Manufacturing method of organ model and organ model

Abstract

To provide an organ model for enabling a medical instrument to easily enter a lumen, and a manufacturing method of the same.SOLUTION: A manufacturing method of an organ model having a lumen inside includes steps of: creating a core for forming a lumen; coating a surface of the core with a coating material containing a silicone rubber composition and a silicone oil; arranging the core in a mold for forming an organ model; and pouring a polyurethane resin-containing molding material for forming the organ model into the mold.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to a model that simulates an internal organ, and in particular to an organ model that can be used for surgical training, and a method for manufacturing the same. [Background technology]

[0002] Training devices with models simulating internal organs are used to learn skills related to operating medical instruments and improve proficiency. In clinical settings, medical instruments are inserted into the body while checking two-dimensional X-ray fluoroscopic images, so training is sometimes performed while viewing images similar to X-ray fluoroscopic images. In this way, training systems have been developed that include a training device and a device for capturing images of the insertion of medical instruments into the training device, in order to make training more similar to clinical conditions and objectively evaluate the level of proficiency in procedures. For example, Patent Documents 1 to 5 describe methods for manufacturing organ models. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Publication No. 2017 / 030145 [Patent Document 2] Japanese Patent Application Laid-Open No. 2008-070847 [Patent Document 3] Patent Publication No. 2021-086096 [Patent Document 4] International Publication No. 2022 / 239490 [Patent Document 5] Japanese Patent Application Laid-Open No. 2010-224069 Summary of the Invention [Problem to be solved by the invention]

[0004] The organ models described in Patent Documents 1 to 5 have room for improvement in terms of ease of insertion of medical instruments into the lumen inside the organ model.

[0005] In view of the above circumstances, an object of the present invention is to provide an organ model that allows medical instruments to be easily inserted into the lumen, and a method for manufacturing the same. [Means for solving the problem]

[0006] The method for producing an organ model according to an embodiment of the present invention that can solve the above problems is as follows. [1] A method for producing an organ model having a lumen therein, comprising: preparing a core for forming the lumen; a step of coating the surface of the core with a coating material containing a silicone rubber composition and a silicone oil; placing the core in a mold for forming the organ model; and pouring a molding material containing polyurethane resin into the mold to form the organ model.

[0007] The method for producing an organ model according to the embodiment of the present invention is preferably any one of the following [2] to [9]. [2] The method for manufacturing an organ model according to [1], wherein the molding material includes a thermosetting liquid polyurethane resin. [3] The method for manufacturing an organ model according to [1] or [2], wherein the blending ratio of the silicone rubber composition and the silicone oil in the coating material is silicone rubber composition / silicone oil = 1 / 4 or more and 4 / 1 or less by weight. [4] The method for manufacturing an organ model according to any one of [1] to [3], wherein in the step of coating the surface of the core with the coating material, the entire surface of the core is coated with the coating material multiple times. [5] The method for manufacturing an organ model according to any one of [1] to [4], wherein the step of coating the surface of the core with the coating material is carried out after the step of placing the core in the mold. [6] A method for manufacturing an organ model according to any one of [1] to [5], further comprising a step of solidifying the molding material after the step of pouring a molding material for forming the organ model into the mold. [7] The method for manufacturing an organ model according to [6], further comprising the step of removing the core from the solidified modeling material after the step of solidifying the modeling material. [8] A method for manufacturing an organ model described in any one of [1] to [7], further comprising a step of solidifying the coating material before the step of pouring a molding material for forming the organ model into the mold. [9] The method further includes a step of solidifying the modeling material after the step of pouring the modeling material for forming the organ model into the mold, [8] The method for manufacturing an organ model according to [8], further comprising the step of removing the solidified coating material from the solidified modeling material after the step of solidifying the modeling material.

[0008] Furthermore, an organ model according to an embodiment of the present invention that can solve the above problems is as follows.

[10] An organ model having a lumen therein, the organ model having a mass-shaped main body, the body portion has an inner surface defining the lumen; An organ model having a silicone rubber composition and / or silicone oil present on the inner surface thereof.

[0009] The organ model according to the embodiment of the present invention is preferably any one of the following

[11] to

[13] .

[11] The organ model described in

[10] , wherein the main body portion is made of a molding material containing a thermosetting liquid polyurethane resin.

[12] The organ model according to

[10] or

[11] , wherein the hardness of the main body is 5 or more when measured with a durometer type E.

[13] The organ model according to any one of

[10] to

[12] , wherein the material constituting the main body has a transparency that allows transmission of 50% or more of light having a wavelength of 410 nm or more and 830 nm or less. [Effects of the Invention]

[0010] According to the above-described method for manufacturing an organ model, by coating the surface of the core with a coating material containing a silicone rubber composition and silicone oil, the coating material can penetrate into the recesses on the surface of the core and smooth out the irregularities. Furthermore, the presence of the coating material on the surface of the core can prevent contact between the core and the molding material that forms the organ model, while suppressing a delay in the reaction of the molding material. As a result, the inner surface of the lumen of the organ model can be made smooth, facilitating the insertion of medical instruments into the lumen. According to the above-described organ model, the presence of the silicone rubber composition and / or silicone oil on the inner surface of the main body smooths out the irregularities on the inner surface, facilitating the insertion of medical instruments into the lumen. [Brief explanation of the drawings]

[0011] [Figure 1] 1 is a flowchart showing a method for manufacturing an organ model according to an embodiment of the present invention. [Figure 2] 10 is a flowchart showing a modified example of the method for producing the organ model shown in FIG. [Figure 3] FIG. 1 is a perspective view showing an example of the shape of a core used in a manufacturing method of an organ model according to an embodiment of the present invention. [Figure 4] 1 is a cross-sectional view showing an example of the shape of a mold used in a manufacturing method of an organ model according to an embodiment of the present invention. FIG. [Figure 5] 1 is a perspective view of an exercise device according to an embodiment of the present invention. FIG. [Figure 6] FIG. 6 is a front view (partial cross-sectional view) of the container and organ model of the training device shown in FIG. 5. [Figure 7] FIG. 6 is a side view (partial cross-sectional view) of the container and organ model of the training device shown in FIG. 5. [Figure 8] FIG. 6 is a plan view of the container and organ model of the training device shown in FIG. 5. [Figure 9] FIG. 6 is a perspective view showing a modification of the training device shown in FIG. 5. [Figure 10] 10 is a schematic diagram showing the connection between the container and organ model and the extension part of the training device shown in FIG. 9. FIG. [Figure 11] FIG. 6 is a perspective view showing another modified example of the training apparatus shown in FIG. [Figure 12] 6 is a side view (partial cross-sectional view) showing a modified example of the arrangement of the light receiving unit of the training device shown in FIG. 5. FIG. [Figure 13] 6 is a plan view showing yet another modified example of the training apparatus shown in FIG. 5. FIG. [Figure 14] FIG. 6 shows a modified example of the organ model shown in FIG. 5, and is an end view of a cross section of the organ model perpendicular to the axial direction of the lumen. [Figure 15] 1 is a schematic diagram of a training system according to an embodiment of the present invention; [Figure 16] 1 is a photograph showing an organ model obtained in Example 1. [Figure 17] 1 is a photograph showing an organ model obtained in Comparative Example 2. DETAILED DESCRIPTION OF THE INVENTION

[0012] The present invention will be described below based on the embodiments, but the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. In addition, hatching and component symbols may be omitted in each drawing for convenience. In such cases, reference should be made to the specification or other drawings. The dimensions of various components in the drawings may differ from actual dimensions, as priority is given to helping understand the features of the present invention.

[0013] A method for manufacturing an organ model according to an embodiment of the present invention is a method for manufacturing an organ model having an internal lumen, comprising the steps of: preparing a core for forming the lumen; coating the surface of the core with a coating material containing a silicone rubber composition and silicone oil; placing the core in a mold for forming the organ model; and pouring a molding material containing a polyurethane resin into the mold to form the organ model. According to the method for manufacturing an organ model, by coating the surface of the core with a coating material containing a silicone rubber composition and silicone oil, the coating material can penetrate into recesses on the surface of the core, smoothing out any irregularities. As a result, the inner surface of the lumen of the organ model can be more easily formed smoothly, facilitating the insertion of medical instruments into the lumen.

[0014] An organ model according to an embodiment of the present invention is an organ model having an internal lumen, the organ model having a mass-shaped main body having an inner surface defining the lumen, and a silicone rubber composition and / or silicone oil present on the inner surface. According to the organ model, the presence of the silicone rubber composition and / or silicone oil on the inner surface of the main body smooths the irregularities on the inner surface, facilitating the insertion of a medical instrument into the lumen.

