JP6741344B2 - Heart simulation device - Google Patents

Description

The present application relates to a surgical simulation system. In particular, it relates to a cardiovascular simulation system, and a device and system for simulating normal and diseased heart and cardiovascular functions. The device and system includes an anatomically accurate left heart simulator for training and medical device testing. Among other things, sensors and other control mechanisms are used to automatically adjust the hydraulic and/or pneumatic components of the system to provide a physiologically representative pressure through the heart and major arteries. And a device and system for realizing flow profiles and simulating normal and diseased heart and cardiovascular function.

Cardiovascular diseases, diseases affecting the heart and vasculature and diseases of the blood vessels, diseases affecting the circulatory system are common conditions, affecting many people worldwide. Diseases of the vascular system may manifest itself in hardening of the arterial wall at specific points. Such disease states affect every tissue in the human body. There are several options to reduce or minimize the risks associated with prolonged vascular disease states. Depending on the severity, lifestyle changes, ie a diet and increased exercise, or the use of drugs may help. When these options are ineffective or the disease is severe, surgical intervention remains a major therapeutic tool. Traditional surgical procedures have been gradually replaced by more minimally invasive procedures. Such minimally invasive advances in endovascular therapy have revolutionized the way surgeons treat vascular disease.

Although surgical treatment of blood vessels is safer than before, complicated blood vessel surgical treatment can result in secondary damage to the patient. There is no risk-free surgery, but the level of skill of the surgeon and his/her team, as well as the ability to minimize unforeseen surprises in performing surgical procedures, prevent patient complications and death. Is the most important for Experienced surgeons who have treated numerous vascular diseases are more likely than less experienced surgeons to complete such surgical procedures with fewer complications. Such experience is gained through training and multiple treatments, and the number of surgical treatments available is a limiting factor. Therefore, not all surgeons will have the same opportunity to perform the number of surgical treatments needed to obtain a skill level that minimizes the risk of treatment undertaken. Moreover, as new therapies are developed, older surgeons may find it difficult to obtain the necessary experience.

Training devices for practicing various surgical treatments are used by surgeons to improve their skills and are known in the art. For example, US Pat. No. 8,016,598, US Pat. No. 7,976,313, and US Pat. No. 7,976,312 disclose patient simulator systems for teaching patient care. US Pat. No. 7,798,815 discloses an electromechanical pump system for simulating a heart beat in a heart surgery training environment. US Pat. No. 7,866,983 discloses a surgical simulator for teaching, practicing and evaluating surgical techniques. The simulator is disclosed as having a cassette of organs, blood vessels and tissue that may be disposable.

US Pat. No. 7,083,418 discloses a model for teaching or explaining surgical and/or medical techniques. The system has a base component representing a tissue or organ and a number of components that are configured and arranged on the base component and/or removably with respect to each other to indicate different positions of each component, It is disclosed as representing different stages in surgical and/or medical techniques.

US Pat. No. 7,063,942 discloses a system for hemodynamic simulation. The system is disclosed as having a vessel of vascular nature, a tank containing a large amount of liquid, a tube connecting the container and the tank, and at least one pump for circulating the liquid in the system. ing.

US Pat. No. 6,843,145 discloses a heart model for simulating a dynamic ventricle. The model is disclosed as two concentrically arranged, fluid-tight, flexible membranes that define a closed space between the walls of the membranes.

US Pat. No. 6,685,481 discloses a training device for cardiac surgery and other similar treatments. The device includes an organ model, such as a heart model, an animation network adapted to provide a motion similar to the natural organ corresponding to the model, and a control device used to control the operation of the animation network. Are disclosed as The heart model consists of two parts: an inner cast that simulates the myocardium and an external shell that simulates the pericardium.

U.S. Pat. No. 5,052,934 discloses a prosthetic valve and a device that acts as a model for the evaluation of ultrasound therapy of the heart. In the device, a controlled pulsatile flow of blood-like fluid flows through a multi-chamber region to a region containing mitral and aortic valves and adjustable and positionable ultrasound transducers.

Although such training devices are known in the art, devices and systems for simulating normal and diseased cardiovascular functions in accordance with the present invention and are more anatomical than prior art devices. It provides a training tool that provides a physiologically accurate pressure and flow profile in the main arteries of the cardiovascular system as well as being biologically accurate. Different profiles of the assumed overall cardiovascular system depending on the location of various arteries at the same time are described, for example, in Cooney et al. (Biomedical Engineering Principles? An Introduction to fluid, Heat, and Mass Transport Processes, By David Cooney, Marcel Dekker, Inc. 1976 pp. 76-80). In order to achieve physiologically accurate pressure and flow, the heart and vasculature must move in harmony (Hemodynamics, William R. Milnor, Williams & Wilkins 1989 pp.290-293), for example the major branch. Geometrical landmarks, such as major bifurcations, must be placed at an appropriate distance from the beating heart, and the elasticity of the arteries must represent the elasticity of the actual blood vessels. (Hemodynamics, William R. Milnor, Williams & Wilkins 1989 pp.225-259). In addition, the example control mechanism provides automatic adjustment of one or more functional elements, namely a resistance valve or a compliance chamber, making it more accurate and representative. It provides a pressure and fluid flow profile, thereby providing a mechanism to reduce collateral damage associated with cardiovascular treatment.

The present invention relates to devices and systems for simulating normal and diseased functions of the heart and vasculature, including anatomically accurate elements for training and examination of medical devices, namely the left heart and Including blood vessels. The systems and devices use a pneumatically pressurized chamber to produce ventricular and atrial contractions. In conjunction with the interaction of the artificial mitral and aortic valves, the system is designed to produce precise volume fractions and pumping movements that produce pulsatile pressure gradients, and Reproduce the pump operation. The system of the present application further uses one or more sensors or meters to monitor and/or modify one or more characteristics of the system. For example, various sensors are used to control or provide the appropriate representation of systolic and/or diastolic pressure as desired. A flow meter for determining and/or modifying the flow rate of the overall system can be utilized as well. Thus, one or more feedback loops are used to adjust such characteristics and allow a more accurate representation of the circulatory system. One or more control units or components are provided to control the overall functionality of the system. By providing a control unit that automatically changes one or more functional components of the system, a pressure and flow profile can be created without the need for manual adjustment.

