Equipment and medical procedure training methods

Abstract

This invention provides an instrument and a medical procedure training method that can easily reproduce the sensation of inserting a medical instrument into an organ from the digestive tract. [Solution] The instrument is a training instrument for procedures including the insertion of instruments into organs from within the digestive tract. The instrument comprises a first model corresponding to the wall of the digestive tract and a second model corresponding to organs.

Description

Technical Field

[0001] This disclosure relates to an instrument and a medical treatment training method.

Background Art

[0002] Non-Patent Document 1 describes that a human phantom in medical diagnosis is used for training in ultrasonic technology. Non-Patent Document 1 also describes that the human phantom is utilized to imitate organs or pathological conditions to improve the accuracy of clinical imaging diagnosis. Further, Non-Patent Document 1 describes that there is a human phantom designed to be able to cope with various situations, by which medical practitioners can enhance ultrasonic diagnostic technology.

[0003] Non-Patent Document 2 describes that human phantoms are widely used for training to learn imaging diagnostic techniques. Non-Patent Document 2 also describes that the human phantom is designed to imitate specific organs or lesions and is used by medical practitioners to safely and effectively acquire diagnostic techniques, thereby improving the diagnostic accuracy for actual patients.

[0004] Non-Patent Document 3 describes a model using porcine tissue as a human phantom used for the evaluation of ultrasonic technology in fracture diagnosis. Porcine tissue is used in the model. Since the hardness and density of porcine tissue are close to those of human bones, it is used as a suitable material for ultrasonic fracture diagnosis training.

Prior Art Documents

Non-Patent Documents

[0005]

Non-Patent Document 1

[0006] One embodiment of the present disclosure provides an instrument and a medical procedure training method that can facilitate the reproduction of the sensation of inserting a medical instrument into an organ from the digestive tract. [Means for solving the problem]

[0007] The first aspect of this disclosure is a training device for procedures including the insertion of a treatment instrument into an organ from within the gastrointestinal tract, comprising a first model corresponding to the wall of the gastrointestinal tract and a second model corresponding to an organ.

[0008] A second aspect of this disclosure is an instrument according to the first aspect, wherein the first model is harder than the second model.

[0009] A third aspect of this disclosure is an apparatus relating to the first or second aspect, wherein the first and second models are apparatus relating to the first or second aspect, differing in thickness, material composition, and / or modulus of elasticity.

[0010] A fourth aspect of the present disclosure is a device relating to any one of the first to third aspects, wherein the resistance of the first model to puncture is different from the resistance of the second model to puncture.

[0011] A fifth aspect of this disclosure is a device according to the fourth aspect, wherein the resistance of the second model to puncture is less than the resistance of the first model to puncture.

[0012] A sixth aspect of this disclosure is an instrument relating to any one of the first to fifth aspects, wherein the second model has a tubular structure corresponding to a tubular organ within an organ.

[0013] The seventh aspect of this disclosure is an apparatus according to the sixth aspect, wherein the shape of the pipe structure is dendritic.

[0014] An eighth aspect of the present disclosure is an apparatus according to the sixth or seventh aspect, wherein the tubular structure has a tubular portion, the tubular portion being rigider than at least the body of the second model among the bodies of the first and second models.

[0015] A ninth aspect of the present disclosure is an instrument according to the eighth aspect, wherein the tubular portion and at least the body of the second model among the first and second models differ in thickness, material composition, and / or modulus of elasticity.

[0016] A tenth aspect according to the present disclosure is an instrument according to any one of the sixth to ninth aspects, in which a liquid is injected into the tube structure.

[0017] An eleventh aspect according to the present disclosure is an instrument according to the tenth aspect, in which the liquid contains a lubricant and / or a contrast agent.

[0018] A twelfth aspect according to the present disclosure is an instrument according to the eleventh aspect, in which at least one end of the tube structure extends to the outer edge of the instrument.

[0019] A thirteenth aspect according to the present disclosure is an instrument according to any one of the sixth to twelfth aspects, in which the tube structure is defined based on three-dimensional volume data related to a tubular organ.

[0020] A fourteenth aspect according to the present disclosure is an instrument according to any one of the sixth to thirteenth aspects, in which the organ is the liver and the tubular organ is the bile duct.

[0021] A fifteenth aspect according to the present disclosure is an instrument according to any one of the sixth to thirteenth aspects, in which the organ is the pancreas and the tubular organ is the pancreatic duct.

[0022] A sixteenth aspect according to the present disclosure is an instrument according to the fourteenth or fifteenth aspect, in which the digestive tract is the stomach or the duodenum.

[0023] A seventeenth aspect according to the present disclosure is an instrument according to any one of the first to sixteenth aspects, in which the positional relationship between the digestive tract and the organ is a positional relationship adjacent to each other.

[0024] An eighteenth aspect according to the present disclosure is an instrument according to the seventeenth aspect, in which the digestive tract is the stomach or the duodenum and the organ is the liver or the pancreas.

[0025] A nineteenth aspect according to the present disclosure is an instrument according to any one of the first to eighteenth aspects, in which the first model and the second model are non-biological materials.

[0026] The 20th aspect according to the present disclosure is the instrument according to the 19th aspect, wherein the non-biological material is a material containing a polymer.

[0027] The 21st aspect according to the present disclosure is a medical treatment training method including performing a simulated treatment corresponding to a treatment on an instrument including a first model corresponding to a wall of the digestive tract and a second model corresponding to an organ, for training of a treatment including puncturing of a treatment instrument from inside the digestive tract to an organ.

Brief Description of Drawings

[0028] [Figure 1] It is a conceptual diagram showing an example of the configuration of a training system. [Figure 2] It is a conceptual diagram showing an example of a mode in which endoscopic ultrasonography-guided biliary drainage is being performed. [Figure 3] It is a conceptual diagram showing an example of a mode in which endoscopic ultrasonography-guided pancreatic duct drainage is being performed. [Figure 4] It is a conceptual diagram showing an example of the configuration of each of the first model and the second model. [Figure 5] It is a conceptual diagram showing an example of a mode in which the first model is bent toward both side surfaces of the second model placed at the center of the first model. [Figure 6] It is a conceptual diagram showing an example of a mode in which the lower surface and both side surfaces of the second model are covered by the first model, and an example of a cross-sectional view of a human phantom. [Figure 7] It is a conceptual diagram showing an example of a mode in which a human phantom is attached to a holder. [Figure 8] It is an exploded perspective view of a human phantom held by a holder, two rods, and two stopper rings. [Figure 9] It is a perspective view showing an example of a mode in which stopper rings are fitted to one end of each of two rods inserted into a human phantom held by a holder. [Figure 10]This is an exploded perspective view of a human phantom held by a holder, and stopper rings fitted to the other ends of the two rods inserted into the human phantom. [Figure 11] This perspective view shows an example of a configuration in which stopper rings are fitted to the other ends of two rods inserted into a human phantom held by a holder. [Figure 12] This is a conceptual diagram showing an example of a configuration in which a holding device for a human phantom is installed inside a container, and an esophageal model and a boundary region model are attached to the container. [Figure 13] This is a schematic perspective view showing an example of the configuration of the training device 12. [Figure 14] This is a conceptual diagram illustrating examples of how the training system is used by trainees. [Figure 15] This is a state transition diagram showing an example of the process by which a puncture needle penetrates a human phantom, viewed in cross-section of the human phantom. [Modes for carrying out the invention]

[0029] Hereinafter, an example of an embodiment of the apparatus and medical procedure training method relating to this disclosure will be described with reference to the attached drawings.

[0030] First, let's explain the terminology used in the following explanation.

