Catheter-simulator and cerebral vessel model

Abstract

The present application provides a catheter simulator capable of improving catheter operation technology for brain diseases through a simple structure. The catheter simulator is characterized by having: a container (10); a cerebral vessel model (100) held in the container in a state of containing a liquid; and a holding unit provided to a side wall of the container and the cerebral vessel model and holding the cerebral vessel model in the container in a state of being filled with the liquid. The holding unit has: a first holding portion (21) that holds an end portion of an ascending aorta (101a) of the cerebral vessel model; and a second holding portion (22) that holds an end portion of a descending aorta (101b) of the cerebral vessel model, the first holding portion (21) has a liquid introduction port that introduces the liquid into the cerebral vessel model, the second holding portion (22) has a catheter introduction port that introduces a catheter into the cerebral vessel model, and an opening portion (121, 122) that controls balance of the liquid circulating in the cerebral vessel model is formed in a casing (100A) constituting the cerebral vessel model.

Description

Technical Field

[0001] This invention relates to a catheter simulator and a cerebral vascular model for the catheter simulator. Background Technology

[0002] In recent years, catheter-based surgeries have been performed for heart and brain diseases. Generally, in catheter-based surgeries, a catheter is inserted into an artery in the arm or leg to reach the affected area and perform various treatments. To master and improve the technique of such catheter-based surgeries, various catheter simulators (hereinafter also referred to as simulators) have been proposed. For example, Patent Document 1 discloses a simulator that sets up a vascular model on a human body model, inserts a catheter relative to the vascular model, and sets up a stent for vascular dilation; and a simulator that allows practice of surgical techniques related to coil tamponade for preventing aneurysm rupture.

[0003] However, for simulators like the one described above, the large size of the simulator itself is due to the inclusion of blood vessel models inside the human body model. Therefore, storage, transportation, preparation, and organization are not easy, making practice difficult.

[0004] Therefore, the inventors have proposed a simulator in which a heart model is suspended in a container filled with a liquid such as water, and an inlet for the liquid to flow in from a pump and an outlet for the liquid to flow out from the pump are formed on the side wall of the container, allowing the liquid to circulate within the heart model (Patent Document 2). In such a simulator, an inlet for catheter insertion is formed on the side wall of the container, and a pulsatile flow is circulated within the heart model by a pump, enabling catheter operation training with a simple structure. In this case, by adjusting the pump output, the heart model can be made to pulsate (periodic contraction), thereby allowing for more realistic practice of catheter surgery techniques on the heart model.

[0005] Prior art literature

[0006] Patent documents

[0007] Patent Document 1: Japanese Patent Application Publication No. 2014-228803

[0008] Patent Document 2: Japanese Patent No. 6452715 Summary of the Invention

[0009] The problem that the invention aims to solve

[0010] Although the simulator disclosed in Patent Document 2 has a simple structure, it uses a model of a real heart to simulate catheterization techniques for heart diseases in order to practice these techniques. Therefore, it cannot be used as a simulator for catheterization techniques for brain diseases (blood vessels in the human brain).

[0011] In the human body, blood flow to the brain originates from the heart, passes through the aorta, and is delivered via the left and right carotid arteries and vertebral arteries. Within the skull, these four vessels branch into multiple vessels. Generally, brain diseases requiring catheterization include cerebral aneurysms and carotid artery stenosis. Catheterization primarily involves inserting a catheter into an artery in the groin (femoral artery), hand, or arm (radial artery, brachial artery) and guiding it to the target site. Specifically, contrast agent is flowed through the blood vessel, and X-rays are used for fluoroscopy. The catheter is guided to the target site while observing the magnified image. A microcatheter, inserted into the main catheter, is then used to perform the prescribed treatment (clamping, coil embolization, etc.).

[0012] When practicing catheterization techniques for such brain diseases, the simulator disclosed in Patent Document 2 requires a dedicated cerebral vascular model to be set up in its container, but the specific structure and setup of the cerebral vascular model are not disclosed. Therefore, it cannot be used to practice catheterization techniques for brain diseases. Furthermore, even if the output of the pump that generates pulsating flow disclosed in Patent Document 2 is directly introduced into the cerebral vascular model, the blood circulation balance within the blood vessels is inadequate, making practical practice impossible.

[0013] The present invention was made in view of the above-mentioned actual situation, and its purpose is to provide a catheter-simulator that can improve catheter surgery techniques for brain diseases through a simple structure, and a cerebral vascular model for the catheter-simulator.

[0014] Solution for solving the problem

[0015] To achieve the above objectives, the catheter-simulator of the present invention is characterized by comprising: a container capable of containing liquid in a receiving portion surrounded by side walls and a bottom; a cerebral vascular model held in a state containing liquid within the container; a pump connected to the container to circulate liquid within the held cerebral vascular model; and a holding unit disposed on the side wall of the container and the cerebral vascular model to hold the cerebral vascular model in a state filled with liquid within the container, the holding unit comprising: a first holding portion holding the end of the ascending aorta of the cerebral vascular model; and a second holding portion holding the end of the descending aorta of the cerebral vascular model, the first holding portion having a liquid inlet for introducing liquid into the held cerebral vascular model, the second holding portion having a catheter inlet for introducing a catheter into the held cerebral vascular model, and an opening formed in the outer shell constituting the cerebral vascular model, the opening discharging liquid introduced by the pump to control the balance of liquid circulating within the cerebral vascular model.