[0015] 1 to 17, an organ model and a manufacturing method for an organ model according to an embodiment of the present invention will be described below. FIG. 1 is a flowchart illustrating a manufacturing method for an organ model according to an embodiment of the present invention. FIG. 2 is a flowchart illustrating a modified example of the manufacturing method for the organ model shown in FIG. 1. FIG. 3 is a perspective view illustrating an example of the shape of a core used in the manufacturing method for an organ model according to an embodiment of the present invention. FIG. 4 is a cross-sectional view illustrating an example of the shape of a mold used in the manufacturing method for an organ model according to an embodiment of the present invention. FIG. 5 is a perspective view of a training device according to an embodiment of the present invention. FIG. 6 is a front view (partially cross-sectional) of the container and organ model of the training device shown in FIG. 5. FIG. 7 is a side view (partially cross-sectional) of the container and organ model of the training device shown in FIG. 5. FIG. 8 is a plan view of the container and organ model of the training device shown in FIG. 5. FIG. 9 is a perspective view illustrating a modified example of the training device shown in FIG. 5. FIG. 10 is a schematic view illustrating the connection portion of the container and organ model with the extension portion of the training device shown in FIG. 9. FIG. 11 is a perspective view illustrating another modified example of the training device shown in FIG. 5. FIG. 12 is a side view (partially cross-sectional) illustrating a modified arrangement of the light receiving unit of the training device shown in FIG. 5. FIG. 13 is a plan view illustrating yet another modified example of the training device shown in FIG. 5. Fig. 14 shows a modified example of the organ model shown in Fig. 5, and is an end view of a cut portion in a cross section perpendicular to the axial direction of the lumen of the organ model. Fig. 15 is a schematic diagram of a training system according to an embodiment of the present invention. Figs. 16 and 17 are photographs showing the organ models obtained in Example 1 and Comparative Example 2, respectively. Note that Figs. 6 to 8, 12 to 13, and 15 show simplified views of the container structure.

[0016] The organ model 1 is a model that simulates an internal organ and can be used for surgical training, particularly for endoscopic surgery. The lumen 5 of the organ model 1 corresponds to the shape of an internal organ lumen, i.e., a lumen of an actual organ. Specifically, the lumen 5 is a three-dimensional simulation of the shape of a lumen of an organ in a human or animal body. The type of lumen 5 simulated by the organ model 1 is not limited, and may be, for example, a digestive system lumen such as a bile duct or pancreatic duct, a circulatory system lumen such as intracardiac blood vessels, or other types of organs. The training device 60 according to an embodiment of the present invention will be described using an organ model 1 that simulates a bile duct as an example. In this specification, the lumen 5 simulates the shape of a bile duct. Therefore, by inserting a medical instrument into the lumen 5 of the organ model 1 through the opening 6, it is possible to simulate the operation of the medical instrument within the bile duct. Note that the external shape of the organ model 1 does not have to simulate the external shape of the organ. For example, in an organ model 1 that has an internal lumen 5 that corresponds to the shape of a bile duct, the external shape of the organ model 1 does not have to match the external shape of a gallbladder.

[0017] A method for producing an organ model is described.

[0018] First, as shown in Figures 1 and 2, a core for forming a lumen is prepared (step S1). The core is a three-dimensional simulation of the shape of the lumen of an organ. It is preferable that the core has an elongated shape in which the length is long relative to the diameter. For example, as shown in Figure 3, it is preferable that core 80 has a three-dimensional shape. The shape, length, and diameter of the core can be adjusted according to the lumen 5 of the organ to be simulated. The core may be branched along the way.

[0019] In the step of producing a core for forming a lumen (step S1), the core is preferably produced using a three-dimensional printer. By using a three-dimensional printer, the core can be produced efficiently in a short time.

[0020] The core is preferably made of a material that dissolves in water, which allows for easy fabrication of organ models with complex shaped lumens. The core is preferably made of a water-soluble resin, such as a polyvinyl alcohol resin, a polyacrylamide resin, or a polyacrylic acid resin, and more preferably a polyvinyl alcohol resin.

[0021] As shown in Figures 1 and 2, it is preferable to apply steam to the fabricated core (step S2). By applying steam to the core, the surface of the core can be melted and smoothed. In particular, for cores fabricated with a 3D printer in step S1, it is possible to smooth out any protrusions formed by layering marks or molding defects caused by the 3D printer.

[0022] In the step of applying steam to the core (step S2), the steam is preferably water vapor. This melts the surface of the core, which is made of a water-soluble resin, making the surface smooth. The temperature of the water vapor is preferably 60°C or higher, more preferably 65°C or higher, and even more preferably 70°C or higher. The temperature of the water vapor is preferably 100°C or lower, and may be 90°C or lower, or may be 80°C or lower. By setting the steam temperature as described above, the surface of the core is melted appropriately, making it easier to smooth the surface of the core.

[0023] In the step of applying steam to the core, it is preferable to apply steam to the core using a thermo-hygrostat. The core can be exposed to steam by placing the core in the thermo-hygrostat, preferably by placing the mold with the core placed inside the thermo-hygrostat.

[0024] In the step of exposing the core to steam, it is preferable to perform a step of exposing the core to steam at a predetermined temperature for a first predetermined time, followed by a step of not exposing the core to steam for a second predetermined time, once or more times. This step is preferably repeated three or more times, more preferably five or more times. By repeatedly exposing the core to steam for short periods in this manner, the surface of the core is melted appropriately, making it easier to smooth the surface of the core.

[0025] The first predetermined time is preferably 5 seconds or more, more preferably 10 seconds or more, and even more preferably 15 seconds or more. The first predetermined time is preferably 40 seconds or less, more preferably 35 seconds or less, and even more preferably 30 seconds or less. The second predetermined time is preferably 100 seconds or more, more preferably 110 seconds or more, and even more preferably 120 seconds or more, and may be 200 seconds or less, 190 seconds or less, or 180 seconds or less.

[0026] As shown in Figures 1 and 2, the surface of the core is coated with a coating material containing a silicone rubber composition and silicone oil (Step S3). By coating the surface of the core with a coating material containing a silicone rubber composition and silicone oil, the coating material can penetrate into the recesses on the surface of the core and smooth out the irregularities. Furthermore, the presence of the coating material on the surface of the core prevents contact between the core and the molding material used to form the organ model while suppressing reaction delays of the molding material. As a result, the inner surface of the lumen of the organ model is made smooth, facilitating the insertion of medical instruments into the lumen. This coating material also functions as a mold release agent, preventing contact between the core and the molding material, thereby facilitating the removal of the core from the solidified molding material. Furthermore, the inclusion of silicone oil in the coating material allows the viscosity of the coating material to be adjusted even when the viscosity of the silicone rubber composition is high, making it easier to apply the coating material to the surface of the core with a uniform thickness. Furthermore, the inclusion of silicone oil in the coating material makes it easier to remove air bubbles that may be mixed in during stirring of the silicone rubber composition.

[0027] In the process of coating the surface of the core with the coating material, the coating material may be applied one or more times, but it is preferable to apply the coating material multiple times, which will make the irregularities on the surface of the core even smoother, making it easier to insert the medical device into the lumen.

[0028] In the step of coating the surface of the core with the coating material, it is preferable to coat the entire surface of the core with the coating material multiple times. Multiple coatings make the surface irregularities even smoother, making it easier to insert a medical device into the lumen.

[0029] The silicone rubber composition contains a polysiloxane, preferably a polyorganosiloxane, having a main skeleton with siloxane bonds (Si-O-Si) as repeating units and organic groups bonded to side chains.

[0030] The silicone rubber composition is preferably a liquid silicone rubber composition. The liquid silicone rubber composition is preferably liquid before the coating material is applied to the surface of the core, and is preferably solidified by the reaction of the polysiloxane contained in the liquid silicone rubber composition. Therefore, the polysiloxane contained in the liquid silicone rubber composition preferably has a reactive group, and the polysiloxane is preferably solidified by the reaction of the reactive group. The reactive group of the polysiloxane is preferably one that can bond polysiloxanes together.

[0031] Examples of reactive groups that polysiloxanes have include amino groups, epoxy groups, mercapto groups, hydrosilyl groups, unsaturated aliphatic groups, carboxy groups, carboxylic anhydride groups, isocyanate groups, sulfo groups, oxazoline groups, hydroxyl groups, carbinol groups, alkoxy groups, aryloxy groups, aralkyloxy groups, aminoxy groups, acetoxy groups, acryloyl groups, methacryloyl groups, and oxime groups. The reactive group is preferably bonded to the silicon atom of the polysiloxane. In addition, when the reactive group is a hydrosilyl group, since the hydrogen atom is bonded to the silicon atom of the polysiloxane, the hydrogen atom can be said to be the reactive group.

[0032] The polysiloxane contained in the liquid silicone rubber composition has, on average, at least two, preferably at least three, more preferably at least 10, and preferably no more than 300, more preferably no more than 200, and even more preferably no more than 100 reactive groups bonded to silicon atoms per molecule.

[0033] The number of siloxane-bonded silicon atoms (degree of polymerization) may be, for example, 10 or more, 50 or more, or 100 or more, and may be 10,000 or less, 5,000 or less, or 2,000 or less.

[0034] The polysiloxane contained in the liquid silicone rubber composition is preferably linear or branched, and more preferably linear.

[0035] The liquid silicone rubber composition may be either a one-component type or a two-component type. A two-component liquid silicone rubber composition is preferred because the solidification rate and other factors can be adjusted by adjusting the mixing amounts of the two components. Examples of liquid silicone rubber compositions include addition reaction curing types and condensation reaction curing types.

[0036] When the liquid silicone rubber composition is a one-component type, the polysiloxane contained in the liquid silicone rubber composition preferably has a hydroxyl group or a hydrolyzable group. Therefore, examples of reactive groups in this case include hydroxyl groups; hydroxyl-containing groups such as carbinol groups; and hydrolyzable groups such as alkoxy groups, aryloxy groups, aralkyloxy groups, aminoxy groups, acetoxy groups, acryloyl groups, methacryloyl groups, and oxime groups. If the polysiloxane has such reactive groups, the polysiloxanes bond together through a condensation reaction between hydroxyl groups (silanol groups) or between hydroxyl groups (silanol groups) and hydrolyzable groups, thereby solidifying the liquid silicone rubber composition.

