Duodenal papilla model

Abstract

Provided is a model capable of reproducing bleeding and training the implementation of a surgery on a duodenal papilla. A duodenal papilla model according to the present invention comprises: a base material layer that simulates a duodenal wall; a protrusion part imitating a duodenal papilla on the surface of the base material layer; and a hole that simulates a nipple opening on the surface of the protrusion. A tubular simulated blood vessel formed from a thermoplastic resin is disposed inside the base material layer or the protrusion.

Description

Technical Field

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

[0002] In recent years, as minimally invasive surgery that puts little burden on the human body, can expect early recovery, and can shorten hospital stays, expectations for surgery using endoscopes have been rising, and the number of cases is increasing. For example, by removing a tumor formed in the lower layer of the mucosa in an organ under an endoscope (endoscopic submucosal dissection), surgery can be performed with a smaller wound than in conventional open surgery. In addition, by stopping bleeding in the digestive tract under an endoscope (endoscopic hemostasis), shock caused by bleeding can be prevented and emergency surgery can be avoided.

[0003] On the other hand, medical treatment as described above requires advanced technology. To improve technology and the quality of medical treatment, organ models that can be used for surgical training have been proposed (Patent Documents 1 to 5).

[0004] Prior art

[0005] Patent Document 1: Japanese Patent Application Publication No. 2006-116206

[0006] Patent Document 2: Japanese Patent Application Publication No. 2008-197483

[0007] Patent Document 3: Japanese Patent Application Publication No. 2018-17769

[0008] Patent Document 4: Japanese Patent Application Publication No. 2017-107094

[0009] Patent Document 5: Japanese Patent Application Publication No. 2016-38563 Summary of the invention

[0010] In recent years, surgery such as observation and imaging of the bile duct or pancreatic duct using an endoscope (endoscopic retrograde cholangiopancreatography: ERCP) or cutting the papilla (the outlet of the common bile duct to the duodenum) with an electric scalpel inserted through an endoscope to expand the papilla (endoscopic sphincterotomy: EST) has become more and more common, but these medical procedures also require advanced techniques. Therefore, a model that can train the operation on the duodenal papilla and reproduce the bleeding that is a problem in the actual operation is required.

[0011] The object of the present invention is to provide a model that can reproduce bleeding and can be used to train surgery on the duodenal papilla.

[0012] The inventors of the present invention studied various methods and found that by making a duodenal papilla model having a base layer simulating the duodenal wall, a raised portion simulating the duodenal papilla on the surface of the base layer, and a hole simulating the nipple opening on the surface of the raised portion, and arranging a tubular simulated blood vessel formed of a thermoplastic resin inside the base layer or the raised portion, a model capable of reproducing bleeding and training surgery on the duodenal papilla was obtained, thereby completing the present invention.

[0013] The present invention has the following embodiments.

[0014] [1] A duodenal papilla model, comprising: a base layer simulating the duodenal wall; a raised portion simulating the duodenal papilla on the surface of the base layer; and a hole simulating the papilla opening on the surface of the raised portion;

[0015] A tubular simulated blood vessel made of a thermoplastic resin is disposed inside the base layer or the protruding portion.

[0016] [2] A duodenal papilla model as described in [1], wherein when the raised portion is observed from the opposite side of the raised portion, at least a portion of the simulated blood vessel is arranged within an area within a diameter of 60 mm including the hollow hole and at an inner position within 30 mm from the front end of the hollow hole in the raised direction of the raised portion.

[0017] [3] The duodenal papilla model described in [2], wherein the simulated blood vessel is arranged in a region within a diameter of 8.0 mm including the hole and avoiding a situation where the long axis direction of the substrate layer simulating the duodenal wall is set to 0 degrees and rotated counterclockwise by 10 degrees to 30 degrees when the raised portion is observed from the opposite side of the raised portion.

[0018] [4] The duodenal papilla model as described in any one of [1] to [3], which is configured with two or more of the above-mentioned simulated blood vessels.

[0019] [5] The duodenal papilla model as described in any one of [1] to [4], wherein the simulated blood vessel is connected to a device capable of supplying simulated blood.

[0020] [6] A duodenal papilla model as described in any one of [1] to [5], which is used for training medical operations involving incision or hemostasis.

[0021] [7] The duodenal papilla model as described in [6], wherein the medical surgery is performed using an endoscope.

[0022] [8] A duodenal papilla model as described in [6] or [7], wherein the medical procedure is a medical procedure using an energy device.

[0023] [9] The duodenal papilla model as described in any one of [1] to [8], which is formed from a conductive composition.

[0024]

[10] The duodenal papilla model as described in any one of [1] to [9], wherein the thickness of the simulated blood vessel is 50 μm to 1000 μm.

[0025] According to the present invention, a model capable of reproducing bleeding and training surgery on the duodenal papilla can be provided. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 It is a figure which shows the duodenal papilla model which concerns on the 1st Embodiment of this invention.

[0027] Figures 2-1 to 2-6 It 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

[0028] 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 with appropriate modifications within a range that does not impair the effects of the present invention.

[0029] [First embodiment]

[0030] Figure 1 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 comprises: a base layer 2 imitating the duodenal wall; a raised portion 3 imitating the duodenal papilla on the surface of the base layer 2; and a hole 4 imitating the papilla opening on the surface of the raised portion 3; and a tubular simulated blood vessel 5 formed of a thermoplastic resin is arranged inside the base layer 2 or the raised portion 3.

[0031] {Substrate layer}

[0032] like Figure 1 As shown, the base material layer 2 is one layer constituting the duodenal papilla model, and is a structure formed to imitate the duodenal wall.

