WO2017165969A1

WO2017165969A1 - Apparatus for simulating a cardiovascular system

Info

Publication number: WO2017165969A1
Application number: PCT/CA2017/050385
Authority: WO
Inventors: Christophe AOKI; Mabel CHAN; Dilani ABEYWICKRAMA; L'hocine BOUSMIA; Jana GHALAYINI; Kyle STOYEL; Rocky PATEL; Alexandre BELANGER; Giuseppe DI LABBIO; Lyes KADEM; Imad AL-HMOUZ; Sebouh AKHIKIAN; Nicholas BONOMO; Constantinos DANIAS; Kevin GANDHI; Tabitha JARAMILLO; Sholom SHUCHAT; Ramit Singh; Zachary ZOLDAN
Original assignee: Valorbec, S.E.C.
Priority date: 2016-03-29
Filing date: 2017-03-29
Publication date: 2017-10-05

Abstract

An apparatus for simulating a cardiovascular system comprising a fluid circulation system for simulating at least a portion of a cardiac vasculature. The fluid circulation system comprising a tubing array having at least one outlet and at least one inlet, the at least one outlet and the at least one inlet each being arranged to be removeably connectable to a heart model to form a fluid pathway through the heart model, in use. The apparatus also comprises an activation system for inducing a waveform in fluid in the fluid pathway, in use, the activation system comprising an actuator for applying pressure to an outer surface of the heart model, a support for supporting the heart model whilst the actuator is applying pressure to the heart model, and a motor for driving the actuator, the motor being controllable by a processor, the actuator being arranged to releasably compress the heart model, in use.

Description

APPARATUS FOR SIMULATING A CARDIOVASCULAR SYSTEM

TECHNICAL FIELD [0001] The present disclosure relates to an apparatus for simulating a cardiovascular system.

BACKGROUND

[0002] Cardiovascular systems in mammals typically comprise a heart for pumping blood around the body and a vasculature for supplying blood to and from the heart. Physical simulators of cardiovascular systems are desirable for studying various properties of cardiovascular systems, for testing of new medical devices, and as surgical and diagnostic training tools for medical personnel.

[0003] Medical devices for use in the cardiovascular system require rigorous safety and effectiveness testing during product development and for regulatory approval before use on humans. Generally, any preclinical testing using physical cardiovascular simulators that is performed ('in vitro' testing) is considered complementary to animal testing ('in vivo' testing), typically in pigs. Animal testing can evaluate a medical device's local and systemic pathological effects, and also provide an opportunity to test and practice delivery methods for the medical devices. However, animal models do not model exactly the anatomical structures of a human cardiovascular system, and they also do not allow the reliable reproduction and study of diseased states. There is also the ethical desire to minimise the amount of animal testing that is performed.

[0004] Therefore there is a need for cardiac simulators that can model the anatomical structures of human and animal cardiovascular systems, in healthy and diseased states.

[0005] In one type of existing cardiac simulator, fluid is made to circulate in a pulsatile manner through a heart model using pumps. A drawback of this type of heart simulator is that it is not possible to reproduce the filling phase which occurs in a real heart and which causes the mitral valve and the tricuspid valve between the atrium and the chamber to close. Therefore, this type of model cannot reproduce accurately the different flow conditions in the different areas of the heart or be used to test some valvular medical devices.

[0006] In another type of simulator, an external pneumatic arrangement generates a pumping action that induces pulsatile flow of a fluid within a left heart model. However, this arrangement does not allow for reproduction of the entire heart left and right sides of the heart as the different pressures and flow conditions existing within different parts of the heart model cannot be easily reproduced. This system also cannot test different heart models and conditions of the heart and vasculature, particularly under overloaded conditions.

[0007] Therefore, there is a need for a cardiovascular simulator which addresses the abovementioned limitations.

SUMMARY

[0008] It is an object of the present to ameliorate at least some of the limitations present in the prior art.

[0009] There is provided an apparatus which can be a used as a teaching aid for medical personnel such as medical students, doctors and surgeons. It can be used to test new medical devices and new surgical methods, as well as testing existing devices in diseased anatomies. It can also be used to support a heart transplant before implantation or to condition biomedical devices with biological material.

[0010] According to one aspect, there is provided an apparatus for simulating a cardiovascular system, the apparatus comprising a fluid circulation system for simulating at least a portion of a cardiac vasculature, the fluid circulation system comprising a tubing array having at least one outlet and at least one inlet, the at least one outlet and the at least one inlet each being arranged to be removeably connectable to a heart model to form a fluid pathway through the heart model, in use; an activation system for inducing a waveform in fluid in the fluid pathway, in use, the activation system comprising an actuator for applying pressure to an outer surface of the heart model, a support for supporting the heart model whilst the actuator is applying pressure to the heart model, and a motor for driving the actuator, the motor being controllable by a processor, the actuator being arranged to releasably compress the heart model, in use. [0011] In certain embodiments, the actuator comprises an actuator body having an actuator contact face. A profile of the actuator contact face may substantially conform to a profile of at least a portion of the outer surface of the heart model.

[0012] In certain embodiments, the support comprises a support body having a support contact face for contacting at least a portion of the outer surface of the heart model. A profile of the support contact face may substantially conform to a profile of at least a portion of the outer surface of the heart model. The actuator contact face and the support contact face may be arranged to contact different portions of the outer surface of the heart model. A distance and/or an angle between the actuator and the support may be adjustable to accommodate different sizes and/or shapes of heart models.

[0013] In certain embodiments, the actuator contact face and/or the support contact face is removeably connectable to the outer surface of the heart model. This can allow a tensile force to be applied to the actuator contact face and/or the support contact face.

[0014] In certain embodiments, the support comprises a support body which is integrally formed in the heart model .

[0015] In certain embodiments, the fluid circulation system further comprises a fluid reservoir in fluid communication with the tubing array. The fluid circulation system may further comprise fluid, the fluid being an incompressible fluid. The fluid may be a blood simulating fluid selected from water, glycerine solution, a solution of glycerine and xantham gum, and blood. In certain embodiments, the apparatus further comprises the processor, the processor including computer readable instructions for controlling a rate and/or an extent of the pressure applied by the actuator. The apparatus may further comprise at least one sensor for measuring a parameter associated with the fluid in the fluid pathway, the at least one sensor being in communication with the processor and the processor being arranged to adapt the rate and/or extent of the pressure applied by the actuator in response to the measured parameter.

[0016] In certain embodiments, the tubing array further comprises at least one valve positioned on at least one tube of the tubing array, the valve being positioned downstream of the at least one outlet, the valve being arranged to restrict a diameter of the at least one tube. The at least one valve may be moveable along the at least one tube to adjust a distance between the at least one valve and the at least one outlet. The apparatus may further comprise a self adjustment mechanism comprising a driver for moving the at least one valve along the at least one tube in response to a measured induced waveform not conforming to a desired output waveform, and a control mechanism for opening and closing the valve.

[0017] In certain embodiments, the apparatus further comprises the heart model. The heart model may comprise a three-dimensional model, at least a portion of the heart model being made of a resilient material. The heart model may be a real heart from a human or animal.

[0018] In certain embodiments, the heart model is modular and comprises at least one module selected from: a left heart module, a right heart module, a left atrium module, a right atrium module, a left ventricle module, a right ventricle module, a full heart module, a valve module, a restriction module and a connector module. The at least one module of the heart model may be anatomically correct. The left heart module and the right heart module may be removeably connected together to simulate a full heart. The left atrium module and the left ventricle module may be removeably connected together to simulate a left side of a heart. The right atrium module and the right ventricle module may be removeably connected together to simulate a right side of a heart.

[0019] In certain embodiments, the left atrium module comprises a left atrium chamber component in fluid communication with at least one pulmonary vein component connectable to the at least one outlet of the fluid circulation system, and an aorta component connectable to the at least one inlet of the fluid circulation system.

[0020] In certain embodiments, the left ventricle module comprises a left ventricle chamber component in fluid communication with at least one pulmonary vein component connectable to the at least one outlet of the fluid circulation system, and an aorta component connectable to the at least one inlet of the fluid circulation system.

[0021] In certain embodiments, the left heart module comprises a left ventricle chamber component in fluid communication with a left atrium chamber component through a mitral valve component, at least one pulmonary vein component in fluid communication with the left atrium chamber component and connectable to the at least one outlet of the fluid circulation system and, and at least one aorta component in fluid communication with the left ventricle chamber component and connectable to the at least one inlet of the fluid circulation system.

[0022] In certain embodiments, the right atrium module comprises a right atrium chamber component in fluid communication with at least one vena cava component connectable to the at least one outlet of the fluid circulation system and, a pulmonary artery component in fluid communication with the right atrium chamber component and connectable to the at least one inlet of the fluid circulation system.

[0023] In certain embodiments, the right ventricle module comprises a right ventricle chamber component, at least one vena cava component in fluid communication with the right ventricle chamber component and connectable to the at least one outlet of the fluid circulation system and, a pulmonary artery component in fluid communication with the right ventricle chamber component and connectable to the at least one inlet of the fluid circulation system.

[0024] In certain embodiments, the right heart module comprises a right ventricle chamber component in communication with a right atrium chamber component through a tricuspid valve component, at least one vena cava component in fluid communication with the right atrium chamber component and connectable to the at least one outlet of the fluid circulation system and, and a pulmonary artery component in fluid communication with the right ventricle chamber component and connectable to the at least one inlet of the fluid circulation system. [0025] In certain embodiments, the full heart module comprises a left heart module and a right heart module, the left heart module comprising a left ventricle chamber component in fluid communication with a left atrium chamber component through a mitral valve component, at least one pulmonary vein component in fluid communication with the left atrium chamber component and connectable to the at least one outlet of the fluid circulation system, and at least one aorta component in fluid communication with the left ventricle chamber component and connectable to the at least one inlet of the fluid circulation system; and the right heart module comprising a right ventricle chamber component in communication with a right atrium chamber component through a tricuspid valve component, at least one vena cava component in fluid communication with the right atrium chamber component and connectable to the at least one outlet of the fluid circulation system, and a pulmonary artery component in fluid communication with the right ventricle chamber component and connectable to the at least one inlet of the fluid circulation system.