[0037] When the liquid silicone rubber composition is a two-component type, the liquid silicone rubber composition preferably contains a first polysiloxane and a second polysiloxane as the polysiloxanes described above. Preferably, the first polysiloxane has a first reactive group, and the second polysiloxane has a second reactive group, and the first polysiloxane and the second polysiloxane are bonded together by reaction between the first reactive group and the second reactive group. For details about the first reactive group and the second reactive group, see the explanation of the reactive group above.

[0038] The first reactive group of the first polysiloxane is preferably at least one selected from the group consisting of amino, epoxy, mercapto, hydrosilyl (hydrogen), unsaturated aliphatic, carboxy, carboxylic anhydride, isocyanate, sulfo, oxazoline, hydroxy, carbinol, alkoxy, aryloxy, aralkyloxy, aminoxy, acetoxy, acryloyl, methacryloyl, and oxime groups. The second reactive group of the second polysiloxane is preferably capable of reacting with the first reactive group. The reaction between the first reactive group and the second reactive group is preferably an addition reaction or a condensation reaction. The first reactive group of the first polysiloxane and the second reactive group of the second polysiloxane react with each other to bond the first polysiloxane and the second polysiloxane, thereby solidifying the liquid silicone rubber composition.

[0039] Examples of combinations of the first reactive group and the second reactive group include a combination of a hydrosilyl group (hydrogen atom) and an unsaturated aliphatic group, a combination of a carboxy group and a hydroxyl group, a combination of a hydrolyzable group and a hydroxyl group, a combination of a carboxy group and an amino group, a combination of a sulfo group and a hydroxyl group, a combination of a sulfo group and an amino group, a combination of an isocyanate group and a hydroxyl group, a combination of an isocyanate group and an amino group, a combination of an oxazoline group and a carboxy group, a combination of an epoxy group and an amino group, and a combination of an epoxy group and a carboxy group or a carboxylic anhydride group.

[0040] Examples of the reaction between the first reactive group and the second reactive group include a hydrosilylation reaction between a hydrosilyl group (hydrogen atom) and an unsaturated aliphatic group, an esterification reaction between a carboxy group and a hydroxyl group, a transesterification reaction between a hydrolyzable group and a hydroxyl group, an amidation reaction between a carboxy group and an amino group, a sulfonic acid esterification reaction between a sulfo group and a hydroxyl group, a sulfonamidation reaction between a sulfo group and an amino group, a urethane reaction between an isocyanate group and a hydroxyl group, a urea reaction between a socyanate group and an amino group, an amide esterification reaction between an oxazoline group and a carboxy group, an epoxide ring-opening reaction between an epoxy group and an amino group, and an epoxide ring-opening reaction between an epoxy group and a carboxy group or a carboxylic acid anhydride group.

[0041] The first polysiloxane and the second polysiloxane are preferably linear or branched, and more preferably linear.

[0042] The first reactive group of the first polysiloxane is preferably an unsaturated aliphatic group, such as a vinyl group, an aryl group, a 3-butenyl group, a 4-pentenyl group, or a 5-hexenyl group, with a vinyl group being preferred.

[0043] The second reactive group of the second polysiloxane is preferably a hydrosilyl group, i.e., the second polysiloxane preferably has hydrogen atoms bonded to at least some of the silicon atoms of the siloxane bonds.

[0044] The liquid silicone rubber composition preferably contains a catalyst. The catalyst can accelerate the solidification reaction of the composition. When the liquid silicone rubber composition contains the first polysiloxane and the second polysiloxane described above, the catalyst preferably causes the first reactive group of the first polysiloxane to react with the second reactive group of the second polysiloxane.

[0045] Examples of the catalyst include platinum compounds, rhodium compounds, and palladium compounds, and among these, platinum compounds are preferred.

[0046] The liquid silicone rubber composition may contain various additives such as plasticizers, reaction regulators, pigments, flame retardants, antistatic agents, lubricants, adhesion improvers, release modifiers, softeners, surfactants, etc., as long as the effects of the present invention are not impaired.

[0047] The kinematic viscosity of the liquid silicone rubber composition at 25°C is not particularly limited, but is preferably 10 mm 2 / s or more is preferable, and 30 mm 2 / s or more is more preferable, and 50 mm 2 / s or more is more preferable, and 5000 mm 2 / s or less is preferable, and 1000 mm 2 / s or less is more preferable, and 100 mm 2 The kinematic viscosity of the liquid silicone rubber composition is more preferably 1 / s or less. The kinematic viscosity of the liquid silicone rubber composition is measured using an Ubbelohde viscometer according to ASTM D445-46T or JIS Z 8803.

[0048] Silicone oil is a polyorganosiloxane having a main skeleton with siloxane bonds (Si-O-Si) as repeating units and organic groups bonded to side chains. Silicone oil is different from the silicone rubber composition. Specifically, silicone oil is preferably a non-reactive silicone compound.

[0049] The silicone oil is preferably a polyorganosiloxane that does not have a reactive group in its molecular structure. Examples of reactive groups that are preferably not contained in the polyorganosiloxane of the silicone oil include the reactive groups contained in the polysiloxane of the liquid silicone rubber composition described above.

[0050] In the molecular structure of silicone oil, it is preferred that only non-reactive organic groups are bonded to the silicon atom of polyorganosiloxane.As non-reactive organic groups, for example, alkyl groups such as methyl group, ethyl group, propyl group, etc.; aryl groups such as phenyl group, tolyl group, naphthyl group, etc.; aralkyl groups such as benzyl group, phenethyl group, etc.; among them, methyl group or phenyl group is preferred.

[0051] The silicone oil may be linear or cyclic, but is preferably linear. As the linear silicone oil, so-called straight silicone oil or modified silicone oil can be used, but straight silicone oil is preferred. As the straight silicone oil, dimethyl silicone oil, methylphenyl silicone oil, etc. can be used. When using modified silicone oil, it is preferable to use a non-reactive oil. In the straight silicone oil, the bonding position of the substituent such as a methyl group or a phenyl group is not particularly limited, and it may be bonded to one or more of both ends of the main chain, one end, or a side chain. As the silicone oil, one of the above-mentioned oils may be used alone, or two or more may be mixed together. Among them, it is preferable to use dimethyl silicone oil as the silicone oil.

[0052] The kinematic viscosity of the silicone oil at 25°C is not particularly limited, but is preferably 1.0 mm 2 / s or more is preferable, and 10 mm 2 / s or more is more preferable, and 30 mm 2 / s or more is more preferable, and 5000 mm 2 / s or less is preferable, and 1000 mm 2 / s or less is more preferable, and 100 mm 2 The kinematic viscosity of the silicone oil is more preferably 1 / s or less. The kinematic viscosity of the silicone oil is measured using an Ubbelohde viscometer according to ASTM D445-46T or JIS Z 8803.

[0053] The kinematic viscosity of the silicone oil at 25°C is preferably smaller than that of the liquid silicone rubber composition at 25°C. This allows the silicone oil to reduce the catalyst concentration in the liquid silicone rubber composition when the liquid silicone rubber composition is mixed with the silicone oil, thereby suppressing reaction delays of the molding material. As a result, it becomes easier to adjust the thickness of the coating layer formed on the surface of the core.

[0054] In silicone oil, the number of siloxane-bonded silicon atoms (degree of polymerization) may be, for example, 10 or more, 50 or more, or 100 or more, or 10,000 or less, 5,000 or less, or 2,000 or less.

[0055] When the liquid silicone rubber composition is a two-component type and contains a first and a second liquid, it is preferable to mix the first and second liquids before the step of applying the coating material to the surface of the core. In this case, the first liquid may contain the first polysiloxane, and the second liquid may contain the second polysiloxane. Also, the first liquid may contain a catalyst, and the second liquid may contain a catalyst.

[0056] The first liquid and the second liquid are preferably mixed before the step of mixing the liquid silicone rubber composition and the silicone oil, but the second liquid may be mixed after the first liquid and the silicone oil are mixed, or the first liquid may be mixed after the second liquid and the silicone oil are mixed.

[0057] It is preferable to mix the liquid silicone rubber composition with silicone oil before the step of coating the surface of the core with the coating material.

[0058] In the coating material, the blending ratio of the silicone rubber composition to the silicone oil is preferably silicone rubber composition / silicone oil = 1 / 4 or more, more preferably 1.5 / 3.5 or more, and even more preferably 2 / 3 or more. Furthermore, the blending ratio of the silicone rubber composition to the silicone oil in the coating material is preferably silicone rubber composition / silicone oil = 4 / 1 or less, and even more preferably 3.5 / 1.5 or less. By using the silicone rubber composition and silicone oil in the coating material at the above blending ratio, the silicone oil reduces the catalyst concentration in the silicone rubber composition, effectively suppressing reaction delays of the modeling material. As a result, the thickness of the coating layer formed on the surface of the core can be easily adjusted, preventing the inclusion of air bubbles and cloudiness in the organ model due to reaction delays of the modeling material.

