Medical simulator

Abstract

[Problem] The purpose of the present invention is to provide a medical simulator using an upper gastrointestinal tract model, the medical simulator being capable of enabling practice of a procedure closer to actual clinical practice. [Solution] Provided is a medical simulator 10 using an upper gastrointestinal tract model 30 including an esophagus model 31, a stomach model 32, and a duodenum model 33, the medical simulator 10 comprising a shape changing unit configured to change a shape of the upper gastrointestinal tract model 30 due to rotation of a mounting table 461 on which the stomach model 32 is placed.

Description

Medical simulator

[0001] The present invention relates to a medical simulator. More specifically, it relates to a medical simulator that can perform hands-on training close to actual practice using an upper gastrointestinal tract model equipped with at least a stomach model in the training of endoscopic procedures using an endoscope scope of an endoscopic system.

[0002] In the medical field, endoscopic systems are widely used, and many types of endoscopic systems are provided according to the luminal organs and usage purposes, such as upper gastrointestinal endoscopes, colonoscopes, bronchoscopes, thoracoscopes, and intravascular endoscopes. This endoscopic system mainly consists of a video scope (endoscope scope) equipped with an imaging element, a system body composed of a video system and a light source device that convert an electrical signal from the endoscope scope into a video signal, and a monitor that displays the video signal from the system body. In addition, some endoscopic systems can not only view the images inside the organs but also enable tissue sampling and polyp resection.

[0003] In the examination using this endoscopic system, the operator must insert the insertion part of the endoscope scope into the organ without damaging the inside of the organ and discover the lesion without missing it. Therefore, highly skilled techniques are required for endoscopic procedures. Thus, medical simulators such as those in Patent Document 1 and endoscopic training visceral gastrointestinal models such as those in Patent Document 2 are known.

[0004] The invention of Patent Document 1 is a medical simulator that reproduces an upper gastrointestinal tract model from the mouth to the duodenum, and the invention of Patent Document 2 is a training model that reproduces an upper gastrointestinal tract model equipped with at least a stomach model.

[0005] Also, as in Non-Patent Document 1 and Non-Patent Document 2, medical simulators of ERCP (endoscopic retrograde cholangiopancreatography) lumen models that reproduce upper gastrointestinal tract models are actually sold.

[0006] Japanese Patent No. 7339679, Japanese Unexamined Patent Application Publication No. 61-213877

[0007] U-A Co., Ltd. "ERCP model" Accessed: October 25, 2024 <https: / / u-art.jp / ercp-model / > Tohoku University "Development of a biliary and pancreatic endoscopy simulator model including reproduction of bleeding complications" Accessed: October 25, 2024 <https: / / www.med.tohoku.ac.jp / wp-content / uploads / 2024 / 02 / press_release_kanno.pdf>

[0008] In the medical simulators described in Patent Document 1, Patent Document 2, Non-Patent Document 1, and Non-Patent Document 2, the upper gastrointestinal tract model is simply fixed to a case or stand. However, there are individual differences in the shapes of the esophageal model, stomach model, and duodenal model that make up the upper gastrointestinal tract, and the shapes differ from person to person.

[0009] In particular, the shape of the stomach, which is used as a model of the stomach, is known to vary greatly depending on the individual. For example, the "hook-shaped stomach" is common in Japanese people, the "ox-horn-shaped stomach" is common in Westerners, and the "waterfall-shaped stomach" is common in others. The difficulty of endoscopic procedures also varies greatly depending on the shape of the stomach.

[0010] Furthermore, in ERCP cannulation, the difficulty of approaching the ampulla of Vater in the duodenum varies greatly depending on the shape of the stomach.

[0011] However, the conventional medical simulators using the upper gastrointestinal tract models described above could not accommodate individual differences in shape, so the practice of endoscopic procedures that could be applied to actual clinical practice was limited. In other words, the medical simulators in Non-Patent Literature 1 and Non-Patent Literature 2 were the same every time up to the ampulla of Vater, and therefore did not allow for practice of cannulation procedures, including the approach to the ampulla of Vater.

[0012] Therefore, the present invention aims to provide a medical simulator that uses an upper gastrointestinal tract model and allows for more realistic practice of medical procedures.

[0013] To achieve the above objective, the medical simulator of the present invention is a medical simulator that uses an upper gastrointestinal tract model equipped with at least a stomach model, and is characterized by being equipped with a shape changing means that can change the shape of the upper gastrointestinal tract model.