[0031] CT stands for "Computed Tomography." MRI stands for "Magnetic Resonance Imaging." EL stands for "Electro-Luminescence." CMOS stands for "Complementary Metal Oxide Semiconductor." CCD stands for "Charge Coupled Device." BLI stands for "Blue Light Imaging." LCI stands for "Linked Color Imaging."

[0032] In this specification, “orthogonal” means not only perfect orthogonality but also orthogonality that includes errors generally accepted in the art to which the disclosed technology belongs. In this specification, “perpendicular” means not only perfect perpendicularity but also perpendicularity that includes errors generally accepted in the art to which the disclosed technology belongs. In this specification, “parallel” means not only perfect parallelism but also parallelity that includes errors generally accepted in the art to which the disclosed technology belongs. In this specification, “horizontal” means not only perfect horizontality but also horizontality that includes errors generally accepted in the art to which the disclosed technology belongs. In this specification, “transparency” means not only perfect transparency but also transparency that includes errors generally accepted in the art to which the disclosed technology belongs.

[0033] In this specification, "A and / or B" is synonymous with "at least one of A and B." That is, "A and / or B" means that it may be A alone, or B alone, or a combination of A and B. Furthermore, in this specification, the same concept as "A and / or B" applies when expressing three or more things linked by "and / or."

[0034] Figure 1 shows an example of the overall configuration of a training system 10 used for training in ultrasound-guided puncture procedures, including ultrasound-guided biliary drainage and ultrasound-guided pancreatic duct drainage.

[0035] As shown in Figure 1, the training system 10 comprises an endoscope system 11 and a training device 12. The endoscope system 11 comprises an ultrasound endoscope 14, a light source device 16, an ultrasound observation device 17, an endoscope processor device 18, and a display device 20. In this embodiment, the ultrasound endoscope 14 is an example of an "ultrasound endoscope" according to the disclosure.

[0036] The ultrasound endoscope 14 is inserted into a tubular organ of a subject (e.g., a patient) by a physician and manipulated by the physician to perform medical procedures within the tubular organ. Examples of tubular organs include the esophagus, stomach, and duodenum. The medical procedure is a procedure using the ultrasound endoscope 14. The medical procedure includes observation and treatment. Examples of organs on which medical procedures are performed include the stomach, duodenum, liver, pancreas, bile duct, and pancreatic duct.

[0037] The ultrasound endoscope 14 has an optical upper gastrointestinal endoscope. The ultrasound endoscope 14 is an endoscope equipped with an ultrasonic transducer at the tip of an optical upper gastrointestinal endoscope. The ultrasound endoscope 14 is inserted into the upper gastrointestinal tract, which is an example of a tubular organ, and detects the reflected light obtained by irradiating light into the upper gastrointestinal tract and outputting the detection result as an electrical signal to the endoscope processor device 18. In addition, the ultrasound endoscope 14 detects the reflected waves obtained by emitting ultrasound in the upper gastrointestinal tract by the ultrasound observation device 17. The ultrasound observation device 17 outputs an ultrasound image, which is an image showing the detection result of detecting the reflected waves, to the display device 20. The display device 20 displays the ultrasound image input from the ultrasound observation device 17. Here, an example is given in which the ultrasound observation device 17 directly outputs the ultrasound image to the display device 20, but this is only an example, and the ultrasound observation device 17 may also output the ultrasound image to the display device 20 via the endoscope processor device 18.

[0038] The ultrasound endoscope 14 performs imaging within tubular organs. Here, the concept of imaging includes both optical imaging and ultrasound imaging. In other words, imaging as used here refers to the process of detecting physical energy from the object being observed within a tubular organ (e.g., reflected light or reflected ultrasound waves) and outputting the detection result as an electrical signal that can be visualized.

[0039] The ultrasound endoscope 14 comprises an operating section 22 and an insertion section 24. The insertion section 24 is tubular in shape. The insertion section 24 has a tip section 26, a bending section 28, and a flexible section 30. The tip section 26, the bending section 28, and the flexible section 30 are arranged in that order from the tip side to the proximal end of the insertion section 24. The flexible section 30 is made of a long, flexible material and connects the operating section 22 and the bending section 28. The bending section 28 bends partially when the operating section 22 is operated. The ultrasound endoscope 14 may also be configured so that the bending section 28 rotates around the axis of the insertion section 24 when the operating section 22 is operated. The insertion section 24 is advanced into the tubular organ by bending or rotating around the axis of the insertion section 24 according to the shape of the tubular organ (for example, the shape of the tubular passage of the upper digestive tract).

[0040] The tip portion 26 is provided with an ultrasonic probe 32 and an opening 34 for treatment instruments. The ultrasonic probe 32 is located on the tip side of the tip portion 26. The ultrasonic probe 32 is a convex-type ultrasonic probe having an ultrasonic transducer. The ultrasonic probe 32 emits ultrasonic waves by activating the ultrasonic transducer. The ultrasonic probe 32 receives the reflected waves obtained when the emitted ultrasonic waves are reflected from a target area such as the stomach wall, liver, pancreas, bile duct, or pancreatic duct. Here, a convex-type ultrasonic probe is given as an example of the ultrasonic probe 32, but this is merely an example, and for example, a radial-type ultrasonic probe may also be used. The ultrasonic observation device 17 generates an ultrasonic image based on the reflected waves detected by the ultrasonic probe 32 and displays the generated ultrasonic image on the display device 20.

[0041] The instrument opening 34 is formed on the proximal end side of the tip portion 26 of the ultrasound probe 32. The instrument opening 34 is an opening for the instrument 36 to protrude from the tip portion 26. An instrument insertion port 38 is formed in the operating section 22, and the instrument 36 is inserted into the insertion section 24 through the instrument insertion port 38. The instrument 36 passes through the insertion section 24 and protrudes to the outside of the ultrasound endoscope 14 through the instrument opening 34. The instrument opening 34 is also used as a suction port for aspirating blood and bodily waste, and as an outlet for discharging fluids.

[0042] In the example shown in Figure 1, a puncture needle 36A is shown as the treatment instrument 36. However, this is merely one example, and other examples of treatment instruments 36 include guide wires, drainage tubes, catheters, cannulas, puncture needles with guide sheaths, grasping forceps, papillotome knives, and snares.

[0043] The ultrasound endoscope 14 is equipped with an illumination device 40. The illumination device 40 has a light-transmitting window 40A and a light guide (not shown). The light-transmitting window 40A is provided at the tip 26. The light guide is built into the ultrasound endoscope 14. The illumination device 40 is connected to a light source device 16. Light generated by the light source device 16 is supplied to the illumination device 40. The light supplied from the light source device 16 to the illumination device 40 is emitted from the light-transmitting window 40A at the tip 26 of the ultrasound endoscope 14 via the light guide. Examples of the types of light emitted from the light-transmitting window 40A include white light and special light. Examples of special light include light for BLI and / or light for LCI.

[0044] The ultrasound endoscope 14 is equipped with an optical imaging system 42. The optical imaging system 42 has an optical system (not shown) and an image sensor (not shown). The optical system has an objective lens 42A, a magnification lens, and an imaging lens. The objective lens 42A is provided at the tip 26. When light is irradiated from the luminous organ by the illumination device 40, the light reflected from the imaging target area (e.g., the esophageal wall, stomach wall, or duodenal wall, etc.) enters the optical system. The imaging target area light is imaged onto the light-receiving surface of the image sensor via the optical system.

[0045] A first example of an image sensor is a CMOS image sensor. A second example of an image sensor is a CCD image sensor. Note that other types of image sensors besides CMOS and CCD image sensors may also be used. The image sensor captures the light of the target area, which is imaged onto the light-receiving surface via an optical system.