[0059] In the coating material, the content of the silicone rubber composition is preferably 20 wt% or more, more preferably 30 wt% or more, even more preferably 40 wt% or more, and preferably 80 wt% or less, more preferably 70 wt% or less, and even more preferably 60 wt% or less. Furthermore, the content of the silicone oil in the coating material is preferably 20 wt% or more, more preferably 30 wt% or more, even more preferably 40 wt% or more, and preferably 80 wt% or less, more preferably 70 wt% or less, and even more preferably 60 wt% or less. By setting the content of the silicone rubber composition and the content of the silicone oil in the coating material within the above ranges, it becomes easier to prevent air bubbles from being mixed into the organ model or clouding due to a delayed reaction of the modeling material.

[0060] As shown in Figures 1 and 2, a core is placed in a mold for forming an organ model (step S4). The position of the lumen in the organ model can be adjusted by adjusting the placement of the core in the mold. The core is preferably fixed to the mold so that the position of the core in the mold does not shift when the molding material is poured into the mold. The core is preferably fixed to the bottom of the mold. The core may also be fixed to the side wall of the mold. It is preferable that one or more points of the core are fixed to the mold.

[0061] The shape of the mold is not particularly limited as long as it is a shape that allows the molding material for forming an organ model to be poured into the mold. For example, as shown in FIG. 4, mold 81 may have a bottom and a side wall connected to the bottom and extending upward. In plan view, the bottom of the mold may have a rectangular shape, with side walls disposed on each side of the rectangle. It is preferable that the mold has a shape that is open at the top. The molding material can be poured into the mold from the top of the mold.

[0062] The mold is preferably configured to be dismantled. The components constituting the mold, such as the bottom and side walls, are preferably connected to each other with parts such as screws, which makes it easier to remove the manufactured organ model from the mold.

[0063] The material of the mold is not particularly limited and may be resin, metal, glass, or a combination thereof. In order to make it easier to observe the core and molding material placed in the mold, it is preferable that the mold, especially the side walls, be made of a light-transmitting material such as glass or acrylic resin.

[0064] In the step of placing a core in a mold for forming an organ model, it is preferable that the core be fixed to the mold. Methods for fixing the core to the mold include adhesion with an adhesive, fastening with screws, clamps, bolts, nuts, etc., engagement, fitting, magnetic force, and methods such as pressing the core from above with another member. When an adhesive is used, it is preferable that the adhesive be removed together with the core in the core removal step (step S8), and therefore the adhesive is preferably a water-soluble adhesive.

[0065] While Figure 1 shows an example in which the step of placing the core in the mold (step S4) is performed after the step of applying steam to the core (step S2), as shown in Figure 2, it is preferable to perform the step of applying steam to the core (step S2) after the step of placing the core in the mold (step S4). This makes it easier to apply steam to the core because the core is fixed in the mold. Furthermore, since the step of pouring the modeling material into the mold (step S6) can be performed without removing the core after the steam application step, organ models can be produced efficiently while preventing deformation of the core.

[0066] FIG. 1 shows an example in which the process of placing the core in the mold (step S4) is performed after the process of coating the surface of the core with a coating material (step S3). However, as shown in FIG. 2, the process of coating the surface of the core with a coating material (step S3) is preferably performed after the process of placing the core in the mold (step S4). This fixes the core in the mold, making it easier to coat the core. Furthermore, after the process of coating the surface of the core with a coating material (step S3), the molding material can be poured into the mold without removing the core (step S6). This allows for efficient production of organ models while preventing deformation of the core. Furthermore, by performing the process of coating the surface of the core with a coating material (step S3) after the process of placing the core in the mold (step S4), not only the core but also the inside of the mold can be coated with the coating material. As a result, the surface inside the mold can be smoothed and the organ model can be prevented from becoming air bubbles or cloudy due to a delayed reaction of the molding material, regardless of the mold material. As shown in FIG. 1, steps S2, S3, and S4 may be performed in that order, or as shown in FIG. 2, steps S4, S2, and S3 may be performed in that order.

[0067] As shown in FIGS. 1 and 2, a molding material containing polyurethane resin is poured into the mold to form an organ model (step S6). The molding material poured into the mold is unsolidified molding material. The molding material may be in a liquid state, or may be in a paste or sol state that has fluidity. FIG. 4 shows a state in which molding material 82 has been poured into mold 81 in which core 80 is placed.

[0068] The modeling material may be composed of one or more liquid agents. The modeling material may contain a liquid resin and a liquid solidifying agent. The solidifying agent may be a curing agent. When the modeling material contains a liquid resin and a liquid solidifying agent, it is preferable to mix the resin and the solidifying agent for a predetermined period of time, and it is more preferable to knead them for a predetermined period of time. It is preferable to mix, preferably knead, the liquid resin and the liquid solidifying agent and then vacuum degas them. This makes it difficult for air bubbles to enter the modeling material, thereby preventing air bubbles from being included in the resulting organ model.

[0069] Examples of molding materials include thermosetting resins such as polyurethane resin, silicone resin, epoxy resin, phenolic resin, and urea resin; thermoplastic resins such as polymethyl methacrylate; elastomers such as silicone elastomer and polyurethane elastomer; and gels such as silicone hydrogel, gelatin, and agar. Among these, molding materials containing thermosetting liquid polyurethane resin are preferred. The organ model is formed by removing the core from the solidified molding material. By using a molding material containing thermosetting liquid polyurethane resin, the organ model can be given appropriate flexibility and refractive index.

[0070] To promote the solidification of the molding material, the molding material may contain a catalyst, a solidification accelerator, etc.

[0071] The build material may contain pigments to make the organ model resemble the color of the actual organ.

[0072] The step of pouring the molding material into the mold to form the organ model is preferably carried out in an environment at room temperature with a relative humidity of 50% or less, more preferably 45% or less, and even more preferably 40% or less. Alternatively, the step of pouring the molding material into the mold to form the organ model may be carried out in an environment at room temperature with a relative humidity of 5% or more, 10% or more, or 20% or more.

[0073] As shown in Figures 1 and 2, the above manufacturing method preferably further includes a step of solidifying the coating material (step S5) before a step of pouring a molding material for forming an organ model into a mold (step S6). The solidified coating material can temporarily protect the luminal surface of the organ model. It can also prevent the organ model from being damaged by the solid core when it is removed from the organ model.

[0074] After the step of solidifying the coating material (step S5) is completed, the coating material should be in a solid state with no fluidity, for example, a state that does not fall off from the surface of the core, and may be in a gel state or may be hardened.

[0075] The coating material may be solidified at room temperature (for example, 24°C) or by heating.

[0076] To promote the solidification of the coating material, the coating material may contain a catalyst, a solidification accelerator, etc.

[0077] 1 and 2, the above manufacturing method preferably further includes a step of solidifying the modeling material (step S7) after the step of pouring a modeling material for forming an organ model into a mold (step S6). By solidifying the modeling material, an elastic body with flexibility similar to that of an organ can be obtained, which can be used for training in surgical techniques.

[0078] After the step of solidifying the modeling material (step S7) is completed, the modeling material may be in a solid state without fluidity, may be in a gel state, or may be hardened.

[0079] The solidification of the molding material may be carried out by heating, cooling, leaving it to stand in a room temperature environment, irradiating it with light, or the like.

[0080] As shown in FIGS. 1 and 2, the above manufacturing method preferably includes a step of removing the solidified modeling material from the mold (step S8).

[0081] Although not shown, the process of removing the solidified modeling material from the mold (step S8) may be performed after the process of solidifying the modeling material (step S7), after the process of removing the core from the solidified modeling material (step S9) described below, or after the process of removing the coating material from the solidified modeling material (step S10) described below.

[0082] 1 and 2, the manufacturing method preferably further includes a step of removing the core from the solidified modeling material (step S9) after the step of solidifying the modeling material (step S7). By removing the core from the solidified modeling material, an organ model having a lumen inside can be obtained.

[0083] In the step of removing the core from the solidified molding material (step S9), the method for removing the core is not particularly limited, but the core may be brought into contact with a solvent such as water, warm water, or an aqueous solution. In particular, if the core is made of a material that dissolves in water in the step of producing the core for forming the lumen (step S1), it is more preferable to bring the core into contact with water in the step of removing the core from the solidified molding material (step S9). Core removal can be performed efficiently even in molds with a complex structure in the lumen portion.

[0084] In the process of removing the core from the solidified modeling material (step S9), it is preferable to inject water into the part of the solidified modeling material where the core is located. Injecting water expands the lumen, making it easier for water to enter between the core and the modeling material, allowing the core to be removed efficiently in a short time.

[0085] In the step of removing the core from the solidified modeling material (step S9), the water temperature is preferably 25°C or higher, more preferably 28°C or higher, and even more preferably 30°C or higher. In addition, in the step of removing the core from the solidified modeling material (step S9), the water temperature is preferably 45°C or lower, more preferably 42°C or lower, and even more preferably 40°C or lower. By using water with a temperature within the above range, heat is applied to the core material, activating thermal movement, thereby increasing the melting efficiency of the core.

[0086] The manufacturing method preferably further includes a step of removing the solidified coating material from the solidified modeling material (step S10) after the step of solidifying the modeling material (step S7). By removing the solidified coating material, an organ model with a lumen surface with a slipperiness suitable for simulated manipulation can be obtained.

[0087] 1 and 2, the step of removing the solidified coating material (step S10) may be performed after the step of removing the core from the solidified modeling material (step S9). Although not shown, the step of removing the solidified coating material (step S10) may be performed before the step of removing the core from the solidified modeling material (step S9).

