Simulation system for extracorporeal membrane oxygenation (ECMO) treatment

Abstract

The present invention discloses a simulation system for Extracorporeal Membrane Oxygenation (ECMO) treatment, wherein the system comprises a drainage line and a return line configured to be connected to an ECMO apparatus. The system further comprises a valve subsystem including one or more electrically actuated valves for regulating fluid flow, wherein said valves are configured to be connected to the drainage and / or return lines. Additionally, the system comprises means for monitoring pressure and / or fluid flow in the drainage and / or return lines, and a control subsystem in communication with the valve subsystem and with the means for monitoring pressure and / or fluid flow. This control subsystem is configured to control pressure and / or flow in said lines through the valve subsystem and the monitoring means. The system also comprises a control display or first display, in communication with the control subsystem or comprising said control subsystem, wherein said display is configured to show one or more simulated patient parameters, one or more simulated or real ECMO apparatus parameters, and one or more pressure and / or flow parameters of the drainage and / or return lines. Moreover, the control display or first display is configured to show an interactive element for setting a target pressure or target flow, and the control subsystem is configured to control the valve subsystem in order to achieve said target pressure or target flow in the drainage and / or return lines.

Description

[0001] EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) TREATMENT SIMULATION SYSTEM

[0002] Technical field of the invention

[0003] The present invention pertains to the field of medical simulation and training in life support technologies. It relates specifically to treatment simulators for extracorporeal membrane oxygenation (ECMO). More precisely, this invention is an advanced ECMO simulation system comprising physical sensing and control components, event generators, and digital components.

[0004] Background of the invention

[0005] Extracorporeal membrane oxygenation (ECMO) is an advanced life support technique used in patients with severe heart or respiratory failure who do not respond to conventional treatments. This technology provides prolonged cardiopulmonary support, allowing the lungs and heart to recover, by removing blood from the patient, oxygenating it, and returning it to the circulatory system. The use of ECMO has increased in recent years, especially in critical situations such as acute respiratory failure secondary to pneumonia and in cases of cardiogenic shock and refractory cardiac arrest.

[0006] Given the complexity of ECMO management, it is essential that medical personnel be adequately trained in its use. Training healthcare professionals in the use of ECMO using treatment simulators is crucial to ensuring competence in emergency situations and reducing the risk of complications. Simulators allow staff to practice in a controlled and safe environment, replicating a wide variety of clinical scenarios that may arise during actual treatment. Most current simulators are entirely digital and accessed via a computer or website. However, it is essential for providing proper training that these simulators have a physical component that allows for adequate simulation of the healthcare professional's interaction with the ECMO machine, drainage and return lines, cannulation, and so on.Face-to-face simulation-based training is an essential element within the training process, according to the recommendations of the international society ELSO.

[0007] Currently, there are several ECMO simulators on the market, which vary in their ability to replicate real-life situations. Most of these devices focus on providing a basic representation of ECMO operation and are designed to familiarize users with the system's components and flow, generally from a completely virtual perspective.

[0008] Because they lack a physical device or hardware, current simulators cannot accurately capture the real-world values ​​of a functioning ECMO machine. On the other hand, those that do have a physical device lack the ability to directly modify crucial parameters, such as the pressure in the lines connected to the ECMO machine, at will, limiting users' ability to learn and respond to dynamic changes in real time.

[0009] Finally, existing simulators are too simplistic and do not allow for realistic physical simulation of complex situations. For example, they cannot simulate events related to cannulation, air entry into the system or emboli, bleeding, or oxygenation levels in drainage and / or return lines, among other possible events. Furthermore, they are static devices that are not easily moved to different locations, and therefore do not allow for the simulation of transport or mobile scenarios. Not only that, current devices are also incomplete, as they do not include relevant parameters such as mechanical ventilation among the patient variables that influence the system's response, nor do they allow for the integrated display of imaging tests or the generation of simulated scenarios. Finally, these systems are not compliant with ELSO (Extracorporeal Life Support Organization) guidelines.The lack of realism in these devices, generated by the aforementioned shortcomings, means that students cannot develop practical skills to deal with critical events that may occur during actual ECMO treatment.

[0010] Therefore, there is a clear need to develop an ECMO treatment simulation solution that adequately addresses these limitations and overcomes the current challenges in the state of the art.

[0011] Summary of the invention

[0012] Given the importance of extracorporeal membrane oxygenation (ECMO) in the treatment of patients with severe heart or respiratory failure, there is an urgent need for an innovative solution that addresses the aforementioned limitations. This solution must provide a simulator that combines physical and digital components to accurately replicate the real-world conditions of a functioning ECMO machine. Furthermore, it must allow for the dynamic modification of crucial parameters such as line pressure and simulate complex scenarios such as cannulation, air entry into the system, embolisms, and other critical events. This invention presents a system that successfully addresses and overcomes the aforementioned limitations in the simulation of extracorporeal membrane oxygenation (ECMO) treatment.The invention's system is an automated system capable of regulating and monitoring flow and pressure in the drainage and return lines connected to an ECMO machine, enabling accurate and realistic treatment simulation. This system includes a subsystem of electrically actuated valves to control fluid flow, means for monitoring pressure and flow, and a control subsystem that communicates with these components. The first screen displays one or more parameters of the simulated patient, the ECMO machine, and the drainage and return lines, as well as interactive events for establishing target pressures and flows. This innovative system allows for the simulation of complex situations and the practice of critical skills in a controlled environment, significantly improving medical staff training and reducing the risk of complications in real-life treatments.

[0013] A first aspect of the invention discloses a simulation system for Extracorporeal Membrane Oxygenation (ECMO) treatment. This system comprises:

[0014] A drain line and a return line configured to be connected to an ECMO machine.

[0015] A valve subsystem comprising one or more electrically actuated valves for regulating fluid flow, wherein the one or more valves are configured to be connected to drain and / or return lines.

[0016] Means for monitoring pressure and / or fluid flow in drain and / or return lines.

[0017] A control subsystem in communication with the valve subsystem and with the means for monitoring pressure and / or fluid flow, wherein the control subsystem is configured to control the pressure and / or flow in the drain and / or return lines through the valve subsystem and said means for monitoring pressure and / or fluid flow.

[0018] A first screen in communication with or comprising the control subsystem, wherein the first screen is configured to display one or more simulated patient parameters; one or more simulated or real ECMO equipment parameters; and one or more pressure and / or flow parameters of the drainage and / or return lines.

[0019] The first screen is further configured to display an interactive element for setting a target pressure or a target flow, and the control subsystem is further configured to control the valve subsystem to achieve said target pressure or target flow in the drain and / or return lines. In a preferred embodiment of the first aspect of the invention, the first screen and / or the user screen are further configured to display mechanical ventilation parameters.

[0020] In a preferred embodiment of the first aspect of the invention, the means for monitoring fluid pressure and / or flow in drain and / or return lines comprise a sensor subsystem comprising one or more pressure or flow sensors configured to monitor fluid pressure and / or flow in drain and / or return lines.

[0021] In an alternative embodiment of the first aspect of the invention, the means for monitoring the pressure and / or fluid flow in the drain and / or return lines comprise a camera in communication with the first display and / or with the control subsystem, wherein the camera is configured to read pressure and / or flow parameters from the ECMO equipment using optical character recognition (OCR) technology.

[0022] In a preferred embodiment of the first aspect of the invention, the first display is further configured to show an interactive element for setting a target time, wherein the target time is associated with the interactive element for setting a target pressure or a target flow, and the control subsystem is configured to control one or more valves to achieve the target pressure or target flow at said target time in the drain and / or return lines.

[0023] In a preferred embodiment of the first aspect of the invention, all parameters displayed on the first screen are modifiable manually or programmatically.

[0024] In a preferred embodiment of the first aspect of the invention, the first screen is configured to display one or more actual parameters of the ECMO equipment, and wherein the system is connected to the ECMO equipment by cable or wirelessly and the actual parameters of the ECMO equipment displayed on the first screen are obtained from the ECMO equipment through said connection

[0025] In a preferred embodiment of the first aspect of the invention, the system further comprises a signaling subsystem that emits one or more visual and / or acoustic signals, wherein the first screen of the system is further configured to display at least one interactive element for signal emission.

[0026] In a more preferred embodiment of the first aspect of the invention, the signaling subsystem comprises one or more light sources that illuminate and / or change the color of the drain and / or return lines. In a preferred embodiment of the first aspect of the invention, the system comprises a processor communicating with a memory, where the memory comprises instructions executable by the processor which, when executed by the processor, cause said processor to perform at least the following task: automatically calculate and adjust the change in diameter of the connection of the valve subsystem to the drain and / or return lines to change the pressure parameters displayed on the first screen. Where the connection may be the internal light of said valves, through which the fluid may circulate.

[0027] In a preferred embodiment of the first aspect of the invention, the one or more simulated patient parameters comprise one or more of the following parameters: electrocardiogram (ECG), cardiac rhythms, heart rate (HR), arterial blood pressure (ABP), ABP modified by intra-aortic balloon pump, ABP modified by pathological cardiac rhythms, central venous pressure (CVP), pulmonary artery pressure (PAP), central venous oxygen saturation (ScvO2), mixed venous oxygen saturation (SvO2), cardiac output (CO), cardiac index (Cl), stroke volume variability (SVV), pulmonary capillary wedge pressure (PCWP), left atrial pressure (LAP), systemic vascular resistance (SVR), pulmonary vascular resistance (PVR), peripheral oxygen saturation (SpO2), respiratory rate, total, compulsory and / or spontaneous respiratory rate, inspiratory tidal volume (Vti), expiratory tidal volume (Vte), fraction of inspired oxygen (FiO2),end-expiratory carbon dioxide level (EtCO2), plateau pressure (Pplat), positive end-expiratory pressure (PEEP), inspiratory pressure (IP), peak pressure (Ppeak), driving pressure (DP), pressure support (PS), respiratory system resistance and compliance (Crs), airflow and FiO2 through high-flow nasal cannula system, volume-controlled ventilation mode, pressure-controlled ventilation mode, spontaneous ventilation mode, partial pressure of oxygen in arterial blood (PaO2), partial pressure of carbon dioxide in arterial blood (PaCO2), blood pH, bicarbonate (HCO3-), lactate, hematocrit (He) and / or hemoglobin (Hb) levels, potassium (K+) levels, sodium (Na+) levels, calcium (Ca++) levels, core body temperature, skin temperature, activated clotting time (ACT), near-infrared spectroscopy (NIRS), bispectral index (BIS), waves of electroencephalogram (EEG),spectral matrix, train of four (TOF), somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), intracranial pressure (ICP), cerebral tissue oxygenation (CtO2), cerebral blood flow (CBF), jugular venous oxygen saturation (SjvO2) and / or cerebral perfusion pressure (CPP).

[0028] In a preferred embodiment of the first aspect of the invention, the one or more simulated or actual ECMO equipment parameters comprise one or more of the following parameters: pressure of one or more drainage lines, pressure of one or more return lines, percentage of drainage line occlusion, percentage of return line occlusion, blood flow in the general and accessory lines for the one or more drainage lines and / or the one or more return lines, gas flow, gas oxygen fraction (FDO2), ECMO equipment data, SvO2, color of drainage line, color in return line, circuit temperature (Te), pre-membrane pressure, post-membrane pressure, transmembrane pressure (delta P).

[0029] In a preferred embodiment of the first aspect of the invention, the system comprises a user display, or second display, in wireless or wired communication with the first display and / or with the control subsystem, wherein the user display is configured to show patient parameters and actual or simulated ECMO equipment parameters.

[0030] In a preferred embodiment of the first aspect of the invention, the system further comprises a bleeding subsystem configured to simulate bleeding by means of the output of simulated blood from an internal reservoir, preferably where the simulated blood flows into one or more cannula insertion areas or any location of a patient simulator, wherein the first screen of the system is further configured to display an interactive element to activate the output of simulated blood.

[0031] In a preferred embodiment of the first aspect of the invention, the system further comprises a bubble-generating subsystem in wireless or wired communication with the control subsystem or with the first display, and in fluid communication with at least one of the drain or return lines, wherein the bubble-generating subsystem is configured to generate bubbles in at least one of the drain or return lines, and wherein the first display of the system is further configured to display an interactive element to activate bubble generation in the drain and / or return lines.

[0032] In a preferred embodiment of the first aspect of the invention, the one or more simulated patient parameters, the one or more simulated or real ECMO equipment parameters, the one or more pressure and / or flow parameters of the drainage (7) and / or return (8) lines, and the interactive element for setting a target pressure or a target flow (430), are comprised in a first graphical interface (200) configured to be displayed on the first screen (2).

[0033] In a preferred embodiment of the first aspect of the invention, the system further comprises one or more adaptable cannulas and / or one or more tubes of adaptable lengths, configured to allow the drainage and return lines to be connected to different extracorporeal life support devices.

[0034] In a preferred embodiment of the first aspect of the invention, the system further comprises a battery to allow the system to be used without being connected to the electrical grid. In a preferred embodiment of the first aspect of the invention, the system further comprises a wireless connectivity subsystem communicating with the control subsystem.

[0035] In a preferred embodiment of the first aspect of the invention, the control subsystem, the valve subsystem, and the sensor subsystem are comprised in an event-generating box configured to seamlessly connect to the drain and / or return lines.

[0036] In a preferred embodiment of the first aspect of the invention, the system further comprises at least one infusion bag connected to the valve subsystem and / or the event generator box via a continuation of the drain line and / or via a continuation of the return line.

[0037] In a preferred embodiment of the first aspect of the invention, the first screen and / or the user screen are further configured to display blood gas images, graphs of analytical variables, conventional radiography images, clinical reports, ultrasound videos, computed tomography videos, manuals and / or scientific articles.

[0038] In a preferred embodiment of the first aspect of the invention, at least one of the one or more simulated patient parameters is associated with the pressure and / or fluid flow values ​​monitored in the drainage and / or return lines, preferably where these parameters are ABP, SpO2, SvO2 and / or NIRS, more preferably where these parameters are SpO2, SvO2 and NIRS in veno-venous ECMO treatment simulations, and ABP, SvO2 and NIRS in veno-arterial ECMO treatment simulations.

[0039] In a preferred embodiment of the first aspect of the invention, the drainage and / or return lines have a length suitable to accommodate different cannulation configurations, where such cannulation configurations comprise femoral-jugular, jugular-femoral, femoral-femoral and double lumen configurations.

[0040] In a preferred embodiment of the first aspect of the invention, the first screen and / or the user screen are further configured to display one or more pre-programmed training scenarios or configurations that programmatically control the value of at least one of the following parameters: one or more simulated patient parameters, one or more simulated ECMO equipment parameters, and / or one or more pressure and / or flow parameters of the drainage and / or return lines. Additionally, it may also control the valve subsystem, the signaling subsystem, the bubble generator subsystem, and / or the bleeding subsystem.

[0041] In a preferred embodiment of the first aspect of the invention, the first display and / or the user display are configured to show one or more simulated electrocardiogram waveforms in at least one of the following situations: sinus rhythm, asystole, ventricular tachycardia, ventricular fibrillation, atrial fibrillation, 2:1 atrial flutter, 3:1 atrial flutter, first-degree atrioventricular block, second-degree type I atrioventricular block, second-degree type II atrioventricular block, complete atrioventricular block, torsades de pointes, and / or diseased sinus node.

