Duodenal papilla model

Abstract

Provided is a model which can reproduce bleeding, and with which procedures on the duodenal papilla can be trained.　A duodenal papilla model has: a base layer that mimics a duodenal wall; a ridge that mimics a duodenal papilla on the surface of the base layer; and a hole that mimics a papilla opening on the surface of the ridge, wherein a tubular simulated blood vessel formed of a thermoplastic resin is arranged inside the base layer or the ridge.

Description

[Technical Field]

[0001] The present invention relates to a duodenal papilla model. [Background technology]

[0002] In recent years, expectations have been rising for endoscopic surgery as a minimally invasive procedure that places less strain on the human body, allows for faster recovery, and shortens hospital stays, and the number of cases is increasing. For example, by removing tumors that have developed under the mucous membrane inside organs using an endoscope (endoscopic submucosal dissection), surgery can be performed with smaller incisions than in standard open surgery. Also, by stopping bleeding in the digestive tract using an endoscope (endoscopic hemostasis), shock caused by bleeding can be prevented, and emergency surgery can be avoided.

[0003] On the other hand, such medical procedures require advanced techniques. To improve techniques and the quality of medical procedures, organ models that can be used for surgical training have been proposed (Patent Documents 1 to 5). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2006-116206 [Patent Document 2] Japanese Patent Application Laid-Open No. 2008-197483 [Patent Document 3] Japanese Patent Application Publication No. 2018-17769 [Patent Document 4] Japanese Patent Application Laid-Open No. 2017-107094 [Patent Document 5] Japanese Patent Application Laid-Open No. 2016-38563 Summary of the Invention

[0005] In recent years, procedures such as endoscopic retrograde cholangiopancreatography (ERCP), which uses an endoscope to observe and visualize the bile duct and pancreatic duct, and endoscopic sphincterotomy (EST), which uses an endoscope to incise the duodenal papilla (the exit of the common bile duct into the duodenum) with an electric scalpel inserted through an endoscope to widen the papilla, have become common, but these medical procedures also require advanced techniques.Therefore, there is a need for a model that can be used to train procedures on the duodenal papilla and that can reproduce the bleeding that occurs during actual procedures.

[0006] An object of the present invention is to provide a model that can reproduce bleeding and can be used to train procedures on the duodenal papilla.

[0007] After examining various means, the inventors discovered that a duodenal papilla model could be created by providing a base layer simulating the duodenal wall, a raised portion on the surface of the base layer simulating the duodenal papilla, and holes on the surface of the raised portion simulating the papilla opening, with tubular simulated blood vessels made of thermoplastic resin placed inside the base layer or the raised portion, thereby reproducing bleeding and providing a model that can be used to train in procedures on the duodenal papilla, and thus completed the present invention.

[0008] The present invention relates to the following: [1] A device comprising a base layer simulating the duodenal wall, a protrusion simulating the duodenal papilla on the surface of the base layer, and a hole simulating the papilla opening on the surface of the protrusion, A duodenal papilla model, in which a tubular simulated blood vessel formed from a thermoplastic resin is placed inside the base layer or the protrusion. [2] A duodenal papilla model as described in [1], wherein at least a portion of the simulated blood vessel is positioned within an area of ​​60 mm in diameter including the hole when the protrusion is viewed from the opposite side, and within 30 mm inward from the tip of the hole in the direction of protrusion of the protrusion. [3] The duodenal papilla model described in [2], wherein the simulated blood vessels are arranged so as to avoid an area of ​​8.0 mm in diameter including the pore when the protrusion is viewed from the opposite side, and a range of 10 to 30 degrees counterclockwise when the longitudinal axis direction of the base material layer simulating the duodenal wall is set to 0 degrees. [4] The duodenal papilla model according to any one of [1] to [3], in which two or more simulated blood vessels are arranged. [5] A duodenal papilla model according to any one of [1] to [4], wherein the simulated blood vessel is connected to a device capable of supplying simulated blood. [6] A duodenal papilla model according to any one of [1] to [5], for use in training medical procedures including incision or hemostasis. [7] The duodenal papilla model according to [6], wherein the medical procedure is an endoscopic medical procedure. [8] The duodenal papilla model according to [6] or [7], wherein the medical procedure is a medical procedure using an energy device. [9] The duodenal papilla model according to any one of [1] to [8], which is formed from a conductive composition.

[10] The duodenal papilla model according to any one of [1] to [9], wherein the simulated blood vessel has a thickness of 50 μm to 1000 μm.

[0009] According to the present invention, it is possible to provide a model that can reproduce bleeding and that can be used to train procedures on the duodenal papilla. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a diagram showing a duodenal papilla model according to a first embodiment of the present invention. [Figure 2] FIG. 2 is a diagram showing the arrangement of blood vessels in the duodenal papilla model according to the first embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0011] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. The present invention is not limited to the following embodiments, and can be implemented by making appropriate modifications within the scope that does not impair the effects of the present invention.

[0012] [First embodiment] 1 is a diagram showing a duodenal papilla model 1 according to a first embodiment of the present invention. In this embodiment, the duodenal papilla model 1 has a base layer 2 simulating the duodenal wall, a raised portion 3 simulating the duodenal papilla on the surface of the base layer 2, and a hole 4 simulating the papilla opening on the surface of the raised portion 3, with a tubular simulated blood vessel 5 made of a thermoplastic resin disposed inside the base layer 2 or the raised portion 3.

[0013] {Base material layer} As shown in FIG. 1, the base layer 2 is one of the layers that constitute the duodenal papilla model, and is a structure formed to resemble the duodenal wall. The shape of the base layer 2 is not particularly limited and can be set according to the intended use. The method for forming the base layer 2 can be appropriately selected from extrusion molding, cast molding, injection molding, compression molding, etc., according to the desired shape. In one embodiment of the present invention, the thickness of the base layer 2 can be 3 to 50 mm, 3 to 30 mm, or 30 to 50 mm. In one embodiment of the present invention, the size of the base layer 2 when viewed from the side opposite its upper surface can be 10 to 70 mm×10 to 70 mm, 10 to 40 mm×10 to 40 mm, or 40 to 70 mm×40 to 70 mm.