[0088] Although not shown, the step of removing the solidified coating material (step S10) may be started after the step of removing the core from the solidified modeling material (step S9) but before its completion. Furthermore, the step of removing the solidified coating material (step S10) may be started or completed simultaneously with the step of removing the core from the solidified modeling material (step S9). That is, step S10 may be performed together with step S9.

[0089] The method for removing the solidified coating material is not particularly limited, and wet etching using a solvent can be used, which allows for efficient removal of the coating material even from molds with a complex structure in the lumen portion of the core.

[0090] An organ model obtained by the above-described manufacturing method, a training device having the organ model, and a training system having the training device will be described below.

[0091] In this specification, the organ model 1 and the training device 60 preferably have a vertical direction y and a horizontal direction x that is perpendicular to the vertical direction y. An upper side and a lower side are defined relative to the vertical direction y. In this specification, a medical instrument that is preferably inserted into the organ model 1 has a longitudinal axis direction and a distal end and a proximal end along the longitudinal axis direction. The direction toward the user's hand along the longitudinal axis direction is referred to as the proximal side, and the opposite side from the proximal side, i.e., the direction toward the treatment target, is referred to as the distal side. The longitudinal axis direction can also be referred to as the near-to-far direction or the extension direction of the medical instrument. The radial direction refers to the radial direction of the medical instrument, and inward in the radial direction refers to the direction toward the longitudinal axis of the medical instrument, and outward in the radial direction refers to the direction extending radially from the longitudinal axis opposite the inward side.

[0092] As shown in Figures 6 and 7, the organ model 1 has an internal lumen 4, and the organ model 1 has a mass-shaped main body 2, which has an inner surface 4 that defines a lumen 5, and a silicone rubber composition and / or silicone oil is present on the inner surface 4. According to this organ model 1, the presence of the silicone rubber composition and / or silicone oil on the inner surface 4 of the main body 2 smooths out the irregularities on the inner surface 4, making it easier to insert a medical instrument into the lumen 5.

[0093] The silicone rubber composition and / or silicone oil is preferably present over the entire axial direction of the lumen 5, but may be present only in a portion of the axial direction of the lumen 5. Furthermore, the silicone rubber composition and / or silicone oil is preferably present over the entire circumferential direction of the lumen 5, but may be present only in a portion of the circumferential direction of the lumen 5.

[0094] In the above-described manufacturing method, even after the core is coated and removed, the coating material that coated the core may remain on the inner surface 4 of the main body 2. As a result, a silicone rubber composition and / or silicone oil is present on the inner surface 4. The silicone rubber composition may be in a liquid or solid state. That is, the silicone rubber composition present on the inner surface 4 may be a liquid silicone rubber composition, or a solidified or cured liquid silicone rubber composition. For the specific compositions of the liquid silicone rubber composition and silicone oil, please refer to the explanation of the manufacturing method.

[0095] Body 2 preferably has an outer surface 3 that defines the shape of the mass, and an inner surface 4 that defines a lumen 5 within body 2 .

[0096] The main body 2 of the organ model 1 may be in the shape of a cylinder, an elliptical cylinder, a polygonal prism, a polygonal prism with rounded corners, or a truncated cone.

[0097] 6 and 7, the main body 2 preferably has a top surface 2A, a bottom surface 2B, and one or more side surfaces 2C, and more preferably has one top surface 2A, one bottom surface 2B, and one side surface 2C. Furthermore, it is preferable that the top surface 2A of the main body 2 has an opening 6 that connects the lumen 5 with the outside of the organ model 1.

[0098] The top surface 2A of the main body 2 may be along a horizontal plane, and the bottom surface 2B of the main body 2 is preferably along a horizontal plane.

[0099] As shown in Figure 8, it is preferable that the main body 2 has a rounded shape in plan view. It is preferable that the side surface 2C of the main body 2 is composed only of curved surfaces. This makes it difficult to provide edges on the outer surface 3 of the side surface 2C of the main body 2, making it easier to ensure a clear field of view when observing the organ model 1 from the outside. A rounded shape in plan view is, for example, a shape with no corners on the outer periphery of the main body 2 in plan view. Examples of shapes that are rounded in plan view include a circle, an ellipse, and a polygon with rounded corners such as a rounded square or a rounded rectangle.

[0100] 5 to 8, the training device 60 preferably includes an organ model 1 and a container 11 that contains a liquid and in which the organ model 1 is placed. Therefore, the organ model 1 is placed so as to be immersed in the liquid 25 contained in the container 11. In other words, the liquid 25 is present around the organ model 1.

[0101] It is preferable that a liquid be poured into the lumen 5 of the organ model 1, and that the same liquid 25 be poured as the liquid 25 contained in the container 11. In this way, the same liquid 25 is filled around the lumen 5 and the organ model 1, and the refractive index of the liquid 25 in the container 11 and the constituent materials of the organ model 1 and the container 11 can be adjusted. Adjusting the refractive index makes it possible to make the outline of the main body 2 invisible, making it easier to observe the behavior of the medical instrument in the lumen 5. Furthermore, pouring the liquid 25 into the lumen 5 can impart slipperiness to the inner surface 4 of the lumen 5, allowing the medical instrument to pass through the lumen 5 smoothly.

[0102] 6 and 7, it is preferable that the liquid 25 is contained in the container 11 up to above the upper end in the vertical direction y of the organ model 1. By making the refractive index values of the adjacent materials in the liquid 25, the organ model 1, and the container 11 similar, it is possible to make the outline of the main body 2 of the organ model 1 invisible, making it easier to observe the behavior of the medical instrument in the lumen 5.

[0103] As shown in Figures 6 and 7, the container 11 preferably has a bottom 12 and a sidewall 13 connected to the bottom 12 and extending upward in the vertical direction y. In Figure 8, the bottom 12 of the container 11 has a rectangular shape in plan view, with sidewalls 13 arranged on each side of the rectangle. While Figure 8 shows an embodiment in which the upper side of the container 11 in the vertical direction y is open, the container 11 may also have a bottom, sidewalls, and an upper part. In this case, an opening that connects the inside and outside of the container 11 may be arranged in the upper part of the container 11. The opening of the container 11 is preferably arranged at a position corresponding to the opening 6 of the organ model 1. By opening the upper side of the container 11 in the vertical direction y, it becomes easier to insert a medical instrument into the opening 6 of the organ model 1 housed in the container 11.

[0104] 6 and 7, it is preferable that the organ model 1 is placed in the container 11 in a state where it is in contact with the bottom 12 of the container 11. This prevents the height of the container 11 containing the organ model 1 from becoming too large.

[0105] The organ model 1 may be fixed to the bottom 12 of the container 11. This fixes the position of the organ model 1 within the container 11, allowing for stable insertion of medical instruments into the organ model 1. Methods for fixing the organ model 1 to the container 11 include welding the organ model 1 to the container 11, bonding with an adhesive, fastening with screws, clamps, bolts, nuts, etc., engaging, mating, and magnetic force, as well as methods such as pressing down the organ model 1 from above with another member or pressing down the container 11 with the organ model 1's own weight.

[0106] The lumen 5 preferably communicates with the outside of the organ model 1. This makes it easier for the liquid 25 contained in the container 11 to flow into the lumen 5.

[0107] The axial direction of the lumen 5 can also be said to be the direction in which the lumen 5 extends. It is preferable that a medical device is inserted along the axial direction of the lumen 5. The axial direction of the lumen 5 may be along the vertical direction y or along the horizontal direction x. Furthermore, the axial direction of the lumen 5 may extend so as to approach the outer surface 3 as it moves from the upper side to the lower side in the vertical direction y.

[0108] The shape, length and diameter of the lumen 5 can be set according to the shape of the lumen 5 of the organ to be simulated. For example, the lumen 5 may be branched midway as shown in Figures 6 to 7.

[0109] The opening 6 of the organ model 1 is for inserting and removing medical instruments. As shown in FIGS. 5 to 8 , the opening 6 preferably faces upward in the vertical direction y. Having the opening 6 facing upward in the vertical direction y prevents liquid leakage from the container 11. Furthermore, having the opening 6 facing upward in the vertical direction y allows air bubbles contained in the liquid 25 in the container 11 to easily escape through the opening 6, preventing a decrease in visibility due to air bubbles when photographing the organ model 1. Furthermore, because the lumen 5 of the organ model 1 corresponds to the shape of a lumen in the body and the opening 6 faces upward in the vertical direction y, the training device 60 including the organ model 1 can be easily configured to be compact. Therefore, a practical, portable training device 60 and training system 100 can be provided that prevent liquid leakage while providing good visibility when photographing the organ model 1.

[0110] The organ model 1 may have a plurality of openings 6 facing upward in the vertical direction y, but it is preferable that the organ model 1 has only one opening.

[0111] The position where the opening 6 of the organ model 1 is provided is not particularly limited, as long as the normal vector of the surface where the opening 6 of the organ model 1 is provided contains a component facing upward in the vertical direction y. When the main body 2 has a top surface 2A, a bottom surface 2B, and one or more side surfaces 2C, the opening 6 may be located on the top surface 2A or on the side surface 2C. In particular, it is preferable that the opening 6 be located on the top surface 2A of the organ model 1.

