Neonate simulation device and fetal manikin

Abstract

A neonate simulation device includes a physical fetal model and a virtual fetal model connected by a controller. The physical fetal model includes a skin, skeleton and internal electronic and mechanical components that are arranged to simulate a human fetus. The virtual fetal modal is a digital twin of the physical fetal model. It receives inputs from sensors in the physical fetal model and compares them to expected thresholds. It also provides input controls to the physical fetal model according to preset scenarios.

Description

NEONATE SIMULATION DEVICE AND FETAL MANIKINCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 717,942, filed on 08 November 2024, which is incorporated herein by reference in its entirety.BACKGROUND

[0002] Extremely immature neonates, including but not limited to those bom between 2 and 28 weeks gestation, experience poor survival outcomes in standard incubators; this is due in part to their immature lungs.

[0003] Perinatal life support technology may include a liquid-based incubator alternative for the care of these extremely premature infants. Preclinical studies with animals have shown successful maintenance of fetuses on extra-uterine, liquid-based, life support. Nevertheless, the physiology and anatomy of animals differs from that of humans. Organisms which bear more resemblance to humans, such as primates, would give better predictions, but require extensive pilot studies before an approval from ethical committees is justified. As a result, the step from animal-based studies to human translation and patient-centered care is still immense. Possible future in-human studies will also pose many challenges including the unpredictable nature of preterm births, the high-risk therapeutic uncertainties and the emotional load on the patient’s families and clinical staff. However, to design, develop and train medical professions in the use of extra-uterine life support technology - and the ecosystem of related tools and its protocols - is important to test the situation as realistic as possible.

[0004] To overcome the obstacles of developing and testing efficacy and safety of novel medical technology in human patients, simulation-based development using realistic manikins representing extremely immature neonates, referred herein as fetal manikins, may help develop medical procedures and improve quality of care.SUMMARY

[0005] A neonate simulation device includes a physical fetal model, a virtual fetal model, and control unit. The physical fetal model is arranged for anatomically and biomechanically mimicking a fetus. The physical fetal model is arranged for outputting fetal output data elements associated with a condition of the physical fetal model and / or arranged for receiving fetal input data elements associated with a predetermined anatomical and biomechanical1LEGAL\81273831\3condition of a fetus for operating the physical fetal model to mimic an anatomical and biomechanical status of the fetus associated with the fetal input data elements.

[0006] The virtual fetal model is arranged for providing a virtual anatomical and biomechanical representation of the fetus comprising a model engine that anatomically and biomechanically simulates the fetus. The virtual fetal model is arranged for outputting the fetal input data elements associated with a predetermined anatomical and biomechanical condition of the virtual fetal model and / or arranged for receiving the fetal output data elements associated with an anatomical and biomechanical condition of the physical fetal model.

[0007] The control unit is communicatively connected to the physical fetal model and the virtual fetal model. The control unit is arranged for controlling the physical fetal model using predefined and / or simulated the fetal input data elements and / or providing the fetal output data elements to the virtual fetal model to simulate the anatomical and biomechanical status of the physical fetal model.

[0008] A fetal manikin for use with the neonate simulation device includes at least one temperature sensor within the manikin, a skeletal structure covered by a flexible skin, at least one airflow sensor disposed in an airway of the fetal manikin, at least one pump within the fetal manikin, and at least one sensor. The at least one pump is configured to pump fluid through a tube coupled to an umbilicus of the fetal manikin. The pump may be an indenter pump, a piston pump, or a peristaltic pump. The at least one sensor is within the manikin and adapted to measure flow or pressure from the pump.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. lA is a schematic diagram of a neonate simulation device, in embodiments.

[0010] FIG. IB illustrates the neonate simulation device of FIG. 1A in a typical usage scenario.

[0011] FIG. 2 A illustrates the skin of a physical fetal model for use in the neonate simulation device of FIG. 1A, in embodiments.

[0012] FIG. 2B illustrates a mold for producing the skin of FIG. 2 A

[0013] FIG. 2C illustrates a close-up view of the physical fetal model of FIG. 2 A.

[0014] FIG. 3A is an exploded view of the skin of FIG. 2A and an internal anatomical skeleton , in embodiments.

[0015] FIG. 3B illustrates embedding the skeleton after insertion into the skin of FIG. 2 A.

[0016] FIG. 3C illustrates a partial view of the skeleton of FIG. 3A.

[0017] FIG. 3D illustrates assembly of a skull of the skeleton of FIG. 3 A.2LEGAL\81273831\3

[0018] FIG. 4Ais a schematic diagram of internal electronic components of a physical fetal model, in embodiments.

[0019] FIG. 4B is an exploded diagram of the physical fetal model of FIG. 4A showing the location of embedded printed circuit boards (PCBs) in the skeleton of FIG. 3 A.

