Mucous membrane model

Abstract

The present invention provides a mucous membrane model on which, when a marking is applied on a surface thereof, the location of the marking is visually recognized easily.　This mucous membrane model has a first layer and a second layer laminated on the first layer. The thickness of the first layer is 0.01-3 mm. The volume resistivity of the entire surface or a part of the second layer is 1.0 × 101 to 1.0 × 107 Ω•cm. The color difference ∆E between the first layer and the second layer is 20 or larger.

Description

Mucosa model

[0001] The present disclosure relates to mucosal models.

[0002] In recent years, expectations have been rising for minimally invasive surgeries, such as those using endoscopes or laparoscopes, which place less strain on the human body and are expected to result in a faster recovery, and the number of such surgeries is increasing. For example, by endoscopically removing tumors that have developed in the mucosal layer inside organs (endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)), surgery can be performed with smaller incisions than with conventional open surgery. Furthermore, by endoscopically stopping bleeding in the digestive tract (endoscopic hemostasis), shock due to bleeding can be prevented, and emergency surgery can be avoided. This reduces the physical burden on patients, shortens hospital stays, and allows for earlier rehabilitation.

[0003] As a result, there is an increasing demand for models for doctors and medical students to practice procedures using endoscopes and laparoscopes, and medical procedure training models have been proposed to improve skills and the quality of medical procedures (Patent Documents 1 to 5).

[0004] JP 2006-116206 A JP 2008-197483 A JP 2018-17769 A JP 2017-107094 A JP 2016-38563 A

[0005] During procedures such as resections and dissections using endoscopes or laparoscopes, prior to the procedure, the area to be resected or dissected and its surroundings are often marked with an energy device as a guide to confirm the resection area. The marking process involves heating the mucous membrane at the contact point with the energy device, which in humans causes the mucosal tissue (light red) to turn white due to thermal denaturation of proteins, thereby marking the area to be resected or dissected and its surroundings. The marking determines the tumor resection area. If marking is not performed before resection or dissection, it may be difficult to determine whether the entire lesion has been included during electroresection. Conventional organ models cannot reproduce the phenomenon in which the mucosal tissue (light red) turns white when heated at the contact point with the energy device, making it difficult to visually confirm the marking. The present disclosure aims to provide a mucosal model that allows easy visual confirmation of the marking area when marking is applied to the surface.

[0006] After considering various means, the inventor discovered a mucosal model in which a mark can be easily visually recognized by marking the mucosal tissue with an energy device by providing a simulated mucosal layer with a color difference between the first and second layers in a conventional mucosal model and by setting the thickness of the first layer and the volume resistivity of the second layer within a predetermined range, and thus completed the present disclosure.

[0007] The present disclosure includes the following aspects: <1> A mucosa model having a first layer and a second layer laminated on the first layer, wherein the thickness of the first layer is 0.01 to 3 mm, and the volume resistivity of the entire surface or a part of the second layer is 1.0 × 10 １ ~1.0 x 10 ７ a mucosal model having a color difference ΔE between the first layer and the second layer of 20 or more; <2> an organ model including the mucosal model; <3> an endoscopic surgery training method including performing endoscopic surgery training using the mucosal model.

[0008] According to the present disclosure, it is possible to provide a mucosal model in which, when markings are applied to the surface, the markings can be easily confirmed visually.

[0009] FIG. 1 is a schematic cross-sectional view of a mucosal model according to a first embodiment of the present disclosure; FIG. 2 is a schematic cross-sectional view of a simulated mucosal layer in a mucosal model according to a first embodiment of the present disclosure, in which the simulated mucosal layer around a simulated lesion set on a first layer is marked with an energy device so as to surround the simulated lesion; FIG. 3 is a plan view of the mucosal model according to a first embodiment of the present disclosure, in which the simulated mucosal layer around a simulated lesion set on the first layer is marked with an energy device so as to surround the simulated lesion; FIG. 4 is a schematic cross-sectional view of a mucosal model according to a second embodiment of the present disclosure, in which a simulated submucosal layer is provided below a second layer of the simulated mucosal layer in the mucosal model according to the first embodiment; FIG. 5 is a perspective view of a mucosal model according to a second embodiment of the present disclosure, in which the simulated mucosal layer around a simulated lesion set on the first layer is marked with an energy device so as to surround the simulated lesion;

[0010] An embodiment of the present disclosure will be described in detail below. However, the scope of the present disclosure is not limited to the embodiment described herein, and various modifications can be made without departing from the spirit of the present disclosure. Each aspect disclosed in this specification can be combined with any other feature disclosed in this specification. Furthermore, when multiple upper and lower limit values ​​are described for a specific parameter, any of these upper and lower limit values ​​can be combined to form a suitable numerical range. Furthermore, the lower and / or upper limit values ​​of a numerical range described in this disclosure are numerical values ​​within that numerical range and may be replaced with numerical values ​​shown in the examples. The expression "X to Y" indicating a numerical range means "X or more and Y or less." If a specific description described for one embodiment also applies to other embodiments, that description may be omitted in other embodiments.

[0011] [First embodiment] A mucosa model according to a first embodiment is a mucosa model having a first layer and a second layer laminated on the first layer, wherein the thickness of the first layer is 0.01 to 3 mm, and the second layer has a volume resistivity of 1.0 × 10 over the entire surface or a part thereof. １ ~1.0 x 10 ７This mucosal model has a resistance of Ω·cm and a color difference ΔE between the first layer and the second layer of 20 or more. The mucosal model according to this embodiment allows for easy differentiation of the layers of mucosal tissue exposed during procedures such as resection and dissection, and has excellent visibility. Furthermore, it is easy to perform resection and dissection using an energy device such as a general electric scalpel. Therefore, it is possible to train for, for example, resection and / or dissection of mucosal tissue using an energy device, or for marking the resection site prior to such procedures, and it is easy to determine whether the intended procedures have been performed.

[0012] As used herein, the "mucosa" of a mucosal model refers to any tissue capable of secreting mucus in a living animal, including at least a portion of the mucosa in organs such as the digestive, urinary, reproductive, and respiratory organs. Examples of digestive organs include the oral cavity, pharynx, esophagus, stomach, duodenum, small intestine, large intestine, rectum, and anus. Examples of urinary organs include the ureter, bladder, and urethra. Examples of reproductive organs include the fallopian tubes, uterus, vagina, vas deferens, penis, and urethra. Examples of respiratory organs include, but are not limited to, the nasal cavity, trachea, and bronchi. The mucosal model is not limited to any particular animal species, and may be a mucosal model of any animal species, including mammals (including humans), birds, reptiles, amphibians, and fish. A mucosal model can be selected appropriately by a person skilled in the art depending on the needs for training in medical procedures.

[0013] 1 is a cross-sectional view of a mucosal membrane model 1 according to one embodiment. The mucosal membrane model 1 shown in FIG.

[0014] <First Layer> The first layer is a layer that constitutes the surface (uppermost layer) of the mucosal model 1. In this example, the first layer is shown as a flat plate-like structure, but the shape is not limited as long as it can be supplied to a treatment surface where a simulated lesion is excised and sectioned in training for endoscopic submucosal dissection using a mucosal model.