Cardiovascular training and assessment simulator systems and devices suitable for training and medical device testing have been adapted to provide anatomically and physiologically accurate representations of normal and diseased cardiovascular systems. To do. In one embodiment, the system is adapted to simulate a patient's vasculature and a pneumatically actuated heart module for simulating a patient's heart function, and fluidly connected to the heart module. And a control component operably coupled to the cardiac module and the vascular system module. The heart module has an atrial assembly for simulating the atria of the heart and a ventricle assembly for simulating the ventricles of the heart. The heart module is adapted to operate with pneumatics operating independently on the components representing the left ventricle and the left atrium. Alternatively, the heart module may simply include one or more pumps. The control unit controls and modifies parameters relating to one or more operations of the system. The parameters include pulse, ejection fraction, systemic vascular resistance and compliance, and temperature. By changing the parameters of the system, pathological circulation including, but not limited to, sepsis, hyperdynamic therapy with vasopressors, or cardiac arrhythmias such as atrial fibrillation or flutter. The state of kinetics can be reproduced. The system may also include other parts of the human body, preferably the cerebrovascular system.

Thus, the system and device provide a mechanism that can be used to reduce collateral damage to patients undergoing vascular treatment due to the surgeon's inexperience or lack of complex treatment experience. To do. By providing a device that replicates the heart and vasculature, the surgeon can perform such treatment prior to the endovascular treatment of the actual patient. Thus, device selection, placement and optimization can be determined prior to the actual surgery, eliminating the risks associated with performing such tasks during the course of treatment.

In one embodiment, a system for simulating a human or other mammalian cardiovascular system in which one or more operating parameters are automatically controlled without the need for manual adjustments is provided. A control unit operably coupled to the closed-loop pneumatic circuit and configured to simulate human or other mammalian cardiovascular function and configured to simulate human or other mammalian cardiovascular function And a closed loop hydraulic circuit. The control unit has one or more components configured to receive or process data and actuate at least one functional component based on the received or processed data. At least one sensor is configured to control one or more parameters of the closed loop pneumatic circuit, or one or more sensors are configured to control one or more parameter of the closed loop hydraulic circuit. Has been done. The control unit is configured to provide a physiologically accurate representation of a normal or diseased cardiovascular system, the one or more operating parameters requiring manual adjustment. And automatically controlled without. The system may also include a cardiac system module, the cardiac system module being adapted to have atrial and ventricular actuators and human or other mammalian arterial or venous characteristics and at least the cardiac system module. A vasculature system module including at least one vascular tissue fluidly connected to a portion and a region of the head. Also, liquid tanks and compliance chambers may be utilized.

Accordingly, it is a first object of the present invention to provide devices and systems for simulating normal and diseased heart and cardiovascular function.

A further object of the present invention is a device for simulating normal and diseased cardiovascular function, including anatomically accurate cardiac and cardiovascular simulators for training and examination of medical devices, and It is to provide a system.

Another object of the invention is to simulate normal and diseased cardiovascular function designed to produce an accurate volume fraction to produce a pumping action that reproduces the volume fraction of the heart. To provide a device and system for

A further object of the present invention is the function of normal and diseased cardiovascular conditions designed to provide a pulsatile pressure gradient that reproduces the pulsatile pressure gradient of cardiac and/or vascular components. To provide a device and a system for simulating.

Another object of the present invention is a device and system for simulating normal and diseased cardiovascular function, wherein the function controls air pressure level, fluid pressure, and pulse, The result is to provide devices and systems for inducing contractions that simulate a wide variety of cardiac conditions.

Another object of the invention is to simulate normal cardiovascular function by controlling air pressure level, fluid pressure, and pulse to induce contractions that simulate a wide variety of cardiac conditions with normal heart function. It is to provide a device and a system for

Another object of the invention is the control of air pressure levels, fluid pressure, and pulse to induce contractions that simulate a wide variety of cardiac conditions with diseased or damaged cardiac conditions. It is to provide devices and systems for simulating cardiovascular function.

Another object of the invention is adapted to provide an anatomically and physiologically accurate representation of the cardiovascular system in normal and diseased states, suitable for training and examination of medical devices. Training and evaluation simulator systems and devices.

Another object of the invention is adapted to control or modify one or more control parameters of the system, including pulse, temperature of fluids such as simulated blood, ejection fraction, systemic vascular resistance and vascular compliance. A training and evaluation simulator system and device having a controlled module.

Other objects of the present invention include pathological hemodynamics including, but not limited to, sepsis, hyperdynamic therapy with pressor drugs, or cardiac arrhythmias such as atrial fibrillation or flutter. It is to provide a training and evaluation simulator system and device in which conditions can be reproduced.

Another object of the present invention is to provide a training and evaluation simulator system and device that allows a surgeon to perform an endovascular procedure prior to performing an endovascular procedure on an actual patient.

Another object of the invention is the risk associated with the surgeon deciding on device selection, placement and optimization prior to the actual surgery and the need to perform such tasks during the actual procedure. It is to provide a training and evaluation simulator system and device that allows it to be eliminated.

Another object of the present invention is a device and system for simulating cardiovascular function in normal and diseased states that achieves the physiological representation of biological profiles utilizing feedback control mechanisms. Is to provide.

Another object of the invention is to simulate the normal and diseased cardiovascular function of achieving a physiological representation of a biological profile utilizing a system for automatically adjusting fluidic elements. To provide a device and a system for doing so.

Another object of the present invention is the function of normal and diseased cardiovascular conditions to achieve a physiological representation of biological profiles utilizing a system that passively controls fluid flow by a pump mechanism. To provide a device and a system for simulating.

Another object of the present invention is to provide a physiological representation of temperature, pressure and flow profiles utilizing feedback control and self-regulation of fluidic and pump controls to achieve normal and diseased states. To provide devices and systems for simulating the cardiovascular function of the.

Another object of the present invention is to provide a control unit for controlling a cardiovascular simulation device using closed loop pneumatic and hydraulic circuits.

Another object of the invention is to configure a closed loop pneumatic circuit configured to simulate a human or other mammalian cardiovascular function and a human or other mammalian cardiovascular function configured. Providing a control unit operably coupled to a closed loop hydraulic circuit, the control unit including one or more components for receiving or processing data, the cardiovascular simulation device or system comprising: Operating at least one functional component based on the received or processed data.

Another object of the present invention is to provide a system or device for simulating a human cardiovascular system in which one or more operating parameters are automatically adjusted without the need for manual adjustment.

Other objects and benefits of the present invention will be apparent from the following description taken in conjunction with the accompanying drawings. This description, by way of explanation and illustration, shows some embodiments of the invention. The drawings included herein form a part of the specification and illustrate exemplary embodiments of the invention and illustrate various objects and features of the invention.