[0042] In a more preferred embodiment of the first aspect of the invention, at least one of the simulated electrocardiogram curves comprises at least one of the following variations: ventricular extrasystole, supraventricular extrasystole, ST segment elevation, ST segment depression, presence of pacemaker with ventricular stimulation, presence of 1:1 intra-aortic balloon counterpulsation, presence of 2:1 intra-aortic balloon counterpulsation and / or presence of 3:1 intra-aortic balloon counterpulsation.

[0043] In a preferred embodiment of the first aspect of the invention, the first display and / or the user display are configured to show a simulated blood pressure curve without pulse pressure in patients with a heart rate substantially equal to 0, and / or in cases of asystole or ventricular fibrillation, preferably automatically adapted to the ECMO equipment flow.

[0044] In a preferred embodiment of the first aspect of the invention, the first display and / or user display are configured to show at least one simulated ABP curve and one simulated SpO2 curve, wherein the amplitude of one of these two simulated curves is proportional to the amplitude of the other mentioned curve.

[0045] In a preferred embodiment of the first aspect of the invention, the valve subsystem comprises an actuator configured to perform intermittent openings and closings in at least one of the drainage or return lines, configured to generate an oscillating drainage effect suitable for simulating real clinical situations.

[0046] In a preferred embodiment of the first aspect of the invention, the first screen and / or the user screen are configured to display a cardiopulmonary resuscitation scenario with ECMO support (ECPR).

[0047] In a more preferred embodiment of the first aspect of the invention, said ECPR scenario comprises displaying on said first screen and / or the user screen simulated or real brain and / or lower limb near-infrared (NIRS) spectroscopy values.

[0048] In a more preferred embodiment of the first aspect of the invention, said ECPR scenario further comprises displaying on the first screen and / or the user screen a simulated invasive blood pressure curve automatically adapted to the ECMO equipment flow (5) and, preferably, to SpO2 levels.

[0049] In a more preferred embodiment of the first aspect of the invention, said ECPR scenario further comprises displaying on the first screen and / or user screen the frequency and / or depth of compressions generated by an external or simulated automatic or manual chest compression device in communication with the system and modifying, in a manner synchronized with said data, the amplitude and frequency of a simulated invasive blood pressure curve displayed on said first screen and / or user screen.

[0050] In a more preferred embodiment of the first aspect of the invention, said ECPR scenario further comprises displaying on the first screen and / or the user screen one or more simulated electrocardiogram curves corresponding to shockable rhythms, non-shockable rhythms and / or ST segment elevation rhythms.

[0051] In a preferred embodiment of the first aspect of the invention, wherein the first screen and / or the user screen (3) are configured to display one or more medical images corresponding to clinical tests, selected from the list comprising: a computed tomography image, a static electrocardiogram image, an echocardiography video, a chest x-ray image of pulmonary edema or aspiration pneumonia, a tracheal aspirate culture result image and / or an electroencephalogram (EEG) image.

[0052] In a preferred embodiment of the first aspect of the invention, the first display and / or the user display are configured to show a simulated blood pressure curve with an intra-aortic balloon pump effect, where said effect comprises the appearance of waves synchronized with the cardiac cycle or with a simulated intra-aortic balloon pump generator.

[0053] In a preferred embodiment of the first aspect of the invention, the first screen and / or the user screen are configured to allow the adjustment of mechanical ventilation parameters based on predefined clinical situations, comprising at least one pulmonary edema scenario and one aspiration pneumonia scenario.

[0054] Brief description of the drawings

[0055] To allow a better understanding of the present disclosure, and to show how the present disclosure may be carried out, reference will now be made, by way of example only, to the accompanying schematic drawings, in which: Figure 1 shows a schematic diagram of the components of the system of the invention according to one or more embodiments of the invention.

[0056] Figure 2 shows a top view of an event generator box and its connections, according to one or more embodiments of the invention.

[0057] Figure 3 shows a schematic representation of an event generator box connected by a drain line and a return line to an ECMO machine and an infusion bag, according to one or more embodiments of the invention.

[0058] Figure 4 shows a schematic representation with realistic elements of an event-generating box of the system of the invention connected by a drain line and a return line to an ECMO machine and an infusion bag, where it is further shown that the drain and return lines comprise the signaling subsystem integrated therein, and the control and user screens are shown, according to one or more embodiments of the invention.

[0059] Figure 5 shows a schematic representation of a first graphical interface arrangement for the first screen of the system according to one or more embodiments of the invention.

[0060] Figure 6 shows a schematic representation of a second graphical interface arrangement for the system user screen according to one or more embodiments of the invention.

[0061] Figure 7 shows a photograph of the system of the invention according to one or more embodiments, wherein said system comprises an event-generating box located between the legs of a patient model, wherein said box is connected to an ECMO machine and an infusion bag via return and drainage lines, which comprise integrated signaling means (LED lights), and wherein the user display can be seen at the top of the image.

[0062] Figure 8 shows another photograph of an event-generating box according to one or more embodiments of the system of the invention, where said box is located between the legs of a patient model, and where said event-generating box is connected to an ECMO machine and an infusion bag via return and drainage lines. Description of the invention

[0063] Definitions

[0064] It should be noted that, as used herein, the singular forms "a," "an," "the," and "the" include plural references unless the context clearly indicates otherwise. Furthermore, unless otherwise stated, the expression "at least" preceding a series of items shall be understood to refer to all items in the series. Those skilled in the art will recognize, or be able to determine using nothing but routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be covered by the present invention.

[0065] It should be noted that the term "approximately", as used herein, refers to + / - 30%, preferably + / - 20%, preferably + / - 15%, more preferably + / - 10%, of the stated value to which reference is made.

[0066] As used herein, the conjunction "and / or" between multiple recited elements is understood to encompass both individual and combined options. For example, when two elements are joined by "and / or," a first option refers to the applicability of the first element without the second. A second option refers to the applicability of the second element without the first. A third option refers to the joint applicability of the first and second elements. Any one of these options is understood to be included within the meaning and thus satisfy the requirement of the term "and / or" as used herein. It is also understood that the concurrent applicability of more than one of the options is included within the meaning and thus satisfies the requirement of the term "and / or."

[0067] Throughout this specification and the claims that follow, unless the context otherwise requires, the word "comprises," and variations such as "comprising" and "comprising," shall be understood to imply the inclusion of an integer or step or group of integers or steps, but not the exclusion of any other integer or step or group of integers or steps. When used herein, the term "comprises" may be substituted for the term "contains" or "includes," or, sometimes, when used herein, for the term "having." Any of the foregoing terms (comprising, containing, including, having), whenever used herein in the context of an aspect or embodiment of the present invention, may be substituted for the term "consisting of," although less preferred.When used herein, "consisting of" excludes any element, step, or ingredient not specified in the claim. When used herein, "consisting essentially of" does not exclude materials or steps that do not materially affect the basic and novel characteristics of the claim.

[0068] The term “Extracorporeal Membrane Oxygenation (ECMO) therapy,” in the context of the invention, refers to an advanced medical procedure used to provide cardiac and respiratory support to patients whose critical conditions prevent their hearts and lungs from functioning properly. This therapy involves circulating the patient’s blood through a device that adds oxygen and removes carbon dioxide before returning the oxygenated blood to the body. The ECMO system or device comprises several components, including a pump, a membrane oxygenator, drainage and return lines, and control systems that ensure the maintenance of appropriate physiological parameters during therapy.

[0069] The term “extracorporeal membrane oxygenation (ECMO) treatment simulation,” in the context of the invention, refers to a simulation or training system that replicates the ECMO procedure by incorporating physical and digital components to provide a comprehensive and realistic simulation. Thus, the system of the invention may comprise physical, electromechanical, and / or hydraulic elements such as drainage and return lines, valves, and pressure and flow sensors, which can obtain real parameters from the ECMO machine or the drainage and return lines, as well as adjust and reflect the changes in blood pressure and flow that would occur in an actual ECMO treatment.Furthermore, the system includes digital components, preferably a primary screen and a secondary or user screen, which display parameters for the patient, ventilator, and ECMO machine, and in the case of the primary screen, allow for their modification. These parameters can be digitally simulated or obtained in real time from sensors and devices connected to the system, such as an actual ECMO device or ventilator, enabling a faithful and adjustable representation of the clinical environment.

[0070] The term “drainage line,” in the context of the invention, refers to a flexible or rigid conduit designed to fluidly connect the system of the invention to an ECMO device. This line simulates the fluidic communication of blood between a patient and the ECMO device, thereby transporting fluid to the Extracorporeal Membrane Oxygenation (ECMO) system. Additionally, an infusion bag may be connected to the system of the invention via this drainage line or an extension thereof. The drainage line represents the portion of the extracorporeal circuit that allows for the continuous and controlled removal of blood for oxygenation and carbon dioxide removal from the body.

[0071] The term “return line,” in the context of the invention, refers to a flexible or rigid conduit designed to fluidly connect the system of the invention to an ECMO device. This conduit simulates the fluidic communication of blood between a patient and the ECMO device, thereby transporting fluid from the Extracorporeal Membrane Oxygenation (ECMO) system to the system of the invention. Additionally, an infusion bag may be connected to the system of the invention via this return line or an extension thereof. The return line represents the portion of the extracorporeal circuit that allows for the reinfusion of oxygenated blood into the patient.

[0072] The term “electrically actuated valves,” in the context of the invention, refers to flow control devices that can be operated by electrical signals. These valves are integrated into the ECMO simulation system to regulate blood pressure and flow within the drainage and return lines, preferably responding to commands from the control subsystem. Such valves may be fluidically connected to the drainage or return lines, allowing fluid to pass through the valve, for example, to control the flow within it by opening or closing. Alternatively, the valves may be externally connected to the lines, actuated by mechanisms that, for example, clamp or constrict the lines to regulate fluid flow.These configurations allow for precise and versatile control of blood flow in the simulation system, faithfully replicating the conditions and responses that would occur in a real clinical environment.

[0073] The term “control subsystem,” in the context of the invention, refers to one or more electronic components configured to control pressure and / or flow in the drain and / or return lines through the valve subsystem and means for monitoring fluid pressure and / or flow, such as pressure and / or flow sensors. This subsystem, therefore, functions similarly to a PID control system, continuously controlling pressure and / or flow to maintain desired values. The control subsystem may comprise an integrated circuit, a microcontroller, and / or a processor, which may be housed in an event-generating box along with other system elements such as valves and sensors, or it may be integrated into a front panel or a remote server. The valves and sensors may be controlled by said control subsystem using digital or analog components.The term “target pressure,” in the context of the invention, refers to a pressure value that is desired to be achieved and maintained within the drainage and / or return lines or the ECMO system. This value is communicated to the control subsystem, which uses sensors to monitor the actual pressure and valves to adjust the fluid flow, thus allowing the target pressure to be achieved and maintained. Preferably, this target pressure value is entered manually by the instructor or automatically through pre-programmed scenarios, which can modify these values ​​based on time or the occurrence of events.

[0074] The term “target flow,” in the context of the invention, refers to a desired flow rate that is to be achieved and maintained within the drainage and / or return lines or the ECMO system. This value is communicated to the control subsystem, which uses sensors to monitor the actual flow and valves to adjust the fluid flow, thus enabling the target flow to be achieved and maintained. Preferably, this target flow rate is entered manually by the instructor or automatically through pre-programmed scenarios, which can modify these values ​​based on time or the occurrence of events.

[0075] The term “interactive element,” in the context of the invention, refers to any event, action, or interaction that the user / instructor can generate using control elements available in the simulation system. These elements may include buttons, dials, and digital or analog controls, preferably integrated into the first screen or the main graphical interface of that screen. For example, interactive elements may be numbers that are directly editable or connected to increment or decrement buttons. In some embodiments, these elements may allow the user to set parameters such as target pressure or target flow, and / or initiate specific simulations such as bleeding, plunger, or bubble simulations, or change the color or lighting of the drain and / or return lines.

[0076] The term “simulated patient parameters,” in the context of the invention, refers to the various physiological metrics that can be simulated, monitored, and / or adjusted within the simulation system to replicate the state of a real patient. These parameters can be pre-programmed, digitally edited, or detected by sensors or medical instruments, and can encompass cardiorespiratory, neurophysiological, and / or other health indicators. For example, simulated patient parameters may preferably include electrocardiogram (ECG), arterial blood pressure (ABP), peripheral oxygen saturation (SpO2), heart rate (HR), central venous pressure (CVP), pulmonary artery pressure (PAP), mixed venous oxygen saturation (SvO2), respiratory rate, expiratory tidal volume (Vte), positive end-expiratory pressure (PEEP), and / or inspiratory pressure (IP).

[0077] The term “ECMO device parameters,” in the context of the invention, refers to various operational and performance metrics that can be monitored and adjusted within the ECMO simulation system, representing or replicating the operation of an ECMO device. These parameters can be simulated or captured in real time and comprise data relevant to the control and monitoring of the treatment.For example, ECMO equipment parameters may include the pressure of one or more drainage lines, the pressure of one or more return lines, the percentage of occlusion of the drainage and return lines, the blood flow in the drainage and return lines, the gas flow, the fraction of oxygen in the gas (FDO2), the angular velocity data of the ECMO equipment, the mixed venous oxygen saturation (SvO2), the color of the drainage and return lines, the circuit temperature, the pre-membrane pressure, the post-membrane pressure, the transmembrane pressure (delta P), hematocrit (He) and hemoglobin (Hb) levels, the Hc / Hb ratio, and / or the activated clotting time (ACT).

[0078] The term “mechanical ventilator parameters,” in the context of the invention, refers to the various parameters, metrics, and / or operating settings that can be simulated, monitored, and / or adjusted within the simulation system to replicate the operation of a mechanical ventilator. These parameters can be simulated digitally or received in real time. For example, mechanical ventilator parameters may include respiratory rate, inspiratory tidal volume (Vti), expiratory tidal volume (Vte), fraction of inspired oxygen (FiO2), end-tidal carbon dioxide level (EtCO2), plateau pressure (Pplat), positive end-expiratory pressure (PEEP), inspiratory pressure (IP), peak pressure (Ppeak), minute volume (MV), and / or volume-controlled, pressure-controlled, and spontaneous ventilation modes.

[0079] The term “neurophysiological parameters,” in the context of the invention, refers to various parameters, metrics, and / or settings that can be simulated and adjusted within the simulation system to replicate the neurophysiological or neuronal state of a real patient. These parameters can be displayed on the first screen and / or the patient screen. For example, neurophysiological parameters may include near-infrared spectroscopy (NIRS), bispectral index (BIS), electroencephalogram (EEG), intracranial pressure (ICP), cerebral tissue oxygenation (CtO2), and / or cerebral blood flow (CBF). The term “graphical interface,” in the context of the invention, refers to the interactive visual representation that enables communication between the user or instructor and the ECMO simulation system.Preferably, the system comprises at least two types of graphical interface: one for the primary screen and one for the user's screen. The primary screen's graphical interface allows for parameter editing and includes interactive events such as bubble or plunger generation, bleeding, line color or illumination changes, and pressure and flow modification. Ideally, this interface is designed to provide all these interactive functionalities on a single, intuitive screen. The secondary graphical interface, intended for the user or patient's screen, allows for viewing the parameters and observing the changes made on the primary screen, but preferably without the ability to edit the values.