[0016] The aforementioned catheter simulator creates a cerebral blood vessel model the same size as a real human body. This model is placed in a container filled with liquid, which is then circulated within it by a pump to create blood flow similar to that of a real human. A catheter is inserted into this cerebral blood vessel model through a catheter inlet, allowing for practice of catheter surgery techniques using this simple structure. In a real human body, approximately 15% of the blood pumped from the heart circulates in the brain, and approximately 90% circulates throughout the body. Therefore, by creating an opening in the outer shell of the cerebral blood vessel model, the balance of fluid circulating in the brain's blood vessels can be regulated, enabling the simulation of catheter surgery techniques under conditions closely resembling that of a real human body.

[0017] In addition, to achieve the above objectives, the present invention is characterized in that, when providing a cerebral vascular model for practice of catheter surgery techniques held in a container containing liquid and in a state of internal fluid circulation, an opening is formed in the outer shell constituting the cerebral vascular model to control the balance of the circulating liquid.

[0018] Based on this cerebral vascular model, if a container is placed in the catheter simulator and a liquid is circulated inside, the flow of the liquid can be controlled by means of an opening formed in the outer shell. Therefore, catheter surgery techniques can be simulated in a state that is close to the actual blood flow in the human body.

[0019] Invention Effects

[0020] According to the present invention, it is possible to obtain a catheter-simulator that can improve catheter surgery techniques for brain diseases through a simple structure, as well as a cerebral vascular model for the catheter-simulator. Attached Figure Description

[0021] Figure 1 This is a diagram illustrating one embodiment of the catheter-simulator of the present invention.

[0022] Figure 2 It is shown Figure 1 The top view of the container of the conduit simulator shown.

[0023] Figure 3 It shows the setting in Figure 1 A diagram illustrating a structural example of a cerebral vascular model of the container of the catheter-simulator.

[0024] Figure 4 It is shown in Figure 2 The container shown is a top view of the state of a cerebral blood vessel model.

[0025] Figure 5 Observing from one side Figure 2 The diagram shows the state of a cerebral blood vessel model set up in a container.

[0026] Figure 6 This is a cross-sectional view showing an example of a vascular component that can be replaced in a cerebral vascular model.

[0027] Figure 7 This is a diagram showing the first example of a flow regulation unit for fluid flowing into a cerebral blood vessel model.

[0028] Figure 8 It is along Figure 7 A cross-sectional view along line AA.

[0029] Figure 9 This is a diagram showing a second example of a flow regulation unit for fluid flowing into a cerebral blood vessel model.

[0030] Figure 10 This is a diagram showing a third example of a flow regulation unit for fluid flowing into a cerebral blood vessel model.

[0031] Figure 11 This is a diagram showing a modified example of the vascular group in a cerebral vascular model.

[0032] Figure 12 This is a diagram showing a second variation of the vascular group in a cerebral vascular model. Detailed Implementation

[0033] The following refers to the attached diagram. Figures 1 to 5 The embodiments of the catheter simulator and blood vessel model of the present invention will be described.

[0034] Figure 1 This is a diagram illustrating one embodiment of the catheter-simulator of the present invention. Figure 2 It shows the composition Figure 1 The top view of the container of the conduit simulator shown. Figure 3 This is a diagram illustrating a structural example of a cerebral blood vessel model. Figure 4 This is a top view showing the state in which a cerebral vascular model is set up in a container, and, Figure 5 This is a diagram showing the state of a cerebral blood vessel model set up in a container from one side.

[0035] The catheter simulator 1 of this embodiment includes: a container 10 for housing a cerebral vascular model 100 as a simulation object; and a pump (pulsating flow generating pump) 50 for circulating the liquid (mainly water) contained in the container 10.

[0036] The container 10 is configured as a generally rectangular box with four side walls 11-14 and a bottom 15. The upper surface is open, and liquid is contained in the receiving part 10A surrounded by the side walls 11-14 and the bottom 15 through the opening on the upper surface, and the cerebral blood vessel model 100 is held in a detachable manner.

[0037] The sidewalls 11-14 and the bottom 15 are made of a material with strength capable of stably accommodating and holding the liquid and the cerebral vascular model. Furthermore, it is preferable to form them from a transparent, lightweight, and strong material (e.g., acrylic, polycarbonate, PET, polystyrene, etc.) so that the behavior of catheters inserted from the outside of the cerebral vascular model and container can be visually observed during simulation.

[0038] It should be noted that the container 10 can also be made of an opaque material, making it impossible to visually inspect its interior. In this way, even if the interior of the container cannot be visually inspected, the simulation of controlling the catheter can be performed solely on a monitor by taking a picture with a camera and displaying it on a monitor, or by using X-ray imaging and displaying it on a monitor. That is, the container 10 can also be configured to allow for selection of visual inspection, monitor display inspection, or X-ray imaging depending on the stage and content of the training (even with a transparent material, a cover can be used for simulation).

[0039] Regarding the shape and size of the container 10, there are no limitations on its shape and size as long as a cerebral vascular model that is approximately the same size as the actual human cerebral blood vessels can be stably maintained. As described above, the element housed in the container 10 is a cerebral vascular model of the same size as the human cerebral blood vessels, and only a stable amount of liquid is needed to hold the model, thus allowing the container 10 to be miniaturized. Specifically, the amount of liquid filling the container 10 can be set to approximately 3L to 6L. As long as the size of the container 10 is within this range, the space of the simulation implementation site will not be wasted, thereby improving the storage and transportability of the catheter-simulator 1. In addition, the container 10 has an opening at the top, but a cover that can be opened, closed, or removed can also be provided there. Thus, while preventing the reduction in visual confirmation due to water surface fluctuations and reflections, the preparation and organization of training operations such as housing liquid in the housing section 10A and holding the cerebral vascular model in the container can be carried out efficiently through the opening on the upper surface of the container.