[0020] FIG. 4C illustrates a motherboard for use in the neonate simulation device of FIG. 1A.

[0021] FIG. 5 is a block diagram of modules of a virtual fetal model for use in the neonate simulation device of FIG. 1A, in embodiments.

[0022] FIGS. 6 A - 6E illustrate limb actuators and bone analogs of the physical fetal model, in embodiments.DETAILED DESCRIPTION OF THE EMBODIMENTS

[0023] Neonate simulation device 100 may be understood as a hybrid physical-digital twin that may help bridge the gap between preclinical research and clinical translation, and provide a low-risk environment to complement animal studies and facilitate technology development and clinician training. Physical-Digital twins merge physical and virtual components arranged for anatomically and biomechanically mimicking a fetus, allowing for two-way data flow where modulations in one twin impact the other. Users, such as clinicians, can obtain updates via monitors from the digital twin and haptic and visual feedback from the physical model.

[0024] The physical manikin is intended for development and verification of an artificial womb environment where an extremely immature neonate, or fetus, is incubated and maintained using total parenteral nutrition administered through the umbilicus, and oxygenated in part or in full by extracorporeal oxygenation delivered through the umbilicus. It may also be used for training users to operate an artificial womb environment.

[0025] FIG. lA is a schematic diagram of neonate simulation device 100, which includes one or more of a physical fetal model 102 (e.g., a manikin), a control unit 106, and a virtual fetal model 104. Control unit 106 may include a processor, such as a microcontroller, and / or control circuitry.

[0026] Physical fetal model 102 may include circuitry, actuators, sensors, and other components (not shown) that may be used to control and monitor functioning of model 102. Physical fetal model 102 may also be connected to control unit 106 to send and receive digital data as indicated by arrow 108 or by an umbilical cord 110.

[0027] Virtual fetal model 104 may include a model engine 112 having, for example, processor 114 and memory 116 for storing software for execution by processor 114. Virtual3LEGAL\81273831\3fetal model 104 may also include an interface for communicating with control unit 106 as indicated by arrow 120. Interface 118 may be or include data acquisition hardware. As will be described in more detail below, arrows 108 and 120 represent fetal output data elements and fetal input data elements that communicated between physical fetal model 102 and virtual fetal model 104.

[0028] Memory 116 may be transitory and / or non-transitory and may include one or both of volatile memory (e.g., SRAM, DRAM, computational RAM, other volatile memory, or any combination thereof) and non-volatile memory (e.g., FLASH, ROM, magnetic media, optical media, other non-volatile memory, or any combination thereof). Part or all of memory 116 may be integrated into processor 114.

[0029] Memory 116 stores software that includes non-transitory machine-readable instructions. When executed by processor 114, software causes processor 114 to implement the functionality of virtual fetal mode 104 and / or device 100 as described herein. The software may be, or include, firmware.

[0030] Processor 114 represents any type of circuit or integrated circuit capable of performing logic, control, and input / output operations. For example, processor 114 may include one or more of a microprocessor with one or more central processing unit (CPU) cores, a graphics processing unit (GPU), a digital signal processor (DSP), a field-programmable gate array (FPGA), a system-on-chip (SoC), a microcontroller unit (MCU), and an applicationspecific integrated circuit (ASIC). Processor 114 may also include a memory controller, bus controller, and other components that manage data flow between processor 114 and memory 116.

[0031] Device 100 is based on clinical data (anatomically and physiologically realistic) and simulates essential vital signs such as lung aeration, temperature, heart rate, oxygenation, blood flow, and pressure. Sensors in physical fetal model 102 may be used to monitor environmental impacts for transfer to virtual fetal model 104 as fetal output data elements. In embodiments, scenarios may be generated in virtual fetal model 104 which may send fetal input data elements to physical fetal model 102 that are used to control actuators in the physical component so that it may display symptoms such as cyanosis, altered fetal movement of the limbs and breathing, for example.

[0032] FIG. IB illustrates the neonate simulation device of FIG. 1A in a typical usage scenario. Physical fetal model 102 may be placed in artificial womb environment 122, where it may be acted upon by medical staff. Sensors in physical fetal model 102 may provide sensor4LEGAL\81273831\3output 124, or fetal output data elements, to virtual fetal model 104 which may then identify symptoms and other cues 126 to the medical staff. In embodiments, scenarios may be designed in virtual fetal model 104 so that cues 126 are provided as fetal input data elements and displayed as behavior of physical fetal model 102.Physical fetal model

[0033] Several components are included in physical fetal model 102, also referred to as a fetal manikin. These components include:

[0034] (1) outer skin layer

[0035] (2) structural elements to account for anatomical and biomechanical realism,

[0036] (3) sensing elements to allow for monitoring of parameters,

[0037] (4) components to simulate symptoms,

[0038] (5) connection with the digital twin and

[0039] (6) electronic components for communication and control between the different elements.

