Catheter simulator and heart model

Abstract

Provided is a catheter simulator capable of achieving an improved procedure in a catheter procedure for a tissue responsible for a heart structure. This catheter simulator comprises: a container 10 into which a liquid is filled; a heart model 100 which is installed in the container 10 in a state of being filled with the liquid, and is provided with an outer wall and a septum; and a pulsation pump 50 which is connected to the heart model 100 and generates a pulsatile flow in an internal space of the heart model. The heart model 100 is characterized in that a portion to be varied by the pulsatile flow is thinned compared with the other portions, and a space including the thinned portion is formed in a substantially closed state.

Description

Catheter simulator and heart model

[0001] This specification discloses a catheter simulator and a heart model used in the catheter simulator.

[0002] Cardiac catheterization involves catheterization procedures for cardiac structures, such as the atrial septum and ventricular septum. One example is atrial septal puncture, which is performed to approach the left atrium from the right atrium. In this procedure, a catheter is inserted into the right atrium and a hole is created in the atrial septum between the right and left atria by inserting or cauterizing the needle. The puncture site for this procedure varies depending on the patient's illness and the procedure being performed. Incorrect manipulation can lead to complications such as cardiac tamponade or puncture of the esophagus, a tissue surrounding the heart. Even if the atrial septum is punctured correctly, the success rate of subsequent procedures depends heavily on the appropriate puncture site.

[0003] Another example is catheterization to close holes in the atrial septum (atrial septal defect), ventricular septal defect, or surgically-induced holes in the atrial or ventricular septum. This procedure involves inserting a catheter into the right atrium or right ventricle, and then inserting a catheter loaded with an occluding plug (called a prog) into the atrial septum between the right and left atria or the ventricular septum between the right and left atria. The plug is then placed in the hole in the septum to close the hole. Because this procedure is performed while the heart is beating, precise catheter manipulation is required, even while the atrial or ventricular septum moves due to blood flow or pressure within the cardiac chambers. As with atrial septal puncture, incorrect manipulation can result in cardiac tamponade by injuring a different part of the heart, or the plug can become dislodged from the intended location and drift into the cardiac chamber or blood vessels. Another similar example is the placement of pacemaker leads or leadless pacemakers. While these procedures do not involve placing a plug in a congenital septal hole, they are performed while the heart is beating when placing the lead or pacemaker body in the atrial or ventricular septum. Therefore, they share a commonality with catheter treatments for hole closure in that they require meticulous catheter manipulation while the atrial or ventricular septum moves due to blood flow or pressure within the cardiac chambers.

[0004] In order to prevent the above-mentioned complications and to achieve puncture at an appropriate location depending on the procedure, it is essential to train the procedure through simulation. The present inventors have proposed a simulator that includes multiple heart models corresponding to different types of heart disease, a container for holding each heart model, and a pump for circulating water through the container, in order to improve catheterization procedures for various heart diseases (e.g., Patent Documents 1 and 2). These patent documents disclose a catheterization simulator and heart model that allows practicing procedures similar to those performed in actual surgeries for various heart diseases by filling a small container with water to float the heart model, creating a flow within the heart using the pump to generate a pulsatile flow, and inserting and operating a catheter into the floating heart model.

[0005] Patent No. 7251746 Patent No. 7401867

[0006] Currently, in cardiac catheterization, no catheter simulator has been proposed for training cardiac catheterization procedures such as atrial septal puncture, atrial septal closure, or ventricular septal closure, using imaging devices such as X-ray fluoroscopy and ultrasound that are used as guides in actual clinical practice, under conditions in which tissues that govern the structure of the heart, such as the atrial septum and ventricular septum, move due to flow and pressure caused by pulsation.It is known that the atrial septum and ventricular septum in actual clinical practice move due to autonomous contraction and expansion, pressure within the cardiac chambers, or blood flow, and reproducing this movement and blood flow is important for improving procedures through simulation.

[0007] The present inventors performed the above-mentioned procedure using a conventional catheter simulator and a heart model, and found that the movement of actual heart components (such as the outer wall and septum) could not be accurately reproduced, and that there was room for further improvement. That is, conventional catheter simulators do not take into account the pressure or blood flow within the cardiac chambers of the placed heart model, and therefore cannot accurately reproduce the movement of the actual heart.

[0008] The purpose of this specification is to provide a catheter simulator that can improve techniques in catheter procedures on tissues that control the structure of the heart, which are mainly performed for arrhythmias and structural heart diseases, and a heart model that can be installed in such a catheter simulator.

