Mucosal model

Abstract

To provide a mucous membrane model in which a marking place is easily visually confirmed when marking is applied to a surface.SOLUTION: A mucosa model including a first layer and a second layer laminated on the first layer, in which a thickness of the first layer is 0.01 to 3mm, a volume resistivity of an entire surface or a part of the second layer is 1.0 * 101 to 1.0 * 107 Ω·cm, and a color difference Δ E between the first layer and the second layer is 20 or more.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] This disclosure relates to a mucosal model. [Background technology]

[0002] In recent years, there has been growing interest in minimally invasive surgery, such as endoscopy and laparoscopy, which places less burden on the body and allows for earlier recovery, and the number of such surgeries is increasing. For example, by removing tumors that have formed in the mucosal layer inside organs using an endoscope (endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)), surgery can be performed through smaller incisions compared to conventional open surgery. In addition, by stopping bleeding in the gastrointestinal tract using an endoscope (endoscopic hemostasis), shock due to bleeding can be prevented, and emergency surgery can be avoided. As a result, the physical burden on the patient is reduced, and a shorter hospital stay and earlier return to society can be expected.

[0003] Therefore, there is a growing demand for surgical practice models for doctors and medical students that are compatible with endoscopic and laparoscopic surgery, and several models for training medical procedures have been proposed to improve skills and the quality of medical treatment (Patent Documents 1-5). [Prior art documents] [Patent Documents]

[0004] [Patent Document 1] Japanese Patent Publication No. 2006-116206 [Patent Document 2] Japanese Patent Publication No. 2008-197483 [Patent Document 3] Japanese Patent Publication No. 2018-17769 [Patent Document 4] Japanese Patent Publication No. 2017-107094 [Patent Document 5] Japanese Patent Publication No. 2016-38563 [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] In surgical procedures such as resection and dissection using endoscopes or laparoscopes, it is common practice to mark the area to be resected or dissected, or its surroundings, with an energy device prior to the procedure to confirm the extent of resection. This marking process involves heating the mucous membrane where the energy device makes contact, causing the mucosal tissue (pale red) to change color to white due to protein denaturation in humans, thereby marking the area to be resected or dissected. This marking helps to define the extent of tumor resection. If marking is not performed before resection or dissection, it may be difficult to determine whether the entire lesion was included during electrocautery. Conventional organ models have been unable to reproduce the phenomenon of mucosal tissue (pale red) changing color to white due to heating of the mucous membrane where the energy device makes contact, making it difficult to visually confirm the markings. This disclosure aims to provide a mucosal model that allows for easy visual confirmation of the marked areas when markings are applied to the surface. [Means for solving the problem]

[0006] As a result of considering various methods, the inventors have found a mucosal model in which, in a conventional mucosal model, a simulated mucosal layer having a color difference between the first and second layers is provided, and the thickness of the first layer and the volume resistivity of the second layer are within a predetermined range, thereby enabling the marking of mucosal tissue with an energy device to be easily observed visually, and have completed this disclosure.

[0007] This disclosure includes the following aspects: <1> A mucosal 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 × 10⁻¹⁰ in its entirety or in part. 1 ~1.0×10 7 A mucosal model having a density of Ω·cm and a color difference ΔE between the first and second layers of 20 or more. <2> Organ models, including the aforementioned mucosal model. <3> An endoscopic procedure training method, which includes performing endoscopic procedure training using the aforementioned mucosal model. [Effects of the Invention]

[0008] According to this disclosure, it is possible to provide a mucosal model in which the marked areas can be easily visually identified when markings are applied to the surface. [Brief explanation of the drawing]

[0009] [Figure 1] This is a schematic cross-sectional view of a mucosal model according to the first embodiment of this disclosure. [Figure 2] This is a schematic cross-sectional view of the simulated mucosal layer in a mucosal model according to the first embodiment of the present disclosure, in which the simulated mucosal layer surrounding a simulated lesion set on a first layer is marked with an energy device. [Figure 3] This is a plan view of the mucosal model according to the first embodiment of the present disclosure, in which the simulated mucosal layer surrounding the simulated lesion, which is set on the first layer, is marked with an energy device. [Figure 4] This is a schematic cross-sectional view of a mucosal model according to the second embodiment of the present disclosure, which is a cross-sectional view of a mucosal model according to the first embodiment in which a simulated submucosal layer is provided below the second layer of the simulated mucosal layer. [Figure 5] This is a perspective view of a mucosal model according to a second embodiment of the present disclosure, in which the simulated mucosal layer surrounding the simulated lesion, which is set on the first layer, is marked with an energy device. [Modes for carrying out the invention]

[0010] One embodiment of this disclosure will be described in detail below, but the scope of this disclosure is not limited to the embodiment described herein, and various modifications can be made without departing from the spirit of this disclosure. Each embodiment disclosed herein can be combined with any other features disclosed herein. Furthermore, if multiple upper and lower limits are given for a particular parameter, any combination of these upper and lower limits can be used to create a suitable numerical range. Also, the lower and / or upper limits of the numerical ranges described herein may be replaced with numerical values ​​within that range, as shown in the examples. The expression "X~Y" indicating a numerical range means "X or greater and Y or less". If a particular description given for one embodiment also applies to other embodiments, that description may be omitted in the other embodiments.

[0011] [First Embodiment] The mucosal model according to the first embodiment is a mucosal 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 × 10⁻¹⁰ in its entirety or in part. 1 ~1.0×10 7 The mucosal model has a density of Ω·cm and a color difference ΔE between the first and second layers of 20 or more. According to the mucosal model of this embodiment, it is easy to distinguish each layer of mucosal tissue exposed during procedures such as excision and dissection, and visibility is excellent. Furthermore, it is easy to excise and dissect using energy devices such as general electrosurgical units. Therefore, for example, training can be conducted on mucosal tissue excision and / or dissection using energy devices, as well as marking of the excision site performed prior to such training, and it is easy to determine whether the intended procedure is being performed correctly.