[0014] In one embodiment of the present invention, the substrate layer 2 may be formed from a conductive composition. The composition of the conductive composition is not particularly limited, but examples thereof include thermoplastic resins, thermoplastic elastomers, monosaccharides, polysaccharides, proteins, etc., which may be used alone or in combination of two or more. They may also be alloyed in any ratio. The volume resistivity of the conductive composition is preferably 1.0×10 2 ~1.0×10 7 Ω·cm, and more preferably 1.0×10 2~5.0×10 4 The volume resistivity is Ω·cm. For example, in accordance with JIS C2139, a 1.0 mm thick sheet of any shape can be measured at 23±1°C using a commercially available resistivity meter (for example, the Loresta GX (MCP-T700) manufactured by Nitto Seiko Analytech Co., Ltd.).

[0015] Examples of thermoplastic resins include urethane elastomers (TPU), styrene resins, polyolefin resins, polyvinyl chloride resins, and polyvinyl alcohol.

[0016] Thermoplastic elastomers include those having a structure combining a soft polymeric substance and a hard polymeric substance, such as styrene-based elastomers, olefin-based elastomers, vinyl chloride-based elastomers, polyester-based elastomers, and polyamide-based elastomers.

[0017] Monosaccharides are those that cannot be decomposed into simpler sugars by hydrolysis, and examples of monosaccharides that can be used include glucose, fructose, and galactose.

[0018] Polysaccharides are polymers formed by glycosidic bonds of monosaccharides such as glucose, fructose, and galactose, and examples of polysaccharides that can be used include xanthan gum, guar gum, pectin, carrageenan, agar, starch, and mannans.

[0019] The protein is a polymer in which amino acids are linked by peptide bonds, and collagen, gelatin, textured vegetable protein, fibrous vegetable protein, etc. can be used.

[0020] If necessary, oil, a conductivity imparting agent, a colorant, and other additives may be added to the material of the base layer 2 within a range that does not impair the effects of the present invention.

[0021] ·oil The oil is not particularly limited, but examples thereof include paraffinic process oil, naphthenic process oil, aromatic process oil, mineral oil such as liquid paraffin, silicone oil, castor oil, linseed oil, olefin wax, and mineral wax.

[0022] Conductive agent The conductivity-imparting agent is not particularly limited, but examples thereof include electrolytes, carbon-based materials, metal oxides, metal particles, water-soluble polymer hydrogels, conductive polymers, and ionic liquids.

[0023] Coloring agents The coloring agent is not particularly limited, and examples thereof include pigments, dyes, etc. In particular, when using the model as a duodenal papilla model, it is preferable to use a coloring agent such as a pigment or dye to color the model in a color similar to that of a living body, as long as the purpose is not impaired.

[0024] Other additives The material of the base layer 2 may be blended with other resins, elastomers, rubbers, plasticizers, fillers, stabilizers, antioxidants, light resistance improvers, UV absorbers, dispersants, softeners, lubricants, processing aids, anti-fogging agents, anti-blocking agents, crystal nucleating agents, foaming agents, fibers, etc., as needed.

[0025] {ridge} The raised portion 3 is formed to resemble a duodenal papilla and is a portion that protrudes from the surface of the base layer 2. In one embodiment of the present invention, the raised portion 3 may be formed from a conductive composition. The shape of the protuberance 3 is not particularly limited, and may be, for example, a substantially cylindrical convex portion, or may have a shape corresponding to an actual duodenal papilla. The shape corresponding to an actual duodenal papilla can be selected from separate opening type, onion type, nodular type, villous type, flat type, and vertically elongated type based on the Inomata classification (see Inomata Masaaki, Terui Torahiko, Saito Shinji, et al.: Fundamentals and Tips of ERCP / Scope Insertion by the Pull Method, Basic Techniques of Selective Cannulation, and Solutions for Difficult Cases of Cannulation, Gastroenterological Endoscopy. 17: 1768-1776, 2005), and the protuberance may be formed to resemble such a shape. The diameter of the raised portion 3, when viewed from the opposite side, is preferably 2 to 40 mm, more preferably 5 to 30 mm, and even more preferably 5 to 20 mm. The height of the raised portion 3 from the surface of the base layer 2 in the raising direction is preferably 1 to 20 mm, more preferably 2 to 15 mm, and even more preferably 2 to 10 mm.

[0026] {vacancy} The holes 4 are holes formed on the surface of the protuberance 3, for example, near the center. The shape of the holes 4 is not particularly limited and may be a recess or a hole penetrating the base layer 2 and the protuberance 3. The holes 4 may be angled, and may have an angle that mimics the angle of the actual bile duct or pancreatic duct that connects to the nipple orifice. The number of holes 4 may be one or more. One hole may branch into two, or two holes may merge into one. These holes may mimic the bile duct or pancreatic duct. Furthermore, the holes may be approximately circular or rectangular, but a shape that mimics the shape corresponding to the actual nipple orifice is preferred. Specifically, based on the classification of the confluence of the pancreatic and biliary ducts (see Oi, I.: Duodenoscopy and endoscopic pancreaticocholangiography. Gastroenterol. Endosc., 28: 2881-2883, 1986; Inomata, M., Terui, T., Endo, M., et al.: Intubation methods for the pancreatic and biliary ducts: anatomy of the papilla, endoscopic classification, and fundamentals of intubation methods. Gastroenterological Endoscopy. 20: 1793-1803, 2008), a separate type (separate opening type, onion type), septum type, or common duct type can be selected and formed to imitate that shape. The diameter of the holes 4 is preferably 0.1 to 5 mm, more preferably 0.3 to 3 mm, and even more preferably 0.5 to 2 mm. When the holes 4 are recesses, the depth or length of the recesses in the protruding direction of the protrusions 3 is preferably 1 to 50 mm, more preferably 5 to 40 mm, and even more preferably 15 to 30 mm.

