Catheter simulator and pulsatile flow generation method

Abstract

Provided is a catheter simulator capable of reproducing, in a heart model held in a liquid in a container, a blood flow and cardiac pulsations in a living body. The catheter simulator comprises: a container 10 filled with a liquid; an elastic heart model 100 which is installed in the container 10 in a state of being filled with the liquid and in which a ventricle and a large blood vessel continuous with the ventricle are provided; and a pulsation pump 50 which is connected to the large blood vessel of the heart model 100 or is connected a space continuous with the large blood vessel, and which generates negative pressure in the ventricle by suctioning the liquid.

Description

Catheter simulator and pulsatile flow generation method

[0001] The present specification discloses a catheter simulator and a pulsatile flow generation method for generating a pulsatile flow for a heart model installed in the catheter simulator.

[0002] Cardiac catheterization involves inserting a catheter into the coronary vein to perform angiography or to place a device. One of these procedures involves intravenous pacemaker lead placement, which requires placing leads in the atrium, ventricle, or both. Experience is required to master these procedures, and simulator-based training is considered useful, especially for first-time practitioners. Cardiac resynchronization therapy (CRT) in particular requires placing leads in the coronary vein. This procedure requires retrograde (opposite the direction of blood flow) placement of the lead from the subclavian vein through the right atrium, which can be challenging even for experienced practitioners and can result in increased procedure time and X-ray exposure.

[0003] On the other hand, if an incorrect operation during the procedure causes a hole in the heart wall, blood can accumulate around the heart, resulting in complications such as tamponade, which ultimately leads to cardiac arrest. Furthermore, the fact that the leads must be placed in a heart that moves with the heart's beat also makes the procedure more difficult. Furthermore, even if the leads are placed correctly, the effectiveness of the surgery depends greatly on whether they are placed in the right location.

[0004] Simulation-based training is essential to master these procedures, prevent complications, and ensure proper placement of leads. Several simulators exist that can perform simulations using cardiac models created to resemble the actual heart, helping to improve catheterization techniques. To perform procedures using contrast agents under X-ray fluoroscopy, which is important in clinical practice, a mechanism capable of reproducing the blood flow and heartbeat of a living body is required.

[0005] There are several configurations of catheter simulators, and the present inventors have proposed simulators for improving catheter manipulation techniques, for example, in Patent Documents 1 and 2. In conventional simulators, a heart model is suspended in liquid, and a pump is used to discharge liquid into the heart model body, thereby generating a pulsatile flow. That is, an inlet port, which does not exist in an actual heart, is formed at the apex of the heart model, and a pulsatile pump is used to introduce liquid into the heart model from this port in a pulsatile or steady flow, thereby reproducing the blood flow and cardiac pulsation within the heart model.

[0006] Patent No. 7251746 Patent No. 7401867

[0007] However, because the fluid inflow into the cardiac model described above is via a different route from the actual blood flow within the heart, it cannot be said to perfectly replicate the anatomical structure of a living body. In particular, practical issues include the possibility of a catheter inserted into the apex of the heart being misplaced into this inflow route, or the contrast agent flow being replicated differently from that in a living body. Specifically, if flow is introduced from the apex of the right ventricle, blood may flow back or stop flowing into the superior vena cava, inferior vena cava, and coronary veins, which can interfere with simulations when performing contrast imaging under X-ray fluoroscopy as in a real clinical setting.

[0008] This specification discloses a catheter simulator and a pulsatile flow generation method that can reproduce the blood flow and heartbeat of a living body for a heart model held in a liquid container.

[0009] The catheter simulator disclosed in this specification is characterized by comprising: a container filled with liquid; an elastic heart model that is placed in the container filled with liquid and has a ventricle and a large blood vessel connected to the ventricle; and a pulsatile pump that is connected to the large blood vessel of the heart model or a space connected to the large blood vessel and generates negative pressure in the ventricle by suctioning the liquid.