[0026] In certain embodiments, the apparatus further comprises a separator component positioned between the left heart module and the right heart module, the separator component being separate to, or integral with, the full heart module. The separator component may be positionable between the left atrium and the right atrium, or between the left ventricle and the right ventricle. The separator component may be configured to support the heart model relative to a base of the apparatus. The separator component may be separate to the full heart module and have a profile, on at least one side, which substantially conforms to an external profile of an adjacent portion of the full heart module. Alternatively, or in addition, the separator component may be integral with at least a portion of the full heart model.

[0027] In certain embodiments, the apparatus further comprises the connector module which is configured to removeably connect at least one module to another module, the connector module comprising a cylindrical body defining an inner channel, and having two connector ends, each connector end being configured to mate with at least one of the module inlet or the module outlet of the modules. The connector module may further comprising a valve portion having a valve seat for housing a valve, the valve portion being removeably connectable to the connector module to position the valve in the inner channel. The connector may further comprise a seal component to seal a connection between the connected modules.

[0028] In certain embodiments, the apparatus further comprises one of a pulmonary valve, an aortic valve, a mitral valve and a tricuspid valve, which may be sourced from humans or animals, or man-made. The valve portion may house any one of the pulmonary valve, the aortic valve, the mitral valve and the tricuspid valve. [0029] In certain embodiments, the heart model comprises a left heart model and the actuator comprises a left ventricle actuator having a left ventricle actuator body with a left ventricle contact surface for applying pressure to an outer surface of the left ventricle chamber component, and a left atrium actuator having a left atrium actuator body with a left atrium contact surface for applying pressure on an outer surface of the left atrium chamber component. The motor can be arranged to drive the left ventricle actuator, the left atrium actuator or left ventricle actuator and the left atrium actuator. In certain embodiments, the motor comprises a ventricle motor for driving the left ventricle actuator, and an atrium motor for driving the left atrium actuator, the ventricle motor and the atrium motor being controllable by the processor. The support may comprise a left ventricle support having a left ventricle support surface for supporting the left ventricle chamber component whilst the left ventricle actuator is applying pressure on the left ventricle chamber component. A profile of at least one of the left ventricle support surface, the left ventricle contact surface, or the left atrium contact surface may be concave. The left ventricle support may be fixed on a base of the apparatus and be angled with respect to the base to anatomically position the left ventricle chamber component.

[0030] In certain embodiments, the heart model comprises a full heart model and the actuator comprises: a left ventricle actuator having a left ventricle actuator body with a left ventricle contact surface for applying pressure to an outer surface of the left ventricle chamber component, a left atrium actuator having a left atrium actuator body with a left atrium contact surface for applying pressure on an outer surface of the left atrium chamber component, a right ventricle actuator having a right ventricle actuator body with a right ventricle contact surface for applying pressure on an outer surface of the right ventricle chamber component, and a right atrium actuator having a right atrium actuator body with a right atrium contact surface for applying pressure to an outer surface of the right atrium chamber component. The motor may be arranged to drive at least one of the left ventricle actuator, the left atrium actuator, the right ventricle actuator and the right atrium actuator. The motor may comprise a ventricle motor for driving at least one of the left ventricle actuator and the right ventricle actuator, and an atrium motor for driving at least one of the left atrium actuator and the right atrium actuator, the ventricle motor and the atrium motor being controllable by the processor. In certain embodiments the ventricle motor is driven independently of the atrium motor. In this way, different pressures and waveforms can be applied to the ventricles and atria. In certain embodiments, physiologic waveforms can be induced in the ventricles and/or the atria. The apparatus may further comprise a stand for supporting the heart model at an angle, relative to a base of the apparatus, which simulates an anatomical angle of a heart relative to a spine. [0031] In certain embodiments, the apparatus further comprises the restriction module which is configured to be actuable between a normal state and an actuated state to narrow an internal diameter of a resilient tube of the tubing array, the restriction module comprising a sleeve having a body comprising an outer wall and an inner wall, the outer wall and the inner wall defining a fluidly sealable chamber therebetween, the inner wall defining a sleeve channel with two open ends for receiving a portion of the resilient tube, wherein at least a portion of the inner wall comprises a resilient material such that increasing a pressure in the chamber causes the inner wall to expand and to narrow the sleeve channel. The inner wall can include struts extending axially along the inner wall. The sleeve may have an inlet and an inlet valve for allowing fluid flow into the chamber and for maintaining the fluid in the chamber. The restriction module may be useful for testing of new medical devices such as stents. For example, when activated, the restriction module will narrow a portion of the resilient tube representing a vein or an artery that is received within the sleeve channel. Due to the resilient nature of both the tube and the inner wall, a stent can be positioned in the narrowing and expanded whilst maintaining the restriction module in the inflated state.

[0032] In certain embodiments, the apparatus further comprises the valve module which is configured to house a valve having at least one valve leaflet, the valve module being connectable to the fluid circulation system to allow fluid to flow through the valve housed in the valve module, in use, and a valve adjustment mechanism connectable to the at least one valve leaflet and configured to limit an extent that the at least one valve can open or close when housed in the housing. The valve module may comprise a valve seat portion for removeably housing the valve and a valve retaining portion connectable to the valve seat portion to retain the valve in the valve seat portion. The valve module may comprise at least one port extending from an outside of the valve module to an inner channel, and the valve adjustment mechanism comprises a guide receivable through the port and having a free end which is attachable to the at least one valve leaflet, and a driver for controllably moving the guide. In certain embodiments, the valve module comprises three ports and three valve adjustment mechanisms for adjusting three valve leaflets housed in the valve module. The valve module may include the valve which is selected from: a pulmonary valve, an aortic valve, a mitral valve and a tricuspid valve. In another embodiment, the valve module includes two ports and two adjustment mechanisms for adjusting a valve having two valve leaflets housed in the valve module. [0033] From another aspect, there is provided a modular cardiovascular simulation system, the system comprising a fluid circulation system for simulating at least a portion of a cardiac vasculature, the fluid circulation system comprising a tubing array having at least one outlet and at least one inlet, the at least one outlet and the at least one inlet each being arranged to be removeably connectable to a heart model to form a fluid pathway through the heart model, in use; an activation system for inducing a waveform in fluid in the fluid pathway, in use; wherein the heart model comprises at least one module selected from: a left ventricle module, left atrium module, right atrium module, a right ventricle module, a left heart module, a right heart module, a full heart module, a connector module, a restriction module, to simulate restriction of an artery or a vein, and a valve module to simulate a pathology of a valve. In certain embodiments, any one or more of the left ventricle module, the left atrium module, the right atrium module, the right ventricle module, the left heart module, the right heart module, the full heart module, the connector module, the restriction module, are as described above. The activation system may comprise an actuator and optionally a support as described above. [0034] From a yet further aspect, there is provided an apparatus for simulating a cardiovascular simulation system, the apparatus comprising: a left fluid circulation system for simulating at least a portion of a cardiac vasculature related to a left side of a heart, the left fluid circulation system having a left fluid circulation system inlet fluidly connectable to an outlet of a left heart model, and a left fluid circulation system outlet fluidly connectable to an inlet of a left heart model; a right fluid circulation system for simulating at least a portion of a cardiac vasculature related to a right side of a heart, the right fluid circulation system having a right fluid circulation system inlet fluidly connectable to an outlet of a right heart model, and a left fluid circulation system outlet fluidly connectable to an inlet of a right heart model; an activation system for inducing a waveform in fluid in a fluid pathway in the left and right heart models when connected to the left and right fluid circulation systems, respectively, in use, the activation system comprising at least one actuator for applying pressure to an outer surface of the left and right heart models to releasably compress the left and right heart models, and a motor for driving the actuator, the motor being controllable by a processor. In certain embodiments, at least two actuators are provided and are independently controllable by the motor. In certain embodiments, the left fluid circulation system and the right fluid circulation system are each closed fluid circuits, independent of one another. The left and right heart models may comprise one or more of a left ventricle module, a left atrium module, a right ventricle module, a right atrium module, a restriction module, a connector module, and a valve module.

[0035] From another aspect, there is provided a restriction module for use in a cardiovascular simulation apparatus to simulate a narrowing of a vein or an artery simulated by a resilient tube, the restriction module comprising a sleeve having a body comprising an outer wall and an inner wall, the outer wall and the inner wall defining a fluidly sealable chamber therebetween, the inner wall defining a sleeve channel with two open ends for receiving a portion of the resilient tube, wherein at least a portion of the inner wall comprises a resilient material such that increasing a pressure in the chamber causes the inner wall to expand and to narrow the sleeve channel. The inner wall may include struts extending axially along the inner wall. In certain embodiments, the sleeve has an inlet and an inlet valve for allowing fluid flow into the chamber and for maintaining the fluid in the chamber. The restriction module may further comprise a driver for controllably driving fluid into the chamber to simulate different extents of vein or artery narrowing. [0036] From a further aspect, there is provided use of certain embodiments of the restriction module with any of the aspects and embodiments of the above described apparatus and system.

[0037] From a yet further aspect, there is provided a valve module for use in a cardiovascular simulation apparatus for simulating valve leaflet pathologies, the valve module comprising a valve housing portion for housing a valve having at least one valve leaflet, the valve module being connectable to a fluid circulation system to allow fluid to flow through the valve housed in the valve module, in use, and a valve adjustment mechanism connectable to the at least one valve leaflet and configured to limit an extent that the at least one valve can open or close when housed in the housing. The valve housing portion may comprise a valve seat portion for removeably housing the valve and a valve retaining portion connectable to the valve seat portion to retain the valve in the valve seat portion. At least one port may be provided, extending from an outside of the valve housing to an inner channel, for accessing the at least one valve leaflet. The valve adjustment mechanism may comprise a guide receivable through the at least one port and having a free end which is attachable to the at least one valve leaflet, and a driver for controllably moving the guide. In certain embodiments, the valve module comprises three ports and three valve adjustment mechanisms for adjusting three valve leaflets housed in the valve module. The valve module may further comprise the valve which is selected from: a pulmonary valve, an aortic valve, a mitral valve and a tricuspid valve. The valve module may be used to simulate various valvular conditions such as stenosis and regurgitation by restriction of the full opening or full closing of the valve leaflets.

[0038] From a further aspect, there is provided use of certain embodiments of the valve module with any of the aspects and embodiments of the above described apparatus and system. In this way, the apparatus with the valve module can allow the evaluation of the performance of new medical devices or surgical techniques on patients having such conditions.