[0033] The shape of the base material layer 2 is not particularly limited and can be set according to its application. In addition, the molding method of the base material layer 2 can be appropriately selected from extrusion molding, casting molding, injection molding, compression molding, etc. according to the shape to be molded.

[0034] In one embodiment of the present invention, the thickness of the substrate layer 2 may be set to 3 to 50 mm, 3 to 30 mm, or 30 to 50 mm.

[0035] In one embodiment of the present invention, the size of the base material layer 2 when viewed from the side opposite to the upper surface thereof may 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.

[0036] In one embodiment of the present invention, the substrate layer 2 may be formed of a conductive composition. The composition of the conductive composition is not particularly limited, and for example, thermoplastic resins, thermoplastic elastomers, monosaccharides, polysaccharides, proteins, etc. may be used, and they may be used alone or in combination of two or more. In addition, they may be alloyed in any ratio. The volume resistivity of the conductive composition is preferably 1.0×10 2 ~1.0×10 7 Ω·cm, more preferably 1.0×10 2 ~5.0×10 4 Ω·cm. The volume resistivity can be measured, for example, in accordance with JIS C2139 using a commercially available resistivity meter (eg, Loresta GX (MCP-T700) manufactured by Nitto Seiko Analytech Co., Ltd.) at 23±1° C. for a sheet having a thickness of 1.0 mm and any shape.

[0037] Examples of the thermoplastic resin include polyurethane elastomers (TPU), styrene resins, polyolefin resins, polyvinyl chloride resins and polyvinyl alcohol.

[0038] Thermoplastic elastomers include those having a structure in which a soft polymer substance and a hard polymer substance are combined, and specific examples thereof include styrene-based elastomers, olefin-based elastomers, vinyl chloride-based elastomers, polyester-based elastomers, and polyamide-based elastomers.

[0039] Monosaccharides are substances that cannot be decomposed into simpler sugars by hydrolysis, and glucose, fructose, galactose, etc. can be used.

[0040] Polysaccharides are polymers formed by glycosidic bonds of monosaccharides such as glucose, fructose, and galactose, and xanthan gum, guar gum, pectin, carrageenan, agar, starch, mannans, and the like can be used.

[0041] Protein is a macromolecule formed by amino acids linked by peptide bonds, and collagen, gelatin, tissue-like vegetable protein, fibrous vegetable protein, etc. can be used.

[0042] Oil, a conductivity imparting agent, a coloring agent, other additives, and the like may be added to the material of the base material layer 2 as necessary within a range not inhibiting the effects of the present invention.

[0043] ·Oil

[0044] The oil is not particularly limited, and 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, mineral wax, and the like.

[0045] Conductivity imparting agent

[0046] The conductivity-imparting agent is not particularly limited, and examples thereof include electrolytes, carbon-based materials, metal oxides, metal particles, water-soluble polymer hydrogels, conductive polymers, and ionic liquids.

[0047] ·Dyeing agent

[0048] The coloring agent is not particularly limited, and pigments, dyes, etc. can be used. In particular, when used as a duodenal papilla model, it is preferably dyed to a color close to that of a living body, for example, using a coloring agent such as a pigment or dye, within a range that does not hinder the purpose.

[0049] Other additives

[0050] The material of the substrate layer 2 can be mixed with other resins, elastomers, rubbers, plasticizers, fillers or stabilizers, anti-aging agents, light resistance enhancers, ultraviolet absorbers, dispersants, softeners, lubricants, processing aids, anti-fogging agents, anti-blocking agents, crystal nucleating agents, foaming agents, fibers, etc. as needed.

[0051] {Bump}

[0052] The raised portion 3 is a portion raised from the surface of the base layer 2 and formed to imitate the duodenal papilla. In one embodiment of the present invention, the raised portion 3 may be formed of a conductive composition.

[0053] The shape of the protrusion 3 is not particularly limited, and may be, for example, a substantially cylindrical protrusion or a shape corresponding to the actual duodenal papilla. The shape corresponding to the actual duodenal papilla may be selected from single opening type, onion type, nodular type, villus type, flat type, and longitudinal type based on the pig's thigh classification (see Inomata Masaaki, Terui Torahiko, Saito Shinji, and others: Basics and Techniques of ERCP / Inserting an Observation Scope Using the Pull Method, Basic Surgery for Selective Intubation, Methods for Difficult Intubation Cases, Digestive Organ Endoscopy. 17: 1768-1776, 2005.), and formed to imitate the shape.

[0054] When the raised portion 3 is viewed from the opposite side of the raised portion 3, the diameter of the raised portion 3 is preferably 2 to 40 mm, more preferably 5 to 30 mm, and further preferably 5 to 20 mm. The height of the raised portion 3 from the surface of the base layer 2 in the raised direction is preferably 1 to 20 mm, more preferably 2 to 15 mm, and further preferably 2 to 10 mm.

[0055] {empty hole}

[0056] The hole 4 is a hole formed on the surface of the protrusion 3, for example, near the center. The shape of the hole 4 is not particularly limited, and it can be a recessed portion or a hole that penetrates the substrate layer 2 and the protrusion 3. The hole 4 can have an angle, and can be an angle that imitates the angle of the bile duct or pancreatic duct connected to the actual nipple opening. The number of holes 4 can be one or more. One hole can be divided into two in the middle, and two holes can be combined into one in the middle. These holes can imitate the bile duct or pancreatic duct. In addition, although it can be roughly circular or roughly rectangular, it is preferably a shape that imitates the shape corresponding to the actual nipple opening. Specifically, based on the classification of the morphology of the pancreatic duct / bile duct confluence (see Oi Toshi: Duodenal endoscopy and endoscopic pancreaticocholangiography. Gastroenterol. Endosc., 28: 2881-2883, 1986., Inomata Masaaki, Terui Torahiko, Endo Masaki and others: Anatomy, endoscopic classification, and basis of cannulation of the pancreatic duct / bile duct papilla. Digestive Organ Endosc. 20: 1793-1803, 2008.), it can be selected from the separated type (single opening type, onion type), septal wall type and common duct type and imitated to form the shape.

