Medical simulator and detachable papilla of vater

Abstract

[Problem] The purpose of the present invention is to provide a medical simulator for performing a procedure practice of cannulation in ERCP, the medical simulator making it possible to perform a procedure practice that is similar to an actual practice. [Solution] This medical simulator 10 uses an upper gastrointestinal tract model 30 comprising an esophagus model 31, a stomach model 32, and a duodenum model 33 provided with a detachable papilla-of-vater model 60, the upper gastrointestinal tract model 30 being housed in an opaque casing 40.

Description

Medical simulator and detachable sphincter papilla

[0001] The present invention relates to a medical simulator and a detachable sphincter papilla. Specifically, in the practice of endoscopic procedures using an endoscope scope of an endoscopic system, it relates to a medical simulator incorporating an upper gastrointestinal tract model consisting of an esophagus model, a stomach model, and a duodenum model, which can perform hands-on practice close to actual situations, and a detachable sphincter papilla used for this medical simulator.

[0002] In the medical field, endoscopic systems are widely used, and many types of endoscopic systems are provided according to the type of luminal organ and the purpose of use, such as upper gastrointestinal endoscopes, colon endoscopes, bronchoscopes, thoracoscopes, and intravascular endoscopes. This endoscopic system mainly consists of a video scope (endoscope scope) equipped with an image pickup device, a system main body including 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 main body. Some endoscopic systems can not only view the images inside the organ 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 must detect the lesion without missing it. Therefore, high skills are required for endoscopic procedures.

[0004] Non-Patent Document 1 and Non-Patent Document 2 disclose a medical simulator using an ERCP (endoscopic retrograde cholangiopancreatography) lumen model that reproduces an upper gastrointestinal tract model consisting of an esophagus model, a stomach model, and a duodenum model, and the duodenum model has a sphincter papilla, and it is actually sold.

[0005] 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>

[0006] The medical simulators described in Non-Patent Documents 1 and 2 are used in a way that, when actually used for procedural practice, the upper gastrointestinal tract model is placed directly on the mounting platform, resulting in the upper gastrointestinal tract model being exposed during use.

[0007] Therefore, when actually practicing, the upper gastrointestinal tract model will be visible to the trainee. Furthermore, in actual clinical practice, the upper gastrointestinal tract model is not exposed in this manner. Consequently, currently available ERCP medical simulators have not been sufficient in terms of providing practice for endoscopic procedures that can be applied to actual clinical practice.

[0008] Therefore, the present invention aims to provide a medical simulator that allows for more realistic practice of ERCP cannulation techniques. Furthermore, it aims to provide a detachable Vater's nipple suitable for use with this medical simulator.

[0009] To achieve the above objective, the medical simulator of the present invention is a medical simulator that uses an upper gastrointestinal tract model consisting of an esophageal model, a stomach model, and a duodenal model equipped with the ampulla of Vater, characterized in that the upper gastrointestinal tract model is housed in an opaque casing.

[0010] According to the medical simulator of the present invention, since the upper gastrointestinal tract model is housed in an opaque casing, the user cannot directly view the upper gastrointestinal tract model, thus enabling practice of ERCP cannulation techniques in an environment closer to actual clinical practice.

[0011] Furthermore, it is preferable that the medical simulator of the present invention has a bile duct model and a pancreatic duct model provided at the tip of the ampulla of Vater located on the duodenum model, and that the bile duct model and the pancreatic duct model are provided with detection means capable of detecting the insertion of a cannula or guidewire.

[0012] According to the medical simulator of the present invention, during practice of cannulation techniques, it is possible to know whether the tip of the cannula (or guidewire) has entered the bile duct model or the pancreatic duct model. Therefore, the medical simulator of the present invention is very suitable for practicing selective cannulation techniques into the bile duct and pancreatic duct.