[0046] The ultrasound endoscope 14 is connected to the endoscope processor device 18. The endoscope processor device 18 acquires electrical signals from the ultrasound endoscope 14 and processes the acquired electrical signals to create an image. In other words, the endoscope processor device 18 generates a medical image based on the electrical signals acquired from the ultrasound endoscope 14. The endoscope processor device 18 outputs the generated medical image. Possible output destinations for the medical image include a display device 20, storage (not shown), a personal computer, and / or a server (not shown).

[0047] The endoscope processor device 18 generates and outputs optical images and ultrasound images as medical images. Optical images are generated based on the light of the imaging target area detected by the image sensor of the optical imaging system 42. Ultrasound images are generated based on the reflected waves detected by the ultrasound probe 32.

[0048] The display device 20 is connected to the endoscope processor device 18 and displays various information, including medical images, under the control of the endoscope processor device 18. An example of the display device 20 is a liquid crystal display or an EL display.

[0049] The training device 12 is used for training in medical procedures using an ultrasound endoscope 14. For example, the training device 12 is used for training in ultrasound-guided puncture procedures using an ultrasound endoscope 14. The training device 12 comprises a human phantom 44, a container 46, liquid 48, a holding device 50, an esophageal model 52, and a boundary site model 54.

[0050] The human phantom 44 is a model corresponding to the liver and stomach wall of the human body. In this embodiment, "corresponding model" can also be read as "imitated model" or "assumed model." The human phantom 44 is a training device used for training in medical procedures using an ultrasound endoscope 14. For example, here, a medical procedure using an ultrasound endoscope 14 refers to a medical procedure that includes puncturing an organ (here, for example, the liver parenchyma and intrahepatic bile duct) from the digestive tract of the human body (here, for example, the stomach) with a puncture needle 36A.

[0051] The container 46 is a transparent, cube-shaped container with a rectangular opening at the top. The container 46 holds a liquid 48. One example of the liquid 48 is water, which is used as a medium for transmitting ultrasonic waves. The human phantom 44 is placed inside the container 46. Furthermore, the human phantom 44 is submerged in the liquid 48 contained within the container 46.

[0052] The holding device 50 movably holds the human phantom 44 within a container 46 containing liquid 48. The esophageal model 52 is a model corresponding to the human esophagus and communicates with the outside to the inside of the container 46. The boundary site model 54 is a model corresponding to the boundary site between the human esophagus and stomach (for example, the area where the esophageal sphincter and cardia are located).

[0053] In this embodiment, the human phantom 44 is an example of the “device” according to the disclosure. Also in this embodiment, the container 46 is an example of the “container” according to the disclosure. Also in this embodiment, the esophageal model 52 is an example of the “third model” according to the disclosure. Also in this embodiment, the boundary region model 54 is an example of the “valve-like member” according to the disclosure.

[0054] Incidentally, endoscopic ultrasound-guided puncture procedures include endoscopic ultrasound-guided biliary drainage and endoscopic ultrasound-guided pancreatic duct drainage. As an example, as shown in Figure 2, in endoscopic ultrasound-guided biliary drainage, puncture is performed from the inside of the stomach 56 into the intrahepatic bile duct 58. In this case, the puncture needle 36A is inserted from the stomach wall 56A through the liver parenchyma 60 of the liver 59 into the intrahepatic bile duct 58 of the liver 59. After puncture, a guidewire is inserted into the intrahepatic bile duct 58, and a drainage tube is inserted into the intrahepatic bile duct 58 along the guidewire.

[0055] On the other hand, as shown in Figure 3 as an example, in ultrasound-guided pancreatic duct drainage, a puncture is performed from the inside of the stomach 56 into the pancreatic duct 62 within the pancreas 61. In this case, the puncture needle 36A is inserted from the stomach wall 56A through the pancreatic parenchyma 64 (in other words, the pancreatic body) of the pancreas 61 into the pancreatic duct 62. After the puncture, a guidewire is inserted into the pancreatic duct 62, and a drainage tube is inserted into the pancreatic duct along the guidewire.

[0056] Ultrasonographic endoscopic puncture procedures, such as the ultrasound-guided biliary drainage shown in Figure 2 and the ultrasound-guided pancreatic duct drainage shown in Figure 3, are known to be difficult procedures due to their high incidence of complications. However, with recent improvements to ultrasound endoscopes 14 and instruments 36, these procedures are becoming more established. In this context, the number of physicians wishing to perform ultrasound-guided puncture procedures is increasing, but there is a challenge in the limited opportunities for training. Furthermore, even when training opportunities are available, conventionally known human phantoms deviate significantly from actual clinical practice, resulting in very few cases where actual ultrasound-guided puncture procedures can be performed immediately after training.

[0057] While conventional human phantoms allow trainees to learn the procedures for endoscopic ultrasound-guided punctures, they do not provide a realistic clinical experience. For example, conventional human phantoms all have simplified bile duct or pancreatic duct routes, which differ from actual routes. Also, human phantoms without a stomach wall cannot perform punctures through the stomach wall. Furthermore, conventional human phantoms do not provide the tactile sensation of puncturing the bile duct during training in the sequence of puncturing the stomach, liver, and bile duct. In addition, conventional human phantoms lack a cardia, resulting in a different sensation of fixing the endoscope compared to actual clinical practice, making the training less difficult than in real clinical situations. Moreover, conventional human phantoms are not durable enough for repeated use. Furthermore, conventional human phantoms have the drawbacks of being complicated to set up and having poor reproducibility. Therefore, there is a need for the development of a human phantom that can reproduce an environment close to actual clinical practice and allow trainees to transition to actual procedures after training.

[0058] In light of these circumstances, in this embodiment, the training device 12 is used for training in endoscopic ultrasound-guided puncture procedures (see Figures 1 and 12-14). An example of the training device 12 will be described in detail below.

[0059] Figures 4 to 6 show an example of how to make a human phantom 44 used in the training device 12. As an example, as shown in Figure 4, the human phantom 44 includes a first model 66 and a second model 68. The human phantom 44 is made of a material that is transparent to radiation. In other words, a material that is transparent to radiation can be described as a material that allows for visual recognition of the internal configuration of the human phantom 44 from radiation images obtained by imaging the human phantom 44 with a radiation imaging device, or a material that is transparent to radiation.

[0060] The first model 66 is a model corresponding to the wall of the digestive tract. The second model 68 is a model corresponding to an organ. The organ assumed by the second model 68 is an organ located adjacent to the digestive tract assumed by the first model 66. In this embodiment, the digestive tract assumed by the first model 66 is the stomach (see Figures 2 and 3), and the organ assumed by the second model 68 is the liver 59. Also, in this embodiment, the wall of the digestive tract refers to the stomach wall 56A (see Figures 2 and 3).

[0061] In the following, we will describe an example of a configuration in which training for endoscopic ultrasound-guided biliary drainage is performed, but this is merely one example, and this disclosure is valid even when training for endoscopic ultrasound-guided pancreatic duct drainage is performed. When training for endoscopic ultrasound-guided pancreatic duct drainage is performed, the first model 66 is a model corresponding to the stomach wall 56A, and the second model 68 is a model corresponding to the pancreas 61, which is an organ located adjacent to the stomach 56.