[0009] The catheter simulator disclosed in this specification includes a container filled with liquid, a heart model having an outer wall and a septum and placed in the container filled with liquid, and a pulsatile pump connected to the heart model and generating a pulsatile flow in the internal space of the heart model. The heart model is characterized in that a region that is caused to fluctuate by the pulsatile flow is thinner than other regions, and the space including the thinner region is formed in a substantially closed shape.

[0010] In the catheter simulator configured as described above, the pulsating pump generates a pulsating flow in the heart model. The heart model has a portion that is affected by the pulsating flow that is thinner than other portions. Since the space including this thinned portion is formed in a substantially closed state, when the pulsating pump discharges (introduces) and sucks in the pulsating flow into the heart model, the thinned portion repeatedly vibrates in the same way as an actual heart. This makes it possible to perform a simulation that closely resembles the movement of an actual heart.

[0011] The heart model disclosed in this specification is formed from a flexible material and includes outer walls that form the right and left atria and an atrial septum that separates them, or outer walls that form the right and left ventricles and an interventricular septum that separates them. One or more of the right atrium, left atrium, right ventricle, and left ventricle are formed as a substantially closed space, and a portion of the structural portion that forms the substantially closed space is configured to be thinner than the other structural portions.

[0012] With the heart model configured as described above, when it is suspended in a container containing liquid and a pulsating pump is connected, it is possible to repeatedly generate vibrations similar to those of an actual heart in the thin-walled part in a substantially closed space.

[0013] The catheter simulator and heart model described in this specification can improve catheter techniques for tissues that control the structure of the heart, which are performed in cardiac catheterization treatments, such as atrial septal puncture, atrial septal closure, ventricular septal closure, and pacemaker lead or body placement, mainly for arrhythmia disorders and structural disorders.

[0014] 8 is a diagram showing an embodiment of a catheter simulator. A diagram showing a container portion of the catheter simulator shown in FIG. 1 as viewed from above. A perspective view of the container portion of the catheter simulator shown in FIG. 1 as viewed from the front. A perspective view of the container portion of the catheter simulator shown in FIG. 1 as viewed from the rear. A schematic diagram showing the mechanism of a general heart. A diagram showing an embodiment of a heart model, with the outer wall constituting the right atrium removed to expose the atrial septum. A cross-sectional view of the heart model. A diagram showing a state in which a detachable thin film member is attached to the atrial septum. A plan view showing the heart model shown in FIG. 8 set in a container. A perspective view of a holder holding a thin film member as viewed from the back side. A perspective view of a holder holding a thin film member as viewed from the front side. A perspective view of a holder holding a thin film member as viewed from a different angle on the front side.

[0015] 1 shows a cardiac model for atrial septal puncture, which is one embodiment of a catheter simulator and a cardiac model used therein. The catheter simulator according to this embodiment is configured to be suitable for practicing the procedure of feeding a catheter into the right atrium mainly via the inferior vena cava, puncturing the atrial septum to form a hole, and introducing the catheter into the left atrium.

[0016] 1 includes a container 10 that houses a heart model 100, and a pulsatile flow generating pump (hereinafter referred to as the pump) 50 that circulates a liquid W, such as water, filled in the container 10. The heart model 100 is held in the container 10 so that it floats in the liquid W, and the pump 50 repeatedly performs suction and discharge operations on a space formed in a closed (approximately closed) shape, causing the right and left atria in the heart to repeatedly expand and contract, as will be described later.

[0017] The heart model 100 is made of a flexible material similar to an actual human heart, such as PVA (polyvinyl alcohol), polyurethane, epoxy resin, unsaturated polyester, phenolic resin, silicone, or similar materials, or other thermosetting or thermoplastic resins, either alone or in combination, allowing practice of catheter manipulation with a tactile sensation similar to that of a human organ.

[0018] As described below, the heart model 100 is configured to be suitable for a procedure in which a catheter is introduced through the superior vena cava or inferior vena cava, the atrial septum is punctured from the right atrium, and the catheter is introduced into the left atrium. The color of the heart model 100 may be the same as that of a real heart so that the interior cannot be seen, allowing the trainee to simulate while observing a monitor displaying an X-ray fluoroscopic image or an ultrasound image. Alternatively, the heart model 100 may be transparent or translucent so that the trainee can simulate while directly visually observing the movement of the inserted catheter, guide wire, or other device. Even if the heart model is made of a material that can be seen by the trainee, a cover or the like may be placed on the container 10 to prevent the heart model from being seen, allowing the trainee to understand the behavior of the catheter only from the X-ray fluoroscopic image or ultrasound image on the monitor.