[0039] From a yet further aspect, there is provided a mechanism for adjusting an output waveform in a cardiac simulation apparatus, such as any of those described above. The mechanism comprises a valve for restricting flow through a tubing portion of a cardiac simulation apparatus, the valve being positioned down stream of an output of a heart model of the cardiac simulation apparatus. The mechanism also comprises a driver for moving the valve along the tubing portion in response to a measured induced waveform not conforming to a desired output waveform. The driver, or another driver, can also open and close the valve. In certain embodiments, the valve is moveably mounted on the tubing portion and moveable along a longitudinal axis of the tubing portion by the driver. The driver may comprise a lead screw (thread and nut configuration), a belt drive, a ball screw and/or a linear motor. The motor may be the same motor 36 as the activation system 16, or a different motor. The mechanism may also comprise a sensor for measuring a waveform in the tubing portion and sending it to a processor. The processor can be arranged to compare the measured waveform with a desired waveform. The processor can be arranged to send instructions to the driver until the sensor detects a desired waveform. The sensor can be arranged to send the measured waveform at pre-set intervals, or continuously, to the processor.

[0040] In certain embodiments, the apparatus is capable of reproducing physiological heart function such as heart rate, pressure and flow waveforms under normal and pathological conditions. This can be a useful tool for medical device testing, and medical personnel training. In certain embodiments, the modularity of the apparatus and system provides ease of testing a broad range of heart model geometries and conditions. This may be important in testing of new medical devices and in surgical and diagnostic techniques. Embodiments of the apparatus can enable testing across the normal^' range which can provide a better idea of the performance of a new medical device in the entire range of the population.

[0041] In certain embodiments, a simulation of the whole heart system may be achieved and allow practice of surgical interventions requiring access from one side of the heart to the other. For example, procedures in the left side which require access from the vena cava of the right side of the heart, or procedures to treat defects between the left and right sides such as a hole between the left and right atria (tetralogy of fallot). Surgical technique is an important factor in the success of such medical devices.

[0042] In certain embodiments, the external activation system not only can allow separate control of the different heart modules but also provide ease of interchangeability of the heart modules. In certain embodiments, the apparatus and modules are suitable for MRI and ultrasound imaging which can provide a useful training tool particularly for diagnostic training.

Definitions:

[0043] It must be noted that, as used in this specification and the appended claims, the singular form "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. [0044] As used herein, the term "about" in the context of a given value or range refers to a value or range that is within 20%, preferably within 10%, and more preferably within 5% of the given value or range.

[0045] As used herein, the term "and/or" is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example "A and/or B" is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein. [0046] As used herein, the term "cardiac vasculature" means at least a portion of one or both of the arterial and venous systems connecting to a heart.

[0047] As used herein, the term "heart model" means a physical model of a portion, or a whole, of a heart. The heart may be human or animal. The heart model may also include part of a vasculature connecting to the heart.

[0048] Additional and/or alternative features, aspects, and advantages of implementations of the present technology will become apparent from the following description, the accompanying drawings, and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0049] For a better understanding of the present technology, as well as other aspects and further features thereof, reference is made to the following description which is to be used in conjunction with the accompanying drawings, where:

[0050] Figure 1A is a schematic illustration of an apparatus for simulating a cardiovascular system, according to one embodiment of the present disclosure, and including a heart model, and Figures B-E are schematic illustrations of different embodiments of the heart model of Figure 1A, simulating a left atrium (Figure IB), a left ventricle (Figure 1C), a right ventricle (Figure ID) and a right atrium (Figure IE), respectively;

[0051] Figure 2 is a schematic illustration of the apparatus of Figure 1, according to another embodiment of the present disclosure;

[0052] Figure 3 is a left heart model according to an embodiment of the present disclosure;

[0053] Figure 4 is a connector module according to an embodiment of the present disclosure;

[0054] Figure 5 is the connector module of Figure 4 when partially connected to a right atrium chamber component and a right ventricle chamber component, according to an embodiment of the present disclosure; [0055] Figure 6A is a ventricle actuator, having a ventricle body and a ventricle contact face, according to an embodiment of the present disclosure, and Figure 6B is a close-up of the ventricle contact face of Figure 6 A;

[0056] Figure 7 is a ventricle support, according to an embodiment of the present disclosure;

[0057] Figure 8 is a ventricle actuator, having a ventricle body and a ventricle contact face, according to another embodiment of the present disclosure;

[0058] Figure 9 is an atrium actuator, according to an embodiment of the present disclosure; [0059] Figure 10 is a perspective view of the apparatus of Figure 2 when assembled with the ventricle actuator of Figure 6, and the ventricle support of Figure 7;

[0060] Figure 11A is a schematic illustration of another embodiment of the apparatus of

Figure 1, and Figure 1 IB is a flow diagram of an embodiment of the apparatus of Figure 11 A;

[0061] Figure 12 is a perspective view of a separator component of the apparatus of Figure 11, according to another embodiment of the present disclosure;

[0062] Figure 13 is a perspective view from the top of a restriction module, according to an embodiment of the present disclosure, in (A) a normal state, and (B) an inflated state, and Figure 13C is a top plan view of the restriction module of Figures 13A, B with an annular end sleeve removed and in a normal state; [0063] Figure 14 is an exploded view of the restriction module of Figure 13;

[0064] Figure 15 is a top plan view of a valve module including three valve adjustment mechanisms and a valve; according to an embodiment of the present disclosure;

[0065] Figure 16 is an exploded view of the valve module of Figure 15, with two of the valve adjustment mechanisms removed for clarity; [0066] Figure 17 is a top plan view of the valve of the Figure 15 with a portion one of the valve adjustment mechanisms;

[0067] Figure 18 is an exploded view of valve module of Figure 15, with the three valve adjustment mechanisms removed for clarity, and including an aorta component and a left ventricle chamber component;

[0068] Figure 19 is (A) an exploded view, and (B) an assembled view, of the valve module of Figure 15 with the three valve adjustment mechanisms removed for clarity;

[0069] Figure 20 is an exploded view of a valve module, according to another embodiment of the present disclosure;

[0070] Figure 21 is an example pressure waveform graph induced by the apparatus of

Figure 2, according to an embodiment of the present disclosure;

[0071] Figure 22 is an example pressure waveform graph induced in a right ventricle chamber component and pulmonary component by the apparatus of Figure 11 at 50 bpm, according to an embodiment of the present disclosure;

[0072] Figure 23 is an example pressure waveform graph induced by the apparatus of

Figure 11 in a left ventricle chamber component and an aorta component, according to an embodiment of the present disclosure;

[0073] Figure 24 is an example pressure waveform graph induced by the apparatus of

Figure 11 when assembled with the valve module of Figure 15 simulating stenosis, according to an embodiment of the present disclosure; and

[0074] Figure 25 is an example pressure waveform graph induced by the apparatus of

Figure 11 when assembled with the valve module of Figure 15 simulating regurgitation, according to an embodiment of the present disclosure.

DETAILED DESCRIPTION [0075] The present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including", "comprising", or "having", "containing", "involving" and variations thereof herein, is meant to encompass the items listed thereafter as well as, optionally, additional items. In the following description, the same numerical references refer to similar elements.

[0076] Broadly, as best seen in Figure 1A, there is provided an apparatus 10 for simulating a cardiovascular system, the apparatus 10 comprising a fluid circulation system 12 for simulating at least a portion of a cardiac vasculature, the fluid circulation system 12 being removeably connectable to a heart model 14 to form a fluid pathway through the heart model 14, in use, and an activation system 16 for inducing a waveform in fluid in the fluid pathway, in use. The waveform can be defined in terms of pressure or flow properties. The activation system 16 acts as a driver for pulsatile flow through the fluid circulation system 12.

[0077] The apparatus 10 is modular in that it can be connected to different modules of the heart model 14 simulating portions of a heart, in healthy or diseased states. Physiological waveforms of healthy or diseased states can be induced in the different heart model modules using the apparatus 10. In this respect, the apparatus 10 can be used for testing medical devices, or as a training tool for medical practitioners for surgical and diagnostic purposes, under a broad range of conditions.

[0078] The heart model modules can comprise any component of a heart or its vasculature, and combinations thereof. In this embodiment, the heart model modules are selected from: a left heart module, a right heart module, a left atrium module, a right atrium module, a left ventricle module, a right ventricle module, a full heart module, a valve module, a connector module and a restriction module. The heart model modules can include one or more chambers, one or more arteries, one or more pulmonary veins, or one or more valves. At least some of the heart model modules can be removeably and fluidly connected together. The choice of heart module 14 to use with the apparatus 10 can be made based on the medical device being tested and its intended location, as well as the anatomical structures required to simulate certain medical procedures that require access therethrough. For example, a full heart module can be used to test a device to be implanted in the left side but which requires access through the right side of the heart. [0079] The fluid circulation system 12 comprises a tubing array 18 having an outlet 20 and an inlet 22 which are each respectively fluidly connectable to the heart model 14 to form the fluid pathway through the heart model 14. In this respect, the heart model 14 has a heart model inlet 24, for connecting to the tubing array outlet 20, and a heart model outlet 26 for connecting to the tubing array inlet 22. When the fluid circulation system 12 is connected to the heart model 14, the fluid pathway is a closed loop which extends through the fluid circulation system 12, through the outlet 20 of the tubing array 18 into the heart model 14, and out of the heart model 14 back into the inlet 22 of the tubing array 18. The arrows in Figure 1A represent a direction of fluid flow.

[0080] In its simplest form, as shown in Figure 1 A, the tubing array 18 comprises a main tube 28 having the outlet 20 and the inlet 22, defining a single fluid path through the heart model 14 and the fluid circulation system 12. In certain other embodiments (not shown), the tubing array 18 includes a plurality of tubes fluidly connected together. For example, the tubing array 18 comprises the main tube 28, the outlet 20 of the tubing array 18 comprising four separate outlets extending to four subsidiary tubes, representing four pulmonary veins, and the inlet 22 of the tubing array 18 representing at least a portion of an aorta. In another example, the inlet 22 of the tubing array 18 branches into two subsidiary tubes representing a left and a right pulmonary artery.

[0081] The fluid circulation system 12 and the tubing array 18 may differ from the configuration illustrated in Figure 1A and described above. The tubing array 18 can have any configuration of tubing including any number of subsidiary tubes connected to, and/or branching off the main tube 28 to simulate different portions of a vasculature, as needed.

[0082] At least some parts of the tubing array 18 are made of a resilient material, such as silicone, rubber or the like. The diameter and/or length of at least some portions of the tubing array 18 are anatomical. For example, a diameter of tubing representing the aorta and pulmonary artery can be based on actual measurements of human aorta and pulmonary arteries.