[0027] {Simulated blood vessel} The simulated blood vessel 5 is a tubular structure molded from a thermoplastic resin composition. The simulated blood vessel 5 may have a single-layer structure molded from one type of thermoplastic resin composition or a thermoplastic resin composition alloyed with two or more types of thermoplastic resin compositions, or may have a multilayer structure molded from two or more types of thermoplastic resin compositions. Furthermore, the simulated blood vessel 5 may have a structure in which a conductive layer is disposed on at least a portion of the outer surface or both surfaces of the single-layer structure or multilayer structure formed from these thermoplastic resin compositions.

[0028] The thermoplastic resin composition of this embodiment mainly contains a thermoplastic resin. Here, "mainly contains" means that the thermoplastic resin is contained in the thermoplastic resin composition in an amount of 50% by mass or more. In another embodiment, the thermoplastic resin composition may contain 70% by mass or more, or 90% by mass or more, or may consist solely of the thermoplastic resin.

[0029] In one embodiment, the thermoplastic resin composition has a melting point of 50 to 300° C. The melting point of the thermoplastic resin composition is preferably 50 to 250° C., and more preferably 50 to 200° C. By using a thermoplastic resin composition with a melting point of 50° C. or higher, it is possible to suppress changes in the shape of the resin composition due to the influence of temperature, and by using a thermoplastic resin composition with a melting point of 300° C. or lower, it becomes possible to cut using an energy device. In this embodiment, the melting point is measured using a differential scanning calorimeter (DSC; manufactured by METTLER TOLEDO K.K., DSC 3+) in a nitrogen atmosphere at a temperature increase rate of 10° C. / min.

[0030] In one embodiment, the thermoplastic resin composition has a tensile modulus of 0.01 to 50 MPa. The tensile modulus of the thermoplastic resin composition is preferably 0.05 to 30 MPa, and more preferably 0.1 to 15 MPa. By setting the tensile modulus to 50 MPa or less, it becomes possible to crush the simulated blood vessel by grasping with the energy device, thereby stopping the bleeding of the simulated blood flowing through the simulated blood vessel. The tensile modulus is measured in accordance with JIS K7127, the tensile test method for plastics, by punching out a 1.0 mm thick sheet into the shape of a Type 5 test piece, and measuring it at a temperature of 23±1°C using a tensile tester (Shimadzu Corporation, Autograph AG-Xplus) at a tension speed of 50.0 mm / min, and calculating it from the slope of the initial straight line in the stress-strain curve.

[0031] The thermoplastic resin contained in the thermoplastic resin composition used in this embodiment is not particularly limited, but is preferably selected from the group consisting of ethylene-vinyl acetate resins, urethane elastomers, polyvinyl chloride resins, and thermoplastic elastomers. Among these, thermoplastic resins selected from the group consisting of ethylene-vinyl acetate copolymers, thermoplastic polyurethanes, vinyl chloride resins, polybutadiene thermoplastic elastomers, and hydrogenated styrene thermoplastic elastomers are preferably used.

[0032] In this embodiment, the ethylene-vinyl acetate resin refers to a resin containing an ethylene-vinyl acetate copolymer. It is acceptable for the resin to contain multiple types of ethylene-vinyl acetate copolymers. The ethylene-vinyl acetate copolymer is a copolymer of ethylene and vinyl acetate, but chlorinated ethylene, vinyl chloride, vinylidene fluoride, etc. may also be copolymerized. The vinyl acetate content of the ethylene-vinyl acetate resin is preferably 10 to 35% by mass, more preferably 15 to 35% by mass, and even more preferably 20 to 35% by mass. By setting the vinyl acetate content to 10% by mass or more, the flexibility of the simulated blood vessel is improved, and when a conductive material dispersion is applied to the surface of the simulated blood vessel, the adhesiveness is improved. Furthermore, by setting the vinyl acetate content to 35% by mass or less, the heat resistance of the resin composition is improved.

[0033] Thermoplastic elastomers include those having a structure combining a soft polymeric substance and a hard polymeric substance. Specific examples include styrene-based elastomers, hydrogenated styrene-based thermoplastic elastomers, olefin-based elastomers, vinyl chloride-based elastomers, polyamide-based elastomers, and polybutadiene-based thermoplastic elastomers. These elastomers can be selected from commercially available products.

[0034] In one embodiment, the thickness of the simulated blood vessel 5 is 50 to 1000 μm. The thickness of the simulated blood vessel 5 is preferably 50 to 300 μm, and more preferably 50 to 150 μm. If the thickness of the simulated blood vessel 5 is 1000 μm or less, heat is transferred to the simulated blood vessel 5 in a short time when the energy device comes into contact with it, and bleeding can be reproduced.

[0035] In one embodiment of the present invention, the diameter, i.e., the outer diameter, of the simulated blood vessel 5 is 0.5 to 10.0 mm. In another embodiment of the present invention, the diameter of the simulated blood vessel 5 is preferably 0.5 to 5.0 mm, and more preferably 0.5 to 2.0 mm. By making the diameter of the simulated blood vessel 5 0.5 mm or more, processing stability during molding and handleability during preparation of a duodenal papilla model are improved, and by making the diameter of the simulated blood vessel 5 10.0 mm or less, the reproducibility of human blood vessels is improved, and the inability to cut with an energy device is suppressed. The inner diameter of the simulated blood vessel 5 is preferably 0.3 to 9.95 mm, more preferably 0.3 to 4.95 mm, and even more preferably 0.3 to 1.95 mm.

[0036] Conductive layer In one embodiment, the simulated blood vessel 5 has a conductive layer containing a conductive material on the outer surface thereof. The conductive layer is not necessary, but providing the conductive layer makes it easier to cut the simulated blood vessel 5 when the energy device comes into contact with the simulated blood vessel 5.