[0015] (Base Material) The base material of the first layer is not particularly limited as long as it does not melt at room temperature and can be heated and melted by a general energy device. For example, the first layer preferably contains one or more selected from the group consisting of thermoplastic resins, proteins, and polysaccharides. Examples of polysaccharides include dietary fiber. Examples of dietary fiber include cellulose.

[0016] Examples of the cellulose-containing substrate include cotton, hemp, wool, pulp, and tree bark. The cellulose-containing substrate may be used alone or in combination of two or more. When the first layer contains cellulose, the first layer may contain, for example, one or more selected from nonwoven fabrics such as cotton, hemp, wool, and pulp; Japanese paper (tree bark); and decorative paper (pulp).

[0017] Examples of thermoplastic resins include styrene-based resins, polyolefin-based resins, polyester-based resins, thermoplastic polyurethane-based resins, vinyl chloride-based resins, ethylene-vinyl acetate-based resins, and polyacrylic resins, and it is preferable to include at least one selected from these. One type of thermoplastic resin may be used alone, or two or more types may be used in combination. From the viewpoint of flexibility, it is preferable for the styrene-based resin to include a hydrogenated styrene-based thermoplastic elastomer or a polyolefin-based elastomer. Examples of hydrogenated styrene-based thermoplastic elastomers include polystyrene-poly(ethylene / propylene) block (SEP), polystyrene-poly(ethylene / propylene) block-polystyrene (SEPS), polystyrene-poly(ethylene / butylene) block-polystyrene (SEBS), and polystyrene-poly(ethylene-ethylene / propylene) block-polystyrene (SEEPS). Examples of polyolefin-based resins include polyethylene, polypropylene, ethylene-propylene copolymer, and ethylene-vinyl acetate copolymer (EVA), and it is preferable for the resin to include polyethylene and / or polypropylene from the viewpoints of versatility, cost, and moldability. Examples of polyester-based resins include polyethylene terephthalate (PET), polybutylene terephthalate (PBT), etc. Examples of thermoplastic polyurethane-based resins include various thermoplastic polyurethane-based resins (TPU) such as polycarbonate-based, polyester-based, polyether-based, acrylic-based, and aliphatic-based.

[0018] Examples of the protein include gelatin, collagen, etc. One type of protein may be used alone, or two or more types may be used in combination.

[0019] Examples of polysaccharides include dietary fiber, starch, etc. One type of polysaccharide may be used alone, or two or more types may be used in combination.

[0020] Examples of dietary fibers include cellulose, agarose (agar), pectin, carrageenan, xanthan gum, galactomannans, etc. Dietary fibers may be used alone or in combination of two or more.

[0021] In one embodiment, the first layer preferably comprises one or more materials selected from hydrogenated styrene-based thermoplastic elastomers, PP resins, nonwoven fabrics, Japanese washi paper, decorative paper, thermoplastic polyurethane resins, and agar. In one embodiment, the substrate of the first layer may be, for example, polyester; nonwoven fabrics such as cotton, linen, wool, and pulp; films (PP, PE, PET); Japanese washi paper (bark), decorative paper (pulp); tattoo stickers (polyolefin); or a substrate containing SEEPS, process oil, an ionic liquid, and a compatibilizer. In one embodiment, the first layer may be polyester; nonwoven fabrics such as cotton, linen, wool, and pulp; PP film, PE film, PET film; Japanese washi paper (bark), decorative paper (pulp); tattoo stickers (polyolefin); or a substrate (SEEPS / process oil / ionic liquid / compatibilizer).

[0022] (Colorant) The first layer preferably contains a colorant such as a pigment or dye to facilitate adjustment of the color difference ΔE between the first layer and the second layer. The colorant may be mixed into the first layer or may be coated or printed on the surface of the first layer. The type of colorant is not limited, and known colorants such as red colorants, white colorants, orange colorants, brown colorants, and yellow colorants may be used alone or in combination of two or more. When a colorant is coated or printed on the surface of the first layer, the coating or printing method is not limited, and for example, a liquid obtained by dissolving aqueous paint in water or acrylic paint (acrylic resin) may be applied, or printing may be performed using an inkjet printer or the like. In one embodiment, the first layer is preferably a reddish layer from the viewpoint of approximating the appearance of mucosal tissue of the human body.

[0023] (Other Components) The first layer may contain oil, ionic liquid, polymeric antistatic agent, compatibilizer, etc. to mimic the texture of the human mucosa. Furthermore, a lubricating composition may be applied to the surface (upper side) of the first layer to improve the slipperiness of the energy device. Oil can be used, for example, to soften the substrate constituting the first layer and adjust the elastic modulus and hardness of the mucosa model. Examples of oils include, but are not limited to, paraffinic process oil, naphthenic process oil, aromatic process oil, mineral oil such as liquid paraffin, silicone oil, castor oil, linseed oil, olefin wax, mineral wax, etc. Among these, paraffinic and / or naphthenic process oils are preferred. Examples of process oils include the Diana Process Oil Series (manufactured by Idemitsu Kosan Co., Ltd.) and JOMO Process P (manufactured by Japan Energy Corporation). One type of oil may be used alone, or two or more types may be used in combination. From the viewpoint of workability, it is preferable to allow the oil to be absorbed into the substrate constituting the first layer in advance.

[0024] The content of the oil is preferably 100 to 1,000 parts by mass, more preferably 100 to 700 parts by mass, even more preferably 100 to 600 parts by mass, and most preferably 200 to 500 parts by mass, relative to 100 parts by mass of the base material constituting the first layer.

[0025] Ionic liquids can be used, for example, to adjust the tensile elongation at break and volume resistivity of the substrate constituting the first layer. The ionic liquid is not particularly limited, but examples of commercially available products include CIL312 (N-butyl-3-methylpyridinium bistrifluoromethanesulfonylimide, manufactured by Nippon Carlit Co., Ltd.), Aminoion AS100 (manufactured by Nippon Nyukazai Co., Ltd.), Aminoion AS300 (manufactured by Nippon Nyukazai Co., Ltd.), FC-4400 (tri-n-butylmethylammonium bistrifluoromethanesulfonimide, manufactured by 3M Corporation), and Hishicolin (dodecyltributylphosphonium chloride, manufactured by Nippon Chemical Industry Co., Ltd.). Ionic liquids may be used alone or in combination of two or more. The content of the ionic liquid is preferably 50 to 250 parts by mass, more preferably 50 to 200 parts by mass, and even more preferably 70 to 150 parts by mass, relative to 100 parts by mass of the substrate constituting the first layer. By setting the content of the ionic liquid to 50 parts by mass or more per 100 parts by mass of the base material constituting the first layer, it is easy to suppress an increase in volume resistivity, and by setting it to 250 parts by mass or less, it is easy to suppress the ionic liquid from bleeding out from the material.

[0026] Examples of polymeric antistatic agents include copolymers of hydrophobic polymers and hydrophilic polymers. More specifically, examples include polyethers having hydrophilic groups and being block copolymerized (nonionic types such as polyetheresteramides, ethylene oxide-epichlorohydrins, and polyetheresters; anionic types such as polystyrene sulfonic acids; and cationic types such as quaternary ammonium-containing poly(meth)acrylates). Among these, diblock copolymers having a structure in which a polyethylene glycol block and a polypropylene glycol block, a polyether block and a polyolefin block are bonded via at least one bond selected from an ester bond, an amide bond, an ether bond, a urethane bond, and an imide bond, and block copolymers having a structure in which hydrophilic blocks and hydrophobic blocks are repeatedly and alternately bonded can be used. As an example, a block copolymer having a volume resistivity of 10 ５ ~10 １１Examples of suitable block copolymers include those having a structure in which polyether blocks, which are hydrophilic blocks with a resistance of Ω cm, and polyolefin blocks are repeatedly and alternately bonded. The number average molecular weight (Mn) of such block copolymers is preferably 500 to 60,000.