[0080] The term “event generator box,” in the context of the invention, refers to a compartment or housing comprising one or more elements of the system of the invention. Preferably, it comprises the control subsystem, the valve subsystem, and the sensor subsystem. Furthermore, it may comprise additional subsystems, such as the bubble generator, the bleeding subsystem, and the signaling subsystem, and various fluidic or electrical connections or ports that allow such connections with one or more elements housed within the box. The event generator box preferably has compact dimensions, with a maximum side length of between 20 and 40 cm and a weight preferably less than 5 kg, which, together with a handle and an integrated battery, facilitates its transport and installation in various environments.

[0081] The term “infusion bag,” in the context of the invention, refers to a container, preferably flexible, that stores fluids and which, in some embodiments, may be connected to the ECMO simulation system via extensions to the drainage and / or return lines, the valve subsystem, and / or the event generator box. This infusion bag allows for fluid storage and contributes to the realistic simulation of infusion conditions in a clinical setting.

[0082] The term “preprogrammed training scenarios or configurations,” in the context of the invention, refers to sets of programmed conditions, predetermined events, or algorithms designed to simulate various clinical and operational situations in the ECMO system in a manner similar to how they might occur in a real clinical setting. These scenarios may be static, change over time, or respond to user actions in a preprogrammed manner. These scenarios are preferably integrated into the first screen and allow for the programmatic management of various simulation system parameters. For example, preprogrammed scenarios can control simulated patient parameter values, such as heart rate, blood pressure, and oxygen saturation, as well as ECMO device parameters, including pressure and flow in the drainage and return lines, and the device's angular velocity.Furthermore, these scenarios can manipulate the valve subsystem, activate the signaling subsystem, generate bubbles or embolus via the bubble generator subsystem, and initiate bleeding events through the bleeding subsystem. These pre-programmed scenarios enable the creation of varied and realistic training situations, facilitating user preparation for different clinical challenges in a controlled and safe environment. It is important to note that the system of the invention also allows for the configuration, modification, or creation of these pre-programmed scenarios.

[0083] The term “first screen,” also referred to as the “control screen,” in the context of the invention represents the main interface of the system (1) from which the user, instructor, teacher, or supervisor preferably controls and manages the simulation parameters and events. Preferably, the first screen (2) is configured to display one or more graphical interfaces, comprising interactive elements that allow the modification of variables or the activation of actions in the system (1). In some embodiments, the first screen (2) comprises or communicates with a processor and memory. Preferably, this memory comprises instructions that, when executed by the processor, cause the generation and execution of at least one or more of the configurations, scenarios, values, events, interactions, curves, simulations, graphs, visualizations, or functionalities described in any of the embodiments described herein.This processor, also referred to as the control element or controller, is configured to manage the simulation logic, either directly or indirectly. In some embodiments, it communicates with the control subsystem (40), and in others, it can directly control various subsystems, such as the valve subsystem (41), signaling subsystem (46), sensor subsystem (42), bleeding subsystem (45), bubble generator subsystem (44), and / or the management of simulated patient parameters and the ECMO equipment. Preferably, the first screen (2) includes interactive elements or events such as buttons, dials, graphical controls, scenario selectors, parameter editing fields, sliders, or selection interfaces, enabling the user to configure, modify, activate, or deactivate functions of the simulation system.These elements are designed to allow the instructor to interact and edit during normal use of the system (1).

[0084] The term “user screen,” also referred to as “second screen,” in the context of the invention, corresponds to the visual interface preferably intended for the student or simulation participant. This screen is preferably configured to continuously and / or on-demand display the simulated patient parameters, the actual or simulated parameters of the ECMO device (5), as well as other data, curves, images, or visual events generated by the system (1), most preferably without allowing their modification. Preferably, the user screen (3) does not include interactive event elements, and / or in some embodiments, it comprises only visual elements, without the ability to modify the state of the system (1).In this regard, the user screen (3) in certain implementations acts as a passive representation of the clinical environment, simulating what a medical professional would see in a real hospital setting during ECMO treatment. In some implementations, the user screen (3) can display, synchronized with the first screen (2), physiological curves, numerical values ​​of vital signs, clinical images, and visual simulations of scenarios, such as bleeding, bubbles, line colorations, cardiac or respiratory events, among others. This functionality allows the student or trained user to interpret clinical information in real time without intervening in the scenario's development.

[0085] Description of the preferred embodiments of the invention

[0086] Proper training of medical personnel in the management of ECMO (Extracorporeal Membrane Oxygenation) is essential due to the complexity of the treatment and the emergency situations that can arise. Many current simulators are entirely digital, lacking physical components that would allow for realistic interaction with the ECMO equipment, thus limiting users' ability to learn and respond to dynamic changes in real time. Simulators that include analog elements, on the other hand, cannot accurately capture the actual values ​​of a functioning ECMO machine and do not allow for the physical simulation of complex situations and unexpected events that are common or can occur in a real-world setting.The lack of realism and the inability to obtain and modify critical parameters such as pressure in a direct way on the lines connected to the ECMO machine reduce the effectiveness of the training and do not adequately prepare students to face critical events.

[0087] The system of the invention addresses these limitations through a control subsystem that communicates with sensors and valves, operating similarly to a PID system. This allows for the selection and modification of the target pressure and / or flow in the drainage and return lines. Furthermore, this system can include physical components that simulate real-world events, such as bleeding, embolisms, or bubbles, and color changes in the lines, providing an interactive and realistic training experience. Unlike purely digital simulators, the system of the invention enables physical interaction that accurately reflects the conditions and challenges of a real clinical environment, thus providing more comprehensive and effective learning.

[0088] The system can also digitally simulate and control medical parameters and instruments such as sensors, ventilators, and ECG / EKG monitors, integrating both physical and digital elements for a comprehensive simulation. Furthermore, it offers various cannulation strategies, such as veno-venous, veno-jugular, or jugular-venous, allowing students to learn and practice in different cannulation scenarios. This multifaceted approach ensures that healthcare professionals are better prepared for diverse clinical situations, increasing the effectiveness of ECMO treatment and reducing the risk of complications.

[0089] On the other hand, the system of the invention, being configured to be compact and portable, with small dimensions (maximum side between 20 and 40 cm) and a light weight (no more than 5 kg), and preferably equipped with a handle and integrated battery, facilitates its transport and installation in various training environments. These characteristics, along with its ability to simulate a wide range of events and parameters in real time, represent clear advantages over existing simulators. It provides a more realistic simulation and more comprehensive learning experience, allowing users to develop practical skills to handle critical events and improve their competence in ECMO management.

[0090] Each embodiment disclosed herein is deemed applicable to each of the other disclosed embodiments. Therefore, all combinations of the various elements described herein are within the scope of the invention. It should also be understood that, unless clearly stated otherwise, in any method claimed herein that includes more than one step or act, the order of the steps or acts of the method is not necessarily limited to the order in which the steps or acts of the method are recited.

[0091] A first aspect of the invention relates to a system (1) for simulating Extracorporeal Membrane Oxygenation (ECMO) treatment. Said system (1) comprises a drain line (7) and a return line (8) configured to be seamlessly connected to an ECMO device (5).

[0092] It is important to mention that lines, such as the drain line (7) and the return line (8), can comprise various forms of tubing, conduits, or channels configured for fluid transport. These lines can be made from a variety of materials, such as, but not limited to, medical-grade silicone, polyvinyl chloride (PVC), polyurethane, or other biocompatible polymers. Lines may also include reinforcing materials, such as braided polyester, to enhance durability and flexibility.

[0093] It is further noted that the ECMO device (5) can be an integral component of the system (1) or a separate unit connected to the system (1). A seamless connection to the ECMO device (5) can be achieved using luer connectors, quick-release connectors, and / or push-fit connectors. Additionally, the system (1) can be electrically connected to the ECMO device (5) via cables or through wireless and / or wired communication interfaces, such as Bluetooth, Wi-Fi, RS-232, Modbus, TCP / IP, or other suitable protocols.

[0094] The system (1) further comprises a valve subsystem (41) comprising one or more electrically actuated valves for regulating fluid flow, wherein the one or more valves are configured to be fluidly or externally connected to the drain (7) and / or return (8) lines.

[0095] These one or more valves may include, but are not limited to, proportional valves, flow control valves, throttle valves, check valves, timers, solenoid valves, piezoelectric valves, and / or motor-operated ball valves. That is, depending on the valve type, they may be fluidly connected to the drain (7) and / or return (8) lines, or surround these lines (7, 8) and restrict the flow through them by throttling or pinching. These valves may be fluidly connected to the drain (7) and / or return (8) lines via various types of couplings, such as quick-connect couplings or threaded connectors. These valves preferably include mechanical means for changing their internal diameter.The valves can be constructed from materials such as stainless steel, plastic compounds, or other suitable materials that ensure biocompatibility and reliability in a medical environment.

[0096] The system (1) of the invention further comprises means for monitoring the pressure and / or fluid flow in the drain (7) and / or return (8) lines. These means for monitoring the pressure and / or fluid flow may comprise various types of sensors. These may include flow meters, pressure sensors, or a combination of both. In some embodiments, these sensors may include piezoelectric pressure sensors, electromagnetic flow sensors, and / or ultrasonic sensors. In some embodiments, these means may include a direct connection to the ECMO equipment (5), from which the pressure and flow data are read. Other embodiments may employ a camera equipped with OCR (Optical Character Recognition) technology to recognize and record this data directly from the ECMO machine displays. Preferably, these means comprise pressure and / or flow sensors.In certain alternative embodiments, the system (1) of the invention comprises the calibration necessary to calculate the opening or closing level of the valve subsystem (41), and thus be able to calculate the pressure and / or flow in the system without the need for sensors.

[0097] Additionally, the system (1) comprises a control subsystem (40) communicating with the valve subsystem (41) and with the means for monitoring fluid pressure and / or flow, wherein the control subsystem (40) is configured to control the pressure and / or flow in the drain (7) and / or return (8) lines via the valve subsystem (41) and said means for monitoring fluid pressure and / or flow. This control subsystem (40) may comprise integrated circuits, microcontrollers, processors, and preferably memory for storing the instructions necessary to receive data from the pressure and / or flow monitoring means and to control the valve subsystem (41) to regulate the pressure and / or flow in the drain (7) and / or return (8) lines, similarly to a proportional-integral-derivative (PID) controller.Therefore, the control subsystem (40) can execute stored instructions to automatically adjust the valve subsystem (41) to achieve the target pressure and / or flow, based on pressure and / or flow measurements from monitoring devices or sensors. In certain embodiments, the microcontrollers may be from the ARM Cortex, PIC, or AVR families, and the memories may be SRAM, DRAM, or Flash. In some embodiments, the system (1) of the invention comprises a power stage connected to the control subsystem (40), in addition to a battery and / or a power supply. Preferably, it also comprises a server router and an integrated circuit.

[0098] The system of the invention (1) further comprises a first screen (2) communicating with or comprising the control subsystem (40), wherein the first screen (2) is configured to display, and preferably to allow modification of: one or more simulated patient parameters; one or more simulated or real ECMO equipment parameters; and one or more pressure and / or flow parameters of the drainage (7) and / or return (8) lines. The first screen (2) is further configured to display an interactive element for setting a target pressure or a target flow (430), and the control subsystem (40) is further configured to control the valve subsystem (41) to achieve said target pressure or target flow in the drainage (7) and / or return (8) lines.

[0099] Simulated patient parameters may include, but are not limited to, electrocardiograms (ECGs), neurophysiological parameters, heart rate, blood pressure, oxygen saturation (SpO2), body temperature, and / or respiration. Preferably, they also include mechanical ventilation parameters. ECMO equipment parameters, which may be simulated or real, may include, but are not limited to, activated clotting time (ACT), blood pressure, gas flow, venous pressure, venous oxygen saturation (SvO2), and / or hemoglobin / hematocrit (Hb / Hc) levels.

[0100] Preferably, all simulated parameters shown on the first screen (2), including the simulated patient parameters mentioned above or any simulated parameters mentioned throughout this text, can be modified. Such modification of the simulated parameters preferably determines the system's response or affects the value of other parameters. For example, these parameters can be modified manually through a graphical interface included on the first screen (2), or programmatically through the implementation of different scenarios.

[0101] In turn, the first screen can be part of an electronic device such as a computer, tablet, television, virtual reality glasses, or be the surface onto which an image is projected. Furthermore, the interactive element that allows setting a target pressure or target flow (430) of the first screen (2) is preferably implemented through a graphical user interface that includes touch buttons, sliders, or numeric input fields. Preferably, the system (1) of the invention is configured to be transported in a wheeled case, more preferably comprising such a case.

[0102] Advantageously, the ECMO treatment simulation system (1) of the invention, unlike the prior art, comprises sensors and valves that allow for the modification of pressure and flow parameters at will, thus providing direct control over the circuit and enabling the physical simulation of realistic conditions. It also allows for data extraction and the modification of pressure and flow rates in the lines (7, 8) at will, allowing for the establishment of target values ​​instead of opening or closing valves to gauge pressure changes. This makes it much more precise and suitable for teaching. Furthermore, the ability to display patient parameters and ECMO equipment parameters on the same screen (2), and to allow for the variation of pressure and flow values, offers several significant advantages. For the student, this provides a realistic and comprehensive simulation of ECMO treatment, facilitating more complete and practical learning.For the instructor, it allows the creation of situations or scenarios by modifying parameters, which the student must then respond to. Integrating these parameters into a single screen or user interface improves the understanding and operation of the ECMO system. In a preferred embodiment, the means for monitoring the pressure and / or fluid flow in the drain (7) and / or return (8) lines comprises a sensor subsystem (42) comprising one or more pressure (421) or flow (422) sensors configured to monitor the pressure and / or fluid flow in the drain (7) and / or return (8) lines.

[0103] Pressure sensors (421) can be of various types, such as piezoelectric, capacitive, resistive, or MEMS (Micro Electro Mechanical Systems) sensors, among others. These sensors can be made of materials such as silicon, stainless steel, ceramic, or biocompatible polymers, and can be designed to withstand specific pressure ranges according to the ECMO system requirements. Flow sensors (422), on the other hand, can include electromagnetic, light, ultrasonic, turbine, and / or thermal sensors, among others. These sensors can be configured to measure both the volumetric and mass flow rates of the fluid in the drain (7) and / or return (8) lines.Flow sensors can be made from materials such as stainless steel, medical-grade plastic, or aluminum alloys, and can be designed for different flow ranges and fluid viscosities.

[0104] The sensor subsystem (42) can be integrated with wired communication systems, such as RS-232, RS-485, Modbus, or Ethernet connections, and / or wireless systems, such as Bluetooth, Wi-Fi, or ZigBee, or via wired / wireless protocols such as TCP / IP, to transmit the collected data to the control subsystem (40). Preferably, the sensors can be calibrated periodically to ensure the accuracy of the measurements and may include additional functionalities such as self-diagnostics and fault alerts.

