Organ model, training device, and training system

Abstract

To provide an organ model, a training device, and a training system in which, even when a difference in refractive index between the organ model and liquid placed around the organ model or in a lumen of the organ model is small, the lumen shape inside the organ model is easily distinguished and observation can be readily performed.SOLUTION: An organ model 1 comprises a lump-shaped main body 2. The main body 2 has an outer surface 3 and an inner surface 4 defining a lumen 5. A plurality of bubbles are formed between the outer surface 3 and the inner surface 4. The number of bubbles in a specific size observed in a first sliced section 71 which is parallel to a cross-section of the main body 2 in a direction perpendicular to the axial direction of the lumen 5 and has a thickness of 10 mm in the axial direction satisfies the following requirement. (Requirement) In the first sliced section 71, the number N1 of specific bubbles SB contained in a first potion 711 located on the side close to the inner surface 4 of the lumen 5 is greater than the number N2 of specific bubbles SB contained in a second potion 712 located on the outer side in the radial direction of the lumen 5 relative to the first portion 711.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] The present invention relates to an organ model, a training device, and a training system for surgical training, particularly for endoscopic surgery. [Background technology]

[0002] Training devices with models simulating internal organs are used to acquire skills and improve proficiency in operating medical instruments. In clinical settings, medical instruments are inserted into the body while checking two-dimensional X-ray fluoroscopic images, so training is sometimes conducted 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.

[0003] For example, Patent Document 1 describes a catheter surgery simulator that generates fluoroscopic images using a translucent three-dimensional model into which a catheter can be inserted, in which at least the surrounding area of a cavity that reproduces a body cavity is made of an elastic material, and that is characterized by comprising the three-dimensional model, a translucent liquid having a refractive index similar to that of the three-dimensional model, a container for holding the translucent liquid, and an imaging device for observing the three-dimensional model, and that is capable of taking fluoroscopic images of a catheter inserted into the three-dimensional model.

[0004] Patent document 2 describes a catheter examination simulation system that includes an organ model that simulates an organ and into which a catheter can be inserted, a catheter position determination means that determines the position of the catheter inserted into the organ model, a simulated data generation means that generates simulated bioinformation data corresponding to the position of the catheter determined by the catheter position determination means, and a display unit that displays the bioinformation data.

[0005] Patent document 3 describes a catheter simulator having a container capable of holding a liquid in a storage section surrounded by side walls and a bottom, a digestive system organ model held in the container with the liquid contained therein, a holding protrusion provided on the container for holding the organ model and having an insertion passage for guiding a catheter into the held organ model, a connecting section provided on the organ model that is detachably connectable to the holding protrusion and through which a catheter can be inserted, and a catheter introduction section that is integrated with the holding protrusion and protrudes outside the side wall to allow the catheter to be introduced. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Japanese Patent Application Laid-Open No. 2008-70847 [Patent Document 2] Japanese Patent Application Laid-Open No. 2005-241883 [Patent Document 3] Japanese Patent Publication No. 2023-42214 Summary of the Invention [Problem to be solved by the invention]

[0007] In organ models such as those described in Patent Documents 1 to 3, the materials of the various components and the type of liquid are generally selected so as to reduce the difference in refractive index between the organ model and the liquid surrounding the organ model or placed in the lumen. However, setting the refractive index in this way makes it difficult to visually recognize the boundaries between the components, which makes it difficult to focus when observing the organ model or a medical instrument inserted into the organ model from the outside by imaging, etc., and can make observation difficult.

[0008] In view of the above circumstances, the present invention aims to provide an organ model, training device, and training system that makes it easy to observe the shape of the lumen within the organ model, even when the difference in refractive index between the organ model and the liquid surrounding the organ model or placed in the lumen is small. [Means for solving the problem]

[0009] The organ model according to an embodiment of the present invention that can solve the above problems is as follows. [1] A mass-shaped body portion; the body portion has an outer surface that defines the mass shape and an inner surface that defines a lumen within the body portion; the lumen has an axial direction and a radial direction perpendicular to the axial direction; a plurality of bubbles are formed between the outer surface and the inner surface inside the main body; An organ model in which the number of bubbles observed in a first cut slice section that is parallel to the cut surface of the main body section in a direction perpendicular to the axial direction and has a thickness of 10 mm in the axial direction satisfies the following requirement 1. (Requirement 1) In the radial direction of the lumen in the first cut slice portion, the position of the inner surface is defined as position P1, a position 10 mm outwardly of the radial direction from position P1 is defined as position P2, and a position 10 mm outwardly of the radial direction from position P2 is defined as position P3, A portion of the first cut slice portion from the position P1 to the position P2 is defined as a first portion, and a portion of the first cut slice portion from the position P2 to the position P3, which is located radially outward of the first portion, is defined as a second portion, When the specific bubbles SB are those among the plurality of bubbles having a diameter of 0.2 mm or more and 1 / 3 or less of the maximum diameter of the lumen in the first cut slice portion, The number N1 of the specific bubbles SB contained in the first portion is greater than the number N2 of the specific bubbles SB contained in the second portion.