[0112] The organ model 1 may have one or more side holes 7 in addition to the opening 6. As shown in Figures 6 and 7, the organ model 1 has a top surface 2A, a bottom surface 2B, and a side surface 2C, and it is preferable that the side surface 2C has one or more side holes 7. This makes it easier for liquid 25 to pass through the side hole 7 into the lumen 5. When the organ model 1 is viewed from the outside, it is preferable that the opening area of the side hole 7 is smaller than the opening area of the opening 6.

[0113] The main body 2 is preferably made of a molding material manufactured by the above-described manufacturing method. The main body 2 is preferably made of a translucent material. Examples of molding materials for the main body 2 of the organ model 1 include thermosetting resins such as polyurethane resin, silicone resin, epoxy resin, phenolic resin, and urea resin; thermoplastic resins such as polymethyl methacrylate; elastomers such as silicone elastomer and polyurethane elastomer; and gels such as silicone hydrogel, gelatin, and agar. Among these, the main body 2 of the organ model 1 is preferably made of a molding material containing polyurethane resin, and more preferably made of a molding material containing thermosetting liquid polyurethane resin. By making the main body 2 of the organ model 1 from a molding material containing polyurethane resin, particularly thermosetting liquid polyurethane resin, the organ model 1 can be endowed with appropriate flexibility and refractive index. This makes it easier to insert medical instruments into the lumen 5 of the organ model 1 and to observe the organ model 1 from the outside.

[0114] The hardness of the main body 2, as measured with a durometer type E, is preferably 5 or more. Having such flexibility in the main body 2 allows the hardness to be closer to that of an actual organ, allowing training that is in line with actual procedures. The hardness of the main body 2, as measured with a durometer type E, can be selected within the range of 5 to 60 inclusive depending on the organ to be prepared. For example, in the case of a bile duct, the hardness may be 6 or more, 7 or more, or 30 or less, 20 or less is also acceptable.

[0115] The material constituting the main body 2 preferably has a transparency that allows it to transmit at least 50% of light with a wavelength between 410 nm and 830 nm. When the material constituting the main body 2 has such high transparency, the shape of the lumen 5 within the organ model 1 becomes more prominent, making it possible to obtain images suitable for training. The transparency (unit: %) of the material constituting the main body 2 can be determined by measuring how much light, relative to the light emitted from the light source 42, passes through the main body 2.

[0116] The material constituting the main body 2 preferably has a transparency that transmits 60% or more of light having a wavelength of 410 nm or more and 830 nm or less, more preferably has a transparency that transmits 70% or more, and even more preferably has a transparency that transmits 80% or more. The liquid may also have a transparency that transmits 100% or less, 98% or less, or 95% or less of light having a wavelength of 410 nm or more and 830 nm or less.

[0117] The container 11 is preferably made of a light-transmitting material to facilitate observation of the organ model 1 placed in the container 11. Examples of materials that can be used to make the container 11 include glass and acrylic resin.

[0118] The type of liquid 25 placed in the container 11 and the lumen 5 is not particularly limited, but examples thereof include water, physiological saline, a mixed solution containing water and glycerin, and a mixed solution of α-monobromonaphthalene and liquid paraffin. A surfactant may be mixed into the liquid 25. The liquid 25 placed in the container 11 and the lumen 5 may be a colored liquid that simulates blood or a contrast agent.

[0119] It is preferable that liquid 25 has a viscosity within a predetermined range in order to prevent leakage to the outside of container 11 during the simulated operation. For example, the viscosity of liquid 25 at 25°C is preferably 1.0 mPa·s or more, more preferably 1.5 mPa·s or more, and even more preferably 2.0 mPa·s or more, and is preferably 5.0 mPa·s or less, more preferably 4.5 mPa·s or less, and even more preferably 4.0 mPa·s or less.

[0120] It is preferable that the liquid 25 has a transparency that allows it to transmit at least 50% of light having a wavelength of 410 nm or more and 830 nm or less. When the liquid has such high transparency, the shape of the lumen 5 inside the organ model 1 becomes more prominent, making it easier to observe the organ model 1. The optical transparency (unit: %) of the liquid 25 can be determined by measuring how much light is transmitted relative to the light emitted from the light source 42.

[0121] Liquid 25 preferably transmits 60% or more of light having a wavelength of 410 nm or more and 830 nm or less, more preferably 70% or more, and even more preferably 80% or more of light having a wavelength of 410 nm or more and 830 nm or less. Liquid 25 may also transmit 100% or less, 98% or less, or 95% or less of light having a wavelength of 410 nm or more and 830 nm or less.

[0122] As shown in FIGS. 9 and 10 , the training device 60 may further include an extension 20 attached to the organ model 1 and extending out of the container 11. In this case, the extension 20 preferably has a lumen 21 therein, and the lumen 5 of the organ model 1 and the lumen 21 of the extension 20 are preferably connected to each other. The extension 20 can be used to simulate a different lumen from the lumen 5 of the organ model 1. For example, if the lumen 5 of the organ model 1 simulates a bile duct, the lumen 21 of the extension 20 preferably simulates a route from the mouth to the duodenum. Providing the extension 20 in this manner facilitates the reproduction of a clinical condition, thereby facilitating training that is in line with actual procedures. The training device 60 shown in FIGS. 9 and 10 allows participants to experience the operation of inserting a catheter into the bile duct from the forceps port channel of an endoscope via the Vater papilla.

[0123] It is preferable that the lumen 21 of the extension portion 20 is a three-dimensional simulation of the shape of a lumen of an organ in a human or animal body. The shape, length, and diameter of the lumen 21 can be set according to the shape of the lumen of the organ to be simulated. The lumen 21 may be branched along the way. As shown in FIG. 9, it is preferable that the extension portion 20 is a long member. The extension portion 20 may be tubular.

[0124] The lumen 21 of the extension portion 20 may have an axial direction. It is preferable that a medical instrument is inserted along the axial direction of the lumen 21. The lumen 21 of the extension portion 20 may be along the vertical direction y or the horizontal direction x.

[0125] 9 and 10, the lumen 21 of the extension portion 20 preferably has a first end 21A and a second end 21B in the axial direction of the lumen 21. A first end opening 22 is preferably arranged on the side of the first end 21A of the lumen 21 of the extension portion 20, and a second end opening 23 is preferably arranged on the side of the second end 21B of the lumen 21 of the extension portion 20. The first end opening 22 is preferably arranged so as to face the opening 6 of the lumen 5 of the organ model 1. The second end opening 23 preferably communicates with the outside of the training device 60. A medical instrument is preferably inserted from the second end opening 23, and then inserted into the lumen 5 of the organ model 1 through the first end opening 22 and the opening 6 of the organ model 1. The first end opening 22 may be disposed at the position of the first end 21A in the axial direction of the lumen 21, or may be disposed at a position closer to the second end 21B than the first end 21A in the axial direction of the lumen 21 as shown in Fig. 10. Furthermore, when the extension portion 20 is tubular as shown in Fig. 7, the first end opening 22 may be disposed on the side of the extension portion 20, i.e., on the tube wall.

[0126] It is preferable that the organ model 1 and the extension part 20 are connected directly or indirectly via another member so that the first end opening 22 of the extension part 20 communicates with the opening 6 of the lumen 5 of the organ model 1. Although an example in which the organ model 1 and the extension part 20 are connected to each other by a tubular connecting member 30 is shown in Figures 9 and 10, the structure of the connecting member 30 is not particularly limited.

[0127] In the extending portion 20, it is preferable that the normal vector of the surface on which the first end opening 22 is provided contains a component that faces downward in the vertical direction y, and it is more preferable that the normal vector faces downward in the vertical direction y. It is preferable that the normal vector of the surface on which the second end opening 23 is provided contains a component that faces in the horizontal direction x, and it is more preferable that the normal vector faces in the horizontal direction x.

[0128] It is preferable that a part of the extension part 20 is arranged above the organ model 1 in the vertical direction y. A part of the extension part 20 may be arranged so as to be located directly above the organ model 1. It is preferable that the remaining part of the extension part 20 is arranged outside the organ model 1 in a plan view of the training device 60. The extension part 20 may have a part in which the axial direction of the lumen 21 is parallel to the horizontal plane, or the axial direction of the lumen 21 may be inclined with respect to the horizontal plane.

[0129] The extension portion 20 may have a first portion in which the lumen 21 of the extension portion 20 extends from the first end 21A toward the second end 22B from the top to the bottom in the vertical direction y of the organ model 1, and a second portion located closer to the second end 22B than the first portion, in which the lumen 21 of the extension portion 20 extends along a horizontal plane.

[0130] When using the training device 60, it is preferable that an endoscope be inserted into the extension portion 20. To reproduce a condition close to that observed in clinical practice, it is preferable that the extension portion 20 be deformed by adjusting the angle or pushing of the endoscope. For this reason, the minimum thickness of the tube wall of the extension portion 20 is preferably 8.0 mm or less, more preferably 7.0 mm or less and even more preferably 6.0 mm or less, and preferably 2.0 mm or more, more preferably 3.0 mm or more, and even more preferably 4.0 mm or more.

[0131] Examples of materials that can be used to construct the extension portion 20 include thermosetting resins such as silicone resin, polyurethane resin, epoxy resin, phenolic resin, and urea resin; thermoplastic resins such as polymethyl methacrylate; and elastomers such as silicone elastomers and polyurethane elastomers. Among these, it is preferable that the extension portion 20 be constructed from a material containing silicone resin. Constructing the extension portion 20 from a material containing silicone resin makes it easier to impart hardness similar to that of an actual organ, allowing for training in inserting an endoscope into the extension portion 20 in a clinically-like environment. The material that constructs the extension portion 20 may also contain a colorant. This makes it easier to obtain endoscopic images that are similar to those in clinical settings. While the main body 2 and extension portion 20 of the organ model 1 may be constructed from the same material, it is preferable that they be constructed from different materials.