[0105] Advantageously, the ECMO treatment simulation system (1) of the invention, by comprising a sensor subsystem (42) with pressure (421) and flow (422) sensors, enables accurate, real-time monitoring of critical pressure and flow parameters in the drain (7) and return (8) lines. This ensures that the system can respond quickly to any changes in fluid conditions, providing a more realistic and detailed simulation. The integration of these sensors with the control subsystem (40) and the first display (2) enhances the training capabilities for users, allowing for a deeper understanding and a more effective response to variations in the simulated ECMO treatment.

[0106] In another preferred embodiment of the system (1) of the invention, the means for monitoring the pressure and / or fluid flow in the drain (7) and / or return (8) lines comprise a camera in communication with the first display (2) and / or with the control subsystem (40), wherein the camera is configured to read pressure and / or flow parameters from the ECMO equipment using optical character recognition (OCR) technology. This technology converts text images into digital data, enabling accurate monitoring.

[0107] The camera can be of various types, such as analog video cameras, digital video cameras, CCD (Charge-Coupled Device) cameras, CMOS (Complementary Metal-Oxide Semiconductor) cameras, or infrared cameras. This camera can be mounted in a fixed or mobile manner, allowing flexibility in its location and viewing angle to optimize data capture by the ECMO equipment. Optical character recognition (OCR) can be implemented using specialized software that processes the images captured by the camera. This software can be hosted in the control subsystem (40), in the cloud, on the first screen (2), or on a dedicated processing unit, and preferably utilizes advanced machine learning algorithms and neural networks to improve recognition accuracy.

[0108] Advantageously, the ECMO treatment simulation system (1) of the invention, by comprising a camera with optical character recognition capability, allows for the indirect but effective monitoring of the pressure and flow parameters of the ECMO equipment. This facilitates the integration of real-time data on the first screen (2), improving the simulation quality and the responsiveness and adjustability of the control subsystem (40). For students, this configuration provides an additional tool for understanding and visualizing how these parameters are monitored and adjusted in a real-world environment, contributing to a more comprehensive and detailed learning experience.

[0109] In a preferred embodiment of the system (1) of the invention, the first display (2) is further configured to show an interactive element for setting a target time (431), wherein the target time is associated with the interactive element for setting a target pressure or a target flow (430), and the control subsystem (40) is configured to control one or more valves to achieve the target pressure or target flow at said target time in the drain (7) and / or return (8) lines.

[0110] This first screen (2) can use touch technology, physical buttons, or a combination of both to facilitate user interaction with interactive events. Interactive events can be designed with intuitive interfaces, such as sliders, numerical selections, or graphics.

[0111] On the other hand, the control subsystem (40) may comprise microcontrollers or programmable processors with software that synchronizes the valve actions with the defined time, pressure, and flow parameters. This subsystem may include control algorithms to ensure that the pressure and flow targets are achieved accurately and efficiently within the set time.

[0112] Advantageously, the ECMO treatment simulation system (1), by allowing the configuration of a target time along with pressure and flow parameters, provides an advanced simulation tool. This enables students to react based on time and within predetermined time intervals, simulating real-life temporal progression or narrow timeframes for reaction.

[0113] In a preferred embodiment of the system (1) of the invention, all parameters shown on the first screen (2) are modifiable manually or programmatically.

[0114] The parameters can be adjusted manually via the touchscreen interface, using buttons, sliders, or input fields. Alternatively, they can be adjusted programmatically through the first screen (2), the control subsystem (40), or a cloud server, which can run predefined programs or receive instructions from an external computer.

[0115] The ability to manually modify parameters allows users to make quick and direct adjustments during simulation, while programmatic modification facilitates the execution of complex and repeatable scenarios, allowing the automation of certain tasks and the implementation of specific treatment protocols.

[0116] Advantageously, the ability to modify all parameters manually or programmatically in the ECMO treatment simulation system (1) allows for exceptional flexibility and control. This provides instructors and practitioners with a versatile tool for training and practice in realistic, simulated conditions, modifying conditions in real time so that students react accordingly, and creating scenarios that improve their ability to respond appropriately in real clinical situations, thus ensuring more comprehensive and detailed training.

[0117] In a preferred embodiment of the system (1) of the invention, the first screen (2) is configured to display one or more actual parameters of the ECMO device (5), wherein the system (1) is connected to the ECMO device by cable or wirelessly, and the actual parameters of the ECMO device displayed on the first screen (2) are obtained from the ECMO device (5) through this connection. Alternatively, these actual parameters of the ECMO device (5) are obtained using a camera and text recognition software, wherein the camera records the screen of the ECMO device (5) and the software extracts the values ​​of the parameters of interest. Advantageously, the ability of the ECMO treatment simulation system (1) to display actual parameters of the ECMO device (5) on the first screen (2) significantly improves the quality of the simulation by incorporating real parameters, thereby more accurately reproducing the situations that students will encounter in actual practice.

[0118] In a preferred embodiment of the system (1) of the invention, the system (1) further comprises a signaling subsystem (46) that emits one or more visual and / or acoustic signals, wherein the first screen (2) of the system (1) is further configured to display at least one interactive element for signal emission (460).

[0119] The signaling subsystem (46) may comprise various devices for emitting visual and / or audible signals. These devices may include LEDs of different colors or RGB LEDs, LCD screens with alert messages, audible alarms, vibrators, and / or combinations thereof. Visual signals may include flashing lights, color indicators that change according to the patient's clinical condition (blue or red, depending on blood oxygenation level) or the severity of the alert (e.g., green, yellow, red), or text messages on the first screen (2). The signaling subsystem (46) may also include audible signals such as alarm tones, buzzers, or prerecorded voice messages. The intensity and type of audible signal may vary to differentiate between types of alerts, such as changes in pressure, flow, or target time.

[0120] The interactive element for signaling (460) shown on the first screen (2) can be configured by the user to manually activate the signals, or it can be programmed to activate automatically in response to certain parameters being reached or exceeded. This interactive element can include touch buttons, cones, or drop-down menus that allow the user to select and customize the signaling conditions and types.

[0121] Advantageously, the inclusion of a signaling subsystem (46) in the ECMO treatment simulation system (1) provides an additional layer of safety and communication, alerting users to critical changes in system parameters. This improves the responsiveness of students and healthcare professionals, enabling rapid and effective intervention. The ability to customize and interact with visual and audible signals via the first screen (2), as well as program them, offers a more realistic simulation experience adaptable to different clinical scenarios.In a more preferred embodiment of the system (1) of the invention, the signaling subsystem (46) comprises one or more light sources that allow the drain (7) and / or return (8) lines to be illuminated and / or their color changed, preferably comprising LED light sources (461) within said lines, more preferably comprising red (462) and / or blue (464) LED strips, or RGB LED strips capable of illuminating in any color as a combination of red, blue, and green. Preferably, the at least one interactive element for signal emission (460) comprises at least one interactive element for light emission in the drain (7) and / or return (8) lines.

[0122] The interactive element for light emission in the drain and / or return lines can be activated and / or configured via the first screen (2), allowing the user to manually adjust the conditions under which the lights change color or turn on. This control can be implemented through intuitive graphical interfaces, such as touch buttons, sliders, or drop-down menus.

[0123] Furthermore, the system may include sensors that detect changes in fluid parameters and automatically activate LED light sources (461) in response to those changes. These sensors may be integrated into the drain (7) and / or return (8) lines, providing continuous and accurate monitoring.

[0124] Advantageously, the inclusion of LED light sources (461) in the signaling subsystem (46) allows for the simulation of clinical situations and events related to blood oxygen levels, such as hypoxia, which is indicated by a blue light. This enables users to quickly learn to identify critical conditions and respond appropriately.

[0125] In a preferred embodiment of the system (1) of the invention, the system (1) comprises a processor communicating with a memory, preferably included in the system (1), wherein the memory comprises instructions executable by the processor which, when executed by the processor, cause said processor to perform at least the following task: automatically calculate and adjust a change in the diameter of the connection of the valve subsystem (41) to the drain (7) and / or return (8) lines corresponding to a manual or automatic change in the pressure parameters displayed on the first screen (2), or to change the pressure parameters displayed on the first screen (2). Said memory and processor may be included, for example, in the control subsystem (40) and / or in the first screen (40).or in an accessory device such as a Raspberry Pi or other type of integrated circuit and microcontrollers. In a preferred embodiment of the system (1) of the invention, the one or more simulated patient parameters comprise one or more of the following parameters: electrocardiogram (ECG), heart rhythms, heart rate (HR), arterial blood pressure (ABP), ABP modified by intra-aortic balloon pump, ABP modified by pathological heart rhythms, central venous pressure (CVP), pulmonary artery pressure (PAP), central venous oxygen saturation (SCVO2), mixed venous oxygen saturation (SVO2), cardiac output (CO), cardiac index (CI), stroke volume variability (SVV), pulmonary capillary wedge pressure (PCWP), left atrial pressure (LAP), systemic vascular resistance (SVR), pulmonary vascular resistance (PVR), peripheral oxygen saturation (SpO2), respiratory rate, total respiratory rate, compulsory and / or spontaneous respiratory rate,inspiratory tidal volume (Vti), expiratory tidal volume (Vte), fraction of inspired oxygen (FiO2), end-expiratory carbon dioxide level (EtC2), plateau pressure (Pplat), positive end-expiratory pressure (PEEP), inspiratory pressure (IP), peak pressure (Ppeak), driving pressure (DP), pressure support (PS), respiratory system resistance and compliance (Crs), airflow and FiO2 through high-flow nasal cannula system, volume-controlled ventilation mode, pressure-controlled ventilation mode, spontaneous ventilation mode, partial pressure of oxygen in arterial blood (PaO2), partial pressure of carbon dioxide in arterial blood (PaC2), blood pH, bicarbonate (HCO3-), lactate, hematocrit (He) and / or hemoglobin (Hb) levels, potassium (K+) levels, sodium (Na+) levels, calcium (Ca++) levels, core body temperature, temperature skin, activated clotting time (ACT),near-infrared spectroscopy (NIRS), bispectral index (BIS), electroencephalogram (EEG) waveforms, spectral array, train of four (TOF), somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), intracranial pressure (ICP), cerebral tissue oxygenation (CtÜ2), cerebral blood flow (CBF), jugular venous oxygen saturation (SjvÜ2) and / or cerebral perfusion pressure (CPP), preferably where patient parameters comprise ECG, ABP, HR, SpÜ2, Vti, FiO2, PEEP, Ppeak, PaO2, PaCO2, He and / or Hb, NIRS, BIS and / or EEG.

[0126] In a preferred embodiment of the system (1) of the invention, the one or more simulated or actual ECMO equipment parameters comprise one or more of the following parameters: pressure of one or more drainage lines (7), pressure of one or more return lines (8), percentage of drainage line occlusion (7), percentage of return line occlusion (8), blood flow in the main and accessory lines for the one or more drainage lines (7) and / or the one or more return lines (8), gas flow, gas oxygen fraction (FDO2), ECMO equipment angular velocity data (5), SvO2, drainage line color, return line color, circuit temperature (Te), pre-membrane pressure, post-membrane pressure, transmembrane pressure (delta P), preferably where the simulated or actual ECMO equipment parameters comprise drainage branch (7) and / or return branch (8) pressure, drainage branch (7) and / or return branch (8) flow values, ECMO equipment angular velocity data (5),SvO2, He and / or Hb levels, Hb / Hc ratio (Hemoglobin / Hematocrit) levels, and / or activated clotting time (ACT),

[0127] In a preferred embodiment of the system (1) of the invention, the first screen (2) and / or the user screen (3) (or second screen (3)) are configured to further display ventilation or mechanical ventilator parameters, wherein said ventilation or mechanical ventilator parameters may be simulated or may be actual parameters received through communication from the control subsystem (40) with a mechanical ventilator, preferably wherein said one or more parameters are simulated, more preferably wherein said one or more parameters comprise respiratory rate, total respiratory rate, compulsory and / or spontaneous, Vti, Vte, FiO2, EtCO2, Pplat, PEEP, PEEP high, PEEP low, IP, Ppeak, DP, PS, minute volume (MV), Crs, airway resistance (Raw), inspiratory trigger, expiratory trigger, airflow curve morphology, esophageal pressure, transpulmonary pressure,airflow and F02 through high-flow nasal cannula system, volume-controlled ventilation mode, pressure-controlled ventilation mode, spontaneous ventilation mode and / or APRV ventilation mode.

[0128] In a preferred embodiment of the system (1) of the invention, the system comprises a user screen (3) in wireless or wired communication with the first screen (2) and / or with the control subsystem (40), wherein the user screen (3) is configured to display patient parameters and actual or simulated ECMO equipment parameters, wherein said parameters are preferably contained in a second graphical interface (300). Preferably, wherein the parameters displayed on the user screen (3) cannot be manually modified, but are synchronized with the parameters of the first screen (2), which can be manually modified by the instructor. Alternatively, said parameters can be modified programmatically, through pre-programmed scenarios or in response to changes in the simulation system (1) or to actions of the user and / or instructor.

[0129] The user display (3) can be of various types, such as LCD, OLED, or e-ink, and can range in size from portable to stationary devices. The user display (3) can be part of other electronic devices such as a mobile phone, tablet, computer, television, virtual reality glasses, or be a projection of an image from a projector onto a surface. Advantageously, the inclusion of a user display (3) in the ECMO treatment simulation system (1) improves the accessibility and visibility of critical data, preferably presented within a single graphical interface (300), facilitating real-time monitoring and analysis of all relevant parameters simultaneously. This provides an important tool for education and training, allowing users to interact with the simulation more dynamically and effectively.

[0130] In a preferred embodiment of the system (1) of the invention, the first display (2) and / or the patient display (3) are further configured to display one or more simulated neurophysiological parameters (24) on the first and / or second graphical interfaces (200, 300) respectively, wherein the one or more neurophysiological parameters (24) comprise one or more of the following parameters: near-infrared spectroscopy (NIRS), bispectral index (BIS), electroencephalogram (EEG), somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), intracranial pressure (ICP), cerebral tissue oxygenation (CtO2), cerebral blood flow (CBF), jugular venous oxygen saturation (SjvO2), cerebral perfusion pressure (CPP), cerebral temperature, and cerebral autoregulation, preferably wherein the neurophysiological parameters (24) comprise near-infrared spectroscopy (NIRS) and / or bispectral index (BIS).

[0131] It is important to note that the patient parameters described above may therefore include neurophysiological parameters, mechanical ventilator parameters, or any other type of parameter obtained from relevant medical instruments during ECMO treatment. In other implementations, patient parameters do not include neurophysiological or mechanical ventilator parameters; these are instead categorized separately.