[0010] The organ model according to the embodiment of the present invention is preferably any one of the following [2] to

[12] . [2] The organ model according to [1], wherein the main body has a rounded shape in a planar view. [3] The organ model according to [1] or [2], wherein the main body is made of a material containing polyurethane resin. [4] The organ model according to any one of [1] to [3], 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. [5] The organ model according to any one of [1] to [4], wherein the number N1 of the specific bubbles SB contained in the first portion is 1 or more and 50 or less. [6] The organ model according to any one of [1] to [5], wherein the number N2 of the specific bubbles SB contained in the second portion is 25 or less. [7] The organ model according to any one of [1] to [6], wherein in the first portion, bubbles are in contact with the inner surface. [8] The organ model according to any one of [1] to [7], wherein a coating material is present on the inner surface. [9] The organ model according to any one of [1] to [8], wherein the number of bubbles observed in the first cut slice satisfies the following requirement 2. (Requirement 2) In the radial direction of the lumen, a position 10 mm outward from the position P3 in the radial direction is set as a position P4, When a portion of the first cut slice portion from the position P3 to the position P4 is defined as a third portion, The number N3 of the specific bubbles SB contained in the third portion is smaller than the number N1 of the specific bubbles SB contained in the first portion.

[10] The organ model according to [9], wherein the number N3 of the specific bubbles SB contained in the third portion is smaller than the number N2 of the specific bubbles SB contained in the second portion.

[11] An organ model described in any one of [1] to

[10] , wherein the number of bubbles observed in a second cut slice section parallel to the second cut surface of the main body section in the horizontal direction of the organ model and having a thickness of 10 mm in the vertical direction satisfies the following requirement 3. (Requirement 3) In the second cutting slice portion, a position of the outer surface of the side surface of the main body portion of the organ model is set to P5, and a position 10 mm inward of the main body portion from the position P5 is set to P6, When the portion of the second cut slice portion from the position P5 to the position P6 is defined as a fourth portion, The number N4 of the specific bubbles SB contained in the fourth portion is smaller than the number N1 of the specific bubbles SB contained in the first portion.

[12] An organ model according to

[11] , wherein the number of bubbles observed in the second cut slice satisfies the following requirement 4. (Requirement 4) For all the lumens included in the second cut slice portion, the position of the inner surface is defined as position P11, a position 10 mm outward in the radial direction from position P11 is defined as position P12, and a position 10 mm outward in the radial direction from position P12 is defined as position P13, A portion of the second cut slice portion from the position P11 to the position P12 is defined as an inner portion, and a portion of the second cut slice portion from the position P12 to the position P13 that is located radially outward of the inner portion is defined as an outer portion, When the bubbles among the plurality of bubbles have a diameter of 0.2 mm or more and 1 / 3 or less of the maximum diameter of the lumen in the second cut slice portion, the bubbles are designated as specific bubbles SB. The number N of the specific bubbles SB contained in all the inner portions 11 is the number N of the specific bubbles SB contained in all the outer portions 21 More than.

[0011] Furthermore, a training device according to an embodiment of the present invention that can solve the above problems is as follows.

[13] The organ model according to any one of [1] to

[12] , a container that contains a liquid and in which the organ model is placed; A training device in which the liquid has a transparency that allows it to transmit 50% or more of light with a wavelength of 410 nm or more and 830 nm or less.

[0012] Furthermore, a training system according to an embodiment of the present invention that can solve the above problems is as follows.

[14] An organ model according to any one of [1] to

[12] ; a container that contains a liquid and in which the organ model is placed; a light source disposed outside the container and irradiating the organ model with light; a training device having a light receiving unit disposed outside the container; a processing unit connected to the training device and configured to process images acquired by the light receiving unit; A training system in which the liquid has a transparency that transmits 50% or more of light with a wavelength of 410 nm or more and 830 nm or less. [Effects of the Invention]

[0013] The above-mentioned organ model, training device, and training system are configured so that bubbles are likely to exist in the first part even when the difference in refractive index between the organ model and the liquid surrounding the organ model or placed in the lumen is small, making it easier to observe the organ model because the shape of the lumen within the organ model becomes more prominent. [Brief explanation of the drawings]

[0014] [Figure 1] 1 is a perspective view of an exercise device according to an embodiment of the present invention. FIG. [Figure 2] 2 is a front view (partial cross-sectional view) of the container and organ model of the training device shown in FIG. 1, showing a first cutting slice portion. FIG. [Figure 3] 3 is a side view (partial cross-sectional view) of the container and organ model of the training device shown in FIG. 2, showing a first cutting slice portion. FIG. [Figure 4] FIG. 2 is a plan view of the container and organ model of the training device shown in FIG. 1. [Figure 5] FIG. 2 is a front view showing a modified example of the lumen shape of the organ model shown in FIG. [Figure 6] FIG. 3 is a plan view showing a first cut slice portion of the organ model shown in FIG. 2. [Figure 7] 10 is a front view (partial cross-sectional view) showing a modification of the container and organ model of the training apparatus shown in FIG. 2, illustrating a second cutting slice portion. FIG. [Figure 8]8 is a side view (partial cross-sectional view) showing a modification of the container and organ model of the training device shown in FIG. 7, illustrating the second cutting slice portion. FIG. [Figure 9] FIG. 8 is a plan view showing a second cut slice portion of the organ model shown in FIG. 7. [Figure 10] 8 is a plan view showing another second cut slice portion of the organ model shown in FIG. 7. FIG. [Figure 11] FIG. 2 is a perspective view showing a modification of the training apparatus shown in FIG. [Figure 12] 12 is a schematic diagram showing the connection between the container and organ model and the extension part of the training device shown in FIG. 11. FIG. [Figure 13] 1. FIG. 4 is a perspective view showing another modified example of the training apparatus shown in FIG. [Figure 14] 1. FIG. 4 is a side view (partial cross-sectional view) showing a modified example of the arrangement of the light receiving unit of the training apparatus shown in FIG. [Figure 15] 1. FIG. 4 is a plan view showing yet another modified example of the training apparatus shown in FIG. [Figure 16] FIG. 2 shows a modified example of the organ model shown in FIG. 1, and is an end view of a cross section of the organ model perpendicular to the axial direction of the lumen. [Figure 17] 1 is a schematic diagram of a training system according to an embodiment of the present invention; DETAILED DESCRIPTION OF THE INVENTION

[0015] 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.