[0010] In the catheter simulator described above, a pulsating pump applies suction force through the large blood vessels connected to the ventricles, i.e., the pulmonary artery in the case of the right ventricle, or the aorta in the case of the left ventricle. For example, by providing a suction port in the pulmonary artery or aorta and applying suction force from this port to the heart model suspended in liquid using the pulsating pump, it is possible to reproduce the ejection flow and the contraction and expansion of the ventricles, just like in an actual heart.

[0011] The pulsatile flow generating method disclosed in this specification is characterized in that a pulsatile pump is connected to an elastic heart model that is placed in a liquid-filled container and has a right ventricle, a left ventricle, or both, and the liquid in the right ventricle or the liquid in the left ventricle is continuously and repeatedly sucked out via the pulsatile pump, thereby generating a pulsatile flow in the heart model.

[0012] Because the heart model has elasticity, when continuous suction is applied by the pulsatile pump, negative pressure acts on the right or left ventricle, causing it to contract and generate blood flow. This blood flow is pulsatile, in the same direction as the blood flow from the superior vena cava and inferior vena cava into the heart itself, just like in an actual heart, and reproduces the blood flow and heartbeat in a living body.

[0013] The catheter simulator and pulsatile flow generating method described in this specification make it possible to reproduce the blood flow and heartbeat in a living body, thereby improving catheterization techniques.

[0014] 1 is a diagram showing one embodiment of a catheter simulator. 2 is a diagram showing a container portion of the catheter simulator shown in FIG. 1 as viewed from above. 3 is a front view showing the configuration of a heart model used in the catheter simulator shown in FIG. 1. 4 is a side view showing the configuration of a heart model used in the catheter simulator shown in FIG. 1. 5 is a back view showing the configuration of a heart model used in the catheter simulator shown in FIG. 1. 6 is a cross-sectional view taken along the vertical direction of the heart model shown in FIG. 3. 7 is a diagram showing the state in which the heart model is set in a container as viewed from the top. 8 is a diagram showing another embodiment of a heart model.

[0015] Fig. 1 is a diagram showing one embodiment of a catheter simulator, a heart model used therein, and a pulsatile flow generating method, and Fig. 2 is a plan view showing the container portion. The catheter simulator and heart model according to this embodiment are configured to enable training of a procedure for placing a transvenous pacemaker (a procedure for placing leads in the atrium, the ventricle, or both) or a procedure for placing leads in a coronary vein (a procedure for performing cardiac resynchronization therapy) under conditions similar to those of an actual heart.

[0016] 1 includes a container 10 that houses a heart model 100, and a pulsatile flow generating pump (hereinafter referred to as 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 as to float in the liquid W, and the pump 50 is configured to repeatedly perform a continuous (intermittent) suction operation on a space formed in a closed (or substantially closed) shape.

[0017] The heart model 100 is made of a flexible material similar to a real 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 for catheter manipulation practice with a tactile sensation similar to that of a human organ.The heart model of this embodiment is configured as a right-sided heart model that generates negative pressure in the right ventricle via the pulmonary artery.

[0018] As shown in Figures 3 to 6, the heart model 100 (main body 100A) of this embodiment includes a superior vena cava 102A, an inferior vena cava 102B, and a pulmonary artery 103, and is formed with three chambers: a right atrium 110, a right ventricle 111, and a left ventricle 121. The vena cava (superior vena cava 102A and inferior vena cava 102B) protrudes from the right atrium 110, and the pulmonary artery 103 protrudes from the right ventricle 111. The left subclavian vein 105 branches off from the superior vena cava 102A. Although the heart model 100 of this embodiment does not include the left atrium that is present in a normal heart, the left atrium may be formed (in Figure 5, the left atrium 120 is formed in the portion removed by the notch opening edge 120a).