[0037] In one embodiment of the present invention, the thickness of the conductive layer is 20 to 10,000 nm. The thickness of the conductive layer is preferably 50 to 5,000 nm, and more preferably 150 to 1,000 nm. By making the thickness of the conductive layer 20 nm or more, sufficiently high conductivity can be exhibited and the surface smoothness of the simulated blood vessel 5 can be improved. By making the thickness of the conductive layer 10,000 nm or less, the coating thickness of the conductive layer becomes thin, and cracks when the simulated blood vessel 5 is bent can be suppressed.

[0038] In one embodiment of the present invention, the conductive material of the conductive layer is not particularly limited, but may be one or more conductive polymers, metal materials such as silver, copper, tin oxide, and zinc oxide, or carbon materials such as carbon black, carbon nanotubes, graphite, and diamond-like carbon. The conductive polymer is a π-conjugated conductive polymer. The π-conjugated conductive polymer is not particularly limited as long as it exhibits the effects of the present invention, as long as it is an organic polymer whose main chain is composed of a π-conjugated system. Examples of the π-conjugated conductive polymer include polythiophene-based conductive polymers, polypyrrole-based conductive polymers, polyacetylene-based conductive polymers, polyphenylene-based conductive polymers, polyphenylene vinylene-based conductive polymers, polyaniline-based conductive polymers, polyacene-based conductive polymers, polythiophene vinylene-based conductive polymers, and copolymers thereof. From the viewpoint of stability in air, polypyrrole-based conductive polymers, polythiophene-based conductive polymers, and polyaniline-based conductive polymers are preferred, and from the viewpoint of transparency, polythiophene-based conductive polymers are more preferred.

[0039] Polythiophene-based conductive polymers include polythiophene, poly(3-methylthiophene), poly(3-ethylthiophene), poly(3-propylthiophene), poly(3-butylthiophene), poly(3-hexylthiophene), poly(3-heptylthiophene), poly(3-octylthiophene), poly(3-decylthiophene), poly(3-dodecylthiophene), poly(3-octadecylthiophene), poly(3-bromothiophene), poly(3-chlorothiophene), and poly(3-iodothiophene). thiophene), poly(3-cyanothiophene), poly(3-phenylthiophene), poly(3,4-dimethylthiophene), poly(3,4-dibutylthiophene), poly(3-hydroxythiophene), poly(3-methoxythiophene), poly(3-ethoxythiophene), poly(3-butoxythiophene), poly(3-hexyloxythiophene), poly(3-heptyloxythiophene), poly(3-octyloxythiophene), poly(3-decyloxythiophene), poly(3-dodecyloxythiophene) oxythiophene), poly(3-octadecyloxythiophene), poly(3,4-dihydroxythiophene), poly(3,4-dimethoxythiophene), poly(3,4-diethoxythiophene), poly(3,4-dipropoxythiophene), poly(3,4-dibutoxythiophene), poly(3,4-dihexyloxythiophene), poly(3,4-diheptyloxythiophene), poly(3,4-dioctyloxythiophene), poly(3,4-didecyloxythiophene), poly(3,4-di dodecyloxythiophene), poly(3,4-ethylenedioxythiophene), poly(3,4-propylenedioxythiophene), poly(3,4-butylenedioxythiophene), poly(3-methyl-4-methoxythiophene), poly(3-methyl-4-ethoxythiophene), poly(3-carboxythiophene), poly(3-methyl-4-carboxythiophene), poly(3-methyl-4-carboxyethylthiophene), and poly(3-methyl-4-carboxybutylthiophene). Examples of polypyrrole-based conductive polymers include polypyrrole, poly(N-methylpyrrole), poly(3-methylpyrrole), poly(3-ethylpyrrole), poly(3-n-propylpyrrole), poly(3-butylpyrrole), poly(3-octylpyrrole), poly(3-decylpyrrole), poly(3-dodecylpyrrole), poly(3,4-dimethylpyrrole), poly(3,4-dibutylpyrrole), poly(3-carboxypyrrole), poly(3-methyl-4-carboxypyrrole), poly(3-methyl-4-carboxyethylpyrrole), poly(3-methyl-4-carboxybutylpyrrole), poly(3-hydroxypyrrole), poly(3-methoxypyrrole), poly(3-ethoxypyrrole), poly(3-butoxypyrrole), poly(3-hexyloxypyrrole), and poly(3-methyl-4-hexyloxypyrrole). Examples of polyaniline-based conductive polymers include polyaniline, poly(2-methylaniline), poly(3-isobutylaniline), poly(2-anilinesulfonic acid), and poly(3-anilinesulfonic acid). Among the above π-conjugated conductive polymers, poly(3,4-ethylenedioxythiophene) is particularly preferable in terms of conductivity, transparency, and heat resistance. The π-conjugated conductive polymers may be used alone or in combination of two or more.

[0040] In another embodiment of the present invention, the conductive polymer further comprises a polyanion. A polyanion is a polymer having two or more monomer units with an anionic group in the molecule. The anionic group of this polyanion functions as a dopant for a π-conjugated conductive polymer, improving the conductivity of the π-conjugated conductive polymer. The anionic group of the polyanion is preferably a sulfo group or a carboxy group. Specific examples of such polyanions include polymers having sulfonic acid groups, such as polystyrene sulfonic acid, polyvinyl sulfonic acid, polyallyl sulfonic acid, polyacrylic sulfonic acid, polymethacrylic sulfonic acid, poly(2-acrylamido-2-methylpropanesulfonic acid), polyisoprene sulfonic acid, polysulfoethyl methacrylate, poly(4-sulfobutyl methacrylate), and polymethacryloxybenzenesulfonic acid, and polymers having carboxylic acid groups, such as polyvinyl carboxylic acid, polystyrene carboxylic acid, polyallyl carboxylic acid, polyacrylic carboxylic acid, polymethacrylic carboxylic acid, poly(2-acrylamido-2-methylpropanecarboxylic acid), polyisoprene carboxylic acid, and polyacrylic acid. These may be homopolymers or copolymers of two or more types. Among these polyanions, polymers having sulfonic acid groups are preferred, and polystyrene sulfonic acid is more preferred, as they can provide higher antistatic properties. The polyanions may be used alone or in combination of two or more. The mass average molecular weight of the polyanion is preferably 20,000 or more and 1,000,000 or less, and more preferably 100,000 or more and 500,000 or less. The mass average molecular weight in this specification is a value measured by gel permeation chromatography using polystyrene as a standard substance.