[0016] An organ model according to an embodiment of the present invention has a mass-shaped main body, the main body having an outer surface that defines the mass shape and an inner surface that defines a lumen inside the main body, the lumen having an axial direction and a radial direction perpendicular to the axial direction, a plurality of bubbles formed between the outer and inner surfaces inside the main body, and the number of bubbles observed in a first cut slice that is parallel to the cut surface of the main body in a direction perpendicular to the axial direction and has a thickness of 10 mm in the axial direction satisfies the following requirement 1. (Requirement 1) In the radial direction of the lumen in the first cut slice portion, the position of the inner surface is defined as position P1, a position 10 mm radially outward from position P1 is defined as position P2, and a position 10 mm radially outward from position P2 is defined as position P3; the portion of the first cut slice portion from position P1 to position P2 is defined as a first portion, and the portion of the first cut slice portion from position P2 to position P3 that is radially outward from the first portion is defined as a second portion; and among the plurality of bubbles, those with a diameter of 0.2 mm or more and 1 / 3 or less of the maximum diameter of the lumen in the first cut slice portion are defined as specific bubbles SB. The number N1 of the specific bubbles SB contained in the first portion is greater than the number N2 of the specific bubbles SB contained in the second portion.

[0017] The organ model is configured so that bubbles are likely to exist in the first part even when the difference in refractive index between the organ model and the liquid surrounding the organ model or placed in the lumen is small, making the shape of the lumen within the organ model more prominent and making it easier to observe the organ model.

[0018] Hereinafter, a training device and a training system according to an embodiment of the present invention will be described with reference to FIGS. 1 to 17. FIG. 1 is a perspective view of a training device according to an embodiment of the present invention. FIG. 2 is a front view (partially cross-sectional) of the container and organ model of the training device shown in FIG. 1, showing the first cutting slice portion. FIG. 3 is a side view (partially cross-sectional) of the container and organ model of the training device shown in FIG. 2, showing the first cutting slice portion. FIG. 4 is a plan view of the container and organ model of the training device shown in FIG. 1. FIG. 5 is a front view showing a modified example of the luminal shape of the organ model shown in FIG. 1. FIG. 6 is a plan view showing the first cutting slice portion of the organ model shown in FIG. 2. FIG. 7 is a front view (partially cross-sectional) of a modified example of the container and organ model of the training device shown in FIG. 2, showing the second cutting slice portion. FIG. 8 is a side view (partially cross-sectional) of a modified example of the container and organ model of the training device shown in FIG. 7, showing the second cutting slice portion. FIG. 9 is a plan view showing the second cutting slice portion of the organ model shown in FIG. 7. FIG. 10 is a plan view showing another second cutting slice portion of the organ model shown in FIG. 7. FIG. 11 is a perspective view showing a modified example of the training device shown in FIG. 1. FIG. 12 is a schematic diagram showing the connection between the container and organ model of the training device shown in FIG. 11 and the extension part. FIG. 13 is a perspective view showing another modified example of the training device shown in FIG. 1. FIG. 14 is a side view (partially cross-sectional view) showing a modified example of the arrangement of the light receiving part of the training device shown in FIG. 1. FIG. 15 is a plan view showing yet another modified example of the training device shown in FIG. 1. FIG. 16 shows a modified example of the organ model shown in FIG. 1, and is an end view of a cut part in a cross section perpendicular to the axial direction of the lumen of the organ model. FIG. 17 is a schematic diagram of a training system according to an embodiment of the present invention. As shown in FIGS. 1 to 6, the organ model 1 has a main body 2, which has an outer surface 3 and an inner surface 4. The main body 2 also has a first cutting slice 71. In requirement 1, the organ model 1 has positions P1, P2, and P3, a first portion 711, and a second portion 712 in the first cutting slice 71.

[0019] 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.

[0020] 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.

[0021] As shown in Figures 1 and 2, the organ model 1 has a mass-shaped main body 2. The main body 2 has an outer surface 3 that defines the mass shape, and an inner surface 4 that defines a lumen 5 inside the main body 2. The lumen 5 has an axial direction m and a radial direction perpendicular to the axial direction m.

[0022] 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.

[0023] 2 and 3, 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.

[0024] 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.

[0025] As shown in Figure 4, 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.

[0026] 1 and 2, 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.

[0027] 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.

[0028] In the organ model 1, multiple bubbles are formed between the outer surface 3 and inner surface 4 inside the main body 2, and as shown in Figures 2 to 3 and 6, the number of bubbles observed in the first cut slice 71, which is parallel to the cut surface 70A of the main body 2 in a direction perpendicular to the axial direction m and has a thickness of 10 mm in the axial direction, satisfies the following requirement 1. (Requirement 1) In the radial direction of the lumen 5 in the first cut slice portion 71, the position of the inner surface 4 is defined as position P1, a position 10 mm radially outward from position P1 is defined as position P2, and a position 10 mm radially outward from position P2 is defined as position P3. The portion of the first cut slice portion 71 from position P1 to position P2 is defined as a first portion 711, and the portion from position P2 to position P3 radially outward from the first portion 711 is defined as a second portion 712. When, among the multiple bubbles, those having a diameter of 0.2 mm or more and 1 / 3 or less of the maximum diameter of the lumen 5 in the first cut slice portion 71 are defined as specific bubbles SB, the number N1 of specific bubbles SB contained in the first portion 711 is greater than the number N2 of specific bubbles SB contained in the second portion 712.

