Simulator

Abstract

The invention relates to a simulator comprising a flexible simulation chamber simulating a living body chamber, the flexible simulation chamber having at least one opening; a valve comprising a valve leaflet; a papillary muscle entity model; and chordae tendineae connecting the papillary muscle entity model and the valve leaflets; at least one valve arm extends through the flexible simulation cavity, so that the far end of the valve arm is arranged in the flexible simulation cavity, the near end of the valve arm is arranged outside the flexible simulation cavity, the far end of the valve arm is fixed relative to the papillary muscle entity model, and the position of the far end of the valve arm can be controlled from the near end; and a control device for controlling the simulation process. Such a simulator allows for precise simulation of motion of a living body chamber, such as the left ventricle or the right ventricle of a human heart, in which case precise rotation and / or other motion of the chamber during a pulsation can be simulated.

Description

[0001] This application is a divisional application of Chinese Patent Application (filing date: January 7, 2022, application number: 2022100185799, invention title: Simulator, artificial heart valve, method for manufacturing artificial heart valve and arm, prediction method). Technical Field

[0002] The present invention relates to a device for simulating open-heart surgery and minimally invasive cardiac therapies, including all traditional and new repair and implantation therapies, and relates to education, training, research, new therapy development, and clinical applications. The present invention also relates to the simulation of other organs and cavities in the human or animal body, simulators, and prostheses. Background Art

[0003] For decades, bioengineers have been attempting to predict, compare, and optimize the outcomes of cardiac therapies. An effective method is to rehearse therapies in an in-vivo or in-vitro environment, including open-heart surgery and minimally invasive therapies, such as transcatheter repair and implantation. In-vitro therapy simulation is to practice or develop therapies in a controllable mechanical system. Previous in-vitro systems included an isolated animal heart or a 3D-printed human heart model, and the latest developments in this technology have brought fluid-dynamic mechanical systems with fluid-solid structure interaction. Although the existing state-of-the-art simulators are considered to be close to the human structure and function, due to the lack of comprehensive cardiac function simulation, the in-vitro etiological studies performed by the existing simulators are often not optimal and have no clinical applications, such as clinical prognosis.

[0004] Embodiments of the present invention will now be described only by way of example and with reference to the drawings, in which:

[0005] Figure 1 is a schematic diagram of a pre-existing heart simulator including a ventricular simulation module 1, an atrial simulation module 2, and a pump 3. The ventricular simulation module 1 includes a ventricular model 12 and the atrial simulation module 2 includes an atrial model 22. The ventricular model 12 and the atrial model 22 are connected on one side by a mitral valve model and on the other side by a regulating chamber 4. The pump 3 controls and applies external pressure to the ventricular model 12 and the atrial model 22 to simulate the beating of the heart. The illustrated simulator can simulate the left heart or the right heart (i.e., the left or right side of the heart).

[0006] Figure 2 is a schematic diagram of another existing heart simulator that lacks the ventricular pulsation function. Instead, a regulating chamber 4 and a simulated blood pump 31 are serially arranged in a pipeline connecting the blood inlet of the atrial model and the blood outlet of the ventricular model. An arm 112 extending outside the ventricular simulation module 1 fixes the position of the papillary muscle solid model at the start of the simulation to control the movement of the valve leaflets of the valve.

[0007] Cardiac valve regurgitation is the most common valvular heart disease. A major cause of cardiac valve regurgitation is the abnormal displacement of the papillary muscle. Previous researchers have shown that in an in vitro simulator, either the position of the papillary muscle or the ventricular geometry can affect the simulation results. However, current cardiac simulators with mitral or tricuspid valve structures cannot simulate the complete cardiac valve function, due to the lack of papillary muscle position adjustment function or the pulsatile function of the left ventricle, both of which are fundamental physiological cardiac functions that have been incompatible in cardiac simulators to date.

[0008] This technical limitation in existing simulators is the result of the incompatibility of two functions in the mechanical system. The arm 112 has been made small to fit into the limited working space in simulation modules 1 and 2, and it is impossible to control the large range of papillary muscle tip positions within the ventricle without disturbing the physiological beating motion of the left ventricle.

[0009] Although some recent simulators have simulated the beating function of the left ventricle, their simulated beating only mimics the symmetric deformation of a heart-shaped balloon. In fact, the human left ventricle does not move symmetrically, and such simulators cannot simulate the physiological motion of the left ventricle and do not have ideal accuracy. Summary of the Invention

[0010] The present invention seeks to address the drawbacks of existing technology simulators and provide improved papillary muscle position control and left ventricular physiological motion in a simulator.

[0011] In the simulator of the present invention, the left ventricle rotates slightly periodically about a vertical base-apex axis (base of the heart - apex of the heart) synchronously with the periodic pulsatile motion. In addition, in the present invention, the previously conflicting papillary muscle regulation and left ventricular pulsatile functions are combined in one simulator. The present invention makes the in vitro patient-specific prognosis closer to its clinical application and makes the simulation environment for future in vitro etiological research closer to the physiological conditions of real humans.

[0012] According to a first aspect of the present invention, there is provided a simulator comprising: a chamber container; a flexible chamber model disposed within the chamber container and simulating a living chamber; at least one chamber arm disposed within the chamber container, the distal end of the chamber arm being fixed relative to a point on the simulated chamber, and the position of the distal end being controllable from the proximal end. A control device for controlling the motion of the simulated living chamber, the control device being adapted to change the position of the distal end during the simulation.

[0013] Such a simulator allows for the precise simulation of the motion of a living chamber, such as the left or right ventricle of the human heart, in which case the precise rotation and / or other motions of the chamber during pulsation can be simulated.

[0014] According to a second aspect of the present invention, there is provided a simulator comprising: a flexible simulation cavity simulating a living body cavity, the flexible simulation cavity having at least one opening; leaflets including a valve; a physical model of a papillary muscle; chordae tendineae connecting the physical model of the papillary muscle and the leaflets; at least one valve arm extending through the flexible simulation cavity such that a distal end of the valve arm is disposed within the flexible simulation cavity and a proximal end is disposed outside the flexible simulation cavity, and a position of the distal end of the valve arm relative to a position of the simulated papillary fixed muscle and the distal end of the valve arm is controllable from the proximal end; and a control device for controlling the simulation process.

[0015] Despite the use of a flexible chamber, this simulator allows precise control of the physical model of the papillary muscle.

[0016] Preferably, the position of the distal end is adjustable to the end-systolic position of the physical model of the living papillary muscle.