[0041] In a conductive composite containing a π-conjugated conductive polymer and a polyanion, the content of the polyanion is preferably in the range of 1 part by mass to 1,000 parts by mass, more preferably 10 parts by mass to 700 parts by mass, and even more preferably 100 parts by mass to 500 parts by mass, per 100 parts by mass of the π-conjugated conductive polymer. If the content of the polyanion is below the lower limit, the doping effect on the π-conjugated conductive polymer tends to be weak, resulting in insufficient conductivity and reduced dispersibility of the conductive composite in the dispersion. On the other hand, if the content of the polyanion exceeds the upper limit, the content of the π-conjugated conductive polymer decreases, making it difficult to obtain sufficient conductivity.

[0042] The conductive complex is formed by doping a π-conjugated conductive polymer with a polyanion coordinated therewith. However, in the polyanion of this embodiment, not all of the anionic groups are doped into the π-conjugated conductive polymer, and there are excess anionic groups that do not contribute to doping.

[0043] dispersion medium In one embodiment of the present invention, the conductive layer contains a dispersion medium together with the conductive material. Examples of the dispersion medium used in this embodiment include water, an organic solvent, and a mixture of water and an organic solvent. Examples of organic solvents include ester-based solvents, ether-based solvents, hydrocarbon-based solvents, nitrogen atom-containing solvents, alcohol-based solvents, and ketone-based solvents. Examples of the ester solvent include ethyl acetate, propyl acetate, and butyl acetate. Examples of the ether solvent include diethyl ether, dimethyl ether, ethylene glycol, propylene glycol, propylene glycol dialkyl ether, and diethylene glycol diethyl ether. Examples of hydrocarbon solvents include hexane, cyclohexane, pentane, octane, decane, dodecane, benzene, toluene, xylene, ethylbenzene, propylbenzene, and isopropylbenzene. Examples of nitrogen atom-containing solvents include N-methylpyrrolidone, dimethylacetamide, and dimethylformamide. Examples of alcohol-based solvents include methanol, ethanol, 1-propanol, 2-propanol, 2-methyl-2-propanol, 1-butanol, 2-butanol, 2-methyl-1-propanol, allyl alcohol, propylene glycol monomethyl ether, and ethylene glycol monomethyl ether. Examples of ketone solvents include diethyl ketone, methyl propyl ketone, methyl butyl ketone, methyl isopropyl ketone, methyl isobutyl ketone, methyl amyl ketone, diisopropyl ketone, methyl ethyl ketone, acetone, and diacetone alcohol. The organic solvents may be used alone or in combination of two or more. Among the dispersion media, at least one solvent selected from the group consisting of ester solvents, hydrocarbon solvents, ether solvents, and N-methylpyrrolidone is preferred, and at least one solvent selected from the group consisting of ethyl acetate, butyl acetate, heptane, toluene, and diethylene glycol diethyl ether is more preferred.

[0044] The content of the conductive material in the dispersion of this embodiment is preferably 0.1% by mass or more and 80% by mass or less, more preferably 0.5% by mass or more and 50% by mass or less, and even more preferably 1% by mass or more and 30% by mass or less, relative to the total mass of the dispersion. When the content of the conductive material in the dispersion is equal to or greater than the lower limit, a thick conductive layer can be easily formed by a single coating. When the content of the conductive material in the dispersion is equal to or less than the upper limit, the dispersibility of the conductive material in the dispersion can be increased, and transparency can be improved.

[0045] Transparent binder component The dispersion liquid in one embodiment of the present invention contains a transparent binder component together with the conductive material. The transparent binder component is a transparent compound such as a thermoplastic resin, a thermosetting compound, or a photocurable compound. The thermoplastic resin becomes the binder resin described below as it is. The thermosetting compound and the photocurable compound are each a monomer or oligomer. The thermosetting compound becomes the binder resin described below by thermal curing, and the photocurable compound becomes the binder resin described below by photocuring. If the dispersion contains a transparent binder component together with a conductive material, a conductive layer that is transparent, conductive, and adheres well to the substrate can be easily formed.

[0046] Examples of transparent binder components include acrylic resin, polystyrene, styrene-acrylic copolymer, polycarbonate, ethylene-vinyl acetate copolymer, polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, cyclic polyolefin, polyester resin, polyurethane resin, polyimide resin, melamine resin, acrylic compound having one or more acryloyl groups, epoxy compound having two or more epoxy groups, etc. These may be dissolved in a dispersion medium or dispersed in a colloidal dispersion or emulsion. Among the transparent binder components, examples of the thermoplastic resin include acrylic resin, polystyrene, styrene-acrylic copolymer, polycarbonate, ethylene-vinyl acetate copolymer, polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, and cyclic polyolefin. Among the transparent binder components, examples of the thermosetting compound include an acrylic compound and an epoxy compound. The photocurable compound may be an acrylic compound. Among the transparent binder components, thermoplastic acrylic resins are preferred because they have high transparency and can be easily cured. The transparent binder component may be used alone or in combination of two or more kinds. When the transparent binder component is a thermosetting compound, it is preferable to add a thermal polymerization initiator to the conductive particle dispersion liquid, and when the transparent binder component is a photocurable compound, it is preferable to add a photopolymerization initiator to the dispersion liquid.

[0047] The content of the transparent binder component in the dispersion of this embodiment is preferably 100 parts by mass or more and 10,000 parts by mass or less, more preferably 100 parts by mass or more and 5,000 parts by mass or less, and even more preferably 100 parts by mass or more and 1,000 parts by mass or less, relative to 100 parts by mass of the conductive material. If the content of the transparent binder component in the conductive material dispersion of this embodiment is equal to or greater than the lower limit, the strength of the conductive layer can be improved. If the content of the transparent binder component in the conductive material dispersion of this embodiment is equal to or less than the upper limit, a decrease in conductivity due to a decrease in the conductive material content can be prevented.