[0019] The heart model 100 is preferably formed as a single unit without any artificial seams. This prevents the occurrence of fluid flows (blood flows) not seen in the human body due to seams. Furthermore, it prevents seams from blocking the view during catheter insertion and prevents the appearance of unnatural shadows under X-ray fluoroscopy. Optical modeling, for example, can be used as a method for forming a heart model using a material that satisfies the above-described properties. Using this modeling method, a highly accurate heart model for each patient can be created at a relatively low cost and in a short period of time based on radiographic data of the human organs (cardiac CT data). This allows trainees to create a patient-specific heart model and simulate catheter manipulation prior to actual surgery. Furthermore, catheter simulators can be used as a preliminary preparation for actual catheter manipulation, such as selecting and considering the optimal catheter and various devices for the patient prior to examination or surgery.

[0020] When heart model 100 is formed using the optical modeling method described above, a state close to that of the human body can be reproduced, and therefore the surface of the heart model is not smooth and contains slight irregularities, just like the human body. In this case, even if the heart model is formed using a transparent or translucent material as described above, visible light may be diffused by the uneven surface, reducing visibility. In this case, after the heart model is formed, the surface can be coated with the same material to smooth the uneven surface, thereby reducing diffuse reflection and improving visibility.

[0021] Furthermore, the catheter simulator 1 using the heart model 100 of this embodiment uses the pump 50 to repeatedly discharge and suction liquid into the main body 100A of the heart model 100, thereby generating a flow inside the heart model 100. As a result, the elastic main body 100A, specifically the left and right atria, repeatedly expand (positive pressure) and contract (negative pressure), allowing the liquid to flow like blood in an actual heart. By repeatedly discharging and suctioning liquid in this way, in simulations using a contrast agent, it is possible to prevent the contrast agent from accumulating inside the heart, and the behavior of the catheter can be monitored.

[0022] Next, the container 10, the pump 50, and the heart model 100 will be described with reference to FIGS. 1 to 4 and 9. FIG.

[0023] Note that heart model 100 of this embodiment is formed with a structure suited to simulation (a structure different from the actual heart), such as by omitting some elements that constitute the heart and adding holding parts that are not present in the actual heart. The specific structure of the heart model of this embodiment will be described later.

[0024] The container 10 of this embodiment has a storage section 10a that stores a liquid W such as water or electrolyzed water, and is formed by four side walls 11 to 14 and a bottom surface 15. In this case, the side wall 11 is on the leg side of an actual human body, and the side wall 12 is on the head side of an actual human body.

[0025] The side walls 11 and 12 are formed with holding portions 11A, 11B and holding portions 12A, 12B that can hold the heart model 100 when the container 10a is filled with liquid. These holding portions are provided so as to protrude into the container 10a and are formed, for example, in a cylindrical shape. By forming the holding portions in a cylindrical shape, cylindrical portions formed on the heart model 100 (in this embodiment, the upper and lower vena cava, the esophagus, and cylindrical connecting portions that do not exist in an actual heart) can be inserted, and the heart model 100 is held in a floating state within the container 10 filled with liquid.

[0026] In this case, it is preferable that each of the holding parts 11A, 11B and 12A, 12B has one or more flanges 16 formed on its outer circumferential surface, the flanges tapering toward the tip. This makes it difficult for each connection part to come loose when the heart model 100 is placed, and makes it possible to stably hold the heart model 100.

[0027] In this embodiment, the holding parts 11B, 12B also function as introduction parts for inserting a catheter, and are configured to insert and hold the large veins (superior vena cava 102A, inferior vena cava 102B) of the heart model 100, respectively. For this purpose, introduction parts 11B', 12B' that protrude coaxially to the outside of the container are integrally formed with the holding parts 11B, 12B, and an introduction tube (not shown) of a catheter is connected to each introduction part.

[0028] A connection part 123 that is connected to the left atrium 120 of the heart model 100 is connected to the holding part 11A. This connection part 123 is a component that does not exist in an actual heart, and when the intake / exhaust pipe 52 of the pump 50 is connected to a tube part 11a that protrudes to the outside on the same axis as the holding part 11A, a flow of liquid occurs within the left atrium 120, and the left atrium 120 repeatedly expands and contracts.

[0029] It is preferable that a connection mechanism 17 is provided on the tube portion 11a protruding outside the container, so that the suction and discharge tube 52 of the pump 50 can be attached and detached with a single touch. It is also preferable that an on-off valve (not shown) is provided in the flow path of this connection mechanism 17, so that the liquid does not leak out by operating an on-off operating member 17a. This makes it possible to prevent the liquid from leaking from the storage portion when the suction and discharge tube 52 is attached and detached.