[0027] The content of the polymer antistatic agent is preferably 10 to 100 parts by mass, more preferably 10 to 90 parts by mass, and even more preferably 10 to 50 parts by mass, relative to 100 parts by mass of the substrate constituting the first layer.

[0028] The lubricating composition is not particularly limited, but examples thereof include low molecular weight compounds such as water, sodium chloride, magnesium chloride, potassium chloride, sodium hydroxide, sodium dihydrogen phosphate, sodium phosphate, glycerin, propylene glycol, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, and butyl parahydroxybenzoate; water-absorbing polymers such as hydrogenated castor oil, 12-hydroxystearic acid, glucono-delta-lactone, and sodium polyacrylate; water-soluble polymers such as polyethylene glycol, polypropylene glycol, hyaluronic acid, alginic acid, carrageenan, dextrin, xanthan gum, guar gum, glycosaminoglycans, collagen, water-soluble vinyl polymers (including carboxyvinyl polymers and polyvinyl alcohols), hypromellose, methylcellulose, polyacrylic acid, polymethacrylic acid, and hydroxyethyl cellulose; and the like. One or more of these may be included. In one embodiment, the lubricating composition may be an aqueous sodium chloride solution or an aqueous sodium polyacrylate solution. Various commercially available lubricating jellies for medical use and jellies for ultrasound examinations may also be used as the lubricating composition. The lubricating composition may further contain one or more electrolytes, conductive materials such as carbon nanomaterials, conductive polymers, and metal fillers, preservatives, fragrances, pigments, narcotic ingredients, pH adjusters, dispersants, thickeners (including thixotropic agents, anti-settling agents, and anti-sagging agents), surfactants, antioxidants, and the like.

[0029] In one embodiment, the lubricating composition has a volume resistivity of 1.0 to 1.0×10 ５Ω cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0 to 1.0 × 10 ５ Preferably, the composition has a viscosity of 0.05 MPa·s. The applicability is the property that the simulated mucus composition does not have excessive viscosity (stickiness) when applied to the simulated organ, and remains on the surface of the simulated organ after application. A lubricating composition having such properties can be prepared by adjusting the components contained in the composition and the content of each component, measuring the volume resistivity and viscosity, and confirming that they fall within the above ranges. Here, the volume resistivity can be calculated by AC impedance measurement at a measurement temperature of 25°C.

[0030] Specifically, a measurement sample is placed in a liquid measurement cell with a diameter of 13 mm and a thickness of 5 mm, and the metal terminals on both ends of the cell that are in contact with the measurement sample are connected to the terminals of an AC impedance measurement device (Solartron SI 1287, Frequency Response Analyzer 1252A, manufactured by Toyo Corporation). Using a small environmental tester (manufactured by Espec Corporation, model number: SU-241), the resistivity of the cell is measured in an environment at a temperature of 25 ° C. The result is divided by the thickness of 5 mm to calculate the volume resistivity. Viscosity can be measured using a rheometer (MCR-92 manufactured by Anton Paar) according to the measurement method specified in JIS Z8803, using a 50 mm diameter cone plate as a jig, a measurement temperature of 25 ° C., and a shear rate of 10 / s.

[0031] In the mucosal model according to this embodiment, when the surface of the first layer simulating the mucosal surface is coated with a lubricating composition, it becomes easier to reproduce the behavior of mucus (e.g., continuous bubble generation, etc.) during treatment of mucosal tissue in a living body using an energy device. Furthermore, it is possible to reduce the risk of deformation or malfunction of the energy device due to the application of electricity and heating of thermoplastic resin, which has been used in conventional medical procedure training.

[0032] (Method of Producing First Layer) When the substrate is a thermoplastic resin, the first layer can be produced by a known sheet-forming method such as press molding or extrusion molding. When the substrate is a protein, polysaccharide, or the like, the first layer can be produced by dissolving the protein, polysaccharide, or the like in water or hot water, forming the liquid into a predetermined thickness, and cooling it. Alternatively, commercially available PP resin sheets, nonwoven fabrics, Japanese paper, decorative paper, polyurethane resin sheets, or the like may be procured and colored as necessary.

[0033] (Physical Properties of First Layer, etc.) The thickness of the first layer is preferably 0.01 to 3 mm, more preferably 0.02 to 2 mm, and even more preferably 0.02 to 1 mm. By having the thickness of the first layer be 0.01 to 3 mm, it is possible to provide a mucosal model in which, when marking is applied to the surface, the marking location can be easily confirmed visually.

[0034] The melting point of the first layer may be within a range that does not melt at room temperature but can be heated and melted by an energy device. For example, the melting point of the first layer is preferably 50 to 240°C, more preferably 50 to 220°C, and even more preferably 130 to 220°C. The melting point of the first layer is preferably equal to or lower than the melting point of the second layer. If the melting point of the first layer is equal to or lower than the melting point of the second layer, when the mucosal model is used for medical procedure training using an energy device, the heat generated by the energy device melts the heated portion of the first layer, forming a hole and exposing the second layer. In this embodiment, the color difference ΔE between the first and second layers is 20 or greater, resulting in a color difference between the melted portion of the first layer and the second layer, making it easy to distinguish between them. As a result, training in marking the mucosal model can be effectively performed. In this specification, the melting point is a value measured using a differential scanning calorimeter (manufactured by METTLER TOLEDO, model number: DSC3+) in a nitrogen atmosphere at a temperature rise rate of 10° C. / min.

[0035] The energy device may be, for example, a high-frequency knife such as an electric scalpel used in endoscopic submucosal dissection. The knife length of the high-frequency knife may be, for example, 0.5 to 5.0 mm.

[0036] The volume resistivity of the first layer is not particularly limited, and may be, for example, 1.0×10 １ ~1.0 x 10 ７ The volume resistivity is preferably Ω·cm. The method for measuring the volume resistivity will be described later.

[0037] First layer L ＊ , a ＊ , b ＊ The value of the standard white board (L ＊ = 97.8, a ＊ = -0.09, b ＊ = 0.04). ＊ The value of a is preferably 0 to 100, ＊ The value of is preferably 0 or more, and b ＊ The value of a is preferably −50 or more, ＊ The value of b may be less than or equal to 100, ＊ The value of L of the first layer can be 100 or less. ＊ , a ＊ , b ＊ By setting the value of in the above range, it is easy to adjust the color difference ΔE between the first and second layers to a predetermined range. Also, it is possible to approximate the appearance of human mucosal tissue (particularly the lamina propria mucosa).

[0038] <Second Layer> The mucosal model 1 shown in Fig. 1 has a second layer 22 laminated on a first layer 21. In the mucosal model 1 shown in Fig. 1, the second layer 22 is laminated directly on one surface (e.g., the back surface) of the first layer 21. The back surface of the first layer 21 refers to the surface of the first layer 21 opposite to the surface that serves as the outermost surface of the mucosal model 1. In this example, the second layer 22 is shown as a flat plate-shaped structure, but its shape is not limited as long as it can be supplied to a treatment surface where a simulated lesion is excised and sectioned in medical procedure training using a mucosal model.