[0132] As shown in FIGS. 9 and 10, the training apparatus 60 may further include one or more support members 31 that support the extension portion 20. In FIG. 10, the first support member 311 supports the extension portion 20 above the upper end of the container 11 in the vertical direction y. The first support member 311 is preferably fixed to the upper side of the container 11 in the vertical direction y. The other support members 31 may be arranged on a horizontal plane. For example, in FIG. 9, the second support member 312, the third support member 313, and the fourth support member 314 are arranged on a horizontal plane in this order from the first end 21A toward the second end 21B, and support the extension portion 20 above the horizontal plane in the vertical direction y.

[0133] As can be seen from FIG. 9 , the training device 60 may have a holding member 18 located above the container 11 to prevent the organ model 1 from floating up. The holding member 18 may extend in the radial direction of the organ model 1 so as to pass through the centroid of the organ model 1 in a plan view of the organ model 1. The holding member 18 may have, for example, a long, thin plate shape. In this case, first and second longitudinal ends of the holding member 18 may be fixed to the upper edge of the container 1, and a middle portion of the holding member 18 in the longitudinal direction may be disposed so as to face the opening 6 of the organ model 1. The holding member 18 may be disposed between the extension 20 and the organ model 1 in the vertical direction y.

[0134] It is preferable that a through-hole be provided in the holding member 18 at a position facing the opening 6 of the organ model 1. This allows the opening 6 of the organ model 1 to communicate with the first end side opening 22 of the extension part 20.

[0135] The material for forming the pressing member 18 can be the same as that for the container 11 .

[0136] As shown in Figure 11, the training device 60 is preferably arranged outside the container 11 and further includes a light-shielding wall 40 that blocks external light. By covering the container 11 with the light-shielding wall 40, external light can be blocked, allowing an appropriate amount of light to be irradiated onto the organ model 1, and images of the organ model 1 and the medical instruments inside the organ model 1 can be stably captured.

[0137] The light-shielding wall 40 may cover only a portion of the container 11, but preferably covers the entire container 11. This allows the organ model 1 and the medical instruments inside the organ model 1 to be observed without being affected by external light. As shown in FIG. 11 , a plurality of light-shielding walls 40 may be arranged to form a rectangular parallelepiped. The light-shielding walls 40 are preferably arranged on the top side and the side wall 13 side of the container 11. If the bottom 12 side of the container 11 is shaded by a desk, table, floor, etc. on which the training device 60 is placed, the light-shielding wall 40 does not need to be arranged on the bottom 12 side of the container 11. The light-shielding walls 40 may be arranged on the top, bottom 12, and side wall 13 sides of the container 11.

[0138] Examples of materials for the light-shielding wall 40 include resins such as acrylic resin, and metals such as aluminum, copper, and tungsten. An acrylic plate with a light transmittance set within a predetermined range can also be used as the light-shielding wall 40. Alternatively, the light-shielding wall 40 can be an acrylic plate with a metal film of aluminum, copper, tungsten, or the like disposed on the surface thereof.

[0139] The light transmittance (unit: %) of the baffle wall 40 is evaluated based on the amount of external light other than that from the light source 42 that reaches the inside of the baffle wall 40. For example, if no external light reaches the inside of the baffle wall 40 at all, the transmittance is 0%.

[0140] The light-shielding wall 40 does not have to completely block light. The light transmittance of the light-shielding wall 40 is preferably 50% or less, more preferably 45% or less, and even more preferably 40% or less. The light transmittance of the light-shielding wall 40 may also be 3% or more, 5% or more, or 10% or more.

[0141] 5, the training device 60 preferably further includes a light source 42 arranged outside the container 11 to irradiate the organ model 1 with light, and a light receiving unit 46 arranged outside the container 11. The amount of light irradiated onto the organ model 1 by the light source 42 can be appropriately set, and the organ model 1 and the medical instruments inserted therein can be clearly photographed by the light receiving unit 46.

[0142] The light source 42 is not particularly limited in type as long as it generates light, and may be a point light source, a linear light source, or a surface light source. In particular, the light source 42 is preferably a sheet-like or plate-like surface light source. This makes it easier to arrange the light source 42 over a wide area so that a shadow is not cast on the organ model 1 when the organ model 1 is photographed by the light-receiving unit 46. The light source 42 may be an inorganic EL sheet or an organic EL sheet.

[0143] The type of lamp of the light source 42 is not particularly limited, and examples thereof include an LED lamp and a laser lamp.

[0144] The light-receiving unit 46 may have any structure as long as it has a light-receiving surface. The training device 60 may have one or more cameras 45, and the cameras 45 may have the light-receiving unit 46. The camera 45 also preferably has a lens 49 for collecting light reflected by the organ model 1 or a medical instrument inserted into the lumen 5 when light is irradiated from the light source 42, and forming an image on the light-receiving surface of the light-receiving unit 46. The light-receiving unit 46 converts the light formed on the light-receiving surface into an electrical signal, allowing the medical instrument inserted into the lumen 5 of the organ model 1 to be observed as an image. The light-receiving unit 46 may include a light-receiving sensor such as an image sensor. The image sensor may be a CMOS sensor or a CCD sensor.

[0145] 5, it is preferable that the container 11 is disposed between the light source 42 and the light receiving unit 46 in the horizontal direction x perpendicular to the vertical direction y. By disposing the light source 42, the light receiving unit 46, and the container 11 in this manner, it becomes easier to observe the medical instrument inserted into the lumen 5.

[0146] 5, the light receiving unit 46 includes a first light receiving unit 47 and a second light receiving unit 48, and in a plan view of the organ model 1, the first light receiving unit 47 and the second light receiving unit 48 are preferably arranged at different positions around the organ model 1. The training device 60 has multiple light receiving units 46, allowing simultaneous observation from multiple directions. The training device 60 has multiple light receiving units 46, allowing imaging from multiple directions, and therefore allowing simulated images to be generated using three-dimensional information.

[0147] 13, training device 60 may have first camera 451 and second camera 452, first camera 451 may have first light receiving unit 47 and first lens 491, and second camera 452 may have second light receiving unit 48 and second lens 492. In this way, first light receiving unit 47 and second light receiving unit 48 are preferably arranged in different cameras.

[0148] In the training device 60, it is preferable that the direction in which the light receiving surface of the first light receiving unit 47 faces is different from the direction in which the light receiving surface of the second light receiving unit 48 faces. Furthermore, in the initial state in which the first light receiving unit 47 and the second light receiving unit 48 are not moved, it is preferable that the direction in which the light receiving surface of the first light receiving unit 47 faces is perpendicular to the direction in which the light receiving surface of the second light receiving unit 48 faces.

[0149] It is preferable that the first light receiving section 47 and the second light receiving section 48 are located on the same horizontal plane.

[0150] Training device 60 may have first camera 451 and second camera 452, first camera 451 may have first light receiving unit 47 and first lens 491, and second camera 452 may have second light receiving unit 48 and second lens 492. The direction in which first lens 491 faces may be different from the direction in which second lens 492 faces. When first camera 451 and second camera 452 are not moved, the direction in which first lens 491 faces and the direction in which second lens 492 faces may be perpendicular to each other.

[0151] As shown in Fig. 12, in the vertical direction y, the light receiving unit 46 is preferably arranged below the upper end of the organ model 1 but above the lower end of the organ model 1, and the light source 42 is preferably arranged from above the upper end of the organ model 1 to below the lower end of the organ model 1. By arranging the light source 42, the light receiving unit 46, and the organ model 1 in this manner, shadows are less likely to appear on the organ model 1 when the organ model 1 is photographed by the light receiving unit 46, making it easier to observe the medical instrument inserted into the lumen 5. In Fig. 12, the range in which light from the light source 42 is required for the organ model 1 is indicated by a dotted line, and the viewing angle of the camera is indicated by a dashed line.

[0152] As shown in Figure 12, the training device 60 is disposed outside the container 11 and further includes a light-shielding wall 40 that blocks external light, and the light source 42 and the light-receiving unit 46 are preferably disposed between the light-shielding wall 40 and the container 11. This makes it easier to observe the medical instrument inserted into the lumen 5 without being affected by external light.

[0153] 12, it is preferable that the light-shielding wall 40 covers the container 11, the light source 42, and the light-receiving unit 46. This makes it easier to observe the medical instrument inserted into the lumen 5 without being affected by external light.

[0154] 5, the light source 42 may be fixed to the light-shielding wall 40. By fixing the light source 42 to the light-shielding wall 40, the position of the light source 42 relative to the organ model 1 is fixed, and therefore, the organ model 1 can be stably photographed by the light-receiving unit 46. For example, the light source 42 may have a first surface and a second surface, with the first surface bonded to the light-shielding wall 40 and light being emitted from the second surface.

[0155] 14, when the organ model 1 has an inner surface 4 that defines a lumen 5, it is preferable that a surfactant 27 be present on the inner surface 4. The presence of surfactant 27 on the inner surface 4 makes the inner surface 4 smooth, facilitating the insertion of a medical instrument into the lumen 5.