[0030] A connection mechanism 18 that is connected to the internal space of the container may be provided on the side wall 11. This connection mechanism 18 is not used in the simulation of this embodiment, but when a different heart model is attached, it can be connected to a pump 50 to circulate liquid inside the heart model or to function as a drain pipe for draining liquid stored in the container 10.

[0031] The holding portion 12A provided on the side wall 12 is provided so that transesophageal echocardiography can be performed. Transesophageal echocardiography is used to observe the heart from the inside by introducing an ultrasound probe into the esophagus. For this reason, the main body 100A of the heart model 100 of this embodiment is formed with an esophagus 105 adjacent to the vena cava (superior vena cava 102A, inferior vena cava 102B) (in contact with the back of the heart model), into which an ultrasound probe for transesophageal echocardiography can be inserted.

[0032] One end 105a of the esophagus 105 is inserted into and held in the holding portion 12A, and the other end 105b is open inside the container. Furthermore, a tubular portion 60 for inserting an ultrasonic probe toward the inside of the container is provided on the outside of the container of the holding portion 12A. That is, since X-ray fluoroscopy, intracardiac ultrasound, transesophageal ultrasound, and the like are used when puncturing the atrial septum, it is preferable that a port for introducing transesophageal ultrasound be integrally formed.

[0033] The side walls 11-14 and bottom surface 15 of the container 10 described above may be formed from a material strong enough to stably contain the liquid and the heart model. The container 10 may be formed into a shape that can stably contain the liquid and the heart model. Furthermore, the materials of the side walls 11-14 and bottom surface 15 that constitute the container are preferably transparent. By making the side walls and bottom surface transparent, it becomes possible to visually observe the behavior of the heart model placed inside the container 10 and the catheter inserted from outside the container 10 during simulation. Examples of such strong and transparent materials include acrylic, polycarbonate, PET, and polystyrene.

[0034] Even if the container 10 is made of a material that can be seen by the trainee, a camera can be installed and displayed on a monitor, or an image can be fluoroscopically viewed using X-rays and displayed on a monitor, allowing a simulation to be performed in which the behavior of the catheter can be grasped only on the monitor, thereby realizing a more realistic situation. Depending on the stage and content of the training, visual recognition, monitor display confirmation, or X-ray imaging can be selected.

[0035] The container 10 has an opening at the top, which may be fitted with an openable lid. This allows efficient work through the opening at the top of the container when preparing for practice or cleaning up, such as filling the storage section 10a with liquid W or placing the heart model in the liquid. Making the lid transparent also prevents dust from entering. Furthermore, by tightly fitting the lid to the liquid surface, it is possible to prevent reduced visibility due to the swaying of the liquid surface.

[0036] The holders 11B and 12B function not only to hold the heart model but also to serve as catheter introduction sections. As described above, introduction tubes for introducing a catheter operated by the trainee from outside the container 10 are connected to the introduction sections 11B' and 12B' that protrude outward coaxially with the holders 11B and 12B, respectively.

[0037] In an actual simulation, the container 10a is filled with liquid W, and the heart model 100 is placed in a floating state in the liquid. The floating state of the heart model 100 allows the trainee to obtain a more realistic feel when manipulating the catheter. In addition to the holding part described above, for example, a dedicated holder may be placed on the bottom of the container to support the heart model 100 from below and hold it in the liquid.

[0038] The container 10 can be made compact because the only components required are a heart model 100, the same size as a human heart, and a liquid W sufficient to suspend it. In this embodiment, the external dimensions of the container 10 are approximately 20 cm x 20 cm x 15 cm, and the amount of liquid (water) required to fill the container is approximately 3 L to 6 L. Miniaturizing the container 10 eliminates wasted space at the simulation site and improves the storage and portability of the container 10 and the catheter simulator using the container 10. Furthermore, since only approximately 6 L of water needs to be filled into the container's storage section 10a, simulations can be performed in locations without running water by transporting water in a tank, expanding the range of possible locations. Furthermore, the weight of the container filled with water is light enough for a trainee to handle alone, facilitating simulation setup and cleanup without the need for an assistant.

[0039] Next, the specific configuration of the heart model 100 according to this embodiment will be described with reference to Figures 5 to 9. In these figures, Figure 5 is a schematic diagram showing the structure of a typical heart, Figure 6 shows the heart model of this embodiment, with the outer wall constituting the right atrium (right ventricle) removed to expose the atrial septum, Figure 7 is a cross-sectional view of the heart model, Figure 8 is a diagram showing a state in which a detachable thin film member is attached to the atrial septum, and Figure 9 is a plan view showing the heart model shown in Figure 8 set in a container.