[0039] (Substrate) The substrate of the second layer is preferably a conductive material. The second layer preferably contains a conductive material and one or more selected from the group consisting of a thermoplastic resin, a protein, and a polysaccharide. Examples of the thermoplastic resin, protein, and polysaccharide that can be contained in the second layer include the same examples as those exemplified in the section on the first layer above, and the second layer can be formed from the same or a different material as the first layer.

[0040] When a thermoplastic resin is used for the second layer, examples of the conductive material include a metal material such as a conductive polymer, silver, copper, tin oxide, or zinc oxide, a carbon material such as carbon black, carbon nanotubes, graphite, or diamond-like carbon, or the ionic liquid contained in the first layer. When a protein or polysaccharide is used for the second layer, examples of the conductive material include an aqueous solution containing an ionic substance such as tap water or saline (aqueous solution of sodium chloride).

[0041] The content of the conductive material is preferably 50 to 15,000 parts by mass, and more preferably 70 to 13,000 parts by mass, relative to 100 parts by mass of the substrate of the second layer.

[0042] (Colorant) The second layer preferably contains a colorant such as a pigment or dye to facilitate adjustment of the color difference ΔE from the first layer. The type and content of the colorant can be those exemplified in the section on the first layer, and are selected so that the color difference ΔE from the first layer falls within a predetermined range. In one embodiment, the second layer is preferably a whitish layer from the viewpoint of approximating the appearance of mucosal tissue of the human body.

[0043] (Other Components) In order to approximate the state of the mucous membrane of the human body, the second layer may contain oil, ionic liquid, polymeric antistatic agent, compatibilizer, etc. The types and contents of the oil, ionic liquid, polymeric antistatic agent, and compatibilizer can be exemplified as those described in the section for the first layer.

[0044] (Physical Properties of Second Layer) The second layer has a volume resistivity of 1.0×10 １ ~1.0 x 10 ７ Ω cm, preferably 1.3×10 ３ ~1.0 x 10 ６ Ω cm, more preferably 1.3×10 ３ ~7.0 x 10 ５ The volume resistivity of the second layer is 1.0×10 ７By setting the volume resistivity of the second layer to 1.0×10 Ω cm or less, when the mucosal model is used for medical procedure training using an energy device, it becomes easier to reproduce the behavior of a lesion in a living body, and incision treatment becomes easier. １ The volume resistivity can be measured, for example, in accordance with JIS C2139, using a commercially available machine (e.g., Hiresta UXMCP-HT800 manufactured by Mitsubishi Chemical Analytech Co., Ltd.) on a sheet of 1.0 mm thickness and of any shape at 23±1°C.

[0045] The method for adjusting the volume resistivity of the second layer is not limited, and for example, the content of the conductive agent can be adjusted to 50 to 15,000 parts by mass relative to 100 parts by mass of the substrate.

[0046] The thickness of the second layer may be within a range that allows the simulated mucosal layer to be marked with an energy device without penetrating the second layer and is feasible as a mucosal model. Specifically, the thickness of the second layer is preferably 0.1 mm to 50 mm, more preferably 0.1 to 30 mm, and even more preferably 0.5 to 10 mm.

[0047] The melting point of the second layer is preferably 50 to 240°C, and more preferably 50 to 220°C.

[0048] The melting point of the second layer is preferably equal to or higher than the melting point of the first layer. In this case, the base material of the second layer may be selected from materials having a melting point equal to or higher than the melting point of the first layer. As a result, when electricity is applied from the energy device, the heated portion of the first layer melts, forming a hole, and exposing the second layer, which has a melting point equal to or higher than the melting point of the first layer. In this embodiment, the color difference ΔE between the first layer and the second layer is 20 or more, so a color difference occurs between the melted portion of the first layer and the second layer, making it easy to distinguish between the two. As a result, it is easy to effectively practice marking the mucosal model. The method for measuring the melting point is as described above.

[0049] Second layer L ＊ , a ＊ , b ＊ The value of the standard white board (L ＊ = 97.8, a ＊= -0.09, b ＊ = 0.04). ＊ The value of a is preferably 30 or more. ＊ The value of can be between −100 and 100, and b ＊ The value of L of the second layer can be from -100 to 100. ＊ , a ＊ , b ＊ By setting the value of in the above range, it is easy to adjust the color difference ΔE between the first and second layers within a predetermined range. Furthermore, it is possible to approximate the appearance of mucosal tissue (particularly the muscularis mucosa) of the human body. The second layer can be produced by the same method as that for the first layer.

[0050] <Color difference ΔE between the first layer and the second layer> The color difference ΔE between the first layer and the second layer is preferably 20 or more, more preferably 30 or more, even more preferably 40 or more, and may be 60 or more, or even 70 or more. The color difference ΔE between the first layer and the second layer may be, for example, 200 or less. When the color difference ΔE between the first layer and the second layer is 20 or more, a clear color difference occurs between the melted portion of the first layer and the second layer, and it is possible to visually recognize that the perforation of the first layer is good. When the color difference ΔE between the first layer and the second layer is less than 20, even if there is a perforation in the first layer, the color difference between the first layer and the second layer is not clear and the color difference cannot be visually recognized, making it difficult to effectively learn techniques such as resection or dissection of mucosal tissue. The color difference ΔE between the first layer and the second layer is calculated by the L of the first layer obtained by a color difference meter. ＊ , a ＊ , b ＊ and the L value of the second layer obtained by the color difference meter ＊ , a ＊ , b ＊ Specifically, a color difference meter (Nippon Denshoku Color Meter Color Difference System ZE2000) was used to measure the difference between the material of the first layer and a standard white board (L ＊ = 97.8, a ＊ = -0.09, b ＊ = 0.04) was measured in reflection mode so that the measurement surface was the material of the first layer, and the L of the first layer ＊ 1. a ＊ 1, b ＊The second layer, which is the reference color, is measured in the same way, and the value of L ＊ 0, a ＊ 0, b ＊ Next, from the obtained value, CIE 1976 L according to JIS Z 8781-4 is calculated. ＊ a ＊ b ＊ The color difference ΔE between the first layer and the second layer is calculated using the following formula: ΔE={(L ＊ 1-L ＊ 0) ２ + (a ＊ 1-a ＊ 0) ２ +(b ＊ 1-b ＊ 0) ２} １／２

[0051] <Simulated Lesion Area> The mucosal model of the present disclosure can have a simulated lesion area on the first layer. The simulated lesion area is, for example, an area simulating a cancerous area (cancerous tissue) and is placed on the first layer of the simulated mucosal layer. To set the lesion resection area, a mark (resection area setting mark) can be placed on the simulated mucosal layer around the simulated lesion area using an energy device, surrounding the simulated lesion area set on the first layer, and used as a guide for incising or peeling the simulated lesion area.

[0052] 2 is a diagram showing a cross section of the simulated mucosal layer in the mucosal model 1 according to the first embodiment of the present disclosure, in which the first layer 21 around the simulated lesion 24 is marked with an energy device so as to surround the simulated lesion 24. The first layer 21 has holes 23 formed at the marked locations, and the second layer 22 is exposed through the holes 23.