It is a block diagram showing a hydraulic circuit of a simulator system by an embodiment of the present invention. FIG. 2 is a diagram including a pneumatic circuit in the block diagram shown in FIG. 1 of the simulator system according to the embodiment of the present invention. FIG. 3 is a diagram including an electric circuit in the block diagram shown in FIG. 2 of the simulator system according to the embodiment of the present invention. FIG. 6 is a block diagram illustrating an embodiment of the invention in which a pump is used to represent a heart module. FIG. 6 is a partial perspective view of a heart simulator module and a ventricle module. 5A is a partial cross-sectional view showing an aortic valve and an aortic arch taken along line 5A-5A in FIG. 4. FIG. 6A is a partial cross-sectional view of the atrial compression mechanism, atrial chamber and mitral valve taken along line 6A-6A of FIG. 4. FIG. FIG. 6 is a rear view of a heart simulator module showing a ventricular compression chamber, an aortic arch and an atrial compression mechanism. FIG. 3 is an exploded view of a heart simulator module. FIG. 8 is a side view of one embodiment of a ventricular chamber and a ventricular compression chamber. 7 is an alternative embodiment of a ventricular chamber and a ventricular compression chamber. FIG. 6 is a perspective view of an exemplary embodiment of a head unit. It is a perspective view which has a cerebrovascular system of the head unit shown in FIG. It is a figure which shows the accumulator which was filled with gas. FIG. 5 is a diagram showing a piston accumulator filled with gas. It is a figure which shows the piston accumulator with a spring. It is a figure showing an embodiment of a cardiovascular simulator system.

1 to 3 are schematic block diagrams of a simulator system, which shows a system collectively called a cardiovascular simulator system 10. Cardiovascular simulator system 10 is described and described as a cardiovascular system. However, the simulator system is not limited to cardiovascular systems, but is adapted to reproduce other systems. The cardiovascular simulator system 10 has one or more modules including hardware component modules and anatomical component modules. The hardware component module and the anatomical component module interact in a manner that provides a system that is an anatomically and functionally accurate reproduction of the human body system, ie, the heart and/or vascular system. Providing such an anatomically accurate system allows a user to practice and train various surgical treatments and/or techniques on a living person's system to perform such actions. Providing unique tools to do things in advance. Although such systems will be described using human anatomy and systems, the vascular simulator system according to the present invention may be used in domestic animals such as dogs and cats, rodents such as mice and rats. May be adapted to reproduce or model other organism systems such as cattle, cattle, horses, sheep, livestock such as swine/porcine, or other mammals including wild animals such as lions or tigers ..

Both the hardware component module generically referred to as 1000 and the anatomical component module generically referred to as 2000 further include sub-modules. The sub-module comprises individual components that drive the system and/or provide the exact structural and functional replication of the biological system. As described in detail below, the hardware component module 1000 includes one or more sub-modules that include pneumatic components, hydraulic components, and control/electronics components. The cardiovascular simulator system 10 provides an accurate and automatic representation of some of the key components or characteristics of the system, namely the physiology of cardiovascular and cerebrovascular activities, including flow and valve activity. It is designed to include one or more feedback loops that are configured to be expressed in a logical manner. The control unit contains the necessary hardware and monitoring devices to provide automatic operation of the system to bring certain characteristics of blood flow and blood pressure. The control unit may include a pressure sensor indicating arterial and venous pressure and/or a flow meter indicating head or chest flow. To monitor and provide physiological values of pressure and flow rate within the system. The information obtained from the pressure and flow sensors is used as part of a feedback control mechanism to achieve physiologically representative properties. Also, one or more valves may be used to provide liquid flow control in the system. The anatomical module 2000 is referred to herein as a cardiovascular system and consists primarily of three sub-modules, which include a heart simulator module 2100, a vascular simulator module 2200, and one or more peripherals. Includes an organ/tissue simulator module 2300.

Heart module 2100 is configured to be a replica of the left half of the human heart. Pneumatic pressure provides the function of the components of heart module 2100. In this regard, the flow rate of liquid in and out of the heart module 2100 may be controlled by the control unit 130 by the timing of applying air pressure and the speed of a pressurized air generating device such as an air compressor. The control and/or operation of the timing of applying air pressure and the speed of the pressurized air producing device is the result of measuring and monitoring the values as part of the feedback system. The feedback control loop may also be used for other functional aspects of the cardiovascular simulator module 10. For example, a liquid pump may be operated, such as a motor driven pump used to drive the flow of liquid in the system. That is, the speed profile is modified in response to feedback information from any sensor or other monitoring device.

As shown in FIGS. 1-3 and 16, the system is a closed loop system designed to replicate the closed loop circulatory system of a human or other animal. The cardiovascular simulator system 10 includes a liquid tank (also known as a venous chamber) 12 fluidly connected to a heart simulator module 2100, which is the first part of the anatomical module 2000. The liquid tank or vein chamber 12 has a housing unit 14 sized and shaped to receive and retain liquid. Within the housing unit 14, the liquid tank or venous chamber 12 may include one or more heating mechanisms, such as heating coils 15. The heating coil 15 allows the liquid in the cardiovascular simulator system 10 to be warmed to a predetermined temperature that corresponds to the temperature of the physiological liquid in the body. The liquid may be any liquid that simulates blood. In one embodiment, the liquid is a transparent simulated blood that has the properties of replicating the viscosity of human blood and mimicking the coefficient of friction as a device through endovascular devices, wires, and the vasculature system. Alternatively, the liquid may be whole blood, or simply water. Thus, any liquid can be used and can be modified to have a viscosity and/or flow rate that is similar or close to that of the blood flow through an artery or vein. The liquid may be transparent, or it may contain dye and the flow of the liquid may be visualized throughout the system. A fill cap 16 is used to add a liquid, such as water, to the cardiovascular simulator system 10. The liquid tank or venous chamber 12 may be sealed and pressurized to provide a baseline pressure, replicating venous pressure and acting on passive filling of the heart simulator module 2100. The top of the liquid tank or venous chamber 12 may include an instrument such as a gauge (not shown), or a window that may be used to provide visual confirmation of flow level. Alternatively, a sensor may be used, which sensor may be coupled to a control unit (control unit is described below), providing a high, low, or appropriate liquid level indication.