[0057] The diameter of the pores 4 is preferably 0.1 to 5 mm, more preferably 0.3 to 3 mm, and even more preferably 0.5 to 2 mm.

[0058] When the hole 4 is a concave portion, the depth or length of the concave portion in the protruding direction of the protruding portion 3 is preferably 1 to 50 mm, more preferably 5 to 40 mm, and even more preferably 15 to 30 mm.

[0059] {Simulated blood vessels}

[0060] The simulated blood vessel 5 is a tubular structure formed of a thermoplastic resin composition. The simulated blood vessel 5 may be a single-layer structure formed of one thermoplastic resin composition or a thermoplastic resin composition alloyed with two or more thermoplastic resin compositions, or a multilayer structure formed of two or more thermoplastic resin compositions. In addition, a conductive layer may be arranged on at least a portion of the outer surface or both surfaces of a single-layer structure or a multilayer structure formed of these thermoplastic resin compositions.

[0061] The thermoplastic resin composition of this embodiment mainly contains a thermoplastic resin. Here, "mainly contains" means that the thermoplastic resin composition contains 50% by mass or more of the thermoplastic resin. In another embodiment, it may contain 70% by mass or more, or 90% by mass or more, or may consist only of the thermoplastic resin.

[0062] In one embodiment, the thermoplastic resin composition has a melting point of 50 to 300° C. In addition, 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 having a melting point of 50° C. or higher, the shape change of the resin composition due to the influence of air temperature can be suppressed, and by using a thermoplastic resin composition having a melting point of 300° C. or lower, cutting can be performed using an energy device.

[0063] In the present embodiment, the melting point is measured using a differential scanning calorimeter (DSC; manufactured by METTLER TOLEDO Co., Ltd., DSC 3+) in a nitrogen atmosphere at a heating rate of 10° C. / min.

[0064] In one embodiment, the thermoplastic resin composition has a tensile modulus of 0.01 to 50 MPa. In addition, the tensile modulus of the thermoplastic resin composition is preferably 0.05 to 30 MPa, more preferably 0.1 to 15 MPa. By setting the tensile modulus to be 50 MPa or less, the simulated blood vessel can be squeezed by holding the energy device, thereby stopping the bleeding of the simulated blood flowing through the simulated blood vessel.

[0065] The tensile modulus is determined based on the tensile test method for plastics in accordance with JIS K7127. A 1.0 mm thick sheet is punched into a test piece 5 shape, and the test piece is measured at a tensile speed of 50.0 mm / min using a tensile tester (manufactured by Shimadzu Corporation, Autograph AG-Xplus) at 23±1°C. The tensile modulus is calculated based on the slope of the initial straight line in the stress-strain curve.

[0066] The thermoplastic resin contained in the thermoplastic resin composition used in the present embodiment is not particularly limited, but is preferably selected from the group consisting of ethylene-vinyl acetate resins, polyurethane elastomers, polyvinyl chloride resins, and thermoplastic elastomers. Among them, a thermoplastic resin selected from the group consisting of ethylene-vinyl acetate copolymers, thermoplastic polyurethanes, vinyl chloride resins, polybutadiene thermoplastic elastomers, and hydrogenated styrene thermoplastic elastomers can be preferably used.

[0067] In the present embodiment, ethylene-vinyl acetate resin refers to a resin containing ethylene-vinyl acetate copolymer. It can contain a variety of ethylene-vinyl acetate copolymers. As ethylene-vinyl acetate copolymer, ethylene and vinyl acetate are copolymerized, but vinyl chloride, vinyl chloride, vinylidene fluoride, etc. can also be copolymerized. The vinyl acetate content of ethylene-vinyl acetate resin is preferably 10 to 35% by mass, more preferably 15 to 35% by mass, and further preferably 20 to 35% by mass. By setting the vinyl acetate content to more than 10% by mass, the flexibility of the simulated blood vessel is improved, and the adhesion is improved when the conductive material dispersion liquid is applied to the surface of the simulated blood vessel. In addition, by setting the vinyl acetate content to less than 35% by mass, the heat resistance of the resin composition is improved.

[0068] Thermoplastic elastomers include those having a structure in which a soft polymer substance and a hard polymer substance are combined. Specifically, styrene-based elastomers, hydrogenated styrene-based thermoplastic elastomers, olefin-based elastomers, vinyl chloride-based elastomers, polyamide-based elastomers, and polybutadiene-based thermoplastic elastomers can be exemplified. These elastomers can be selected from commonly available commercial products and used.

[0069] In one embodiment, the thickness of the simulated blood vessel 5 is 50 to 1000 μm. In addition, 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 contacts, so that bleeding can be reproduced.

[0070] In one embodiment of the present invention, the diameter of the simulated blood vessel 5, i.e., the outer diameter, 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 setting the diameter of the simulated blood vessel 5 to be 0.5 mm or more, the processing stability during molding and the operability during the production of the duodenal papilla model are improved, and by setting the diameter of the simulated blood vessel 5 to be 10.0 mm or less, the reproducibility of the human blood vessel is improved, and the situation where the energy device cannot be cut is suppressed.

[0071] 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.