[0040] FIG. 2 A illustrates the skin 128 of physical fetal model 102 for use in the neonate simulation device of FIG. 1A. The manikin should resemble the look and feel of an extremely premature infant as realistically as possible, as this will improve the suspension of disbelief and thereby offers a situation that is more in sync to real life cases. For this reason, the skin of the manikin is molded from silicon, rubber, or a similar flexible material. In embodiments, skin 128 may be produced using a vacuum casting machine using a mold as shown in FIG. 2B. The mold may include three parts and may be 3D printed. Outer mold sections 130 are generally half molds separable along a coronal plane of the fetal body although other planes could be used. An inner mold 132 and spacers 134 are positioned within outer mold sections 130 to form a skin that is hollow and allows for the insertion of internal components. Although a representative physical fetal model 102 is depicted, variations may be made in dimensions and coloration, for example.

[0041] FIG. 2C illustrates a close-up view of a head of the manikin of FIG. 2A. Details such as veins and other anatomical features may be added through techniques such as airbrushing to enhance the realism. These details may also be added to other parts of physical fetal model 102.

[0042] Anatomical structures of both internal and external features of a fetus may be modeled based on high-resolution nuclear magnetic resonance imaging (MRI) data of a fetus. Other imaging technologies may also be used. To allow for simulation of non-invasive monitoring of tissue oxygenation by near infrared spectroscopy (NIRS) sensors, optical5LEGAL\81273831\3properties of the skull and brain tissue were imitated. For purposes of illustration, dimensional values for the manikin are provided, but these may be varied based on intended age of the fetus and other criteria. In embodiments, the total manikin volume is 540 cm3, with the head occupying 221 cm3, the torso 230 cm3, a single arm 19 cm3, and a single leg 25 cm3.

[0043] FIG. 3 A is an exploded view of the skin 128 and internal anatomical skeleton 136 of physical fetal model 102. FIG. 3B illustrates embedding the internal skeleton 136 in skin 128. FIG. 3C illustrates a partial view of skeleton 136. FIG. 3D illustrates assembly of a skull of the internal components of FIG. 3 A. FIGS. 3A - 3D are best viewed together in the following discussion.

[0044] In the exploded view of FIG. 3 A, skin 128 is shown in two halves. However, skin 128 would be formed as a single continuous volume with an opening 145 at one or more places for insertion of internal components, as shown in FIG. 3B. Skeleton 136 is generally similar to a human skeleton and include skull 138, ribcage 140, arms 142 and legs 144. Skull 138 may be separable into two halves for the insertion of various electrical and mechanical component as shown in FIG. 3D.

[0045] Electromechanical driven mechanisms (such as servos) may be used to simulate neonate symptoms and behaviors such as cyanosis, limb movement and breathing reflex movement.

[0046] FIG. 4Ais a schematic diagram of internal electronic components of a physical fetal model 402, which is an example of physical fetal model 102. FIG. 4B is an exploded diagram of physical fetal model 402 showing a more detailed view of embedded printed circuit boards (PCBs) placed within skeleton 136. FIG. 4C illustrates an example motherboard for use in the neonate simulation device of FIG. 1 A. FIGS. 4A-4C are best viewed together in the following discussion.

[0047] The schematic diagram of FIG. 4A includes a number of PCBs that support the electronic and mechanical function of physical fetal model 402. Although a specific number of PCBs and functions are described, this is for purposes of illustration and the number, function, location, and connections between described components may be varied without departing from the principles disclosed herein.

[0048] PCB 146 is located in skull 138 and manages the functions necessary to cause physical fetal model 102 to display symptoms of cyanosis and saturation. This may include managing servos or other mechanisms. PCB 148 is located in skull 138 in the vicinity of a mouth of physical fetal model 402 and manages sensors to monitor aeration, i.e., airflow6LEGAL\81273831\3associated with breathing. PCB 150 is generally located at the back of the neck of skeleton 136, just under skin 128, and manages sensors for detecting a temperature of physical fetal model 402.

[0049] PCB 152 is generally located within ribcage 140 and manages servos or other mechanisms to control movements of arms 142 and legs 144 of physical fetal model 402. These functions may also be managed by PCB 154, which also manages data communication with motherboard 156, which may be located in control unit 106 of FIG. 1A.Control Unit / Mother board

[0050] A representative PCB, or motherboard 156, is shown in FIG. 4C to illustrate principles disclosed herein. Motherboard 156 may be part of control unit 106 of FIG. 1A. Various connection fittings 158 are provided for exchanging data with other components of neonate simulation device 100. Motherboard 156 may also include one or more of an emergency stop button 160, indicator lights 162, user control buttons 164, and a power switch 166.