[0017] Preferably, the control device is adapted to change the position of the distal end of the valve arm during the simulation process.

[0018] Preferably, the position of the distal end of the valve arm can be controlled without affecting the movement of the flexible simulation cavity.

[0019] Preferably, the valve arm includes: a first rotary joint disposed on an inner wall of the flexible simulation cavity; a first fixing device facing the distal end for fixing to the physical model of the papillary muscle; and a first telescopic rod between the first rotary joint and the fixing device.

[0020] Preferably, the valve arm further includes: a second rotary joint facing the proximal end and disposed outside the simulation cavity; a second fixing device located between the first and second rotary joints for fixing to the simulation cavity; and a second telescopic rod between the second rotary joint and the second fixing device.

[0021] Preferably, the flexible simulation cavity includes a first simulation cavity and a second simulation cavity, wherein the first simulation cavity and the second simulation cavity are connected by an opening and the valve is located therebetween.

[0022] Preferably, the simulator further includes: a chamber container, and the chamber is disposed in the chamber container.

[0023] Preferably, the proximal end of the valve arm is fixed to a wall of the chamber container; a control motor is disposed adjacent to the wall of the chamber container and connected to the proximal end; and the control device is used to control the control motor to change the position of the distal end of the valve arm.

[0024] Preferably, the simulator further includes: at least one chamber arm disposed within the chamber container, a distal end of the chamber arm being fixed relative to a point on the simulation cavity, and a position of the distal end being controllable from the proximal end, and the control device is adapted to change the position of the distal end of the chamber arm during the simulation process.

[0025] In the first and second aspects of the present invention, preferably, the proximal end of the cavity arm is fixed to the wall of the cavity container; the corresponding control motor is arranged near the wall of the cavity container and connected to the proximal end; the control device is used to control the control motor to change the position of the distal end of the cavity arm.

[0026] Preferably, the cavity arm includes: a cavity arm rotary joint facing the proximal end; a cavity arm fixing device facing the distal end for fixing to the simulation cavity; and a cavity arm telescopic rod located between the cavity arm rotary joint and the cavity arm fixing device.

[0027] Preferably, the cavity arm fixing device includes clamping plates for clamping the simulation cavity arranged on both the inner and outer sides of the simulation cavity.

[0028] Preferably, the cavity arm fixing device is attached to the cavity arm telescopic rod through a ball and socket joint.

[0029] Preferably, the position of each rotary joint is controlled by a corresponding joint control line, and the extension of the said or each telescopic rod is controlled by a corresponding extension control line.

[0030] Preferably, the simulation cavity simulates the left ventricle; the control device is used to control the position of the distal end of the cavity arm so that the left ventricle rotates around the base - apex axis synchronously with the periodic pulsation of the ventricle during the simulation.

[0031] Preferably, the simulator is used to simulate at least one of the left heart and the right heart.

[0032] According to another aspect of the present invention, there is provided an artificial heart valve, including: an annulus; leaflets attached to the annulus; chordae tendineae; and an attachment block; and wherein the ends of the chordae tendineae are respectively attached to the leaflets and the attachment block, the leaflets are formed of a first material, the chordae tendineae are formed of a second material, the attachment block is formed of a third material, and the covering layer is molded around the first, second, and third materials and formed of a fourth material different from the first, second, and third materials.

[0033] Preferably, the valve further includes: a plurality of leaflets and a plurality of attachment blocks, wherein each attachment block is connected to several leaflets through chordae tendineae.

[0034] Preferably, the first, second, and third materials are different from each other.

[0035] Preferably, the first material is a cloth material.

[0036] Preferably, the second material is a braided wire.

[0037] Preferably, the third material is a solid plastic.

[0038] Preferably, the fourth material is silicone.

[0039] Preferably, the first, second, and third materials are stitched together before molding the covering layer.

[0040] Preferably, the valve further includes: the artificial heart valve is a mitral valve.

[0041] Preferably, the artificial heart valve is a prosthesis for human use.

[0042] According to another aspect of the present invention, there is provided a method of manufacturing an artificial heart valve according to the foregoing aspect, the method comprising: forming a mold; positioning first, second, and third materials in the mold; and filling the mold with a fourth material to form a covering material around the first, second, and third materials.

[0043] Preferably, the method further includes: obtaining a scan of the corresponding valve of an individual to form the mold and fixing the first, second, and third materials in the mold such that the positions of the connection points between the chordae tendineae and the attachment blocks and the positions of the connection points between the chordae tendineae and the valve leaflets match the individual morphology in the scan.

[0044] According to another aspect of the present invention, there is provided a chamber arm for a simulator, the simulator having a simulation chamber for simulating a living body. The arm includes: a first fixing device towards the distal end for fixing to a part of the simulation chamber; a first rotary joint towards the proximal end; and a first telescopic rod between the first rotary joint and the first fixing device, wherein the position of the distal end can be controlled from the proximal end.

[0045] Preferably, the chamber arm further includes: a wall fixing device for fixing the proximal end of the chamber arm to the wall of a chamber container containing the simulation chamber.

[0046] Preferably, the rotation of the first rotary joint is controlled by a joint control line, and the extension of the first telescopic rod is controlled by an extension control line.

[0047] Preferably, the chamber arm further includes: a control motor located at the proximal end, the control motor controllably changing the position of the distal end of the arm.

[0048] Preferably, the fixing device includes clamping plates for clamping the simulation chamber disposed on both the inner and outer sides of the wall of the simulation chamber.

[0049] Preferably, the first fixing device is attached to the first telescopic rod through a ball and socket joint.

[0050] According to another aspect of the present invention, there is provided a valve arm, including: a chamber arm according to the foregoing aspect; a second telescopic rod between the first fixing device and the distal end of the valve arm; a second fixing device towards the distal end of the valve arm for fixing to a papillary muscle solid model in the simulation chamber; and a second rotary joint between the second telescopic rod and the first fixing device.

[0051] Preferably, the rotation of the second rotary joint is controlled by respective joint control lines, and the extension of the second telescopic rod is controlled by respective extension control lines.

[0052] According to another aspect of the present invention, there is provided a prediction method for predicting the outcome of a proposed surgical treatment for an organ of a symptomatic individual, the method comprising: obtaining a scan of the organ; forming at least one first solid model based on the scan to simulate the organ in a diseased state; running a first simulation using the first solid model and organ function parameters obtained from the case of the symptomatic patient to obtain a first disease severity index of the organ model; running a second simulation by adjusting the first simulation until the first severity index matches the medical record of the symptomatic patient; performing the proposed surgical treatment in the second simulation and obtaining a second disease severity index of the organ model; and determining the effectiveness of the proposed surgical treatment by comparing the second disease severity index with the medical records of patients in a healthy or previous condition.

