formed, and on it, a coloring layer 3 with a thickness of about 0.1 mm was formed by hand-drawing blood vessels, capillaries, wrinkles, etc. using multi-color silicone resin ink in the same manner as above.

[0044] The surface of the above-mentioned colored layer 3 was degreased and washed with alcohol, corona discharge treatment was performed to increase the surface energy, a reactive silane coupling agent solution was spray-coated and dried by heating, and then an isocyanate-curing type transparent urethane resin paint was coated and reaction-cured to form a surface protection layer 5 with a thickness of about 50 μm. Incidentally, in the stage where the surface protection layer 5 was soft during curing, the pattern of fingerprints was transferred and molded, and then it was completely reaction-cured.

[0045] On the surface protection layer 5, a powder made of silica, talc, and plant starch such as corn starch was coated to form a surface lubricity layer 6. A resin index finger nail was adhered, and an index finger epithesis 11 with a natural, realistic beauty, depth, and texture as shown in FIG. 3 was produced.

Example

[0046] The breast epithesis 12 of Example 2 will be described. A silicone resin blended with 0.2 parts by mass each of red, yellow, and green polyester staple fibers having an average length of 0.5 mm and a fineness of 0.6 dtex was cured by a molding method to mold a base material 1 of a breast epithesis 12 that reproduced blood vessels and redness. Incidentally, in the cross-sectional enlarged view of FIG. 4, the absence of an underline at the lower part of the base material 1 means a solid structure.

[0047] On the base material 1, a short fiber blended layer 2 with a thickness of about 0.4 mm was formed. The short fiber blended layer 2 was obtained by applying and curing a composition in which 0.5 parts by mass of red, yellow, orange, and blue polyester staple fibers having an average length of 0.5 mm and a fineness of 0.6 dtex were blended with a silicone resin toned to skin tone.

[0048] On the short fiber blended layer 2, a colored layer 3 with a thickness of about 0.1 mm was formed by hand-drawing the nipple, areola, blood vessels, etc. using multi-color silicone resin ink.

[0049] The surface of the above-mentioned coloring layer 3 was degreased and washed with alcohol, corona discharge treatment was performed to increase the surface energy, a reactive silane coupling agent solution was spray-coated and dried by heating, and then an isocyanate-curing type urethane resin paint adjusted to a skin tone color was coated and reaction-cured to form a surface protective layer 5 with a thickness of about 50 μm.

[0050] On the above-mentioned surface protective layer 5, a powder composed of silica and plant starch such as corn starch was coated to form a surface lubricity layer 6, and an epithesis 12 of a breast with a natural, real beauty, depth, and texture as shown in FIG. 4 was produced.

Industrial Applicability

[0051] The epithesis of the present invention is characterized by a multilayer structure in which a short fiber blended layer, a coloring layer, a surface layer, etc. are laminated on a base material, and can provide an epithesis with more natural and real beauty and texture, and excellent durability. Therefore, it is suitably used by many wearers.

Explanation of Reference Numerals

[0052] 1 Base material 2 Short fiber blended layer 3 Coloring layer 4 Surface layer 5 Surface protective layer 6 Surface lubricity layer 10 Epithesis 11 Epithesis of index finger 12 Epithesis of breast

Claims

1. An epitaxial layer having a multilayer structure, characterized in that at least one layer selected from a short fiber blended layer and a colored layer is laminated on a substrate, and a surface layer is further laminated on the uppermost layer.

2. An epitaxial layer having a multilayer structure, characterized in that a short fiber blended layer, a colored layer, a short fiber blended layer, and a colored layer are sequentially laminated on a substrate, and a surface layer is further laminated on the uppermost layer.

3. The epitaxial layer according to claim 1 or 2, wherein the surface layer is composed of at least one layer selected from a surface protection layer and a surface lubricity layer.

4. The epitaxial layer according to claim 3, wherein the surface protection layer is composed of either a silicone resin layer or a urethane resin layer.

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