[0014] According to the medical simulator of the present invention, the shape of the upper gastrointestinal tract model can be changed, so differences in organ shape due to individual differences can be reproduced, and practice of endoscopic procedures can be performed in a way that is closer to real-world situations.

[0015] Furthermore, in the medical simulator of the present invention, it is preferable that the upper gastrointestinal tract model further comprises an esophageal model connected to the stomach model and a duodenal model connected to the stomach model.

[0016] The medical simulator of the present invention allows for practice of ERCP (endoscopic respiration colonoscopy) procedures using a duodenal endoscope. Furthermore, in the medical simulator of the present invention, the shape-changing means may be provided for each model of the esophagus, stomach, and duodenum. Alternatively, the shape-changing means may be provided for only a specific model. Each model is usually formed from a flexible material such as silicone rubber. Therefore, in the medical simulator of the present invention, by providing the shape-changing means for a specific model and changing the shape of this specific model, the shapes of other flexible models connected to that specific model can also be changed accordingly.

[0017] Furthermore, in the medical simulator of the present invention, the shape changing means preferably consists of rotating the mounting platform on which the stomach model is placed. According to the medical simulator of the present invention, by rotating the mounting platform of the stomach model, the orientation in which the stomach is placed changes, and this change in orientation allows the stomach model to reproduce shapes such as "hook stomach," "bovine stomach," and "waterfall stomach."

[0018] Furthermore, changing the orientation of the stomach model also changes the orientation of the duodenum model connected to it. Therefore, in ERCP procedure practice, it is possible to practice the approach to the ampulla of Vater in a way that is closer to actual practice. In particular, by controlling the rotation of the mounting platform, the medical simulator of the present invention can set the difficulty level based on differences in stomach shape.

[0019] Furthermore, it is known that there are many classifications of the shape of the ampulla of Vater in the duodenum. Therefore, if many variations of the ampulla of Vater are prepared according to these classifications and can be exchanged, the medical simulator of the present invention will be able to set a wider variety of difficulty levels. In addition, in the medical simulator of the present invention, it is preferable that the fundus of the stomach in the stomach model is fixed to the stand described above.

[0020] As with the medical simulator of the present invention, when the orientation of the stomach model is changed while the dome is fixed to the mounting base, the original stomach model can be returned to its original state by rotating the mounting base. For example, using a "hooked stomach" as the reference shape, the shape of a "bull-horned stomach" can be reproduced by rotating the mounting base by 90 degrees. In this state, if the dome is not fixed to the mounting base when the mounting base is rotated 90 degrees in the opposite direction, the stomach model, made of a flexible material, will not return to the reference shape of the "hooked stomach," requiring, for example, manual correction to return it to its original shape. On the other hand, if the dome is fixed to the mounting base, the "bull-horned stomach" can be returned to the reference shape of the "hooked stomach" simply by rotating the mounting base 90 degrees in the opposite direction. This point was discovered by the inventor through various verifications.

[0021] A is a conceptual diagram of training using the medical simulator of this embodiment, and B is an external view of the medical simulator. This is a top view showing the internal state of the medical simulator of this embodiment. A is an upper digestive tract model housed inside the medical simulator, and B is a top view of the inside of the housing in the medical simulator. This is an image of a prototype of the detachable Vater's papilla model of this embodiment. A is a perspective view showing the inside of the lower case forming the light-shielding chamber, and B is a perspective view showing the back side of the upper case forming the light-shielding chamber. This is a perspective view showing the state in which the duodenum model and the light-shielding chamber of this embodiment are connected. A is an image showing the connection state between the connection part and the light-shielding chamber in the actual medical simulator of this embodiment, and B is an image showing the detached state. This is an image showing the process of removing the detachable Vater's papilla model fitted into the connection part in the actual medical simulator of this embodiment. This is a top view showing the state in which the stomach model has the shape of a "bovine stomach" due to the shape-changing means of this embodiment. This is a block diagram of the medical simulator of this embodiment. This is an image of the inside of the actual medical simulator of this embodiment.

[0022] The embodiments for carrying out the present invention will be described below with reference to the embodiments and drawings. However, the embodiments described below are not intended to limit the present invention to those described herein, and the present invention can be equally applied to various modifications without departing from the technical concept set forth in the claims. In the drawings used for explanation in this specification, each component is shown at a different scale in order to make it recognizable on the drawing, and is not necessarily shown in proportion to the actual dimensions.