[0156] The surfactant 27 is preferably present throughout the entire axial direction of the lumen 5, but may be present only in a portion of the axial direction of the lumen 5. The surfactant 27 is also preferably present throughout the entire circumferential direction of the lumen 5, but may be present only in a portion of the circumferential direction of the lumen 5.

[0157] Methods for making the surfactant 27 present include applying or spraying the surfactant 27 onto the inner surface 4 of the organ model 1, pouring the surfactant 27 into the lumen 5 of the organ model 1 and bringing the surfactant 27 into contact with the inner surface 4, and mixing the surfactant 27 into the liquid 25. When a silicone rubber composition and / or silicone oil is present on the inner surface 4 of the organ model 1, the surfactant 27 may be present on the silicone rubber composition and / or silicone oil.

[0158] The type of surfactant 27 is not particularly limited, and anionic surfactants, cationic surfactants, zwitterionic surfactants, and nonionic surfactants can be used.

[0159] 15 , a training system 100 may include a container 11 that contains a liquid 25, an organ model 1 that is disposed within the container 11 and has a lumen 5 therein that corresponds to the shape of a lumen 5 in the body, and the lumen 5 can contain the liquid 25, a training device 60 that includes a light source 42 that is disposed outside the container 11 and that irradiates light onto the organ model 1, and a light receiving unit 46 that is also disposed outside the container 11, and a processing unit 55 that is connected to the training device 60 and processes images acquired by the light receiving unit 46. The training device 60 may be one that has already been described. By processing the images acquired by the light receiving unit 46 in the processing unit 55, it becomes even easier to observe the medical instrument to be inserted into the lumen 5.

[0160] The processing unit 55 can perform various processes such as noise removal, edge emphasis, and feature extraction on the image acquired by the light receiving unit 46 .

[0161] The training system 100 may have a display unit 56 connected to the processing unit 55, which displays images processed by the processing unit 55. Examples of the display unit 56 include a computer, an external monitor, a mobile phone, a smartphone, and a tablet terminal.

[0162] In the training system 100, the light receiving unit 46 may acquire multiple images. In this case, it is preferable that the processing unit 55 compares the multiple images acquired by the light receiving unit 46. In particular, it is preferable that the light receiving unit 46 acquires images before and after inserting a medical instrument into the lumen 5, and compares a first image before the insertion of the medical instrument with a second image after the insertion. This makes it possible to perform observations using the so-called differential scanning method (DSA method), and enables training using images that are similar to differential images obtained in actual procedures.

[0163] In the training system 100, the light receiving unit 46 may acquire a third image, and after acquiring the third image, the light receiving unit 46 may acquire a fourth image, and the display unit 56 may display a fifth image in which the third image and the fourth image are superimposed. This enables observation using the so-called roadmap method, and training using images similar to those acquired in actual procedures becomes possible.

[0164] The processing unit 55 may be connected to any of the components that make up the training device 60, but is preferably connected to a camera 45 having a light receiving unit .

[0165] At least one of the functions of the training system 100, for example, the function of the processing unit 55, may be realized by hardware or software. Examples of hardware include logic circuits formed in integrated circuits such as LSI (Large Scale Integration) and ASIC (Application Specific Integrated Circuit).

[0166] The training system 100 may include a computer 57 that executes instructions of a program, which is software for realizing the functions of the processing unit 55. The computer 57 preferably includes a processor and a computer-readable recording medium that stores the program. The processor executes the program stored in the computer-readable recording medium, thereby realizing the functions. A CPU (Central Processing Unit) can be used as the processor. A ROM (Read Only Memory) or the like can be used as the recording medium. The recording medium can also include a RAM (Random Access Memory). The program can be supplied to the computer 57 via any transmission medium that can transmit the program. Examples of the transmission medium include a communication network and a communication line. [Example]

[0167] The present invention will be described in more detail below with reference to examples. However, the present invention is not limited to the following examples, and it is possible to carry out the invention by making appropriate modifications within the scope of the above and below-described aims, and all such modifications are included in the technical scope of the present invention.

[0168] (Example of organ model production) Example 1 A core simulating the lumen of a bile duct was created using a 3D printer. The core material was Flashforge Filament water-soluble support material PVA (manufactured by Apple Tree). The core was then fixed to an open-topped box-shaped mold and placed in a thermo-hygrostat. The mold and core were exposed to water vapor at a temperature of 65°C to 70°C and a relative humidity of 95% for 30 seconds, followed by a 180-second cooling period. This process was repeated five times to melt the core's surface. The core's surface was coated three times with a silicone-based coating material. The silicone-based coating material was prepared by mixing two-component liquid rubber KE-1603-A / KE-1603B (manufactured by Shin-Etsu Chemical Co., Ltd.) and silicone oil KF-96-50cs (manufactured by Shin-Etsu Chemical Co., Ltd.) in a weight ratio of two-component liquid rubber silicone composition / silicone oil = 2 / 3. The weight ratio of the two components of the two-component liquid rubber was KE-1603-A / KE-1603B = 1 / 1. Two-component curing urethane RU-835A / RU-835B (manufactured by Nissin Resin Co., Ltd.) was mixed as a modeling material for 1 minute at room temperature of 24°C and a relative humidity of less than 40%, followed by vacuum degassing for 5 minutes. The weight ratio of the two components of the two-component curing urethane was RU-835A / RU-835B = 63 / 37. The two-component curing urethane was placed in a mold and allowed to stand for 24 hours at room temperature of 24°C and a relative humidity of less than 40% to solidify. Tap water at 30°C or higher but lower than 40°C was injected into the portion of the solidified modeling material where the core was located to melt the core. The core was then removed from the solidified modeling material, yielding an organ model according to Example 1. (Comparative Example 1) An organ model was obtained in the same manner as in Example 1, except that the silicone coating material in Example 1 was changed to two-component liquid rubber KE-1603-A / KE-1603B (manufactured by Shin-Etsu Chemical Co., Ltd.). (Comparative Example 2) An organ model was obtained in the same manner as in Example 1, except that the surface of the core was not coated with a silicone coating material.

[0169] The inner surfaces of the lumens of the organ models produced in Example 1, Comparative Example 1, and Comparative Example 2 were examined. The organ model produced in Example 1 is shown in FIG. 16, and the organ model produced in Comparative Example 2 is shown in FIG. 17. When the core was coated with a coating material containing the liquid silicone rubber composition of Example 1 and silicone oil, there was no reaction delay of the modeling material, and no bubbles or cloudiness occurred, resulting in an organ model with a smooth inner surface. On the other hand, when the core was coated with a coating material consisting only of the liquid silicone rubber composition (Comparative Example 1) or when no coating material was used (Comparative Example 2), a reaction delay of the modeling material occurred, resulting in non-uniform solidification, bubbles, and cloudiness. [Explanation of symbols]

[0170] 1: Organ model 2: Main body 4:Inner surface 5:Lumen 11: Container 12: Bottom 13: Side wall 40: Blackout wall 42:Light source 46: Light receiving part 55: Processing section 60: Training equipment 80: Middle child 81: Type 82: Modeling materials 100: Training System x: horizontal direction y: vertical direction

Claims

1. A method for producing an organ model having a lumen therein, comprising: preparing a core for forming the lumen; a step of coating the surface of the core with a coating material containing a silicone rubber composition and a silicone oil; placing the core in a mold for forming the organ model; and pouring a molding material containing polyurethane resin into the mold to form the organ model.

2. The method for manufacturing an organ model according to claim 1 , wherein the molding material includes a thermosetting liquid polyurethane resin.

3. 3. The method for producing an organ model according to claim 1, wherein the blending ratio of the silicone rubber composition to the silicone oil in the coating material is silicone rubber composition / silicone oil = 1 / 4 or more and 4 / 1 or less by weight.

4. 3. The method for manufacturing an organ model according to claim 1, wherein in the step of coating the surface of the core with the coating material, the entire surface of the core is coated with the coating material multiple times.

5. 3. The method for manufacturing an organ model according to claim 1, wherein the step of coating the surface of the core with the coating material is performed after the step of placing the core in the mold.

6. 3. The method for manufacturing an organ model according to claim 1, further comprising the step of solidifying the molding material after the step of pouring the molding material for forming the organ model into the mold.

7. The method for manufacturing an organ model according to claim 6 , further comprising the step of removing the core from the solidified modeling material after the step of solidifying the modeling material.

8. 3. The method for manufacturing an organ model according to claim 1, further comprising a step of solidifying the coating material before the step of pouring a molding material for forming the organ model into the mold.

9. the method further includes a step of solidifying the modeling material after the step of pouring the modeling material for forming the organ model into the mold; The method for manufacturing an organ model according to claim 8 , further comprising the step of removing the solidified coating material from the solidified modeling material after the step of solidifying the modeling material.

10. An organ model having a lumen therein, the organ model having a mass-shaped main body portion, the body portion has an inner surface defining the lumen; An organ model having a silicone rubber composition and / or silicone oil present on the inner surface thereof.

11. The organ model according to claim 10, wherein the main body is made of a molding material containing a thermosetting liquid polyurethane resin.

12. 12. The organ model according to claim 10, wherein the hardness of the main body is 5 or more when measured with a durometer type E.

13. 12. The organ model according to claim 10, wherein the material constituting the main body has a transparency that allows 50% or more of light having a wavelength of 410 nm or more and 830 nm or less to pass through.

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