[0040] Since the heart model only needs to include the minimum components necessary for catheter manipulation, the main body 100A of the heart model 100 of this embodiment has a different structure from that shown in the schematic diagram of Fig. 5. However, when explaining the heart model of this embodiment, the schematic diagram of Fig. 5 will be used to make the components easier to understand.

[0041] As shown in Figure 5, the interior of an actual heart body has four chambers: a right atrium 110, a right ventricle 111, a left atrium 120, and a left ventricle 121. Vena cavae (superior vena cava 102A and inferior vena cava 102B) protrude from the right atrium 110, and a pulmonary artery 140 protrudes from the right ventricle 111. In this embodiment, the inferior vena cava 102B of the heart model is connected to a holding portion 11B (introduction portion 11B') formed in the container 10, and serves as an inlet for a catheter. In addition, the superior vena cava 102A of the heart model is connected to a holding portion 12B (introduction portion 12B') formed in the container 10, and serves as an inlet for a catheter.

[0042] In an actual human body, the inferior vena cava 102B leads to the femoral vein running through the groin, and serves as an introduction path for a catheter introduced from the groin (the base of the leg).The superior vena cava 102A leads to the internal jugular vein running through the base of the neck, and serves as an introduction path for a catheter introduced from the base of the neck.

[0043] The heart model of this embodiment includes outer walls that form the right atrium 110 and the left atrium 120 and an atrial septum 150 that separates them, or outer walls that form the right ventricle 111 and the left ventricle 121 and an interventricular septum 156 that separates them. That is, the main body 100A includes the right atrium 110 and the left atrium 120 that are separated by the interatrial septum 150 so as to be adjacent to each other, and the right ventricle 111 and the left ventricle 121 that are separated by the interventricular septum 156 so as to be adjacent to each other.

[0044] In this case, one or more of the right atrium 110, left atrium 120, right ventricle 111, and left ventricle 121 are formed as a substantially closed space, and a part of the structural part constituting the substantially closed space is configured to be thinner than the other structural parts. Here, the "substantially closed space" means that, as will be described later, when the pump 50 repeatedly draws in and discharges liquid, the thinned part within the space can vibrate, and as long as such vibration can be obtained, the main body 100A may have a partially open part.

[0045] In this embodiment, for example, when performing atrial septal puncture during catheter treatment for atrial fibrillation, the structure is suitable for vibrating the atrial septum 150 (see Figure 7) punctured by the needle portion of the catheter 200 introduced from the right atrium 110.

[0046] In actual treatment, a catheter is introduced into the left atrium 120 through the drilled hole 150a, and, for example, a simulation of energizing treatment by radiofrequency catheter ablation or cooling treatment by a cryoballoon ablation catheter is performed on the junction of the left atrium 120 and pulmonary vein 122. In this case, the catheter 200 to be operated is introduced into the right atrium 110 from the inferior vena cava 102B, punctures the atrial septum 150, and is introduced into the left atrium 120, as shown in FIG.

[0047] When performing the above-described atrial septal puncture, the portion that is formed thinner than the other structural portions is the atrial septum 150. In a simulation of puncturing the atrial septum 150, it is important that the heart model behaves in a similar manner to an actual heart. That is, in actual clinical practice, it is known that the atrial septum moves (vibrates in a direction approximately perpendicular to the atrial septum) due to the pressure and blood flow within the cardiac chamber, and it is important to reproduce such movement and blood flow in a simulation using a heart model.

[0048] In this case, it is possible to ensure a certain degree of reproducibility by connecting the right atrium to a pump 50 to discharge fluid into the heart model and then aspirating the discharged fluid from another location, as in conventional heart models and simulators. On the other hand, the heart of an actual living body ejects blood to various locations by repeating autonomous contraction and expansion, rather than by passive movement caused by a pump. Therefore, even if a heart model were created that was condensed to the same thickness as a living body heart, it would not be possible to make the heart model expand and contract as intended due to the external influence of the suction and discharge operations of the pump 50.

[0049] However, in the heart model, by forming the region where expansion and contraction are desired to occur relatively thinner than other regions and configuring that region to form a closed or semi-closed circuit (by creating a closed or semi-closed space and repeatedly drawing in and discharging liquid within that space), it is possible to cause expansion and contraction at the intended region by the action of the pump. Therefore, in order to realize operation of the atrial septum 150 that is close to that in actual clinical practice, the simulator of this embodiment is configured as follows, allowing practice similar to actual catheter treatment.