[0023] [Embodiment] The medical simulator 10 of this embodiment will be described with reference to the figures. Figure 1A is a conceptual diagram of training in endoscopic procedures using the medical simulator 10, and Figure 1B is an external perspective view of the medical simulator 10. Figure 2 is a top view showing the internal state of the medical simulator 10. Figure 3A is an upper gastrointestinal tract model 30 housed inside the medical simulator 10, and Figure 3B is a top view of the inside of the housing 40 in the medical simulator 10.

[0024] As shown in Figure 1A, the medical simulator 10 is used in conjunction with the endoscopy system 20. The endoscopy system 20 is an existing system installed in an examination room or similar location within the hospital. The endoscopy system 20 mainly consists of a system body 21 having a video system and a light source, a duodenal endoscope 22 with an image sensor mounted on its tip side 221, and a monitor 23 that displays video signals from the system body 21. The tip side 221 of the endoscope 22 is also provided with a conduit (not shown) for inserting treatment instruments such as cannulas and guidewires. Light guided from the light source of the system body 21 illuminates the target object through an illumination lens, and this illuminated object is imaged by the image sensor through an objective lens. The electrical signal is converted into a video signal by the video system of the system body 21 and displayed on the monitor 23.

[0025] The medical simulator 10 used for training procedures in conjunction with such an endoscope system 20 is equipped with an upper gastrointestinal tract model 30 whose interior is imaged by an endoscope scope 22. More specifically, the medical simulator 10 has an openable and closable box-shaped exterior, with the upper gastrointestinal tract model 30 housed inside a box-shaped casing 40.

[0026] The box-shaped enclosure 40, which can be opened and closed, is made of metal or opaque resin, and its interior is not visible. As shown in Figure 1B, the exterior of this enclosure 40 mainly consists of a housing body 41 and an openable top lid 42, and a handle 43 is attached to the top lid 42. Therefore, this medical simulator 10 is small enough to be carried by holding the handle 43. In addition, an input / display unit 83, which is a touch panel display device that forms the input means and display means for the medical simulator 10, is installed on the surface of the top lid 42. In addition to the input / display unit 83, this medical simulator 10 also includes a control unit 81 and various sensors, which will be described later.

[0027] Inside the medical simulator 10 is the upper gastrointestinal tract model 30 shown in Figure 2A. Specifically, this upper gastrointestinal tract model 30 consists of an esophageal model 31 that mimics the esophagus, a stomach model 32 that mimics the stomach, and a duodenal model 33 that mimics the duodenum. The esophageal model 31 is also provided with an oral cavity 311 and a nasal cavity 312 into which an endoscope scope 22 is inserted.

[0028] The oral cavity 311 and nasal cavity 312 are connected to the outside through an opening 44 provided on the side of the housing body 41, and the insertion of the endoscope scope 22 begins through this opening 44. The opening 44 on the side of the housing body 41 has a sliding structure relative to the side, and sliding it opens and closes the oral cavity 311 and nasal cavity 312 to the outside. In Figures 2 and 3A, the oral cavity 311 and nasal cavity 312 are shown in cross-section to show their internal shapes. As can be seen from these figures, the oral cavity 311 and nasal cavity 312 are connected at the pharyngeal region 313 and reach the esophageal region 314 of the esophageal model 31, and a trachea 315 that branches off from the esophageal region 314 is also provided.

[0029] Furthermore, the oral cavity 311, nasal cavity 312, stomach model 32, duodenum model 33, etc., are specifically made of silicone material. These are manufactured by molding using molds created based on three-dimensional information scanned using computed tomography (CT) or magnetic resonance imaging (MRI), or by molding using a three-dimensional printer. In addition, since silicone material has excellent light transmission properties and is easy to color with pigments, etc., it is colored to be as close as possible to the actual color of the organs.

[0030] Furthermore, the esophageal portion 314 of the esophageal model 31 is made of a harder material than the stomach model 32 and duodenum model 33, because the actual esophagus is almost straight and does not deform easily. In this embodiment, the esophageal portion 314 is made of plastic. Also, the upper gastrointestinal tract model 30 can be constructed by making the esophageal model 31 consist only of the esophageal portion 314, as in the medical simulators of Non-Patent Documents 1 and 2. However, since the procedure of passing through the pharyngeal portion 313 is also very difficult and important, the configuration of the upper gastrointestinal tract model 30 in this embodiment is more preferable.