[0053] Figure 3 is a top view of the mucosal model 1 according to the first embodiment of the present disclosure, in which marks (i.e., holes 23) have been made in the first layer 21 around the simulated lesion 24 set on the first layer 21 using an energy device to surround the simulated lesion 24.

[0054] The shape and dimensions of the simulated lesion are not limited and can be any shape and size that mimics the desired lesion. The shape of the simulated lesion can be any shape selected from, for example, circular, elliptical, polygonal, or irregular. The simulated lesion can be molded using known molding methods, and may be molded as a single unit or in separate pieces. For example, when using an inner mold (core) and an outer mold and pouring a material into the space between them, an incision can be made in the resin molded body when removing the inner mold, and the inner mold can be removed from there. At this time, the incision can be glued together to complete the simulated lesion. Alternatively, the simulated lesion can be molded using a male and female mold by heat press molding, vacuum press molding, or the like. Alternatively, multiple tissue portions can be molded separately by injection molding or the like and then glued together to complete the simulated lesion.

[0055] The simulated lesion may be colored using additives such as colorants (pigments, dyes, etc.), fragrances, antioxidants, and antibacterial agents, as long as the purpose is not impaired. Alternatively, red-colored thermoplastic styrene elastomer, red-colored nonwoven fabric, paper, etc. may be attached. The material that will become the simulated lesion may be colored and then molded before molding. It is preferable that the appearance of the simulated lesion allows the mucosal layer and the lesion to be distinguished under endoscopic vision, and it is even more preferable that the mucosal layer and the lesion have different colors. It is preferable that the simulated lesion be colored with a colorant to make it resemble living tissue and / or to distinguish it from other areas of the first layer.

[0056] <Physical Properties of the Mucosal Model, etc.> The shape of the mucosal model can be selected depending on the type of medical procedure to be trained, and can have any shape selected from, for example, a circle, an ellipse, a polygon, or an irregular shape. The total thickness of the first and second layers is preferably 0.1 to 50 mm, more preferably 0.5 to 30 mm, and even more preferably 0.5 to 5 mm. The maximum width in the direction perpendicular to the thickness direction of the mucosal model can be selected depending on the type of medical procedure to be trained, and can be, for example, within a range corresponding to the spread of a typical ulcer, for example, approximately 20 to 200 mm.

[0057] <Method of manufacturing mucosa model> The mucosa model according to the first embodiment can be produced by bonding the lower surface (rear surface) of the first layer to the upper surface of the second layer. The first and second layers can be bonded using a silicone adhesive, a cyanoacrylate adhesive, a hot melt adhesive, an epoxy resin adhesive, or the like, and the first and second layers can also be produced by co-extrusion molding.

[0058] The mucosal model according to this embodiment allows for effective learning of techniques such as resection and dissection of mucosal tissue, and can therefore be suitably used as a mucosal model for endoscopic surgery training, for example.

[0059] The mucosa model may have a configuration in which a simulated submucosa layer is disposed below the simulated mucosa layer, and an example of this configuration will be described below as a second embodiment.

[0060] [Second embodiment] Figure 4 shows an example of a mucosal model according to a second embodiment of the present disclosure. The mucosal model 1 according to the second embodiment shown in Figure 4 includes a simulated mucosal layer 2 including the first layer 21 and second layer 22 described in the first embodiment, and a simulated submucosal layer 3 provided below the second layer 22 of the simulated mucosal layer. That is, the mucosal model 1 includes the first layer 21, the second layer 22, and the simulated submucosal layer 3, in this order.

[0061] <Simulated mucous membrane layer> The simulated mucous membrane layer includes the first layer and the second layer described in the first embodiment. The first layer and the second layer are as described above, and therefore description thereof will be omitted here.

[0062] The thickness of the simulated mucosal layer, as the total thickness of the first and second layers, is preferably 0.1 to 50 mm, more preferably 0.5 to 30 mm, and even more preferably 0.5 to 5 mm. By setting the thickness of the simulated mucosal layer to 0.5 to 5 mm, it is possible to further improve the reproducibility of human mucosal tissue.

[0063] Mucosal tissue in the human body will be described using the stomach wall as an example. For example, the stomach wall has a mucosal layer including the lamina propria mucosa and the muscularis mucosa, a submucosa and blood vessels located below (on the inner surface), and a muscularis mucosa and fat located further below (on the inner surface) of the submucosa and blood vessels. In one embodiment, the simulated mucosal layer can have a simulated lamina propria mucosa including the first layer described above and a simulated muscularis mucosa including the second layer described above. The other descriptions regarding the first and second layers in the first embodiment also apply here.

[0064] The simulated mucosal layer of the mucosal model according to this embodiment has a first layer and a second layer with different colors, and the color difference ΔE between the first layer and the second layer is 20 or more. In one embodiment, the first layer is a light red layer, which mimics the color of the mucosa on the mucosal epithelium side of mucosal tissue in a living body. On the other hand, the second layer is a white layer, which mimics the color of the muscularis mucosae of mucosal tissue. By making the simulated mucosal layer two layers, a light red layer and a white layer, and setting the color difference ΔE between the first layer and the second layer to 20 or more, when the first layer of the simulated mucosal layer is heated with an energy device, the first layer is melted by heat, exposing the white second layer, thereby making it possible to mark the simulated mucosal layer of the mucosal model.

[0065] <Simulated submucosal layer> The simulated submucosal layer is located below the simulated mucosal layer. The base material of the simulated submucosal layer is not limited. The simulated submucosal layer can be formed from the same or different material as the first and / or second layers constituting the simulated mucosal layer. Furthermore, the simulated submucosal layer may be configured such that a liquid injection section is disposed inside the simulated submucosal layer.

[0066] <Simulated Lesion> In the mucosal model according to this embodiment, as in the first embodiment, a simulated lesion may be placed on the simulated mucosal layer. The simulated lesion may be, for example, a portion simulating a cancerous area (cancerous tissue) and is placed (or set) on the first layer of the simulated mucosal layer 2. In this embodiment, a mark (a mark for setting the resection area) can be applied to the simulated mucosal layer around the simulated lesion placed (or set) on the first layer using an energy device, so as to surround the simulated lesion placed (or set). Examples of the shape and forming method of the simulated lesion are the same as those described in the section on the simulated lesion in the first embodiment. Other details described in the section on the simulated lesion in the first embodiment also apply here.

[0067] <Physical Properties of the Mucosal Model, etc.> The shape of the mucosal model can be selected depending on the type of medical procedure being trained, and can have any shape selected from, for example, circular, elliptical, polygonal, or irregular. The total thickness of the mucosal model is not limited, and is preferably 1 to 60 mm, more preferably 1 to 50 mm, and even more preferably 2 to 30 mm, as the sum of the simulated mucosal layer 2 and simulated submucosal layer 3. The shape of the mucosal model is the same as that described in the first embodiment. The hardness of each layer in the mucosal model can be selected appropriately depending on the type of mucosal tissue being assumed. For example, the E hardness of each layer can be set to a range of 3 to 55. The E hardness of the simulated mucosal layer 2, consisting of the first and second layers, is preferably 5 to 45. Furthermore, each layer can be colored depending on the mucosal tissue being assumed.