[0132] In a preferred embodiment of the system (1) of the invention, the system (1) further comprises a bleeding subsystem (45) configured to simulate bleeding by the outflow of simulated blood (452) from an internal reservoir, preferably where the simulated blood (452) flows into one or more cannula insertion areas or any location on a patient simulator (9), wherein the first display (2) of the system (1) is further configured to display an interactive element for activating the simulated blood outflow (450), preferably where the interactive element is displayed on the first graphical interface (200). Preferably, the interactive element for activating the simulated blood outflow (450) comprises integrated safety measures to prevent accidental activation, such as user confirmation.In some embodiments, this bleeding subsystem (45) may comprise peristaltic or diaphragm pumps to control the flow of simulated blood, and / or valves that regulate its output. The simulated blood (452) may consist of water-based solutions mixed with dyes and thickeners to mimic the viscosity and color of real blood. Alternatively, glycol solutions or other biocompatible fluids may be used. The output of the simulated blood (452) may be directed to one or more cannula insertion sites or any location on a patient simulator (9), allowing for the simulation of bleeding at specific points.

[0133] The interactive element for simulated blood release (450) may comprise touch buttons, sliders, or cones in the first graphical interface (200) that allow the user to control the start, location, intensity, and duration of the simulated bleeding.

[0134] Furthermore, the design of the reservoir and the control mechanisms allow for easy refilling of the simulated blood and maintenance of the system.

[0135] Advantageously, the inclusion of a bleeding subsystem (45) in the ECMO treatment simulation system (1) allows for a more realistic simulation of emergency situations, such as hemorrhages. This provides students and healthcare professionals with a valuable tool for practicing their response to critical events, improving their skills and preparedness for real-life clinical situations. The ability to control the simulated hemorrhage via the first screen (2) and the first graphical interface (200) offers a dynamic and interactive learning experience, contributing to more comprehensive and immersive training.

[0136] In a preferred embodiment of the system (1) of the invention, the system (1) further comprises a bubble-generating subsystem (44), preferably mechanical, in wireless or wired communication with the control subsystem (40) or with the first display (2), and in fluid communication with at least one of the drain (7) or return (8) lines, wherein the bubble-generating subsystem (44) is configured to generate bubbles in at least one of the drain (7) or return (8) lines, and wherein the first display (2) of the system (1) is further configured to display an interactive element for activating bubble generation (440) in the drain and / or return lines.

[0137] The bubble-generating subsystem (44) may be designed to introduce air or gas bubbles into at least one of the drain (7) or return (8) lines. This subsystem may comprise, for example, an air pump or micro-pump, a gas injector, or an ultrasonic device that induces bubble formation. Furthermore, the system may include valves and regulators to control the quantity and size of the bubbles generated. Advantageously, the inclusion of a bubble-generating subsystem (44) in the ECMO treatment simulation system (1) allows for the simulation of critical conditions such as gas embolism. This provides students and healthcare professionals with a valuable tool for practicing bubble detection and management in the ECMO circuit, enhancing their skills and preparedness for real-life clinical situations.The ability to control bubble generation through the first screen (2) and interactive events offers a dynamic and realistic learning experience, contributing to a more complete and immersive training.

[0138] In a preferred embodiment of the system (1) of the invention, the one or more simulated patient parameters, the one or more simulated or real ECMO equipment parameters (5), the one or more pressure and / or flow parameters of the drainage (7) and / or return (8) lines, and the interactive element for setting a target pressure or a target flow (430), are comprised in a first graphical interface (200) configured to be displayed on the first screen (2), preferably where the first graphical interface (200) further comprises the interactive element for setting a target time (431), the at least one interactive element for signal emission (460), the interactive element for activating bubble generation (440) in the drainage and / or return lines, and / or the interactive element for light emission in the drainage and / or return lines.

[0139] Advantageously, integrating all these elements into a single graphical interface (200) provides a centralized and user-friendly platform for managing and monitoring the ECMO treatment simulation system (1). This allows users or instructors to quickly access all critical information at a glance, make precise adjustments, and receive real-time alerts, significantly improving the effectiveness of training and preparation for real-world clinical situations. The intuitive and comprehensive interface facilitates a more immersive and detailed learning experience, contributing to a better understanding and management of the ECMO system.

[0140] In a preferred embodiment of the system (1) of the invention, the system (1) further comprises one or more adaptable cannulas and / or one or more tubes of adaptable lengths, configured to allow the drainage (7) and return (8) lines to be connected to different extracorporeal life support devices or ECMO equipment (5).

[0141] Adaptable cannulas can be designed with variable diameters, flexible materials such as medical-grade silicone or polyurethane, and may include features such as beveled tips or inflation balloons to ensure a secure and efficient fit. These cannulas can be of various sizes, adapting to different clinical needs and simulation scenarios. Such cannulas may include quick-release mechanisms for fastening and detachment. Similarly, the tubing may include quick-connect or threaded fittings for easy connection and disconnection, and in some embodiments, the length of the tubing can be adjusted using modular sections or custom cuts, allowing its use in a variety of life support devices and configurations, such as veno-venous, veno-jugular, or jugular-venous, referring to the type of connection of the tubing to veins or arteries.

[0142] The extracorporeal life support devices to which the drainage (7) and return (8) lines can be connected may include oxygenators, circulation pumps, blood warmers, and other ECMO equipment (5), preferably any other ECMO equipment (5) available on the market. The connections may be designed to be secure and leak-proof, using technologies such as luer lock, snap-fit, quick-release, or tonneau-seal connectors to prevent leaks and ensure continuous, controlled flow.

[0143] Advantageously, the inclusion of cannulas and tubes of adjustable lengths in the ECMO treatment simulation system (1) provides greater flexibility and versatility. This allows users to configure the system according to different scenarios and equipment, facilitating more comprehensive and realistic training.

[0144] In a preferred embodiment of the system (1) of the invention, the system (1) further comprises a battery (47) to allow the use of the system (1) without being connected to the electrical network.

[0145] In a preferred embodiment of the system (1) of the invention, said system (1) further comprises a wireless connectivity subsystem (48) in communication with the control subsystem (40).

[0146] In a preferred embodiment of the system (1) of the invention, the control subsystem (40), the valve subsystem (41), and the sensor subsystem (42) are comprised in an event-generating box (4) configured to connect seamlessly to the drain (7) and / or return (8) lines, preferably wherein the bubble-generating subsystem (44), the bleed subsystem (45), and / or the signaling subsystem (46) are further comprised in said event-generating box (4), wherein the dimensions of the event-generating box (4) are less than 20x30x30 cm, preferably less than 15x20x25 cm, more preferably less than 12x20x20 cm, and wherein the weight of said event-generating box (4) is less than 10 kg, preferably less than 8 kg, more preferably less than 5 kg, furthermore, wherein the event-generating box (4) comprises a handle and preferably a battery (47).In a preferred embodiment, the box comprises a handle for easy transport and preferably a battery for autonomous operation.

[0147] The event generator box (4) may be equipped with a handle for easy handling and transport. It may also include an internal battery (47) to power the subsystems during operation, particularly in environments where an external power source is not readily available. The battery may be rechargeable and high-capacity, allowing the system to operate continuously for several hours.

[0148] The compact and lightweight design of the event generator box (4) ensures its suitability for a variety of educational and clinical settings. The ability to integrate one, more, or all relevant subsystems within a single unit simplifies configuration and operation, providing an all-in-one solution for ECMO treatment simulation.

[0149] Advantageously, the inclusion of all subsystems in a compact and portable event generator box (4) significantly improves the usability and versatility of the ECMO treatment simulation system (1). This allows users to easily transport and use the system in different locations, providing a highly efficient and adaptable simulation tool.

[0150] In a preferred embodiment of the system (1) of the invention, the system (1) further comprises at least one infusion bag connected to the valve subsystem (41) and / or to the event generator box (4) through a continuation of the drainage line (7) and / or through a continuation of the return line (8).

[0151] In a preferred embodiment of the system (1) of the invention, the first screen (2) and / or the user screen (3) are further configured to display blood gas images, images or graphs of analytical variables, conventional radiography images, clinical reports, ultrasound videos, computed tomography videos, manuals and / or scientific articles.

[0152] These additional technical features can be implemented using software that supports the display of multiple file formats, including JPEG / PNG images, MP4 videos, PDF documents, and others. The first screen (2) and / or the user screen (3) can be equipped with sufficient storage and processing capacity to handle this data, as well as internet connectivity for accessing online resources. Advantageously, the ability to display blood gas images, analytical variables, X-rays, clinical reports, ultrasound and CT scan videos, as well as manuals and scientific articles on the first screen (2) and / or the user screen (3) significantly enhances the ECMO treatment simulation and the ability to teach and train simultaneously.This provides a comprehensive learning experience, allowing users to interact with a wide range of clinical and educational data in a realistic simulated environment. The integration of these visual and educational resources facilitates a deeper understanding of the complexities of ECMO treatment, improving the preparedness and competence of students and healthcare professionals.

[0153] In a preferred embodiment of the system (1) of the invention, at least one of the one or more simulated patient parameters are associated with the pressure and / or fluid flow values ​​monitored in the drainage (7) and / or return (8) lines, preferably where these parameters are ABP, SpO2, SvO2 and / or NIRS, more preferably where these parameters are SpO2, SvO2 and NIRS in veno-venous ECMO treatment simulations, and ABP, SvO2 and NIRS in veno-arterial ECMO treatment simulations.

[0154] The association of these parameters with the pressure and flow values ​​monitored in the drainage (7) and return (8) lines can be achieved using algorithms, preferably contained in the first screen (2), on a remote server and / or in the control subsystem (40), which correlate the pressure and flow data with clinical parameters. These algorithms can adjust the simulated patient parameters in real time, reflecting changes in the ECMO system conditions.

[0155] Advantageously, the integration of simulated patient parameters associated with pressure and flow values ​​in the drainage (7) and return (8) lines improves the accuracy and realism of ECMO treatment simulations. This provides users with a more authentic and educational experience, allowing them to observe how changes in flow and pressure affect the patient's clinical parameters. The ability to simulate different veno-venous and veno-arterial ECMO scenarios with specific parameters such as ABP, SpO2, SvO2, and NIRS enhances the training and preparation of students and healthcare professionals to manage complex and critical clinical situations.

[0156] In a preferred embodiment of the system (1) of the invention, the drainage (7) and / or return (8) lines are of a suitable length to accommodate different cannulation configurations, where such cannulation configurations comprise femoral-jugular, jugular-femoral, femoral-femoral, and double-lumen configurations, preferably where said length is between 1 and 10 meters for the drainage (7) and / or return (8) lines respectively, more preferably between 2 and 5 meters. In this way, the length of the lines can be adjusted to different cannulation configurations such as femoral-jugular, jugular-femoral, femoral-femoral, and double-lumen, ensuring compatibility with a wide variety of extracorporeal life support configurations.

[0157] In a preferred embodiment of the system (1) of the invention, the first screen (2) and / or the user screen (3) are further configured to display one or more pre-programmed training scenarios or configurations (25) that programmatically control the value of at least one of the following parameters: one or more simulated patient parameters, one or more simulated ECMO equipment parameters, and / or one or more pressure and / or flow parameters of the drainage (7) and / or return lines. Furthermore, these pre-programmed training scenarios or configurations (25) can also control the valve subsystem (41), the signaling subsystem (46), the bubble generator subsystem (44), and / or the bleeding subsystem (45), wherein these training configurations or pre-programmed scenarios are preferably based on guidelines from the Extracorporeal Life Support Organization (ELSO).Preferably they are controlled based on time, patient evolution and / or user response.

[0158] Pre-programmed scenarios may include, for example, emergency scenarios, simulating critical situations such as hemorrhage, oxygenation failure, or pump failure. In some implementations, they may also include routine scenarios, such as standard procedures like ECMO initiation and disconnection or parameter adjustments in response to changes in the patient's condition. Additionally, some implementations may include complication scenarios, such as the detection and management of air embolisms, spontaneous bleeding, hypoxia, infections, or mechanical problems in the ECMO circuit. It is important to note that these scenarios may be programmed to vary over time and respond to the actions of the user or student, and that they may concatenate two or more events at different time intervals.

[0159] Advantageously, the system's ability (1) to display and manage pre-programmed training scenarios or configurations (25) based on ELSO guidelines provides a robust and versatile educational platform. This allows students and healthcare professionals to practice and refine their skills in a controlled and safe environment, facing a variety of realistic and challenging clinical situations. The automation and customization of these scenarios improve training efficiency, ensuring more comprehensive and effective preparation for managing patients on ECMO.In a preferred embodiment of the system (1) of the invention, the first screen (2) and / or the user screen (3) are further configured to allow the creation of one or more pre-programmed training scenarios that programmatically control the value of one or more simulated patient parameters, one or more simulated ECMO equipment parameters, one or more pressure and / or flow parameters of the drainage (7) and / or return lines, the valve subsystem (41), the signaling subsystem (46), the bubble generator subsystem (44), and / or the bleeding subsystem (45). Preferably, only the first screen (2) is configured to allow the creation of one or more pre-programmed training scenarios.

[0160] The interface for creating training scenarios can include intuitive tools such as a scenario editor comprising a graphical interface that allows dragging and dropping elements, adjusting parameters and configuring timed events, where it is also possible to set initial values ​​and define how these values ​​should change during the scenario, including threshold conditions that trigger specific events.

[0161] In certain implementations, users or teachers can save and reuse pre-programmed scenarios, facilitating repetitive training and progress assessment. These scenarios can be customized to specific educational needs, allowing for adjustments in complexity and learning objectives.

[0162] Advantageously, the ability of the first screen (2) and / or the user screen (3), preferably only the first screen (2), to allow the creation of pre-programmed training scenarios offers a very useful and flexible tool for education and training. Users or instructors can design scenarios that reflect a wide variety of clinical situations, customizing the simulation to address specific learning areas and enhancing practical preparation. This functionality increases the effectiveness of training by providing realistic and controlled experiences that can be adapted to the changing needs of the educational and clinical environment.

[0163] In a preferred embodiment of the system (1) of the invention, the first display (2) and / or the user display (3) are configured to show one or more simulated electrocardiogram waveforms in at least one of the following situations: sinus rhythm, asystole, ventricular tachycardia, ventricular fibrillation, atrial fibrillation, 2:1 atrial flutter, 3:1 atrial flutter, first-degree atrioventricular block, second-degree type I atrioventricular block, second-degree type II atrioventricular block, complete atrioventricular block, torsades de pointes, and / or diseased sinus node. Therefore, in some embodiments, the first display (2) and / or the user display (3) are configured to show one or more simulated electrocardiogram waveforms in various clinical situations. These situations may include, but are not limited to, sinus rhythm, referring to the normal heart rhythm originating in the sinus node;Asystole, that is, the total absence of electrical activity in the heart, which can appear as a flat line on the ECG; ventricular tachycardia, which is a rapid heart rate originating in the ventricles; ventricular fibrillation, which is a disorganized rhythm of the ventricles resulting in ineffective contraction of the heart; atrial fibrillation, a common arrhythmia where the atria beat rapidly and uncoordinatedly; atrial flutter in 2:1 and 3:1 patterns, where there is a regular pattern of rapid atrial contractions with every two or three atrial waves leading to a QRS complex; first-degree atrioventricular block, characterized by a prolonged PR interval; second-degree AV block type I (Wenckebach), where the PR interval progressively lengthens until a P wave is not followed by a QRS complex;Second-degree AV block type II, where some P waves are not followed by QRS complexes without a pattern of progressive lengthening of the PR interval; complete AV block, a complete interruption of conduction between the atria and ventricles; torsades de pointes, a form of polymorphic ventricular tachycardia characterized by QRS complexes that change in amplitude and direction; and sick sinus node, a dysfunction of the sinus node that can result in bradycardia, sinus pauses, or alternating arrhythmias.