[0072] Conductive layer

[0073] In one embodiment, the simulated blood vessel 5 has a conductive layer containing a conductive material on the outer surface. Although the conductive layer may not be provided, by providing the conductive layer, the simulated blood vessel 5 can be easily cut when the energy device contacts the simulated blood vessel 5.

[0074] In one embodiment of the present invention, the thickness of the conductive layer is 20 to 10000 nm. The thickness of the conductive layer is preferably 50 to 5000 nm, and more preferably 150 to 1000 nm. By setting the thickness of the conductive layer to be 20 nm or more, sufficiently high conductivity can be exerted, and the smoothness of the surface of the simulated blood vessel 5 is improved. By setting the thickness of the conductive layer to be 10000 nm or less, the coating thickness of the conductive layer becomes thinner, and cracking when the simulated blood vessel 5 is bent can be suppressed.

[0075] In one embodiment of the present invention, the conductive material of the conductive layer is not particularly limited, and may be one or more conductive polymers; metal materials such as silver, copper, tin oxide, zinc oxide; carbon materials such as carbon black, carbon nanotubes, graphite, and diamond-like carbon. The conductive polymer is a π-conjugated conductive polymer. As a π-conjugated conductive polymer, as long as the main chain is an organic polymer composed of a π-conjugated system, as long as it has the effect of the present invention, there is no particular limitation, for example, polythiophene conductive polymers, polypyrrole conductive polymers, polyacetylene conductive polymers, polyphenylene conductive polymers, polyphenylene vinylene conductive polymers, polyaniline conductive polymers, polyphenylene conductive polymers, polythiophene ethylene conductive polymers, and copolymers thereof. In terms of stability in the air, polypyrrole conductive polymers, polythiophene conductive polymers, and polyaniline conductive polymers are preferred, and in terms of transparency, polythiophene conductive polymers are more preferred.

[0076] Examples of the polythiophene conductive polymer 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), poly(3 -iodothiophene), 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), 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-di ...octyloxythiophene), poly(3,4-dioctyloxythiophene), poly(3,4-dioctyloxythiophene), poly(3,4-dioctyloxythiophene), poly(3,4-dioc 3,4-di-dodecyloxythiophene), poly(3,4-ethylenedioxythiophene), poly(3,4-propylenedioxythiophene), poly(3,4-butanedioxythiophene), poly(3-methyl-4-methoxythiophene), poly(3-methyl-4-ethoxythiophene), poly(3-carboxythiophene), poly(3-methyl-4-carboxythiophene), poly(3-methyl-4-carboxyethylthiophene), poly(3-methyl-4-carboxybutylthiophene).

[0077] Examples of the polypyrrole-based conductive polymer 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).

[0078] Examples of the polyaniline-based conductive polymer include polyaniline, poly(2-methylaniline), poly(3-isobutylaniline), poly(2-anilinesulfonic acid) and poly(3-anilinesulfonic acid).

[0079] Among the above-mentioned π-conjugated conductive polymers, poly(3,4-ethylenedioxythiophene) is particularly preferred in terms of conductivity, transparency, and heat resistance.

[0080] The above-mentioned π-conjugated conductive polymers may be used alone or in combination of two or more.

[0081] The conductive polymer in another embodiment of the present invention further contains a polyanion.

[0082] The polyanion is a polymer having two or more monomer units having an anion group in the molecule. The anion group of the polyanion functions as a dopant for the π-conjugated conductive polymer, thereby improving the conductivity of the π-conjugated conductive polymer.

[0083] The anion group of the polyanion is preferably a sulfo group or a carboxyl group.

[0084] Specific examples of such polyanions include polymers having sulfonic acid groups such as polystyrene sulfonic acid, polyvinyl sulfonic acid, polyallyl sulfonic acid, polyacrylic acid sulfonic acid, polymethacrylic acid sulfonic acid, poly(2-acrylamide-2-methylpropanesulfonic acid), polyisoprene sulfonic acid, polysulfoethyl methacrylate, poly(4-sulfobutyl methacrylate), and polymethacryloyloxybenzenesulfonic acid; or polymers having carboxylic acid groups such as polyvinyl carboxylic acid, polystyrene carboxylic acid, polyallyl carboxylic acid, polypropylene carboxylic acid, polymethacrylic acid, poly(2-acrylamide-2-methylpropanecarboxylic acid), polyisoprene carboxylic acid, and polyacrylic acid. These may be homopolymers or copolymers of two or more.

[0085] Among these polyanions, polymers having a sulfonic acid group are preferred, and polystyrene sulfonic acid is more preferred, because the antistatic property can be further improved.

[0086] The above-mentioned polyanions may be used alone or in combination of two or more.

[0087] The mass average molecular weight of the polyanion is preferably 20,000 to 1,000,000, and more preferably 100,000 to 500,000.

[0088] The mass average molecular weight in this specification is a value determined by gel permeation chromatography using polystyrene as a standard substance.

[0089] Relative to 100 parts by mass of π-conjugated conductive polymer, the content ratio of polyanions in the conductive composite containing π-conjugated conductive polymer and polyanions is preferably in the range of more than 1 part by mass and less than 1000 parts by mass, more preferably in the range of more than 10 parts by mass and less than 700 parts by mass, and further preferably in the range of more than 100 parts by mass and less than 500 parts by mass. If the content ratio of polyanions is less than the above lower limit, there is a tendency that the doping effect of π-conjugated conductive polymer weakens, and there is a situation of insufficient conductivity. In addition, the dispersibility of the conductive composite in the dispersion liquid decreases. On the other hand, if the content of polyanions exceeds the above upper limit, the content of π-conjugated conductive polymer decreases, and it is still difficult to obtain sufficient conductivity.