[0031] Furthermore, in this embodiment, an image sensor 87 is installed at the back of the nasal cavity 312 to photograph the pharyngeal region 313. In this embodiment, since the duodenal endoscope 22 has an image sensor on the tip side 221, the image is posteriorly oblique, and therefore the image obtained differs from that of a normal straight-viewing endoscope. Therefore, by obtaining an image similar to that of a straight-viewing endoscope using the image sensor 87, the user can learn by comparing the image from the posteriorly oblique-viewing endoscope with the image from the straight-viewing endoscope, thereby improving the technique when passing through the pharyngeal region 313, which is considered particularly difficult.

[0032] In this embodiment of the upper digestive tract model 30, the ampulla of Vater 331 in the duodenum model 33 is configured as a replaceable, detachable ampulla of Vater model 60, including the ampulla of Vater 331 and the surrounding lumen, as shown in Figure 4. Figure 4 is an image of the prototype detachable ampulla of Vater model 60.

[0033] As shown in Figure 4, the detachable Vater's papilla model 60 consists of an inner surface 61 made of the same material as the duodenum model 33, and a back surface 62 made of a light-shielding material, unlike the inner surface 61. The inner surface 61 is provided with an engaging portion 61a on its side so that it can be attached to and detached from the duodenum model 33. The inner surface 61 is also provided with a thin film portion 61b around its periphery so that when the detachable Vater's papilla model 60 is attached, it can blend seamlessly with the intestinal surface of the duodenum model 33. The back surface 62 is provided with a bile duct connection portion 621 and a pancreatic duct connection portion 622, which connect to the bile duct model 35 and pancreatic duct model 36, respectively, which will be described later. The bile duct connection portion 621 and the pancreatic duct connection portion 622 are connected to the Vater's papilla 331 on the inner surface 61.

[0034] By using a detachable Vater's nipple model 60, the Vater's nipple 331 that has been damaged during use can be easily replaced. It is also known that there are many classifications of the shape of the Vater's nipple 331. Therefore, the medical simulator 10 can prepare many variations of the Vater's nipple 331 according to the classification and make them interchangeable, which allows for difficulty level settings by changing the detachable Vater's nipple model 60. This allows users to set a wider variety of difficulty levels and practice procedures that are closer to real-world situations using the medical simulator 10. As for the classification of the Vater's nipple 331, the Oi classification and the Inomata classification are well known, but it is not necessary to prepare all variations of the Vater's nipple 331; it is sufficient to prepare representative ones or those that account for a large proportion.

[0035] Such an upper gastrointestinal tract model 30 is housed inside a housing 40 as shown in Figure 2. The interior of the housing 40 that houses the upper gastrointestinal tract model 30 has the structure shown in Figure 3B. Specifically, a first fixing part 45 is provided on the inner bottom surface of the housing body 41, which wraps around and secures the oral cavity portion 311 and the nasal cavity portion 312.

[0036] Furthermore, a second fixing part 46 is provided for fixing the stomach model 32. As shown in Figure 3B, this second fixing part 46 consists of a disc-shaped mounting base 461 on which the stomach model 32 is placed, a stomach holding part 462 that holds the middle part 321 of the stomach body of the stomach model 32 with sufficient space between them, and a duodenum holding part 463 that holds a portion of the duodenum model 33 on the opposite side of the ampulla of Vater 331.

[0037] The stomach holding section 462, which holds the stomach model 32, and the duodenum holding section 463, which holds the duodenum model 33, are made of silicone material and are designed to maintain the shape of the stomach model 32 and duodenum model 33, as they are flexible. The duodenum model 44 is held not only by the duodenum holding section 463, but also on the side of the ampulla of Vater 331 by a resin connecting section 332, as shown in Figure 7, along with a detachable ampulla of Vater model 60 equipped with the ampulla of Vater 331. This detachable ampulla of Vater model 60 is held by being fitted into the connecting section 332, as will be described later. Using this housing body 41, the upper digestive tract model 30 is housed inside the housing 40, as shown in Figure 2.

[0038] Furthermore, in this embodiment, the duodenum model 33 forming the upper gastrointestinal tract model 30 is equipped with a bile duct model 35 and a pancreatic duct model 36 connected to the ampulla of Vater 331 (detachable ampulla of Vater model 60) so that the technique of selective cannulation of the bile duct and pancreatic duct in ERCP procedures can be practiced.

[0039] As shown in Figure 2, the bile duct model 35 and the pancreatic duct model 36 are housed in a rectangular light-shielding chamber 47 located on the top surface of the stomach-holding portion 462 in the second fixing portion 46. Figure 5 is a perspective view of the light-shielding chamber 47, where A is a perspective view showing the inside of the lower case 471 that forms the light-shielding chamber 47, and B is a perspective view showing the back side of the upper case 472 that forms the light-shielding chamber 47.