[0040] The subarachnoid cerebrovascular model 100 (see reference) is filled with liquid in the receiving part 10A on the side wall. Figure 3 It is held in a suspended state (not in contact with the bottom 15). The cerebral blood vessel model 100 of this embodiment is constructed by simulating the state of the main blood vessels in the skull of the human head, and its outer shell (body 100A) is formed in the same shape as the actual cerebral blood vessels.

[0041] Here, refer to Figure 3 The structure of the cerebral vascular model 100 of this embodiment will be described.

[0042] As is commonly known, blood flow to the brain primarily originates from the heart, passes through the aorta, and is carried by the left and right carotid arteries (left common carotid artery / right common carotid artery) and the left and right vertebral arteries (left vertebral artery / right vertebral artery) along the neck bone, totaling four blood vessels. Within the skull, numerous blood vessels branch off from these four vessels, forming a network that covers the brain.

[0043] Figure 3 The illustrated cerebral vascular model 100 includes: an ascending aorta 101a supplying blood flow from the heart; an aortic arch 101 formed by descending aorta 101b; and three arteries branching from the middle portion of the aortic arch 101 (brachial artery 102, left common carotid artery 103, and left subclavian artery 104). In this case, the brachiocephalic artery 102 branches into the right subclavian artery 106, the right common carotid artery 107, and the right vertebral artery 108, and the left subclavian artery 104 branches into the left vertebral artery 109. As described above, within the skull, multiple vessels branching from the right common carotid artery 107, the left common carotid artery 103, the right vertebral artery 108, and the left vertebral artery 109 cover the brain (in the cerebral vascular model of the present invention, the multiple branching vessels are represented as vascular group 115).

[0044] The aforementioned cerebral vascular model 100 is held on the inner surface of the side wall of the container 10. In this embodiment, the ends of the ascending aorta 101a and the descending aorta 101b are held, as are the ends of the right subclavian artery 106 and the left subclavian artery 104 (the ends of each vessel), thereby maintaining the cerebral vascular model 100 in a balanced manner as a whole, floating from the bottom. Therefore, holding units for holding the ends of each vessel are provided at corresponding positions on the side walls 11, 13, and 14 of the container 10.

[0045] The structure of the retaining unit will be described below.

[0046] The holding unit of this embodiment includes: a first holding portion 21 holding the end of the ascending aorta 101a, a second holding portion 22 holding the end of the descending aorta 101b, a third holding portion 23 holding the end of the right subclavian artery 106, and a fourth holding portion 24 holding the end of the left subclavian artery 104. In this case, the first holding portion 21 holding the end of the ascending aorta 101a is connected to the side wall of the container 10 at approximately a right angle. The curved aortic arch 101 of the cerebral vascular model 100 is disposed inside the container 10, so that the pulsatile flow flowing in from the ascending aorta side 101a flows along a non-linear but curved blood vessel. This causes pulsatile flow to the left and right internal carotid arteries and vertebral arteries, allowing angiography of only the blood vessels of either the left or right cerebral hemisphere to be performed, just as in actual clinical practice. In this case, structurally, the aortic arch portion can also be disposed outside the container. However, the aortic arch branches into multiple vessels, which makes them difficult to handle, leading to reduced availability, increased risk of rupture, and the container being reflected when viewed under X-ray transmission, potentially causing discrepancies between the container and the actual clinical image.

[0047] On the other hand, there is also the possibility that the aortic arch itself may detach from the structure. In this case, as mentioned above, the pulsatile flow from the pump flows linearly into the intracranial vessels, obstructing the balance of blood flow. That is, this structure is most suitable to meet both the requirements of usability and to achieve a blood flow balance close to that of actual clinical practice.

[0048] It should be noted that the heart can also be connected to the aortic arch in the same way as a real human body, but in this case, the simulator itself becomes larger, leading to reduced usability and an increased risk of breakage. This simulator, specifically designed for cerebrovascular catheterization techniques, allows medical practitioners to easily train in surgical techniques when needed, and achieves these needs through a simple structure.

[0049] In the above structure, the first retaining portion 21 functions as an inlet (liquid inlet) for introducing liquid into the cerebral vascular model. Therefore, the portion for which the first retaining portion 21 is provided has a through hole (liquid inlet) 21a formed in the sidewall 13, and a cylindrical connecting portion (a known one-touch connector) 21A protruding outward from the sidewall 13 is coaxially provided in the through hole 21a. Furthermore, the inlet pipe 51 from the pump 50 is connected to this connecting portion 21A (see reference). Figure 1 ).

[0050] Additionally, on the side wall 13 of the container 10, adjacent to the location where the first holding portion 21 is formed, a discharge port (through hole) 26 is provided for discharging liquid from the receiving portion 10A to the outside. A cylindrical connecting portion (a known one-touch connector) 26A protruding outward from the side wall 13 is coaxially provided at the discharge port 26, where a discharge pipe 52 leading to the pump 50 is connected (see reference). Figure 1 Regarding the outlet, it can also be a structure connected to the cerebral vascular model 100, but by not connecting it to the cerebral vascular model 100, the setup operation becomes easier.

[0051] It should be noted that valves for opening and closing are preferably pre-installed on the connecting parts 21A and 26A (detailed structures are not shown). By rotating the operating parts 21b and 26b provided on each connecting part 21A and 26A, the flow path of each connecting part can be opened or closed. After the simulation is completed, when the pump 50 is removed from the container 10, the valves for blocking will rotate the operating parts 21b and 26b to block the flow path, thereby preventing the liquid in the receiving part 10A from leaking to the outside.