[0050] When the atrial septum 150 is thinned, that portion is more likely to vibrate than other portions (it is more likely to fluctuate (vibrate) in a direction perpendicular to the atrial septum). For this reason, if the space including the atrial septum 150 is closed and the pump 50 shown in FIG. 1 is connected to the interior of the closed space to repeatedly draw in and discharge liquid, the left atrium 120 and the right atrium 110 will repeatedly expand (positive pressure) and contract (negative pressure). This expansion (positive pressure) and contraction (negative pressure) causes the liquid to flow like blood in an actual heart, and the atrial septum 150 can also reproduce the same movement as an actual heart.

[0051] Specifically, the left atrium 120 is left as a substantially closed space, and the connection part 123 formed on the left atrium 120 side is inserted into the holding part 11A of the container 10, and the suction / discharge tube 52 of the pump 50 is connected through a tube part 11a that protrudes to the outside on the same axis as the holding part 11A. The pump 50 has a simple structure that simply repeats the suction and discharge of liquid, and repeats the suction and discharge of liquid to the left atrium 120 through the suction / discharge tube 52. As a result, the left atrium 120, which is a closed space, continuously and repeatedly undergoes expansion (positive pressure) associated with the discharge operation of the pump 50 and contraction (negative pressure) associated with the suction operation of the pump 50.

[0052] Repeated practice of catheter introduction operations on the above-mentioned heart model 100 will damage the atrial septum 150, so in this embodiment, at least a portion of the atrial septum 150, the part that is punctured by the introduced catheter 200, is configured to be detachable.

[0053] In this way, by considering the site to be punctured depending on the surgical procedure and configuring only that site to be detachable, it is possible to avoid unnecessary replacement of the main body 100A. In this embodiment, for the detachable site, as shown in Figures 5, 6, and 8, an opening 150A is formed in advance in the atrial septum 150, and a thin film member 160 having the same flexibility and thickness as an actual heart is configured to be detachable in that portion.

[0054] There are no limitations on the material of the thin film member 160, as long as it is made of a flexible, soft material (such as rubber) that can be punctured with the needle of a catheter. Furthermore, it is desirable that the thin film member 160 be configured with some slack in the center so that it stretches in a tent shape from the right atrium to the left atrium when punctured with a catheter.

[0055] 10 to 12, in this embodiment, the thin film member 160 is attached to a ring-shaped holder (hard frame) 165 having the same size as the opening 150A to facilitate handling of the thin film member 160 and to facilitate attachment and detachment to and from the atrial septum 150. The holder 165 is made of a material (hard plastic, etc.) that is harder than the main body 100A (atrial septum 150), and the thin film member 160 is attached to an opening 165A formed in the central region of the holder 165 by adhesive or the like.

[0056] A step 166 is formed around the periphery of the holder 165, and the opening 150A of the atrial septum is closed by press-fitting the step 166 onto the edge (inner edge) of the opening 150A of the atrial septum 150. Alternatively, an annular groove may be formed around the periphery of the holder 165, and the edge of the opening 150A of the atrial septum 150 may be fitted into this annular groove to form a detachable configuration.

[0057] In this way, by configuring the atrial septum 150 so that only the portion to be punctured is replaceable, it becomes possible to perform simulations repeatedly. In other words, in the procedure for puncturing the atrial septum 150, the catheter insertion position is important (the insertion position varies depending on the procedure), and this can be performed efficiently. Furthermore, since damage occurs during the simulation, by making the heart model replaceable as described above, it is possible to replace only the necessary portion. It becomes possible to perform the procedure multiple times without preparing a large number of heart models 100.

[0058] As described above, the detachably replaceable part may be only a portion of the atrial septum, or the entire atrial septum may be replaceable. Even if only a portion of the atrial septum is replaced using the thin film member 160, it can still move (vibrate) in perpendicular directions. That is, by connecting the pump 50 shown in FIG. 1 so that the left atrium 120 and the right atrium 110 repeatedly expand (positive pressure) and contract (negative pressure), the fluid flows like blood in an actual heart, and the thin film member 160 can also reproduce the same movement as an actual heart. This makes it possible to simulate a catheter puncture operation under conditions closer to actual practice, thereby improving the procedural technique.

[0059] In the above-described heart model, when simulating a procedure in which a catheter 200 is inserted from the right atrium 110 side into the atrial septum 150 and introduced into the left atrium 120 side, unnecessary elements of the heart model, such as the right ventricle 111 and the left ventricle 121, may be omitted. Alternatively, as shown in Fig. 6, a notch 110A may be formed by removing the outer wall (part of the outer wall) that constitutes the right atrium 110. By forming such a notch 110A, the area extending from the internal space of the right atrium 110 to the atrial septum 150 is exposed, allowing the movement of the catheter to be visually confirmed during the simulation, thereby improving the procedure.