[0012] In this specification, the term "mucosa" in a mucosal model is not limited to any tissue capable of secreting mucus in an animal's body, and includes, for example, at least a part of the mucosa of organs such as the digestive organs, urinary organs, reproductive organs, 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 ureters, bladder, and urethra; examples of reproductive organs include the fallopian tubes, uterus, vagina, vas deferens, penis, and urethra; and examples of respiratory organs include the nasal cavity, trachea, and bronchi, but is not limited to these. A mucosal model is not limited to a model that mimics the mucosa of any animal species, and may be a mucosal model of any animal species such as mammals including humans, birds, reptiles, amphibians, and fish, and can be appropriately selected by a person skilled in the art according to the need for training in medical procedures.

[0013] Figure 1 is a cross-sectional view of a mucosal model 1 according to one embodiment. The mucosal model 1 shown in Figure 1 has a first layer 21 and a second layer 22.

[0014] <1st layer> The first layer is the layer that makes up the surface (the uppermost layer) of the mucosal model 1. In this example, it is shown as a flat structure, but its shape is not limited as long as it can be supplied to the treatment surface for excising and sectioning the simulated lesion in training for endoscopic submucosal dissection using the mucosal model.

[0015] (base material) The base material of the first layer is not particularly limited as long as it is a material that 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 cellulose-containing substrates include cotton, hemp, wool, pulp, and tree bark. Cellulose-containing substrates may be used alone or in combination of two or more. When the first layer contains cellulose, for example, the first layer may contain one or more materials selected from nonwoven fabrics such as cotton, hemp, wool, and pulp; Japanese paper (tree bark); and tissue paper (pulp).

[0017] Examples of thermoplastic resins include styrene resins, polyolefin resins, polyester resins, thermoplastic polyurethane resins, vinyl chloride resins, ethylene-vinyl acetate resins, and polyacrylic resins, and it is preferable to include one or more selected from these. The thermoplastic resin may be used alone or in combination of two or more types. From the viewpoint of flexibility, the styrene-based resin preferably includes hydrogenated styrene-based thermoplastic elastomers and polyolefin-based elastomers. 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 resins include polyethylene, polypropylene, ethylene-propylene copolymer, and ethylene-vinyl acetate copolymer (EVA). From the viewpoint of versatility, cost, and moldability, it is preferable to include polyethylene and / or polypropylene. Examples of polyester resins include polyethylene terephthalate (PET) and polybutylene terephthalate (PBT). Examples of thermoplastic polyurethane resins include polycarbonate-based, polyester-based, polyether-based, acrylic-based, and aliphatic-based thermoplastic polyurethane resins (TPU).

[0018] Examples of proteins include gelatin and collagen. Proteins may be used individually or in combination of two or more types.

[0019] Examples of polysaccharides include dietary fiber and starch. Polysaccharides may be used individually or in combination of two or more types.

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

[0021] In one embodiment, the first layer preferably contains one or more materials selected from hydrogenated styrene-based thermoplastic elastomer, PP resin, nonwoven fabric, Japanese paper, tissue paper, thermoplastic polyurethane resin, and agar. In one embodiment, the substrate for the first layer may be, for example, polyester; nonwoven fabrics such as cotton, hemp, wool, or pulp; films (PP, PE, PET); Japanese paper (tree bark), flower paper (pulp); tattoo paper (polyolefin); SEEPS, process oil, ionic liquid, and a compatibilizer. In one embodiment, the first layer may be polyester; nonwoven fabric such as cotton, hemp, wool, or pulp; PP film, PE film, or PET film; Japanese paper (tree bark), flower paper (pulp); tattoo paper (polyolefin); or a base material (seeps / process oil / ionic liquid / compatibilizer).

[0022] (Coloring agent) The first layer preferably contains a coloring agent such as a pigment or dye to facilitate the adjustment of the color difference ΔE between it and the second layer. The coloring agent may be mixed in the first layer, or it may be applied to the surface of the first layer or printed on it. The type of coloring agent is not limited, and known coloring agents such as red coloring agents, white coloring agents, orange coloring agents, brown coloring agents, and yellow coloring agents can be used individually or in combination of two or more. If the coloring agent is applied to the surface of the first layer, the application and printing methods are not limited, and for example, a liquid obtained by dissolving aqueous paint in water or acrylic paint (acrylic resin) may be applied, or it may be printed using an inkjet printer or the like. In one embodiment, the first layer is preferably a reddish layer from the viewpoint of making it resemble the appearance of mucous membrane tissue of the human body.

[0023] (Other ingredients) The first layer may contain oil, ionic liquid, polymer antistatic agent, compatibilizer, etc., to mimic the appearance of human mucous membranes. Furthermore, to improve the lubrication of the energy device, a lubricating composition may be applied to the surface (upper side) of the first layer. The oil can be used, for example, to soften the substrate constituting the first layer and to adjust the elastic modulus and hardness of the mucous membrane model. While not particularly limited, examples of oils include paraffinic process oils, naphthenic process oils, aromatic process oils, mineral oils such as liquid paraffin, silicone oils, castor oil, linseed oil, olefin waxes, and mineral waxes. 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 Co., Ltd.). The oil may be used alone or in combination of two or more types. For ease of use, it is preferable to allow the oil to be absorbed into the substrate constituting the first layer beforehand.

[0024] The oil content is preferably 100 to 1000 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, per 100 parts by mass of the base material constituting the first layer.