[0053] Preferably, the method further comprises: forming at least one corresponding second solid model based on the scan for simulating the organ in a healthy or previous state; running an initial simulation using the first solid model and organ function parameters obtained from a patient in a healthy or previous condition to obtain an initial disease severity index of the organ model before running the first simulation; comparing the initial disease severity index with the medical records of the patient in a healthy or previous condition; adjusting the initial simulation until the initial disease severity index matches the medical record of the patient in a healthy or previous condition; and determining the feasibility of the method by comparing the matched initial disease severity index with the medical records of patients in a healthy or previous condition.

[0054] Preferably, the organ model is the heart, the first solid model and the second solid model simulate the left heart or the right heart, or a part of the left heart or the right heart, and the first simulation and the second simulation are used to simulate the movement of at least one of the left heart or the right heart.

[0055] Preferably, the evaluation of the effectiveness of the surgical treatment includes the damage of the treatment to the organ in the simulated rest state and exercise state.

[0056] Preferably, the method further comprises: making a plurality of first solid models; running respective first and second simulations for each first model; performing different surgical treatments on the respective second simulations; and determining which of the different surgical treatments is the most effective based on which of the respective second disease severity indices best matches the medical records of patients in a healthy or previous condition. Description of the Drawings

[0057] To more clearly illustrate the technical solutions in the embodiments of the present invention, the following will briefly introduce the drawings required for use in the embodiments. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0058] Figure 1 is a schematic diagram of an existing heart simulator that lacks the function of papillary muscle control.

[0059] Figure 2 is a schematic diagram of an existing heart simulator lacking ventricular pulsation function.

[0060] Figure 3 is a schematic diagram of a heart simulator according to the present invention.

[0061] Figure 4 shows Figure 3 a part of the image in, including the ventricular simulation module 1 and the atrial simulation module 2.

[0062] Figure 5 shows Figure 4 the ventricular simulation module 1 in, focusing on describing the mitral valve model 15.

[0063] Figure 6 shows Figure 4 the lower right corner of the left ventricular simulation module 1 in, paying special attention to the mitral valve model 15, highlighting the structural differences between the arm 13A, the arm 13B, and the forearm 14.

[0064] Figure 7 is a 3D view of the arm 13A focusing on its connection method with the wall of the cardiac chamber container 11 or 21 and the motor group 110.

[0065] Figure 8 is a schematic diagram illustrating the components of the arm 13A.

[0066] Figure 9 is Figure 8 a detailed view of the clamping double-plate assembly 134 in.

[0067] Figure 10 is a cross-sectional view of the upper half of the arm 13A, focusing on describing the control mechanism and omitting the motor group 110 for the sake of clarity.

[0068] Figure 11 shows the arm 13C with an optional ball-and-socket joint 139 to connect the clamping double-plate assembly 134 and the rod 133C.

[0069] Figure 12 is Figure 11 a detailed cross-sectional view of the ball-and-socket joint 139 in.

[0070] Figure 13 It is a 3D view of the papillary muscle control arm 111 including the arm 13B and the forearm 14.

[0071] Figure 14 It is a schematic diagram showing the components of the forearm 14.

[0072] Figure 15 It is a cross-sectional view of the upper half of the forearm 14, with emphasis on the control mechanism.

[0073] Figure 16 The content of Figure 6 is the same, with emphasis on how the papillary muscle 151 is connected to the papillary muscle support 111.

[0074] Figure 17 It is a cross-sectional view of the upper half of the arm 13B, with emphasis on the control mechanism.

[0075] Figure 18 It shows the surgical prognosis simulation process using the present invention. Detailed implementation manners

[0076] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without making creative efforts shall fall within the protection scope of the present invention.

[0077] In the present invention, the orientation or positional relationship indicated by the terms "upper", "lower", "left", "right", "front", "rear", "top", "bottom", "inner", "outer", "middle", "vertical", "horizontal", "lateral", "longitudinal", etc. is based on the orientation or positional relationship shown in the accompanying drawings. These terms are mainly used to better describe the present invention and its embodiments, and are not used to limit that the indicated devices, elements or components must have a specific orientation, or be constructed and operated in a specific orientation.

[0078] Moreover, in addition to being able to represent the orientation or positional relationship, some of the above terms may also be used to represent other meanings. For example, the term "upper" may also be used to represent a certain attachment relationship or connection relationship in some cases. For those of ordinary skill in the art, the specific meanings of these terms in the present invention can be understood according to specific situations.

[0079] In addition, the terms "installed", "set up", "equipped with", "connected", and "linked" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral structure; it can be a mechanical connection or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate medium, or an internal communication between two devices, components, or parts. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0080] In addition, the terms "first", "second", etc. are mainly used to distinguish different devices, components, or parts (the specific types and structures may be the same or different), and are not used to indicate or imply the relative importance and quantity of the indicated devices, components, or parts. Unless otherwise specified, the meaning of "a plurality of" is two or more.

[0081] The technical solution of the present invention will be further described below in conjunction with embodiments and drawings.

[0082] 5.1 Overview

[0083] The present invention provides a device and a method that allow an operator (who can be, but is not limited to, a surgeon, an intern, a researcher, a developer of a new therapy, and any medical professional) to use an organ simulator containing a true - sized organ model to simulate an open - cavity or minimally invasive therapy for a human organ with a chamber structure. The organ simulator can simulate the patient - specific characteristics of the organ under healthy, unhealthy, pre - operative, and post - operative conditions, including geometric shape and movement mode.

[0084] The complete therapy simulation process includes multiple steps arranged in chronological order:

[0085] · Fabricate an organ chamber model with patient - specific geometry obtained from clinical scans.

[0086] · Simulate the patient - specific healthy condition.

[0087] · Simulate the patient - specific symptoms (unhealthy conditions).

[0088] · Conduct therapy simulation on the symptomatic organ model.

[0089] · Simulate the post - operative situation of the unhealthy organ model.

[0090] · If the post - operative situation is not satisfactory, repeat all the above steps with another or improved therapy until the best result is observed.

[0091] In addition to clinical applications, the present invention can also be used for the development of new therapies, etiological research, education, training, and the treatment of animal diseases. When used for non-clinical applications, the simulated organ can be the organ geometry for animals, or a general geometry modified by CAD rather than the patient-specific geometry, in order to better reflect the general geometry in a specific population.