[0062] The resistance of the stomach wall 56A to puncture by the puncture needle 36A is different from the resistance of the liver 59 to puncture by the puncture needle 36A. Therefore, in order to reproduce these differences in resistance in the human phantom 44, in this embodiment, the resistance of the first model 66 to puncture by the puncture needle 36A is made different from the resistance of the second model 68 to puncture by the puncture needle 36A. For example, the resistance of the liver 59 to puncture by the puncture needle 36A is smaller than the resistance of the stomach wall 56A to puncture by the puncture needle 36A, so following this, in this embodiment, the resistance of the second model 68 to puncture by the puncture needle 36A is made smaller than the resistance of the first model 66 to puncture by the puncture needle 36A. In other words, this means that the first model 66 is made harder than the second model 68. Making the first model 66 harder than the second model 68 is achieved by differentiating the thickness, material composition, and / or modulus of elasticity between the first model 66 and the second model 68.

[0063] The material of the first model 66 is a non-biological material. In this embodiment, in order to reproduce the sensation of puncturing the stomach wall 56A with a puncture needle 36A, the material of the first model 66 is, for example, polyvinyl alcohol and a polymer such as silicone.

[0064] The first model 66 is flat and has a rectangular shape in plan view. The first model 66 has four through holes 66C. The through holes 66C are formed near each of the four corners in plan view of the first model 66. Each through hole 66C penetrates the first model 66 in the thickness direction. In other words, each through hole 66C penetrates from the top surface 66A, which is one surface of the first model 66 in the thickness direction, to the bottom surface 66B, which is the other surface of the first model 66 in the thickness direction. In the example shown in Figure 4, the four through holes 66C are shown as 66C1, 66C2, 66C3, and 66C4 in a counterclockwise direction when the top surface 66A is viewed in plan view. The through holes 66C1 and 66C4 form pairs between opposite sides in the longitudinal direction of the upper surface 66A, and the through holes 66C2 and 66C3 form pairs between opposite sides in the longitudinal direction of the upper surface 66A.

[0065] The material of the second model 68 is a non-biomaterial. In this embodiment, in order to reproduce the sensation of puncturing the liver 59 with a puncture needle 36A, the material of the second model 68 is, for example, polyvinyl alcohol and a polymer such as silicone.

[0066] The second model 68 has a second model body 68A and a tubular structure 68B. The second model body 68A is the part corresponding to the liver parenchyma 60 and is formed in a rectangular parallelepiped shape. The second model body 68A has a tubular structure 68B. The tubular structure 68B is embedded within the second model body 68A. The tubular structure 68B is the part corresponding to the intrahepatic bile duct 58 and is formed in a dendritic shape.

[0067] The tubular structure 68B is defined based on three-dimensional volume data relating to the intrahepatic bile duct 58. In other words, the geometric properties of the tubular structure 68B correspond to the geometric properties of the intrahepatic bile duct 58 as indicated by the three-dimensional volume data relating to the intrahepatic bile duct 58. Three-dimensional volume data refers to a continuous set of data arranged in three-dimensional space. The three-dimensional volume data relating to the intrahepatic bile duct 58 is generated based on a large number of slice images obtained by imaging the intrahepatic bile duct 58 using CT or MRI.

[0068] The tubular structure 68B has multiple tubular portions 68B1 corresponding to multiple branched intrahepatic bile ducts 58. One end 68B2 of the tubular structure 68B extends to the outer edge 68A1 of the second model body 68A and is exposed to the outside of the second model body 68A. The end 68B2 is open. Here, an example is given in which one end 68B2 is exposed to the outside of the second model body 68A, but this is merely one example, and multiple ends, including end 68B2, may be exposed to the outside of the second model body 68A.

[0069] The tubular portion 68B1 is harder than the first model 66 and the second model body 68A. Making the tubular portion 68B1 harder than the first model 66 and the second model body 68A is achieved by differentiating the thickness, material composition, and / or modulus of elasticity between the tubular portion 68B1 and the first model 66, and by differentiating the thickness, material composition, and / or modulus of elasticity between the tubular portion 68B1 and the second model body 68A.

[0070] Herein, an example of a configuration in which the tubular portion 68B1 is harder than both the first model 66 and the second model body 68A is given. However, this is merely an example, and the disclosure is valid even if the tubular portion 68B1 is harder than only the second model body 68A of the first model 66 and the second model body 68A.

[0071] The tube structure 68B is injected with a liquid 70 corresponding to bile. The liquid 70 corresponding to bile can also be interpreted as a liquid 70 that mimics bile or a liquid 70 that is intended to be bile. The liquid 70 is injected into the tube structure 68B from the opening at end 68B2. The liquid 70 is a lubricant. The lubricant is merely an example; a contrast agent may be used instead of the lubricant, or a liquid mixture of the lubricant and the contrast agent may be used. It is preferable that the tube structure 68B is liquid-tight due to the liquid 70, but this disclosure is valid even if it is not liquid-tight.

[0072] The second model body 68A has a pair of through holes 68C. The pair of through holes 68C are through holes 68C1 and 68C2. Each of the through holes 68C1 and 68C2 penetrates the second model body 68A in a direction that crosses over the pipe structure 68B without interfering with the pipe structure 68B. The position of through hole 68C1 corresponds to the positions of two through holes 66C1 and 66C4 that form a pair between opposite longitudinal sides of the upper surface 66A, and the position of through hole 68C2 corresponds to the positions of two through holes 66C2 and 66C3 that form a pair between opposite longitudinal sides of the upper surface 66A.

[0073] In this embodiment, the first model 66 is an example of the "first model" according to the disclosure. Also, in this embodiment, the stomach 56 is an example of the "gastrointestinal tract" and "stomach" according to the disclosure. Also, in this embodiment, the stomach wall 56A is an example of the "wall of the gastrointestinal tract" according to the disclosure. Also, in this embodiment, the tubular portion 68B1 is an example of the "tubular portion" according to the disclosure. In this embodiment, the second model 68 is an example of the "second model" according to the disclosure. Also, in this embodiment, the second model body 68A is an example of the "body of the second model" according to the disclosure. Also, in this embodiment, the intrahepatic bile duct 58 or pancreatic duct 62 is an example of the "tubular organ within an organ" according to the disclosure. Also, in this embodiment, the intrahepatic bile duct 58 is an example of the "bile duct" according to the disclosure. Also, in this embodiment, the pancreatic duct 62 is an example of the "pancreatic duct" according to the disclosure. Also, in this embodiment, the tubular structure 68B is an example of the "tubular structure" according to the disclosure. Furthermore, in this embodiment, the liver 59 is an example of the “organ” and “liver” as described in this disclosure. Furthermore, in this embodiment, the pancreas 61 is an example of the “organ” and “pancreas” as described in this disclosure.

[0074] As an example, as shown in Figures 4 and 5, the second model 68 is placed in the center of the upper surface 66A of the first model 66 in a predetermined orientation. Here, the predetermined orientation refers to an orientation in which, in a plan view of the upper surface 66A, the through holes 68C1, 66C1, and 66C4 are on the same straight line, and the through holes 68C2, 66C2, and 66C3 are on the same straight line.

[0075] In other words, a predetermined orientation can be described as an orientation in which one opening of through hole 68C1 faces the opening on the upper surface 66A side of through hole 66C1, the other opening of through hole 68C1 faces the opening on the upper surface 66A side of through hole 66C4, one opening of through hole 68C2 faces the opening on the upper surface 66A side of through hole 66C2, and the other opening of through hole 68C2 faces the opening on the upper surface 66A side of through hole 66C3.

[0076] As an example, as shown in Figure 5, with the second model 68 placed in a predetermined position in the center of the upper surface 66A of the first model 66, the first model 66 is bent towards the side of the second model 68 so that the through holes 68C1, 66C1, and 66C4 are in communication, and the through holes 68C2, 66C2, and 66C3 are in communication. Then, as an example, as shown in Figure 6, the upper surface 66A of the first model 66 is brought into contact with the side of the second model 68.