[0083] The activation system 16 comprises an actuator 30 for applying pressure to an outer surface 32 of the heart model 14, a support 34 for supporting the heart model 14 whilst the actuator 30 is applying pressure to the heart model 14, a motor 36 for driving the actuator 30, and a processor 38 for controlling the motor 36. The actuator 30 is arranged to move forwards and backwards, towards and away from the heart model 14, to releasably compress the heart model 14 in cycles of compression and relaxation (also referred to as "release" or "decompression"). The support 34 provides an opposing force or resistance to the applied pressure during the actuator 30 applying pressure to the heart model 14 in order to cause compression to the heart model 14. In this respect, the support 34 is fixed in position relative to the heart model 14. After applying the pressure, the actuator 30 releases the pressure to allow relaxation of the heart model 14. Cyclic application of the pressure and subsequent release causes compression and relaxation of the heart model 14. The frequency of pressure application and the applied force is controlled by the processor 38 to induce a desired waveform which can be physiologic in terms of induced pressure and/or flow rate.

[0084] The actuator 30 comprises an actuator body 40 having an actuator contact face 42 for contacting the outer surface 32 of the heart model 14, and the support 34 comprises a support body 44 having a support contact face 46 for contacting the outer surface 32 of the heart model 14. The actuator contact face 42 and the support contact face 46 are sized, shaped and positioned to contact different portions of the outer surface 32 of the heart model 14. The actuator contact face 42 and the support contact face 46 are substantially oppositely facing. However, they can be positioned relative to each other in any other way which enables the actuator to releasably compress the heart model 14 in use. [0085] In certain embodiments, the arrangement of the actuator 30 and the support 34 allows ease of testing of different sizes and shapes of heart models 14. In this respect, a distance and/or an angle between the actuator 30 and the support 34, in a rest state (i.e. when the actuator is not moving and is not applying pressure to the heart model 14), is adjustable to accommodate different sizes and/or shapes of heart models 14. The actuator 30 and the support 34 can be brought closer together for testing smaller heart models 14 and positioned further apart for larger heart models 14.

[0086] In another embodiment (not shown), the support 34 is integrally formed in the heart model 14 instead of being a separate component. In this case, the support body 44 of the support 34 stiffens a portion of the heart model 14 into which it is integrated in order to provide an opposing force to the applied pressure to cause compression of the heart model 14 when pressure is applied to the heart model 14 by the actuator 30.

[0087] In a different embodiment (not shown), the support 34 is separate to the heart model 14 but is not stationary. It is connected to the motor 36, or another motor, and made to actuate to apply pressure to the outer surface 32 of the heart model 14.

[0088] In another embodiment (not shown), the actuator 30 is arranged to provide a tensile pressure to the heart model 14. In this respect, the actuator contact face 42 is removeably connectable to the outer surface 32 of the heart model 14. The support 34 can also be arranged to provide a tensile pressure to the heart model 14. In this case, the support contact face 46 is removeably connectable to the outer surface 32 of the heart model 14.

[0089] The heart model 14 for use with the apparatus 10 comprises at least a portion of a human or an animal heart. The heart model 14 may be a real heart or a three-dimensional model of a heart. In the three-dimensional model embodiment of the heart model 14, the heart model 14 is made at least partially of a resilient material such as silicone, rubber, any other polymeric material, or the like. In certain embodiments, the heart model 14 is anatomically sized and shaped. In these embodiments, images such as CT images, ultrasound images or the like are converted to the heart model 14 through 3D printing, moulding or any other suitable technique. The heart model 14 can be an anatomical representation of at least a portion of a healthy or a diseased heart, in a human adult or a child, or an animal, to enable medical device testing or training on healthy or diseased hearts.

[0090] The heart model 14 illustrated in Figure 1A comprises a single chamber component selected from any one or more of a left ventricle module 48 (Figure 1C) simulating a left ventricle, a left atrium module 50 (Figure IB) simulating a left atrium, a right ventricle module 52 (shown in Figure ID) simulating a right ventricle, and a right atrium module 54 (Figure IE) simulating a right atrium. In certain embodiments, the single chamber component also includes an associated vasculature.

[0091] As seen in Figure IB, the left atrium module 50 comprises a left atrium chamber component 56 in fluid communication with a pulmonary vein component 58 (which represents at a least a portion of the pulmonary vein and corresponds to the heart model inlet 24), the pulmonary vein component 58 being connectable to the tubing array outlet 20 of the fluid circulation system 12, and an aorta component 60 (which represents at least a portion of the aorta and corresponds to the heart model outlet 26) connectable to the tubing array inlet 22 of the fluid circulation system 12. In certain embodiments, the left atrium module 50 has two heart model inlets 24 simulating two pulmonary veins.

[0092] As seen in Figure 1C, the left ventricle module 48 comprises a left ventricle chamber component 62 in fluid communication with the pulmonary vein component 58 (corresponding to the heart model inlet 24) connectable to the tubing array outlet 20 of the fluid circulation system 12, and the aorta component 60 (corresponding to the heart model outlet 26) connectable to the tubing array inlet 22 of the fluid circulation system 12.

[0093] As seen in Figure IE, the right atrium module 54 comprises a right atrium chamber component 64 in fluid communication with a vena cava component 66 (representing at least a portion of a vena cava and corresponding to the heart model inlet 24) connectable to the tubing array outlet 20 of the fluid circulation system 12, and a pulmonary artery component 68 (representing at least a portion of a pulmonary artery and corresponding to the heart model outlet 26) in fluid communication with the right atrium chamber component 64 and connectable to the tubing array inlet 22 of the fluid circulation system.

[0094] As seen in Figure ID, the right ventricle module 52 comprises a right ventricle chamber component 70, the vena cava component 66 (corresponding to the heart model inlet 24) in fluid communication with the right ventricle chamber component 70 and connectable to the tubing array outlet 20 of the fluid circulation system 12, a pulmonary artery component 68 (corresponding to the heart model outlet 26) in fluid communication with the right ventricle chamber component 70 and connectable to the tubing array inlet 22 of the fluid circulation system 12.

[0095] In each example, the inlet 24 of the heart model 14 is arranged to fluidly connect with the outlet 20 of the tubing array 18, and the outlet 26 of the heart model 14 is arranged to fluidly connect with the inlet 22 of the tubing array 18. In certain embodiments, the fluid connections are removeable allowing the heart model 14 to be replaced, and fluidly sealable when connected.

[0096] The processor 38 can be any type of processor 38 in any device such as a laptop, a tablet, a mobile phone, a personal computer. The processor 38 has a memory for storing computer readable instructions regarding input parameters of the applied pressure by the actuator 30, which it provides to the motor 36, for inducing a physiologically relevant waveform in the fluid in the heart model 14. The input parameters of the applied pressure include a frequency and/or an extent or amplitude of the pressure to be applied. The memory can also store a desired waveform output. [0097] In this respect, in certain embodiments, the apparatus 10 includes at least one sensor (not shown) for detecting the induced waveform in the fluid. The induced waveform can be measured in the fluid in any part of the apparatus 10 such as in the heart model 14 or in the tubing array 18. In certain embodiments, there is a feed-back loop and an adjustment mechanism. The processor 38 is able to receive signals from the sensor, compare them with the desired output and adjust the input parameters applied by the activator 30 such as the frequency of pressure applied and the amount of pressure applied to the activator. A display 72 connected to the processor can display data from the sensor, as well as the input parameters and desired output waveform. When used as a diagnostic training tool, for example, the apparatus 10 can simulate various conditions and output the waveform signals. [0098] The fluid circulation system 12 further comprises fluid, such as an incompressible fluid e.g. water, glycerine solution, a solution of glycerine and xantham gum, blood or any other fluid which simulates a flow property of blood. [0099] A valve 74 (also known as a "resistance valve") is provided on the main tube 28, or any other tube, of the tubing array 18 to restrict a diameter of the main tube 28 and to provide a resistance to adjust pressure in the fluid flowing in the fluid circulation system 12. The valve 74 is positioned downstream of the tubing array outlet 20. The position of the valve 74 is selected according to the output waveform required. In this respect, a feedback loop is used using the sensor and the valve 74 is moved along the main tube 28 to adjust a distance between the valve 74 and the tubing array outlet 20 to adjust the output waveform. When using different heart models 14, the position of the valve 74 may need to be adjusted to achieve a desired waveform for the particular heart model 14 being used. [00100] In one embodiment (not shown), there is provided a self adjustment mechanism comprising a driver for moving the valve 74 along the main tube 28 in response to a measured induced waveform not conforming to a desired output waveform, and a control mechanism for opening and closing the valve. The driver can be any suitable mechanism for moving the valve relative to the main tube. The valve 74 is moveably mounted on the main tube 28 and moveable along a longitudinal axis of the main tube by the driver. Alternatively, the valve 74 is moveably mounted to a shaft having a longitudinal axis parallel to the main tube 28. The driver may comprise a lead screw (thread and nut configuration), a belt drive, a ball screw and/or a linear motor. The motor may be the same motor 36 as the activation system 16, or a different motor.

[00101] Referring now to Figure 2, in which a different embodiment of the apparatus 10 of Figure 1 is shown. The apparatus 10 of Figure 2 differs from that of Figure 1, in that two actuators 30 are provided for independently compressing two fluidly connected chambers of the heart model 14.

[00102] In this embodiment, the heart model 14 is a left heart module 76 comprising the left ventricle module 48 fluidly connected to the left atrium module 50. Specifically, the left heart module 76 comprises the left ventricle chamber component 62 in fluid communication with the left atrium chamber component 56 through a mitral valve component 78, the pulmonary vein component 58 (representing the heart model inlet 24) in fluid communication with the left atrium chamber component 56 and connectable to the tubing array outlet 20 of the fluid circulation system 12, and the aorta component 60 in fluid communication with the left ventricle chamber component 62 and connectable to the tubing array inlet 22 of the fluid circulation system 12, via an aortic valve component 80. An outlet of the aortic valve component 80 represents the heart model outlet 26. The heart model inlet 24 of the left heart module 76 represents at least a part of the pulmonary vein, and the heart model outlet 26 represents at least a part of the aorta. Optionally, a plurality of heart model inlets 24, representing a plurality of pulmonary veins, can also be provided. A pulmonary valve component can also be provided.

[00103] A reservoir 82 is provided in fluid communication with the tubing array 18.