[0092] The organ model is made of tissue-equivalent material, for example, a flexible transparent silicone material such as Transil40-1, on which therapy simulation will be carried out.

[0093] This organ model can usually be a heart model, and the simulator can be appropriately adjusted to simulate therapies in other body organs with similar chambers (such as the lungs). In this document, as an example, the organ model is assumed to be the heart, but the present invention is not limited thereto.

[0094] The organ simulator device includes the following functional components, such as Figure 3 shown: a ventricular simulation module 1 that simulates ventricular pulsation, an atrial simulation module 2 that simulates atrial pulsation, a pump group 3 that drives ventricular pulsation, a regulation system 4 that simulates other parts of the human circulatory system, and a data system 5 that includes a motor drive system for controlling all motors in the simulator and a data acquisition system for monitoring, processing, and reporting the functional data of the simulator, such as heart rate, blood pressure, cardiac output, regurgitation fraction, effective orifice area, and other cardiac performance indicators. Pressure sensors and flow meters are also part of the data system 5.

[0095] The simulation modules 1 and 2 are designed as part of the present invention, while all other functional components of the simulator can generally be obtained from a hydrodynamic simulation platform, such as the ViVitro Pulse Duplicator System provided by ViVitro Labs, Inc., located at 455 Boleskine Road, Victoria, British Columbia, Canada. Blocks 1 and 2 of the present invention are fully compatible with the in vitro pulse duplicator system.

[0096] 5.2 Detailed description

[0097] 5.2.1 Chamber simulation modules 1&2

[0098] There are four chambers in the human heart. This embodiment of the present invention includes two chamber models. The simulator simulates the left or right heart. On the left and right sides of the heart, there is an atrium chamber at the top of each ventricle chamber. There is a heart valve in the connection hole between the new atrium and ventricle chambers to allow blood to flow unidirectionally from the atrium to the ventricle, and another heart valve is in the blood outlet hole of the ventricle. In this embodiment, for example, assume that the left heart is simulated. Therefore, (listed in the order of blood flow) the pulmonary vein, left atrium, mitral valve, left ventricle, aortic valve, and aorta are simulated. Alternatively, when used for right heart simulation, each left heart simulator component can also simulate the relevant tissues and organs of the right heart, including the superior vena cava, right atrium, tricuspid valve, right ventricle, pulmonary valve, and pulmonary artery. In addition, the present invention can also be used by analogy to simulate other body organs with similar chambers, such as the lungs.

[0099] Now refer to Figure 4 , which shows Figure 3 a portion of the images in

[0100] The left ventricle simulation module 1 allows the operator to perform left ventricle simulation under various simulated condition settings, including pre-treatment and post-treatment conditions with different health statuses.

[0101] The housing of the left ventricle simulation module 1 is the left ventricle container 11, which is usually made of transparent plastic glass (such as acrylic) for clear observation of internal components and particle image velocimetry (PIV) studies. To simulate open-chest surgeries, such as papillary muscle correction, papillary muscle repositioning surgery, and left ventricle shape remodeling related to annuloplasty, each plate of the left ventricle container 11 can be disassembled according to the operator's needs to leave a convenient operating space. To simulate minimally invasive therapies, such as transapical interventional chordae implantation for treating mitral regurgitation during beating heart conditions, some plates of the left ventricle container 11 can be replaced with plates having specially designed holes with rubber seals to allow insertion of medical devices. Some openings can be reserved in the left ventricle container 11 for the motion control components and the pump 3, which will be described in detail below.

[0102] The left ventricle model 12 simulates the movement of the real left ventricle. The left ventricle model 12 is made of transparent and flexible materials with physical properties similar to local tissues, such as silicone and rubber. The geometry and properties of the left ventricle model 12 can be modified to meet the specific requirements of each simulation. For example, geometric shapes generated using CAD as the average general geometry of a specific population can be used to study the etiology of that population, while individual patient-specific geometries can be used for prognosis, and some rigid plastic sheets can be embedded in the ventricular wall of the left ventricle 12 to simulate local tissue calcification.

[0103] The left ventricular chamber model 12 is made by casting with a liquid material, having a separate male mold with the geometry of the left ventricular inner wall, or a multi-component mold including a male mold and a female mold, where the female mold of the multi-component mold needs to have the geometry of the left ventricular outer surface. When thickness control is required to adjust the physical properties of a specific area, both the male mold and the female mold are necessary. The mold can be made by a milling machine or a 3D printer. When patient-specific geometry is required, clinical scans such as MRI (Magnetic Resonance Imaging) are needed to generate a geometry file in a format compatible with the mold manufacturing machine, such as the ".stl" format. Otherwise, the geometry file can be modified using CAD to adjust the format of the geometry file.

[0104] The left atrial container 21 has a structure, function, and material similar to or the same as that of the left ventricular container 11. The only difference (or the main difference) between the two containers is the heart chamber (left ventricle or left atrium) that the container holds. The left atrial model 22 has a manufacturing process, function, and material similar to or the same as that of the left ventricular model 12, except that the two model chambers simulate different heart chambers.

[0105] During each cardiac cycle, including diastole and systole, each arm 13A controls the dynamic position of points on the surfaces of the left ventricular solid model 12 and the left atrial solid model 22. In this specification, each arm 13A is referred to as an "arm", but it is obvious that other types of rods, cylinders, arms, or legs, whether connected or not, can be used as the arm 13A.

[0106] In addition, the papillary muscle control arm 111 controls the dynamic position of the papillary muscle 151. Each papillary muscle control arm 111 includes an upper arm 13B and a forearm 14. Similarly, the present invention is not limited to the embodiment using the upper arm and forearm arrangement, and it is obvious to those skilled in the art that other elements of rods, cylinders, arms, and legs can be preferably connected to each other to form the papillary muscle control arm 111.

[0107] Now refer to Figure 6 which shows Figure 4 the lower right corner of the left ventricular simulation module 1 in

[0108] The movement of the arm 13A is controlled by a motor set 110 mounted on the outer surface of the heart chamber container 11 or 21 (see Figure 4 ), through a mechanical drive system inside the arm 13A. In the ventricular container 11 or 21, at least five arms 13A are applied to simulate the physiological movement of the ventricle, including the dynamic rotation of the left ventricle around the base-apex axis.