[0051] To overcome limitations of space and weight in physical fetal model 102, to accommodate the power supply needs of varied actuators, and to minimize the need to open- up skin 128 of physical fetal model 102 to make adjustments, much of the electronic hardware for operating neonate simulation device is located on motherboard 156 of control unit 106. In embodiments, motherboard 156 may include a circular push-pull connector (LEMO) which connects to physical fetal model 402 via a wired umbilical cord phantom. To illustrate principles disclosed herein, representative examples of components that may be used in control unit 106 are provided, but other components may be used.

[0052] In embodiments, motherboard 156 hosts a microcontroller (MCU), such as ESP32- S3 microprocessor which may be loaded with a C++ program that enables the signal processing and connects the sensors, actuators, and virtual fetal model 104. The dual -core microprocessor enables simultaneous code execution on both cores and uses TaskScheduler for cooperative multitasking. This way, certain continuous processes (Wi-Fi™ connection and external communication) are routed on a separate core.

[0053] Motherboard 156 also hosts a medical grade high power connector (Kycon), an emergency stop push button (A165E Series, Omron), a toggle-switch (Knitter Switch), a set of isolated AC / DC converters to guarantee safety (TRACO power), a heat sink (TRACO power), and sufficient capacitors, drivers, and resistors. The board also hosts a plurality of LEDs, some of which may be multi-color (HSMF-C155, Broadcom) programmed to communicate the7LEGAL\81273831\3working status of the components, such as successful Wi-Fi™, communication with virtual fetal model 104, or the (de)activation of certain actuating components. A set of programmable buttons (Omron), of which one is a reset-button, allow for configuration of physical fetal model 102 by simulation participants.

[0054] By linking the digital twin to the manikin through control unit 106, neonate simulation device 100 may activate and modulate a network of parameters. Sensor data from physical fetal model 102 may be directly compared to microprocessor program threshold values or sent as inputs to virtual fetal model 104. Changes in sensor data may result from medical interventions or manipulations of physical fetal model 102. Further, pre-set scenarios in virtual fetal model 104 may provide inputs to physical fetal model 104 and the resulting sensor data may indicate a response of physical fetal model 102 to the scenarios. Based on sensor data provided as fetal output data elements from physical fetal model 102, virtual fetal model 104 may predict outcomes, such as blood flow and pressure in the desired fetal vessels as well as oxygen and carbon dioxide content. As sensor data changes, regulator systems are activated to simulate the impact of these events in physical fetal model 102. This dynamic simulation facilitates a broader range of scenarios by predicting output parameters in approximately real-time. These predictions can be displayed on a neonatal intensive care unit (NlCU)-like monitor and can trigger actuators, thus enhancing simulation dynamics and expanding the spectrum of conditions that may be experienced by physical fetal model 102.

[0055] Sensor output is changed by physical influences, such as an intervention of simulation participants, and is then sent to a processor on motherboard 156, for example, an Arduino Nano ESP32. At timed intervals, sensor output is sent to virtual fetal model 104. Connection between motherboard 156 and virtual fetal model 104 may be achieved through a client-broker style design middleware. Virtual fetal model 104 compares incoming data from sensors in physical fetal model 102 with the set parameter thresholds. In case a threshold is exceeded, information is transmitted on a monitor or through a symptom display.

[0056] Further details of the operation of components of physical fetal model 102 will be described below.Virtual fetal model

[0057] The physical fetal model 102, the manikin, is connected to a fetal circulation mathematical model (i.e., virtual fetal model 104, also referred to as a digital twin) executing on a computer, i.e., model engine 112. Virtual fetal model 104 is based on a mathematical8LEGAL\81273831\3model that is a virtual representation of a fetal cardiovascular system and contains modules that simulate the cardiac function, blood circulation, and gas transport.

[0058] FIG. 5 is a block diagram of modules of a virtual fetal model 500 for use in neonate simulation device 100. Fetal model 500 includes at least one of modules 170, 172, 174, 176, 178 and 180. Fetal model 500 may also include one or more of horizontal dependencies 189, vertical dependencies 192 and / or a computational layer 194. One or more of the above- mentioned modules, dependencies, and computational layer 194 may be (a) stored in memory 116 and executed by processor 114 of FIG. 1A, and / or (b) may be software and / or non- transitory machine-readable instructions stored in memory 116.

[0059] A multiscale and multilevel approach is shown with modules 170, 172, 174, 176, 178 and 180 organized on time scales 182, 184, 186 and 188. Modules with the same time and length scale can have horizontal dependencies 189. Within a module, a multilevel approach may involve virtual dependencies. Over different time scales, modules influence each other through spatial dependencies.