[0013] Furthermore, it is preferable that the detection means of the medical simulator of the present invention comprises a light-shielding chamber in which the bile duct model and the pancreatic duct model are provided, an imaging unit for photographing the inside of the light-shielding chamber, and an illumination unit for illuminating the inside of the light-shielding chamber.

[0014] According to the medical simulator of the present invention, during practice of cannulation procedures, the user can visually confirm whether the tip of the cannula (or guidewire) has entered the bile duct model or the pancreatic duct model through images. Therefore, the user can confirm not only the insertion but also the removal process, for example. Furthermore, this medical simulator can also perform image processing and judgment using these images.

[0015] Furthermore, when imaging is used, it is more preferable to make the space where the bile duct model and pancreatic duct model are located a light-shielding space, as in the present invention. This is because upper gastrointestinal tract models, such as the esophagus model, stomach model, and duodenum model, are usually made of flexible materials such as silicone rubber, and light from the endoscope scope passing through the model inevitably leaks out of the model. Therefore, when the upper gastrointestinal tract model is housed in a housing as in the present invention, light is scattered inside the housing, and if the space where the bile duct model and pancreatic duct model 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.

[0016] Furthermore, in the medical simulator of the present invention, it is preferable that the ampulla of Vater is detachable from the duodenum model, and that the back surface of the ampulla of Vater is made of a light-shielding material.

[0017] During cannulation, light from the duodenal endoscope enters the light-shielding chamber through the ampulla of Vater. By forming the back side (the side facing the light-shielding chamber) of the ampulla of Vater with a light-shielding material, the incidence of light from the duodenal endoscope can be prevented as much as possible.

[0018] Furthermore, the detachable ampulla of Vater of the present invention is an ampulla of Vater that is detachable from a duodenum model, and the ampulla of Vater is used in a medical simulator that uses an upper digestive tract model consisting of an esophagus model and a stomach model together with the duodenum model, and the medical simulator houses the upper digestive tract model in an opaque housing, has a light-shielding chamber with a bile duct model and a pancreatic duct model provided at the tip of the ampulla of Vater, has detection means that can detect when a cannula or guidewire has entered the bile duct model and the pancreatic duct model, and the back side of the ampulla of Vater is made of a light-shielding material.

[0019] The detachable ampulla of Vater of the present invention is ideal as a detachable ampulla of Vater for use in the medical simulator described above. Furthermore, it is known that there are many classifications of the shape of the duodenal ampulla of Vater. Therefore, by preparing detachable ampulla of Vater in various shapes, it becomes possible to set various difficulty levels in procedural practice by changing the ampulla of Vater.

[0020] 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 an upper gastrointestinal tract model housed inside the medical simulator of this embodiment. This is a top view of the inside of the housing of the medical simulator of this embodiment. This is a top view showing the internal state of the medical simulator of this embodiment. 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. A is an image taken by an endoscope scope, and B is a result image showing the result detected by the detection 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.

[0021] 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.

[0022] [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 an upper gastrointestinal tract model 30 housed inside the medical simulator 10. Figure 3 is a top view of the inside of the housing 40 in the medical simulator 10. Figure 4 is a top view showing the internal state of the medical simulator 10.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] The upper gastrointestinal tract model 30 shown in Figure 2 is housed inside the housing 40 that constitutes the medical simulator 10. 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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 5. Figure 5 is an image of the prototype detachable ampulla of Vater model 60.

[0032] As shown in Figure 5, 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.

[0033] 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.

[0034] The upper gastrointestinal tract model 30 is then housed inside the housing 40 shown in Figure 3, as shown in Figure 4. Specifically, the housing 40 that houses the upper gastrointestinal tract model 30 has a first fixing part 45 on the inner bottom surface of the housing body 41 that wraps around and secures the oral cavity 311 and nasal cavity 312.

[0035] Furthermore, a second fixing part 46 is provided for fixing the stomach model 32. As shown in Figure 3, 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.

[0036] 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 shown in Figure 8, together 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 4.

[0037] 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.