[0109] Arm 13B is a special type of arm. In addition to all the structures and functions of arm 13A, arm 13B is also capable of controlling the forearm 14 connected to the upper end of arm 13B. Compared with arm 13A, there are more mechanical drive systems inside arm 13B, which can control the movement of the forearm 14 through the motor set 110. Arm 13B and the forearm 14 together form the papillary muscle control arm 111, which is used to control the movement of the papillary muscle 151, especially the dynamic position of the papillary muscle tip discussed below, so as to control the severity of the simulated papillary muscle displacement disease. From the perspective of mechanical control, the papillary muscle tip in the left ventricular container 11 is independently controlled without affecting the movement of the left ventricular container 11, which is a novel functional invention.

[0110] Although only two are shown, preferably there are three papillary muscle control arms 111 in the multi-purpose ventricular simulation module, which can be used as the left ventricular simulation module 1 or the right ventricular simulation module. In this case, two of the three papillary muscle control arms 111 can be used to simulate the left heart, where two papillary muscles are located in the left ventricle; and all three papillary muscle control arms 111 can be used to simulate the right heart, where three papillary muscles are located in the right ventricle. Alternatively, specially customized simulation modules with an appropriate number and position of papillary muscle control arms 111 can be provided for the left ventricle and the right ventricle respectively.

[0111] Returning to the description of this embodiment, the left atrial simulation module 2 does not include the papillary muscle control arm 111.

[0112] The mitral valve model 15, the aortic valve 16, and the aorta 17 are typical structures of existing simulators. In the simulator according to the present invention, these three components 15, 16, and 17 can be pre-existing non-patient-specific products or fixed isolated animal tissues, or the chambers 12 and 22 can be manufactured using the same materials and methods as the heart model. The casting process of the mitral valve model 15 can be replaced by an upgraded process, which will be discussed below and is a unique and novel feature of the present invention.

[0113] The pump 3 is used to drive the pulsation of the ventricles by periodically pumping the medium liquid 18 filled in the space between the silicone ventricles 12 and 22 and their containers 11 and 21, rather than directly pumping the simulated blood 19 located inside the heart chamber models 12 and 22.

[0114] 5.2.2 Mitral Valve Model 15

[0115] Now refer to Figure 5 which shows Figure 4The ventricular simulation module 1 in it pays particular attention to the mitral valve model 15. The mitral valve model 15 is installed between the orifices connecting the cardiac chamber models 12 and 22 and includes four components: the papillary muscle model 151, the chordae tendineae model 152, the leaflet model 153, and the mitral annulus model 154 (for convenience, these components are sometimes abbreviated as "model" in the following text). Each papillary muscle 151 is controlled by the papillary muscle support 111. The mitral annulus 154 is installed between the orifices connecting the chambers 12 and 22 of the heart model. The leaflets 153 are supported by the mitral annulus, and the chordae tendineae 152 connect the leaflets 153 and the papillary muscles 151. More specifically, the chordae tendineae 152 are connected to the papillary muscles 151 at corresponding points on the surface of the papillary muscle tips. Although not shown, each papillary muscle 151 is connected to two leaflets through the chordae tendineae 152. The chordae tendineae 152 and the leaflets 153 between the papillary muscles 151 and the mitral annulus 154 are otherwise not connected to anything outside the mitral valve structure, unless the therapy involves any changes to these two parts 152 and 153, such as chordae tendineae and leaflet repair therapies.

[0116] The papillary muscle 151 in this embodiment is a solid block and does not contract and relax by itself. Instead, it simulates the tip of the papillary muscle because it is the site where the chordae tendineae attach. In this embodiment, the movement of the papillary muscle tip is simulated by moving the papillary muscle 151 using the papillary muscle control arm 111. Therefore, the papillary muscle 151 can be considered an attachment block for attaching the chordae tendineae 152.

[0117] The manufacturing process of the mitral valve model 15 can be upgraded through an additional process as follows. Before pouring silicone in a closed male and female mold system, some solid additional materials can be placed in the mold. The additional materials vary depending on the different parts of the valve: cotton cloth tailored to the required shape for the leaflets, fishing line used as the chordae tendineae, and 3D printed plastic with the patient-specific papillary muscle tip geometry, where the papillary muscle tip includes the position of the chordae tendineae-papillary muscle attachment point. Before silicone casting, these placed additional materials must be connected to each other in the same way as the physiological connection, usually by suturing. After silicone casting, these additional materials will be embedded in the silicone layer. The 3D printed mold should preferably include details of the mitral valve geometry, such as the leaflet-chordae tendineae and chordae tendineae-papillary muscle attachment points. A vacuum chamber can be used to avoid the presence of air bubbles during the casting process. The fishing line is usually made of braided (multifilament) fibers and has the following properties: no shape memory, wear-resistant, and at least 3N tensile load. All other materials must be strong enough so that the mitral valve 15 model can withstand at least 3N of load.

[0118] When the present invention is used for right heart simulation, the manufacturing method and materials of the mitral valve model 15 are also applicable to the tricuspid valve model.

[0119] 5.2.3 Arm 13A

[0120] Reference is now made to the following three figures:

[0121] · Figure 7 Is a 3D drawing of the arm 13A, highlighting its connection to the wall of the cardiac chamber container 11 or 21 and the motor set 110.

[0122] · Figure 8 Is a schematic diagram illustrating the components of the arm 13A.

[0123] · Figure 9 Is Figure 8 A detailed view of the clamping double plate assembly 134 in

[0124] · Figure 10 Is a cross-sectional view of the upper half of the arm 13A, focusing on the control mechanism and omitting the motor set 110 for ease of explanation.

[0125] In the following description, the connection and use of the arm 13A in the left ventricular container 11 will be described. However, it is obvious that the arm 13A can be attached to and used in the left atrial container 21 in a similar manner to control the left atrial model chamber 22.

[0126] The arm 13A and the motor set 110 are mounted on the inner and outer sides of the wall of the chamber container 11 or 21 ( Figure 7 ). However, it is obvious that a part of the motor set 110 can be arranged inside the chamber container 11, and / or, a part of the arm 13A can extend outside the chamber container 11. The arm portion includes a rotary joint 131 that allows 2D rotational control of the arm portion 13A, including rotation about the X-axis and the Y-axis (see Figure 8 The coordinate system on the left side).

[0127] In another alternative embodiment, the rotary joint 131 can be upgraded to have rotational control with more degrees of freedom rotating about the Z-axis (not shown). For example, such an upgrade can be a digitally controlled ball-and-socket joint that has rotational control about all the x, y, and z axes.