[0019] The heart model 100 of this embodiment includes an outer wall that constitutes the right atrium 110 and an atrial septum that separates the right atrium from the left atrium (formed at the portion of the notched opening edge 120a in Figure 5), and / or outer walls that constitute the right ventricle 111 and the left ventricle 121 and an interventricular septum that separates them.

[0020] Furthermore, the main body 100A is formed with a coronary vein 108. This coronary vein 108 is a portion into which blood from the coronary artery flows, and blood flows into the right atrium 110 via a coronary sinus 108A that opens into the right atrium 110.

[0021] The above-described heart model 100 is configured as a right-sided heart model suitable for cardiac resynchronization therapy (CRT), in which the left subclavian vein 105 serves as a catheter introduction path, and leads are placed in the right atrial septum, the right ventricular apex or ventricular septum, or the coronary veins via the right atrium 110. As will be described later, the catheter simulator 1 (container 10 and pump 50) is configured to reproduce blood flow similar to that of an actual heart for the heart model 100, which is held so as to float in liquid, thereby enabling effective training of such procedures.

[0022] 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. Therefore, the inferior vena cava 102B and the superior vena cava 102A may form a catheter introduction path.

[0023] The color of the heart model 100 described above may be the same as that of a real heart so that the interior cannot be seen, allowing the trainee to perform the simulation while observing a monitor displaying an X-ray fluoroscopic image or an ultrasound image. Alternatively, the color may be transparent or translucent so that the trainee can perform the simulation while directly visually observing the movement of the inserted catheter, guide wire, or other device. Note that even if the heart model is made of a material that can be seen by the trainee, it is also possible to cover the container 10 with a cover or the like so that the heart model cannot be seen, allowing the trainee to understand the behavior of the catheter only from the X-ray fluoroscopic image or ultrasound image on the monitor.

[0024] 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.

[0025] When the heart model 100 is formed using the optical modeling method described above, it is possible to reproduce a state close to that of the human body, 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, resulting in reduced visibility. In such cases, 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.

[0026] The container 10 has a storage section 10a for storing a liquid W such as water or electrolyzed water, which is formed by four side walls 11 to 14 and a bottom surface 15. In this case, the side wall 11 corresponds to the leg side of an actual human body, and the side wall 12 corresponds to the head side of an actual human body.

[0027] The container 10 is formed with a holding portion capable of holding the heart model 100 with the container portion 10a filled with liquid. In this embodiment, the container is configured to hold the superior vena cava 102A, the inferior vena cava 102B, and the pulmonary artery 103 of the heart model 100 by inserting them into the holding portion. That is, the superior vena cava 102A, the inferior vena cava 102B, and the pulmonary artery 103 are components of an actual heart, and the heart model 100 is held in the container filled with liquid by utilizing these blood vessels.

[0028] For this reason, cylindrical holding portions 11A and 12A are provided on side walls 11 and 12 of storage portion 10a, respectively, so as to protrude into the container, and superior vena cava 102A and inferior vena cava 102B of heart model 100 are inserted into these portions. In addition, side wall 12 is provided with cylindrical holding portion 12B into which pulmonary artery 103 of heart model 100 is inserted.

[0029] Each of the holding portions 11A, 12A, 12B preferably has one or more flanges 16 formed on its outer circumferential surface, the diameter of which decreases toward the tip. This makes it possible to stably hold the heart model 100 by preventing the connection portions from coming loose when the heart model 100 is placed therein. A further holding portion having the function of holding the heart model 100 may also be provided within the container 10. Since the catheter simulator of this embodiment is structured to be suitable for introducing a catheter through the left subclavian vein 105, a holding portion 14A is protrudingly formed on the side wall 14, into which the left subclavian vein 105 formed in the heart model 100 is inserted.

[0030] This holding portion 14A may have the same configuration as the holding portions 11A, 12A, and 12B, but since it also functions as an introduction portion through which a catheter is inserted, it is configured, for example, as follows: That is, a tube 14a is inserted into a through-hole formed in the side wall 14, and the left subclavian vein 105 is fitted to the side that protrudes into the container. The holding portion 14A is provided with a sheath 14A' that protrudes coaxially outside the container, and an introduction tube of a catheter is inserted through the sheath 14A'.