[0052] The second retaining portion 22 functions as an inlet (catheter inlet) for introducing a catheter from the outside of the container 10 into the cerebral vascular model 100. Therefore, the portion with the second retaining portion 22 has a through hole (catheter inlet) 22a formed in the side wall 13, and a cylindrical inlet connector 22A protruding outward from the side wall 13 is coaxially disposed in the through hole 22a. Furthermore, the catheter's inlet tube 32 is connected to the inlet connector 22A.

[0053] The catheter insertion tube 32 has a catheter insertion terminal (sheath) 32a at its front end, which has the function of preventing the liquid filling the insertion tube 32 from leaking to the outside (valve function), and has a structure that allows the trainee to insert the catheter into the insertion tube 32 and pull it out of the insertion tube 32.

[0054] The inlet connector 22A has a connection mechanism operable from the outside of the container 10. This connection mechanism is designed to secure / release the inlet tube 32, for example, by inserting the inlet tube 32 and rotating the operating member (nut) 35, allowing for easy installation and removal of the inlet tube 32. It should be noted that when the inlet tube 32 is not inserted (not in use), its opening is blocked by the bolt member 36 (see reference). Figure 2 ).

[0055] Furthermore, in this embodiment, the third retaining portion 23 and the fourth retaining portion 24, like the second retaining portion 22 described above, also function as introduction portions (catheter inlets) for introducing a catheter from the outside of the container 10 into the cerebral vascular model 100. Similar to the second retaining portion 22, the portions where each retaining portion 23, 24 is provided have through holes (catheter inlets) 23a, 24a formed in the sidewalls 12, 11. Cylindrical introduction connectors 23A, 24A protruding outward from the sidewalls are coaxially disposed in these through holes 23a, 24a. Also, similar to the introduction connector 22A described above, the catheter's introduction tube (tube) 32 is connected to these introduction connectors 23A, 24A. It should be noted that such catheter inlets can also be provided in either the third retaining portion 23 or the fourth retaining portion 24.

[0056] The first to fourth retaining parts described above are assembled and retained. Figure 3 The cerebral vascular model 100 is shown. Here, the method of maintaining the cerebral vascular model in this embodiment will be explained.

[0057] As described above, the end of the ascending aorta 101a is held in the first holding portion 21, and the end of the descending aorta 101b is held in the second holding portion 22. In this case, the cerebral vascular model 100 of this embodiment is formed entirely of rigid resin, and rigid flanges 38 are integrally formed at the ends of the ascending aorta 101a and the descending aorta 101b, respectively. In addition, the openings 101e and 101f at the ends of the ascending aorta 101a and the descending aorta 101b are formed to the same size as the through holes 21a and 22a formed on the sidewall 13, respectively. Each flange 38 is pressed tightly against the inner surface of the sidewall 13 of the container, and a screw 40 is inserted from outside the container into the screw hole 38a formed on each flange 38, thereby fixing the flange 38 tightly against the inner surface of the sidewall. That is, the end region of the ascending aorta 101a is connected to the sidewall 13 of the container at approximately a right angle. Thus, the ends of the ascending aorta 101a and the descending aorta 101b are held (fixed) to the inner surface of the container sidewall by means of the first retaining part 21 and the second retaining part 22 in a state of communication with the through holes 21a and 22a.

[0058] Furthermore, the end of the right subclavian artery 106 is held in the third holding portion 23, and the end of the left subclavian artery 104 is held in the fourth holding portion 24. In this case, cylindrical portions 23b and 24b protruding into the container are provided coaxially with the through holes 23a and 24a in each holding portion 23 and 24, and external threads 23c and 24c are formed on the outer peripheral surface of each cylindrical portion. On the other hand, an internal thread 106a is formed at the opening end of the right subclavian artery 106, and similarly, an internal thread (not shown) is also formed at the opening end of the left subclavian artery 104. Thus, by screwing the threaded portions together, the right subclavian artery 106 and the left subclavian artery 104 are held (fixed) to the inner surface of the side wall of the container by the third holding portion 23 and the fourth holding portion 24.

[0059] Furthermore, the holding unit of this embodiment also has a locking member 45 for holding the cerebral blood vessel model 100 on the inner surface of the container 10. This locking member 45, which functions to lock the cerebral blood vessel model and stabilize its holding state, is provided on the side wall 14 of the side wall where no holding portion is provided. The locking member 45 is formed as a rod protruding inwards from the container, capable of locking the blood vessel group 115 of the cerebral blood vessel model 100. Thus, the cerebral blood vessel model 100 is held by all the inner surfaces of each of the side walls 11-14 of the container 10, thereby achieving a stable holding state. In this case, for example, a flat base 45a is pre-installed on the side wall 14, and the locking member 45 is preferably configured to be detachable from the base. In this way, by configuring the locking member 45 to be detachable, it does not hinder operations during the assembly or disassembly of the cerebral blood vessel model.

[0060] An auxiliary plate for strengthening is preferably bonded to the portion where the retaining unit (retaining part) is provided. When strengthening is achieved using this auxiliary plate, the overall container weight can be reduced compared to thickening the entire sidewall to enhance strength. It should be noted that if the visual visibility of passing conduits or the like is reduced due to attaching the auxiliary plate to the sidewall, the sidewall thickness can be increased only on the surface requiring increased strength. Furthermore, the sidewall is preferably a flat plate without any bumps or depressions, thereby improving the visual visibility of the interior by eliminating light refraction.

[0061] When the cerebral vascular model 100 is placed in the container 10 in a liquid-filled state and the liquid is circulated by the pump 50, the input from the pump 50 is introduced into the cerebral vascular model via the first holding part 21 (connecting part 21A). Therefore, an opening for draining liquid needs to be formed in the outer shell 100A of the cerebral vascular model 100.