[0025] Ionic liquids can be used, for example, to adjust the tensile fracture elongation or volume resistivity of the substrate constituting the first layer. While not particularly limited, commercially available examples include CIL312 (N-butyl-3-methylpyridinium bistrifluoromethanesulfonylimide, manufactured by Nippon Carlit Co., Ltd.), Aminoion AS100 (manufactured by Nippon Emulsifier Co., Ltd.), Aminoion AS300 (manufactured by Nippon Emulsifier Co., Ltd.), FC-4400 (tri-n-butylmethylammonium bistrifluoromethanesulfonimide, manufactured by 3M Corporation), and Hishikorin (dodecyltributylphosphonium chloride, manufactured by Nippon Chemical Industries, Ltd.). Ionic liquids may be used individually 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, per 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 substrate constituting the first layer, it is easier to suppress the increase in volume resistivity, and by setting it to 250 parts by mass or less, it is easier to suppress the ionic liquid from bleeding out of 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 polyether ester amides, ethylene oxide-epichlorohydrins, and polyether esters; 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 polyethylene glycol blocks and polypropylene glycol blocks, or polyether blocks and polyolefin blocks are bonded via at least one type of bond selected from ester bonds, amide bonds, ether bonds, urethane bonds, and imide bonds, or block copolymers having a structure in which hydrophilic blocks and hydrophobic blocks are repeatedly and alternately bonded can be used. As an example, a volume resistivity of 10 5 ~10 11 Examples include block copolymers having a structure in which hydrophilic polyether blocks with Ω·cm and polyolefin blocks are repeatedly and alternately bonded. The number-average molecular weight (Mn) of the block copolymer is preferably 500 to 60000.

[0027] The amount of 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, per 100 parts by mass of the substrate constituting the first layer.

[0028] The lubricating composition is not particularly limited, but examples include water, low molecular weight compounds such as 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, superabsorbent polymers such as hydrogenated castor oil, 12-hydroxystearic acid, glucono delta-lactone, and sodium polyacrylate, polyethylene glycol, polypropylene glycol, hyaluronic acid, alginic acid, carrageenan, dextrin, xanthan gum, guar gum, glycosaminoglycan, collagen, water-soluble vinyl polymers (including carboxyvinyl polymers and polyvinyl alcohol), hypromellose, methylcellulose, polyacrylic acid, polymethacrylic acid, and water-soluble polymers such as hydroxyethylcellulose, and may contain one or more of these. In one embodiment, the lubricating composition may be an aqueous solution of sodium chloride or an aqueous solution of sodium polyacrylate. Various commercially available medical lubricating gels and ultrasound examination gels can also be used as lubricating compositions. The lubricating composition may further contain one or more electrolytes, conductive materials such as carbon nanomaterials, conductive polymers, and metal fillers, preservatives, fragrances, dyes, narcotic components, pH adjusters, dispersants, thickeners (including thixotropic agents, anti-settling agents, and anti-dripping agents), surfactants, antioxidants, and the like.

[0029] In one embodiment, the lubricating composition has a volume resistivity of 1.0 to 1.0 × 10⁻¹⁰, from the viewpoint of suitability for application to simulated organs. 5 The viscosity is Ω·cm, and the viscosity at 25°C measured by the measurement method specified in JIS Z8803 is 1.0 to 1.0 × 10⁻⁶. 5The composition is preferably mPa·s. Applicability refers to the characteristic that when the simulated mucus composition is applied to a simulated organ, it does not have excessive viscosity (stickiness) and remains easily on the surface of the simulated organ after application. A lubricating composition having such characteristics can be prepared by adjusting the components contained in the composition, the content of each component, and measuring the volume resistivity and viscosity to confirm that they fall within the above range. Here, the volume resistivity can be calculated by measuring AC impedance at a measurement temperature of 25°C.

[0030] Specifically, the sample to be measured is placed in a liquid measurement cell with a diameter of 13 mm and a thickness of 5 mm. Metal terminals provided at both ends of the cell that are in contact with the sample are connected to the terminals of an AC impedance measuring device (Solartron SI 1287, frequency response analyzer 1252A, manufactured by Toyo Technica Co., Ltd.). Using a small environmental tester (ESPEC Corporation, model number: SU-241), the resistivity of the cell is measured at a temperature of 25°C, and the volume resistivity can be calculated by dividing the obtained result by the thickness of 5 mm. Viscosity can be measured using a rheometer (Anton Paar MCR-92) according to the measurement method specified in JIS Z8803, with a 50mm diameter cone plate 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, which mimics the mucosal surface, is coated with a lubricating composition, it becomes easier to reproduce the behavior of mucus during treatment of biological mucosal tissue using an energy device (e.g., continuous bubble generation). Furthermore, it is possible to reduce the risk of deformation or malfunction of energy devices due to the energization and heating of thermoplastic resins, which have been used in conventional medical procedure training.

[0032] (Method for preparing the first layer) The first layer can be produced by known sheet molding methods such as press molding or extrusion molding if the base material is a thermoplastic resin. If the base material is a protein or polysaccharide, the first layer can be produced by molding a liquid dissolved in water or hot water to a predetermined thickness and then cooling it. Alternatively, commercially available PP resin sheets, nonwoven fabrics, Japanese paper, tissue paper, polyurethane resin sheets, etc., can be obtained and colored as needed.

[0033] (Physical properties of the 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 a first layer thickness of 0.01 to 3 mm, it is possible to provide a mucosal model in which the marked areas can be easily visually identified when markings are applied to the surface.