[0040] As shown in Figure 5, the light-shielding chamber 47 consists of a lower case 471 fixed to the top surface of the stomach holding section 462 and an upper case 472 that covers the upper surface of the lower case 471.

[0041] And, two groove portions are formed on the inner bottom surface of the lower case 471, and these groove portions are respectively the bile duct model 35 and the pancreatic duct model 36. Further, the groove portions forming the bile duct model 35 and the pancreatic duct model 36 are respectively connected to a bile duct connection portion 621 and a pancreatic duct connection portion 622 provided on the back surface side 62 of the detachable sphincter papilla model 60 connected to an opening provided on the side surface of the light shielding chamber 47.

[0042] Thus, in the medical simulator 10, the groove portions forming the bile duct model 35 and the pancreatic duct model 36 are connected to the sphincter papilla 331 of the duodenum model 33, and such a duodenum model 33 is accommodated inside the housing 40. In the present embodiment, the bile duct model 35 and the pancreatic duct model 36 are formed by groove portions. However, the bile duct model 35 and the pancreatic duct model 36 are not limited to this example, and may be formed in a cylindrical shape or may be formed of a different material from the lower case 471.

[0043] Further, in FIG. 2, a state where the duodenum model 33 (or the detachable sphincter papilla model 60) and the light shielding chamber 47 having the bile duct model 35 and the pancreatic duct model 36 are separated is shown, but in actual use, the duodenum model 33 and the light shielding chamber 47 are used in a connected state.

[0044] In this regard, the connection between the duodenum model 33 and the light shielding chamber 47 and the attachment and detachment of the detachable sphincter papilla model 60 will be described in detail using FIGS. 6 to 8. FIG. 6 is a perspective view showing a state where the duodenum model 33 and the light shielding chamber 47 are connected. FIG. 7 is an image of the actual machine showing the attachment and detachment state between the connection portion 332 into which the detachable sphincter papilla model 60 is inserted and the light shielding chamber 47, FIG. 7A is an image of the connection state, and FIG. 7B is an image of the detachment state. FIG. 8 is an image showing a state of taking out the detachable sphincter papilla model 60 inserted into the connection portion 332.

[0045] As shown in Fig. 6, the duodenum model 33 and the light-shielding chamber 47 are connected in the state of use. When the duodenum model 33 and the light-shielding chamber 47 are connected, the bile duct connection part 621 of the detachable sphincter papilla model 60 is positioned inside the light-shielding chamber 47 and is inserted into the groove part of the bile duct model 35. Similarly, the pancreatic duct connection part 622 is positioned inside the light-shielding chamber 47 and is inserted into the groove part of the pancreatic duct model 36.

[0046] At this time, as shown in Fig. 7 of the actual machine photographed, actually, the duodenum model 33 and the light-shielding chamber 47 are connected through the connection part 332 that holds the duodenum model 33. Specifically, as shown in Fig. 7(A), the connection part 332 is screwed to the light-shielding chamber 47 by a connection screw 333. In this state, as shown in Fig. 6, the back surface side 62 of the detachable sphincter papilla model 60 contacts the opening provided on the side surface of the lower case 471 of the light-shielding chamber 47. For this reason, the bile duct connection part 621 and the pancreatic duct connection part 622 are arranged inside the light-shielding chamber 47, and the bile duct model 35 and the pancreatic duct model 36 are respectively connected thereto. Then, by removing the connection screw 333, as shown in Fig. 7(B), the connection part 332 is detached from the light-shielding chamber 47 together with the duodenum model 33.

[0047] In the detached state of the connection part 332 (duodenum model 33) and the light-shielding chamber 47 shown in Fig. 7(B), the detachable sphincter papilla model 60 inserted into the connection part 332 can be taken out from the connection part 332 as shown in Fig. 8(B) by pinching and pulling out the bile duct connection part 621 and the pancreatic duct connection part 622 as shown in Fig. 8(A). Therefore, the detachable sphincter papilla model 60 can be replaced with another detachable sphincter papilla model 60 having a different shape from the sphincter papilla 331 of the detachable sphincter papilla model 60 removed from the connection part 332. In this way, the medical simulator 10 is configured such that the light-shielding chamber 47 having the bile duct model 35 and the pancreatic duct model 36 and the duodenum model 33 can be detached.

[0048] And the medical simulator 10 of the present embodiment is provided with detection means capable of detecting that the tips of the cannula and the guide wire used in the cannulation procedure practice have invaded the bile duct model 35 and the pancreatic duct model 36.