[0048] In one embodiment of the present invention, the conductive layer is formed by applying a dispersion liquid in which a conductive material is dispersed in a dispersion medium to the outer surface of the simulated blood vessel 5. In another embodiment, the conductive layer is formed by a method of immersing the simulated blood vessel in the dispersion liquid of the conductive material, a method of spray coating the dispersion liquid of the conductive material, or the like. Before applying the conductive material dispersion, it is preferable to subject the simulated blood vessel 5 to corona discharge treatment, plasma discharge treatment, flame treatment, or the like to form hydrophilic groups (hydroxyl groups, carbonyl groups, carboxyl groups, etc.) on the surface of the simulated blood vessel 5. If the simulated blood vessel 5 has been subjected to a hydrophilization treatment, the adhesiveness of the conductive layer can be further improved. Alternatively, the adhesiveness between the simulated blood vessel 5 and the conductive layer can be improved by applying a transparent binder as a primer to the simulated blood vessel 5 and then applying the conductive material dispersion.

[0049] The surface resistivity at the location where the conductive layer is placed is 1.0 x 10 0 Ω / □ or more, 1.0×10 6 Ω / □ or less. More preferably, 1.0×10 0 Ω / □ or more, 1.0×10 5 Ω / □ or less, and more preferably 1.0×10 0 Ω / □ or more, 1.0×10 4 It is Ω / □ or less. In this embodiment, the surface resistivity is measured in accordance with JIS C2139 using a resistivity meter (Loresta GX (MCP-T700) manufactured by Nitto Seiko Analytech Co., Ltd.) under conditions of 23±1° C. For the measurement, the thermoplastic resin composition is press-molded at 160 to 200° C. and processed into a resin sheet of 2.5 cm × 2.5 cm and 1.0 mm thickness, and a conductive layer is formed on the surface thereof, and the measurement is performed using a specimen.

[0050] (Method of manufacturing simulated blood vessels) The simulated blood vessel of this embodiment is produced by extrusion molding a thermoplastic resin composition. The conductive layer is formed by applying a dispersion liquid in which a conductive material is dispersed in a dispersion medium, and in another embodiment, it is formed by a method of immersing in the conductive material dispersion liquid, a method of spray coating the conductive material dispersion liquid, or the like. Before applying the conductive material dispersion, it is preferable to subject the surface of the simulated blood vessel to corona discharge treatment, plasma discharge treatment, flame treatment, etc. to form hydrophilic groups (hydroxyl groups, carbonyl groups, etc.) on the surface. The hydrophilization treatment can further improve the adhesiveness of the conductive layer.

[0051] (Duodenal papilla model) The duodenal papilla model 1 of this embodiment has a base layer 2, a raised portion 3, and holes 4, and a simulated blood vessel 5 is disposed inside the base layer 2 or the raised portion 3. Although the duodenum is a tubular organ connecting the stomach and the small intestine, the base layer 2 does not need to be tubular, and may be formed in a flat plate shape to simulate a part of the duodenal wall. In one embodiment, when the protuberance 3 is viewed from the opposite side, at least a portion of the simulated blood vessel 5 is disposed within a region of 60 mm in diameter including the holes 4, and within 30 mm inward from the tips of the holes 4 in the direction of protuberance 3. When multiple holes 4 are present, it is preferable that the region includes all of the holes 4. When the protuberance 3 is viewed from the opposite side, the simulated blood vessel 5 is preferably disposed within 40 mm in diameter including the holes 4, and more preferably within 30 mm. Furthermore, it is preferably disposed within 20 mm, and more preferably within 10 mm, from the tips of the holes 4 in the direction of protuberance 3. In one embodiment, the region is a circle centered on the void 4. When a plurality of voids 4 are present, the region may be a circle centered on any one of the voids 4.

[0052] The simulated blood vessel 5 preferably replicates the physiological anatomical vascular course. In one embodiment, when the protuberance 3 is viewed from the opposite side, the simulated blood vessel 5 is positioned within a region of 8.0 mm in diameter, including the pores 4, and within a range of 10 to 30 degrees counterclockwise, assuming that the longitudinal axis of the base layer 2 simulating the duodenal wall is 0 degrees. Here, the longitudinal axis direction refers to the direction corresponding to the axis of the duodenal tract. For example, when the duodenal papilla model is tubular, the longitudinal axis direction refers to the axial direction of the duodenal papilla model. When the duodenal papilla model is flat, the longitudinal axis direction refers to the direction corresponding to the axial direction of the duodenal papilla model when attached to the duodenal papilla model during training. By positioning the simulated blood vessel 5 as described above, it is possible to replicate the location where bleeding is likely to occur in actual surgery, thereby improving the reproducibility of bleeding. Furthermore, when the raised portion 3 is viewed from its opposite side, it is preferable that the simulated blood vessel 5 is arranged so as to avoid an area within a diameter of 8.5 mm including the holes 4, and a range of 10 to 30 degrees counterclockwise when the longitudinal axis direction of the base layer 2 simulating the duodenal wall is set to 0 degrees; and it is even more preferable that the simulated blood vessel 5 is arranged so as to avoid an area within a diameter of 9.0 mm including the holes 4, and a range of 10 to 30 degrees counterclockwise when the longitudinal axis direction of the base layer 2 simulating the duodenal wall is set to 0 degrees when the raised portion 3 is viewed from its opposite side. In one embodiment, when a plurality of pores 4 are present, it is preferable that the region includes all of the pores 4 . In one embodiment, the region is a circle centered on the void 4. When a plurality of voids 4 are present, the region may be a circle centered on any one of the voids 4.

[0053] In one embodiment, one or more simulated blood vessels 5 are disposed inside the base material layer 2 or the protrusion 3. The number of simulated blood vessels 5 may be two or more, or may be three or more.