[0077] Figures 7 to 11 show an example of the procedure for attaching the human phantom 44 (i.e., the human phantom 44 shown in Figure 6) to the holding device 50 with the upper surface 66A of the first model 66 in contact with the side surface of the second model 68.

[0078] For the sake of explanation, the following description will use three predetermined directions for the training device 12. The three predetermined directions for the training device 12 are the X, Y, and Z directions, which define the orientation in three-dimensional space. The X direction refers to the direction parallel to the width direction of the container 46 (see Figures 1 and 12-14). The Y direction refers to the direction parallel to the depth direction of the container 46 (see Figures 1 and 12-14). The Z direction refers to the height direction of the container 46 (i.e., the direction perpendicular to both the X and Y directions).

[0079] As an example, as shown in Figure 7, a tube 71 corresponding to the extrahepatic bile duct is detachably attached to one end 68B2 of the tubular structure 68B. In other words, the tube 71 corresponding to the extrahepatic bile duct can be interpreted as a tube 71 that mimics the extrahepatic bile duct or a tube 71 that is assumed to be the extrahepatic bile duct. When the tube 71 is attached to end 68B2, liquid 70 is injected into the tubular structure 68B from the tube 71. Liquid 70 is also injected into the tube 71.

[0080] The holding device 50 comprises a pair of rods 72, a support column 74, and a holder 76. In this embodiment, the holder 76 is an example of the “holder” according to the present disclosure.

[0081] A pair of rods 72 are formed in a cylindrical shape along the X direction. The support column 74 has a sliding member 74A and a bracket 74B. The sliding member 74A is formed in a cylindrical shape. The pair of rods 72 are inserted through the sliding member 74A. The sliding member 74A slides along the pair of rods 72 in the X direction when subjected to an external force in the X direction. In this embodiment, the X direction is an example of the "horizontal direction" according to this disclosure.

[0082] The support column 74 is provided with a yaw axis YA parallel to the Z direction. The yaw axis YA is an axis that passes through the center of the upper surface and the center of the lower surface of the slide member 74A. The bracket 74B is provided at the bottom of the slide member 74A and is rotatable around the yaw axis YA.

[0083] Bracket 74B comprises a first member 74B1 and a second member 74B2. The first member 74B1 is provided on the lower surface of the support column 74A. The second member 74B2 is provided on the first member 74B1. A holder 76 is provided on the side surface of the second member 74B2. The holder 76 holds the human phantom 44. The holder 76 has a flat base 76A and a pair of side walls 76B. The pair of side walls 76B are provided on both ends of the base 76A and hold the human phantom 44 from both sides of the base 76A.

[0084] One of the pair of side walls 76B is the first side wall 76B1, and the other of the pair of side walls 76B is the second side wall 76B2. The distance between the first side wall 76B1 and the second side wall 76B2 in the X direction is slightly narrower than the width of the human phantom 44. The width of the human phantom 44 corresponds to the length of the communicating through holes 66C1, 68C1, and 66C4 (see Figure 6), or the length of the communicating through holes 66C2, 68C2, and 66C3 (see Figure 6).

[0085] The first side wall 76B1 is provided with bearings 76B1a and 76B1b at a fixed interval in the Z direction. The second side wall 76B2 is provided with bearings 76B2a and 76B2b at a fixed interval in the Z direction.

[0086] The holding device 50 is provided with a yaw axis YA, a roll axis RA, and a pitch axis PA. The roll axis RA is an axis parallel to the X direction and passes through the lower part of the first member 74B1 along the X direction. The pitch axis PA is parallel to the Y direction and passes through the center of the base body 76A along the Y direction. The second member 74B2 is attached to the first member 74B1 and is rotatable around the roll axis RA relative to the first member 74B1. The base body 76A is attached to the second member 74B2 and is rotatable around the pitch axis PA.

[0087] The human body phantom 44 is press-fitted between the first side wall 76B1 and the second side wall 76B2 with the longitudinal direction of the human body phantom 44 coinciding with the Z direction, and the exposed surface of the second model 68 (i.e., the surface opposite to the surface in contact with the upper surface 66A of the first model 66) facing the base 76A. When the human body phantom 44 is press-fitted between the first side wall 76B1 and the second side wall 76B2 to the point where the exposed surface of the second model 68 contacts the base 76A, the center of the through hole 66C1 coincides with the center of the bearing 76B1a, the center of the through hole 66C2 coincides with the center of the bearing 76B1b, the center of the through hole 66C4 (see Figure 6) coincides with the center of the bearing 76B2a, and the center of the through hole 66C3 (see Figure 6) coincides with the center of the bearing 76B2b.

[0088] When the human body phantom 44 is pressed between the first side wall 76B1 and the second side wall 76B2 in this manner, as shown in Figure 8 as an example, a cylindrical rod 78 is inserted from bearing 76B1a through through holes 66C1, 68C1, and 66C4 to bearing 76B2a (see Figure 7). Also, a cylindrical rod 80 is inserted from bearing 76B1b through through holes 66C2, 68C3, and 66C3 to bearing 76B2b (see Figure 7).

[0089] In this state, as an example, as shown in Figure 9, a stopper ring 82 is fitted to the end of rod 78 on the bearing 76B1a side, and a stopper ring 84 is fitted to the end of rod 80 on the bearing 76B1b side. Similarly, as an example, as shown in Figures 10 and 11, a stopper ring 86 is fitted to the end of rod 78 on the bearing 76B2a side, and a stopper ring 88 is fitted to the end of rod 80 on the bearing 76B2b side. As a result, the human phantom 44 is held by the holder 76.

[0090] The holder 76 changes the position of the human body phantom 44 by receiving an external force while holding the human body phantom 44. Examples of changes in the position of the human body phantom 44 include changes in the horizontal position and the tilt of the human body phantom 44. The horizontal position of the human body phantom 44 is changed by sliding the slide member 74A along the pair of rods 72. The tilt of the human body phantom 44 is changed by rotating the holder 76, while holding the human body phantom 44, around the yaw axis YA, around the roll axis RA, or around the pitch axis PA.

[0091] Figure 12 shows an example of the configuration of the training device 12 when it does not contain liquid 48. As an example, as shown in Figure 12, a holding device 50 is provided inside the container 46 in which a human phantom 44 is held by a holder 76. In the example shown in Figure 12, a pair of rods 72 of the holding device 50 are mounted along the X direction on opposing side walls 46A and 46B of the container 46. This allows the holding device 50, in which the human phantom 44 is held by the holder 76, to slide along the X direction between one side wall 46A and 46B and the other side inside the container 46.

[0092] The esophageal model 52 includes a flexible tube 52A and a cylindrical receiving member 52B with open ends. Both ends of the tube 52A are open. One end 52A1 of the tube 52A is inserted into the container 46 from the side wall 46A. One end 52B1 of the receiving member 52B is attached to the other end 52A2 of the tube 52A. The receiving member 52B accepts the insertion of the ultrasound endoscope 14 from the other end 52B2 and guides the ultrasound endoscope 14 into the tube 52A.

[0093] Within the container 46, a boundary section model 54 is provided at one end 52A1 of the tube 52A. The boundary section model 54 is a valve-like member made of elastic resin, corresponding to the esophageal sphincter and cardia of the human body. In other words, the boundary section model 54 can be described as a valve-like member that mimics the esophageal sphincter and cardia of the human body (i.e., a valve-like member that assumes the esophageal sphincter and cardia of the human body).

[0094] The boundary region model 54 has an annular outer frame 54A and a plurality of flaps 54B. The plurality of flaps 54B are provided inside the outer frame 54A. The flaps 54B are triangular membranes and are arranged at equal intervals along the inner circumference of the outer frame 54A.