[0062] Furthermore, as mentioned above, in the actual human body, approximately 15% of the blood flow from the heart circulates within the brain, and approximately 90% circulates throughout the body. When forming the opening in the outer shell of the cerebral vascular model, the location and size of the opening are considered, thereby allowing for the regulation of the balance of fluid circulating in the blood vessels within the brain. This enables the simulation of catheter surgery techniques under conditions closely resembling those of the actual human body.

[0063] If liquid is introduced into the cerebral vascular model 100 via the pump 50, then as Figure 4 As indicated by the arrows, the fluid flows via the ascending aorta 101a to the brachiocephalic artery 102, left common carotid artery 103, left subclavian artery 104, and descending aorta 101b. Additionally, the fluid flowing in the brachiocephalic artery 102 flows to the right subclavian artery 106, right common carotid artery 107, and right vertebral artery 108, while the fluid flowing in the left subclavian artery 104 flows to the left vertebral artery 109. Furthermore, the fluid flowing in the right common carotid artery 107, right vertebral artery 108, left common carotid artery 103, and left vertebral artery 109 flows directly into the vascular group 115. By forming openings 120 at the front ends of several of these vascular groups 115, the fluid introduced from the ascending aorta 101a generates a flow that circulates within the cerebral blood vessels, reproducing blood flow consistent with that of the actual human cerebral blood vessels. Therefore, the fluid discharged from the openings 120 into the container flows through the container's outlet 26 into the discharge pipe 52 and is circulated by the pump 50.

[0064] In this embodiment, multiple openings 121 are formed at the root of the descending aorta 101b, which is connected to the ascending aorta 101a, to reproduce the same blood flow as that in the chest, abdomen, and lower limbs of an actual human body. That is, if the openings 121 are not formed in the descending aorta 101b, the fluid flow returns to the ascending aorta side at that part, thus creating a flow that does not exist in the human body, making proper simulation impossible.

[0065] Furthermore, in this embodiment, an opening 122 is formed at the ends of the right subclavian artery 106 and the left subclavian artery 104, respectively.

[0066] Thus, by forming openings 122 at the bilateral ends of the left subclavian artery 104 and the right subclavian artery 106, the flow rate can be well controlled in a balanced manner, and the contrast agent will not accumulate in the blood vessel during angiography from the aorta, but will be properly drained. It should be noted that the openings 122 can also be structures formed on either the left subclavian artery 104 or the right subclavian artery 106.

[0067] For the openings 120, 121, and 122 described above, by optimizing their size, location, and number, it is possible to achieve proper blood flow and blood flow balance in the human body. In this case, if an opening is formed in the path of the inserted catheter, the catheter may protrude outside the blood vessel; therefore, it is preferable not to form one in the insertion path. Furthermore, regarding openings 121 and 122, in this embodiment, as... Figure 4 As shown, although they are formed on the upper surface of each blood vessel, there is no limitation on their orientation. For example, by forming them on the lower surface, it is possible to suppress ripples generated on the water surface in the simulation, which helps visual confirmation and improves appearance.

[0068] In addition to the opening for controlling flow, it is preferable to pre-form an air hole for removing air. During initial installation, air may sometimes enter the cerebral vascular model. If the liquid is circulated within the model in this state, air will accumulate at the highest position, potentially causing problems such as obstructing visual confirmation. Therefore, when the cerebral vascular model 100 is installed, an air hole 124 is formed at this highest position (in this embodiment, the highest position of the ascending aorta 101a) to remove air accumulated during liquid circulation.

[0069] As described above, since the outer shell 100A of the cerebral vascular model 100 has openings 120, 121, and 122 for controlling the flow rate of the introduced fluid, the blood flow in the cerebral blood vessels can be easily reproduced with a simple structure. While it is possible to install a regulating valve for adjusting the flow rate at the point where the fluid passes, such a valve mechanism is complex and cumbersome to operate. Furthermore, the regulating valve is reflected in the X-ray fluoroscopy image, thus hindering simulations that closely resemble actual clinical images. In the simulation of catheter surgery techniques that effectively utilize the aforementioned cerebral vascular model, fine adjustments to the blood flow are not necessary; therefore, by optimizing the size and position of the openings, installation can be easy and simple without a regulating valve.

[0070] The aforementioned cerebral vascular model 100 can be integrally formed using a 3D printer from a rigid and transparent resin material (such as polyurethane, epoxy resin, acrylic resin, polycarbonate resin, unsaturated polyester, vinyl chloride resin, polyethylene terephthalate, etc.). In this way, by forming the cerebral vascular model from a rigid material, it can be stably maintained in a fixed state within a container filled with water, preventing unnatural movement and enabling simulations that closely resemble actual catheter manipulation.

[0071] Alternatively, the material can be an elastic resin material that closely resembles the blood vessels of the human body, such as PVA (polyvinyl alcohol), polyurethane, epoxy resin, unsaturated polyester, phenolic resin, silicone, or similar materials, or a material formed by combining or integrating other thermosetting resins or thermoplastic resins, either individually or in combination. When the cerebral vascular model is formed from an elastic resin material, the retaining portions 21-24 constituting the aforementioned retaining unit can be appropriately deformed. For example, a cylindrical protrusion can be formed that protrudes inward from the sidewall and communicates with the outside, and the cerebral vascular model can be held by inserting the opening at the end of the blood vessel into the periphery of this protrusion.