[0038] As shown in Figures 3 and 4, 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 6 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.

[0039] As shown in Figure 6, 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.

[0040] Furthermore, two grooves are formed on the inner bottom surface of the lower case 471, which serve as the bile duct model 35 and the pancreatic duct model 36, respectively. The grooves forming the bile duct model 35 and the pancreatic duct model 36 are connected to the bile duct connection part 621 and the pancreatic duct connection part 622, respectively, which are located on the back side 62 of the detachable ampulla of Vater model 60, which is connected to an opening provided on the side of the light-shielding chamber 47.

[0041] Thus, in the medical simulator 10, the grooves forming the bile duct model 35 and the pancreatic duct model 36 are connected to the ampulla of Vater 331 of the duodenum model 33, and this duodenum model 33 is housed inside the housing 40. In this embodiment, the bile duct model 35 and the pancreatic duct model 36 are formed by grooves. 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 from a different material than the lower case 471.

[0042] Furthermore, although Figure 4 shows the duodenum model 33 (and detachable ampulla of Vater model 60) and the light-shielding chamber 47 containing the bile duct model 35 and pancreatic duct model 36 as separate, in actual use, the duodenum model 33 and the light-shielding chamber 47 are used connected.

[0043] In this regard, Figures 7 to 9 will be used to explain in detail the connection between the duodenum model 33 and the light-shielding chamber 47, and the attachment and detachment of the detachable Vater's papilla model 60. Figure 7 is a perspective view showing the state in which the duodenum model 33 and the light-shielding chamber 47 are connected. Figure 8 is an image of the actual machine showing the attachment and detachment state of the connection part 332 into which the detachable Vater's papilla model 60 is inserted and the light-shielding chamber 47. Figure 8A is an image of the connected state, and Figure 8B is an image of the detached state. Figure 9 is an image showing the state of removing the detachable Vater's papilla model 60 inserted into the connection part 332.

[0044] As shown in FIG. 7, 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 Vater papilla model 60 is located inside the light-shielding chamber 47 and is fitted into the groove part of the bile duct model 35. Similarly, the pancreatic duct connection part 622 is located inside the light-shielding chamber 47 and is fitted into the groove part of the pancreatic duct model 36.

[0045] At this time, as shown in FIG. 8 of the actual machine photograph, actually, the duodenum model 33 and the light-shielding chamber 47 are connected via the connection part 332 that holds the duodenum model 33. Specifically, as shown in FIG. 8(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. 7, the back surface side 62 of the detachable Vater 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. Then, by removing the connection screw 333, as shown in FIG. 8(B), the connection part 332 is detached from the light-shielding chamber 47 together with the duodenum model 33.

[0046] In the state of detachment between the connection part 332 (duodenum model 33) and the light-shielding chamber 47 shown in FIG. 8(B), the detachable Vater papilla model 60 fitted in the connection part 332 can be taken out from the connection part 332 as shown in FIG. 9(B) by pinching and pulling out the bile duct connection part 621 and the pancreatic duct connection part 622 as shown in FIG. 9(A). Therefore, the detachable Vater papilla model 60 can replace the detachable Vater papilla model 60 removed from the connection part 332 with another detachable Vater papilla model 60 having a different shape of the Vater papilla 331. Thus, the medical simulator 10 has a configuration in which 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.

[0047] 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.

[0048] By providing such detection means, in the practice of cannulation techniques, it is possible to know whether the tip of the cannula (or guide wire) has penetrated into either the bile duct model 35 or the pancreatic duct model 36. Therefore, it is very suitable for the practice of selective cannulation techniques for the bile duct and pancreatic duct.