[0060] The modules of FIG. 5 capture functionalities of the fetal cardiovascular system including fetal growth and oxygen transport. Time scales 182, 184, 186 and 188 integrate the physiological functions of a fetus (hemodynamics, oxygen transport, baro-and chemoreceptor reflex, and acidemia) into one system. These functionalities are integrated following a multiscale approach since the modules act in different time scales. The contraction of the heart modeled in module 170 is typically described in about 1000 time steps per cardiac cycle to calculate flow and pressure profiles throughout the entire cardiovascular system. The maternal- fetal oxygen exchange modeled in module 176 is calculated by averaging blood flows and volumes over one cardiac cycle. For the baro- and chemoreceptor reflexes to act as modeled in module 178, it takes up to several seconds. Fetal growth, modeled by module 180, takes place at a time scale of days.

[0061] In similar fashion, the modules are in different length scales as well. Diffusion of oxygen is at cellular scale, while fetal growth is evaluated in centimeters. Integration of these modules at different levels is of importance as the effect of events in the smallest scales have impact on the modules at higher scales. In order to integrate these fetal models based on different time and length scales, every module 170, 172, 174, 176, 178 and 180 includes separate anatomy and physiology parts describing the geometry and physiological parameters of the corresponding module, respectively. These modules are ordered based on their time scales 182, 184, 186 and 188. Virtual fetal model 104 provides horizontal (same time and length9LEGAL\81273831\3scale) dependencies 189 and vertical (same time scale and different length scale) dependencies 192 of physiological processes.

[0062] Hence, the modules on the same time scale (e.g., heart and cardiovascular system) depend on each other by means of input and output. For example, the pressure and flow in the vessels of the cardiovascular system depend on the flow over the valves of the heart (horizontal integration). Within a module, multilevel implementation may be used. For instance, the pressure in a heart chamber depends on the sarcomere length (vertical integration). As software structure is based on time loops, there is a spatial dependency between modules. These modules in different time scales will influence each other. For example, insufficient oxygen supply due to placental dysfunction could result in fetal growth restriction.

[0063] Computational layer 194 includes the mathematical representation of the modules. All these modules, dependencies, and the computational layer are controlled by global mediators (not shown). These mediators may include simulation parameters (e.g., definition of time scales, maximal number of cycles to prevent infinite loops, and convergence tolerance to reach dynamic steady state) and global parameters (e.g., blood density and numerical scheme parameters).

[0064] In embodiments, virtual fetal model 104 also includes regulatory systems to mimic a fetus in distress or to maintain homeostasis, and it is adapted to simulate some of the congenital heart diseases that may pose issues during the fetus-to-neonate transition to permit the manikin being used in training physicians to recognize and treat these conditions in addition to being used in training for normal operation of an extrauterine incubation environment.Physical Fetal Model: Sensors

[0065] For monitoring a temperature of physical fetal model 102, a temperature sensor is located on PCB 150 and embedded in the dorsal part of skeleton 136. PCB 150 is connected to PCB 146 which may include an internal processor temperature sensor to give an indication of hardware overheating. The temperature sensor may be at least partially enclosed by a flexible skin of fetal model 102.

[0066] For aeration detection, a resistive sensor using the conductive properties of water is located on PCB 148. The sensor includes PCB 148 with eight gold-plated conductive contact pads, which can register air (bubbles) through a recovery of the circuit. PCB 148 also includes an operational amplifier to improve the electromagnetic compatibility within physical fetal model 102 and reduce noise from servos on the sensor measurement. The assembled sensor may be placed in the upper respiratory tract of skeleton 136. Alternatively, two sensors may be10LEGAL\81273831\3placed in the inner lining of the lung cavity to test successful endotracheal tube intubation (for a liquid-filled-lung setup, instead of a liquid-filled-chamber).Physical Fetal Model: ActuatorsBreathing (reflex)

[0067] A breathing reflex may be simulated by physical fetal model 102 by inspiratory and expiratory movement of ribcage 140 and the movement of the jaw to simulate a gasp reflex. Jaw movement may achieved through a rotary-linear motion conversion mechanism, while the chest movement was generated using a crank connecting rod mechanism. In embodiments, movement of the ribcage may be accomplished using a linear servo with a string linked to a sternum of skeleton 136. Maximum displacement of the linear servo is sufficient to simulate breathing inhalation and expiration distances and velocities compared to existing metrics of mid-gestation fetuses.Cyanosis

[0068] A hydrochromic color change mechanism may be installed within skull 138 to simulate cyanosis by using colored liquids to simulate cyanosis. This may be accomplished using a color-changing liquid, or by the mechanism disclosed herein, for example.