[0068] <Method for Manufacturing Mucosal Model> The method for manufacturing the mucosal model according to the second embodiment is not particularly limited, and the mucosal model can be manufactured using known methods. For example, the mucosal model according to the second embodiment can be obtained as follows. First, a preformed second layer is bonded to cover the simulated submucosa. The second layer and the simulated submucosa can be bonded using a silicone adhesive, a cyanoacrylate adhesive, a hot-melt adhesive, an epoxy resin adhesive, or the like, and can also be produced by co-extrusion molding the second layer and the simulated submucosa. The first layer is further bonded onto the second layer using a known adhesive such as those described above, and after co-extrusion molding, a simulated lesion is disposed on a portion of the surface of the first layer. Alternatively, the simulated lesion may be disposed on a portion of the surface of the first layer before co-extrusion molding the first and second layers.

[0069] [Third embodiment (organ model)] The organ model according to this embodiment is an organ model including the mucosal model described above. Examples of the organ model include models that mimic organs such as the digestive organs, urinary organs, reproductive organs, and respiratory organs. Examples of the digestive organs, urinary organs, reproductive organs, and respiratory organs are as exemplified in the first embodiment.

[0070] [Fourth Embodiment (Endoscopic Procedure Training Method)] The endoscopic procedure training method according to this embodiment is an endoscopic procedure training method using the mucosal model according to the first embodiment. In one embodiment, the endoscopic procedure training method may be an endoscopic procedure training method using the mucosal model according to the second embodiment or the organ model according to the third embodiment. For example, in a treatment of mucosal tissue in a living organism, the tip of an energy device is brought into contact with the mucosal tissue and electricity is applied to incise and / or stop bleeding of the mucosal tissue. In the endoscopic procedure training method according to this embodiment, the tip of the energy device may be brought into contact with the surface of the simulated mucosal layer (surface of the first layer) of the mucosal model and electricity may be applied, similar to a treatment in an actual living organism.

[0071] More specifically, for example, the surface of the first layer, which mimics the mucosal surface as exemplified in the first embodiment and has a material melting point of 50 to 240°C, is energized for 2 seconds using an electric scalpel or the like to form a hole with a diameter of 1 mm or more.

[0072] Generally, when electricity is applied to mucosal tissue of a living body, the mucus covering the mucosa heats, causing vaporization from within the mucus, which begins to form bubbles. Gradually, continuous bubble generation is observed, and holes form in the mucosal layer. In one embodiment, an endoscopic surgery training method can include, when a mucosal model has a simulated lesion on a portion of the surface of a first layer, marking the first layer around the simulated lesion using an energy device to set a resection area. Specifically, in an endoscopic surgery training method using a simulated tissue model, an energy device is used to apply electricity to the simulated mucosal layer around the simulated lesion, surrounding the simulated lesion set on the first layer, to mark the area. Completion of electricity application can be determined by the formation of a hole with a diameter of 1 mm or more around the simulated lesion, the same as that actually observed when electricity application is completed in the simulated mucosal layer that is the target of the medical procedure being trained. Only the first layer in the heated area melts, exposing the second layer, leaving a mark.

[0073] In one embodiment, the endoscopic surgery training method may be an endoscopic surgery training method using a mucosal model 1 that includes a simulated mucosal layer having a first layer and a second layer, a simulated lesion area, and a simulated submucosal layer provided below the second layer of the simulated mucosal layer.

[0074] FIG. 5 is a perspective view of the mucosal model according to the second embodiment, in which marks are made on the simulated mucosal layer 2 around the simulated lesion 24 set on the first layer using an energy device to surround the simulated lesion 24.

[0075] As shown in Figure 5, when an energy device is used to apply a mark to the first layer 21 around the simulated lesion 24, a color difference occurs between the melted portion of the first layer 21 and the second layer 22. This makes it easy to determine whether the intended procedure (e.g., marking) has been performed. Using the marked portion as a guide, training in the procedure of excising or ablating the simulated lesion 24 can be easily performed.

[0076] The endoscopic surgery training method according to this embodiment allows for effective learning of techniques such as mucosal tissue resection and dissection, and is therefore useful for medical professionals to learn techniques for treating living organisms.

[0077] A non-limiting list of exemplary embodiments and combinations of exemplary embodiments of the present disclosure is disclosed below: [1] A mucosa model having a first layer and a second layer disposed on a back surface of the first layer, wherein the thickness of the first layer is 0.01 to 3 mm, and the second layer has a volume resistivity of 1.0 x 10 or less over the entire surface or a part thereof. １ ~1.0 x 10 ７A mucosal model having a resistance of Ω·cm and a color difference ΔE between the first layer and the second layer of 20 or more. [2] The mucosal model according to [1], wherein the thickness of the second layer is 0.1 mm to 50 mm. [3] The mucosal model according to [1] or [2], wherein the melting point of the first layer is 50 to 240°C. [4] The mucosal model according to any of [1] to [3], wherein the melting point of the second layer is 50 to 240°C. [5] The mucosal model according to any of [1] to [4], wherein the first layer comprises one or more selected from the group consisting of thermoplastic resins, proteins, and polysaccharides. [6] The mucosal model according to any of [1] to [5], wherein the second layer comprises one or more selected from the group consisting of thermoplastic resins, proteins, and polysaccharides. [7] The mucosal model according to any of [1] to [6], wherein a lubricating composition is applied to the surface of the first layer. [8] The mucosal model according to any one of [1] to [7], comprising a simulated mucosal layer having the first layer and the second layer, and a simulated submucosal layer provided below the second layer of the simulated mucosal layer. [9] The mucosal model according to any one of [1] to [8], which is used for endoscopic surgery training.

[10] An organ model comprising the mucosal model according to any one of [1] to [9].

[11] An endoscopic surgery training method comprising conducting endoscopic surgery training using the mucosal model according to any one of [1] to [9] or the organ model according to

[10] .

[12] The endoscopic surgery training method according to

[11] , wherein the mucosal model has a simulated lesion on a portion of the surface of the first layer, and comprises marking the first layer around the simulated lesion with an energy device to set a resection area.

[13] The endoscopic surgery training method according to

[11] or

[12] , wherein the mucosal model comprises a simulated mucosal layer having the first layer and the second layer, and a simulated submucosal layer provided below the second layer of the simulated mucosal layer.

[0078] The configurations and combinations thereof in each embodiment are merely examples, and additions, omissions, substitutions, and other modifications of the configurations are possible as appropriate within the scope that does not deviate from the gist of this disclosure.

[0079] The present disclosure will be described in more detail below with reference to examples, but these examples are not intended to limit the interpretation of the present disclosure. The configurations and combinations thereof in each embodiment are merely examples, and additions, omissions, substitutions, and other modifications of the configurations are possible as appropriate within the scope of the gist of the present disclosure.