[0072] For the blood vessels in the aforementioned cerebral vascular model 100, it is preferable that they be integrally formed without seams, but it is also possible for each blood vessel portion (at any location) to be inserted, for example, so that the blood vessels can be separated from each other. In this case, for example, as Figure 3 , Figure 4 As shown, an anti-dislodgement part (e.g., an annular locking part 130) is pre-formed on the outer peripheral surface of a portion of a blood vessel (left common carotid artery 103, left vertebral artery 109, right common carotid artery 107, right vertebral artery 108, etc.), allowing for the insertion and replacement of this portion of the blood vessel (blood vessel part). The inserted blood vessel part is not easily dislodged by means of the locking part 130, thus enabling stable simulation. Specifically, for example, if the right common carotid artery 107 is cut and designed as a detachable blood vessel part, it can also be... Figure 4 , Figure 6 As shown, either of the vascular parts 107a and 107b with the locking part 130 is pre-covered with the soft connector 132, and the other vascular part is inserted in this state so that the end faces 107A are mated together, thereby making the vascular parts easy to install and remove.

[0073] Such vascular components are not limited to soft resin materials, and can be pre-fabricated as stenosis components or cerebral thrombosis components, etc., to have the same lesion as the actual human body, and this part can be made detachable. That is, by making a part of the vascular portion of the cerebral vascular model 100 detachable, multiple shapes of blood vessels can be installed without the trouble of disassembling the main body from the container 10, thereby allowing for the appropriate simulation of the desired lesion.

[0074] As described above, the cerebral vascular model 100 placed within the container 10 allows for catheter manipulation training, enabling the catheter to reach the lesion and block or dilate it, using sensations similar to those of cerebral blood vessels. In this case, by using a transparent or semi-transparent material to create the cerebral vascular model 100, the trainee can directly observe the movements of the inserted catheter, leads, and other devices, and visually recognize the behavior exhibited by the injectable solution being injected through the catheter. That is, the trainee can simulate catheter manipulation by associating hand movements with the movements of the catheter tip. Furthermore, even when the cerebral vascular model 100 is made of a material that the trainee can visually confirm, if the model is covered by a cover in the container 10 to prevent visual observation, or if it is fluoroscopically examined using X-rays and displayed on a monitor, the behavior of the catheter can be understood solely through the monitor.

[0075] In the catheter-simulator of the above-described embodiment, the pulsatile flow from the pump 50 is configured to flow into the ascending aorta 101a of the cerebral vascular model via the first retainer 21. To directly reproduce the anatomical morphology of the actual human body, the ascending aorta 101a and the first retainer 21 are connected relative to the sidewall 13 of the container 10 not at a right angle, but at an angle. This connection method facilitates a balance of pulsatile flows on the sides of the brachiocephalic artery 102, the left common carotid artery 103, and the left subclavian artery 104, but increases the capacity of the container 10, impairing usability. Furthermore, it increases structural complexity, leading to a more complicated manufacturing process.

[0076] Therefore, as described above, the ascending aorta 101a and the first retaining portion 21 are preferably arranged at right angles relative to the sidewall 13 of the container 10, and preferably the pulsatile flow of the pump 50 flows in at approximately a right angle relative to the sidewall 13 of the container. However, the pulsatile flow flowing in from the ascending aorta side 101a flows along a non-linear but tortuous shape of the blood vessel, in Figure 4 In the configuration of the cerebral vascular model shown, the pulsatile flow on the brachiocephalic artery 102 side may be larger than the pulsatile flow on the left common carotid artery 103 side and the left subclavian artery 104 side (the blood flow distribution towards the intracranial vessels becomes unbalanced). Therefore, for the fluid flowing from the pump 50 into the cerebral vascular model, it is preferable to provide a flow regulation unit in the terminal region of the ascending aorta, which becomes part of the inflow.

[0077] Figure 7 This is a diagram showing the first example of a flow regulation unit for fluid flowing into a cerebral blood vessel model.

[0078] The flow regulating unit has a convex ridge 101A formed on the inner wall of the anterior end of the ascending aorta 101a, which is connected to the inflow portion from the pump, specifically the connection portion 21A of the first holding portion 21. This ridge 101A has the following function: reducing the pulsatile flow on the brachiocephalic artery 102 side and increasing the pulsatile flow on the left common carotid artery 103 side and the left subclavian artery 104 side, thereby regulating the pulsatile flow to become uniform (approximately uniform) on both sides.

[0079] When observed under X-ray fluoroscopy, the convex protrusion 101A may be identified as a protrusion that would not be seen in actual clinical practice. However, as Figure 8 As shown in the cross-sectional view, a gap S is intentionally provided between the base plate side and the opening side of the bulge 101A and the inner wall 101a′ of the ascending aorta 101a connected to the connecting part 21A, thereby maintaining the distribution balance of pulsatile flow and making the X-ray fluoroscopic image closer to the actual clinical situation.

[0080] By forming such a bulge 101A, optimal fluid flow dispersion relative to the left and right intracranial blood vessels (vascular groups, etc.) can be obtained. It should be noted that the method of forming the bulge 101A is not particularly limited; for example, it can be integrally formed on the inner wall of the anterior end of the ascending aorta 101a, or the bulge can be pre-formed separately and assembled to the inner wall of the ascending aorta 101a by adhesion or the like. Furthermore, its formation location, size, etc., can be appropriately modified.

[0081] Furthermore, as described above, an air hole 124 is formed in the ascending aorta 101a to remove air during installation. This air hole 124 is preferably configured as a one-way valve so that air does not flow into the cerebral vascular model from the outside.

[0082] Figure 9 This is a diagram showing a second example of a flow regulation unit for fluid flowing into a cerebral blood vessel model.