[0069] A fetus typically shows cyanosis around the mouth and nose. The hydrochromic color change mechanism of three layers: (1) a cyanotic area, (2) a 3D-printed manikin’s face, and (3) a silicone skin layer. The cyanotic area is designed as a cavity and 3D-printed in a transparent resin. The cavity may be connected to silicone tubes so that colored liquid may be pumped into and out of the cyanotic area. Skull 138 is transparent in the vicinity of the cyanotic area so that color changes may be detectable through skin 128.Cerebral oxygen saturation

[0070] Cerebral oxygen saturation can be monitored through non-invasive Near-Infrared Spectroscopy (NIRS) probes. Physical fetal model 102 may simulate cerebral oxygen saturation using a multipart device. A container may be placed into a hole in skull 138 near the fetus’ temple to form a platform onto which an NIRS probe is positioned. A moving cylinder is placed into the container and hold four black PVC rods of different dimensions (for example, 4, 5 and 6 mm) which, depending on their position, simulate different degrees of oxygen saturation. The cylinder includes a gear at the rear end to drive its rotation. A metal geared micro servo drives the gear of the cylinder.11LEGAL\81273831\3Fetal movement

[0071] Skeleton 136 of physical fetal model 102 includes several components for simulating fetal movement, for example, two leg flexures, two arm flexures, four pulleys, four servos, a rib cage connected to a back plate, two servo brackets, a pelvis, and a collar bone.

[0072] FIGS. 6 A -6E illustrate limb actuators and bone analogs that serve as the leg and arm flexures 196. FIG. 6A is a perspective view of flexure 196, FIG. 6B is a side view, and FIG. 6C is a cross sectional view of flexure 196. FIG. 6D is a perspective view and FIG. 6E is a side view of flexure 196 showing partial flexion.

[0073] Each flexure 196 is actuated by two strings 198 and 200 which are fastened to a pulley (not shown) that is directly mounted on a servo. Strings 198 and 200 are threaded through bone analogs 202, 204 and 206, which are connected by flexure hinges 208 and 210. As shown in FIG. 6C, strings 198 and 200 are angled through bone analog 204 so that the cross and exit bone analog 202 in opposite locations of their position in bone analog 206. The combination of this routing of strings 198 and 200 with the locations of flexure hinges 208 and 210 provides more realistic movement of the arms and legs of physical fetal model 102.

[0074] As pulley rotates, one string is rolled up while the other string is rolled out. All flexures feature two actuation strings: string 198 for extension and string 200 for flexion. Extension strings 198 are used because, without extension actuation, flexure 196 returns to its original (extended) position too slowly compared to observations of real infants at 24 weeks gestational age (both in and ex utero), and full extension would not reliably take place. Flexure hinges 208 and 210 mimic the range of motion that the selected infant joints afford. The flexures are designed such that this range of motion is faithfully captured, with flexion being possible to roughly 150° and extension to roughly -5°. For the shoulder of an arm flexure, bone analog 202 is connected to a curved cylinder 212 as shown in FIGS. 6D-6E.Umbilical blood flow

[0075] Physical fetal model 102 includes an umbilical blood circuit that uses a pump to mimic the heart, with a single-artery and vein setup to mimic the vessels, establishing flow between the phantom placenta and manikin. Apiston pump simulating physiological flow was used to evaluate the fabricated umbilical cord, with a pre-set stroke volume (l-3ml) at a preset heart rate (148bpm). This stroke volume is higher than that of an actual 24-week GA fetus, which ranges 0.44-1.17mL.

[0076] A heart valve is placed between the pump and the umbilical cord, to build up blood pressure in the vessel to approximately 30 mmHg. A blood pressure sensor was placed after the12LEGAL\81273831\3heart valve. To simulate placental resistance, a three-element Windkessel model may be used to simulate arterial compliance, after which blood passed the vein into the catch reservoir.

[0077] Due to the size of piston-type pumps, and the need for integration into the manikin, we opted for a rotational peristaltic pump, consisting of rotors created with bearings attached to a stepper motor. In embodiments, an indenter pump may also be used.Integration

[0078] All sensors and actuator components were mounted onto skeleton 136. Printed circuit boards as described above allow signals to be routed between the different components. Elements are soldered onto the PCBs, which were then embedded in skeleton 136 and connected to the servo’s; PCB 146 placed in the skull, PCB 152 is placed beneath the sternum and PCB 154 is mounted in the pelvic region as shown in FIGS. 4A and 4B. PCB A contains a microchip, connectors to drive and control the servos for cerebral saturation, cyanosis simulation, the aeration and temperature sensors and connecting to the other PCBs. PCB 152 includes a PWM / servo driver, connectors to control the servos that actuate the right and left arm, right and left leg, and the linear servo that creates the breathing movement. PCB 154 includes connectors for the umbilical cord, another is for SCOM, power supply (6V) and for I2C. It includes a DC-DC converter to accommodate the different servo demands, and a power monitor. Efficient usage of the energy capacity is ensured through programming of the servos, such as by duration of activation, to prevent exceeding maximum power.