[0031] In this case, the holding units 11A and 12A may also function as introduction units through which a catheter is inserted from the large veins (superior vena cava 102A and inferior vena cava 102B) of the heart model 100. Therefore, each of the holding units 11A and 12A can be configured similarly to the holding unit 14A. Note that the holding units 11A and 12A may be configured simply to hold the heart model 100 without having the function of introducing a catheter.

[0032] Another holding part may be provided in the container 10. For example, a holding part 11B may be formed on the side wall 11, and a connecting part 160 (a structure that does not exist in an actual heart; see FIG. 3 ) protruding from the apex of the heart model 100 may be inserted into this part to hold the heart model.

[0033] The side wall is provided with a suction unit that continuously (intermittently) sucks liquid into the held heart model 100 via the pump 50. This suction unit has the function of generating a pulsatile flow within the heart model 100. Specifically, by sucking liquid from within the heart model 100 via the suction unit, negative pressure is generated within the ventricle of the held heart model 100, which causes a flow of liquid from the right atrium to the right ventricle.

[0034] In this embodiment, the cylindrical holder 12B into which the pulmonary artery (great blood vessel) 103 of the heart model 100 is inserted functions as a suction part. That is, a suction pipe 52 of the pump 50 is connected to a connecting pipe 12a that protrudes to the outside on the same axis as the holder 12B, and a suction operation is applied, thereby generating negative pressure in the right ventricle 111.

[0035] The side wall is also provided with a discharge portion that returns the liquid into the container 10 via the pump 50. The location at which the discharge portion is provided is not limited, but in this embodiment, a discharge portion (discharge opening) 12C is provided below the side wall 12. Discharge portion 12C connects a discharge pipe 53 of the pump 50 to a connecting pipe 12c that protrudes to the outside, and discharges the liquid into the container 10, thereby returning the liquid sucked by the suction pipe 52 and maintaining a constant liquid level in the container 10.

[0036] The connecting pipes 12a, 12c protruding from the container are preferably provided with a commonly known connecting mechanism 17 so that the suction pipe 52 and discharge pipe 53 of the pump 50 can be attached and detached with a single touch. It is also preferable that an on-off valve (not shown) be provided in the flow path of this connecting mechanism 17 so that the liquid in the container does not leak out by operating an on-off operating member 17a. This prevents the liquid in the container from leaking when the suction pipe 52 and discharge pipe 53 are attached and detached. The connecting mechanism 17 can also function as a drain pipe for discharging the liquid when the simulation is completed.

[0037] A separate holding section may be provided on the side wall of the container so that various simulations can be performed, or a connecting section may be formed on the heart model 100 so that the heart model 100 can be connected to such a holding section. For example, an esophagus into which an ultrasound probe for transesophageal echocardiography can be inserted can be formed adjacent to the superior vena cava 102A and inferior vena cava 102B of the heart model 100 (in contact with the back of the heart model) so that an ultrasound probe can be introduced into the esophagus to observe the heart from the inside.

[0038] One end of the esophagus is inserted into a new holder on the side wall of the container, and the other end is left open inside the container. A tubular section is provided on the outside of the container from the holder, through which an ultrasound probe can be inserted toward the inside of the container, enabling X-ray fluoroscopy, intracardiac ultrasound, transesophageal ultrasound, and other procedures during catheter operation.

[0039] The side walls 11-14 and bottom surface 15 of the container 10 described above are formed from a material strong enough to stably contain the liquid and the heart model. The container 10 is only required to 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 make up the container are preferably transparent. The transparency of the side walls and bottom surface makes it 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.

[0040] 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.