[0164] Additionally, in some embodiments the system (1) may include the ability to simulate other clinical conditions such as Brugada syndrome, supraventricular tachycardia, multifocal atrial tachycardia, atrial fibrillation with rapid ventricular response, prolonged QT interval, and / or Wolff-Parkinson-White syndrome.

[0165] Advantageously, the inclusion of the ability to display various simulated ECG waveforms on the first screen (2) and / or the user screen (3) in certain cardiorespiratory situations or complications that may occur in real life significantly improves the system's functionality (1). This allows for detailed, real-time monitoring of the simulated patient's cardiac activity. It not only facilitates the early detection of cardiac complications but also enables medical professionals and students to practice and refine their skills in ECG interpretation and critical decision-making in emergency situations.

[0166] In a more preferred embodiment of the system (1) of the invention, at least one of the one or more simulated electrocardiogram curves comprises at least one of the following variations: ventricular extrasystole, supraventricular extrasystole, ST segment elevation, ST segment depression, presence of pacemaker with ventricular stimulation, presence of 1:1 intra-aortic balloon counterpulsation, presence of 2:1 intra-aortic balloon counterpulsation and / or presence of 3:1 intra-aortic balloon counterpulsation.

[0167] Therefore, in some realizations, at least one of the simulated electrocardiogram curves comprises at least one of the following variations: ventricular extrasystole, or premature contraction originating in the ventricles, which may present as a premature and abnormal QRS complex; supraventricular extrasystole, which is a premature contraction originating in the atria or AV node and is characterized by a normal but premature QRS complex; ST segment elevation, which is a sign of acute myocardial infarction and manifests as an upward deviation of the ST segment; and ST segment depression, which may indicate myocardial ischemia and presents as a downward deviation of the ST segment.

[0168] Furthermore, the first screen (2) and / or the user screen (3) of the system (1) can be configured, in certain embodiments, to display one or more simulated electrocardiogram waveforms that reflect the presence of implants in the patient, such as pacemakers and / or intra-aortic balloons, among other options. For example, the user screen (3) of the system (1) can be configured to display one or more simulated electrocardiogram waveforms in the presence of a pacemaker with ventricular stimulation, which may show pacemaker spikes followed by wide QRS complexes. They can also show the presence of an intra-aortic balloon pump (IABP) in 1:1, 2:1, and 3:1 modes. These circulatory support devices inflate and deflate a balloon in the aorta to improve coronary perfusion and reduce the workload of the heart, which can be reflected on the ECG as specific changes synchronized with the cardiac cycle.

[0169] Advantageously, these additional variations in the simulated ECG waveforms allow for a more complete and detailed representation of diverse clinical conditions and life support devices. This provides users with a more versatile and robust tool for simulation and training in the management of critically ill patients on ECMO. Therefore, the ability to simulate these variations further enhances the system's functionality (1), enabling the practice and refinement of clinical skills in a wide range of complex medical scenarios, thus facilitating more effective and realistic training for healthcare professionals.

[0170] In another preferred embodiment of the system (1) of the invention, the first display (2) and / or the user display (3) are configured to show a simulated blood pressure curve without pulse pressure, for example in patients with a heart rate substantially equal to 0, and / or in cases of asystole or ventricular fibrillation, preferably automatically adapted to the flow of the ECMO equipment (5).

[0171] Diastolic blood pressure (DBP) indicates the pressure in the arteries when the heart is at rest between beats and is a crucial parameter for assessing organ perfusion. A constant DBP curve in situations where the heart rate is substantially zero can simulate extreme conditions such as asystole, where there is no cardiac contraction and therefore no pulsatile blood flow, and / or ventricular fibrillation.

[0172] In a typical critically ill patient, an ECG reading of 0 indicates that the heart is unable to pump blood, resulting in a drop in blood pressure to 0. However, in a patient with an implanted ECMO machine, the heart's function is taken over by the ECMO pump, allowing blood to continue flowing to the patient's organs. Therefore, even if the patient's heart loses its pulsatility, blood pressure can be maintained thanks to the ECMO's function.

[0173] It is important to note that blood pressure maintained by ECMO will be constant and non-pulsatile, as ECMO circulates blood continuously, unlike the pulsatile heart. This characteristic is crucial for realistically simulating the hemodynamic conditions of a patient on ECMO, since conventional critical care simulation monitors are not designed to reflect this anti-physiological behavior. The ability to display a pulse-free blood pressure waveform with a heart rate of 0 allows system users (1) to understand and analyze the differences in perfusion and blood pressure in ECMO-supported patients.

[0174] Advantageously, the inclusion of the ability to display a simulated blood pressure curve without pulse pressure in patients with a heart rate substantially equal to 0, preferably automatically adapted to the ECMO flow (5), significantly improves the system's functionality (1). This allows healthcare professionals and students to practice and refine their skills in assessing and responding to the unique hemodynamic conditions of ECMO patients, providing more realistic and effective training for the management of these critically ill patients.

[0175] According to a preferred embodiment of the system (1) of the invention, the first display (2) and / or the user display (3) are configured to show at least one simulated blood pressure (BP) curve and one simulated oxygen saturation (SpO2) curve, where the amplitude of one of these two simulated curves is proportional to the amplitude of the other. Blood pressure (BP) is a critical parameter that reflects the pressure in the arteries during a cardiac cycle, indicating the perfusion received by the different organs for their proper functioning. Lower blood pressure implies less blood flow, resulting in lower perfusion and, consequently, a lower concentration of oxygen in the blood (saturation).

[0176] The relationship between blood pressure and oxygen saturation is fundamental in monitoring critically ill patients, as a decrease in blood pressure can lead to a reduction in oxygen saturation due to decreased tissue perfusion. However, this interdependence is not considered in all patient simulator monitors available on the market. The configuration of system (1) to display ABP and SpO2 curves where the amplitude of one is proportional to the amplitude of the other allows for a more realistic and accurate simulation of this critical hemodynamic relationship. The relationship can be explained as follows: lower blood pressure means less blood is being perfused (lower perfusion) and, consequently, there is a lower oxygen concentration (lower SpO2).

[0177] Advantageously, the inclusion of the ability to display a simulated ABP curve and a simulated SpO2 curve, where the amplitude of one is proportional to the amplitude of the other, significantly improves the system's functionality (1), making it more realistic. This is because both curves are related, as explained above.

[0178] In a preferred embodiment of the system (1) of the invention, the system (1) comprises an internal reservoir, preferably removable and refillable, in fluid communication with the drainage (7) and / or return (8) lines.

[0179] This reservoir may comprise or consist of a watertight container of a predetermined volume, configured to be filled with water or another liquid, preferably non-toxic, compatible with the simulation system. The reservoir may be housed inside the event generator box (4) or, preferably, in an additional container of the system (1), wherein said container is preferably flexible and preferably comprises an air valve to prevent vacuum effects and / or bubbles, and is preferably connected by a flexible tubing system to the drain (7) and / or return (8) lines.

[0180] Preferably, the reservoir is provided with a hermetically sealed lid or a valve system that facilitates filling and emptying. In some embodiments, it may include fluid level sensors, allowing the system (1) to accurately calculate the circulating volume. In some embodiments, the reservoir can also be used to represent fluid loss or replacement volumes during simulation, in combination with the bleeding subsystem (45) or infusion systems connected to the system (1).

[0181] Advantageously, the incorporation of an internal reservoir, preferably removable and refillable, allows for precise control of the circulating fluid volume in the system (1), facilitating its calibration and improving the accuracy of the simulations. This optimizes the realism of the simulated clinical scenarios and allows for better adaptation of the system (1) to different types of training.

[0182] In a preferred embodiment of the system (1) of the invention, the valve subsystem (41) comprises an actuator configured to perform intermittent openings and closings in at least one of the drainage (7) or return (8) lines, configured to generate an oscillating drainage effect suitable for simulating real clinical situations.

[0183] In some embodiments this actuator may comprise an electric motor, a solenoid or a micro-actuation system controlled by the control subsystem (40), and may be integrated into a bypass valve or a motorized clamp applied over the tube.

[0184] The oscillating drainage effect, also known as "line chattering", is characteristic of certain states of hypovolemia, partial obstruction or incorrect positioning of the cannulas, and its simulation provides valuable visual and acoustic feedback in clinical training settings.

[0185] In certain embodiments, the oscillation can be adjusted in frequency and intensity from the graphic interface shown on the first screen (2) thanks to an associated interactive element, allowing the simulation of different pathological conditions or the generation of hemodynamic events.

[0186] In some embodiments the system (1) can coordinate this effect with other simultaneous simulations, such as a drop in simulated cardiac output or an increase in circuit pressures, increasing the clinical realism of the scenario.

[0187] Advantageously, the system's (1) ability to generate an oscillating drainage effect allows for the accurate simulation of relevant clinical events that affect the quality of extracorporeal flow. This helps improve the fidelity of the simulation and allows users to identify and interpret simulated physical signs during cannulation or extracorporeal support. In a preferred embodiment of the system (1) of the invention, the first display (2) and / or the user display (3) are configured to show a cardiopulmonary resuscitation scenario with ECMO support (ECPR).

[0188] In some implementations, the ECPR scenario may comprise a comprehensive visual simulation that represents the connection of a patient to an ECMO system during cardiac arrest, being able to integrate multiple simulated clinical variables into a single graphical interface.

[0189] Preferably, the ECPR scenario can be activated from a specific interactive element displayed on the first screen (2) and / or the user screen (3), which preferably triggers automatically at least one configuration of hemodynamic, respiratory and / or neurological monitoring parameters, among others, adapted to an extracorporeal resuscitation environment.

[0190] In some implementations, this scenario may also include a step-by-step guide or visual instructions that indicate the flow of simulated clinical maneuvers during resuscitation, including urgent cannulation, adjustment of support parameters, identification of heart rhythm, and assessment of tissue perfusion.

[0191] Advantageously, the ability to display an ECPR scenario on the first screen (2) and / or the user screen (3) allows real-time training in critical situations where rapid ECMO intervention is required, facilitating decision-making in high-pressure situations and improving preparedness for real emergencies.

[0192] In a preferred embodiment of the system (1) of the invention, said ECPR scenario comprises displaying on the first screen (2) and / or the user screen (3) simulated or real brain and / or lower limb near-infrared (NIRS) spectroscopy values.

[0193] In some implementations, NIRS monitoring can be presented in the form of numerical values ​​and / or trend graphs, representing regional tissue oxygen saturation, preferably in critical anatomical regions.

[0194] In certain realizations, these values ​​can simulate situations of cerebral hypoperfusion, ineffective recirculation, or progressive recovery during the ECPR scenario, correlated with ECMO flow and other simulated patient parameters.

[0195] In some embodiments, the first screen (2) and / or the user screen (3) allows modification of NIRS values ​​as part of training through interactive elements, or activation of automatic responses based on predefined thresholds, such as visual alerts or changes in the blood pressure curve.

[0196] Advantageously, the inclusion of NIRS values ​​in the ECPR scenario allows the user to train in the interpretation of tissue oxygenation indicators in cardiac arrest situations, improving the ability to assess perfusion and guide clinical decision-making during extracorporeal life support.

[0197] In a preferred embodiment of the system (1) of the invention, said ECPR scenario comprises displaying on the first screen (2) and / or the user screen (3) a simulated invasive blood pressure curve automatically adapted to the ECMO equipment flow (5), and, preferably, to SpO2 levels.

[0198] In some embodiments, an interactive element displayed on the first screen (2) and / or the user screen (3) allows modification of ECMO equipment flow parameters (5) from the graphical interface, observing the resulting effects on the displayed invasive blood pressure curve.

[0199] Preferably, this adaptation can be complemented with interactive elements to modify target parameters that allow a desired PAM range to be established, preferably where the system (1) automatically adjusts the curve morphology to maintain said target.

[0200] Advantageously, the system's ability (1) to display an invasive blood pressure curve adapted to ECMO flow, and, preferably, to SpO2 levels, during an ECPR scenario enhances the physiological realism of the simulation, and allows the user to understand the importance of extracorporeal mechanical support in maintaining perfusion during cardiac arrest situations.

[0201] In a preferred embodiment of the system (1) of the invention, said ECPR scenario comprises displaying on the first screen (2) and / or the user screen (3) the frequency and / or depth of compressions generated by an external or simulated automatic or manual chest compression device in communication with the system (1), and modifying, in a manner synchronized with said data, the amplitude and frequency of a simulated invasive blood pressure curve displayed on said screens.

[0202] Preferably, the system (1) receives this compression data in real time via wired or wireless communication with devices such as, but not limited to, LUCAS®, AutoPulse®, or via manual instructor input or automatic simulation of such a device, in which case wired or wireless communication would not be required. In some embodiments, the invasive blood pressure waveform may show oscillations synchronized with each compression, reflecting the mechanical effectiveness of chest compressions during cardiac arrest. In other embodiments, the interface may include graphical tools to visualize compression rate, blood pressure, and / or simulated cerebral oxygenation in parallel, allowing for a comprehensive analysis of resuscitation quality.

[0203] Advantageously, the synchronized visualization of chest compressions and their effect on the blood pressure curve allows users to evaluate the effectiveness of CPR during ECMO support, facilitating the learning of advanced resuscitation techniques in highly complex scenarios.

[0204] In a preferred embodiment of the system (1) of the invention, said ECPR scenario comprises displaying on the first screen (2) and / or the user screen (3) one or more simulated electrocardiogram curves corresponding to shockable rhythms, non-shockable rhythms and / or ST segment elevation rhythms.

[0205] In some realizations, shockable rhythms may include ventricular fibrillation and / or pulseless ventricular tachycardia; non-shockable rhythms may include asystole and / or pulseless electrical activity (PEA); and ST elevation rhythms may simulate acute myocardial infarctions with typical ECG tracing presentation, among other options.

[0206] In certain implementations, the user can select the desired rhythm using an interactive element displayed in the graphical interface, or the rhythms can be automatically modified during the performance, depending on the time or user actions.

[0207] More preferably, the interface can combine ECG visualization with MAP, SpO2, SvO2 and NIRS values, generating an integrated clinical view of the patient in cardiac arrest.

[0208] Advantageously, the system's ability (1) to display clinically relevant simulated heart rhythms during an ECPR scenario allows the user to be trained in the recognition and interpretation of electrocardiographic tracings, facilitating decision-making such as defibrillation, urgent cannulation, or drug administration during extracorporeal resuscitation.

[0209] Simulated hyperoxygenation can be visualized, in some implementations, by a color change in the drainage line (7), generated by the signaling subsystem (46), which may comprise RGB light sources or LEDs of different colors and / or addressable LEDs. Advantageously, the system's (1) ability to display a recirculation scenario in a VV configuration allows for the simulation of one of the most frequent and relevant complications in venovenous ECMO, facilitating early visual recognition of the problem and training the user in its interpretation and appropriate correction.