Although not illustrated, a reservoir 82 can also be provided in the apparatus 10 of Figure 1. A pressure in the fluid circulation system 12 can be adjusted by adjusting a height of the reservoir 82 relative to the heart model 14.

[00104] The left heart module 76 is itself modular with the left ventricle module 48, the mitral valve component 78, the left atrium module 50, and the aortic valve component 80 being removeably connectable to one another, in any suitable way.

[00105] As seen in Figure 3, in one embodiment, a male-female connection is provided between an outlet 84 of the left atrium module 50 and an inlet 86 of the left ventricle module 48. In this embodiment, the outlet 84 is male and the inlet 86 is female. However, alternative configurations are possible in that the outlet 84 may be female and the inlet 86 be male, or both the inlet 86 and the outlet 84 are male, or both the inlet 86 and the outlet 84 are female. A seal (not shown) is provided over the connection. The seal can be internal or external to the connection and can be of any suitable form, such as rubber rings, o-rings, silicone, tape, adhesive, or the like. An outlet 88 of the left ventricle module 48 and the tubing array inlet 22 are connected in the same male-female manner as the left ventricle module inlet 86 and the left atrium module outlet 84, although a different connection manner could be used within the same heart module 14. [00106] In the embodiment of Figure 3, the mitral valve component 78 comprises a mechanical bi-leaflet valve representing the mitral valve. The left atrium module outlet 86 is configured to seat the valve 78, and to position it in the fluid path. The left atrium module outlet 84 is provided with an outer rim 92 and an inner groove 94. The mitral valve component 78 is positionable on the inner groove 94. Similarly, the left ventricle module outlet 88 is configured to seat the aortic valve component 80, which is a mechanical bi-leaflet valve, and to position it in the fluid path. The left ventricle module outlet 88 is provided with an outer rim 96 and an inner groove 98. The aortic valve component 80 is positionable on the inner groove 98.

[00107] Instead of the mechanical bi-leaflet valves of Figure 3, any other suitable valves can be used in the heart model 14 to simulate the valves of the heart. The valves can be artificial or biological, such as from a human, animal (e.g. pig, cow, horse), or made from a biological biomaterials.

[00108] Figures 4 and 5 illustrate another embodiment of connecting different heart modules to each other, and of connecting the heart modules to the tubing array 18. In the embodiment of Figures 4 and 5, a connector module 100 is provided which is configured to connect two modules together or to connect a heart module with the tubing array 18. In the embodiment of Figure 4, the connector module 100 is also arranged to connect a valve to the heart module or to the tubing array 18. In this respect, the connector module 100 comprises a connector portion 102 and a valve portion 104, the connector and valve portions 102, 104 being interconnectable. In the embodiment of Figures 2 and 4, the mitral valve component 78 comprises the valve portion 104 and a mitral valve (which can be a mechanical valve or a real valve). Similarly, the aortic valve component 80 comprises the valve portion 104 and a aortic valve (which can be a mechanical valve or a real valve). The connector module 100, and optionally the valve portion 104, can be used in any of the embodiments of the apparatus 10. [00109] The connector portion 102 has cylindrical body 106 with two connector ends 108.

The cylindrical body 106 defines an inner channel 110. There is a rim 112 between the two connector ends 108 which extends circumferentially around the cylindrical body 106. Each connector end 108 is configured to mate with the heart module inlet 24, heart model outlet 26, the tubing array inlet 22 or the tubing array outlet 20 to connect any of these together. In this embodiment, each of the connector ends 108 functions as a male connector. An end of the heart module/tubing array inlet/outlet abuts against the rim 112 when connected. In other embodiments, the connector ends 108 can function as a female or a male connector for being received or receiving the heart module inlet 24, heart model outlet 26, the tubing array inlet 22 or the tubing array outlet 20. [00110] The valve portion 104 is configured to mount a valve and position it in the fluid path. The valve portion 104 is also configured to connect with one of the connector ends 108 when the valve is mounted therein. The valve portion 104 comprises a cylindrical body 114 having a mandrel portion 116 and a rim portion 118, the mandrel portion 116 having a smaller diameter than the rim portion 118. The mandrel portion 116 is sized and shaped to seat a valve, such as a mechanical valve as shown in Figure 3 or a biological valve, representing one of the aortic valve, the mitral valve, the tricuspid valve or the pulmonary valve. The valve portion 104 connects with the connector portion 102 by interconnection of the mandrel portion 116 with one of the connector ends 108 of the connector portion 102. [00111] In use, when a valve is mounted on the mandrel portion 116 of the valve portion

104, and the valve portion 104 is connected with the connector portion 102, the valve is positioned within the inner channel 110 of the cylindrical body 106. When the connector module 100 is fluidly connected with the fluid circulation system 12 the fluid pathway flows through the inner channel 110 and through the valve mounted therein. [00112] As seen in the embodiment of Figure 5, one connector end 108 is received in a right atrium module outlet 119, and the other connector end 108 with the valve portion 104 connected thereto, is received in a right ventricle module inlet 121. Fasteners 120, in this case hose clamps, are secured around the overlapping portions of the right atrium module outlet 119 and the connector end 108, and the right ventricle module inlet 121 and the connector end 108. The right atrium module outlet 119 and the right ventricle module inlet 121 are lipped to avoid slippage of the fastener 120. Instead of hose clamps, any other type of fastener can be used such as clips, tape, pegs, or the like. The configuration of Figure 5 can be applied to any module connection.

[00113] Any other mutually engageable configuration of the connector module 100 is possible which allows the heart model 14 to be removeably connectable from the apparatus 10, and which provides a fluid seal when they are connected.

[00114] Referring back to Figure 2, it can be seen that the actuator 30 comprises a left ventricle actuator 122 having a left ventricle actuator body 124 with a left ventricle contact face 126 for applying pressure to an outer surface 128 of the left ventricle module 48, and a left atrium actuator 130 having a left atrium actuator body 132 with a left atrium contact face 134 for applying pressure to an outer surface 136 of the left atrium module 50. The support 34 comprises a left ventricle support 138 having a left ventricle support body 139 and a left ventricle support face 140 for supporting the left ventricle module 48 whilst the left ventricle actuator 122 is applying pressure to the left ventricle module 48. The left ventricle support 138 has a ventricle stand 139 (Figures 6a, and 8) for positioning the left ventricle support face 140. In certain embodiments, a left atrium support (not shown) may also be provided. Generally, the left ventricle actuator 122 is arranged to apply a larger pressure than the left atrium actuator 130.

[00115] The motor 36 comprises a ventricle motor 142 for driving the left ventricle actuator 122, and an atrium motor 144 for driving the left atrium actuator 130, the ventricle motor 142 and the atrium motor 144 being controllable by the processor 38. The ventricle motor 142 and the atrium motor 144 are arranged to actuate the left atrium actuator 130 and the left ventricle actuator 122 independently. This can be useful for applying a non-synchronized pressure to each of the left atrium chamber component 56 and the left ventricle chamber component 62. However, in other embodiments (not shown), a single motor may be provided for driving both the left atrium actuator 130 and the left ventricle actuator 122, and including a converter for de-synchronizing the actuation of one of the left ventricle actuator 122 or the left atrium actuator 130.

[00116] In this embodiment, the ventricle motor is a linear motor which drives a hydraulic assembly connected to the ventricle actuator, and the atrium motor is a servo-motor. However, both the ventricle motor and the atrium motors are linear motors in certain embodiments which can go into an MRI. The apparatus of Figure 2 can also be provided with the display 72 to display induced waveforms in the left atrium module 50 and the left ventricle module 48.

[00117] As best seen in Figures 6-10, the left atrium contact face 134, the left ventricle contact face 126, and the left ventricle support face 140 each have a concave profile, like a cup, to provide a certain amount of conformity to the profile of the outer surface of the left atrium chamber component 56 and the left ventricle chamber component 62 that they are in contact with. A close matching of the profiles of the actuator and/or the support to the heart model outer surface with which they will be in contact can help to more equally distribute the applied pressure.

[00118] The stand 146 of the left ventricle actuator 122 (Figure 6a) enabling the positioning of the left ventricle contact face 126 at an appropriate angle relative to the heart model 14. The stand 146 has a stand base 148, which can be fixed to a base 150 of the apparatus 10 (Figure 10), and a stand body 152 extending from the stand base 148 at a desired angle. The left ventricle actuator 122 extends from the stand body 152. The angle of the left ventricle contact face 126 can be adjusted relative to the base 150 of the apparatus 10 in order to compress a heart model 14 which is mounted at an anatomically realistic angle with respect to the spine (along the base 150). Typically, a plane of the left ventricle contact face 126 is angled at about 23-30° relative to the base 150.

[00119] Another embodiment of the left ventricle actuator 122 is shown in Figure 8 in which a height of the stand body 152 can be adjusted relative to the stand base 148, but not the angle. Any suitable configuration of a stand base 148 and stand body 152 for positioning the left ventricle contact face 126 relative to the heart model 14 can be used.

[00120] Figure 9 illustrates one embodiment of the left atrium actuator 130 comprising a stand 154 which is connectable to the base 150 of the apparatus 10.

[00121] Figure 10 shows the left ventricle actuator 122, the left atrium actuator 130 and the left ventricle support 138 connected to the left heart module 76 of Figure 2, including the apparatus base 150, the reservoir 82, the display 72 and a rib cage structure.

[00122] In certain embodiments, the left atrium contact face 134, the left ventricle support face 140, and/or the left ventricle contact face 126 are removeably attachable to the motor 36, the ventricle motor 142, and/or the atrium motor 144, in order to provide different sizes and shapes of contact faces for different geometries of heart models 14.

[00123] Referring now to Figures 11A and B, there is shown an embodiment of the apparatus 10 which differs from that of Figures 1 and 2 in that the apparatus 10 is configured to fluidly connect to and activate a heart model 14 comprising a full heart module 156. [00124] The fluid circulation system 12 of Figure 11 comprises a left fluid circulation system 158 comprising a left tubing array 160 and having a left tubing array inlet 162 and a left tubing array outlet 164, and a right fluid circulation system 166 comprising a right tubing array 168 and having a right tubing array inlet 170 and a right tubing outlet 172. [00125] The full heart module 156 comprises the left heart module 76, as described earlier with reference to Figure 2, which is fluidly connectable to the left fluid circulation system 158, and a right heart module 174 which is fluidly connectable to the right fluid circulation system 166. The left heart module 76 comprises the left ventricle module 48 in fluid communication with the left atrium module 50 through the mitral valve component 78, the left atrium module 50 being connectable to an outlet of left tubing array 164, an the left ventricle module 48 connectable to an inlet of the tubing array 162, via the aortic valve component 80.