[0054] In one embodiment, the Asker E hardness of the duodenal papilla model 1 is preferably 40 or less, more preferably 5 to 30, and even more preferably 5 to 20. An Asker E hardness of 40 or less provides a feel close to that of an actual duodenal papilla, which is expected to improve medical techniques. The Asker E hardness can be measured in accordance with JIS K 6253-3.

[0055] In one embodiment, the duodenal papilla model may further include a first band-like ridge simulating a headband fold. The first band-like ridge has a circular portion 2 to 20 mm above (toward the mouth of) the hole 4, in the range of -120 to 120 degrees clockwise when the longitudinal axis direction of the base layer 2 simulating the duodenal wall is set to 0 degrees. In a further embodiment, a second band-like ridge simulating a circular pleat may be provided, which is spaced 0.5 to 20 mm above the first band-like ridge and extends substantially parallel to the first band-like ridge.

[0056] (Manufacturing method of duodenal papilla model) The duodenal papilla model 1 according to this embodiment can be manufactured by a conventional molding method. For example, it can be manufactured by placing a simulated blood vessel 5 in the cavity of a mold shaped to correspond to the duodenal wall, duodenal papilla, and papilla opening, and then casting or filling a material (e.g., a conductive composition) into the mold to form the model. Alternatively, a through-hole for placing the simulated blood vessel 5 may be formed in the cavity, and the simulated blood vessel 5 may be inserted later. The molding temperature can be varied as appropriate depending on the resin used; for example, when a conductive composition mainly containing carrageenan is used, the model is molded by casting at 70 to 100°C and cooling to 25°C.

[0057] [Application] The duodenal papilla model 1 can be used for training medical procedures including incision and hemostasis, particularly a procedure using an endoscope to observe and visualize the bile duct or pancreatic duct (endoscopic retrograde cholangiopancreatography: ERCP) and a procedure using an endoscope to incise the duodenal papilla (the exit of the common bile duct into the duodenum) with an electric scalpel inserted through an endoscope (endoscopic sphincterotomy: EST). In this case, the duodenal papilla model 1 may be fitted into a model mounting portion provided on a model of the upper digestive tract (stomach, esophagus, duodenum, etc.), or the duodenal papilla model 1 may be attached to the inner wall of the digestive tract model. The model mounting portion of the digestive tract model may be a frame or recess formed by partially removing a portion of the wall, or a jig for model mounting may be attached to the inner or outer wall of the digestive tract model. The duodenal papilla model 1 may be fitted into a model mounting portion provided on a bile duct model, attached with a jig, or attached. The bile duct model may have a structure that includes the pancreatic duct. The model attachment portion and the jig for attaching the model may be separate from the digestive system model and the bile duct model. Furthermore, models of the oral cavity, esophagus, stomach, duodenum, etc., which mimic the pathway from the oral cavity to the digestive system including the duodenum of an actual human body, may be integrated or each model may be joined together. The duodenal papilla model 1 can be attached to the inner wall of the digestive organ model using adhesive, pressure sensitive adhesive, double-sided tape, or the like.

[0058] Examples of medical procedures involving incision include incision and resection using scalpels, scissors, or energy devices. Examples of medical procedures involving hemostasis include so-called mechanical methods, such as grasping the bleeding site with hemostatic forceps or clips, and thermal coagulation methods using energy devices. Examples of energy devices include high-frequency hemostatic forceps, high-frequency knives, EST knives, electric scalpels, ultrasonic scalpels, high-frequency radiofrequency scalpels, heat probes, microwave scalpels, and laser scalpels. [Example]

[0059] An embodiment of the present invention will be described in detail below. The present invention is not limited to the following embodiment, and can be carried out by making appropriate modifications within the scope that does not impair the effects of the present invention.

[0060] The various raw materials and production methods used in the examples are as follows. (A) Duodenal papilla model main body (base layer and protuberance) Glucose (69 wt%): Grape sugar (Marugo Corporation, product code: Marugo41) Locust bean gum (7 wt%): Locust bean gum (manufactured by Unitec Foods Co., Ltd., product code 83) Carrageenan (9 wt%): Kappa-type carrageenan (manufactured by Unitech Foods Co., Ltd., product code 78) Potassium dihydrogen phosphate (2 wt%): Potassium dihydrogen phosphate (Hayashi Pure Chemical Industries, Ltd., product number 47005285) PVA pigment (13 wt%): Palm Paint Polar Bear Red (Turner Color Co., Ltd.) (B) Simulated blood vessel Ethylene-vinyl acetate resin (Evaflex EV170, manufactured by Dow Mitsui Polychemicals Co., Ltd.) Polythiophene-based conductive polymer dispersion Denatron PT-436 (Nagase ChemteX Corporation, pure water / alcohol dispersion) (C) Simulated blood Saline solution ·Powder edible red No. 102 (Powdered edible red No. 102 was dispersed in physiological saline at 0.5% by mass.)

[0061] -Method for manufacturing simulated blood vessels The thermoplastic resin composition was extruded to prepare a simulated blood vessel, which was a tubular structure having a thickness of 125 μm, an outer diameter of φ1.0 mm, and an inner diameter of φ0.75 mm. Next, a polythiophene-based conductive polymer dispersion was applied to the outer surface of the tubular structure as a conductive layer, and the tubular structure was dried at room temperature for 24 hours to obtain a surface resistivity of 5×10 3 A simulated blood vessel was fabricated having a conductive layer with a resistance of Ω / □.