[0029] The organ model 1 and training device are configured so that bubbles are likely to exist in the first part 711 even when the difference in refractive index between the organ model 1 and the liquid surrounding the organ model 1 or placed in the lumen 5 is small, making it easier to observe the organ model 1 because the shape of the lumen 5 within the organ model 1 becomes more prominent.

[0030] In requirement 1, the bubble diameter refers to the equivalent spherical diameter, that is, the diameter of a sphere having the same volume as the bubble, if the bubble is not spherical. The same applies to requirements 2, 3, and 4 described below.

[0031] The thickness direction of the first cut slice portion 71 may be along the vertical direction y, along the horizontal direction x, or inclined relative to the vertical direction y. For example, in the first cut slice portion 71A shown in FIG. 2, the axial direction m of the lumen 5 is along the vertical direction y, and therefore the thickness direction of the first cut slice portion 71 is also along the vertical direction y. The cut surface 70A of the first cut slice portion 71A is parallel to the horizontal direction x. On the other hand, in the first cut slice portion 71B shown in FIG. 2, the axial direction m of the lumen 5 is inclined relative to the vertical direction y, and therefore the thickness direction of the first cut slice portion 71B is also inclined relative to the vertical direction y.

[0032] The number of specific bubbles SB can be measured as follows. A three-dimensional image of the main body 2 of the organ model 1 is obtained using a microfocus X-ray CT device (Shimadzu Corporation, inspeXio SMX-225CT FPD HR Plus), and then a simulated cut on the image is defined as the first cut slice 71. Next, the number of specific bubbles SB of a predetermined size contained in each portion of the first cut slice 71 is counted on the image. While the first cut slice 71 has been used as an example in this example, the number of specific bubbles SB in the second cut slice 72 can also be measured in a similar manner. Another measurement method involves cutting out a portion of the actual organ model 1 that corresponds to the first cut slice 71 using a cutting tool such as a utility knife, measuring the size of all bubbles contained in the first cut slice 71 using a microscope or magnifying glass, and then counting the number of specific bubbles SB.

[0033] When one specific bubble SB is arranged so as to overlap the boundary between multiple portions, the specific bubble SB is counted as being arranged in the portion with the larger volume occupancy. For example, when one specific bubble SB is arranged across the first portion 711 and the second portion 712, and the volume of the bubble arranged in the first portion 711 is larger than the volume of the bubble arranged in the second portion 712, the specific bubble SB is counted as being arranged in the first portion 711. Note that when the volumes of one specific bubble SB arranged in multiple portions are equal, the specific bubble SB is not counted.

[0034] In requirement 1, 1 mm of the first part 711 3 The number N1 of specific bubbles SB contained in each of the second portions 712 is 3 It is preferable that the number N1 of the specific bubbles SB contained in the first portion 711 is larger than the number N2 of the specific bubbles SB contained per mm of the first portion 711. When the number N1 of the specific bubbles SB contained in the first portion 711 is in the above range, the shape of the lumen 5 becomes more conspicuous, which makes it easier to observe the lumen 5 and the medical instrument inserted into the lumen 5. Here, 3 The number N1 of specific bubbles SB contained per 1 mm of the second portion 712 refers to the value obtained by dividing the number of all specific bubbles SB contained in the first portion 711 by the volume of the first portion 711. 3 Number of specific bubbles SB contained in the per unit N2, 1mm of the third part 713 3 Number of specific bubbles SB included in the per unit N3, 1mm of the 4th part 714 3 Number of specific bubbles SB contained in the per N4, 1mm of the inner part 751 3 Number of specific bubbles SB contained in a hit N 11 , outer part 752 1mm 3 Number of specific bubbles SB contained in a hit N 21 The same is true for .

[0035] In requirement 1, the first portion 711 has, for example, a cylindrical shape. Also, in requirement 1, the second portion 712 has, for example, a cylindrical shape.

[0036] In requirement 1, the number N1 of specific bubbles SB contained in the first portion 711 is preferably 1 or more, more preferably 2 or more, and even more preferably 3 or more. In requirement 1, the number N1 of specific bubbles SB contained in the first portion 711 is preferably 50 or less, more preferably 40 or less, and even more preferably 30 or less. When the number N1 of specific bubbles SB contained in the first portion 711 is within the above range, the shape of the lumen 5 becomes more prominent, making it easier to observe the lumen 5 and the medical instrument inserted into the lumen 5.

[0037] In requirement 1, the number N2 of specific bubbles SB contained in the second portion 712 may be 0, but is preferably 1 or more, and more preferably 2 or more. Furthermore, in requirement 1, the number N2 of specific bubbles SB contained in the second portion 712 is preferably 25 or less, more preferably 20 or less, and even more preferably 15 or less. When the number N2 of specific bubbles SB contained in the second portion 712 is within the above range, an appropriate difference in the number of specific bubbles SB between the second portion 712 and the first portion 711 is created, making the shape of the lumen 5 more prominent and facilitating observation of the lumen 5 and a medical instrument inserted into the lumen 5.

[0038] 6, it is preferable that the air bubbles are in contact with the inner surface 4 in the first portion 711. When the air bubbles are in contact with the inner surface 4, recesses are formed on the surface of the inner surface 4. This makes it easier for the coating material to enter the recesses, making it possible to impart slipperiness to the surface of the inner surface 4 and facilitating the insertion of a medical instrument into the lumen 5.