[0128] The rod 133A is inserted into the tube 132 to form an extendable arm. The double clamping plate assembly 134 is used to clamp the walls of the cardiac chamber models 12 and 22 ( Figure 9 ) to achieve control of a point on the ventricular surface. The clamping double plate assembly 134 includes an upper plate 1341 that is integral with the rod 133A and a lower plate 1342 that is a separate component. These two plates 1341 and 1342 are tightened with at least three threaded screws. The angle of the double plate assembly 134 can be customized during the manufacturing process to fit the geometry of a specific ventricle 12 and 22.

[0129] The degrees of freedom of rotation and extension are controlled by a series of control mechanisms. As Figure 10As shown, the swivel joint in this embodiment includes a double pivot joint 131, which allows rotation about the X-axis and Y-axis respectively. As shown in the figure. Refer to Figure 10 and 11 , four joint control lines 135 are attached to a portion of the holding tube 132 to adjust the rotation posture about the X-axis and Y-axis, but are omitted from other figures for ease of illustration. In the figure, the two front side control lines 135 of the wire will cause the tube to rotate forward about the X-axis, the two rear side control lines 135 of the wire will cause the tube to rotate backward about the X-axis, the two right side control lines 135 of the wire will cause the tube to rotate right about the Y-axis, and pulling the two left side control lines 135 of the wire will cause the tube to rotate left about the Y-axis. The spring 137 provides a thrust to push the rod 133A in the Z+ direction, and an extension control line 136 overcomes the spring thrust to pull the rod 133A in the Z- direction, thereby controlling the pulling distance.

[0130] The four joint control lines 135 and the extension control line 136 can be pulled / loosened to adjust the length, so that the rod 133A and the clamping double plate assembly 134 can move in any direction.

[0131] For ease of illustration, Figure 7 , Figure 8 and Figure 13 the wires 135 and 136 are omitted in Figure 10 and Figure 11 the motor group is omitted in

[0132] The joint control lines 135 and the extension control lines 136 pass through the joint 131 and the holes 138 in the chamber containers 11 or 21 and extend to the motor group 110. The motor group 110 is operated to control the position of the clamping double plate assembly 134. The holes 138 are designed to allow unobstructed sliding of all the lines 135 and 136, and the length of each of these lines is controlled by one of the motors in the motor group 110.

[0133] The extension control line 136 and the spring 137 assembly can be replaced by any other digitally controllable extension control device, such as a gear system and a hydraulic pump.

[0134] In Figure 11 and Figure 12 the preferred arm 13C shown, a ball and socket joint 139 ( Figure 12 ) can be added between the rod 133A and the double clamping plate assembly 134. The ball and socket joint has an uncontrolled 3D rotational freedom to avoid unnecessary deformation of the controlled surface points of the heart chamber models 12 and 22. Although not shown, the ball in the ball joint 139 can be pressed through the surface of the rod by inserting a threaded screw into the surface of the rod 133A if needed in a more precise simulation.

[0135] Similar to the arm 13A, the plates clamping the double - plate assembly 134 are separable, and three (or any suitable number) of screws (not shown) are used to clamp the plates together, holding the heart chamber models 12, 22 therebetween. In other words, the mounting plate 1341 is inside the ventricles 12, 22 and the plate 1342 is outside thereof. The same arrangement applies to 13B and 13C.

[0136] 5.2.4 Papillary Muscle Control Arm 111

[0137] Now refer to the following three figures:

[0138] · Figure 13 is a 3D drawing of the papillary muscle bracket 111, which includes the arm 13B and the forearm 14.

[0139] · Figure 14 is a schematic diagram showing the components of the forearm 14.

[0140] · Figure 15 is a cross - sectional view of the upper half of the forearm 14, with emphasis on the control mechanism.

[0141] The papillary muscle control arm 111 includes the arm 13B and the forearm 14 ( Figure 13 ). The forearm 13B includes the same structure as the forearm 13A, but the forearm 14 has additional fittings and controls. As Figure 4 and Figure 6 shown, the arm 13B is attached to the left ventricle container 11 and is disposed between the chamber container 11 and the left ventricle model 12. The upper and lower plates 1341, 1342 clamp the left ventricle model 12. The forearm 14 is mounted on the surface of the upper plate 1341 of the clamping double - plate assembly 134 of the arm 13B, and the forearm 14 is located inside the ventricle model 12. The forearm 14 has a similar structure to the arm 13A ( Figure 14 ) and the same control mechanism ( Figure 15 ).

[0142] The following table shows the same structures between the forearm 14 and the upper arm 13A for each row.

[0143]

[0144]

[0145] The joint control line 145 and the extension control line 146 pass through the double - clamping plate assembly 134, the rod 133B ( Figure 17 ), the tube 132, the rotary joint 131, and the holes 138 in the joint 131 and the wall of the left ventricle container 11 into the motor set 110 for control in a manner similar to the arm 13A. For the sake of illustration, Figure 13 、 Figure 14 and Figure 17 omit the lines 145, 146,Figure 15 The arm 13B is omitted, and Figure 13 、 Figure 15 and Figure 17 the motor set is omitted.

[0146] The only other major difference between the forearm 14 and the upper arm 13A is the part above the rod 143. The connecting pad 144 is adhesively bonded to the top of the rod 143, or otherwise attached to the rod 143, or integrally formed with the rod 143. The connecting pad 144 has at least two threaded holes 1441, so that the papillary muscle 151 can be firmly connected to the connecting pad 144 by screws 148 ( Figure 16 ).

[0147] Viewed from the outside, the arm 13B looks the same as the arm 13A ( Figure 13 ), because the only difference is the internal structure ( Figure 17 ). The arm 13B has all the components of the arm 13A. In addition, the arm 13B also has the following components. The hole 138 drilled through the rod 133B is to allow the wires 145 and 146 for controlling the posture of the forearm 14 to reach the motor set 110 and be controlled by the motor. The wires 145 and 146 also share the routes occupied by the wires 135 and 136.

[0148] In another way of controlling the postures of the upper arms 13A, 13B, 13C and the forearm 14, the manual wire length control can replace the motor digital control, effectively saving costs, but sacrificing the dynamic position control of the relevant components. A typical application of this simplified device is the simulation of functional mitral regurgitation caused by papillary muscle displacement, because the only moment when the papillary muscle position affects the mitral valve leaflet closure is at the end of systole. In this application, so far, academic research believes that it is acceptable to keep the papillary muscle in a fixed position.

[0149] 5.2.5 Dynamic Simulation Control

[0150] One function of the control system 5 is to apply control signals to drive the motor set 110 and provide precise control over the dynamic positions of the left ventricular left atrial surface and the papillary muscles.