The cardiovascular simulator system 10 is designed to replicate blood flow from the left side of the heart to other parts of the body. As such, the heart simulator module 2100 may include a pump designed to force fluid from the module to other components of the cardiovascular simulator system 10 thereby allowing blood to pass through the left atrium and left ventricle. Reproduce the flow. Instead of using a simple pump, aspects of the heart simulator module 2100 that include replicating the anatomy of the heart may be used (FIGS. 4-10). As shown, the heart simulator module 2100 includes several chambers that represent the left side of the heart, as well as an atrial actuator, shown herein as a left atrial assembly 2108, and a left ventricle herein. Includes a ventricular actuator shown as assembly 2110. The atria and ventricles can be shaped to standard sizes and shapes. Preferably, the present invention uses atria and ventricles shaped with a computer tomography (CT Scan) image of the heart and its vasculature. Left atrial assembly 2108 and left ventricular assembly 2110 may be shaped to represent precise sizes and shapes similar to those of an individual patient.

The left atrium assembly 2108 is pneumatically connected via tubing 17 and tube 19 to a pneumatic module, shown as compressor 100 (see FIG. 2). The pneumatic module includes the components necessary to provide compressed air to one or more modules of the cardiovascular simulator system 10. The generated compressed air compresses and forces out any substance described below, such as a liquid contained in one or more of the components of the heart simulator module 2100, which is pneumatically connected to the compressor 100. To be able to do. Thus, the air compressor operates to provide the heart simulator module 2100 with an accurate representation of the dynamic function of the heart.

Pressurized air enters the left atrium assembly 2108 via an atrial pneumatic in-connector 2111 that is coupled to an elbow connection 2112 to a tube barb 2114 for fitting a tube (see FIGS. 6 and 7). The left atrium assembly 2108 preferably includes an ambient air pneumatic support structure 2116 made from a rigid, sturdy, clear cast plastic such as urethane. Inside the outside air pneumatic support structure 2116 is provided a flexible bellows assembly 2120 that is pneumatically connected to a connection 2112 to the tube barb 2114. Air pressure generated from a pneumatic module, ie compressor 100, pneumatically connected to the atrial pneumatic in-connector 2111 expands the bellows. Additional injection ports may be included to provide a mechanism for injecting a dye or representative drug into various locations within the cardiovascular simulator system 10. When expanded, the bellows assembly 2120 compresses the left atrial chamber 2122. The bottoms 2124 and 2126 of the extraatrial air pneumatic support structure 2116 connect to the plates 2228 and 2230 (see FIG. 8).

The left atrial chamber 2122 is preferably made of a soft, flexible, transparent silicone that is capable of contracting and expanding. The left atrial assembly 2108 is illustrated herein to allow fluid to flow to the left ventricle at the appropriate time, ie, when the left atrium contracts, without expanding and backflowing fluid into the left atrium. 6 includes a one-way valve, shown as synthetic valve 2129. The valve 2129 represents a mitral valve and, by way of example, may be a synthetic replica. Alternatively, the valve may be an implant of a real mammalian mitral valve, such as a swine, or a human mitral valve.

With reference to FIGS. 4, 6 and 8, the left ventricle module assembly 2110 consists of a left ventricle pneumatic chamber 2130 surrounding a left ventricle chamber 2132. Left ventricular pneumatic chamber 2130 is preferably manufactured from a rigid, sturdy, clear cast plastic such as urethane. The left ventricle chamber 2132 is preferably made of a soft, flexible, clear plastic such as silicone. The first end 2134 of the left ventricular pneumatic chamber 2130 includes a flange 2136 for connection to the left atrial assembly 2108, preferably to the cardiac support structure 2137. The second end 2138 of the left ventricular pneumatic chamber 2130 includes a second flange 2140. The second flange 2140 connects to a ring 2141 sized and shaped to surround the apex 2142 of the left ventricular chamber 2132. In this example, the apex 2142 does not contract due to the rest of the left ventricular chamber 2132. In an alternative embodiment, the apex 2142 is completely surrounded by the left ventricle pneumatic chamber 2130 as shown in FIG.

As shown in FIG. 9, the left ventricle chamber 2132 does not contain the vasculature. In the alternative embodiment of FIG. 10, the left ventricle chamber 2132 includes the left coronary artery, left circumflex artery (left circumflex branch), left marginal artery (left limb branch), left anterior descending artery (left anterior descending branch) of the left ventricle chamber 2132. ), and an anatomically accurate vasculature 2144, such as a diagonal branch. The vasculature may be a "normal" vasculature, or a diseased vasculature. In addition, the normal or diseased vasculature may be adapted (by using CT scan, MRI and/or rotational angiography) to represent the exact vasculature of an individual patient, Alternatively, it may be specifically configured to represent a normal/disease state of a non-patient. Further, a portion of the left ventricle chamber 2132 includes a thicker portion 2146 (simulating ventricular hypertrophy) and/or a thinner portion 2148 (simulating ventricular failure), as shown in FIG. Different resistances of the heart to dilation may be simulated. Although not shown, such features may apply to the atrial chamber 2122 as well. The left ventricle module 2110 is fluidly connected to one or more components of the vasculature module 2200 via various connectors. For example, as shown in FIG. 5, fluid exits the left ventricle and flows to the vasculature module 2200 via a valve, shown here as a synthetic aortic valve 2150. The synthetic aortic valve 2150 may be constructed of synthetic plastic or of an animal or human aortic valve such as swine/pig. In either case, the valve 2150 is designed to allow fluid to flow in one direction at the appropriate time, ie, out of the left ventricle chamber 2132 and into the vasculature module 2200.

The vasculature module 2200 is comprised of multiple components such as synthetic tubes that provide fluid flow into and away from the heart simulator module 2100. As with the atria and ventricles, the tubing of the vasculature module 2200 may be made replicating the size, shape and tonometry of the vasculature of a particular patient. Preferably, the tube is made of a transparent medical grade plastic with a flexural modulus or rigidity that corresponds to the desired needs. Referring to FIGS. 4 and 7, fluid exits the left ventricle chamber 2132 and flows into the tubes representing the aorta 2202 and the aortic arch 2203. One or more aortic connectors, such as, but not limited to, 2204 (the subclavian artery), 2206 (the right common carotid artery), and 2208 (the brachiocephalic artery) may be coupled to other vasculature modules 2200, such as tubes representing vertebral arteries 2210. It is used to fluidly attach to the components of and of the peripheral organ/tissue module 2300 using tubing representing the left and right common carotid arteries. In addition, fluid flows to the descending aorta 2216 and connects to tubes representing the right iliac artery 2218 and the left iliac artery 2220. The fluid flow exiting the cardiac simulator module 2100 is directed through additional tubes depending on the part of the organ in which the fluid travels.