[0095] As an example, as shown in Figure 13, a holding device 50 is provided inside the container 46, in which the human phantom 44 is held by the holder 76. With the esophagus model 52 and boundary region model 54 provided in relation to the container 46, liquid 48 is poured into the container 46. Liquid 48 accumulates in the container 46, and part or all of the human phantom 44 is immersed in the liquid 48.

[0096] Next, the operation and effects of the training system 10, including the training device 12 configured as shown in Figure 13, will be explained with reference to Figures 14 and 15. For the sake of explanation, the case in which a trainee 89 performs training simulating endoscopic ultrasound-guided biliary drainage will be described.

[0097] As an example, as shown in Figure 14, the trainee 89 performs a simulated procedure on a human phantom 44 using an ultrasound endoscope 14 (in this case, ultrasound endoscope-guided biliary drainage as an example). In this case, first, the trainee 89 inserts the tip 26 of the ultrasound endoscope 14 into the esophagus model 52 from the other end 52B2 of the receiving member 52B. Next, the trainee 89 places the tip 26 of the ultrasound endoscope 14 from the esophagus model 52 through the boundary site model 54 into the liquid 48 in the container 46. This allows the trainee 89 to grasp the feel of manipulating the ultrasound endoscope 14 during the process of inserting it from the esophagus to the stomach 56 (see Figure 2) of a human body. Furthermore, since the boundary site model 54 is a model corresponding to the esophageal sphincter and cardia of a human body, the trainee 89 can grasp the feel of manipulating the ultrasound endoscope 14 during the process of passing through the esophageal sphincter and cardia of a human body.

[0098] In the liquid 48 inside the container 46, the ultrasound probe 32 emits ultrasound waves. The ultrasound waves are reflected by the human body phantom 44, and the reflected waves are detected by the ultrasound probe 32. The ultrasound image 90 generated based on the detection results by the ultrasound probe 32 is displayed on the display device 20. In the example shown in Figure 14, the ultrasound image 90 shows multiple tubular parts 68B1. The trainee 89 identifies the puncture site in the human body phantom 44 while observing the ultrasound image 90. This allows the trainee 89 to visualize the human body phantom 44 in the liquid 48 as the stomach 56 and liver 59 in the context of ultrasound-guided biliary drainage. The trainee 89 can also get a feel for operating the ultrasound endoscope 14 in the liquid accumulated in the stomach 56 when ultrasound-guided biliary drainage is performed. Furthermore, the trainee 89 can get a feel for identifying the puncture site in the stomach wall 56A (see Figure 2).

[0099] Once trainee 89 identifies the site to be punctured in the human phantom 44, he extends the puncture needle 36A from the tip 26 of the ultrasound endoscope 14 and inserts the puncture needle 36A into the first model 66 (see Figure 15). Since the first model 66 is a model corresponding to the stomach wall 56A (see Figure 2), trainee 89 can get a feel for inserting the puncture needle 36A into the stomach wall 56A from the inside of the stomach 56.

[0100] As an example, as shown in Figure 15, when trainee 89 inserts the puncture needle 36A further into the human phantom 44, the tip of the puncture needle 36A eventually enters the second model body 68A from the first model 66. The first model 66 is a model corresponding to the stomach wall 56A (see Figure 2), and the second model body 68A is a part corresponding to the liver parenchyma 60 (see Figure 2), which is located adjacent to the stomach wall 56A (in other words, a part that mimics the liver parenchyma 60 or a part that assumes the liver parenchyma 60). Furthermore, the second model body 68A is softer than the first model 66. Therefore, trainee 89 can grasp the sensation of inserting the puncture needle 36A from the stomach wall 56A into the liver parenchyma 60, which is located adjacent to the stomach wall 56A.

[0101] Furthermore, when trainee 89 inserts the puncture needle 36A further into the human phantom 44, the tip of the puncture needle 36A eventually enters the tubular portion 68B1 from the second model body 68A. The tubular portion 68B1 is a model corresponding to the intrahepatic bile duct 58 and is harder than the first model 66 and the second model body 68A. Therefore, trainee 89 can get a feel for inserting the puncture needle 36A from the liver parenchyma 60 into the intrahepatic bile duct 58.

[0102] Furthermore, the tubular structure 68B, including the tubular portion 68B1, is formed in a dendritic manner based on three-dimensional volume data relating to the intrahepatic bile duct 58. Therefore, trainees 89 can practice the procedure of inserting a puncture needle 36A into the tubular structure 68B, which has geometric characteristics similar to those of the actual intrahepatic bile duct 58.

[0103] Trainee 89 inserts the puncture needle 36A into the tubular section 68B1, then inserts a guidewire into the tubular section 68B1 from inside the puncture needle 36A, and inserts the drainage tube into the tubular section 68B1 along the guidewire. This training simulates a medical procedure in which a drainage tube is inserted into the intrahepatic bile duct 58 to perform drainage.

[0104] Liquid 70 is injected into the tubular structure 68B. Liquid 70 is a liquid corresponding to bile (in other words, a liquid that mimics bile or is intended to resemble bile). When the trainee 89 inserts a drainage tube into the intrahepatic bile duct 58, the liquid 70 in the tubular portion 68B1 is drained out of the human phantom 44 through the drainage tube. Through this training (i.e., training in which a puncture procedure is performed by puncturing the tubular portion 68B1, which is part of the tubular structure 68B, followed by a guidewire insertion procedure to insert a guidewire, a drainage tube insertion procedure to insert a drainage tube which is a tubular component, and a drainage procedure to drain the liquid 70 out of the human phantom 44), the trainee 89 can get a feel for the medical procedures after the puncture needle 36A has been inserted into the intrahepatic bile duct 58 (i.e., guidewire insertion, drainage tube insertion, and bile drainage, etc.).

[0105] As described above, the human phantom 44 according to this embodiment is a training device for procedures including the insertion of a puncture needle 36A from the stomach 56 into the liver 59, and comprises a first model 66 and a second model 68. The first model 66 is a model corresponding to the stomach wall 56A, and the second model 68 is a model corresponding to the liver 59, which is located adjacent to the stomach 56. Therefore, the human phantom 44 according to this embodiment makes it easier to reproduce the sensation of inserting a puncture needle 36A from inside the stomach 56 into the liver 59.

[0106] Furthermore, in this embodiment, the first model 66 is harder than the second model 68. Therefore, according to the human phantom 44 of this embodiment, it is possible to easily reproduce the sensation of inserting a puncture needle 36A into the liver 59 from inside the stomach 56, which is harder than the liver 59.

[0107] Furthermore, in this embodiment, the first model 66 and the second model 68 differ in thickness, material composition, and / or elastic modulus. Therefore, the reproducibility of the tactile sensation when inserting the puncture needle 36A from the stomach 56 into the liver 59 can be easily improved.

[0108] Furthermore, in this embodiment, the resistance of the second model 68 to puncture is smaller than that of the first model 66 to puncture. Therefore, the reproducibility of the sensation when inserting the puncture needle 36A from the stomach 56 into the liver 59 can be improved.

[0109] Furthermore, in this embodiment, the second model 68 has a tubular structure 68B corresponding to the intrahepatic bile duct 58. The tubular structure 68B also has a tubular portion 68B1, and the tubular portion 68B1 is harder than the first model 66 and the second model body 68A. Therefore, the trainee 89 can be trained to perform puncture while being aware of the presence of the intrahepatic bile duct 58. In addition, the trainee 89 can be allowed to experience the sensation of puncturing the intrahepatic bile duct 58 from inside the stomach 56 through the liver parenchyma 60.