[0210] In a preferred embodiment of the system (1) of the invention, the first screen (2) and / or the user screen (3) are configured to display one or more medical images corresponding to clinical tests, selected from the list comprising: a computed tomography image, a static electrocardiogram image, an echocardiography video, a chest x-ray image of pulmonary edema or aspiration pneumonia, a tracheal aspirate culture result image and / or an electroencephalogram (EEG) image.

[0211] It is important to note that these images can be integrated into the simulated clinical scenario or presented in isolation, for example to allow for real-time analysis.

[0212] In some implementations, the images can be displayed in sync with simulated events, such as hemodynamic deterioration or the appearance of a new ECG rhythm, activated by interactive elements in the interface or automatically according to the scenario script.

[0213] Preferably, these images can be incorporated from a pre-installed library or loaded from an external medium through a graphical interface that allows navigation between different studies, the parameters included in the first screen (2) and / or by artificial intelligence.

[0214] Advantageously, the ability to display relevant clinical images on the first screen (2) and / or user screen (3) enriches the simulation by integrating real or realistic diagnostic elements, promoting the user's clinical reasoning, training in results interpretation, and decision-making based on visual data.

[0215] In a preferred embodiment of the system (1) of the invention, the first display (2) and / or the user display (3) are configured to show a simulated blood pressure curve with an intra-aortic balloon pump effect, where said effect comprises the appearance of waves synchronized with the cardiac cycle or with a simulated intra-aortic balloon pump generator.

[0216] In some implementations, this curve may exhibit a double-peak morphology reflecting the inflation and deflation of the intra-aortic balloon in synchrony with the cardiac cycle. In certain implementations, synchronization can be achieved using a simulated ECG rhythm displayed simultaneously on the interface, or with an external device that emulates the operation of a real balloon, communicating with the system (1).

[0217] Preferably, the user can activate or deactivate this functionality from an interactive element on the screen and select between different counter-pulse modes, such as, but not limited to, 1:1, 2:1 or 3:1.

[0218] Advantageously, the visualization of an arterial pressure curve with an intra-aortic balloon pump effect allows the user to be trained in the interpretation and control of this advanced hemodynamic support technique, facilitating its integration into complex clinical scenarios such as cardiogenic shock or combined support with ECMO.

[0219] Advantageously, the ability to adjust mechanical ventilation parameters based on specific clinical scenarios allows for the simulation of complex pulmonary conditions and the evaluation of the impact of the user's ventilatory decisions, improving pathophysiological understanding and clinical responsiveness during training.

[0220] In a preferred embodiment of the system (1) of the invention, the system (1) is configured to simulate different types of life support using Extracorporeal Membrane Oxygenation (ECMO) therapy, preferably comprising venovenous (VV), venoarterial (VA), support during extracorporeal resuscitation procedures (ECPR), and / or support in the context of controlled donation after circulatory death (donation). Preferably, one or more of these modalities are integrated into the system (1) as distinct training paths, accessible from the first screen (2), allowing the user to select and activate specific clinical scenarios according to the desired ECMO support modality.

[0221] Ideally, each support mode represents not only a distinct technical configuration of the simulated ECMO system, but is also implemented as a progressive learning environment where the user can follow a structured learning path, progressing from the basics of cannulation to complex clinical decision-making. Ideally, the system interface (1) allows the simulation of each mode to begin with a pre-configured simulated patient and enables the programmatic or manual modification of relevant hemodynamic and respiratory values ​​based on the selected support mode.

[0222] From a functional and physiological perspective, in some embodiments, the system (1) allows for the representation of key dynamic relationships between fundamental clinical parameters for each type of ECMO. In a preferred embodiment, in venovenous (VV) ECMO mode, the system (1) is configured to simulate and display the relationship between extracorporeal flow (L / min) and peripheral oxygen saturation (SpO2). In this mode, typical respiratory failure conditions without circulatory compromise are simulated, allowing observation of how an increase in flow improves oxygenation but also increases recirculation, which can be visualized as a change in the SvO2 value and / or in the simulated venous-to-arterial saturation ratio. The system (1) also preferably allows for the simulation of the influence of preload and pulmonary vascular resistance.

[0223] In an alternative or additional embodiment, in venoarterial (VA) ECMO mode, the system (1) can be configured to represent the relationship between the flow generated by the ECMO device and the mean arterial pressure (MAP or ABP), allowing for the simulation of severe heart failure scenarios. In this environment, the user can observe how insufficient flow leads to simulated tissue hypoperfusion, expressed in parameters such as lactic acidosis, decreased cardiac output (CO), or drops in the cerebral perfusion index (CPP), while excessive flow can produce an increase in afterload, visualized in the post-membrane pressure or invasive arterial pressure curves.

[0224] In some embodiments, the system (1) allows alternating between these modalities during the same training session, adapting the simulated physiological parameters of the patient, the conditions of the ECMO equipment and the hemodynamic responses observed at the interface.

[0225] Advantageously, the integration of different ECMO support modalities into the system (1), including venovenous, venoarterial, ECPR, and donation, allows for the establishment of a progressive and structured clinical training platform. This implementation not only replicates the technical aspects of extracorporeal support but also facilitates a systemic understanding of its physiology, promoting critical training focused on clinical decision-making. The system (1) thus becomes an advanced training tool that guides the user from the fundamentals to the management of complex clinical scenarios, enabling autonomous, safe training adapted to the diverse professional profiles within the healthcare field.

[0226] To facilitate a better understanding of this disclosure, reference will be made, by way of example only, to the accompanying schematic drawings. It is important to note that the following figures are provided solely as exemplary, non-limiting embodiments of the invention. Accordingly, the drawings should be regarded as illustrative rather than restrictive, serving only to assist in explaining the principles and possible applications of the invention. Figure 1 shows a schematic drawing of a system (1) according to one or more embodiments of the system (1) of the invention, where an ECMO machine or device (5) is fluidly connected to the event generator box (4) by means of the drain (7) and return (8) lines. The box (4) is, in turn, fluidly connected to the infusion bag (6) by means of extensions of the drain (7) and return lines.A first screen (2) and a user screen (3) are connected by cable or wirelessly, preferably wirelessly via Wi-Fi or Bluetooth, to the control system (40) or to different microcontrollers of other subsystems (41, 42, 44, 45, 46, 48) contained in the box (4) or in the system (1). Figure 1 shows the following subsystems (41, 42, 44, 45, 46, 48): valve subsystem (41), sensor subsystem (42), which may comprise one or more pressure sensors (421) and / or one or more flow sensors (422), preferably one or more pressure sensors (421), the bubble generator subsystem (44) or plungers, the bleeding subsystem (45), the signaling subsystem (46), which may comprise colored LED light strips, and the wireless connectivity subsystem (48), as well as the battery.These subsystems and the battery appear in Figure 1 integrated into the event generator box (4), but in other embodiments they may not be included in said box (4) and may be included in other means or not be included in the system (1) in certain embodiments.

[0227] It is important to emphasize that in other embodiments, one or more of the subsystems (41, 42, 44, 45, 46, 48) contained in the box (4) according to Figure 1 may not be contained within said box (4), or may be only partially contained within it. For example, the signaling system (46) must be at least partially outside the event-generating box (4), connected to the drain (7) and / or return (8) lines, if said signaling system (46) includes, for example, LED lights to provide visual signals to the user. Additionally, in other embodiments of the system (1) of the invention, different combinations of the subsystems (41, 42, 44, 45, 46, 48) may or may not be present, as is the case with the battery (47).

[0228] Figure 2 shows a schematic drawing of a top view of an event-generating box (4) according to one or more embodiments of the invention, where various connections to the box can be seen. At the top, extensions of the drainage line (7) and return line (8) seamlessly connect the box to an infusion bag. At the bottom, the drainage line (7) and return line (8) seamlessly connect to an ECMO device or equipment (5).Additionally, the lower part of the box (4) comprises a fluidic connection to the bleeding subsystem (45), where said system may comprise capsules or containers with simulated blood inside the box (4), and separately comprises an electrical connection to the signaling system (46), which in the case of Figure 2 comprises LED light strips attached to or included in the drainage (7) and return (8) lines, where said LED strips may preferably illuminate in one or more colors, such as blue or red, or in different colors for each line (7, 8). On the left side of the image, the box (4) has a connection to other devices (401), which is optional and may not be included in some embodiments, and a USB port for connecting to a cable (400), preferably intended for maintenance, which is also optional and may not be included in some embodiments.The right side of the image shows a power cable (471) that can be connected to the battery (47) contained in the box (4) or directly power said box (4) and the subsystems contained therein.

[0229] Note that the dimensions, length, positions, and sizes, as well as the number and type of connections, may vary from one embodiment to another, and what is illustrated in Figure 2 is only one example of an embodiment.

[0230] Figure 3 shows a schematic embodiment. A patient mannequin or simulator (9) is lying on a bed, and an event-generating box (4) is located at its legs. This box (4) is connected via drainage (7) and return (8) lines to an ECMO machine or device (5), and is also connected to an infusion bag (6) via extensions of these drainage (7) and return (8) lines. Note that the mannequin (9) is preferably not included in the system (1) of the invention, but in some embodiments, the system may include the mannequin (9), or the event-generating box (4) and / or part of the system (1) may be integrated into the patient mannequin or simulator (9). In this case, the patient simulator (9) would include connections or cannulas seamlessly connected to the box (4) or to the system (1).The size, shape, and dimensions of the system elements (1) shown in Figure 3 are merely illustrative and may change in different embodiments.

[0231] Figure 4 shows an example of an embodiment similar to Figure 3, displaying a more realistic image of the event generator box (4), the ECMO machine (5), the infusion bag (7, 8), and the drainage (7) and return (8) lines, according to one or more embodiments of the invention. In addition, this figure shows further system components such as the control (2) and user (3) displays, which are wirelessly connected, for example, via Wi-Fi or Bluetooth, to the event generator box (4), and the signaling subsystem (46), which in this case comprises colored LED strips (preferably capable of emitting red and / or blue light) integrated into the drainage (7) and return (8) lines leading to the ECMO machine (5).Regarding the control screens (2) and user screens (3), Figure 4 shows an embodiment where both display various patient parameters, ventilator parameters, ECMO equipment parameters (5), neurophysiological parameters, and pressure and / or flow parameters of the drainage (7) and / or return (8) lines, all integrated into a first graphical interface (200) for the first screen (2), and a second graphical interface (300) for the user screen (3). Furthermore, the first screen (2) also displays, integrated into the first graphical interface (200), interactive events such as events to set a target pressure or flow (430), to set a target time (431) to reach that target pressure or flow, to emit signals (460) such as turning the LED light sources (461) of the signaling system (46) on or off, to activate simulated blood output (450), and to activate bubble generation (440).It is important to note that in other embodiments of the invention, the first graphical interface may comprise some, all, or even additional events related to ECMO training, and that the number of events shown in Figure 4 is for illustrative purposes only, as are their size, position, and shape. These interactive events, as can be seen in Figure 4, may be digital buttons, dials, increment or decrement arrows, alphanumeric input for entering a numerical value, or any other digital means of interacting with a display known in the prior art. In some embodiments, these interactive events are found in two or more graphical interfaces. Additionally, the system (1) may comprise physical buttons or devices such as pedals or switches to activate these events, either in addition to or instead of the digital interactive events described above.

[0232] Figure 5 shows an example of the layout for the first graphical interface (200) of the first screen (2), according to one or more embodiments of the invention. It is important to note that in some embodiments this layout may differ, comprising more or fewer elements, or with different sizes or shapes, or where these elements are integrated into two or more user interfaces. The advantage of integrating everything into the same user interface, as shown in Figure 5, is that it allows for comprehensive control of the simulation on a single screen, at a glance, and much faster and more efficiently than if the elements shown in the image—that is, the parameters and events—were separated into different interfaces or accessible through different menus, which would require making decisions without having all the information readily available.The parameters displayed on the first screen (2) can be simulated by the system (1) or real, obtained from the means for monitoring pressure and / or fluid flow in the drain (7) and / or return (8) lines, from the sensor subsystem (42), or from connections to external devices such as the ECMO machine or equipment (5), a mechanical ventilator, or medical systems such as ECG or NIRS, where these parameters are preferably simulated, except for the pressure and / or fluid flow parameters. Additionally, the parameters displayed on the first screen (2) are preferably editable, unlike those displayed on the user screen (3). In some implementations, the parameters of both screens (2, 3) can also be modified programmatically using pre-programmed scenarios.

[0233] Figure 5 shows boxes to indicate the presence of ECMO parameters (21) such as SVO2, Hb / Hc, blood pressure, venous temperature, etc., boxes to indicate the presence of patient parameters (22) such as electrocardiograms, ventilator parameters (23) such as respiratory rate, PEEP, FiO2, etc., neurophysiological parameters (24) such as NIRS and / or BIS, and a box for complementary samples, that is, to be able to select to view images of relevant medical tests available, such as blood gas analyses, graphs of analytical variables, radiographs, clinical reports, ultrasound and / or computed tomography videos, manuals, and / or scientific articles.Furthermore, Figure 5 shows a possible positioning of various interactive events, such as the element to set a target pressure and / or flow (430), the interactive element to achieve a target pressure and / or flow in a given time, as well as interactive events for signal emission (460), for example to select the color in the drain (7) and / or return (8) lines, with the possibility of configuring the duration or start time of said color change by means of an interactive element for color change timing (420), an interactive element for bubble generation (440) and its associated duration or start time, and a bleeding simulation element, as well as its associated duration or start time.In certain embodiments of the invention, the system (1) may comprise such interactive events, parts thereof, or additional events not shown in Figure 5, and it is possible that such events may be comprised in different arrangements, shapes, colors, and sizes than those shown in Figure 5, which is present for illustrative purposes.

[0234] Figure 6 shows an example of the layout for the second graphical interface (300) of the user screen (3), according to one or more embodiments of the invention. It is important to note that in some embodiments this layout may differ, comprising more or fewer elements, or with different sizes or shapes, or where such elements are integrated into two or more user interfaces. The user screen shown in Figure 6 shares the advantages of integrating everything into a single user interface with the first user interface for the first screen (2).

[0235] Figure 6 shows boxes for ECMO parameters (21) such as SVO2, Hb / Hc, blood pressure, venous temperature, etc., boxes for patient parameters (22) such as electrocardiograms, ventilator parameters (23) such as respiratory rate, PEEP, F102, etc., neurophysiological parameters (24) such as NIRS and / or BIS.

[0236] Figure 7 shows a photograph of the system (1) of the invention according to one or more embodiments. The user display (3), the signaling subsystem (46) with LED light sources (461) integrated into or adjacent to the drain (7) and return (8) lines, where said strips may comprise red (462) and / or blue (464) LEDs, and an ECMO system or device (5) to which said lines are connected, can be seen. In some embodiments, the LED light sources (461) may comprise green LEDs, in addition to red and blue, to be able to emit light in any RGB color. In particular, the event generator box, which in this case would be located between the legs of the mannequin, under the hospital sheet, and where said box is connected to the drain (7) and return (8) lines, is not visible in Figure 7.