[0041] The container 10 has an opening at the top, which may be fitted with an openable lid. This allows for efficient preparation and cleanup of practice, such as filling the storage section 10a with liquid and placing the heart model in the liquid, through the opening at the top of the container. 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.

[0042] 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.

[0043] The container 10 can be made compact because the only components required to be contained in the container 10 are a heart model 100 the same size as a human heart and a liquid W sufficient to suspend it. In this embodiment, the outer dimensions of the container 10 are approximately 21 cm x 23 cm x 20 cm. When the water level is 2 cm below the top edge of the container, the amount of liquid (water) required to fill the container is 19 cm x 21 cm x 18 cm, or approximately 7.2 L. By miniaturizing the container 10 in this way, it is possible to eliminate wasted space at the simulation site and improve the storability and portability of the container 10 and the catheter simulator using the container 10. Furthermore, because only approximately 7 L of water needs to be filled into the container's storage section 10a, simulations can be performed in locations where running water is unavailable by transporting water in a tank, expanding the range of possible locations. Furthermore, the weight of the container filled with water is light enough that a trainee can handle it by himself, making it easy to set up and take down the simulation without the constraints of an assistant.

[0044] Next, a procedure for practicing cardiac resynchronization therapy procedures using the catheter simulator 1 configured as described above and the method for generating pulsatile flow for a cardiac model will be described.

[0045] First, the heart model 100 shown in Figures 3 to 6 is set in the container 10 filled with liquid W (see Figures 1 and 7). Specifically, the superior vena cava 102A of the heart model 100 is inserted into the holder 12A, and the inferior vena cava 102B is inserted into the holder 11A. Furthermore, the pulmonary artery 103 is inserted into the holder 12B, and the left subclavian vein 105 is inserted into the holder 14A. Then, the suction tube 52 of the pump 50 is connected to the connecting tube 12a of the holder 12B, and the discharge tube 53 of the pump 50 is connected to the connecting tube 12c of the discharge tube 12C.

[0046] When pump 50 is driven in this state, liquid in the space connected to the pulmonary artery (right ventricle 111) is sucked through suction tube 52 and pulmonary artery 103, generating negative pressure in right ventricle 111. Since pump 50 applies a suction action continuously (intermittently), liquid is sucked from superior vena cava 102A and inferior vena cava 102B through right atrium 110 and right ventricle 111 and out of pulmonary artery 103.

[0047] The flow of liquid caused by this suction is a flow in which the liquid is pumped from the right ventricle through the pulmonary artery 103. Therefore, physiological blood flow similar to that of an actual heart can be reproduced. In this case, the liquid in the coronary vein 108 also flows into the right atrium 110 through the coronary sinus 108A. Therefore, physiological blood flow similar to that of an actual heart can be reproduced, and when coronary venography is performed under X-ray fluoroscopy, an angiographic image seen in actual clinical practice can be reproduced.

[0048] It is preferable to form an opening 108a in each coronary vein 108. Such an opening 108a is preferably formed at the tip, and by forming such an opening 108a, when the pump 50 applies suction, a flow toward the right atrium is effectively generated in the coronary vein 108, thereby reproducing a physiological flow in the coronary vein.

[0049] Cardiac resynchronization therapy (CRT) requires the insertion of a catheter through the left subclavian vein to access the right atrium and the placement of a lead in the coronary vein, which requires coronary venography. In living subjects, the coronary veins flow from the periphery toward the central part of the heart (returning to the right atrium, where the coronary veins open). Therefore, coronary venography is performed by occluding the coronary vein entrance with a balloon catheter and injecting a contrast agent. In this embodiment, the above-described liquid aspiration via the pulmonary artery 103 and the formation of the opening 108a in the coronary vein 108 allow coronary venography to be performed using the same procedure as in clinical practice. Specifically, a balloon-equipped catheter is inserted into the coronary sinus 108A, the balloon is inflated to block blood flow, and a contrast agent is injected from the tip of the balloon catheter, allowing the coronary vein 108 to be visualized under X-ray fluoroscopy.