[0039] In the first portion 711, some of the multiple bubbles may be in contact with the inner surface 4, and the remaining bubbles may be located closer to the outer surface 3 than the inner surface 4. In other words, the remaining bubbles may not be in contact with the inner surface 4. Even with this configuration in which some of the multiple bubbles are in contact with the inner surface 4, when the coating material enters the recesses formed on the inner surface 4, the unevenness of the surface is smoothed, thereby making it easier to insert a medical device into the lumen 5.

[0040] 16, it is preferable that a coating material 86 be present on the inner surface 4. The presence of the coating material 86 on the inner surface 4 smooths out the irregularities on the surface, making it easier to insert a medical instrument into the lumen 5.

[0041] As a method for making the coating material 86 present on the inner surface 4, the coating material 86 may be poured into the lumen 5 of the organ model 1 before placing the organ model 1 in the container 11. Alternatively, by coating the core that forms the lumen 5 with the coating material 86 when producing the organ model 1, the coating material 86 remains on the inner surface 4 even after the core is removed from the lumen 5, and therefore the coating material 86 can also be made present in this manner.

[0042] The type of coating material 86 is not particularly limited, but examples include fluororesin and silicone resin.

[0043] As shown in FIGS. 2 to 3 and 6, it is preferable that the number of bubbles observed in the first cut slice portion 71 satisfies the following requirement 2. (Requirement 2) In the radial direction of the lumen 5, when a position 10 mm radially outward from position P3 is defined as position P4, and the portion of the first cut slice portion 71 from position P3 to position P4 is defined as a third portion 713, the number N3 of specific bubbles SB contained in the third portion 713 is smaller than the number N1 of specific bubbles SB contained in the first portion 711. When the number N3 of specific bubbles SB contained in the third portion 713 is within this range, the shape of the lumen 5 becomes more prominent, making it easier to observe the lumen 5 and the medical instrument inserted into the lumen 5.

[0044] In requirement 2, 1 mm of the third part 713 3 The number N3 of specific bubbles SB contained in each of the first portions 711 is 3 It is preferable that the number N3 of specific bubbles SB contained in the third portion 713 is smaller than the number N1 of specific bubbles SB contained in the third portion 713. When the number N3 of specific bubbles SB contained in the third portion 713 is in this range, the shape of the lumen 5 becomes more prominent, making it easier to observe the lumen 5 and the medical instrument inserted into the lumen 5.

[0045] In the requirement 2, the first portion 711 has, for example, a cylindrical shape. In the requirement 2, the third portion 713 has, for example, a cylindrical shape.

[0046] In requirements 1 and 2, it is preferable that only one lumen 5 exists within the first cut slice portion 71. In detail, it is preferable that the first cut slice portion 71 includes only a lumen 5 having an axial direction m for defining the first cut slice portion 71, and does not include a lumen 5 having an axial direction m that does not define the first cut slice portion 71.

[0047] In requirement 2, it is preferable that the number N3 of specific bubbles SB contained in the third portion 713 is smaller than the number N2 of specific bubbles SB contained in the second portion 712. When the number N3 of specific bubbles SB contained in the third portion 713 is within the above range, the specific bubbles contained in the third portion 713 are less likely to be in focus and do not interfere with observation. This makes the shape of the lumen 5 more prominent, making it easier to observe the lumen 5 and the medical instrument inserted into the lumen 5.

[0048] In requirement 2, 1 mm of the third part 713 3 The number N3 of specific bubbles SB contained in each 1 mm 3 It is preferable that the number N3 of specific bubbles SB contained in the third portion 713 is smaller than the number N2 of specific bubbles SB contained in the third portion 713. When the number N3 of specific bubbles SB contained in the third portion 713 is in this range, the shape of the lumen 5 becomes more prominent, making it easier to observe the lumen 5 and the medical instrument inserted into the lumen 5.

[0049] The number N3 of specific bubbles SB contained in the third portion 713 may be 0, 1 or more, or 2 or more, but is preferably 20 or less, 15 or less, or 10 or less. When the number N3 of specific bubbles SB contained in the third portion 713 is within the above range, the specific bubbles contained in the third portion 713 are less likely to be in focus and do not interfere with observation, making it easier to observe the lumen 5 and the medical instrument inserted into the lumen 5.

[0050] 7 to 9, it is preferable that the number of bubbles observed in the second cut slice portion 72, which is parallel to the second cut surface 70B of the main body portion 2 in the horizontal direction x of the organ model 1 and has a thickness of 10 mm in the vertical direction y, satisfy the following requirement 3. When the number N3 of specific bubbles SB contained in the fourth portion 714 is within the following range, the shape of the lumen 5 becomes more prominent, making it easier to observe the lumen 5 and the medical instrument inserted into the lumen 5. (Requirement 3) In the second cutting slice portion 72, when the position of the outer surface 3 of the side of the main body portion 2 of the organ model 1 is P5, and the position 10 mm inward from position P5 into the main body portion 2 is position P6, and the portion of the second cutting slice portion 72 from position P5 to position P6 is the fourth portion 714, the number N4 of specific bubbles SB contained in the fourth portion 714 is less than the number N1 of specific bubbles SB contained in the first portion 711.

[0051] Regarding requirement 3, in FIGS. 7 to 9, the first portion 711 and the fourth portion 714 are defined in the second cut slice portion 72A.