[0083] In this structural example, an example is shown where the flow regulating member is disposed within the opening region of the ascending aorta 101a, rather than within the inner wall of the end region of the ascending aorta 101a. The flow regulating member is disposed within an opening 101e (see reference 38) on the flange 38. Figure 3 The nozzle 101B within the aorta is configured such that its front end faces the left common carotid artery 103. In this nozzle configuration, similar to the aforementioned protrusion 101A, optimal fluid flow dispersion relative to the left and right intracranial vessels can be achieved. It should be noted that the direction of the nozzle 101B and the direction of the connection portion to the ascending aorta 101a can be appropriately modified. For example, it can be set to be... Figure 9The nozzle 101B shown is oriented in the opposite direction, and the base portion of the ascending aorta 101a is bent toward the descending aorta 101b and connected to the connecting portion 21A, thereby achieving the same blood flow as an actual heart and obtaining optimal fluid dispersion.

[0084] in addition, Figure 10 This diagram illustrates a third example of a flow regulation unit for fluid flowing into a cerebral vascular model. In this structural example, the nozzle 101C is constructed by pre-bending to form a cylindrical nozzle 101g with a central portion 101g′, and integrally forming a flange 101h at the base end of the nozzle 101g. A screw-in mechanism is formed on the outer surface of the flange 101h. Figure 3 The threaded portion 101i formed by the opening 101e of the flange 38 shown adjusts the orientation of the pulsatile flow guided into the ascending aorta 101a by screwing the two together.

[0085] Based on this nozzle structure, flow regulation can be performed simply by connecting the ascending aorta 101a of the cerebral vascular model 100 to the connecting part 21A, making assembly and flow regulation easy.

[0086] Figure 11 This is a diagram showing a modified example of the vascular group 115 of the cerebral vascular model 100.

[0087] As described above, openings 120, 121, and 122 are formed at appropriate locations in the cerebral vascular model 100 to reproduce the same blood flow as in actual blood and to perform appropriate simulation. In this case, if the openings are formed with the front end of the vessel group 115 facing upwards, the fluid flow will surge upwards, causing the liquid surface (water surface) to slosh or spray, potentially hindering proper simulation. Figure 11 As shown, by forming a bend 120a with the opening at the front end of the vessel assembly 115 facing downwards relative to the horizontal plane (liquid surface), the liquid surface can be stabilized during simulation. Alternatively, the top plate can float on the liquid surface instead of the above method. The top plate suppresses sloshing of the liquid surface and prevents reduced visual confirmability due to ripples, so it is preferred regardless of the orientation of the opening at the front end of the vessel assembly 115.

[0088] Figure 12 This is a diagram showing a second variation of the vascular group 115 of the cerebral vascular model 100.

[0089] As described above, the cerebral vascular model 100, being made of a rigid material, can be stably maintained in a fixed state within a container containing water. The model does not move unnaturally, allowing for simulations consistent with actual catheter manipulation. In contrast, if the vascular assembly 115 were made of a rigid material, it could be damaged, such as breaking or snapping, during installation into or removal from the container 10, or during transport. In particular, the vascular assembly 115 has a small diameter, making it prone to damage if it comes into contact with other objects or is subjected to stress.

[0090] Therefore, it is preferable to integrally form multiple connecting pieces 115A together with the blood vessel group so that the blood vessel group 115 is integrally connected to each other (integrated). The connecting piece 115A is a thin plate-shaped component that is disposed within the blood vessel group in a manner that integrally connects any blood vessel of the blood vessel group 115 to each other. The connecting piece 115A need only be a component that integrally connects at least a portion of the blood vessel group 115.

[0091] The connector 115A, like the vascular assembly, is made of a transparent material, so it will not be an obstacle in actual simulations and can be easily handled.

[0092] In the cerebral vascular model 100, to obtain images close to those in actual clinical settings under X-ray fluoroscopy, it is preferable that the connecting piece 115A is not projected as part of the image. Since X-rays in angiography are projected from one direction across the subject in the opposite direction, if the connecting piece 115A is planar, it tends to be easily identified as a non-transmittable object when its direction is perpendicular to the X-ray projection direction. Therefore, the connecting piece 115A is preferably curved compared to a planar structure. Furthermore, air tends to accumulate in curved structures, but this problem can be solved by providing an air escape hole at the top of the curved surface. Also, in the cerebral vascular model, images are mostly taken at an angle perpendicular to the bottom surface of the container 10; therefore, it is preferable that the connecting piece 115A is formed with a surface approximately parallel to the bottom surface of the container 10.

[0093] The above describes one embodiment of the catheter-simulator and cerebral blood vessel model of the present invention. However, the present invention is not limited to the above embodiment, and various modifications can be made without departing from the spirit of the invention. For example, as long as the cerebral blood vessel model 100 is held in a container 10 filled with liquid, a fluid flow similar to that of an actual human body is generated inside the blood vessels, and the catheter insertion operation is performed in such a holding state, the structure (fixation method) of the holding part is not limited. In addition, the structure of the blood vessels of the cerebral blood vessel model 100, especially the blood vessel group 115, can be appropriately modified. Furthermore, the structure of the holding unit for holding the cerebral blood vessel model in the container can also be appropriately modified. For example, it may be a structure that includes a platform for placing the cerebral blood vessel model 100.

[0094] Explanation of reference numerals in the attached figures:

[0095] 1. Catheter Simulator

[0096] 10 containers

[0097] 21-24 First Holding Section to Fourth Holding Section (Holding Unit)

[0098] 45. Locking component (holding unit)

[0099] 50 pumps

[0100] 100 cerebral vascular models

[0101] 100A Housing

[0102] 115 Vascular Group

[0103] 120, 121, 122 Openings.