[0034] The melting point of the first layer should be within a range where it 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. Preferably, the melting point of the first layer is less than or equal to the melting point of the second layer. When the melting point of the first layer is less than or equal to the melting point of the second layer, when the mucosal model is used for medical procedure training with an energy device, the heat generated when the energy device is energized causes the heated area of ​​the first layer to melt, forming a hole and exposing the second layer. In this embodiment, since the color difference ΔE between the first and second layers is 20 or more, a color difference is created between the melted area of ​​the first layer and the second layer, making it easy to distinguish between the two. As a result, it is easier to effectively train in marking the mucosal model. In this specification, the melting point is defined as the value measured using a differential scanning calorimeter (METTLER TOLEDO, model number: DSC3+) under a nitrogen atmosphere at a heating rate of 10°C / min.

[0035] Incidentally, the energy device may be, for example, a high-frequency knife such as an electric scalpel used for endoscopic submucosal dissection. The length of the knife part 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 for example, it is preferably 1.0×10 1 ~1.0×10 7 Ω·cm. The method for measuring the volume resistivity will be described later.

[0037] The L * , a * , b * values of the first layer were measured using a standard white plate (L * =97.8, a * =-0.09, b * =0.04). The value of L * is preferably 0 to 100, the value of a * is preferably 0 or more, the value of b * is preferably -50 or more, the value of a * can be 100 or less, and the value of b * can be 100 or less. By setting the L * , a * , b * values of the first layer within the above ranges, it is easy to adjust the color difference ΔE between the first layer and the second layer to a predetermined range. Also, it is possible to approximate the appearance of the mucosal tissue (especially the lamina propria) of the human body.

[0038] <Second layer> The mucosal model 1 shown in FIG. 1 has a second layer 22 laminated on the first layer 21. In the mucosal model 1 shown in FIG. 1, the second layer 22 is directly laminated on one surface (for example, 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 that is opposite to the surface that becomes 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 the treatment surface for excising and sectioning the simulated lesion part in medical procedure training using the mucosal model.

[0039] (Base material) The substrate for the second layer is preferably a conductive material. The second layer preferably comprises a conductive material and one or more selected from the group consisting of thermoplastic resins, proteins, and polysaccharides. The thermoplastic resins, proteins, and polysaccharides that may be included in the second layer are the same as those exemplified in the section on the first layer above, and can be molded from the same or different materials as the first layer.

[0040] Examples of conductive materials when a thermoplastic resin is used for the second layer include conductive polymers, metallic materials such as silver, copper, tin oxide, and zinc oxide, carbon materials such as carbon black, carbon nanotubes, graphite, and diamond-like carbon, and ionic liquids contained in the first layer. When proteins or polysaccharides are used for the second layer, examples of conductive materials include aqueous solutions containing ionic substances such as tap water or saline solution (sodium chloride aqueous solution).

[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, per 100 parts by mass of the substrate of the second layer.

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

[0043] (Other ingredients) The second layer may contain oil, ionic liquid, polymer antistatic agent, compatibilizer, etc., to approximate the appearance of human mucous membranes. The types and amounts of oil, ionic liquid, polymer antistatic agent, and compatibilizer can be exemplified in the same way as those described in the section on the first layer.

[0044] (Properties of the second layer) The second layer has a total or partial volume resistivity of 1.0 × 10⁻⁶ 1 ~1.0×10 7 The coefficient of gravity is Ω·cm, preferably 1.3 × 10⁻⁶. 3 ~1.0×10 6 Ω·cm, more preferably 1.3 × 10 3 ~7.0×10 5 It is Ω·cm. The volume resistivity of the second layer is 1.0 × 10⁻⁶. 7 By setting the volume resistivity to Ω·cm or less, when using the mucosal model for medical procedure training with energy devices, it becomes easier to reproduce the behavior of lesions in living organisms, and incision procedures become easier. The volume resistivity of the second layer is 1.0 × 10⁻⁶. 1 Making the density Ω·cm or greater makes it easier to form into a sheet. Volume resistivity can be measured, for example, in accordance with JIS C2139, using a commercially available machine (e.g., the HighResta UXMCP-HT800 manufactured by Mitsubishi Chemical Analytec Corporation) on a sheet of any shape with a thickness of 1.0 mm, under conditions of 23 ± 1 °C.

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

[0046] The thickness of the second layer should be within a range that is acceptable for a mucosal model, such that the second layer does not penetrate when the simulated mucosal layer is marked with an energy device. 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 greater than the melting point of the first layer. In this case, the substrate for the second layer can be selected from a material whose melting point is equal to or greater than that of the first layer. As a result, the heat generated when current is applied by the energy device melts the heated area of ​​the first layer, forming a hole and exposing the second layer, which has a melting point equal to or greater than that of the first layer. In this embodiment, since the color difference ΔE between the first and second layers is 20 or more, a color difference is created between the melted area of ​​the first layer and the second layer, making it easy to distinguish between the two. As a result, training in marking the mucous membrane model can be effectively performed. The method for measuring the melting point is as described above.

[0049] L of the second layer * a * , b * The value of the standard whiteboard (L * =97.8, a * = -0.09, b * The measurement was performed using L = 0.04. * The value of is preferably 30 or greater. * The value of can be between -100 and 100, and b * The value can range from -100 to 100. L of the second layer * a * , b * By setting the value within the above range, it becomes easier to adjust the color difference ΔE between the first and second layers to a predetermined range. Furthermore, it is possible to approximate the appearance of human mucosal tissue (especially the muscularis mucosae). The same method as for the first layer is also exemplified for the fabrication of the second layer.