[0090] The conductive composite is formed by doping polyanions into π-conjugated conductive polymers.

[0091] However, in the polyanion of the present embodiment, it is not necessary for all the anion groups to be doped into the π-conjugated conductive polymer, but the polyanion has excess anion groups that do not contribute to doping.

[0092] Dispersion medium

[0093] In one embodiment of the present invention, the conductive layer contains both the conductive material and a dispersion medium. Examples of the dispersion medium used in this embodiment include water, an organic solvent, and a mixed solution of water and an organic solvent.

[0094] Examples of the organic solvent include ester solvents, ether solvents, hydrocarbon solvents, nitrogen atom-containing solvents, alcohol solvents, and ketone solvents.

[0095] Examples of the ester solvent include ethyl acetate, propyl acetate and butyl acetate.

[0096] Examples of the ether solvent include diethyl ether, dimethyl ether, ethylene glycol, propylene glycol, propylene glycol dialkyl ether, and diethylene glycol diethyl ether.

[0097] Examples of the hydrocarbon solvent include hexane, cyclohexane, pentane, octane, decane, dodecane, benzene, toluene, xylene, ethylbenzene, propylbenzene and cumene.

[0098] Examples of the nitrogen atom-containing solvent include N-methylpyrrolidone, dimethylacetamide, and dimethylformamide.

[0099] Examples of the alcohol solvent 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.

[0100] Examples of the ketone solvent 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.

[0101] The above-mentioned organic solvents may be used alone or in combination of two or more.

[0102] The above-mentioned dispersion medium is preferably at least one solvent selected from the group consisting of ester solvents, hydrocarbon solvents, ether solvents, and N-methylpyrrolidone. Furthermore, the above-mentioned dispersion medium is more preferably at least one solvent selected from the group consisting of ethyl acetate, butyl acetate, heptane, toluene, and diethylene glycol diethyl ether.

[0103] The content of the conductive material in the dispersion of the present 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 further preferably 1% by mass or more and 30% by mass or less relative to the total mass of the dispersion. If the content of the conductive material in the dispersion is above the lower limit, a conductive layer having a thickness can be easily formed by one coating. If the content of the conductive material in the dispersion is below the upper limit, the dispersibility of the conductive material in the dispersion can be improved, and the transparency can be improved.

[0104] Transparent adhesive ingredients

[0105] The dispersion in one embodiment of the present invention contains the above-mentioned conductive material and a transparent binder component at the same time. The transparent binder component is a thermoplastic resin, a heat-curing compound, a photocuring compound, etc., and a transparent compound can be mentioned. The thermoplastic resin directly uses the binder resin described later. The heat-curing compound and the photocuring compound are each a monomer or an oligomer, and the heat-curing compound becomes the binder resin described later by heat curing, and the photocuring compound becomes the binder resin described later by photocuring.

[0106] When the dispersion contains both the conductive material and the transparent binder component, a conductive layer having transparency, conductivity, and adhesion to a substrate can be easily formed.

[0107] As the transparent adhesive component, for example, acrylic resin, polystyrene, styrene-acrylic acid copolymer, polycarbonate, ethylene-vinyl acetate copolymer, polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, cyclic polyolefin, polyester resin, polyurethane resin, polyimide resin, melamine resin, acrylic acid compound having one or more acryl groups, epoxy compound having two or more epoxy groups, etc. These may be dissolved in the dispersion medium or dispersed in a colloidal dispersion or emulsion.

[0108] Examples of the thermoplastic resin in the transparent adhesive component include acrylic resin, polystyrene, styrene-acrylic acid copolymer, polycarbonate, ethylene-vinyl acetate copolymer, polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, and cyclic polyolefin.

[0109] In the above-mentioned transparent adhesive component, examples of the thermosetting compound include acrylic compounds and epoxy compounds.

[0110] As the photocurable compound, an acrylic compound may be mentioned.

[0111] Among the above-mentioned transparent adhesive components, thermoplastic acrylic resins are preferred because they have high transparency and can be easily cured.

[0112] The transparent adhesive component may be used alone or in combination of two or more.

[0113] When the transparent binder component is a thermosetting compound, it is preferred that the conductive particle dispersion contains a thermal polymerization initiator. When the transparent binder component is a photocurable compound, it is preferred that the dispersion contains a photopolymerization initiator.

[0114] The content of the transparent binder component in the dispersion of the present 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 further 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 the present embodiment is above the above 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 the present embodiment is below the above upper limit, the reduction in conductivity caused by the reduction in the content of the conductive material can be prevented.

[0115] In one embodiment of the present invention, the conductive layer is formed by applying a dispersion 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 immersing in a conductive material dispersion, spraying a conductive material dispersion, or the like.

[0116] Before applying the conductive material dispersion, the simulated blood vessel 5 is preferably subjected to corona discharge treatment, plasma discharge treatment, flame treatment, etc. to form hydrophilic groups (hydroxyl, carbonyl, carboxyl, etc.) on the surface of the simulated blood vessel 5. If the simulated blood vessel 5 is subjected to hydrophilization treatment, the adhesion of the conductive layer can be further improved. In addition, by applying a transparent adhesive as a primer to the simulated blood vessel 5 and then applying the conductive material dispersion, the adhesion between the simulated blood vessel 5 and the conductive layer can be improved.

[0117] The surface resistivity of the portion where the conductive layer is disposed is 1.0×10 0 Ω / □ or more and 1.0×10 6 Ω / □ or less. More preferably 1.0×10 0 Ω / □ or more and 1.0×10 5 Ω / □ or less, more preferably 1.0×10 0 Ω / □ or more and 1.0×10 4 Ω / □ or less.