[0049] By incorporating such detection means, it is possible to know whether the tip of the cannula (or guidewire) has entered the bile duct model 35 or the pancreatic duct model 36 during cannulation technique practice, making it very suitable for practicing selective cannulation of the bile duct and pancreatic duct.

[0050] In this embodiment, the detection means is formed by the light-shielding chamber 47 shown in Figure 5. More specifically, as shown in Figure 5B, on the back side of the upper case 472, there is an imaging unit 88 consisting of an image sensor that photographs the inside of the light-shielding chamber 47, and an illumination unit 89 consisting of an LED element that illuminates the inside of the light-shielding chamber 47. The detection means is formed by the light-shielding chamber 47 in which the bile duct model 35 and the pancreatic duct model 36 are formed in the lower case 471, the imaging unit 88 provided in the upper case 472, and the illumination unit 89.

[0051] With the detection means configured in this way, the medical simulator 10 of this embodiment can directly determine, through images, whether the tip of the cannula (or guidewire) has entered the bile duct model 35 or the pancreatic duct model 36. In other words, trainees can visually confirm the situation, for example, not only during insertion but also during removal. Furthermore, it becomes possible to make determinations using image processing with the images.

[0052] In this embodiment, the detection means is image-based detection, but it is also possible to configure the system to detect contact in grooves that serve as bile duct model 35 or pancreatic duct model 36, rather than relying on image-based detection.

[0053] On the other hand, when detection is performed by imaging as in this embodiment, it is preferable to make the space where the bile duct model 35 and the pancreatic duct model 36 are located a light-shielding chamber 47, as in this embodiment. This is because, normally, in the upper gastrointestinal tract model 30, such as the esophagus model 31, stomach model 32, and duodenum model 33, light from the endoscope scope passing through the model inevitably leaks out of the model. Therefore, when the upper gastrointestinal tract model 30 is housed in the housing 40, light is scattered inside the housing 40, and if the space where the bile duct model 35 and the pancreatic duct model 36 are located is not made a light-shielding space, there is a risk of false detection due to the influence of light inside the housing 40.

[0054] Therefore, in this embodiment, the detachable ampulla of Vater model 60 is formed on its inner surface 61 from the same material as the duodenum model 33, and its back surface 62 from a light-shielding material. This prevents as much light as possible from entering the light-shielding chamber 47 through the detachable ampulla of Vater model 60. Also, since light may enter the light-shielding chamber 47 through the hole in the ampulla of Vater 331, as shown in Figure 6A, the grooves constituting the bile duct model 35 and the pancreatic duct model 36 are formed to rise upward as they move inward from the bile duct connection portion 621 and the pancreatic duct connection portion 622.

[0055] Furthermore, the medical simulator 10 of this embodiment is equipped with a shape-changing means that can change the shape of the upper gastrointestinal tract model. This shape-changing means changes the shape of the upper gastrointestinal tract model 30, reproducing the differences in organ shape due to individual differences. By being equipped with such a shape-changing means, the medical simulator 10 can perform practice that is closer to real-world situations when practicing the endoscopic scope 22 procedure.

[0056] In this embodiment, the shape-changing mechanism is configured by the rotation of the mounting base 461 of the stomach model 32, which forms the second fixing portion 46. Specifically, as shown in Figures 2 and 3B, a motor 84 is positioned on the inner bottom surface of the housing body 41, and a link body 464 connected to this motor 84 is connected to the back surface of the mounting base 461. As the motor 84 rotates, the mounting base 461 connected via the link body 464 also rotates.

[0057] In this way, as the motor 84 rotates, the mounting base 461 rotates, which changes the orientation of the stomach model 32 placed on the mounting base 461. By changing the orientation of the stomach model 32, it is possible to reproduce shapes such as "hooked stomach," "bovine stomach," and "waterfall stomach." Figure 9 shows the stomach model 32 in the shape of a "bovine stomach" after rotating the mounting base 90 degrees from the state of the "hooked stomach."

[0058] As the orientation of the stomach model 32 changes, the route to approach the duodenum model 33 also changes, thus altering the difficulty level. Furthermore, not only does the approach to the duodenum model 33 change, but the orientation of the duodenum model 32 also changes in accordance with the changes in the stomach model 32. Consequently, the route changes even more. Therefore, in practicing ERCP cannulation techniques, the user can practice the approach to the ampulla of Vater 331 in a way that is closer to real-world practice. In addition, by controlling the rotation of the mounting platform 461, the medical simulator 10 can arbitrarily set the difficulty level based on the difference in shape of the stomach model 32. Furthermore, the medical simulators in Non-Patent Literature 1 and Non-Patent Literature 2 do not allow practice of cannulation techniques including the approach to the ampulla of Vater, as the approach to the ampulla of Vater is the same every time. On the other hand, the medical simulator 10 allows practice of techniques including the approach to the ampulla of Vater.