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

[0051] <Simulated lesion> The mucosal model of this disclosure can have a simulated lesion on the first layer. The simulated lesion is, for example, a portion that mimics a cancerous area (cancer tissue) and is placed on the first layer of the simulated mucosal layer. To set the lesion resection range, an energy device can be used to mark the simulated mucosal layer surrounding the simulated lesion so as to serve as a guide for incision and dissection of the simulated lesion.

[0052] Figure 2 shows a cross-section of the simulated mucosal layer in a mucosal model 1 according to the first embodiment of the present disclosure, in which the first layer 21 surrounding the simulated lesion 24 set on the first layer 21 is marked with an energy device. The first layer 21 has holes 23 formed at the marked locations, and the second layer 22 is exposed at these 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 the first layer 21 is marked (i.e., has holes 23) with an energy device so as to surround the simulated lesion 24 set on the first layer 21.

[0054] The shape and dimensions of the simulated lesion are not limited and can be those of the target lesion. The shape of the simulated lesion can be any shape selected from, for example, a circle, an ellipse, a polygon, or an irregular shape. The simulated lesion can be molded by known molding methods, and may be molded integrally or in sections. For example, when using an inner mold (core) and an outer mold and pouring material into the space between them, the inner mold may be removed by making an incision in the resin molded body and removing the inner mold from there, and the incision can then be glued to complete the simulated lesion. Alternatively, the simulated lesion may be molded using male and female molds by hot press molding, vacuum press molding, etc., or multiple tissue parts may be molded separately by injection molding, etc., and then glued together to complete the simulated lesion.

[0055] The simulated lesion area may be colored using additives such as pigments, dyes, fragrances, antioxidants, and antibacterial agents, to the extent that it does not hinder the purpose. Alternatively, red-colored thermoplastic styrene elastomer, red-colored nonwoven fabric, or paper may be attached. The material that will become the simulated lesion area may be colored before molding. It is preferable that the appearance allows the mucosal layer and the lesion area to be distinguished in the endoscopic field of view, and it is even more preferable that there is a difference in color between the mucosal layer and the lesion area. It is preferable that the simulated lesion area is colored with a coloring agent in order to approximate the tissue of living organisms and / or to make it distinguishable from other areas of the first layer.

[0056] <Physical properties of mucosal models, etc.> The shape of the mucosal model can be selected depending on the type of medical procedure being trained, but it can have any shape, such as circular, oval, polygonal, or irregular. 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 of the mucosal model in the direction perpendicular to the thickness direction can be selected depending on the type of medical procedure being trained, but it can also be a range that corresponds to the extent of a typical ulcer, for example, around 20 to 200 mm.

[0057] <Method for manufacturing a mucosal model> The mucosal model according to the first embodiment can be manufactured by joining the upper surface of the second layer to the lower surface (back surface) of the first layer. The joining of the first and second layers can be done using a silicone adhesive, a cyanoacrylate adhesive, a hot melt adhesive, an epoxy resin adhesive, etc., and the model can also be manufactured by co-extrusion molding of the first and second layers.

[0058] According to the mucosal model of this embodiment, techniques such as mucosal tissue resection and dissection can be effectively learned, and therefore it can be suitably used, for example, as a mucosal model for endoscopic procedure training.

[0059] The mucosal model may also have a configuration in which a simulated submucosal layer is placed beneath the simulated mucosal layer. An example of this case is described below as a second embodiment.

[0060] [Second Embodiment] Figure 4 shows an example of a mucosal model according to the second embodiment of this disclosure. The mucosal model 1 according to the second embodiment shown in Figure 4 comprises a simulated mucosal layer 2 including the first layer 21 and the 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 has the first layer 21, the second layer 22, and the simulated submucosal layer 3 in this order.

[0061] <Simulated mucosal layer> The simulated mucosal layer includes the first and second layers described in the first embodiment. Since the first and second layers are as described above, their description is omitted here.

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

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

[0064] In the simulated mucosal layer of the mucosal model according to this embodiment, there are two layers, a first layer and a second layer, with different colors, and the color difference ΔE between the first and second layers is 20 or more. In one embodiment, the first layer is made of a light red color to mimic the color of the mucosal epithelium side of mucosal tissue in living organisms. On the other hand, the second layer is made of a white color to mimic the color of the muscularis mucosa of mucosal tissue. The simulated mucosal layer consists of two layers: a light red layer and a white layer. By setting the color difference ΔE between the first and second layers to 20 or more, when the first layer of the simulated mucosal layer is heated with an energy device, the first layer melts due to the heat, exposing the white second layer. This allows markings to be placed on the simulated mucosal layer of the mucosal model.

[0065] <Simulated submucosa> The simulated submucosa is located beneath the simulated mucosa. The substrate of the simulated submucosa is not limited. The simulated submucosa can be molded from the same or different material as the first and / or second layers that constitute the simulated mucosa. Alternatively, the liquid injection section may be located inside the simulated submucosal layer.

[0066] <Simulated lesion> In the mucosal model according to this embodiment, a simulated lesion may be placed on the simulated mucosal layer, similar to the first embodiment. The simulated lesion may be, for example, a portion that mimics a cancerous area (cancer tissue), and is placed (or set) on the first layer of the simulated mucosal layer 2. In this embodiment, an energy device can be used to mark (mark for setting the excision range) the simulated mucosal layer surrounding the simulated lesion placed (or set) on the first layer. The shape and molding method of the simulated lesion are exemplified by those described in the section on simulated lesions in the first embodiment. Other contents described in the section on simulated lesions in the first embodiment also apply here.