[0079] Power, ground, and data cables may be wired through the umbilical cord, to external power supply and control signals in control unit 106. Data cables were combined to reduce wire count in the umbilical cord. The loaded skeleton may then be placed in silicone skin 128 as shown in FIG. 3B, with the backside of the skinsuit closed and made watertight using silicone adhesive.Combinations of features

[0080] The presently disclosed concepts can be combined in multiple ways. Among combinations anticipated are:

[0081] A neonate simulation device designated Al including a physical fetal model, a virtual fetal model, and a control unit.

[0082] A neonate simulation device designated A2 including the neonate simulation device designated Al wherein the virtual fetal model is set to a scenario associated with a predetermined anatomical and biomechanical state of the fetus.13LEGAL\81273831\3

[0083] A neonate simulation device designated A3 including the neonate simulation device designated Al of A2 wherein the virtual fetal model includes a model engine that simulates cardiac function, blood circulation, gas transport, and / or autonomic nervous system in the fetus considering the fetal output data elements or a predetermined scenario mimicking a fetus in distress.

[0084] A neonate simulation device designated A4 including the neonate simulation device designated Al , A2, or A3 wherein the virtual fetal model is further arranged for outputting simulation output data elements associated with the simulated anatomical and biomechanical status of the fetus, wherein the simulation device and includes an output device arranged for outputting the anatomical and biomechanical status associated with the simulated anatomical and biomechanical status of the fetus for display.

[0085] A neonate simulation device designated A5 including the neonate simulation device designated Al, A2, A3 or A4 wherein the physical fetal model includes a sensor arrangement arranged for monitoring fetal parameters of the physical fetal model and wherein the sensor arrangement is arranged for outputting sensor data elements, wherein the fetal output data elements are further associated with the sensor data elements, wherein the sensor arrangement comprises at least one of: a temperature sensor arranged for detecting a temperature at a predetermined position of the physical fetal model; an aeration sensor arranged for detecting a presence of air in the physical fetal model; a saturation sensor arranged for detecting a cerebral saturation of the physical fetal model; a heart rate sensor arranged for detecting a fetal heart rate; and a flow sensor arranged for detecting an amount of blood flow in an umbilical cord.

[0086] A neonate simulation device designated A6 including the neonate simulation device designated Al, A2, A3, A4 or A5 wherein the physical fetal model comprises at least one of a breathing reflex arrangement arranged for mimicking a breathing reflex of the fetus, wherein the breathing reflex arrangement comprises a breathing reflex actuator for realizing an inspiratory and expiratory movement of a chest of the physical fetal model and / or for realizing a movement of a jaw of the physical fetal model to simulate a gasp reflex, wherein the breathing reflex arrangement is arranged for mimicking the breathing reflex taking into account the fetal input data elements; a color setting arrangement arranged for mimicking a color of the fetus, wherein the color setting arrangement is arranged for mimicking the color of the fetus considering the fetal input data elements; a limb movement arrangement arranged for mimicking movement of a limb of the fetus, wherein the limb movement arrangement is arranged for mimicking the movement of a limb of the fetus considering the fetus input data14LEGAL\81273831\3elements; an umbilical blood flow arrangement arranged for mimicking a blood flow and heartbeat of the fetus, wherein the blood flow arrangement is arranged for mimicking the blood flow and heartbeat of the fetus considering the fetus input data elements; and a heart rate arrangement arranged for mimicking the heartbeat, including its sound.

[0087] A neonate simulation device designated A7 including the neonate simulation device designated Al, A2, A3, A4, A5 or A6 wherein the blood flow arrangement comprises at least one of: a pump for mimicking the heart of a fetus, the pump selected from the group consisting of an indenter pump, a piston pump, and a peristaltic pump, the pump configured with a stroke volume selected from a configurable stroke volume and a pre-set stroke volume, the pump configured to operate at a pump frequency selected from a pre-seat pump frequency and a configurable pump frequency; a flow line, attached to provide fluid flow to the pump, for mimicking an umbilical cord and couplable to an artificial womb environment; a valve, provided in the flow line, to build up pressure in the flow line and the pump, wherein in a first position of the valve the flow line is blocked for fluid flow; and at least one sensor selected from a flow sensor configured to measure flow in the flow line and a pressure sensor arranged for detecting a pressure in the flow line or the pump.

[0088] A neonate simulation device designated A8 including the neonate simulation device designated Al, A2, A3, A4, A5, A6 or A7 wherein the physical fetal model is arranged for allowing the limb to be moved by application of an external force to the limb, wherein the limb movement arrangement is arranged for outputting limb data elements and wherein the fetal output data elements are further associated with the limb data elements.