[00126] The right heart module 174 comprises the right atrium module 54 in communication with the right ventricle module 52 through a tricuspid valve component 176, the vena cava component 66 in fluid communication with the right atrium chamber component 64 and connectable to the right fluid circulation system outlet 172, and the pulmonary artery component 68 in fluid communication with the right ventricle chamber component 70 and connectable to the right fluid circulation system inlet 170.

[00127] The left fluid circulation system 158 and the right fluid circulation system 166 are each closed fluid circuits, independent of one another. As indicated by the arrows in Figures 11 A and B, they each form an independent pathway through the respective left heart module 76 and the right heart module 174. In the embodiment of Figures 11 A and B, in the left fluid circulation system 158, the reservoir 82 is a left reservoir 178 and in the right fluid circulation system 166, the reservoir 82 is a right reservoir 180. Fluid from the left reservoir 178 can be diverted from the left fluid circulation system 158 to a drainage container 182 via a left reservoir valve 184 which can control and direct the flow of the fluid from the left reservoir 178. Fluid from the right reservoir 180 can be diverted from the right fluid circulation system 166 to the drainage container 182 via a right reservoir valve 186 which can control and direct the flow of the fluid from the right reservoir 180. [00128] A pressure in the left fluid circulation system 158 is configured to replicate anatomical pressures in a left heart (an average of about 100 mm of mercury), and a pressure in the right fluid circulation system 166 is configured to replicate anatomical pressures in a right heart (an average of about 10-20 mm of mercury). The pressure in the right and left fluid circulation systems 158, 166 can be adjusted in any way, such as adjusting the height of the left and right reservoirs 178, 180, or by the use of valves (not shown). Alternatively, a single reservoir (not shown) can be provided for both the left and right fluid circulation systems 158, 166 with a pressure control valve (not shown) at outlet (not shown) of the single reservoir.

[00129] The actuator 30 comprises the left ventricle actuator 122 and the left atrium actuator 130 as described above, and a right ventricle actuator 188 and a right atrium actuator 190. The right ventricle actuator 188 has a right ventricle actuator body 192 with a right ventricle contact face 194 for applying pressure on an outer surface 194 of the right ventricle chamber component 70, and the right atrium actuator 190 has a right atrium actuator body 194 with a right atrium contact face 196 for applying pressure to an outer surface 198 of the right atrium chamber component 64. The right atrium contact face 196 and/or the right ventricle contact face 194 has a profile which substantially conforms to a profile of the right atrium chamber component 64 and the right ventricle chamber component 70, respectively. The profile is substantially concave.

[00130] In Figure 11 A, a single motor 36 drives each of the left and right ventricle actuators 122, 188 and the left and right atrium actuators 130, 188. In Figure 11B, the ventricle motor 142 drives both the left and right ventricle actuators 122, 188, and the atrium motor 144 drives both the left and right atrium actuators 130, 188. Alternatively, separate motors can be provided to drive each of the left and right ventricle actuators 122, 188 and the left and right atrium actuators 130, 188.

[00131] Although the left heart module 76 is separate to the right heart module 174, they are mounted next to each other. A separator component 200 (Figure 11a, 12) is provided between the left heart module 76 and the right heart module 174 to minimize compression of one or both of the left heart module 76 or the right heart module 174 by the adjacent heart module. The separator component 200 can also function as a support, providing resistance against the applied pressure from the actuators. The separator component 200 has a left face 202 facing the left heart module 76, and a right face 204 facing the right heart module 174. A profile of the left face 202 substantially conforms to an external profile of an adjacent portion of the full heart module 156, and a profile of the right face 204 substantially conforms to an external profile of an adjacent portion of the full heart module 156. The separator component 200 may be configured to separate the left and right atrium chamber components 56, 64 and/or the left and right ventricle chamber components 62, 70.

[00132] In certain embodiments (not shown), the separator component 200 is integral with the full heart module 156, is integrally formed with one or more of the left ventricle chamber component 62, the right ventricle chamber component 70, the left atrium chamber component 56, and the right atrium chamber component 64. In these embodiments, the separator component 200 can be made of a less resilient material than that of the heart model 14 in order to minimize or avoid stress transfer.

[00133] As with the embodiments of Figures 1A and 2, the heart model 14 of the embodiment of Figure 1 1A and B can be mounted to the apparatus 10 at an anatomically correct angle and orientation. In this respect, one or more stands (not shown) are provided to support one or more components of the full heart model 156 in a chosen position.

[00134] Turning now to Figures 13 and 14, there is shown a restriction module 210 for use with any of the embodiments of the apparatus 10. In fact the restriction module 210 can be used with any apparatus in which a narrowing of a tubular diameter is required. The restriction module 210 is arranged to be placed around any one of the tubes of the fluid circulation system 12 and can be actuated between a normal state and an actuated state to narrow an internal diameter of this tube to simulate for example a narrowing of a vein or an artery, for example as occurs in coarctation of the aorta or artery stenosis, or the like.

[00135] The restriction module 220 comprises a sleeve 212 having two open ends 214 and a sleeve channel 216 extending therebetween, the sleeve channel 216 being arranged to receive the tube. The sleeve 212 has an outer wall 218, an inner wall 220 defining the sleeve channel 216, and two annular end plates 222 fluidly attachable to the outer wall 218 at the two open ends 214. The outer wall 218, the inner wall 220 and the two annular end plates 222 define a chamber 224 which can be fluidly sealed. An inlet 226 to the chamber 224 is provided through the sleeve outer wall 218 to increase a pressure in the chamber 224. At least a portion of the inner wall 220 comprises a resilient material such that increasing the pressure in the chamber 224 causes the resilient material of the inner wall 220 to expand and to narrow the sleeve channel 216. The inner wall 220 is more resilient than the outer wall 218 to ensure that when the chamber 224 is pressurized, only the inner wall 220 expands circumferentially inwards.

[00136] Struts 228 are provided along the inner wall 220, which extend axially along the inner wall 220 and connect to the end plates 222. The struts 228 are stiffer than the resilient material of the inner wall 220 and restrict expansion of portions of the resilient material when the chamber 224 is pressurized. As seen in Figures 13 and 14, four struts 228 are provided which are equally spaced around the inner wall 220. When the resilient material expands, the struts 228 ensure that the inner wall 220 remains attached to the annular end plates 222. More or less than the four struts 228 illustrated can be provided. The struts 228 can be integral with, or separate to, the resilient material. One or more of the outer wall 218, inner wall 220, the end plates 222 and the struts 228 can be formed as one piece instead of the separate components illustrated. [00137] The two annular end plates 222 can be attached to the sleeve 212 by fasteners 230, such as screws, bolts, clips or the like. Seals 232, such as rubber rings and o-rings, are provided to fluidly seal the end plate 222 and the outer wall 218, and the end plate 222 and the inner wall 220. However, it will be appreciated that the chamber 224 can be fastened or sealed in any other way. [00138] The pressure in the chamber 224 can be increased by providing fluid through the chamber inlet 226. In this respect, the restriction module 210 also includes a fluid source (not shown) and a pump 234 (Figure 10). In one embodiment, the fluid is air and the pump is a manual pump such as a sphygmomanometer bulb, compression of which drives air into the chamber 224. A pressure gauge (not shown) measures and displays the pressure in the chamber 224. The measure of the pressure in the chamber 224 can be related to the severity of the narrowing of the aorta or vein. Therefore, artery or vein narrowing of measurable and repeatable severities can be simulated by the restriction module 210.

[00139] Turning now to Figures 15-18, there is provided a valve module 240 for use with any of the embodiments of the apparatus 10 described herein, or with any other cardiac simulator apparatus in which control of a valve leaflet 242 of a valve 244 (such as the one illustrated in Figure 15) is required. The valve module 240 is used to simulate certain malfunctions such as valve stenosis, when one or more of the valve leaflets 242 do not open fully, and regurgitation when one or more of the valve leaflets 242 do not close fully. Valve stenosis occurs most frequently on the aortic valve but does also occur in other valves in humans. Embodiments of the present valve module 240 can be used to simulate various pathologies on any of the valves in the cardiovascular system, including, the aortic valve, the pulmonary valve, the tricuspid valve and the mitral valve.

[00140] The valve module 240 comprises the inter-engageable connector portion 102 and the valve portion 104 of the connector module 100 (as illustrated in Figures 4 and 5). The connector portion 102 comprises the cylindrical body 106 with the two connector ends 108. The rim 112 between the two connector ends 108 extends circumferentially around the cylindrical body 106. Each connector end 108 is configured to mate with corresponding open ends of the heart module or the tubing array to connect them together. [00141] The valve module 240 of Figures 15-18 differs from the connector module 100 of

Figures 4 and 5, in that ports 246 are provided through the cylindrical body 106 at the rim 112 to provide access through the cylindrical body 106 to the valve 244 mounted in the inner channel 110, in use. A pair of annular clamps 248 is also provided (Figures 15 and 18), one of which is configured to slot over the valve portion 104 at the connector end 108, and the other to slot over the other connector end 108. The annular clamps 248 are connected together by fasteners 250 such as bolts, nuts, screws, or the like. These annular clamps 248 and fasteners are also provided in certain embodiments of the connector module 100.

[00142] In the embodiment of Figure 15-18, the valve 244 has three valve leaflets 242 and derives from a pig, cow, or horse or human cadaver. However, valves 244 with different numbers of leaflets, artificial valves or valves from any other source can be used. The valve 244 may be made from a resilient material to simulate a real valve. Three ports 246 are provided corresponding to each one of the three valve leaflets 242.

[00143] The valve module 240 further comprises a valve adjustment mechanism 252 for limiting an extent that at least one of the valve leaflets 242 can open or close. In other words, the valve adjustment mechanism 2552 is arranged to restrict at least one of the valve leaflets 242 from closing fully or is arranged to restrict at least one of the valve leaflets 242 from opening fully. The valve adjustment mechanism 252 is arranged to control each one of the valve leaflets 242, independently, to simulate different pathologies. Three valve adjustment mechanisms 252 are provided, one for each port 246. For example, the valve adjustment mechanism 252 can maintain a valve leaflet in a partially open position which means that when fluid flows through the valve 244, the valve leaflet will open fully but will not be able to close fully. Alternatively, the valve adjustment mechanism 252 can restrict the full opening of the valve leaflets 242 so that when fluid flows through the valve 244, the valve leaflets 242 will close fully but will not be able to open fully.