[0059] It should be noted that the ability to reproduce the shapes of "hooked stomach," "bovine stomach," and "waterfall stomach" by changing the orientation of the stomach model 32 does not mean that the exact shapes of "hooked stomach," "bovine stomach," and "waterfall stomach" are reproduced. In reality, simply changing the orientation of one stomach model 32 is not enough to perfectly reproduce all the shapes, so the medical simulator 10 reproduces shapes similar to "hooked stomach," "bovine stomach," and "waterfall stomach" by changing the orientation of the stomach model 32. In particular, the inventors have found through their own verification that the difficulty level changes significantly just by changing the orientation of the stomach model 32. Therefore, changing the orientation of the stomach model 32 has a significant impact on the difficulty level.

[0060] Furthermore, it is known that there are many classifications of the shape of the ampulla of Vater in the duodenum. Therefore, in this embodiment, the ampulla of Vater 331 in the duodenum model 33 is also provided as a detachable ampulla of Vater model 60 that reproduces multiple shapes. By adopting such a configuration of detachable ampulla of Vater model 60, the medical simulator 10 can set the difficulty level not only by the difference in shape of the stomach model 32 as described above, but also by changing the ampulla of Vater 331, allowing for a wider variety of difficulty settings, and enabling more realistic procedural practice with the medical simulator 10.

[0061] Furthermore, when the shape-changing mechanism is configured by rotating the mounting base 461, as in this embodiment, the orientation of the stomach model 32 changes. In this case, for example, if the "fishing stomach" is used as the standard shape, and the mounting base 461 is rotated based on this state, the shape becomes that of a "big horn stomach" or a "waterfall stomach." On the other hand, when returning from the shape of a "big horn stomach" or a "waterfall stomach" to the standard shape of a "fishing stomach," the inventors have found through numerous tests that simply rotating the mounting base 461 will not return the stomach model 32 to its original "fishing stomach" shape because it is made of a flexible material. Therefore, to return it to its original shape, one could open the top cover 42 and manually return it to the shape of a "hanging stomach." However, according to the inventor's verification, by fixing the so-called fundus 322 of the stomach model 32 (the bulge at the top of the stomach near the cardia, which is the junction of the stomach and esophagus: the gastric fundus) to the mounting stand, the original shape of a "hanging stomach" can be returned by rotating the mounting stand 461.

[0062] The control configuration of the medical simulator 10 described above will now be explained. Figure 10 is a block diagram of the medical simulator 10. As shown in Figure 10, the medical simulator 10 consists of a control unit 81, a storage unit 82, an input / display unit 83, a motor 84, an audio output unit 85, a terminal unit 86, an image sensor 87, an imaging unit 88, an illumination unit 89, and first sensors 91 to fifth sensors 95.

[0063] The control unit 81 controls the entire medical simulator 10. The memory unit 82 stores the programs executed by the control unit 81 and the data necessary for their operation. As previously described, the input / display unit 83 consists of a touch panel display device installed on the surface of the top cover 42 of the housing 40, and in addition to displaying images taken by the endoscope scope 22, it can be used to input operations such as starting and stopping the system and setting various conditions.

[0064] The motor 84 constitutes the shape-changing mechanism described earlier and rotates the mounting base 461 on which the stomach model 32 is placed via the link body 464. The notification unit 85 provides notifications such as navigation and warnings using voice, beeps, and flashing LEDs. The terminal unit 86 consists of an HDMI® port, a USB port, etc., for connecting to external devices.

[0065] The image sensor 87 is positioned at the back of the nasal cavity 312 as described earlier and captures images of the pharyngeal region 313. The imaging unit 88 and illumination unit 89 constitute the detection means described earlier and are positioned on the back side of the upper case 472 of the light-shielding chamber 47 to obtain images of the cannula (or guidewire) that enters the bile duct model 35 or pancreatic duct model 36.

[0066] The first sensor 91 to the fifth sensor 95 are sensors that detect the passage of the endoscope scope 22. Each of these sensors will be explained using Figure 11. Figure 11 is an image of the inside of the actual medical simulator 10 to which the first sensor 91 to the fifth sensor are installed.