[0060] That is, when puncturing the atrial septum 150, a notch 110A is formed in the outer wall of the right atrium 110 to allow the catheter 200 to access the right atrium 110 from the inferior vena cava 102B, making it possible to visually observe the movement of the catheter being operated even in an environment without X-rays or ultrasound. Visibility can be ensured by forming the heart model 100 from a transparent material without removing the outer wall portion that constitutes the right atrium. Furthermore, the aorta 127 and pulmonary artery 118 do not need to be formed on the left atrium 120 side to create a closed space, and even if they are formed, their tips are blocked.

[0061] As described above, the portions of the components of the heart model 100 to be removed can be determined depending on the surgical procedure to be simulated. For example, the heart model may be formed with all or part of the outer walls constituting the right atrium 110, the left atrium 120, the right ventricle 111, or the left ventricle 121 removed. Alternatively, the outer walls may be cut out or an opening formed so that the atrial septum 150 or the ventricular septum 156 is exposed.

[0062] Furthermore, even if such an opening is formed, the right atrium 110 side experiences continuous and repeated contraction (negative pressure) and expansion (positive pressure), which are opposite movements, due to fluctuations in the thin film member 160 of the atrial septum 150. As a result, the atrial septum (the thin film member 160, which is mobile and has the minimum necessary size) reciprocates in perpendicular directions, just like in an actual heart.

[0063] The movement of the thin film member 160 described above reproduces the same movement as the atrial septum of an actual heart, making it possible to simulate the catheter puncture operation in a more realistic manner, thereby improving the technique.

[0064] The pumps used in conventional simulations were designed to introduce one-way flow into the heart model and suck up the liquid that flows out of the heart into a container, making connection work cumbersome. On the other hand, the pump of this embodiment has a structure that repeatedly sucks in and discharges from a single port, making it easy to set up.

[0065] Furthermore, although the pump 50 was connected to the left atrium 120 side of the heart model 100, as long as the movement of the thin film member 160 as described above can be realized, it may be configured to be connected to the right atrium 110, or to a space continuous with the left atrium 120 and the right atrium 110. In this case, it is sufficient that at least one of the right atrium 110 and the left atrium 120 of the heart model 100 forms a closed circuit (meaning a configuration in which the left and right atria can repeatedly expand and contract continuously due to the inflow / outflow of liquid) with the pump 50 connected, or, if an opening is provided in part of the atrial septum, a semi-closed circuit in which the part other than the atrial septum is closed.

[0066] Furthermore, the pump 50 may be connected to a location other than the left atrium (left ventricle). For example, the pump 50 may be connected to the pulmonary vein 122 of the left atrium 120 to form the closed circuit described above.

[0067] In the configuration of this embodiment, the left atrium 120 is a closed space (approximately closed space), but in another embodiment, for example, in the case of atrial septum closure, part of the atrial septum remains open. By closing the part other than the atrial septum, the left atrium 120 can be maintained as a semi-closed space. This allows the behavior of the atrial septum to be maintained.

[0068] In the catheter simulator configured as described above, the pulsatile pump 50 is configured to repeatedly draw and discharge the liquid, continuously generating negative and positive pressures in the right and left atria. In this embodiment, the flow is not unidirectional but back and forth, which can lead to air accumulation within the pump or the connecting path between the pump and the container. For this reason, it is preferable to connect the pulsatile pump 50 to the container 10 and install an air discharge path (e.g., a thin tube connected via a path separate from the liquid suction and discharge) within the pulsatile pump 50 to discharge accumulated air bubbles into the container 10. This allows for efficient air removal. In this case, while it is possible to drop a tube into the liquid from the liquid surface on the container side, it is preferable to provide a connection port on the tank sidewall for one-touch attachment and detachment from the viewpoint of visibility and usability.

[0069] Although the embodiments of the catheter simulator and the heart model have been described above, the configurations proposed in this specification are not limited to the above-described embodiments and can be modified in various ways. For example, the structure of the heart model can be modified as needed, and the holding position and holding manner relative to the container 10 can be modified as needed.