[0237] Figure 8 shows a photograph of the system (1) of the invention according to one or more embodiments. In this case, since the mannequin is not covered by any sheet, the event generator box (4) connected to the drain (7) and return (8) lines can be seen.

[0238] It is important to note that the mannequin is completely accessory, and may or may not form part of system (1), preferably not part of system (1).

Claims

1. CLAIMS 1. Extracorporeal Membrane Oxygenation (ECMO) treatment simulation system (1), wherein the system (1) comprises: i. a drainage line (7) and a return line (8) configured to be connected to an ECMO device (5); i. a valve subsystem (41) comprising one or more electrically actuated valves for regulating fluid flow, wherein the one or more valves are configured to be connected to the drain (7) and / or return (8) lines; iii. means for monitoring the pressure and / or fluid flow in the drain (7) and / or return (8) lines; iv. a control subsystem (40) in communication with the valve subsystem (41) and with the means for monitoring the pressure and / or fluid flow, wherein the control subsystem (40) is configured to control the pressure and / or flow in the drain (7) and / or return (8) lines through the valve subsystem (41) and said means for monitoring the pressure and / or fluid flow; and v. a first screen (2) in communication with the control subsystem (40) or comprising said control subsystem (40), wherein the first screen (2) is configured to display vi.one or more simulated patient parameters, vii. one or more simulated or real ECMO equipment parameters, and viii. one or more pressure and / or flow parameters of the drainage (7) and / or return (8) lines; wherein the first screen (2) is further configured to display an interactive element for setting a target pressure or a target flow (430), and wherein the control subsystem (40) is further configured to control the valve subsystem (41) to achieve such target pressure or target flow in the drainage (7) and / or return (8) lines.

2. The system (1) according to claim 1, wherein the means for monitoring the pressure and / or fluid flow in the drain (7) and / or return (8) lines comprise a sensor subsystem (42) comprising one or more pressure sensors (421) or flow (422) configured to monitor pressure and / or fluid flow in the drain (7) and / or return (8) lines.

3. The system (1) according to claim 1, wherein the means for monitoring the pressure and / or fluid flow in the drain (7) and / or return (8) lines comprise a camera in communication with the first display (2) and / or with the control subsystem (40), wherein the camera is configured to read pressure and / or flow parameters from the ECMO equipment using optical character recognition (OCR) technology.

4. The system (1) according to any of the preceding claims, wherein the first screen (2) is further configured to display an interactive element for setting a target time (431), wherein the control subsystem (40) is configured to control one or more valves to achieve the target pressure or target flow at said target time in the drain (7) and / or return (8) lines.

5. The system (1) according to any of the preceding claims, wherein all parameters shown on the first screen (2) are modifiable manually or programmatically.

6. The system (1) according to any of the preceding claims, wherein the first screen (2) is configured to display one or more actual parameters of the ECMO equipment, and wherein the system (1) is connected to the ECMO equipment by cable or wirelessly and the actual parameters of the ECMO equipment displayed on the first screen (2) are obtained from the ECMO equipment through said connection.

7. The system (1) according to any of the preceding claims, wherein the system (1) further comprises a signaling subsystem (46) in communication with the control subsystem (40) that emits one or more visual and / or acoustic signals, wherein the first screen (2) of the system (1) is further configured to display at least one interactive element for the emission of said signals (460).

8. The system (1) according to claim 7, wherein the signaling subsystem (46) comprises one or more light sources that allow the illumination and / or color change of the drainage (7) and / or return (8) lines.

9. The system (1) according to any of the preceding claims, wherein the system (1) comprises a processor communicating with a memory, wherein the memory comprises instructions executable by the processor which, when executed by the processor, cause said processor to perform at least the following task: i. Automatically calculate and adjust the change in diameter of the valve subsystem connection (41) to the drain (7) and / or return (8) lines to change the pressure parameters shown on the first screen (2).

10. The system (1) according to any of the preceding claims, wherein the one or more simulated patient parameters comprise one or more of the following parameters: electrocardiogram (ECG), heart rhythms, heart rate (HR), arterial blood pressure (ABP), intra-aortic balloon pump modified ABP, pathological heart rhythm modified ABP, central venous pressure (CVP), pulmonary artery pressure (PAP), central venous oxygen saturation (SCVO2), mixed venous oxygen saturation (SVO2), cardiac output (CO), cardiac index (Cl), stroke volume variability (WS), pulmonary capillary wedge pressure (PCWP), left atrial pressure (LAP), systemic vascular resistance (SVR), pulmonary vascular resistance (PVR), peripheral oxygen saturation (SpO2), respiratory rate, total, compulsory and / or spontaneous respiratory rate, inspiratory tidal volume (Vti), expiratory tidal volume (Vte), fraction of inspired oxygen (FiO2),end-expiratory carbon dioxide level (EtCÜ2), plateau pressure (Pplat), positive end-expiratory pressure (PEEP), inspiratory pressure (IP), peak pressure (Ppeak), driving pressure (DP), pressure support (PS), respiratory system resistance and compliance (Crs), airflow and FiO2 through high-flow nasal cannula system, volume-controlled ventilation mode, pressure-controlled ventilation mode, spontaneous ventilation mode, partial pressure of oxygen in arterial blood (PaÜ2), partial pressure of carbon dioxide in arterial blood (PaCÜ2), blood pH, bicarbonate (HCO3-), lactate, hematocrit (He) and / or hemoglobin (Hb) levels, potassium (K+) levels, sodium (Na+) levels, calcium (Ca++) levels, core body temperature, skin temperature, activated clotting time (ACT), near-infrared spectroscopy (NIRS), bispectral index (BIS), electroencephalogram (EEG) waves,spectral matrix, train of four (TOF), somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), intracranial pressure (ICP), cerebral tissue oxygenation (CtO2), cerebral blood flow (CBF), jugular venous oxygen saturation (SjvO2) and / or cerebral perfusion pressure (CPP).

11. The system (1) according to any of the preceding claims, wherein the one or more parameters of the simulated or actual ECMO equipment comprise one or more of the following parameters: pressure of one or more drainage lines (7), pressure of one or more return lines (8), percentage of drainage line occlusion (7), percentage return line occlusion (8), blood flow in general and accessory lines for the one or more drainage lines (7) and / or the one or more return lines (8), gas flow, gas oxygen fraction (FDO2), ECMO equipment data (5), SvÜ2, drainage line color, return line color, circuit temperature (Te), pre-membrane pressure, post-membrane pressure, transmembrane pressure (delta P).

12. The system (1) according to any of the preceding claims, wherein the first screen (2) and / or the user screen (3) are configured to further display mechanical ventilation parameters.

13. The system (1) according to any of the preceding claims, wherein the system comprises a user display (3) in wireless or wired communication with the first display (2) and / or with the control subsystem (40), wherein the user display (3) is configured to show patient parameters and actual or simulated ECMO equipment parameters.

14. The system (1) according to any of the preceding claims, wherein the system (1) further comprises a bleeding subsystem (45) in communication with the control subsystem (40) configured to simulate bleeding by means of the output of simulated blood (452) from an internal reservoir, preferably wherein the simulated blood (452) is released into one or more cannula insertion areas or any location of a patient simulator (9), wherein the first display (2) of the system (1) is further configured to display an interactive element for activating the output of simulated blood (450).

15. The system (1) according to any of the preceding claims, wherein the system (1) further comprises a bubble generator subsystem (44) in wireless or wired communication with the control subsystem (40) or with the first screen (2), and in fluid communication with at least one of the drain (7) or return (8) lines, wherein the bubble generator subsystem (44) is configured to generate bubbles in at least one of the drain (7) or return (8) lines, and wherein the first screen (2) of the system (1) is further configured to display an interactive element to activate bubble generation (440) in the drain and / or return lines.

16. The system (1) according to any of the preceding claims, wherein the one or more simulated patient parameters, the one or more simulated or real ECMO equipment parameters, the one or more pressure and / or flow parameters of the drainage lines (7) and / or return lines (8), and the interactive event (430) to establish A target pressure or a target flow are contained in a first graphical interface (200) configured to be displayed on the control screen (2).

17. The system (1) according to any of the preceding claims, wherein it further comprises one or more cannulas and / or one or more tubes of suitable lengths to allow the connection of the drainage lines (7) and / or return lines (8) to different extracorporeal life support devices or ECMO equipment (5), as well as adaptable cannulas and tubes of suitable diameter and length to allow the connection of the system (1), preferably the drainage lines (7) and / or return lines (8), to CRRT and apheresis machines.

18. The system (1) according to any of the preceding claims, wherein it further comprises a battery (47) to allow the use of the system (1) without being connected to the electrical network.

19. The system (1) according to any of the preceding claims, wherein it further comprises a wireless connectivity subsystem (48) in communication with the control subsystem (40).

20. The system (1) according to any of the preceding claims, wherein the control subsystem (40), the valve subsystem (41) and the sensor subsystem (42) are comprised in an event generating box (4) configured to connect seamlessly to the drain (7) and / or return (8) lines.

21. The system (1) according to any of the preceding claims, wherein the system (1) further comprises at least one infusion bag connected to the valve subsystem (41) and / or to the event generator box (4) through a continuation of the drainage line (7) and / or through a continuation of the return line (8).

22. The system (1) according to any of the preceding claims, wherein the first screen (2) and / or the user screen (3) are further configured to display blood gas images, graphs of analytical variables, conventional radiography images, clinical reports, ultrasound videos, computed tomography videos, manuals and / or scientific articles.

23. The system (1) according to any of the preceding claims, wherein at least one of the one or more simulated patient parameters is associated with the pressure and / or fluid flow values ​​monitored in the drainage (7) and / or return (8) lines, preferably wherein these parameters are ABP, SpO2, SvO2 and / or NIRS, more preferably wherein these parameters are SpO2, SvO2 and NIRS in simulations of veno-venous ECMO treatment, and ABP, SvO2 and NIRS in veno-arterial ECMO treatment simulations.

24. The system (1) according to any of the preceding claims, wherein the drainage (7) and / or return (8) lines have a length suitable to accommodate different cannulation configurations, wherein said cannulation configurations comprise femoral-jugular, jugular-femoral, femoral-femoral and double lumen configurations.

25. The system (1) according to any of the preceding claims, wherein the first screen (2) and / or the user screen (3) are further configured to display one or more pre-programmed training scenarios or configurations (25) that programmatically control the value of one or more simulated patient parameters, one or more simulated ECMO equipment parameters, one or more pressure parameters and / or flow parameters of the drainage (7) and / or return lines, the valve subsystem (41), the signaling subsystem (46), the bubble generator subsystem (44), and / or the bleeding subsystem (45).

26. The system (1) according to any of the preceding claims, wherein the first screen (2) and / or the user screen (3) are further configured to allow the creation of one or more pre-programmed training scenarios (25) that programmatically control the value of one or more simulated patient parameters, one or more simulated ECMO equipment parameters, one or more pressure parameters and / or flow parameters of the drainage (7) and / or return lines, the valve subsystem (41), the signaling subsystem (46), the bubble generator subsystem (44), and / or the bleeding subsystem (45).

27. The system (1) according to any of the preceding claims, wherein the first screen (2) and / or the user screen (3) are configured to display one or more simulated electrocardiogram waveforms in at least one of the following situations: sinus rhythm, asystole, ventricular tachycardia, ventricular fibrillation, atrial fibrillation, 2:1 atrial flutter, 3:1 atrial flutter, first-degree atrioventricular block, second-degree type I atrioventricular block, second-degree type II atrioventricular block, complete atrioventricular block, torsades de pointes, and / or diseased sinus node.

28. The system (1) according to claim 27, wherein at least one of the one or more simulated electrocardiogram curves comprises at least one of the following variations: ventricular extrasystole, supraventricular extrasystole, elevation of ST segment, ST segment depression, presence of pacemaker with ventricular stimulation, presence of 1:1 intra-aortic balloon counterpulsation, presence of 2:1 intra-aortic balloon counterpulsation and / or presence of 3:1 intra-aortic balloon counterpulsation.

29. The system (1) according to any of the preceding claims, wherein the first display (2) and / or the user display (3) are configured to show a simulated blood pressure curve without pulse pressure in patients with a heart rate substantially equal to 0, and / or in cases of asystole or ventricular fibrillation, preferably automatically adapted to the flow of the ECMO equipment (5).

30. The system (1) according to any of the preceding claims, wherein the first display (2) and / or the user display (3) are configured to display at least one simulated ABP curve and one simulated SpO2 curve, wherein the amplitude of one of these two simulated curves is proportional to the amplitude of the other mentioned curve.

31. The system (1) according to any of the preceding claims, wherein the valve subsystem (41) comprises an actuator configured to perform intermittent openings and closings in at least one of the drainage (7) or return (8) lines, configured to generate an oscillating drainage effect suitable for simulating real clinical situations.

32. The system (1) according to any of the preceding claims, wherein the first screen (2) and / or the user screen (3) are configured to display a cardiopulmonary resuscitation scenario with ECMO support (ECPR).

33. The system (1) according to claim 32, wherein said ECPR scenario comprises displaying on said first screen (2) and / or the user screen (3) simulated or real brain and / or lower limb near-infrared (NIRS) spectroscopy values.

34. The system (1) according to claim 32 or 33, wherein said ECPR scenario further comprises displaying on the first screen (2) and / or the user screen (3) a simulated invasive blood pressure curve automatically adapted to the ECMO equipment flow (5) and, preferably, to SpO2 levels.

35. The system (1) according to any of claims 32 to 34, wherein said ECPR scenario further comprises displaying on the first screen (2) and / or the user screen the frequency and / or depth of the compressions generated by a device external or simulated automatic or manual chest compression in communication with the system (1) and to modify, in a synchronized manner with said data, the amplitude and frequency of a simulated invasive blood pressure curve shown on said first screen (2) and / or user screen (3).

36. The system (1) according to any of claims 32 to 35, wherein said ECPR scenario further comprises displaying on the first screen (2) and / or the user screen one or more simulated electrocardiogram curves corresponding to shockable rhythms, non-shockable rhythms and / or ST segment elevation rhythms.

37. The system (1) according to any of the preceding claims, wherein the first screen (2) and / or the user screen (3) are configured to display one or more medical images corresponding to clinical tests, selected from the list comprising: a computed tomography image, a static electrocardiogram image, an echocardiography video, a chest x-ray image of pulmonary edema or aspiration pneumonia, a tracheal aspirate culture result image and / or an electroencephalogram (EEG) image.

38. The system (1) according to any of the preceding claims, wherein the first screen (2) and / or the user screen (3) are configured to display a simulated blood pressure curve with an intra-aortic balloon pump effect, wherein said effect comprises the appearance of waves synchronized with the cardiac cycle or with a simulated intra-aortic balloon pump generator.

39. The system (1) according to any of the preceding claims, wherein the first screen (2) and / or the user screen (3) are configured to allow the adjustment of mechanical ventilation parameters based on predefined clinical situations, comprising at least one pulmonary edema scenario and one aspiration pneumonia scenario.

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