[0067] <Physical properties of mucosal models, etc.> The shape of the mucosal model can be selected depending on the type of medical procedure being trained, but it can have any shape, such as circular, oval, polygonal, or irregular. The total thickness of the mucosal model is not limited, but 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 the simulated submucosal layer 3. The shape of the mucosal model is the same as that described in the first embodiment. In a mucosal model, the hardness of each layer can be appropriately selected according to the type of mucosal tissue being assumed, but for example, the E hardness of each layer can be set in the range of 3 to 55. The E hardness of the simulated mucosal layer 2, which consists of the first and second layers, is preferably 5 to 45. Furthermore, each layer can be colored according to the envisioned mucosal tissue.

[0068] <Method for manufacturing a mucosal model> The method for manufacturing the mucosal model according to the second embodiment is not particularly limited and can be manufactured using known methods. For example, the mucosal model according to the second embodiment can be obtained as follows. First, a pre-formed second layer is joined so as to cover the simulated submucosal layer. The second layer and the simulated submucosal layer can be joined using a silicone adhesive, cyanoacrylate adhesive, hot melt adhesive, epoxy resin adhesive, etc., and the second layer and the simulated submucosal layer can also be manufactured by co-extrusion molding. The first layer is further bonded on top of the second layer using a known adhesive such as those described above, and after co-extrusion molding, a simulated lesion is placed on a part of the surface of the first layer. Alternatively, the simulated lesion may be placed on a part 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 that includes the mucosal model described above. Examples of organ models 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 illustrated in the first embodiment described above.

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

[0071] More specifically, for example, as illustrated in the first embodiment, the surface of the first layer, which mimics a mucous membrane and has a melting point of 50-240°C, is subjected to an electric current for 2 seconds using an electrosurgical unit or the like to form holes with a diameter of 1 mm or more.

[0072] Generally, when electricity is applied to the mucosal tissue of a living organism, the mucus covering the mucosa is heated, causing vaporization to occur from within the mucus, which begins to form bubbles. Gradually, continuous bubble formation is observed, and holes are created in the mucosal layer. In one embodiment, the endoscopic procedure training method may include marking the resection range on the first layer surrounding a simulated lesion using an energy device, if the mucosal model has a simulated lesion on a part of the surface of the first layer. Specifically, in the endoscopic procedure training method using a simulated tissue model, an energy device is used to apply current to the simulated mucosal layer surrounding the simulated lesion so as to surround the simulated lesion set on the first layer, thereby marking it. The completion of current application may be judged by the fact that a hole with a diameter of 1 mm or more is formed around the simulated lesion, just as would be observed when current application is completed in the simulated mucosal layer that is the target of the medical procedure being trained, and that only the first layer of the heated portion melts, leaving a mark as the second layer is exposed.

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

[0074] Figure 5 is a perspective view of the mucosal model according to the second embodiment described above, in which the simulated mucosal layer 2 surrounding the simulated lesion 24 set on the first layer is marked with an energy device.

[0075] As shown in Figure 5, when an energy device is used to apply current to the first layer 21 surrounding a simulated lesion 24 set on the first layer 21, a color difference is created between the melted area 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. Training in procedures such as excising or dissecting the simulated lesion 24 using the marked area as a guide can be easily performed.

[0076] According to the endoscopic procedure training method of this embodiment, techniques such as mucosal tissue resection and dissection can be effectively acquired, and therefore, it is useful for medical professionals to acquire techniques for procedures on living organisms.

[0077] A non-limiting list of exemplary embodiments and combinations of exemplary embodiments of this disclosure are disclosed below. [1] A mucosal model having a first layer and a second layer disposed on the back surface of the first layer, The thickness of the first layer is 0.01 to 3 mm. The second layer has a volume resistivity of 1.0 × 10⁻¹⁰ in its entirety or in part. 1 ~1.0×10 7 It is Ω·cm, A mucosal model in which the color difference ΔE between the first layer and the second layer is 20 or more. [2] The mucosal model described in [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 one of [1] to [3], wherein the melting point of the second layer is 50 to 240°C. [5] The mucosal model according to any one 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 one of [1] to [5], wherein the second layer comprises one or more selected from the group consisting of thermoplastic resins, proteins, and polysaccharides. [7] A mucosal model according to any one of [1] to [6], wherein a lubricating composition is applied to the surface of the first layer. [8] A 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] A mucosal model described in any of [1] to [8] for use in endoscopic procedure training. Organ models, including the mucosal model described in any of

[10] [1] to [9]. An endoscopic procedure training method, which includes performing endoscopic procedure training using a mucosal model described in any of

[11] [1] to [9], or an organ model described in

[10] .

[12] The endoscopic procedure training method according to

[11] , wherein the mucosal model has a simulated lesion on a part of the surface of the first layer, and the method includes marking the first layer around the simulated lesion with an energy device to mark the resection range.

[13] The endoscopic procedure 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] Each configuration and its combinations in each embodiment are examples, and additions, omissions, substitutions, and other modifications can be made as appropriate without departing from the spirit of this disclosure. [Examples]

[0079] The present disclosure will be further illustrated by the following examples, but these examples will not limit the interpretation of the present disclosure. Each configuration and combination thereof in each embodiment is an example, and additions, omissions, substitutions, and other modifications can be made as appropriate without departing from the spirit of the present disclosure.