[0080] To prepare mucosal models for the Examples and Comparative Examples, (1) a simulated mucosal layer was prepared using the following materials. (1) The following sheets were prepared as materials for constituting the first and second layers of the simulated mucosal layer. (Sheet 1) Sheet 1 was prepared by printing on a PP resin sheet (manufactured by ELECOM Co., Ltd., product name: Handmade Tattoo Sticker, product number: EJP-TAT, thickness: 0.02 mm, melting point: 160°C) using an inkjet printer (EPSON PX-S740) with an RGB value set to 255 153 153. (Sheet 2) Sheet 2 was prepared using nonwoven fabric (manufactured by Sasagawa Co., Ltd., product name: Nonwoven Fabric J Roll Beni 15, product number: 49-9004, thickness: 0.15 mm, melting point: 165°C). (Sheet 3) A colored styrene-based thermoplastic elastomer (3) prepared by the method described below was used to form a sheet. The sheet was then subjected to a hot press method (180°C, 5 minutes, pressure 50 kg / cm). ２) to prepare a sheet 3 having a thickness of 1 mm, width of 50 mm, and length of 50 mm. (Sheet 3: red pigment 0.02%, thickness: 1 mm, melting point: 220°C) (Sheet 4) Using a colored styrene-based thermoplastic elastomer (4) prepared by the method described below, sheet 4 was prepared in the same manner as sheet 3. (Sheet 4: red pigment 0.002%, thickness: 1 mm, melting point: 220°C) (Sheet 5) Using a colored styrene-based thermoplastic elastomer (5) prepared by the method described below, sheet 5 was prepared in the same manner as sheet 3, except that the thickness was changed to 3 mm. (Sheet 5: red pigment 0.02%, thickness: 3 mm, melting point: 220°C) (Sheet 6) Using a colored styrene-based thermoplastic elastomer (6) prepared by the method described below, sheet 6 was prepared in the same manner as sheet 3. (Sheet 6: red pigment 0.1%, thickness: 1 mm, melting point: 220°C) (Sheet 7) Washi paper (manufactured by Maruju Paper Enterprise Association, product name: Rakusui paper pink, product number: MN-MRJ-050-90, thickness: 0.06 mm, melting point: 189°C) was prepared as Sheet 7. (Sheet 8) Flower paper (manufactured by Toyo Co., Ltd., product name: Flower paper (single color) peach, product number: 108315, thickness: 0.1 mm, melting point: 216°C) was prepared as Sheet 8. (Sheet 9) A polyurethane resin sheet (manufactured by Okura Kogyo Co., Ltd., product name: TPU film, product number: HM105, thickness: 0.04 mm, melting point: 130°C) was coated with acrylic paint (manufactured by Sakura Color Products Corporation, product name: Acrylic Gouache, 4.5 g of white, 3 g of carmine) dissolved in 4.5 g of water to a thickness of 100 μm. The coating was then dried to a thickness of 20 μm to produce Sheet 9. (Sheet 10) Sheet 10 was produced in the same manner as Sheet 3 using a colored styrene-based thermoplastic elastomer (10) prepared as described below. (Sheet 10: 5% white pigment, thickness: 1 mm, melting point: 220°C) (Sheet 11) 125 g of boiling water was added to 1 g of agar (manufactured by Ina Food Industry Co., Ltd., product name: Kanten Papa) and stirred. After adding 10% by mass of salt to the total amount and stirring until dissolved, 1% by mass of acrylic gouache white manufactured by Sakura Color Products Corporation was added as a pigment and further stirred, and the mixture was molded into a thickness of 1 mm and cooled to room temperature to produce sheet 11.(Sheet 11: 1% white pigment, thickness: 1 mm, melting point: 90°C) (Sheet 12) Sheet 12 was produced in the same manner as Sheet 3, using a colored styrene-based thermoplastic elastomer (12) prepared by the method described below. (Sheet 12: 0.0005% red pigment, thickness: 1 mm, melting point: 220°C) (Sheet 13) A liquid prepared by dissolving 7.5 g of white paint in 4.5 g of water was applied to the surface of a silicone rubber sheet (manufactured by AS ONE Corporation, product number: 2-9317-01, thickness: 1 mm, melting point: 250°C) to a thickness of 100 μm. Next, the applied layer was dried to a thickness of 20 μm to produce Sheet 13. (Sheet 14) Sheet 14 was prepared by printing on a PP resin sheet (manufactured by ELECOM Co., Ltd., product name: Handmade Tattoo Sticker, product number: EJP-TAT, thickness: 0.02 mm, melting point: 160°C) using an inkjet printer (EPSON PX-S740) with an RGB value set to 255 239 239. (Sheet 15) Sheet 15 was prepared in the same manner as Sheet 3 using a colored styrene-based thermoplastic elastomer (15) prepared by the method described below. (Sheet 15: red pigment 0.001%, thickness: 1 mm, melting point: 220°C) (Sheet 16) Sheet 16 was prepared in the same manner as Sheet 3 using a colored styrene-based thermoplastic elastomer (16) prepared by the method described below. (Sheet 16: red pigment 0.005%, thickness: 1 mm, melting point: 220°C) (Sheet 17) Sheet 17 was produced in the same manner as Sheet 3, except that the thickness was 4 mm, using a colored styrene-based thermoplastic elastomer (17) prepared by the method described below. (Sheet 17: red pigment 0.02%, thickness: 4 mm, melting point: 220°C) (Sheet 18) Washi paper (manufactured by Maruju Paper Cooperative, product name: Rakusui Paper White, product number: MN-MRJ-050-00, thickness: 0.06 mm, melting point: 189°C) was prepared as Sheet 18.

[0081] Preparation Example 1: Preparation of colored styrene-based thermoplastic elastomers (3) to (6), (10), (12), and (15) to (17) Colored styrene-based thermoplastic elastomers (3) to (6), (10), (12), and (15) to (17) used to produce sheets 3 to 6, 10, 12, and 15 to 17 were prepared using the following materials and by the methods described below. Hydrogenated styrene thermoplastic elastomer: SEEPS (SEPTON 4055, manufactured by Kuraray Co., Ltd.) (MFR (temperature 230°C, load 2.16 kg) 0.0 g / 10 min (0.0 g / 10 min means no flow), styrene content 30 mass%, hydrogenation rate 90 mol% or more) Paraffin oil (Diana Process Oil PW90, manufactured by Idemitsu Kosan Co., Ltd.) Polyolefin / polyether copolymer (Pelectron PVL, manufactured by Sanyo Chemical Industries, Ltd.) (MFR (measured at 190°C, load 2.16 kg) 8 to 15 g / 10 min) Ionic liquid: CIL-312 (manufactured by Japan Carlit Co., Ltd.) Red pigment: "FASTOGEN (registered trademark) SUPER MAGENTA R" manufactured by DIC Corporation White pigment: "HT0110" manufactured by Toho Titanium Co., Ltd. 100 parts by weight of hydrogenated styrene-based thermoplastic elastomer were charged into a container with 500 parts by weight of paraffin oil, 30 parts by weight of polyolefin / polyether copolymer, and 100 parts by weight of ionic liquid. Furthermore, the pigment listed in Table 1 was added in the amount listed in Table 1 relative to 100% by weight of the total amount of all components. The mixture was then stored at room temperature for at least 12 hours to allow the paraffin oil and ionic liquid to fully penetrate the styrene-based thermoplastic elastomer. Using a segment mixer (Labo Plastomill KF70V2, manufactured by Toyo Seiki Co., Ltd.), the mixture was kneaded at 180°C for 15 minutes at a rotation speed of 100 rpm to obtain colored styrene-based thermoplastic elastomers (3) to (6), (10), (12), and (15) to (17). The melting point of the resulting styrene-based thermoplastic elastomer measured by differential scanning calorimetry was 220°C.