With reference to FIGS. 11 and 12, the peripheral organ/tissue module 2300 is shown as a head 2302. The head 2302 includes a bottom 2304 connected to the board 2305 and/or the top 2306 via fasteners 2308 such as screws or nuts. Such a configuration allows the upper portion 2306 to be removed or replaced. The bottom 2304 includes one or more fluid connectors 2310 and 2312 configured to fluidly connect the head 2302 to one or more components of the vasculature module 2200. Such a fluid connection allows the user to assess the effectiveness of surgical techniques or procedures on surrounding organs or tissues.

FIG. 12 illustrates a head 2302 having a plurality of tubes 2312 and 2314 representing the cerebrovascular system. The cerebrovascular system is placed within a gel-like substance 2316 to mimic the compliance of blood vessels within the subarachnoid space and the surrounding brain. The vascular system and any pathologies from the carotid bifurcation to the intracranial circulation can be replicated. Head unit 2302 may also include an additional tube 2318 connectable to other parts of cardiovascular simulator system 10.

Cardiovascular simulator system 10 may use one or more compliance chamber modules. The compliance chamber module acts as a system fluid storage device and is adapted to functionally provide compensation due to the fact that the entire vascular system is not modeled. Thus, the compliance chamber provides an anatomically correct range of cardiac system compliance and compensation if the cardiovascular simulator system 10 does not replicate the vessels of all vasculature contained within the entire human cardiovascular system. For example, the vasculature to the lower extremities, and in particular the feet, is not generally included as part of the vasculature module 2200. A compliance chamber is used to replicate accurate cardiac dynamics with anatomically accurate cardiac physiology while pumping to an imperfectly modeled vascular system. The compliance chamber simulates vascular volume and pressure measurements of non-molded parts of the system. The vascular pressure measurement can be modified by simulating arterial tone and adding or removing air from the compliance chamber. Depending on the air volume, hypertensive or hypotensive conditions can be simulated.

With reference to FIGS. 1-3B, the compliance module is shown as an accumulator and is referred to as the arterial compliance chamber 18. 13-15 illustrate some aspects of accumulators. FIG. 13 shows an accumulator 18A that is filled with gas. Accumulator 18A includes a housing unit 20 that surrounds internal cavity 22. Inside the inner cavity 22 is a rubber bladder 24 for separating the gas 26 (inserted via the gas inlet 25) and any liquid stored in the inner cavity 22. A valve may be disposed inside the exhaust port 30. Figure 14 shows a gas filled accumulator using a piston,
The accumulator is referred to as 18B. The accumulator 18B also has a housing unit 32 having an internal cavity 34. The piston 36 separates the gas 38 and the liquid in the internal cavity 34. FIG. 15 shows a piston accumulator 18C with a spring. The spring-loaded piston accumulator 18C also includes a housing unit 40 having an internal cavity 42. The piston 44 operates in the same manner as the gas-filled piston, except that the piston 44, together with the spring 46, pushes the piston against the stored liquid. Although not shown, other accumulator types known in the art may be used as well, such as, for example, a diaphragm-based accumulator. The liquid tank 12 may be configured similarly to the accumulator.

Referring again to FIG. 1, the fluid that has either flowed directly from the heart module 2100, or that has redirected back to the arterial compliance chamber 18 and returned from the arterial compliance chamber 18, includes the vasculature simulator module 2200. Directional module and/or one or more peripheral organ/tissue simulator module 2300 of anatomical module 2000. Regulation of the flow rate can be achieved by a control mechanism. For example, the flow rate of fluid entering the vasculature simulator module 2200 may be controlled by the first resistance valve 48, also referred to as the body resistance valve. Preferably, the resistance valve 48 is an electrically adjustable fluid resistance valve including a linear stepper motor and a globe valve. The resistance valve 48 can be automatically adjusted to achieve the desired flow rate into the body. The flow rate of fluid into one or more peripheral organ/tissue simulator modules, ie the head, may be controlled by a second resistance valve 50, also referred to as a head resistance valve. The second resistance valve 50 is preferably an electrically adjustable fluid resistance valve including a linear stepper motor and a globe valve. The resistance valve 50 can be automatically adjusted to achieve the desired head flow rate.

Each path, the vasculature pathway and the one or more peripheral organ/tissue pathways, includes one or more monitoring or detection mechanisms. As shown in FIG. 1, the vasculature pathway includes a first flow meter 52, also referred to as a body flow meter. The body flow meter 52 may be, for example, a paddle wheel flow meter configured to convert a volumetric flow rate into an electrical signal. This signal is used by the system controller (discussed below) to determine when a change to the setting of the flow resistance valve 48 is required to achieve the desired flow rate. The one or more peripheral organs/tissues may include a second flow meter 54, also referred to as a head flow meter. Further, the head flow meter 54 may be a paddle wheel type flow meter configured to convert the volume flow rate into an electric signal. The signal is used by the system controller to determine when a change to the setting of the second flow resistance valve 50 is required to achieve the desired flow rate. The fluid is carried back to the liquid tank 12. The check valve 56 ensures that the returned fluid flows into the liquid tank 12 while preventing backflow, ie, the opposite flow out of the liquid tank 12, and reproduces the behavior of the anatomical vein.

Fluid may be drained from the cardiovascular simulator system 10 via a drain connector, such as a Schrader type quick disconnect valve 58. The valve 58 may be connected to a drainage hose or tubing attached during the drain cycle operation. The fluid is preferably drained into a fluid holding container or container, shown as a jug 60.

Referring to FIG. 2, the cardiovascular simulator system 10 is shown with pneumatic components. The air compressor 100 is responsible for several functions within the cardiovascular simulator system 10. The air compressor 100 provides a flow of compressed air to the heart module 2100 via tubes 110 and 112. Specifically, compressed air is supplied to left atrial assembly 2108 and left ventricle assembly 2110. The control of the flow of air to the heart simulator 2100, that is, the control of the air that flows into the left atrial assembly 2108 or the left ventricle assembly 2110 and allows each component to simulate a heart beat, is controlled by one or more. Provided by the control mechanism. Control of the left atrial assembly 2108 can be accomplished using a valve, shown in FIG. 2 as the actuation solenoid valve 114, also referred to as the atrial actuation solenoid valve. When voltage is applied to the atrial actuation solenoid valve 114, compressed air from the compressor 100 is allowed to enter the bellows 2120 (FIG. 6). Such motion compresses the left atrium assembly 2108. When the atrial actuation solenoid valve 114 is powered off, pressure is released from the bellows, allowing the left atrial assembly 2108 to relax. A second actuation solenoid, also referred to as ventricular actuation solenoid valve 116, controls air to the left ventricle 2110. Energization of ventricular actuation solenoid valve 116 allows compressed air from compressor 100 to enter left ventricular pneumatic chamber 2130 (FIGS. 4-10) surrounding left ventricle 2110. This action allows the left ventricle 2110 to squeeze and expel the fluid in the left ventricle chamber 2132. When the ventricular actuation solenoid valve 116 is powered off, pressure is released from the left ventricle pneumatic chamber 2130, allowing the left ventricle 2110 to relax. Such movements simulate physiological contractions and then the heartbeat on the left side of the heart. Also, the compressed air may cause one or more portions of the heart module, such as the left ventricle chamber 2132, to move partially about its axis and more accurately simulate the heartbeat.