[0050] In the above-described configuration of the heart model 100, if the right atrium 110, right ventricle 111, superior vena cava 102A, and inferior vena cava 102B form a closed space (including a semi-closed space), sufficient suction cannot be achieved, causing the right atrium and right ventricle to contract and failing to reproduce physiological blood flow. For this reason, it is preferable to form an opening (hole) 128 upstream of the path through which liquid flows within the heart model, specifically, at one or more distal ends of the superior vena cava, inferior vena cava, and left subclavian vein. By forming such an opening 128, continuous pulsation can be obtained when drawing liquid from the container 10, and physiological blood flow can be reproduced within the heart model 100. In this embodiment, the openings 128 are formed on the bottom surfaces of the ends of the superior vena cava 102A and inferior vena cava 102B.

[0051] The opening 128 is formed to a size that allows the heart to beat, since if it is too large, the heart will not beat. Furthermore, it is preferable that the opening 128 is positioned so that it faces the bottom side of the container 10. By forming the opening 128 on the bottom side in this way, the water surface does not sway, and it does not get in the way when operating the catheter.

[0052] Although the catheter simulator and heart model described above are configured as a right-sided heart model, they may also be configured as a left-sided heart model. Specifically, by repeatedly applying continuous suction from any part of the aorta (large blood vessel) 109 formed in the main body 101A using the pump 50, negative pressure can be generated in the space connected to it (the left ventricle). In this case, by providing a hole (opening) in the apex of the left ventricle 121, the left atrium 120, or the pulmonary artery, continuous pulsation and physiological flow can be reproduced, as in the above-described right-sided heart model embodiment.

[0053] Furthermore, in the heart model having the above-described configuration, it is preferable that one or more of the right atrium, left atrium, right ventricle, and left ventricle be formed as a substantially closed space, and that a portion of the structural portion constituting the substantially closed space be configured to be thinner than the other structural portions. For example, by making the atrial septum thinner than the other portions, when a pulsatile flow is generated by the above-described configuration, it is possible to vibrate the atrial septum in the same manner as the human body.

[0054] In this case, a "substantially closed space" means that when the pump 50 repeatedly sucks up the liquid, the thinned portion within the space can vibrate, and as long as such vibrations can be obtained, the main body 100A may have a partially open portion.

[0055] With this configuration, a hole is drilled in the atrial septum, a catheter is introduced into the left atrium through the hole, and, for example, it is possible to simulate radiofrequency catheter ablation treatment or cryoablation treatment using a cryoballoon ablation catheter at the junction of the left atrium and the pulmonary vein. The catheter to be operated is introduced into the right atrium 110 from the inferior vena cava 102B, punctures the atrial septum, and is introduced into the left atrium.

[0056] In clinical practice, it is known that the atrial septum moves (vibrates in a direction approximately perpendicular to the atrial septum) due to pressure and blood flow within the cardiac chambers. It is important to reproduce such movement and pulsatile flow in simulations using a cardiac model. As described above, in the cardiac model, the area where expansion and contraction are desired is formed relatively thinner than other areas, and the area is made into a closed or semi-closed space. The liquid in the space is continuously (intermittently) aspirated, thereby allowing contraction and expansion of the intended area.

[0057] In the above configuration, repeated practice of catheter introduction can damage the atrial septum. Therefore, it is preferable to configure at least a portion of the atrial septum, the portion to be punctured by the introduced catheter, to be detachable. In this way, by considering the portion to be punctured depending on the surgical procedure and configuring only that portion to be detachable, unnecessary replacement of the main body can be avoided. In this case, an opening is formed in advance at the corresponding location for the detachable portion. It is possible to configure the opening to accommodate a detachable thin film member with flexibility and thickness comparable to that of a real heart.