[0080] To prepare mucosal models of the examples and comparative examples, (1) a simulated mucosal layer was prepared using the following materials. (1) Simulated mucosal layer The following sheets were prepared as materials for constructing the first and second layers of the simulated mucosal layer. (Sheet 1) Sheet 1 was prepared by printing on a PP resin sheet (ELECOM Co., Ltd., product name: Handmade Tattoo Stickers, product number: EJP-TAT, thickness: 0.02 mm, melting point: 160℃) using an inkjet printer (EPSON PX-S740) with the RGB values ​​set to 255 153 153. (Sheet 2) A nonwoven fabric (manufactured by Sasagawa Co., Ltd., product name: Nonwoven Fabric J-Roll Red 15, product number: 49-9004, thickness: 0.15 mm, melting point: 165°C) was prepared as sheet 2. (Sheet 3) Using the colored styrene-based thermoplastic elastomer (3) prepared by the method described later, a heat press method (180°C, 5 minutes, 50 kg / cm² pressure) was used. 2 A sheet 3 with a thickness of 1 mm, a width of 50 mm, and a length of 50 mm was prepared using the following method. (Sheet 3: 0.02% red pigment, thickness: 1 mm, melting point: 220°C) (Sheet 4) Sheet 4 was prepared using the same method as Sheet 3, with a colored styrene-based thermoplastic elastomer (4) prepared by the method described later. (Sheet 4: 0.002% red pigment, thickness: 1 mm, melting point: 220°C) (Sheet 5) Sheet 5 was prepared using the same method as Sheet 3, except that the thickness was 3 mm, using a colored styrene-based thermoplastic elastomer (5) prepared by the method described later. (Sheet 5: 0.02% red pigment, thickness: 3 mm, melting point: 220°C) (Sheet 6) Sheet 6 was prepared using the same method as Sheet 3, with a colored styrene-based thermoplastic elastomer (6) prepared by the method described later. (Sheet 6: 0.1% red pigment, thickness: 1 mm, melting point: 220°C) (Sheet 7) Washi paper (manufactured by Marushige Paper Manufacturing Cooperative, 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) Sheet 8 was prepared using flower paper (manufactured by Toyo Co., Ltd., product name: Flower paper (single color) pink, product number: 108315, thickness: 0.1 mm, melting point: 216℃). (Sheet 9) A 100 μm thick layer of acrylic paint (Sakura Color Products Corporation, product name: Acrylic Gouache, 4.5 g white, 3 g carmine) dissolved in 4.5 g of water was applied to the surface of a polyurethane resin sheet (manufactured by Okura Industries Co., Ltd., product name: TPU film, product number: HM105, thickness: 0.04 mm, melting point: 130 °C). Next, the coated layer was dried to a thickness of 20 μm to produce sheet 9. (Sheet 10) Sheet 10 was prepared using the same method as for sheet 3, with a colored styrene-based thermoplastic elastomer (10) prepared by the method described later. (Sheet 10: 5% white pigment, thickness: 1 mm, melting point: 220°C) (Sheet 11) 125g of boiling water was added to 1g of agar (manufactured by Ina Food Industry Co., Ltd., Kanten Papa, product name: Kanten Cook) and stirred. After adding 10% by mass of salt and stirring until dissolved, Sakura Color Products Corporation's acrylic gouache white was added as a pigment to a total weight of 1% and stirred further. The mixture was then molded to a thickness of 1mm and cooled to room temperature to produce sheet 11. (Sheet 11: 1% white pigment, thickness: 1mm, melting point: 90℃) (Sheet 12) Sheet 12 was prepared using the same method as for sheet 3, with a colored styrene-based thermoplastic elastomer (12) prepared by the method described later. (Sheet 12: 0.0005% red pigment, thickness: 1 mm, melting point: 220°C) (Sheet 13) A 100 μm thick layer of 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, product number: 2-9317-01, thickness: 1 mm, melting point: 250 °C). Next, the coated 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 Stickers, product number: EJP-TAT, thickness: 0.02 mm, melting point: 160℃) using an inkjet printer (EPSON PX-S740) with the RGB values ​​set to 255 239 239. (Sheet 15) Sheet 15 was prepared using the same method as for Sheet 3, with a colored styrene-based thermoplastic elastomer (15) prepared by the method described later. (Sheet 15: 0.001% red pigment, thickness: 1 mm, melting point: 220°C) (Sheet 16) Sheet 16 was prepared using the same method as for Sheet 3, with a colored styrene-based thermoplastic elastomer (16) prepared by the method described later. (Sheet 16: 0.005% red pigment, thickness: 1 mm, melting point: 220°C) (Sheet 17) Sheet 17 was prepared using the same method as Sheet 3, except that the thickness was 4 mm, using a colored styrene-based thermoplastic elastomer (17) prepared by the method described later. (Sheet 17: 0.02% red pigment, thickness: 4 mm, melting point: 220°C) (Sheet 18) Washi paper (manufactured by Marushige Paper Manufacturing 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)-(6), (10), (12), (15)-(17)] Using the following materials, colored styrene-based thermoplastic elastomers (3)-(6), (10), (12), and (15)-(17) were prepared for the production of sheets 3-6, 10, 12, and 15-17 by the method described below. • Hydrogenated styrene-based thermoplastic elastomer: SEEPS (SEPTON 4055, manufactured by Kuraray Co., Ltd.) (MFR (temperature 230℃, load 2.16kg) 0.0g / 10min (0.0g / 10min means no flow), styrene content 30% by 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): 8-15 g / 10 min) • Ionic liquid: CIL-312 (manufactured by Nippon Carlit Co., Ltd.) • Red pigment: DIC Corporation, "FASTOGEN® SUPER MAGENTA R" • White pigment: Toho Titanium Co., Ltd., "HT0110" To 100 parts by mass of hydrogenated styrene-based thermoplastic elastomer, 500 parts by mass of paraffin oil, 30 parts by mass of polyolefin / polyether copolymer, and 100 parts by mass of ionic liquid were placed in a container. Furthermore, the pigments listed in Table 1 were added in the amounts specified in Table 1 relative to 100% by mass 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 thoroughly permeate the styrene-based thermoplastic elastomer. Using a segment mixer (Toyo Seiki Co., Ltd. Laboplastmill KF70V2 model), the mixture was kneaded at 100 revolutions / minute at 180°C for 15 minutes to obtain colored styrene-based thermoplastic elastomers (3)-(6), (10), (12), (15)-(17). The melting point of the obtained styrene-based thermoplastic elastomers, measured by differential scanning calorimetry, was 220°C.