The air compressor 100 may be fluidly connected to the arterial compliance chamber 18 via a tube 118 to reduce the water level in the arterial compliance chamber 18. To aid in draining the fluid therein from the cardiovascular simulator system 10, the compressor 100 may be fluidly connected to the fluid tank 12 via a tube 120. Liquid can be drained via a drain disconnect valve 58 that pumps compressed air through the arterial chamber 18 and the venous chamber 12. Various control mechanisms for delivering compressed air from the compressor 100 are preferably utilized. A valve, also referred to as a venous chamber venting valve 122, is used to control the amount of air into the venous chamber 12 as well as the pressure associated therewith. For example, manipulation of the venous chamber vent valve 122, which releases air pressure from the venous chamber 12, may be used if the average venous pressure is detected to be too high. A second valve, also referred to as venous chamber pressurization valve 124, may be used to allow pressurized air to enter venous chamber 12, eg, to increase the baseline venous pressure. .. Manipulation of the venous chamber pressurization valve 124 may be used to force pressurized air through the cardiovascular simulator system 10 during the drain cycle. The pressurized air forced through the cardiovascular simulator system 10 expels fluid through the drain disconnect valve 58.

One of them, the simulation of the arterial chamber, likewise uses various control mechanisms. The valve, also referred to as arterial chamber vent valve 126, is designed to act on the hydraulic pressure in the arterial compliance chamber 18. Manipulation of the arterial chamber vent valve 126 releases air pressure from the arterial compliance chamber 18. This has the effect of allowing more water to enter the chamber, which reduces the volume of air. It also has the effect of reducing the hydraulic compliance of the arterial compliance chamber 18. A second valve, also referred to as arterial chamber pressurization valve 128, may be used to control the flow of air to the arterial compliance chamber 18. Manipulation of the arterial chamber pressurization valve 128 allows pressurized air to enter the arterial compliance chamber 18. The inflow of pressurized air drives any liquid out of the arterial compliance chamber 18. As the liquid is expelled, the volume of air in the arterial compliance chamber 18 increases, which in turn increases the compliance of the arterial compliance chamber 18. Further, the arterial chamber pressurization valve 128 may be used to force pressurized air through the cardiovascular simulator system 10 in the drain cycle. As the pressurized air travels and passes through the cardiovascular simulator system 10, any liquid in the cardiovascular simulator system 10 is expelled through the drain disconnect valve 58.

The cardiovascular simulator system 10 is designed to allow control of various parameters to be performed automatically. Such control allows the cardiovascular system to function more effectively and more accurately to represent blood flow and/or other physical characteristics. Referring to FIG. 3A, the control unit 130 is electrically connected to various components of the cardiac system via connector members 132A-132M, collectively referred to as connector members 132. The connector member 132 may be, for example, a wireless connection using Bluetooth (registered trademark) (Blue tooth (registered trademark)) technology, or a wiring such as a computer cable using a USB (Universal Serial Bus) connection, for example. It can be hardwired. The control unit is preferably a computer with the necessary software to drive or control the functions of the hardware and the various other components required for processing power, storage capacity, for example a print with the necessary integrated circuits. It may include a logic board such as a substrate, a central processing unit, RAM, ROM, and/or a hard drive. The control unit 130 must be designed to handle various system parameters measured by the body flow meter 52 and the head flow meter 54. Further, the cardiovascular simulator system 10 may include sensors 134 and 136. The sensor 134, also referred to as a venous pressure sensor, is a pressure sensor configured to convert a measurement of gauge pressure in the liquid chamber 12 into an electrical signal. The signal may be transmitted to the system control unit 130. In the system control unit 130, a decision to adjust the pressurization of the liquid chamber 12 can be made. The sensor 136, also referred to as an arterial pressure sensor, is a pressure sensor configured to convert the measured gauge pressure of the arterial compliance chamber 18 into an electrical signal. The signal may be transmitted to the system control unit 130. In the system control unit 130, an adjustment of pump operation may be determined and/or created for the heart module 2100 to achieve various system pressures, ie, representing predetermined systolic and diastolic pressures. Further, the control unit 130 may, for example, 1) set the body flow resistance valve 48, 2) set the head flow resistance valve 50, 3) the speed profile of the compressor 100, 4) the atrial actuation solenoid valve 114 and the ventricle actuator. It may be configured to use command values that affect other system operations via control of the timing and actuation of the solenoid solenoid valve 116. In addition, the control unit 130 may be programmed to work in conjunction with the arterial chamber vent valve 126 and the arterial chamber pressurization valve 128 to control the use of the compressor 100 to alter the fluid level within the arterial compliance chamber 18. And change compliance accordingly. The control unit 130 may include an information display, such as an LCD screen, for example, and may provide an interface to the user to allow manipulation of one or more parameters.

A second computing device, shown as tablet computer 138, may be used in conjunction with control unit 130. The tablet computer 138 may include the necessary hardware, such as a processor and memory, as well as the software necessary to provide a user interface for displaying one or more operations of the system and adjusting settings. .. The tablet computer 138 may be electrically connected to the control unit 130 by a wireless or hardwire connection 140. Preferably, the connection 140 is wireless and uses, for example, Bluetooth technology. However, the connection 140 may be a connection via a cable, such as a cable using a USB connection.

FIG. 3B shows a cardiovascular simulator system 10 in which a cardiac module 2100 within the cardiovascular simulator system 10 uses the electrically driven pump 141. Pump 141 provides a pulsatile flow characteristic similar to that of an anatomical heart model as described above. Such embodiments can potentially provide similar physiological pressure and flow characteristics at lower cost, smaller size, higher reliability, or better control of flow characteristics.