[0151] Each motor controls one of the wires 135, 136, 145 or 146. All the motors jointly control the traction distance of the wires, and thus control the rotation angles of the joints 131 and 141, as well as the extension lengths of the rods 133A, 133B, 133C and 143. The controlled joints and the extended rods jointly achieve the 3D position control of the free ends of the upper arms 13A, 13B, 13C and the forearm 14.

[0152] The multi - degree - of - freedom movement of arms 13A, 13B, and 13C enables the controlled movement of multiple points on the chamber surface. The control points, together with pump 3 that controls the cardiac chamber volume, beating amplitude, and frequency, drive the cardiac chamber to beat in accordance with the patient - specific physiological movement. An example of the physiological movement of the cardiac chamber is the periodic slight rotational movement of the left ventricle around the vertical (base - apex axis) base - apex axis.

[0153] The drive signal must be periodically changed with reasonable accuracy to achieve the desired physiological cardiac chamber movement. Similarly, patient - specific papillary muscle dynamics control is achieved through the dynamic control of forearm 14 connected to the papillary muscle model.

[0154] Importantly, from a mechanical control perspective, the papillary muscle tips within the left ventricular container 11 can be independently controlled without affecting the movement of the left ventricular container 11, which is a novel functional invention.

[0155] 3D scanning (such as MRI) will be applied to the heart simulator and the patient to obtain the cardiac chamber movement and papillary muscle movement trajectories. The digital signals are adjusted accordingly to ensure the accuracy of the simulated actions. The MRI scan can run for a certain period, such as several seconds, to generate a 4D video, or a so - called 4D scan. 3D or 4D scans can be used in the present invention.

[0156] Thus, the control device 5 can control the ends of arms 13A, 13C (and the points on the chambers 12, 22 to which they are attached) to move periodically in three dimensions during the simulation operation, in synchronization with the beating of the heart. They can also be moved to a predetermined position before the simulation starts. For example, the periodic slight rotation of the left ventricle around the vertical base - apex axis can be synchronized with the periodic pulsatile movement.

[0157] There may be two cardiac chamber models and two valves with sub - valvular structures, simulating the cardiac structure of the patient's left or right heart.

[0158] Preferably, the simulator has patient - specific geometry, function, and symptoms obtained from body scans, clinical tests, and / or CAD. The abnormal tissue deformation that causes functional diseases is controlled by digitally or manually driven mechanical components. The abnormal tissue degeneration and calcification that cause organic diseases and other organic heart diseases are simulated by tissue - equivalent materials. These equivalent materials have patient - specific physical properties, such as stiffness, strength, and geometry, including damaged geometry.

[0159] A series of programmable motor groups are configured to simulate the dynamic patient - specific cardiac chamber tissue movement and deformation by controlling the movement of mechanical components, thereby simulating the specific cardiac manifestations of the patient in healthy conditions and functional heart diseases (including abnormal hearts), such as chamber dilation and papillary muscle displacement.

[0160] The present invention can be used to simulate patient-specific healthy, unhealthy, pre-operative and post-operative conditions.

[0161] 5.2.6 Simulation process

[0162] Figure 18 The prediction simulation process using the present invention is shown. When the treatment outcome of a predetermined treatment is to be predicted, the following steps are taken:

[0163] 1. Clinical scan (usually MRI) data of the patient's target organ (taking the left ventricle as an example) is obtained from the patient's historical medical records. The geometry of the left ventricle, including health conditions and disease conditions, is scanned and obtained and used to 3D print molds for making heart models, such as left ventricle molds and mitral valve molds.

[0164] 2. Fabrication of the heart model, for example by casting silicone into a 3D printed mold (above). The silicone is selected to have physical properties similar to human tissue. If necessary, other materials will be embedded in the silicone layer to achieve calcification, tissue damage, and rupture of chordae tendineae. Healthy heart chamber models and unhealthy heart chamber models need to be made separately.

[0165] 3. Run separate simulations under healthy and unhealthy conditions. In the healthy state simulation, a model heart chamber with healthy geometry is set to simulate the healthy state, and the simulation condition setting uses cardiac function parameters obtained from medical records during the healthy period, such as cardiac output, heart rate, heart chamber beat waveform, volume pumped per beat, and blood pressure. The output of the simulation is disease severity indicators, such as mitral valve effective orifice area, mitral valve regurgitation fraction, which will be compared with the healthy medical records. It is expected that the simulation output will match the healthy medical records, otherwise adjustments such as adjusting chambers and blood viscosity will be made until a match is observed. The healthy state simulation serves as a benchmark to compare the results of experimental therapies. The healthy state simulation can also be used to determine whether subsequent therapy simulation processes will be effective. If the parameters of the healthy state simulation cannot be adjusted so that the simulation state output matches the healthy medical records, the subsequent therapy simulation will not be sufficient to determine whether the experimental therapy is effective. The unhealthy state simulation has the same process, except that the medical records used as simulation condition settings and for comparison with expected results are medical data in the unhealthy state.

[0166] 4. While the simulator is applying the unhealthy state settings, apply multiple therapies to the heart chamber model, with the goal of increasing the simulation output (symptom severity) without adjusting the simulation condition settings. The therapies can be open-chamber surgeries, such as surgical mitral valve repair and replacement, or minimally invasive therapies, such as transcatheter valve repair and replacement. For minimally invasive therapies that do not require the heart to stop beating during the treatment, the heart chamber model must also keep beating during the treatment.

[0167] 5. For each therapy, multiple trials with different methods can be conducted on different simulation chambers. For example, researchers reported that the angle, size, and geometry of a cardiac implant can result in different outcomes.

[0168] 6. After the therapy simulation is completed, various settings will be applied, including rest state and exercise state, as well as any situations the patient may face for the rest of his / her life, to provide a safety zone boundary for subsequent therapies and predict the service life of the implant.

[0169] 7. After simulating all possible conditions, the heart chamber model will be removed for future comparison. Obviously, in different simulation chambers after each treatment, which heart chamber has suffered greater damage may represent the longest pain and recovery period. This information is part of the simulation results.

[0170] 8. The simulated therapies and their results will be compared and discussed. Innovative improvements can be simulated in more rounds of simulation until satisfactory results with acceptable risks are obtained.

[0171] 9. The above procedure can be used for the research and development of innovative therapies such as new implants.

[0172] 5.3 Others

[0173] The foregoing is only a description given by way of example, and the scope of the present invention is not limited to the described embodiments. Those skilled in the art know that the present invention can be modified within the scope defined by the appended claims.