[0070] Furthermore, in the heart model 100, the portion formed thinner than the other structural portions may be the ventricular septum. Furthermore, the heart model 100 may be any one or more of the following cardiac chambers: the right atrium, the left atrium, the right ventricle, and the left ventricle. For example, in a heart model having only the right atrium and no left atrium, a thin-walled portion may be formed in a portion of the outer wall of the right atrium that corresponds to the atrial septum. In a heart model having only the right ventricle and no left ventricle, a thin-walled portion may be formed in a portion of the outer wall of the left ventricle that corresponds to the ventricular septum. In a heart model having multiple cardiac chambers, the combination of the cardiac chambers is not limited, and the septum may be either the atrial septum or the ventricular septum, or both. The pulsatile pump 50 may be connected to any of the spaces formed according to the combination of cardiac chambers, such as the right atrium or the left atrium, or a space connected to the left atrium and the right atrium, or a space connected to the right ventricle or the left ventricle, or a space connected to the left ventricle and the right ventricle.

[0071] REFERENCE SIGNS LIST 1 Catheter simulator 10 Container 10a Storage section 50 Pump 52 Suction and discharge tube 100 Heart model 100A Main body 102A Inferior vena cava 102B Superior vena cava 105 Esophagus 110 Right atrium 120 Left atrium 123 Connection section 150 Atrial septum 150A Opening 160 Thin film member 165 Holder

Claims

1. A catheter simulator comprising: a container filled with liquid; a heart model having an outer wall and a septum and placed in the container filled with liquid; and a pulsatile pump connected to the heart model and generating pulsatile flow in the interior space of the heart model, wherein the heart model has a portion that is changed by the pulsatile flow that is thinner than other portions, and the space including the thinned portion is formed in a substantially closed shape.

2. The catheter simulator according to claim 1, wherein the pulsation pump is connected to the space formed in a substantially closed shape and repeats the operation of introducing a liquid and the operation of suctioning the introduced liquid.

3. A catheter simulator according to claim 1 or 2, characterized in that the heart model has an interatrial septum as the septum and further includes a right atrium, a left atrium, or both, and the pulsatile pump is connected to a space continuous with the right atrium, the left atrium, or the right and left atria.

4. The catheter simulator according to claim 3, wherein the pulsatile pump continuously generates negative and positive pressures in the right or left atrium by repeating the suction and discharge of the liquid.

5. A catheter simulator according to claim 3, wherein at least one of the right atrium and the left atrium of said heart model forms a closed circuit with said pulsatile pump connected thereto.

6. The catheter simulator according to claim 3, wherein the cardiac model is closed except for the atrial septum, and forms a substantially closed circuit with the pulsatile pump connected.

7. A catheter simulator according to claim 1 or 2, characterized in that the heart model has a right ventricle, a left ventricle, or both, and the septum is an interventricular septum, and the pulsatile pump is connected to a space continuous with the right ventricle, the left ventricle, or the right and left ventricles.

8. The catheter simulator according to claim 7, wherein the pulsatile pump continuously generates negative and positive pressures in the right or left ventricle by repeating the suction and discharge of the liquid.

9. A catheter simulator according to claim 7, wherein at least one of the right ventricle and the left ventricle of said heart model forms a closed circuit with said pulsatile pump connected thereto.

10. The catheter simulator according to claim 7, wherein the cardiac model is closed except for the ventricular septum, and forms a substantially closed circuit with the pulsatile pump connected.

11. A catheter simulator according to claim 1, characterized in that an air discharge path is provided that connects the pulsating pump to the container and discharges air bubbles accumulated in the pulsating pump into the container.

12. The catheter simulator according to claim 11, wherein the air discharge path is a path independent of the liquid suction and discharge paths.

13. A heart model for a catheter simulator, formed from a flexible material and comprising an atrial septum or ventricular septum and at least one heart chamber selected from the right atrium, left atrium, right ventricle and left ventricle, wherein the heart chamber is formed in a substantially closed space, and a portion of the structural part that constitutes the substantially closed space is thinner than the other structural parts.

14. The cardiac model according to claim 13, wherein the portion formed to be thinner than the other structural portions is the atrial septum or the ventricular septum.

15. The cardiac model according to claim 14, wherein at least a portion of the atrial septum or the ventricular septum is detachable.

16. The heart model according to claim 14 or 15, characterized in that an opening is formed in the atrial septum or the ventricular septum, and a portion of the opening is covered by a thin film member.

17. The heart model according to claim 16, wherein the thin film member is formed of a material harder than the atrial septum or the ventricular septum and is held by a holder that can be attached and detached to the periphery of the opening.

18. The cardiac model according to claim 16, wherein the thin film member has a slack in the center.

19. The cardiac model according to claim 14, characterized in that a notch is formed to expose the atrial septum or the ventricular septum.

20. The heart model according to claim 14, wherein an esophagus is provided in contact with the back surface of the heart model.

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