[0118] In the present embodiment, the surface resistivity is measured at 23±1°C using a resistivity meter (Loresta GX (MCP-T700) manufactured by Nitto Seiko Analytech Co., Ltd.) in accordance with JIS C2139. During the measurement, the thermoplastic resin composition is press-molded at 160 to 200°C to form a 2.5 cm×2.5 cm, 1.0 mm thick resin sheet, and the test body having a conductive layer formed on the surface is used for evaluation.

[0119] (Method for manufacturing simulated blood vessels)

[0120] The simulated blood vessel of the present embodiment is produced by extrusion molding a thermoplastic resin composition.

[0121] The conductive layer is formed by applying a dispersion in which a conductive material is dispersed in a dispersion medium. In another embodiment, the conductive layer is formed by immersing in the conductive material dispersion, spraying the conductive material dispersion, or the like.

[0122] Before applying the conductive material dispersion, the simulated blood vessel surface is preferably subjected to corona discharge treatment, plasma discharge treatment, flame treatment, etc. to form hydrophilic groups (hydroxyl groups, carbonyl groups, etc.) on the surface. If hydrophilization treatment is performed, the adhesiveness of the conductive layer can be further improved.

[0123] (Duodenum Papilla Model)

[0124] The duodenal papilla model 1 of this embodiment includes a base layer 2, a protrusion 3, and a hole 4, and a simulated blood vessel 5 is arranged inside the base layer 2 or the protrusion 3. In addition, 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 can be formed into a flat plate to imitate a part of the duodenal wall.

[0125] In one embodiment, when the raised portion 3 is observed from the opposite side of the raised portion 3, at least a portion of the simulated blood vessel 5 is arranged in an area within 60 mm in diameter including the pores 4 and at an inner position within 30 mm from the front end of the pores 4 in the raised direction of the raised portion 3. When there are multiple pores 4, the above-mentioned area preferably includes all the pores 4. When the raised portion 3 is observed from the opposite side of the raised portion 3, the simulated blood vessel 5 is preferably arranged within 40 mm in diameter including the pores 4, and more preferably arranged within 30 mm. In addition, it is preferably arranged within 20 mm from the front end of the pores 4 in the raised direction of the raised portion 3, and more preferably arranged within 10 mm.

[0126] In one embodiment, the region is a circle centered on the hole 4. When there are a plurality of holes 4, the region may be a circle centered on any one of the holes 4.

[0127] The simulated blood vessel 5 preferably reproduces the physiological anatomical blood vessel course. In one embodiment, when the raised portion 3 is observed from the opposite side of the raised portion 3, the simulated blood vessel 5 is arranged in an area within a diameter of 8.0 mm including the hole 4 and avoiding the range of 10 to 30 degrees counterclockwise rotation when the long axis direction of the substrate layer 2 imitating the duodenal wall is set to 0 degrees. Here, the long axis direction refers to the direction corresponding to the direction in which the tubular axis of the duodenum extends. For example, when the duodenal papilla model is tubular, the long axis direction refers to the tubular axis direction of the duodenal papilla model. When the duodenal papilla model is flat, the long axis direction refers to the direction consistent with the tubular axis direction of the duodenal model when it is installed on the duodenal model during training. By configuring the simulated blood vessel 5 as described above, the position where bleeding is prone to occur during actual surgery can be reproduced, and the reproducibility of bleeding is further improved. In addition, it is preferred that when the raised portion 3 is observed from the opposite side of the raised portion 3, the simulated blood vessel 5 is arranged in an area within a diameter of 8.5 mm including the pores 4 and in a range of 10 to 30 degrees counterclockwise rotated when the long axis direction of the substrate layer 2 simulating the duodenal wall is set to 0 degrees, and it is more preferred that when the raised portion 3 is observed from the opposite side of the raised portion 3, the simulated blood vessel 5 is arranged in an area within a diameter of 9.0 mm including the pores 4 and in a range of 10 to 30 degrees counterclockwise rotated when the long axis direction of the substrate layer 2 simulating the duodenal wall is set to 0 degrees.

[0128] In one embodiment, when there are a plurality of pores 4 , the region preferably includes all of the pores 4 .

[0129] In one embodiment, the region is a circle centered on the hole 4. When there are a plurality of holes 4, the region may be a circle centered on any one of the holes 4.

[0130] In one embodiment, one or more simulated blood vessels 5 are arranged inside the base layer 2 or the raised portion 3. The number of simulated blood vessels 5 may be two or more, or three or more.

[0131] 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. When the ASKER E hardness is 40 or less, the touch is close to the actual duodenal papilla, and it is expected to improve medical surgery technology. The ASKER E hardness can be measured according to JIS K6253-3.

[0132] In one embodiment, the duodenal papilla model may further include a first band-shaped protrusion that simulates a coiled fold. The first band-shaped protrusion has a circular portion that is 2 to 20 mm away from the hole 4 toward the upper side (mouth side) within the range of -120 to 120 degrees when the long axis direction of the base layer 2 that simulates the duodenal wall is set to 0 degrees and rotated clockwise.

[0133] In another embodiment, a second belt-shaped raised portion imitating annular folds may be provided. The second belt-shaped raised portion is separated from the first belt-shaped raised portion by 0.5 to 20 mm toward the upper side and extends substantially parallel to the first belt-shaped raised portion.