[0052] In requirement 3, the number N4 of specific bubbles SB contained in the fourth portion 714 is preferably smaller than the number N2 of specific bubbles SB contained in the second portion 712. Furthermore, the number N4 of specific bubbles SB contained in the fourth portion 714 is preferably smaller than the number N3 of specific bubbles SB contained in the third portion 713. When the number N3 of specific bubbles SB contained in the fourth portion 714 is within the above range, the specific bubbles contained in the fourth portion 714 are less likely to be in focus and do not interfere with observation. This makes the shape of the lumen 5 more prominent, facilitating observation of the lumen 5 and the medical instrument inserted into the lumen 5.

[0053] In requirement 3, 1 mm of the fourth part 714 3 The number N4 of specific bubbles SB contained in each of the first portions 711 is 3 It is preferable that the number of specific bubbles SB contained in the fourth portion 714 is smaller than the number N1 of the specific bubbles SB contained in the fourth portion 714. 3 The number N4 of specific bubbles SB contained in each 1 mm 3 It is preferable that the number of specific bubbles SB contained in each of the fourth portions 714 is smaller than the number N2 of the specific bubbles SB contained in each of the fourth portions 714. 3 The number N4 of specific bubbles SB contained in the third portion 713 is 3 It is preferable that the number N3 of specific bubbles SB contained in the fourth portion 714 is smaller than the number N3 of specific bubbles SB contained in the fourth portion 714. When the number N3 of specific bubbles SB contained in the fourth portion 714 is within the above range, the specific bubbles contained in the fourth portion 714 are less likely to be in focus and do not interfere with observation. This makes the shape of the lumen 5 more prominent, making it easier to observe the lumen 5 and the medical instrument inserted into the lumen 5.

[0054] In requirement 3, the first portion 711 has, for example, a cylindrical shape. In requirement 3, the fourth portion 714 has, for example, a cylindrical shape.

[0055] The number N4 of specific bubbles SB contained in the fourth portion 714 may be 0, 1 or more, or 2 or more, but is preferably 20 or less, 15 or less, or 10 or less. When the number N4 of specific bubbles SB contained in the fourth portion 714 is within the above range, the specific bubbles contained in the fourth portion 714 are less likely to be in focus and do not interfere with observation, making it easier to observe the lumen 5 and the medical instrument inserted into the lumen 5.

[0056] As can be seen from FIGS. 7 to 8 and 10, it is preferable that the number of bubbles observed in the second cut slice portion 72 satisfy the following requirement 4. (Requirement 4) For all lumens 5 included in the second cut slice section 72, the position of the inner surface 4 is defined as position P11, a position 10 mm radially outward from position P11 as position P12, and a position 10 mm radially outward from position P12 as position P13. The portion of the second cut slice section 72 from position P11 to position P12 is defined as an inner portion 751, and the portion from position P12 to position P13 that is radially outward from the inner portion 751 is defined as an outer portion 752. Among the multiple bubbles, those with a diameter of 0.2 mm or more and 1 / 3 or less of the maximum diameter of the lumen 5 in the second cut slice section 72 are defined as specific bubbles SB. The number N of specific bubbles SB included in all of the inner portions 751 is 11 is the number N of specific bubbles SB contained in all the outer portions 752 21 More than.

[0057] Regarding requirement 4, the lumen 5A and the lumen 5B are included in the second cut slice portion 72B in Figures 7 to 8 and 10. An inner portion 751 and an outer portion 752 are defined for the lumen 5A and the lumen 5B, respectively.

[0058] In the organ model 1 and training device 60 that satisfy requirement 4, even if the difference in refractive index between the organ model 1 and the liquid surrounding the organ model 1 or placed in the lumen 5 is small, the organ model 1 and training device 60 are configured so that bubbles are likely to exist in the inner part 751, making the shape of the lumen 5 inside the organ model 1 more prominent and making it easier to observe the organ model 1.

[0059] In requirement 4, 1 mm of all inner parts 751 3 Number of specific bubbles SB contained in a hit N 11 All outer parts 752 mm 3 Number of specific bubbles SB contained in a hit N 21 Thus, the distance between the inner portion 751 and the outer portion 752 is preferably 1 mm or more. 3 By setting the number of specific bubbles SB contained in each hit, the shape of the lumen 5 in the organ model 1 becomes more prominent, making it easier to observe the organ model 1.

[0060] In the fourth requirement, the inner portion 751 has, for example, a cylindrical shape. In the first requirement, the outer portion 752 has, for example, a cylindrical shape.

[0061] In requirement 4, the number N1 of specific bubbles SB contained in the inner portion 751 is preferably 1 or more, more preferably 2 or more, and even more preferably 3 or more. In requirement 4, the number N1 of specific bubbles SB contained in the inner portion 751 is preferably 50 or less, more preferably 40 or less, and even more preferably 30 or less. When the number N1 of specific bubbles SB contained in the inner portion 751 is within the above range, the shape of the lumen 5 becomes more prominent, making it easier to observe the lumen 5 and the medical instrument inserted into the lumen 5.

[0062] In requirement 4, the number N2 of specific bubbles SB contained in the outer portion 752 may be 0, but is preferably 1 or more, and more preferably 2 or more. Furthermore, in requirement 4, the number N2 of specific bubbles SB contained in the outer portion 752 is preferably 25 or less, more preferably 20 or less, and even more preferably 15 or less. When the number N2 of specific bubbles SB contained in the outer portion 752 is within the above range, an appropriate difference in the number of specific bubbles SB between the outer portion 752 and the inner portion 751 is created, making the shape of the lumen 5 more prominent and facilitating observation of the lumen 5 and a medical instrument inserted into the lumen 5.

[0063] 10 , it is preferable that the air bubbles contact the inner surface 4 in the inner portion 751. When the air bubbles contact the inner surface 4, recesses are formed on the surface of the inner surface 4. This makes it easier for the coating material to enter the recesses, making it possible to impart slipperiness to the surface of the inner surface 4 and facilitating the insertion of a medical instrument into the lumen 5.