Referring to FIG. 16 (as well as FIGS. 4-10 in referring to particular components of the heart or vascular module), an illustrative embodiment of the cardiovascular simulator system 10 is shown. Cardiovascular simulator system 10 may include support structure 142 used to support various components of cardiovascular simulator system 10. Each of the components may be secured to the support structure using, for example, screws, nuts and bolts, or may be secured using chemical securing, such as an adhesive. Liquid stored within the liquid tank module 12 is passed through the system using a compressor 100 that forces pressurized air into the liquid tank module 12. The action of the pressurized air allows the heart simulator module 2100 to move through contraction and expansion into the blood vessel simulator module 2300 to a fluid that represents the flow of blood and to function like a human or animal myocardium. To do. The control unit 130 is designed to deliver a pulse of pressurized air to the heart module 2100. Hydraulic pressure and fluid dynamics/flows are generated by the pumping action of the heart module itself. The liquid is forced out of the liquid tank module 12 into the anatomical module 2000 and represents oxygenated blood returning from the lungs not used in the system described herein, the left and right pulmonary disease veins. Into the left atrium assembly 2108 via a tube that represents

The atrial chamber 2122 is filled with liquid, the pressure of which is measured in the systolic circuit and is, by the control unit 130, the minimum normal range (50-80 mmHg) of diastolic blood pressure of the human heart. To be controlled. The actual blood pressure obtained by the system, 120/80 (systole/diastole), is the fluid flow volume (simulated by operating the control unit 130 in association with the heart simulator module). , Heart simulated heart rate, atrial compression, ventricular compression (or ejection fraction, simulated as atrial chamber or volume of fluid ejected from the ventricular chamber), capillary resistance (of compliance chamber 18). The effect simulated by the operation) and the pressure measurement method or tension (effect simulated by the operation of the compliance chamber 18).

The cardiovascular simulator module 10 adjusts the systolic and diastolic values independently using various combinations of parameters that act to bring the systolic and diastolic values to varying degrees. Is designed. The value of diastolic blood pressure can be manipulated to values above or below the normal range to simulate various disease states using the control module. In addition to any of the components described above, the control unit 130 is shown to have one or more circuit boards, and is used herein to control printed voltage boards (PCBs) for controlling voltage sensing. ) 144 and second PCB 146. A power source 148, which may include a battery, powers the entire heart simulator system 10. Activated by the control module 130, the left atrium is contracted. Left atrial contraction is controlled by compressor 100, which controls when and how much pressurized air is forced into left atrial chamber 2128. The generated pressurized air flows through the tube into the outside air pneumatic support structure 2116 of the left atrial chamber 2122. The air causes the atrial bellows 2120 to compress the left atrial chamber 2122, reducing the volume within the left atrial chamber 2122. As a result of the reduced volume, liquid is expelled through the mitral valve 2129 and enters the left ventricular pneumatic chamber 2130.

The generated pressurized air travels through the vasculature module tubing and enters the left ventricular pneumatic chamber 2130. Pressurized fluid (pressurized air) reduces the volume within the left ventricle chamber 2132, resulting in the drainage of fluid (liquid) into the aortic arch 2203 via the synthetic aortic valve 2150. Depending on the feedback system utilized, the cardiovascular simulator system 10 is configured to adjust various physiological parameters. The pressure of the liquid can be set, for example, within the range of normal physiologically representative systolic/diastolic blood pressure. For example, the cardiovascular simulator system 10 has the following set points: 1) default 120 mmHg systolic blood pressure, 2) default 80 mmHg diastolic blood pressure, 3) default 10 mmHg venous pool pressure, 4) default 12 mL/sec blood flow, representing average head flow (whole head flow), 5) default 20 mL/sec blood flow, average chest flow (abdominal aorta, not visceral) and 6) It may include the default liquid temperature Fahrenheit 98.6 degrees. These values or set points may be modified to represent abnormal values. The set point of the physiological parameter is user adjustable. In addition, the system uses feedback control to automatically guarantee changes in the set point.

The states can be manipulated by the control unit 130 changing corresponding pressures, volumetric flow rates, ejection fractions, or a combination thereof as the liquid moves through the system. The fluid expelled from the left ventricular chamber is pressurized and represents or simulates various portions of ventricular tissue such as, for example, the vertebral artery, the left common carotid artery, and the right common carotid artery. ) Flow through the tube. The liquid also flows into the descending aorta and enters the right and left iliac arteries. As such, the cardiovascular simulator system 10 adjusts the volume of pressurized air generated by the compressor 100 and used to compress the atria and ventricles to determine the average systolic and diastolic blood pressure. Is configured to adjust. A time-varying air flow rate (as opposed to a constant flow rate) within the cycle is preferably generated. Adjusting the pressure differential between typical systolic and diastolic blood pressure is accomplished by adjusting the volume of air in the arterial compliance chamber 18 (and consequently hydraulic compliance). Adjustment of the resistance valve provides typical head and chest flow regulation. The flow meter is preferably located in a representative venous segment rather than a typical arterial segment of the system. Therefore, the flow at the flow meter is continuous rather than pulsating and adjustments to average flow rather than ejection fraction or peak flow may be utilized.

With respect to heating the liquid, the heater surface temperature and the replicator liquid temperature are determined by the control unit 130 heating the liquid to a desired temperature while ensuring that the heater surface temperature does not exceed a predetermined upper limit. It can be determined and controlled.

Finally, all the liquid is returned to the liquid tank 12 whose flow rate is adjusted. The tension of blood vessels is, for example, through the use of compliance valves and resistance valves, as well as through a vasculature simulator module that represents arteries that are molded into molds and have various durometer values, and the like. Can be simulated and adjusted via several mechanisms. Although not shown, fluid flow may be directed to the peripheral organ/tissue module, namely the head 2302 and its representative vasculature tube. When used as part of the cardiac simulator system 10, the head 2302 may be secured to the support structure frame 142 via the head support structure 150. The head 2302 may include a quick connect connector that connects/disconnects to the support structure frame 142 quickly and easily to allow angle conversion. Thus, the liquid returns to the tube representing the lung tissue and eventually returns to the heart module 2100 to begin a new cycle.

Body resistance valve 48, head resistance valve 50, body flow meter 52 and head flow meter 54 may be housed within housing structures 152, 154, 156 and 158. Compliance control valves such as venous chamber vent valve 122, arterial chamber pressurization valve 126, and/or arterial chamber pressurization valve 128 may be housed within housing structure 160.