[0049] In this embodiment, this detection means is formed by the light-shielding chamber 47 shown in FIG. 6. More specifically, as shown in FIG. 6B, on the back side of the upper case 472, there are installed a photographing unit 88 composed of an imaging element for photographing the inside of the light-shielding chamber 47 and an illumination unit 89 composed of an LED element for illuminating the inside of the light-shielding chamber 47. And the detection means is formed by the light-shielding chamber 47 formed in the lower case 471 for the bile duct model 35 and the pancreatic duct model 36, the photographing unit 88 provided in the upper case 472, and the illumination unit 89.

[0050] With the detection means configured in this way, in the medical simulator 10 of this embodiment, it is possible to directly know or determine by means of an image which of the bile duct model 35 and the pancreatic duct model 36 the tip of the cannula (or guide wire) has penetrated into. That is, for the trainee, it can be visually confirmed. For example, not only the insertion situation but also the situation during removal can be confirmed. Also, it is possible to perform determination by image processing using the image.

[0051] Note that the detection means in this embodiment is detection by imaging. However, even if it is not by imaging, for example, detection means for detecting contact with the groove portions serving as the bile duct model 35 and the pancreatic duct model 36 may be provided, and it may be configured to detect by detecting the contact.

[0052] 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.

[0053] 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.

[0054] Next, the detection means in this embodiment detects, using images, whether the tip of the cannula (or guidewire) has entered the bile duct model 35 or the pancreatic duct model 36, and an example of the display of the detection result will be explained using a figure.

[0055] Figure 10 shows an example of the display screen on a dedicated practice display device for performing procedural practice using medical simulation 10, which is different from the monitor 22 and other components that make up the endoscopy system 20 described earlier.

[0056] This display screen can show the image captured by the endoscope scope 22, as shown in Figure 10A. Note that the image shown in Figure 10A is the same image displayed on the monitor 22 of the endoscope system 20.

[0057] Figure 10B shows the detection results of the detection means of this embodiment, which uses images to determine whether the tip of the cannula (or guidewire) has entered the bile duct model 35 or the pancreatic duct model 36.

[0058] In this embodiment, the result image 100 shown in Figure 10B is an image created by capturing images of the inside of the light-shielding room 47 with the imaging unit 88, extracting only the images of the bile duct model 35 and the pancreatic duct model 36 in real time through image processing, and then combining the extracted real-time images 101 of the bile duct model 35 and the pancreatic duct model 36 with a still image 102 that was prepared in advance using the original MRI or the like. In actual clinical practice, both the image captured by the endoscope scope 22 and the contrast-enhanced image of the bile duct and pancreatic duct are displayed during the procedure. By using a composite image, the medical simulator 10 can perform procedural practice that is closer to actual clinical practice.

[0059] As shown in Figure 10B, the system displays enlarged areas on the still image 102, where parts of the bile duct model 35 and the pancreatic duct model 36 are each enclosed in a rectangular frame. When insertion of the tip of a cannula (or guidewire) is detected, the side where the insertion occurred flashes, visually displaying the result to the trainee. The detection of tip insertion of a cannula (or guidewire) using images can be achieved by utilizing changes in brightness caused by the insertion of the cannula, etc. Furthermore, since the medical simulator 10 has a light-shielding chamber 47 in the space where the bile duct model 35 and the pancreatic duct model 36 are located, it is less susceptible to the influence of ambient light, and accurate detection is possible even when using an inexpensive image sensor (imaging unit 88).

[0060] Incidentally, the images captured by the endoscope scope 22 in Figure 10A and the detection result images by the detection means in Figure 10B, as shown in Figure 10, can be displayed using a separately prepared display device, but they can also be displayed using the input / display unit 83 provided in the housing 40 of the medical simulator 10 in this embodiment. Furthermore, the captured images in Figure 10A and the detection result images in Figure 10B can be displayed side by side simultaneously, and the display method may be selectable.

[0061] Furthermore, a separate display device prepared for displaying such images, or the input / display unit 83 of the housing 40, can also display images from the image sensor 87 installed deep inside the nasal cavity 312.

[0062] 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.

[0063] 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 3 and 4, a motor 84 is located on the inner bottom surface of the housing body 41, and a link body 465 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 465 also rotates.