[0082] [Color difference measurement] For the sheets 1 to 18 prepared above, a color difference meter (Color Meter manufactured by Nippon Denshoku, model number; ZE2000) was used to measure the L * a * b * color space. The color of the second layer sheet was used as the reference L * 0, a * 0, b * 0, and for the first layer sheet, L * 1, a * 1, b * 1. During the measurement, for the sample laminated with a standard white plate (L * = 97.8, a * = -0.09, b * = 0.04) on the back surface of each sheet, the measurement was performed in the reflection mode such that the measurement surface side was the sheets 1 to 18. In accordance with JIS Z 8781-4, the color difference ΔE was calculated from the obtained values using the following formula for obtaining the CIE 1976 L * a * b * color difference. The results are shown in Table 1. ΔE = {(L * 1 - L[[ID=​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​A mucosal model was obtained by bonding a sheet 1 for the first layer 21 of the simulated mucosal layer 2 onto a sheet 10 for the second layer 22 of the simulated mucosal layer 2, which had been pre-formed, and then bonding them together as a single unit. A resin-specific adhesive was used for bonding. A simulated lesion area, 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 2-10, Comparative Examples 1-7) Except for using the sheets for the first layer 21 and the second layer 22 of the simulated mucosal layer 2 as shown in Table 2, a mucosal model was obtained in the same manner as in Example 1, and the simulated lesion area was set up in the same manner as in Example 1.

[0086] [Methods for evaluating mucosal models] The mucosal model was evaluated by marking the simulated mucosal layer surrounding the simulated lesion, which was set on the first layer of simulated mucosal layer, using an energy device. Furthermore, since sheets 2, 7, and 8 are often used as materials for mucosal models with a lubricating composition applied to them to more closely resemble human mucous membranes, the evaluation was conducted with the lubricating composition applied to the surface. [Evaluation of power supply] (Perforated) Using an Erbe VIO-100C and a disposable high-frequency knife KD-650L (extended cutting knife length: 2mm), current was applied in FORCED COAG mode at 30W for 2 seconds. The number of times it took for a hole of 1mm or more in diameter to form in the first layer 21 of the simulated mucosal layer 2, exposing the second layer 22, was measured and evaluated as "perforation". In addition, for materials with a first layer thickness of 0.08mm or more, gel was applied before the current application evaluation. The evaluation of "perforation" was performed based on the following criteria, and the evaluation results are shown in Tables 2 and 3. A: It melts within two applications of electricity, creating a hole in the first layer. B: After applying current 3 to 5 times, it melts and a hole is created in the first layer. C: The first layer does not melt even after being energized 6 or more times. (Appearance evaluation) The appearance of the simulated mucosal layer after electrical current was visually evaluated. The visual 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 to the naked eye. C: There is almost no color difference between the first and second layers; the difference is indistinguishable. (burnt) The charring of the simulated mucosal layer after electric current was evaluated visually. The charring was evaluated based on the following criteria, and the evaluation results are shown in Tables 2 and 3. A: There is almost no burning. B: Part of the heated area is burnt. C: The heated area is completely blackened and burnt.

[0087] [Table 2]

[0088] [Table 3]

[0089] As shown in Table 2, the mucosal models of Examples 1 to 10 generally met 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 made 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 because the thickness of the first layer was 4 mm, it was not possible to reproduce the markings around the simulated lesion. In Comparative Example 7, where the volume resistivity of the second layer was high, the first layer did not melt due to poor electrical conductivity evaluation. [Industrial applicability]

[0090] The mucosal model of this embodiment includes a simulated mucosal layer having a color difference between the first and second layers. 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 marked areas are easily visible when markings are applied to the surface. [Explanation of symbols]

[0091] 1. Mucosal model 2 Simulated mucosal layer 3 Simulated submucosa 21 1st layer 22 2nd layer 23 holes 24 Simulated lesion area

Claims

1. A mucosal model having a first layer and a second layer laminated on the first layer, A simulated mucosal layer having the first layer and the second layer, The simulated mucosal layer comprises a simulated submucosal layer provided below the second layer of the simulated mucosal layer, The thickness of the first layer is 0.01 to 3 mm. The second layer has a volume resistivity of 1.0 × 10⁻¹⁰ in its entirety or in part. １ ~1.0 x 10 ７ It is Ω·cm, A mucosal model in which the color difference ΔE between the first layer and the second layer is 20 or more.

2. A mucosal model having a first layer and a second layer laminated on the first layer, The thickness of the first layer is 0.01 to 3 mm. The second layer has a volume resistivity of 1.0 × 10⁻¹⁰ in its entirety or in part. １ ~1.0 x 10 ７ It is Ω·cm, The color difference ΔE between the first layer and the second layer is 20 or more. A mucosal model in which the melting point of the first layer is below the melting point of the second layer.

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

4. The mucosal model according to claim 1 or 2, wherein the melting point of the first layer is 50 to 220°C.

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

6. The mucosal 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.

7. The mucosal 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.

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

9. A mucosal model according to claim 1 or 2, for use in endoscopic procedure training.

10. An organ model comprising the mucosal model described in claim 1.

11. An endoscopic procedure training method comprising performing endoscopic procedure training using the mucosal model described in claim 1 or 2, or the organ model described in claim 10.

12. The endoscopic procedure training method according to claim 11, wherein the mucosal model has a simulated lesion on a part 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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