[0134] (Method for manufacturing duodenal papilla model)

[0135] The duodenal papilla model 1 of the present embodiment can be manufactured by a conventional molding method. For example, it can be manufactured by setting the simulated blood vessel 5 in a mold cavity of a mold having a shape corresponding to the duodenal wall, the duodenal papilla and the papilla opening, and casting or filling the material (such as a conductive composition) into the mold for molding. In addition, a through hole for setting the simulated blood vessel 5 can also be provided in the mold cavity, and then the simulated blood vessel 5 is inserted. The temperature during molding can be appropriately changed according to the resin used, but for example, when a conductive composition mainly containing carrageenan is used, it is molded by casting at 70 to 100°C and cooling to 25°C.

[0136] [use]

[0137] The duodenal papilla model 1 can be used for training of medical surgeries including incision or hemostasis, in particular, surgery for observing and imaging the bile duct or pancreatic duct using an endoscope (endoscopic retrograde cholangiopancreatography: ERCP), or surgery for incising the papilla (the outlet of the common bile duct to the duodenum) using an electric scalpel inserted through an endoscope (endoscopic sphincterotomy: EST), etc. In this case, the duodenal papilla model 1 can be embedded in a model mounting portion provided in an upper digestive organ (stomach, esophagus, duodenum, etc.) model, or the duodenal papilla model 1 can be attached to the inner wall of the digestive organ model. The model mounting portion of the digestive organ model can be a frame or a recess formed by a partial defect in the wall, or a jig for model mounting can be installed on the inner wall or outer wall of the digestive organ model. The duodenal papilla model 1 can be embedded in a model mounting portion provided in a bile duct model, or can be mounted using a jig, or can be attached. The bile duct model can be made into a structure including the pancreatic duct. The model mounting part or the jig for model mounting can be independent from the digestive organ model or the bile duct model. In addition, a structure in which the models of the oral cavity, esophagus, stomach, duodenum, etc. that simulate the path from the oral cavity of a real human body to the digestive organs including the duodenum are integrated or a structure in which the respective models are joined can be made.

[0138] The duodenal papilla model 1 can be attached to the inner wall of the digestive organ model using adhesives, sticky agents, double-sided tape, etc.

[0139] Examples of medical procedures involving incision include methods of incision and excision using scalpels, scissors, or energy devices. Examples of medical procedures involving hemostasis include so-called mechanical methods such as holding the bleeding site with hemostats or clamps, and thermal coagulation methods such as thermal coagulation methods using energy devices. Examples of energy devices include high-frequency hemostats, high-frequency knives, EST knives, electric scalpels, ultrasonic scalpels, high-frequency radio wave scalpels, thermal probes, microwave scalpels, laser scalpels, and the like.

[0140] Example

[0141] Hereinafter, one embodiment of the present invention will be described in detail. The present invention is not limited to the following embodiment, and can be implemented with appropriate modifications within a range that does not inhibit the effects of the present invention.

[0142] Various raw materials and production methods used in Examples etc. are as follows.

[0143] (A) Main body of the duodenal papilla model (base material layer and raised part)

[0144] Glucose (69 wt%): Glucose (Marugo Corporation, product code marugo41)

[0145] Locust bean gum (7 wt%): Locust bean gum (Unitec Foods Co., Ltd., product code 83)

[0146] Carrageenan (9 wt%): kappa carrageenan (Unitec Foods Co., Ltd., product code 78)

[0147] Potassium dihydrogen phosphate (2 wt%): Potassium dihydrogen phosphate (produced by Hayashi Jun Chemical Industries, Ltd., product number 47005285)

[0148] ·PVA pigment (13 wt%): water-based pigment Palm White Bear Red (manufactured by Turner Color Co., Ltd.)

[0149] (B) Simulated blood vessels

[0150] · Ethylene vinyl acetate resin (EVAFLEX EV170, manufactured by Mitsui Dow Polychemicals, Inc.)

[0151] · Polythiophene-based conductive polymer dispersion Denatron PT-436 (manufactured by Nagase Chemicals Co., Ltd., pure water / alcohol dispersion)

[0152] (C) Simulated blood

[0153] Normal saline

[0154] · Edible red powder No. 102

[0155] (Prepared by dispersing 0.5% by mass of powder Edible Red No. 102 in physiological saline)

[0156] ·Method for manufacturing simulated blood vessels

[0157] The thermoplastic resin composition was extruded to produce a tubular structure having a thickness of 125 μm, an outer diameter of φ1.0 mm, and an inner diameter of φ0.75 mm, i.e., a simulated blood vessel. Then, a polythiophene-based conductive polymer dispersion was applied to the outer surface of the tubular structure as a conductive layer, and dried at room temperature for 24 hours to produce a surface resistivity of 5×10 3 Ω / □ conductive layer simulated blood vessels.

[0158] [Manufacturing of Duodenal Papilla Model]

[0159] (Example 1)

[0160] A metal wire with a diameter of 1.0 mm is set in the mold cavity of a mold having a shape corresponding to the duodenal wall, duodenal papilla and papilla opening so that a simulated blood vessel 5 can be passed thereafter, and 35 g of the pre-mixed material A and 100 ml of tap water are mixed, heated at 70 to 100° C., and the resulting aqueous solution of the conductive composition is filled into the mold and cooled to 25° C. to produce a molded body. The metal wire is pulled out and the simulated blood vessel 5 is passed through the molded body, thereby obtaining a duodenal papilla model. The arrangement of the simulated blood vessel 5 is shown in FIG. Figure 2-1 middle.

[0161] (Examples 2 to 6)

[0162] In addition to setting the simulated blood vessel 5 as follows Figure 2-2 to Figure 2-6 The duodenal papilla model was obtained in the same manner as in Example 1 except as shown.