[0110] Furthermore, in this embodiment, the thickness, material composition, and elastic modulus of the tubular portion 68B1 and the first model 66 are different, and the thickness, material composition, and elastic modulus of the tubular portion 68B1 and the second model body 68A are also different. Therefore, the reproducibility of the tactile sensation when inserting the puncture needle 36A from the liver parenchyma 60 into the tubular portion 68B1 can be easily improved.

[0111] Furthermore, in this embodiment, the shape of the tubular structure 68B is dendritic. Therefore, trainees 89 can be instructed to practice puncture while being aware of the shape of the intrahepatic bile duct 58.

[0112] Furthermore, in this embodiment, a liquid 70 corresponding to bile is injected into the tube structure 68B. As a result, as shown in Figure 14, the tubular portion 68B1, which is part of the tube structure 68B into which the liquid 70 is injected, is visible in the ultrasound image 90. This allows the trainee 89 to virtually experience a scenario in which medical procedures are performed while observing the intrahepatic bile ducts 58 through a medical image (i.e., an ultrasound image) obtained by imaging the liver 59 with an ultrasound endoscope 14. In addition, since the liquid 70 injected into the tube structure 68B is a lubricant and / or contrast agent, the trainee 89 can experience the sensation of passing a guidewire or the like through an intrahepatic bile duct 58 filled with bile.

[0113] Furthermore, in this embodiment, one end 68B2 of the tube structure 68B extends to the outer edge 68A1 of the second model body 68A. As a result, the end 68B2 is exposed to the outside of the second model body 68A, allowing liquid 70 to be injected into the tube structure 68B from the end 68B2. Also, during training to pass a guidewire through the tube structure 68B, the trainee 89 can visually confirm from the end 68B2 whether or not the guidewire is inside the tube structure 68B. In addition, a tube 71 corresponding to the extrahepatic bile duct can be connected to the end 68B2, making it possible to reproduce an appearance close to that of an actual organ.

[0114] Furthermore, in this embodiment, the tubular structure 68B is determined based on three-dimensional volume data relating to the intrahepatic bile duct 58. Therefore, it becomes possible to practice puncturing the puncture needle 36A or inserting guidewires and drainage tubes into the tubular structure 68B, which has geometric characteristics similar to those of the intrahepatic bile duct 58.

[0115] Furthermore, in this embodiment, the first model 66 and the second model 68 are non-biological materials. As non-biological materials, for example, materials containing polyvinyl alcohol and polymers such as silicone are used. Note that the polymer is not limited to polyvinyl alcohol and / or silicone, but can also be synthetic polymers such as polyurethane and natural polymers such as gelatin or agar, as long as it exhibits desired physical properties such as elastic modulus. Multiple materials may also be mixed or used in combination.Therefore, while human phantoms made from the tissues of living organisms such as animals, which are used to represent the stomach 56 and liver 59, generate unpleasant odors and are difficult to use repeatedly for training, the human phantom 44 according to this embodiment does not generate unpleasant odors and has high durability for repeated training.Furthermore, an arbitrary range in which physical properties such as elastic modulus can be partially controlled by additives such as plasticizers and / or by controlling the curing rate of the polymer can be obtained.This increases the degree of freedom in design.It also increases the degree of freedom in manufacturing.

[0116] Furthermore, in this embodiment, the human phantom 44 is placed inside the container 46. The human phantom 44 is also placed in the liquid 48 stored in the container 46. Therefore, the trainee 89 can be given training that simulates operating the ultrasound endoscope 14 in the liquid (for example, water) stored in the stomach 56. In addition, since ultrasound imaging is performed in the liquid 48, an ultrasound image 90 with image quality similar to that of an ultrasound image obtained by performing ultrasound imaging in the liquid stored in the stomach 56 can be displayed on the display device 20.

[0117] In this embodiment, the human phantom 44 is held by the holder 76, and the position of the human phantom 44 is changed by changing the position of the holder 76. For example, the tilt of the human phantom 44 is changed by rotating the holder 76 holding the human phantom 44 around the yaw axis YA, around the roll axis RA, or around the pitch axis PA. Also, the position of the human phantom 44 held by the holder 76 in the X direction is changed by sliding the slide member 74A along the pair of rods 72. In this way, the human phantom 44 can be placed in a position that assumes the position of the stomach 56 and the liver 59 for each patient.

[0118] Furthermore, in this embodiment, the training device 12 is equipped with an esophageal model 52. The esophageal model 52 is a model that corresponds to the human esophagus. The esophageal model 52 is inserted into the container 46 via the side wall 46A of the container 46. That is, the esophageal model 52 communicates with the outside to the inside of the container 46. This makes it easier to reproduce the sensation of inserting a puncture needle 36A into the liver 59 from inside the stomach 56 into which the ultrasound endoscope 14 has been inserted from the esophagus. In addition, the trainee 89 can practice operating the ultrasound endoscope 14 when it has been inserted into the stomach 56 from the esophagus.

[0119] Furthermore, in this embodiment, the training device 12 is equipped with a boundary region model 54. The boundary region model 54 is a model corresponding to the esophageal sphincter and cardia. Therefore, compared to a training device that does not take the esophageal sphincter and cardia into consideration, it is possible to accurately reproduce the operability of the ultrasound endoscope 14 when inserting a puncture needle 36A into the liver 59 from inside the stomach 56 into which the ultrasound endoscope 14 has been inserted from the esophagus.

[0120] Furthermore, in this embodiment, the human phantom 44 is made of a material that can be seen through with radiation. Therefore, the trainee 89 can see through and observe the inside of the human phantom 44.

[0121] In the above embodiment, an example was given in which training simulating ultrasound-guided biliary drainage is performed using the training device 12. However, this is merely one example, and training simulating ultrasound-guided pancreatic duct drainage can be performed in a similar manner. In this case, the second model 68 can be made into a model representing the pancreas. When the second model 68 is made into a model representing the pancreas, the second model body 68A can be made into a model representing the pancreatic parenchyma, and the tubular structure 68B can be made into a structure representing the pancreatic duct. In this way, the trainee 89 can perform a simulated procedure corresponding to ultrasound-guided pancreatic duct drainage on the human phantom 44, and the same effect as in the above embodiment can be obtained.

[0122] Furthermore, while the above embodiment illustrates a training device 12 for training in puncturing the liver 59 from within the stomach 56, the disclosure is not limited thereto. For example, medical procedures involving puncturing and draining the liver 59 or pancreas 61 from within the duodenum are also conceivable. For training in puncturing the liver 59 or pancreas 61, which are organs adjacent to the duodenum, from within the duodenum, a model corresponding to the duodenal wall may be used instead of the first model 66 corresponding to the stomach wall 56A. In this case, the duodenum is an example of the "digestive tract" and "duodenum" as described in this disclosure, the duodenal wall is an example of the "wall of the digestive tract" as described in this disclosure, and the model corresponding to the duodenal wall is an example of the "first model" as described in this disclosure.

[0123] Furthermore, the human phantom 44, holding device 50, esophageal model 52, and boundary region model 54 described in the above embodiment may be detachable from the container 46. When the human phantom 44, holding device 50, esophageal model 52, and boundary region model 54 are not in use, they are removed from the container 46. The human phantom 44, holding device 50, esophageal model 52, and boundary region model 54 removed from the container 46 may be housed in a portable case or the like. In this way, the set of human phantom 44, holding device 50, esophageal model 52, and boundary region model 54 can be managed together. In addition, the set of human phantom 44, holding device 50, esophageal model 52, and boundary region model 54 can be carried and used in various locations.