[0058] An example of a treatment other than cardiac resynchronization therapy is a treatment for controlling blood flow and pressure in the coronary sinus. In this treatment, a device called a coronary sinus reducer (CSR) is placed in the coronary vein. In this procedure, coronary venography is also performed, and the device is placed by inserting a delivery catheter mainly through the inferior vena cava 102B. In training for this procedure, the placed device can be removed by inserting forceps or the like through the inferior vena cava 102B, but removal can be made even easier by providing a removal mechanism in part of the coronary vein 108.

[0059] 8, a detachment mechanism 108D is provided in a part of the coronary vein 108, and a tubular coronary vein part 108d constituting the coronary vein 108 is configured to be detachable from this part. The detachment mechanism 108D has a large-diameter portion 108e that is larger than the diameter of the coronary vein 108, and both ends of the coronary vein part 108d can be inserted into and detached from this large-diameter portion 108e.

[0060] The provision of this detachment mechanism 108D allows for easy removal of the CSR device placed in the coronary vein. That is, after placing the device in the coronary vein 108 and performing a prescribed procedure, the placed device can be retrieved by removing the coronary vein part 108d. Furthermore, the presence of this detachment mechanism also facilitates removal of the placed cardiac resynchronization therapy lead. The mechanism disclosed in Japanese Patent No. 7054112, previously filed by the present inventors, can be applied to the detachment mechanism described above.

[0061] Furthermore, the components of the heart model shown in the drawings can be combined as appropriate. The container in which the heart model is suspended may also have a larger capacity.

[0062] 1 Catheter simulator 10 Container 10a Storage section 50 Pump 52 Intake tube 53 Discharge tube 100 Heart model 100A Main body 102A Inferior vena cava 102B Superior vena cava 103 Pulmonary artery 105 Left subclavian vein 108 Coronary vein 109 Aorta 110 Right atrium 111 Right ventricle

Claims

1. A catheter simulator comprising: a container filled with liquid; an elastic heart model that is placed in the container filled with liquid and has a ventricle and a large blood vessel connected to it; and a pulsatile pump that is connected to the large blood vessel of the heart model or a space connected to it and generates negative pressure in the ventricle by suctioning the liquid.

2. The catheter simulator according to claim 1, wherein the large blood vessel is a pulmonary artery formed in the heart model.

3. A catheter simulator as described in claim 2, characterized in that the cardiac model is formed with one or more of the superior vena cava, inferior vena cava, and subclavian vein, and at least one of these is formed with a hole through which the liquid filled in the container flows.

4. The catheter simulator according to claim 3, wherein the hole is formed on the bottom side of the container.

5. A catheter simulator according to claim 3, characterized in that the heart model is kept floating within the container by holding any one of the superior vena cava, inferior vena cava, subclavian vein, and pulmonary artery.

6. The catheter simulator according to claim 1, wherein the cardiac model includes coronary veins.

7. The catheter simulator according to claim 6, wherein an opening is formed in the coronary vein.

8. A catheter simulator according to claim 6 or 7, characterized in that the coronary vein is provided with a detachable mechanism at a part of the blood vessel.

9. The catheter simulator of claim 1, wherein the cardiac model comprises one or more of a detachable apex, a detachable ventricular septum, and a detachable atrial septum.

10. A catheter simulator according to claim 1, characterized in that the cardiac model comprises one or more of a left ventricle, a left atrium, and a pulmonary vein, and the one or more of the left ventricle, the left atrium, and the pulmonary vein have openings formed therein through which the liquid filled in the container communicates.

11. A pulsatile flow generating method comprising connecting a pulsatile pump to an elastic heart model having a right ventricle, a left ventricle, or both, which is placed in a liquid-filled container, and generating a pulsatile flow within the heart model by continuously and repeatedly sucking the liquid within the right ventricle or the liquid within the left ventricle via the pulsatile pump.

12. A pulsatile flow generating method as described in claim 11, characterized in that the heart model has holes formed therein through which the liquid filled in the container flows when the pulsatile pump sucks.