Claims

1. A catheter simulator, characterized in that, The catheter simulator has the following features: A container that can contain liquids in a containment section surrounded by side walls and a bottom; A cerebral vascular model, which is held in a state in which liquid is contained within the container; A pump, connected to the container, circulates fluid within the held cerebral vascular model; and A holding unit, disposed on the side wall of the container and the cerebral vascular model, holds the cerebral vascular model in the container in a state filled with liquid. The holding unit includes: a first holding portion for holding the end of the ascending aorta of the cerebral vascular model; and a second holding portion for holding the end of the descending aorta of the cerebral vascular model. The first holding part has a liquid inlet for introducing liquid into the cerebral vascular model in the held state. The second holding part has a catheter inlet for inserting a catheter into the cerebral vascular model in the held state. The outer shell constituting the cerebral vascular model has an opening that discharges liquid introduced by the pump, thereby controlling the balance of the liquid circulating within the cerebral vascular model. A flow regulation unit is provided at the end region of the ascending aorta of the cerebral vascular model, which regulates the flow dispersion of fluid relative to the left and right intracranial blood vessels.

2. The catheter simulator according to claim 1, characterized in that, The opening is located in the descending aorta held in the second holding portion.

3. The catheter simulator according to claim 1 or 2, characterized in that, The opening is located at the end of the blood vessel constituting the cerebral vascular model.

4. The catheter simulator according to claim 3, characterized in that, The opening at the end of the blood vessel is formed so as to face downward relative to the liquid surface contained in the container.

5. The catheter simulator according to claim 1, characterized in that, The cerebral vascular model is held in a state where it does not contact the bottom of the container.

6. The catheter simulator according to claim 1, characterized in that, A portion of the aortic arch of the cerebral vascular model is disposed inside the container.

7. The catheter simulator according to claim 1, characterized in that, The holding unit has a third holding part and a fourth holding part, which respectively hold the ends of the right subclavian artery and the left subclavian artery of the cerebral vascular model.

8. The catheter simulator according to claim 7, characterized in that, The opening is formed in either or both of the right and left subclavian arteries.

9. The catheter simulator according to claim 7 or 8, characterized in that, The third and fourth holding parts are provided with a catheter inlet for inserting the catheter into the cerebral vascular model in the held state.

10. The catheter simulator according to claim 1, characterized in that, The retaining unit has a flange integrally formed on the vascular end of the cerebral vascular model. The cerebral vascular model is held inside the container by attaching the flange tightly to the inner surface of the container.

11. The catheter simulator according to claim 1, characterized in that, The retaining unit has an internally threaded portion integrally formed on the inner surface of the vascular end of the cerebral blood vessel model. The cerebral vascular model is held inside the container by screwing the internal threaded portion into the external threaded portion formed on the outer peripheral surface of the cylindrical portion protruding from the inner surface of the container.

12. The catheter simulator according to claim 1, characterized in that, The holding unit has a locking member disposed on the inner surface of the container and for locking the cerebral vascular model.

13. The catheter simulator according to claim 1, characterized in that, A drain outlet is provided on the side of the container, which discharges the liquid inside the container and is connected to the pump.

14. The catheter simulator according to claim 1, characterized in that, A portion of the blood vessels in the cerebral vascular model constitutes a lesion, which is configured as a detachable vascular component.

15. The catheter simulator according to claim 1, characterized in that, The terminal region of the ascending aorta of the cerebral vascular model is connected to the sidewall of the container at approximately a right angle.

16. The catheter simulator according to claim 1, characterized in that, The flow regulating unit is a convex protrusion formed on the inner wall of the anterior end of the ascending aorta.

17. The catheter simulator according to claim 1, characterized in that, The flow regulating unit is a nozzle disposed in the opening region of the ascending aorta.

18. The catheter simulator according to claim 16, characterized in that, A gap is provided between the base plate side and the opening side of the convex protrusion formed on the inner wall of the anterior end of the ascending aorta and the inner wall of the ascending aorta.

19. The catheter simulator according to claim 1, characterized in that, The first retaining part of the container is disposed approximately at a right angle to the side wall of the container.

20. The catheter simulator according to claim 1, characterized in that, The pump's pulsating flow enters at approximately a right angle relative to the sidewall of the container.

21. A cerebral vascular model held within a container containing liquid for use during practice of catheter surgery techniques while the liquid is circulated internally, characterized in that... The outer shell constituting the cerebral vascular model has openings that control the balance of circulating fluid. A flow regulation unit is provided at the end region of the ascending aorta of the cerebral vascular model, which regulates the flow dispersion of fluid relative to the left and right intracranial blood vessels.

22. The cerebral vascular model according to claim 21, characterized in that, The opening is formed at the end of the blood vessel constituting the cerebral vascular model.

23. The cerebral vascular model according to claim 21, characterized in that, The opening is formed at at least one of the ends of the descending aorta, the right subclavian artery, and the left subclavian artery that constitute the cerebral vascular model.

24. The cerebral vascular model according to claim 21, characterized in that, The outer shell constituting the cerebral blood vessel model has a rigid portion. The cerebral vascular model is held within the container by the rigid portion.

25. The cerebral vascular model according to claim 24, characterized in that, At least a portion of the vascular group constituting the cerebral vascular model is integrally connected by a connecting piece configured as a thin plate.

26. The cerebral vascular model according to claim 25, characterized in that, At least one of the connecting pieces has a curved structure.

27. The cerebral vascular model according to claim 25 or 26, characterized in that, At least one of the connecting pieces has a hole for air to escape.

28. The cerebral vascular model according to claim 21, characterized in that, A portion of the blood vessels constituting the cerebral vascular model can be freely assembled and disassembled as vascular components.

Images