[0064] 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. By changing the orientation of the stomach model 32, it is possible to reproduce shapes such as a hooked stomach, a bovine stomach, and a cascading stomach.

[0065] 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 33 also changes in accordance with the changes in the stomach model 32. Consequently, the route changes even more. Therefore, in practicing ERCP cannulation techniques, it is possible to 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 user can arbitrarily set the difficulty level based on the difference in shape of the stomach model 32. Moreover, the medical simulators in Non-Patent Literature 1 and Non-Patent Literature 2 do not allow for 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 for practice of techniques including the approach to the ampulla of Vater.

[0066] 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.

[0067] Furthermore, in this embodiment, since a detachable Vater nipple model 60 is used, the difficulty level can be adjusted by changing this model, allowing for a wider variety of difficulty settings, and enabling more realistic practice of the procedure using the medical simulator 10.

[0068] The control configuration of the medical simulator 10 described above will now be explained. Figure 11 is a block diagram of the medical simulator 10. As shown in Figure 11, 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.

[0069] 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.

[0070] 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 465. 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.

[0071] 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.

[0072] 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 12. Figure 12 is an image of the inside of the actual medical simulator 10 to which the first sensor 91 to the fifth sensor are installed.

[0073] 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 not function. As a result, the user is unable to change the shape of the stomach model 32 during the procedure practice.

[0074] 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 the endoscope can pass through the pharyngeal portion 313, which is considered a difficult area in the procedure, thus reducing the need for images from the image sensor 87. For this reason, 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.

[0075] While photosensors can be used as the second sensor 92 and the third sensor 93, in the case of the duodenal endoscope scope 22, the irradiation is from the side of the tip, so there is a risk that detection may not be possible on the opposite side of the irradiation direction. For this reason, the medical simulator 10 of this embodiment uses two sensors, the second sensor 92 and the third sensor 93, and is configured to be positioned opposite each other.

[0076] 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 enable 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 the composite image shown in Figure 10B along with the image captured 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.

[0077] 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 4), the left-to-right direction (up-down direction in Figure 4), or the up-and-down direction (front-to-back direction in Figure 4). 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.

[0078] 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.

[0079] 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 332: Connection part 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 88: Imaging unit 89: Illumination unit 60: Detachable ampulla of Vater model 61: Inner side 62: Back side 100: Result image 101: Real-time image 102: Still image

Claims

1. A medical simulator using an upper gastrointestinal tract model comprising an esophageal model, a stomach model, and a duodenal model with an ampulla of Vater, wherein the upper gastrointestinal tract model is housed in an opaque enclosure.

2. The medical simulator according to claim 1, characterized in that a bile duct model and a pancreatic duct model are provided at the tip of the ampulla of Vater provided in the duodenum model, and the bile duct model and the pancreatic duct model are provided with detection means capable of detecting the insertion of a cannula or guidewire.

3. The medical simulator according to claim 2, characterized in that the detection means comprises a light-shielding chamber in which the bile duct model and the pancreatic duct model are provided, an imaging unit for photographing the inside of the light-shielding chamber, and an illumination unit for illuminating the inside of the light-shielding chamber.

4. The medical simulator according to claim 3, characterized in that the ampulla of Vater is detachable from the duodenum model, and the underside of the ampulla of Vater is made of a light-shielding material.

5. A detachable ampulla of Vater for a duodenum model, wherein the ampulla of Vater is used in a medical simulator that uses an upper digestive tract model consisting of an esophagus model and a stomach model together with the duodenum model, the medical simulator houses the upper digestive tract model in an opaque housing, has a light-shielding chamber with a bile duct model and a pancreatic duct model provided at the tip of the ampulla of Vater, has detection means capable of detecting when a cannula or guidewire has entered the bile duct model and the pancreatic duct model, and the back side of the ampulla of Vater is made of a light-shielding material.

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