[0067] The first sensor 91 is positioned at the opening 44 to detect the insertion of the endoscope scope 22 into the oral cavity 311. When the endoscope scope 22 is inserted into the oral cavity 311 by the first sensor 91, the control unit 81, for example, controls the shape-changing means of the motor 84 to disable its function. This prevents the user from changing the shape of the stomach model 32 during the procedure practice. Furthermore, since the endoscope will now pass through the pharyngeal region 313, an image from the image sensor 87 becomes necessary. For this reason, the control unit 81 can, for example, start displaying the image from the image sensor 87.

[0068] The second sensor 92 and the third sensor 93 are positioned opposite the entrance to the esophageal portion 313 in the esophageal model 31. These second and third sensors allow the medical simulator 10 to detect when the tip of the endoscope scope 22 reaches the esophageal portion 313. This means that it can detect that the endoscope has passed through the pharyngeal portion 313, which is considered difficult in the procedure, thus reducing the need for images from the image sensor 87. Therefore, the control unit 81 can, for example, reduce the size of the image displayed by the image sensor 87 or hide the image display altogether. While photosensors can be used as the second and third sensors 92 and 93, in the case of the duodenal endoscope scope 22, the illumination is from the side of the tip, which may prevent detection on the opposite side of the illumination direction. Therefore, the medical simulator 10 in this embodiment uses two sensors, the second sensor 92 and the third sensor 93, and is configured to be positioned opposite each other.

[0069] The fourth sensor 94 and the fifth sensor 95 are positioned before and after the ampulla of Vater 331 in the duodenum model 33, that is, before and after the connection portion 332 into which the detachable ampulla of Vater model 60 is inserted. These fourth sensor 94 and fifth sensor 95 allow the medical simulator 10 to detect when the tip of the endoscope scope 22 has reached near the ampulla of Vater 331. For this reason, for example, the control unit 81 can start displaying an image of the inside of the light-shielding chamber 47 taken by the imaging unit 88 next to the display of the image taken by the endoscope scope 22. Note that the sensors are not limited to the first sensors 91 to the fifth sensors 95 as in this embodiment, and the medical simulator 10 can also be equipped with and use other sensors.

[0070] Furthermore, although the shape-changing means in this embodiment was configured by rotating the mounting base 461, other configurations can also be adopted. Specifically, a structure can be provided to hold the esophagus model 31 with a movable means, allowing it to move in the front-to-back direction (left-to-right direction in Figure 2), the left-to-right direction (up-down direction in Figure 2), or the up-and-down direction (front-to-back direction in Figure 2). Alternatively, the duodenum holding part 463 can be moved to directly change the orientation and position of the duodenum model 33. Also, since the upper digestive tract model 30 is composed of the esophagus model 31, stomach model 32, and duodenum model 33 connected together, shape-changing means can be provided for each model. However, if it is provided for a specific model, the other connected models will also change as the corresponding model is modified.

[0071] Furthermore, in this embodiment, the angle between the grooves forming the bile duct model 35 and the pancreatic duct model 36 in the light-shielding chamber 47 is approximately 45 degrees in Figures 6A and 7. When the inventors changed this angle and conducted tests, they found that the smaller the angle, the more difficult the cannulation procedure became. Therefore, the medical simulator may be provided with multiple light-shielding chambers 47 with different angles between the bile duct model 35 and the pancreatic duct model 36, and the difficulty level may be adjusted by changing the light-shielding chamber 47.

[0072] 10: Medical simulator 20: Endoscopy system 22: Endoscope scope 30: Upper gastrointestinal tract model 31: Esophagus model 32: Stomach model 321: Mid-stomach body 322: Fundus 33: Duodenum model 331: Ampulla of Vater 35: Bile duct model 36: Pancreatic duct model 40: Housing 41: Main housing 42: Top lid 46: Second fixing part 461: Mounting platform 47: Light-shielding chamber

Claims

1. A medical simulator using an upper gastrointestinal tract model that includes at least a stomach model, characterized in that it is equipped with a shape-changing means that can change the shape of the upper gastrointestinal tract model.

2. The medical simulator according to claim 1, characterized in that the upper gastrointestinal tract model further comprises an esophageal model connected to the stomach model and a duodenal model connected to the stomach model.

3. The medical simulator according to claim 2, characterized in that the shape changing means consists of rotating the mounting platform on which the stomach model is placed.

4. The medical simulator according to claim 3, characterized in that the fundus of the stomach in the stomach model is fixed to the stand described above.

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