[0163] The configuration of the simulated blood vessel 5 in Examples 1 to 6 is as follows: Figure 2-1 to Figure 2-6 As shown, when the protrusion is viewed from the opposite side of the protrusion, at least a portion of the simulated blood vessel is arranged in an area within a diameter of 60 mm including the hole and within 30 mm from the front end of the hole in the protrusion direction of the protrusion. In addition, when the protrusion is viewed from the opposite side of the protrusion, the simulated blood vessel is arranged in an area within a diameter of 8.0 mm including the hole and away from a range of 10 to 30 degrees counterclockwise when the long axis direction of the substrate layer simulating the duodenal wall is set to 0 degrees.

[0164] (Comparative Example 1)

[0165] A duodenal papilla model was obtained in the same manner as in Example 1 except that the simulated blood vessel 5 was not provided.

[0166] (Comparative Example 2)

[0167] A simulated blood vessel was arranged on the outside of the duodenal papilla model of Comparative Example 1 (the surface of the substrate layer on the side without the protrusions), thereby obtaining a duodenal papilla model.

[0168] The evaluation methods of various properties of the duodenal papilla models prepared in the Examples and the like are as follows.

[0169] (1) Evaluation of the reproducibility of incision of the main body of the duodenal papilla model

[0170] The reproducibility of the incision state (whether the incision was made in response to the electric scalpel) when the electric scalpel (conditions: monopolar, incision mode AUTOCUT, 40W) was pressed against the main body of the duodenal papilla model was evaluated. The case where the incision could be reproducible was rated as ○, and the case where the incision could not be fully reproducible was rated as ×.

[0171] (2) Evaluation of bleeding reproducibility

[0172] The simulated blood vessel connected to the syringe capable of supplying simulated blood was visually evaluated for the degree of simulated blood dissolution when the simulated blood vessel was cut using an electric surgical knife (high-frequency surgical device manufactured by ERBE: VIO100C, conditions: monopolar, incision mode AUTOCUT, 40W). The case where blood dissolution from the blood vessel was reproduced was marked as ○, and the case where it could not be reproduced was marked as ×.

[0173] (3) Evaluation of reproducibility of hemostatic operation

[0174] The simulated blood vessel with simulated blood dissolved was subjected to hemostasis using an electric scalpel (conditions: monopolar, FORCED coagulation mode, 40W), and the degree of dissolution of simulated blood during the hemostasis was visually evaluated. The case where the hemostasis by the hemostasis was reproduced was rated as ○, and the case where it could not be reproduced was rated as ×.

[0175] (4) Evaluation of the reproducibility of the duodenal papilla model

[0176] When an electric scalpel (conditions: monopolar, incision mode AUTOCUT, 40W) was placed against the duodenal papilla model, the long axis direction of the base material layer was set to 0 degrees, and the incision was rotated 20 degrees counterclockwise, the reproducibility of the incision at this time was evaluated. The case where the feeling of the actual incision could be reproduced was rated as ○, and the case where it could not be fully reproduced was rated as ×.

[0177] The results of evaluation of the duodenal papilla models of Examples and Comparative Examples are shown below.

[0178] [Table 1]

[0179]

[0180] 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 cause simulated blood to dissolve from the simulated blood vessels, and thus could not fully reproduce the feeling of an actual incision. The duodenal papilla model of Comparative Example 2 did not cause simulated blood to dissolve from the simulated blood vessels, and thus could not fully reproduce the feeling of an actual incision, unless the substrate layer was penetrated by incision using an electric scalpel.

[0181] In addition, by connecting the simulated blood vessels of the duodenal papilla models of Examples 1 to 6 to a syringe and manually pushing the piston of the syringe in accordance with the pulsation, it is possible to reproduce heavy bleeding with pulsating spurts. Therefore, it is known that the duodenal papilla models of Examples 1 to 6 can reproduce complications associated with bleeding.

[0182] Industrial availability

[0183] The duodenal papilla model of the present invention can be used as a training tool for performing surgery on the duodenal papilla.

[0184] Explanation of symbols

[0185] 1: Duodenal papilla model

[0186] 2: Base material layer

[0187] 3: Raised part

[0188] 4: Empty hole

[0189] 5: Simulate blood vessels

Claims

1. A duodenal papilla model, comprising: a base layer simulating the duodenal wall; a raised portion simulating the duodenal papilla on the surface of the base layer; and a hole simulating the papilla opening on the surface of the raised portion; A tubular simulated blood vessel formed of a thermoplastic resin is arranged inside the base material layer or the protruding portion.

2. The duodenal papilla model according to claim 1, wherein when the raised portion is observed from the opposite side of the raised portion, at least a portion of the simulated blood vessel is arranged within an area within a diameter of 60 mm including the hollow hole and at an inner position within 30 mm from the front end of the hollow hole in the raised direction of the raised portion.

3. The duodenal papilla model as described in claim 2, wherein when the raised portion is observed from the opposite side of the raised portion, the simulated blood vessel is arranged in an area within a diameter of 8.0 mm including the hole and avoiding a range of 10 to 30 degrees rotated counterclockwise when the long axis direction of the substrate layer simulating the duodenal wall is set to 0 degrees. 4 . The duodenal papilla model according to claim 1 , wherein two or more simulated blood vessels are provided.

5. The duodenal papilla model according to any one of claims 1 to 3, wherein the simulated blood vessel is connected to a device capable of supplying simulated blood.

6. The duodenal papilla model according to any one of claims 1 to 3, which is used for training medical operations involving incision or hemostasis.

7. The duodenal papilla model according to claim 6, wherein the medical procedure is a medical procedure using an endoscope.

8. The duodenal papilla model of claim 6, wherein the medical procedure is a medical procedure using an energy device. 9 . 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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