[0174] For example, the simulator can have only a single simulation chamber container and a single model chamber. The chamber model can have a single inlet / outlet, or none, and it is not always necessary to set up valves. In the case of providing two simulation chambers, it is not necessary to provide arm 13A for both of them.

[0175] On the one hand, the present invention relates to providing an arm to control the position movement of points on the chamber model during simulation. In the case of providing valves, it is not necessary to be able to control the position of the model papillary muscles during simulation, or even control them at all.

[0176] Similarly, other aspects of the present invention relate to controlling the position of the tissue model, in a particular embodiment, controlling the position of the papillary muscle tip, by a movable control arm (before or during simulation). Preferably, the papillary muscle control arm includes an articulated arm for movement in three dimensions with six degrees of freedom (each of the upper arm 13B and the forearm 14 can move with three degrees of freedom). The tissue model can be moved independently of the chamber container in which it is located, and even independently of the chamber (if any) in which the tissue model (such as the papillary muscle 151) is located. Thus, it should be clear that, in addition to the chamber container, providing a chamber model is not necessary for this aspect of the present invention. Therefore, the arm 13A, 13C or the control arm 111 of the present invention can be used to control the position of the papillary muscle tip, rather than using Figure 2 the papillary muscle control arm 112 in the simulation to provide a fixed position.

[0177] The present invention is not limited to simulating the left heart and can also be used to simulate the right heart. It can also be used to simulate the whole heart. In any such simulator, any one or more of the cardiac chamber models and valves can be controlled by the arm 13A, 13C or the control arm 111, whether for controlling the papillary muscle model or for controlling another tissue part.

[0178] The present invention can also simulate other organs, such as the lungs or a pair of lungs, the kidneys or a pair of kidneys and the bladder, or a combination of organs. Thus, it is obvious that it may not be necessary to include valves or any inlets or outlets in the simulator according to the present invention. A single orifice can also be used as both an inlet and an outlet at the same time.

[0179] The above has introduced in detail the simulator, artificial heart valve, methods for manufacturing an artificial heart valve and an arm, and prediction method disclosed in the embodiments of the present invention. Specific examples are used herein to illustrate the principles and implementation manners of the present invention. The description of the above embodiments is only used to help understand the simulator, artificial heart valve, methods for manufacturing an artificial heart valve and an arm, and prediction method of the present invention and its core idea; at the same time, for those of ordinary skill in the art, according to the idea of the present invention, there will be changes in the specific implementation manners and application scopes. In summary, the content of this specification should not be construed as a limitation to the present invention.

Claims

1. A simulator, characterized in that, Comprising: A flexible simulation cavity simulating a living body cavity, the flexible simulation cavity having at least one opening; A valve, comprising Valve leaflets; A papillary muscle solid model; And Chordae tendineae connecting the papillary muscle solid model and the valve leaflets; At least one valve arm extends through the flexible simulation cavity such that the distal end of the valve arm is disposed within the flexible simulation cavity and the proximal end is disposed outside the flexible simulation cavity, the distal end of the valve arm being fixed relative to the papillary muscle solid model and the position of the distal end of the valve arm being controllable from the proximal end; And A control device for controlling the simulation process.

2. The simulator according to claim 1, wherein The position of the distal end is adjustable to simulate the position at the end of systole of the living body papillary muscle.

3. The simulator according to claim 1 or claim 2, characterized in that The control device is adapted to change the position of the distal end of the valve arm during the simulation process.

4. The simulator according to any one of claims 1 to 3, characterized in that The position of the distal end of the valve arm can be controlled without affecting the movement of the flexible simulation cavity.

5. The simulator according to claim 4, wherein The valve arm comprises: A first rotary joint disposed on the inner wall of the flexible simulation cavity; A first fixing device facing the distal end for fixing to the papillary muscle solid model; and A first telescopic rod between the first rotary joint and the fixing device.

6. The simulator according to claim 5, wherein The valve arm further comprises: A second rotary joint facing and connecting the proximal end and disposed outside the flexible simulation cavity; A second fixing device located between the first rotary joint and the second rotary joint for fixing to the flexible simulation cavity; and A second telescopic rod between the second rotary joint and the second fixing device.

7. The simulator according to any one of claims 1 to 6, characterized in that, The flexible simulation cavity comprises a first simulation cavity and a second simulation cavity, wherein the first simulation cavity and the second simulation cavity are connected by an opening and the valve is located therebetween.

8. The simulator according to any one of claims 1 to 7, characterized in that, Further comprising: A chamber container, in which a chamber model is provided.

9. The simulator according to claim 8, wherein The proximal end of the valve arm is fixed to the wall of the chamber container; The control motor is disposed adjacent to the wall of the chamber container and connected to the proximal end; and The control device is used to control the control motor to change the position of the distal end of the valve arm.

10. The simulator according to claim 8 or claim 9, characterized in that, Further comprising: At least one chamber arm is disposed within the chamber container, the distal end of the chamber arm being fixed relative to a point on the flexible simulation cavity and the position of the distal end being controllable from the proximal end, The control device is adapted to change the position of the distal end of the chamber arm during the simulation process.

11. The simulator according to claim 1 or claim 10, wherein The proximal end of the chamber arm is fixed to the wall of the chamber container; The corresponding control motor is disposed near the wall of the chamber container and connected to the proximal end; and The control device is used to control the control motor to change the position of the distal end of the chamber arm.

12. The simulator according to claim 10 or 11, characterized in that, The chamber arm comprises: A chamber arm rotary joint facing the proximal end; A chamber arm fixing device facing the distal end for fixing to the flexible simulation cavity; and A chamber arm telescopic rod located between the chamber arm rotary joint and the chamber arm fixing device.

13. The simulator according to claim 12, characterized in that, The chamber arm fixing device comprises clamping plates for clamping the flexible simulation cavity disposed on both the inner and outer sides of the flexible simulation cavity.

14. The simulator according to claim 12 or claim 13, characterized in that, The chamber arm fixing device is attached to the chamber arm telescopic rod through a ball-and-socket joint.

15. The simulator according to any one of claims 5, 6 or 12 to 14, characterized in that, The position of each rotary joint is controlled by respective joint control lines, and the extension of each telescopic rod is controlled by respective extension control devices.

16. The simulator according to any one of claims 10 to 15, wherein The simulation cavity simulates the left ventricle; and The control device is arranged to control the position of the distal end of the chamber arm to rotate the left ventricle about the base-apical axis during the simulation, in synchronization with the periodic pulsatile movement of the ventricle.

17. The simulator according to any one of claims 1 to 16 above, characterized in that, For simulating at least one of the left and right hearts.

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