[00144] As best seen in Figure 16, each valve adjustment mechanism 252 comprises a sealing arrangement 254 to seal the port 246, a guide extending through the sealing arrangement 254 and having a free end 258 which can be connected to the valve leaflet 242. A motor 260 (Figure 11B) is connectable to the guides 256, via a hydraulic system 262 (Figure 17), and can provide actuation of each guide 256 to move the valve leaflet 242 to which it is connected. The motor 260 is controllable by the processor 38. In one embodiment, the motor 260 is a rack and pinion motor. The free end 258 of the guide 256 is connected to valve leaflet 242 in any way such as by hooking or tying a knot through the valve leaflet 242 (Figure 17).

[00145] The sealing arrangement 254 comprises a valve 264, such as a hemostasis valve, extending through tubing 266 into the port 246. The guide 256 is more flexible at its free end 258 to facilitate connection to the valve leaflet 242. In this embodiment, the guide 256 comprises a stiff er portion 268 and a more flexible portion 270 including the free end 258, connected by a thread cap 272. The flexible portion 270 comprises a wire, such as fishing wire, for connection to the valve leaflet. [00146] An alternative embodiment of the valve module 240 is illustrated in Figure 20, in which the valve module 240 comprises a valve mount portion 274 for removeably housing the valve 244, a valve access portion 276 having at least one opening 278 extending therethrough for accessing the valve 244 from outside of the valve module 240, and a retaining portion 280 connectable to the valve access portion 276 to secure the valve 244 in place. The valve module 240 is connectable to the fluid circulation system 12, the left fluid circulation system or the right fluid circulation system 158, 166 to allow fluid to flow through the valve 244 in the valve module 240 in use. The valve module 240 of Figure 20 includes the valve adjustment mechanism 252 of Figures 15-17 so that the free end 258 of the guide 256 extends through the opening 278 and is attachable to the valve leaflet 242. Actuation of the guide 256 by the motor 260 can move the valve leaflets 242 individually in order to simulate stenosis or regurgitation or any other pathologies of the valve leaflets 242.

[00147] By means of at least the embodiments of Figures 1, 2 and 11, physiological waveforms can be induced in the fluid in the heart model 14. Figure 21 demonstrates the physiologic waveforms induced in the left ventricle chamber component 62 and the left atrium chamber component 56 of the embodiment of Figure 2. Similar physiological waveforms were obtained with the embodiments of Figures 1 and 11.

[00148] Figure 21 demonstrates example pressure waveforms measured in the left ventricle chamber component 62 and the aorta component 60 with the apparatus of Figure 2. Figure 22 demonstrates example pressure waveforms, at 50 bpm, measured in the right ventricle chamber component 70 and the pulmonary artery component 68 with the apparatus 10 of the embodiment of Figure 11. Figure 23 demonstrates example pressure waveforms, at 70 bpm, measured in the left ventricle chamber component 62 and the aorta component 60 with the apparatus 10 of the embodiment of Figure 11 using the full heart module 156 and the valve module 240 with the valve leaflets 242 of an aortic valve in a normal function (normal opening and normal closing). Figure 24 demonstrates an example pressure waveform, at 70 bpm, measured in the left ventricle chamber component 62 and the aorta component 60 with the apparatus 10 of the embodiment of Figure 11 using the full heart module 156 and the valve module 240 simulating stenosis (restriction of the opening of each of the valve leaflets 242). Figure 25 demonstrates an example pressure waveform, at 70 bpm, measured in the left ventricle chamber component 62 and the aorta component 60 with the apparatus 10 of the embodiment of Figure 11 using the full heart module 156 and the valve module 240 simulating regurgitation (restriction of the closing of each of the valve leaflets 242). [00149] Modifications and improvements to the above-described embodiments of the present technology may become apparent to those skilled in the art. The disclosed features may be implemented, in any combination and subcombinations (including multiple dependent combinations and subcombinations), with one or more other features described herein. The various features described or illustrated above, including any components thereof, may be combined or integrated in other systems. Moreover, certain features may be omitted or not implemented. Examples of changes, substitutions, and alterations are ascertainable by one skilled in the art and could be made without departing from the scope of the information disclosed herein. [00150] For example, the apparatus 10 is illustrated and described as simulating a cardiovascular system. However, the apparatus 10 is not limited to cardiovascular systems and can be adapted to replicate other systems such as the lung.

[00151] The foregoing description is intended to be exemplary rather than limiting. The scope of the present technology is therefore intended to be limited solely by the scope of the appended claims.

Claims

CLAIMS What is claimed is: CLAIMS What is claimed is:

1. An apparatus for simulating a cardiovascular system, the apparatus comprising

a fluid circulation system for simulating at least a portion of a cardiac vasculature, the fluid circulation system comprising a tubing array having at least one outlet and at least one inlet, the at least one outlet and the at least one inlet each being arranged to be removeably connectable to a heart model to form a fluid pathway through the heart model, in use;

an activation system for inducing a waveform in fluid in the fluid pathway, in use, the activation system comprising an actuator for applying pressure to an outer surface of the heart model, a support for supporting the heart model whilst the actuator is applying pressure to the heart model, and a motor for driving the actuator, the motor being controllable by a processor, the actuator being arranged to releasably compress the heart model, in use.

2. The apparatus of claim 1, wherein the actuator comprises an actuator body having an actuator contact face.

3. The apparatus of claim 2, wherein a profile of the actuator contact face substantially conforms to a profile of at least a portion of the outer surface of the heart model.

4. The apparatus of any of claims 1-3, wherein the support comprises a support body having a support contact face for contacting at least a portion of the outer surface of the heart model.

5. The apparatus of claim 4, wherein a profile of the support contact face substantially conforms to a profile of at least a portion of the outer surface of the heart model.

6. The apparatus of any of claims 2-5, wherein the actuator contact face and the support contact face are arranged to contact different portions of the outer surface of the heart model.

7. The apparatus of any of claims 1-3, wherein the support comprises a support body and is integrally formed in the heart model.

8. The apparatus of any of claims 2-7, wherein the actuator contact face is removeably connectable to the outer surface of the heart model.

9. The apparatus of any of claims 2-6, and claim 8, wherein the support contact face is removeably connectable to the outer surface of the heart model.

10. The apparatus of any of claims 1-9, wherein a distance and/or an angle between the actuator and the support is adjustable to accommodate different sizes and/or shapes of heart models.

11. The apparatus of any of claims 1-10, wherein the fluid circulation system further comprises a fluid reservoir in fluid communication with the tubing array.

12. The apparatus of any of claims 1-11, wherein the fluid circulation system further comprises fluid, the fluid being an incompressible fluid.

13. The apparatus of claim 12, wherein the fluid is a blood simulating fluid selected from water, glycerine solution, a solution of glycerine and xantham gum, and blood.

14. The apparatus of any of claims 1-13, further comprising the processor, the processor including computer readable instructions for controlling a rate and/or an extent of the pressure applied by the actuator.

15. The apparatus of claim 14, further comprising at least one sensor for measuring a parameter associated with the fluid in the fluid pathway, the at least one sensor being in communication with the processor and the processor being arranged to adapt the rate and/or extent of the pressure applied by the actuator in response to the measured parameter.

16. The apparatus of any of claims 1-15, wherein the tubing array further comprises at least one valve positioned on at least one tube of the tubing array, the valve being positioned downstream of the at least one outlet, the valve being arranged to restrict a diameter of the at least one tube.

17. The apparatus of claim 16, wherein the at least one valve is moveable along the at least one tube to adjust a distance between the at least one valve and the at least one outlet.

18. The apparatus of claim 17, further comprising a self adjustment mechanism comprising a driver for moving the at least one valve along the at least one tube in response to a measured induced waveform not conforming to a desired output waveform, and a control mechanism for opening and closing the valve.

19. The apparatus of any of claims 1-18, further comprising the heart model.

20. The apparatus of claim 19, wherein the heart model comprises a three-dimensional model, at least a portion of the heart model being made of a resilient material.

21. The apparatus of claim 19 or claim 20, wherein the heart model is modular and comprises at least one module selected from: a left heart module, a right heart module, a left atrium module, a right atrium module, a left ventricle module, a right ventricle module, a full heart module, a valve module, a restriction module and a connector module.

22. The apparatus of claim 21, wherein the at least one module of the heart model is

anatomically correct.

23. The apparatus of claim 21 or claim 22, wherein the left heart module and the right heart module can be removeably connected together to simulate a full heart.

24. The apparatus of any of claims 21-23, wherein the left atrium module and the left ventricle module can be removeably connected together to simulate a left side of a heart.

25. The apparatus of any of claims 21-24, wherein the right atrium module and the right ventricle module can be removeably connected together to simulate a right side of a heart.

26. The apparatus of any of claims 21-25, wherein the left atrium module comprises a left atrium chamber component in fluid communication with at least one pulmonary vein component connectable to the at least one outlet of the fluid circulation system, and an aorta component connectable to the at least one inlet of the fluid circulation system.

27. The apparatus of any of claims 21-25, wherein the left ventricle module comprises a left ventricle chamber component in fluid communication with at least one pulmonary vein component connectable to the at least one outlet of the fluid circulation system, and an aorta component connectable to the at least one inlet of the fluid circulation system.

28. The apparatus of any of claims 21-25, wherein the left heart module comprises a left ventricle chamber component in fluid communication with a left atrium chamber component through a mitral valve component, at least one pulmonary vein component in fluid

communication with the left atrium chamber component and connectable to the at least one outlet of the fluid circulation system and, and at least one aorta component in fluid

communication with the left ventricle chamber component and connectable to the at least one inlet of the fluid circulation system.

29. The apparatus of any of claims 21-25, wherein the right atrium module comprises a right atrium chamber component in fluid communication with at least one vena cava component connectable to the at least one outlet of the fluid circulation system and, a pulmonary artery component in fluid communication with the right atrium chamber component and connectable to the at least one inlet of the fluid circulation system.

30. The apparatus of any of claims 21-25, wherein the right ventricle module comprises a right ventricle chamber component, at least one vena cava component in fluid communication with the right ventricle chamber component and connectable to the at least one outlet of the fluid circulation system and, a pulmonary artery component in fluid communication with the right ventricle chamber component and connectable to the at least one inlet of the fluid circulation system.