[0062] [Production of duodenal papilla model] Example 1 A 1.0 mm diameter metal wire was placed in the cavity of a mold shaped to correspond to the duodenal wall, duodenal papilla, and papilla orifice, so that a simulated blood vessel 5 could be passed through later. 35 g of premixed material A was mixed with 100 ml of tap water, heated to 70-100°C, and the resulting aqueous solution of conductive composition was filled into the mold and cooled to 25°C to produce a molded body. The metal wire was removed, and the simulated blood vessel 5 was passed through the molded body to obtain a duodenal papilla model. The arrangement of the simulated blood vessel 5 is shown in Figure 2-1. Examples 2 to 6 A duodenal papilla model was obtained in the same manner as in Example 1, except that the simulated blood vessel 5 was placed as shown in each of Figures 2-2 to 2-6. 2-1 to 2-6, the simulated blood vessel 5 in Examples 1 to 6 is arranged such that, when the protuberance is viewed from the opposite side, at least a portion of the simulated blood vessel is arranged within a region of 60 mm in diameter including the hole and within 30 mm inward from the tip of the hole in the protuberance direction of the protuberance. Furthermore, when the protuberance is viewed from the opposite side, the simulated blood vessel is arranged within a region of 8.0 mm in diameter including the hole and within a range of 10 to 30 degrees counterclockwise, assuming that the longitudinal axis direction of the base layer simulating the duodenal wall is 0 degrees. (Comparative Example 1) A duodenal papilla model was obtained in the same manner as in Example 1, except that the simulated blood vessel 5 was not placed. (Comparative Example 2) A duodenal papilla model was obtained by placing a simulated blood vessel on the outside of the duodenal papilla model of Comparative Example 1 (the surface of the base material layer on the side without the protuberance).

[0063] The methods for evaluating various properties of the duodenal papilla models prepared in the Examples and the like are as follows.

[0064] (1) Evaluation of the reproducibility of the incision of the duodenal papilla model body When an electric scalpel (conditions: monopolar, incision mode AUTOCUT, 40W) was pressed against the main body of the duodenal papilla model, the reproducibility of the incision (whether it responded to the electric scalpel and made an incision) was evaluated. If the incision could be reproduced, it was marked with an O, and if it was not reproduced sufficiently, it was marked with an X. (2) Evaluation of reproducibility of bleeding The simulated blood vessel connected to a syringe capable of supplying simulated blood was incised with an electric scalpel (Elbe high-frequency surgical device: VIO100C, conditions: monopolar, incision mode AUTOCUT, 40W), and the degree of elution of simulated blood was evaluated visually. If the elution of blood from the blood vessel was reproduced, it was marked with ○, and if it was not reproduced, it was marked with ×. (3) Evaluation of reproducibility of hemostatic maneuvers The simulated blood vessels into which the simulated blood had eluted were subjected to hemostasis using an electric scalpel (conditions: monopolar, FORCED coagulation mode, 40W), and the degree of elution of the simulated blood during the hemostasis procedure was visually evaluated. If hemostasis was achieved by the hemostasis procedure, it was marked with an O, and if not, it was marked with an X. (4) Evaluation of the reproducibility of the duodenal papilla incision The reproducibility of the incision was evaluated when an electric scalpel (conditions: monopolar, incision mode AUTOCUT, 40W) was applied to the duodenal papilla model and an incision was made in a 20-degree counterclockwise direction, with the long axis direction of the base material layer being 0 degrees. If the sensation of an actual incision could be reproduced, it was marked with an O, and if it was not reproduced sufficiently, it was marked with an X.

[0065] The results of evaluation of the duodenal papilla models of the Examples and Comparative Examples are shown below. [Table 1]

[0066] As shown in Table 1, the duodenal papilla models of Examples 1 to 6 satisfied all the evaluation criteria, whereas the mucosal tissue models of Comparative Examples 1 and 2 did not achieve sufficient reproducibility for any of the evaluation criteria. In particular, the duodenal papilla model of Comparative Example 1 did not adequately reproduce the sensation of actually performing an incision, as simulated blood did not elute from the simulated blood vessels. The duodenal papilla model of Comparative Example 2 did not adequately reproduce the sensation of actually performing an incision, as simulated blood did not elute from the simulated blood vessels unless the base layer was penetrated by an incision with an electric scalpel. Furthermore, by connecting the simulated blood vessels of the duodenal papilla models of Examples 1 to 6 to a syringe and manually pressing the plunger of the syringe in time with the pulsation, it was possible to reproduce pulsatile, spurting heavy bleeding. Therefore, it was revealed that the duodenal papilla models of Examples 1 to 6 can reproduce complications accompanied by bleeding. [Industrial Applicability]

[0067] The duodenal papilla model of the present invention can be used as a training tool for treatment of the duodenal papilla. [Explanation of symbols]

[0068] 1. Duodenal papilla model 2 Base material layer 3 ridges 4 Vacancies 5 Simulated blood vessels

Claims

1. a base layer simulating the duodenal wall, a protrusion simulating the duodenal papilla on the surface of the base layer, and a hole simulating the papilla opening on the surface of the protrusion, A duodenal papilla model in which a tubular simulated blood vessel formed from a thermoplastic resin is placed inside the base layer or the raised portion, and when the raised portion is viewed from the opposite side, at least a portion of the simulated blood vessel is placed within an area of ​​60 mm in diameter including the hole, and within 30 mm inward from the tip of the hole in the direction of the raised portion's protrusion.

2. 2. The duodenal papilla model according to claim 1, wherein, when the protrusion is viewed from the opposite side, the simulated blood vessel is arranged so as to avoid an area within a diameter of 8.0 mm including the hole, and a range of 10 to 30 degrees counterclockwise when the longitudinal axis direction of the base layer simulating the duodenal wall is set to 0 degrees.

3. The duodenal papilla model according to claim 1 or 2, wherein two or more simulated blood vessels are arranged.

4. 3. The duodenal papilla model according to claim 1, wherein the simulated blood vessel is connected to a device capable of supplying simulated blood.

5. 3. The duodenal papilla model according to claim 1 or 2, which is used for training medical procedures including incision or hemostasis.

6. The duodenal papilla model according to claim 5 , wherein the medical procedure is an endoscopic medical procedure.

7. The duodenal papilla model according to claim 5 , wherein the medical procedure is a medical procedure using an energy device.

8. 3. The duodenal papilla model according to claim 1, wherein the simulated blood vessel has a thickness of 50 μm to 1000 μm.

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