[0064] 1 to 3, a training device 60 according to an embodiment of the present invention includes the above-described organ model 1 and a container 11 that contains a liquid 25 and in which the organ model 1 is disposed. The liquid 25 preferably has a transparency that allows at least 50% of light having a wavelength of 410 nm or more and 830 nm or less to pass through. When the liquid 25 has such high transparency, the shape of the lumen 5 within 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 the amount of light that is transmitted relative to the light emitted from the light source 42.

[0065] 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.

[0066] 2 and 3, 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.

[0067] As shown in Figures 2 and 3, 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 4, 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 4 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.

[0068] 2 and 3, the organ model 1 is preferably 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.

[0069] 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.

[0070] 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.

[0071] The axial direction m 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 m of the lumen 5. The axial direction m of the lumen 5 may be along the vertical direction y or along the horizontal direction x. Furthermore, the axial direction m 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.

[0072] 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 2 to 3 and 5.

[0073] The opening 6 of the organ model 1 is for inserting and removing medical instruments. As shown in FIGS. 2 and 3, 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, thereby 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 prevents liquid leakage while providing good visibility when photographing the organ model 1.

[0074] 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.

[0075] The position where the opening 6 of the organ model 1 is provided is not particularly limited, and it is preferable that 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.

[0076] The organ model 1 may have one or more side holes 7 in addition to the opening 6. As shown in Figures 2 and 3, 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.

[0077] The main body 2 is preferably made of a translucent material. Examples of materials that can be used to make the main body 2 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 is preferably made of a material containing polyurethane resin, and more preferably a material containing thermosetting liquid polyurethane resin. Making the main body 2 from a material containing polyurethane resin, particularly thermosetting liquid polyurethane resin, can provide the organ model 1 with appropriate flexibility and refractive index. This facilitates insertion of medical instruments into the lumen 5 of the organ model 1 and allows for easy observation of the organ model 1 from the outside.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] The organ model can be produced by the following procedure. A core corresponding to the lumen 5 is produced and placed in a production container. The material that will form the main body 2 of the organ model 1 is poured into the production container, hardened, and then the core is removed to produce the organ model 1. For example, a core having a three-dimensional shape as shown in Figure 5 can be used.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] As shown in FIGS. 11 and 12, the training device 60 may further include an extension portion 20 attached to the organ model 1 and extending out of the container 11. In this case, the extension portion 20 preferably has a lumen 21 therein, and the lumen 5 of the organ model 1 and the lumen 21 of the extension portion 20 are preferably connected to each other. The extension portion 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 portion 20 preferably simulates a route from the mouth to the duodenum. Providing the extension portion 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. 11 and 12 allows a participant to experience the operation of inserting a catheter into the bile duct from the forceps port channel of an endoscope via the Vater papilla.

[0086] 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. 11, it is preferable that the extension portion 20 is a long member. The extension portion 20 may be tubular.

[0087] 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.

[0088] 11 and 12, 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. 12. Furthermore, when the extending portion 20 is tubular as shown in Fig. 12, the first end opening 22 may be disposed on the side of the extending portion 20, i.e., on the tube wall.

[0089] 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 Figures 11 and 12 show an example in which the organ model 1 and the extension part 20 are connected to each other by a tubular connecting member 30, the structure of the connecting member 30 is not particularly limited.

[0090] 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.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] 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.

[0095] As shown in FIGS. 11 and 12, the training apparatus 60 may further include one or more support members 31 that support the extension portion 20. In FIG. 12, 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. 11, 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.

[0096] As can be seen from FIG. 11 , 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.

[0097] 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.

[0098] The material for forming the pressing member 18 can be the same as that for the container 11 .

[0099] As shown in Figure 13, 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.

[0100] 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. 13 , 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 shielded from light 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 wall 40 may be arranged on the top, bottom 12, and side wall 13 sides of the container 11.

[0101] 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.

[0102] 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%.

[0103] 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.

[0104] 1, 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.

[0105] 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.

[0106] The type of lamp of the light source 42 is not particularly limited, and examples thereof include an LED lamp and a laser lamp.

[0107] 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.

[0108] 1, 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.

[0109] 1, 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.

[0110] 15, 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.

[0111] 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.

[0112] It is preferable that the first light receiving section 47 and the second light receiving section 48 are located on the same horizontal plane.

[0113] 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.

[0114] As shown in Fig. 14, 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. 14, 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.

[0115] As shown in Figure 14, 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.

[0116] 14, 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.

[0117] 14, 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.

[0118] 16, 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.

[0119] 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.

[0120] 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 coating material 86 is present on the inner surface 4 of the organ model 1, the surfactant 27 may be present on the coating material 86.

[0121] The type of surfactant 27 is not particularly limited, and anionic surfactants, cationic surfactants, zwitterionic surfactants, and nonionic surfactants can be used.

[0122] As shown in FIG. 17 , the training system 100 includes the above-described organ model 11, a container 11 that contains a liquid 25 and has the organ model 1 disposed therein, a training device 60 having a light source 42 disposed outside the container 11 for irradiating light onto the organ model 1, and a light receiving unit 46 disposed outside the container 11, and a processing unit 55 connected to the training device 60 for processing images acquired by the light receiving unit 46, wherein the liquid 25 has a transparency that allows at least 50% of light having a wavelength of 410 nm or more and 830 nm or less to pass through. The configurations of the training device 60 and the liquid 25 can be those already described. By processing the images acquired by the light receiving unit 46 in the processing unit 55, it becomes easier to observe the medical instrument to be inserted into the lumen 5.