[0124] The descriptions and illustrations presented above are detailed explanations of the parts related to this disclosure and are merely examples of this disclosure. For example, the above explanation of the structure, function, operation, and effect is an example of the structure, function, operation, and effect of the parts related to this disclosure. Therefore, it goes without saying that you may delete unnecessary parts, add new elements, or replace parts of the descriptions and illustrations presented above, as long as you do not deviate from the spirit of this disclosure. Furthermore, in order to avoid confusion and facilitate understanding of the parts related to this disclosure, explanations of common technical knowledge, etc., that do not require special explanation to enable the implementation of this disclosure have been omitted from the descriptions and illustrations presented above.

[0125] All documents, patent applications, and technical standards described herein are incorporated by reference to the same extent as if each individual document, patent application, and technical standard were specifically and individually noted to be incorporated by reference.

[0126] The following additional information is disclosed regarding the embodiments described above.

[0127] (Note 1) A training device for procedures including the insertion of instruments into organs from within the digestive tract, The first model corresponds to the wall of the digestive tract, A second model corresponding to the above organs is provided. Equipment.

[0128] (Note 2) The above-mentioned device is placed inside the container. The equipment described in Appendix 1.

[0129] (Note 3) The above container holds liquid, The above-mentioned apparatus is placed in the above-mentioned liquid. The equipment described in Appendix 2.

[0130] (Note 4) The above-mentioned device is held by a holder that allows the position of the device to be changed. The device described in any one of the appendices 1 through 3.

[0131] (Note 5) The holder described above can change the horizontal position and / or the tilt of the device. The equipment described in Appendix 4.

[0132] (Note 6) A third model is also available that is designed for use with the esophagus. The device described in any one of the appendices 1 through 5.

[0133] (Note 7) The third model described above is provided with a valve-like member corresponding to the esophageal sphincter and / or cardia. The equipment described in Appendix 6.

[0134] (Note 8) The above-mentioned device is placed inside the container. The third model described above is connected from the outside to the inside of the container. The apparatus described in Appendix 6 or Appendix 7.

[0135] (Note 9) The above container holds liquid, The above-mentioned apparatus is placed in the above-mentioned liquid. The equipment described in Appendix 8.

[0136] (Note 10) The above procedure is a medical procedure using an endoscopic ultrasound. The above-mentioned device is a training device for the above-mentioned medical procedure. The device described in any one of the appendices 1 through 9.

[0137] (Note 11) The above-mentioned device is made of a material that allows for radiographic visualization. The device described in any one of the appendices 1 through 10.

[0138] (Note 12) A training device for procedures including puncturing organs from within the digestive tract with a medical instrument, comprising a first model corresponding to the wall of the digestive tract and a second model corresponding to the organs, wherein the device is used to perform a simulated procedure corresponding to the procedure. Medical procedure training methods.

[0139] (Note 13) The above simulated procedure includes a specific procedure to identify the puncture site for the instrument using an endoscope ultrasound. Medical procedure training methods as described in Appendix 12.

[0140] (Note 14) The second model described above has a tubular structure corresponding to the tubular organs within the organ described above. The above-mentioned area is part of the above-mentioned pipe structure. Medical procedure training methods as described in Appendix 13.

[0141] (Note 15) The above simulated procedure includes drainage procedures for the above pipe structure. Medical procedure training methods as described in Appendix 14.

[0142] (Note 16) The above drainage procedure includes a puncture procedure in which a puncture is made in the above portion, and an insertion procedure in which a tubular member is inserted from the first model through the second model after the puncture procedure. Medical procedure training methods as described in Appendix 15. [Explanation of symbols]

[0143] 10 Training Systems 11 Endoscopy System 12 Training equipment 14 Ultrasound Endoscope 16 Light source device 17 Ultrasonic observation device 18 Endoscope processor device 20 Display device 22 Control section 24 Insertion part 26 Tip 28 Curved section 30 Soft part 32 Ultrasound probes 34. Opening of the treatment instrument 36. Treatment tools 36A puncture needle 38. Insertion port for treatment instruments 40 Lighting devices 40A Translucent window 42 Optical Imaging Systems 42A Objective Lens 44 Human Phantom 46 Container 48,70 liquid 50 Holding device 52 Esophageal Model 52A, 71 Tube 52A1,52B1 One end 52A2,52B2 Other end 52B Receiving member 54 Boundary Region Model 54A Outer frame 54B Flap 56 Stomach 56A Stomach wall 58 Intrahepatic bile duct 59 Liver 60 Liver parenchyma 61 Pancreas 62 Pancreatic duct 64 Pancreatic parenchyma 66 First Model 66A Top 66B Bottom 66C,66C1,66C2,66C3,66C4,68C,68C1,68C2 Through hole 68 Second Model 68A Second Model Main Unit 68A1 Outer edge 68B tube structure 68B1 Tubular section 68B2 End 72, 78, 80 rods 74 Pillar 74A Sliding member 74B Bracket 74B1 First Member 74B2 Second component 76 Holder 76A Base 76B side wall 76B1 1st side wall 76B1a, 76B1b, 76B2a, 76B2b bearings 76B2 2nd side wall 82, 84, 86, 88 Stopper rings 89 Trainee 90 Ultrasound Images PA pitch axis RA Roll Axis YA yaw axis

Claims

1. A training device for procedures including the insertion of instruments into organs from within the digestive tract, The first model corresponds to the wall of the digestive tract, A second model corresponding to the aforementioned organ is provided. Equipment.

2. The first model is harder than the second model. The apparatus according to claim 1.

3. The first and second models differ in thickness, material composition, and / or modulus of elasticity. The apparatus according to claim 1.

4. The resistance of the first model to the aforementioned puncture is different from the resistance of the second model to the aforementioned puncture. The apparatus according to claim 1.

5. The resistance of the second model to the aforementioned puncture is smaller than the resistance of the first model to the aforementioned puncture. The apparatus according to claim 4.

6. The second model has a tubular structure corresponding to the tubular organ within the organ. The apparatus according to claim 1.

7. The shape of the aforementioned tube structure is dendritic. The apparatus according to claim 6.

8. The aforementioned pipe structure has a tubular portion, The tubular portion is harder than at least the body of the second model among the bodies of the first and second models. The apparatus according to claim 6.

9. The tubular portion and at least the body of the second model among the first and second models differ in thickness, material composition, and / or elastic modulus. The apparatus according to claim 8.

10. Liquid is injected into the aforementioned tubular structure. The apparatus according to claim 6.

11. The liquid includes a lubricant and / or a contrast agent. The apparatus according to claim 10.

12. At least one end of the pipe structure extends to the outer edge of the device. The apparatus according to claim 11.

13. The tube structure is determined based on three-dimensional volume data relating to the tubular organ. The apparatus according to claim 6.

14. The aforementioned organ is the liver. The tubular organ is the bile duct. The apparatus according to claim 6.

15. The aforementioned organ is the pancreas. The tubular organ is the pancreatic duct. The apparatus according to claim 6.

16. The digestive tract is either the stomach or the duodenum. The apparatus according to claim 14.

17. The positional relationship between the digestive tract and the organs is that they are adjacent to each other. The apparatus according to claim 1.

18. The aforementioned digestive tract is the stomach or the duodenum. The aforementioned organ is either the liver or the pancreas. The apparatus according to claim 17.

19. The first and second models are non-biomaterials. The apparatus according to claim 1.

20. The aforementioned non-biomaterial is a material containing a polymer. The apparatus according to claim 19.

21. A training device for procedures including puncturing organs from within the digestive tract with a medical instrument, comprising a first model corresponding to the wall of the digestive tract and a second model corresponding to the organ, wherein the device is used to perform a simulated procedure corresponding to the said procedure. Medical procedure training methods.

Images