As mentioned above, abnormal cardiac conditions are caused by air bursts generated by the atrial/ventricular assembly through the command sent from the control unit and the coordination of various structures within the system to cause such changes. burst) of different forces, times, and frequencies.

All patents and publications mentioned herein are indicative of the level of ordinary skill in the art to which this invention belongs. All patents and publications are hereby incorporated by reference to the same extent as if each individual publication was specifically and individually incorporated by reference. Included in the specification.

While some forms of the invention have been shown, it should be understood that the invention is not limited to the particular forms or arrangements described or shown herein. It should be considered that various modifications can be made without departing from the scope of the present invention, and that the present invention is not limited to what is shown and described in the detailed description of the invention and the drawings included in the specification. It will be apparent to those skilled in the art.

Those skilled in the art will readily understand that the present invention is appropriately adapted to attain the objects and obtain the above-described results and benefits, and those inherent in the invention. The embodiments, methods, procedures and techniques described herein are representative of preferred embodiments at the time of filing and are exemplary and are not intended to limit the scope of the invention. Variations and other uses that will occur to those skilled in the art are within the spirit of the invention and are defined by the scope of the claims. Although the present invention has been described with reference to particular preferred embodiments, the invention as claimed should not be unduly limited to such particular embodiments. Various modifications of the disclosed modes for carrying out the invention that are obvious to those skilled in the art are within the scope of the following claims.

Claims (19)

A system for simulating a human or other mammalian cardiovascular system in which one or more operating parameters are automatically controlled without the need for manual adjustment,
Operable in a closed loop pneumatic feedback circuit designed to generate or move pneumatic fluid in the system and a closed loop hydraulic feedback circuit designed to move hydraulic fluid in the system A closed loop pneumatic feedback circuit or the closed loop hydraulic feedback circuit is operably connected to a cardiac system module including an atrial actuator and a ventricular actuator, the computer-based control unit The unit receives or processes data obtained from a plurality of sensors installed in the system, and based on the received or processed data, at least one of the atrial actuator or the ventricular actuator. Is configured to make the component work,
At least one sensor disposed in the system is configured to detect or respond to a change in one or more parameters of the closed loop pneumatic feedback circuit,
At least one sensor disposed within the system is configured to detect or respond to a change in one or more parameters of the closed loop hydraulic feedback circuit,
The atrial actuator includes a rigid outer case sized and shaped to house a pressurized air carrying device and fluidly connected to a flexible fluid-filled inner chamber. And the inner chamber filled with fluid (liquid) contracts when the pressure of the pressurized fluid is exerted to discharge the stored fluid (liquid), and when the pressurized fluid is removed. Configured and arranged to extend to
The ventricular actuator includes a flexible ventricular assembly inner member formed in an irregular shape, the ventricular assembly inner member storing the fluid (liquid) therein and, in addition, a hard ventricular assembly outer member. Surrounded by a member, the inner chamber member of the ventricle assembly and the outer member member of the hard ventricle assembly are separated by a space therebetween, and a pressurized fluid inserted into the space applies force to the inner member of the flexible ventricle assembly. By exerting, the flexible ventricle assembly inner member expels the fluid (liquid) stored therein,
The computer-based control unit provides a physiologically accurate representation of the cardiovascular system under normal or diseased conditions, wherein one or more operating parameters are automatically controlled without the need for manual adjustment. A system characterized by The system of claim 1, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment. A system comprising at least one resistance valve configured to regulate. The system of claim 2, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment, wherein the resistance valve is electronically adjusted. A system characterized in that it is a possible fluid valve. The system of claim 1, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment, the control unit comprising: The system is configured to control the timing or speed at which the pressurized air is generated in. The system of claim 1, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment, the closed loop pneumatic feedback circuit or the system. A closed loop hydraulic feedback circuit having at least one vascular system adapted to have arterial or venous properties of a human or other mammal and fluidly connected to at least one portion of the cardiac system module. A system characterized in that it is further operably connected to the module. The system of claim 5, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment, the system further comprising a head module, said head module comprising: The head module comprises a plurality of tubes held in a gel and fluidly connected to the cardiac system module or the vascular system module. 7. The system of claim 6, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment of fluid entering the head module. A system comprising at least one resistance valve configured to regulate a flow rate. The system of claim 1, wherein one or more operating parameters are automatically controlled without the need for manual adjustment to simulate a human or other mammalian cardiovascular system, wherein the fluid is not associated with a head module. Further comprising at least one flow meter configured to convert a volumetric flow rate into an electrical signal, or at least one flow meter configured to convert a volumetric flow rate of a fluid associated with the head module into an electrical signal. A system characterized by that. The system of claim 1, wherein one or more operational parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment, the at least one portion of the atrial actuator. And a pneumatic supply device fluidly connected to at least one portion of the ventricular actuator and configured to supply pressurized or compressed air. The system of claim 1, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment. The system, further comprising a fluid (liquid) tank configured to receive. The system of claim 1, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment. The system further comprising a heating device configured to heat the. The system of claim 1, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment, wherein the fluid is blood. A system characterized by being adapted to have characteristics. The system of claim 1, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment, the system operating on the computer-based control unit. A system further comprising a computing device operably connected. 14. The system of claim 13, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustments, wherein the computing device is computer-based. A system characterized by being connected wirelessly to a control unit. The system of claim 1, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment. The chamber is an anatomical model of the patient's atrium. The system of claim 1, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment. The system is characterized in that the member is anatomically modeled on the ventricle of the patient. The system of claim 1, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment, the operating parameters of the system comprising: Controlled or modified by the computer-based control unit, the operating parameters are simulated heart rate, simulated blood pressure, simulated ejection fraction, simulated body vascular resistance or extensibility, simulated A system characterized by the temperature of the installed system, or a combination thereof. The system of claim 1, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment, the vessel being in a normal or diseased state. further comprising a adapted compliance chamber to simulate the compliance of the system, the compliance chamber and incompressible fluid in the first side, movable separating and compressibility of the fluid on the second side, the System including a closed storage tank having a flexible barrier. The system of claim 1, wherein one or more operating parameters are automatically controlled to simulate a human or other mammalian cardiovascular system without the need for manual adjustment. Detecting or in response to a change in one or more parameters of the at least one sensor or the closed loop hydraulic feedback circuit configured to detect or respond to a change in one or more parameters. The at least one sensor configured to be responsive to monitor temperature, pressure or flow within the system to provide a physiological representation of a characteristic of a human or mammalian cardiovascular system. ..

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