[0123] 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 .

[0124] 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.

[0125] 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.

[0126] 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.

[0127] 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 .

[0128] 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).

[0129] 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. [Explanation of symbols]

[0130] 1: Organ model 2: Main body part 3: Outer surface 4: Inner surface 5: Lumen 11: Container 12: Bottom 13: Side wall 25: Liquid 40: Light-shielding wall 42: Light source 46: Light-receiving part 55: Processing part 60: Training device 711: First part 712: Second part 713: Third part 714: Fourth part 751: Inner part 752: Outer part 100: Training system x: Horizontal direction y: Vertical direction m: Axial direction

Claims

1. It has a block-shaped main body, the body portion has an outer surface that defines the mass shape and an inner surface that defines a lumen within the body portion; the lumen has an axial direction and a radial direction perpendicular to the axial direction; a plurality of bubbles are formed between the outer surface and the inner surface inside the main body; An organ model in which the number of bubbles observed in a first cut slice section that is parallel to the cut surface of the main body section in a direction perpendicular to the axial direction and has a thickness of 10 mm in the axial direction satisfies the following requirement 1. (Requirement 1) In the radial direction of the lumen of the first cut slice portion, a position of the inner surface is defined as a position P1, a position 10 mm outwardly of the lumen in the radial direction of the lumen from the position P1 is defined as a position P2, and a position 10 mm outwardly of the lumen in the radial direction from the position P2 is defined as a position P3. a portion of the first cutting slice portion from the position P1 to the position P2 is defined as a first portion, and a portion of the first cutting slice portion from the position P2 to the position P3, which is located radially outward of the first portion, is defined as a second portion; When the bubbles among the plurality of bubbles have a diameter of 0.2 mm or more and 1 / 3 or less of the maximum diameter of the lumen in the first cut slice portion, the bubbles are defined as specific bubbles SB. The number N of the specific bubbles SB contained in the first portion １ is the number N of the specific bubbles SB contained in the second portion ２ More than.

2. The organ model according to claim 1 , wherein the main body has a rounded shape in a plan view.

3. 3. The organ model according to claim 1, wherein the main body is made of a material containing polyurethane resin.

4. 3. The organ model according to claim 1, 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.

5. The number N of the specific bubbles SB contained in the first portion １ 3. The organ model according to claim 1, wherein the number of the nuclei is 1 or more and 50 or less.

6. The number N of the specific bubbles SB contained in the second portion ２ 3. The organ model according to claim 1, wherein the number of the vertices is 25 or less.

7. 3. The organ model according to claim 1, wherein in the first portion, air bubbles are in contact with the inner surface.

8. 3. The organ model according to claim 1, wherein a coating material is present on the inner surface.

9. 3. The organ model according to claim 1, wherein the number of bubbles observed in the first cut slice portion satisfies the following requirement 2. (Requirement 2) In the radial direction of the lumen, a position 10 mm outward from the position P3 in the radial direction is set as a position P4, When a portion of the first cutting slice portion from the position P3 to the position P4 is defined as a third portion, The number N of the specific bubbles SB contained in the third portion ３ is the number N of the specific bubbles SB contained in the first portion １ Less than.

10. The number N of the specific bubbles SB contained in the third portion ３ is the number N of the specific bubbles SB contained in the second portion ２ The organ model according to claim 9, wherein the number of organs is less than 1.

11. 3. An organ model according to claim 1, wherein the number of bubbles observed in a second cut slice section parallel to the second cut surface of the main body section in the horizontal direction of the organ model and having a thickness of 10 mm in the vertical direction satisfies the following requirement 3. (Requirement 3) In the second cutting slice unit, a position of an outer surface of a side surface of a main body part of the organ model is set to P5, and a position 10 mm inward of the main body part from the position P5 is set to P6. When the portion of the second cut slice portion from the position P5 to the position P6 is defined as a fourth portion, The number N of the specific bubbles SB contained in the fourth portion ４ is the number N of the specific bubbles SB contained in the first portion １ Less than.

12. The organ model according to claim 11 , wherein the number of bubbles observed in the second cut slice portion satisfies the following requirement 4: (Requirement 4) For all the lumens included in the second cutting slice portion, the position of the inner surface is defined as position P11, a position 10 mm outward in the radial direction from position P11 is defined as position P12, and a position 10 mm outward in the radial direction from position P12 is defined as position P13, A portion of the second cut slice portion from the position P11 to the position P12 is defined as an inner portion, and a portion of the second cut slice portion from the position P12 to the position P13 that is located radially outward of the inner portion is defined as an outer portion, When the bubbles among the plurality of bubbles have a diameter of 0.2 mm or more and 1 / 3 or less of the maximum diameter of the lumen in the second cut slice portion, the bubbles are defined as specific bubbles SB. The number N of the specific bubbles SB included in all the inner portions １１ is the number N of the specific bubbles SB contained in all the outer portions ２１ More than.

13. An organ model according to claim 1 or 2; a container that contains a liquid and in which the organ model is placed; The liquid has a transparency that allows it to transmit at least 50% of light with a wavelength of 410 nm or more and 830 nm or less.

14. An organ model according to claim 1 or 2; a container that contains a liquid and in which the organ model is placed; a light source disposed outside the container and irradiating the organ model with light; a training device having a light receiving unit disposed outside the container; a processing unit connected to the training device and configured to process images acquired by the light receiving unit; A training system in which the liquid has a transparency that transmits 50% or more of light with a wavelength of 410 nm or more and 830 nm or less.

Images