31. The apparatus of any of claims 21-25, wherein the right heart module comprises a right ventricle chamber component in communication with a right atrium chamber component through a tricuspid valve component, at least one vena cava component in fluid communication with the right atrium chamber component and connectable to the at least one outlet of the fluid circulation system and, and a pulmonary artery component in fluid communication with the right ventricle chamber component and connectable to the at least one inlet of the fluid circulation system.

32. The apparatus of any of claims 21-25, wherein the full heart module comprises a left heart module and a right heart module, the left heart module comprising a left ventricle chamber component in fluid communication with a left atrium chamber component through a mitral valve component, at least one pulmonary vein component in fluid communication with the left atrium chamber component and connectable to the at least one outlet of the fluid circulation system, and at least one aorta component in fluid communication with the left ventricle chamber component and connectable to the at least one inlet of the fluid circulation system; and the right heart module comprising a right ventricle chamber component in communication with a right atrium chamber component through a tricuspid valve component, at least one vena cava component in fluid communication with the right atrium chamber component and connectable to the at least one outlet of the fluid circulation system, and a pulmonary artery component in fluid

communication with the right ventricle chamber component and connectable to the at least one inlet of the fluid circulation system.

33. The apparatus of claim 32, further comprising a separator component positioned between the left heart module and the right heart module, the separator component being separate to, or integral with, the full heart module.

34. The apparatus of claim 33, wherein the separator component is separate to the full heart module and has a profile, on at least one side, which substantially conforms to an external profile of an adjacent portion of the full heart module.

35. The apparatus of any of claims 21-34, further comprising the connector module which is configured to removeably connect at least one module to another module, the connector module comprising a cylindrical body defining an inner channel, and having two connector ends, each connector end being configured to mate with at least one of the module inlet or the module outlet of the modules.

36. The apparatus of claim 35, the connector module further comprising a valve portion having a valve seat for housing a valve, the valve portion being removeably connectable to the connector module to position the valve in the inner channel.

37. The apparatus of claim 35 or claim 36, further comprising one of a pulmonary valve, an aortic valve, a mitral valve and a tricuspid valve.

38. The apparatus of any of claims 28 and 36-37, wherein the heart model comprises a left heart model and the actuator comprises a left ventricle actuator having a left ventricle actuator body with a left ventricle contact surface for applying pressure to an outer surface of the left ventricle chamber component, and a left atrium actuator having a left atrium actuator body with a left atrium contact surface for applying pressure on an outer surface of the left atrium chamber component.

39. The apparatus of claim 38, wherein the motor is arranged to drive at least one of the left ventricle actuator and the left atrium actuator.

40. The apparatus of claim 38, wherein the motor comprises a ventricle motor for driving the left ventricle actuator, and an atrium motor for driving the left atrium actuator, the ventricle motor and the atrium motor being controllable by the processor.

41. The apparatus of any of claims 38-40, wherein the support comprises a left ventricle support having a left ventricle support surface for supporting the left ventricle chamber component whilst the left ventricle actuator is applying pressure on the left ventricle chamber component.

42. The apparatus of claim 41, wherein a profile of at least one of the left ventricle support surface, the left ventricle contact surface, or the left atrium contact surface is concave.

43. The apparatus of claim 41 or claim 42, wherein the left ventricle support is fixed on a base of the apparatus and is angled with respect to the base to anatomically position the left ventricle chamber component.

44. The apparatus of any of claims 32-37, wherein the heart model comprises a full heart model and the actuator comprises:

a left ventricle actuator having a left ventricle actuator body with a left ventricle contact surface for applying pressure to an outer surface of the left ventricle chamber component,

a left atrium actuator having a left atrium actuator body with a left atrium contact surface for applying pressure on an outer surface of the left atrium chamber component,

a right ventricle actuator having a right ventricle actuator body with a right ventricle contact surface for applying pressure on an outer surface of the right ventricle chamber component, and

a right atrium actuator having a right atrium actuator body with a right atrium contact surface for applying pressure to an outer surface of the right atrium chamber component.

45. The apparatus of claim 44, wherein the motor is arranged to drive at least one of the left ventricle actuator, the left atrium actuator, the right ventricle actuator and the right atrium actuator.

46. The apparatus of claim 44, wherein the motor comprises a ventricle motor for driving at least one of the left ventricle actuator and the right ventricle actuator, and an atrium motor for driving at least one of the left atrium actuator and the right atrium actuator, the ventricle motor and the atrium motor being controllable by the processor.

47. The apparatus of claim 40, wherein the ventricle motor is driven independently of the atrium motor.

48. The apparatus of any of claims 44-47, further comprising a stand for supporting the heart model at an angle, relative to a base of the apparatus, which simulates an anatomical angle of a heart relative to a spine.

49. The apparatus of any of claims 21-48, further comprising the restriction module which is configured to be actuable to narrow an internal diameter of a resilient tube of the tubing array, the restriction module comprising a sleeve having a body comprising an outer wall and an inner wall, the outer wall and the inner wall defining a fluidly sealable chamber therebetween, the inner wall defining a sleeve channel with two open ends for receiving a portion of the resilient tube, wherein at least a portion of the inner wall comprises a resilient material such that increasing a pressure in the chamber causes the inner wall to expand and to narrow the sleeve channel.

50. The apparatus of claim 49, wherein the inner wall includes struts extending axially along the inner wall.

51. The apparatus of claim 49 or claim 50, wherein the sleeve has an inlet and an inlet valve for allowing fluid flow into the chamber and for maintaining the fluid in the chamber.

52. The apparatus of any of claims 21-51, further comprising the valve module which is configured to house a valve having at least one valve leaflet, the valve module being connectable to the fluid circulation system to allow fluid to flow through the valve housed in the valve module, in use, and a valve adjustment mechanism connectable to the at least one valve leaflet and configured to limit an extent that the at least one valve can open or close when housed in the housing.

53. The apparatus of claim 52, wherein the valve module comprises a valve seat portion for removeably housing the valve and a valve retaining portion connectable to the valve seat portion to retain the valve in the valve seat portion.

54. The apparatus of claim 52 or claim 53, wherein the valve module comprises at least one port extending from an outside of the valve module to an inner channel, and the valve adjustment mechanism comprises a guide receivable through the port and having a free end which is attachable to the at least one valve leaflet, and a driver for controllably moving the guide.

55. The apparatus of any of claims 52-54, wherein the valve module comprises three ports and three valve adjustment mechanisms for adjusting three valve leaflets housed in the valve module.

56. The apparatus of any of claims 52-55, further comprising the valve which is selected from: a pulmonary valve, an aortic valve, a mitral valve and a tricuspid valve.

57. A modular cardiovascular simulation system, the system comprising

an activation system for inducing a waveform in fluid in the fluid pathway, in use;

wherein the heart model comprises at least one module selected from: a left ventricle module, left atrium module, right atrium module, a right ventricle module, a left heart module, a right heart module, a full heart module, a connector module, a restriction module to simulate restriction of an artery or a vein, and a valve module to simulate a pathology of a valve.

58. An apparatus for simulating a cardiovascular simulation system, the apparatus comprising: a left fluid circulation system for simulating at least a portion of a cardiac vasculature related to a left side of a heart, the left fluid circulation system having a left fluid circulation system inlet fluidly connectable to an outlet of a left heart model, and a left fluid circulation system outlet fluidly connectable to an inlet of a left heart model;

a right fluid circulation system for simulating at least a portion of a cardiac vasculature related to a right side of a heart, the right fluid circulation system having a right fluid circulation system inlet fluidly connectable to an outlet of a right heart model, and a left fluid circulation system outlet fluidly connectable to an inlet of a right heart model;

an activation system for inducing a waveform in fluid in a fluid pathway in the left and right heart models when connected to the left and right fluid circulation systems, respectively, in use, the activation system comprising at least two actuators for applying pressure to an outer surface of the left and right heart models to releasably compress the left and right heart models, and a motor for driving the actuator, the motor being controllable by a processor.

59. The apparatus of claim 58, wherein the at least two actuators are independently controllable by the motor.

60. The apparatus of claim 58 or claim 59, wherein the left fluid circulation system and the right fluid circulation system are each closed fluid circuits, independent of one another.

61. A restriction module for use in a cardiovascular simulation apparatus to simulate a narrowing of a vein or an artery simulated by a resilient tube, the restriction module comprising a sleeve having a body comprising an outer wall and an inner wall, the outer wall and the inner wall defining a fluidly sealable chamber therebetween, the inner wall defining a sleeve channel with two open ends for receiving a portion of the resilient tube, wherein at least a portion of the inner wall comprises a resilient material such that increasing a pressure in the chamber causes the inner wall to expand and to narrow the sleeve channel.

62. The restriction module of claim 61, wherein the inner wall includes struts extending axially along the inner wall.

63. The restriction module of claim 61 or claim 62, wherein the sleeve has an inlet and an inlet valve for allowing fluid flow into the chamber and for maintaining the fluid in the chamber.

64. The restriction module of any of claims 61-63, further comprising a driver for controllably driving fluid into the chamber to simulate different extents of vein or artery narrowing.

65. A valve module for use in a cardiovascular simulation apparatus for simulating valve leaflet pathologies, the valve module comprising a valve housing portion for housing a valve having at least one valve leaflet, the valve module being connectable to a fluid circulation system to allow fluid to flow through the valve housed in the valve module, in use, and a valve adjustment mechanism connectable to the at least one valve leaflet and configured to limit an extent that the at least one valve can open or close when housed in the housing.

66. The valve module of claim 65, wherein the valve housing portion comprises a valve seat portion for removeably housing the valve and a valve retaining portion connectable to the valve seat portion to retain the valve in the valve seat portion.

67. The valve module of claim 65 or claim 66, further comprising at least one port extending from an outside of the valve housing to an inner channel for accessing the at least one valve leaflet, and the valve adjustment mechanism comprises a guide receivable through the at least one port and having a free end which is attachable to the at least one valve leaflet, and a driver for controllably moving the guide.

68. The valve module of claim 67, wherein the valve module comprises three ports and three valve adjustment mechanisms for adjusting three valve leaflets housed in the valve module.

69. The valve module of any of claims 65-68, further comprising the valve which is selected from: a pulmonary valve, an aortic valve, a mitral valve and a tricuspid valve.

70. The valve module of any of claims 65-69, for use in the apparatus of claims 1-56, 57, or 58- 60.

71. The restriction module of any of claims 61-64, for use in the apparatus of claims 1-56, 57, or 58-60.