[0082] [Color Difference Measurement] The sheets 1 to 18 prepared above were measured using a color difference meter (Color Meter color difference meter manufactured by Nippon Denshoku, model number: ZE2000). ＊ a ＊ b ＊The color space was measured. The color of the second layer sheet was measured using the standard L ＊ 0, a ＊ 0, b ＊ 0, and the first layer sheet is L ＊ 1. a ＊ 1, b ＊ When measuring, a standard white board (L ＊ = 97.8, a ＊ = -0.09, b ＊ Measurements were carried out in reflection mode on a sample in which sheets 1 to 18 (fibers permeability = 0.04) were laminated, with the measurement surface facing sheets 1 to 18. ＊ a ＊ b ＊ The color difference ΔE was calculated from the obtained values ​​using the following formula for calculating color difference. The results are shown in Table 1. ΔE={(L ＊ 1-L ＊ 0) ２ + (a ＊ 1-a ＊ 0) ２ +(b ＊ 1-b ＊ 0) ２} １／２

[0083]

[0084] [Manufacturing of Mucosal Model] (Example 1) A mucosal model having the same configuration as the mucosal model 1 shown in Figure 1 was manufactured. The mucosal model 1 shown in Figure 1 includes a simulated mucosal layer 2 having a first layer 21 and a second layer 22. In the simulated mucosal layer 2, the first layer 21 is located on the front side of the mucosal model 1, and the second layer 22 is provided on the back side. A sheet 1 for the first layer 21 of the simulated mucosal layer 2 was adhered to a sheet 10 for the second layer 22 of the simulated mucosal layer 2, which had been previously molded, to form the mucosal model. A resin-specific adhesive was used for adhesion. A simulated lesion, indicated by reference numeral 24 in Figure 3, was set on the surface of the mucosal model formed by the first layer 21 of the simulated mucosal layer 2.

[0085] (Examples 2 to 10, Comparative Examples 1 to 7) A mucosal model was obtained in the same manner as in Example 1, except that the sheets for the first layer 21 and the second layer 22 of the simulated mucosal layer 2 were as shown in Table 2, and a simulated lesion was set up in the same manner as in Example 1.

[0086] [Method for Evaluating the Mucosal Model] The simulated mucosal layer around the simulated lesion set on the first layer of the simulated mucosal layer was marked with an energy device to surround the simulated lesion, and the mucosal model was evaluated. Note that, when used as materials for mucosal models, sheets 2, 7, and 8 are often coated with a lubricating composition to approximate the appearance of human mucosa. Therefore, evaluation was performed with the lubricating composition coated on the surface. [Energy Evaluation] (Hole Creation) Using a erbe VIO-100C and a disposable high-frequency knife KD-650L (cutting knife length when protruding: 2 mm), electricity was applied in FORCED COAG mode at 30 W for 2 seconds. The number of times until a hole with a diameter of 1 mm or more was created in the first layer 21 of the simulated mucosal layer 2 and the second layer 22 was exposed was counted and evaluated as "hole creation." Furthermore, for materials with a first layer thickness of 0.08 mm or more, jelly was applied before the energy evaluation. The evaluation of "holes" was performed based on the following criteria, and the evaluation results are shown in Tables 2 and 3. A: Melts within two energizations, leaving holes in the first layer B: Melts within three to five energizations, leaving holes in the first layer C: The first layer does not melt even after six or more energizations (Appearance evaluation) The appearance of the simulated mucosal layer after energization was evaluated visually with the naked eye. The appearance evaluation was performed based on the following criteria, and the evaluation results are shown in Tables 2 and 3. A: The difference between the first and second layers is clearly visible with the naked eye C: There is almost no color difference between the first and second layers, and the difference is not discernible (Burning) The scorching of the simulated mucosal layer after energization was evaluated with the naked eye. The scorching evaluation was performed based on the following criteria, and the evaluation results are shown in Tables 2 and 3. A: Almost no scorching B: The heated area is partially scorched C: The heated area is completely scorched

[0087]

[0088]

[0089] As shown in Table 2, the mucosal models of Examples 1 to 10 generally satisfied all evaluation criteria. On the other hand, as shown in Table 3, the mucosal models of Comparative Examples 1 to 7 did not achieve sufficient reproducibility for any of the evaluation criteria. In Comparative Examples 1 to 4 and 6, holes were drilled in the first layer, but the color difference ΔE between the first and second layers was less than 20, making it difficult to visually distinguish between the first and second layers. In Comparative Example 5, the color difference ΔE between the first and second layers of the simulated mucosal layer was 20 or more, but the thickness of the first layer was 4 mm, making it impossible to reproduce marks around the simulated lesion. In Comparative Example 7, in which the volume resistivity of the second layer was high, the first layer did not melt due to a poor current flow evaluation.

[0090] The mucosal model of this embodiment includes a simulated mucosal layer having a color difference between the first and second layers, and by setting the thickness of the first layer and the volume resistivity of the second layer within a predetermined range, it is possible to provide a mucosal model in which the marking location can be easily visually confirmed when marking is applied to the surface.

[0091] REFERENCE SIGNS LIST 1 Mucosal model 2 Simulated mucosal layer 3 Simulated submucosal layer 21 First layer 22 Second layer 23 Hole 24 Simulated lesion area

Claims

1. A mucosa model having a first layer and a second layer laminated on the first layer, wherein the thickness of the first layer is 0.01 to 3 mm, and the second layer has a volume resistivity of 1.0 x 10 over the entire surface or a part thereof. １ ~1.0 x 10 ７ Ω·cm, and a color difference ΔE between the first layer and the second layer is 20 or more.

2. The mucosa model according to claim 1, wherein the thickness of the second layer is 0.1 mm to 50 mm.

3. A mucosal membrane model according to claim 1 or 2, wherein the melting point of the first layer is 50 to 240°C.

4. A mucosal membrane model according to claim 1 or 2, wherein the melting point of the second layer is 50 to 240°C.

5. A mucosal membrane model according to claim 1 or 2, wherein the first layer comprises one or more selected from the group consisting of thermoplastic resins, proteins, and polysaccharides.

6. A mucosal membrane model according to claim 1 or 2, wherein the second layer comprises one or more selected from the group consisting of thermoplastic resins, proteins, and polysaccharides.

7. The mucosal membrane model according to claim 1 or 2, wherein a lubricating composition is applied to the surface of the first layer.

8. A mucosal model according to claim 1 or 2, comprising a simulated mucosal layer having the first layer and the second layer, and a simulated submucosal layer provided below the second layer of the simulated mucosal layer.

9. The mucosal model according to claim 1 or 2, which is used for endoscopic surgery training.

10. An organ model comprising the mucosal model according to claim 1.

11. A method for endoscopic surgery training, comprising conducting endoscopic surgery training using the mucosal model according to claim 1 or the organ model according to claim 10.

12. An endoscopic surgery training method according to claim 11, wherein the mucosal model has a simulated lesion on a portion of the surface of the first layer, and the method includes marking the first layer around the simulated lesion with an energy device to set the resection range.

13. The endoscopic procedure training method according to claim 11, wherein the mucosal model comprises a simulated mucosal layer having the first layer and the second layer, and a simulated submucosal layer provided below the second layer of the simulated mucosal layer.

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