[0089] A neonate simulation device designated A9 including the neonate simulation device designated Al, A2, A3, A4, A5, A6, A7 or A8 wherein the physical fetal model comprises an internal skeleton and wherein at least one of sensor arrangement, the breathing reflex arrangement, the color setting arrangement, the limb movement arrangement, and blood flow arrangement are attached to the skeleton.

[0090] A fetal manikin designated Bl including at least one temperature sensor within the manikin; a skeleton covered by a flexible skin; at least one airflow sensor disposed in an airway of the fetal manikin; at least one pump within the fetal manikin configured to pump fluid through a tube coupled to an umbilicus of the fetal manikin, the pump selected from an indenter pump, a piston pump, and a peristaltic pump; and at least one sensor within the manikin adapted to measure flow or pressure from the pump.15LEGAL\81273831\3

[0091] A fetal manikin designated B2 including the fetal manikin designated Bl and including at least one color change device of the fetal manikin configured to mimic cyanosis; and at least one color change device configured to interface to an external fetal cerebral oxygenation sensor.

[0092] A fetal manikin designated B3 including the fetal manikin designated B or B2 and including at least one limb actuator coupled to provide movement of limbs of the fetal manikin.

[0093] Afetal manikin designated B4 including the fetal manikin designated Bl, B2, or B3, including a computer configured with a digital twin mathematical model.16LEGAL\81273831\3

Claims

CLAIMSWhat is claimed is:

1. A neonate simulation device comprising: a physical fetal model arranged for anatomically and biomechanically mimicking a fetus, wherein the physical fetal model is arranged for outputting fetal output data elements associated with a condition of the physical fetal model and / or arranged for receiving fetal input data elements associated with a predetermined anatomical and biomechanical condition of a fetus for operating the physical fetal model to mimic an anatomical and biomechanical status of the fetus associated with the fetal input data elements; a virtual fetal model arranged for providing a virtual anatomical and biomechanical representation of the fetus comprising circuitry that anatomically and biomechanically simulates the fetus, wherein the virtual fetal model is arranged for outputting the fetal input data elements associated with a predetermined anatomical and biomechanical condition of the virtual fetal model and / or arranged for receiving the fetal output data elements associated with an anatomical and biomechanical condition of the physical fetal model; and a control unit, communicatively connected to the physical fetal model and the virtual fetal model, arranged for controlling the physical fetal model using predefined and / or simulated the fetal input data elements and / or providing the fetal output data elements to the virtual fetal model to simulate the anatomical and biomechanical status of the physical fetal model.

2. The simulation device according to claim 1, wherein the virtual fetal model is set to a scenario associated with a predetermined anatomical and biomechanical state of the fetus, and further arranged for simulating an anatomical and biomechanical status of the fetus corresponding to the set scenario, which generates fetal input data elements associated with the simulated anatomical and biomechanical status of the fetus.17LEGAL\81273831\33. The simulation device according to claim 1 or 2, wherein the virtual fetal model comprises: circuitry that simulates cardiac function, blood circulation, gas transport, and / or autonomic nervous system in the fetus considering the fetal output data elements or a predetermined scenario mimicking a fetus in distress.

4. The simulation device according to claim 1, 2, or 3, wherein the virtual fetal model is further arranged for outputting simulation output data elements associated with the simulated anatomical and biomechanical status of the fetus, wherein the simulation device further comprises: an output device arranged for outputting the anatomical and biomechanical status associated with the simulated anatomical and biomechanical status of the fetus for display.

5. The simulation device according to claim 1 or 2, wherein the physical fetal model comprises a sensor arrangement arranged for monitoring fetal parameters of the physical fetal model and wherein the sensor arrangement is arranged for outputting sensor data elements, wherein the fetal output data elements are further associated with the sensor data elements, wherein the sensor arrangement comprises at least one of: a temperature sensor arranged for detecting a temperature at a predetermined position of the physical fetal model; an aeration sensor arranged for detecting a presence of air in the physical fetal model; a saturation sensor arranged for detecting a cerebral saturation of the physical fetal model; a heart rate sensor arranged for detecting a fetal heart rate; and a flow sensor arranged for detecting an amount of blood flow in an umbilical cord.

6. The simulation device according to any one of claims 1-5, wherein the physical fetal model comprises at least one of: a breathing reflex arrangement arranged for mimicking a breathing reflex of the fetus, wherein the breathing reflex arrangement comprises a breathing reflex actuator for realizing an inspiratory and expiratory movement of a chest of the physical fetal model and / or for realizing a movement of a jaw of the physical fetal model to simulate a gasp18LEGAL\81273831\3reflex, wherein the breathing reflex arrangement is arranged for mimicking the breathing reflex taking into account the fetal input data elements; a color setting arrangement arranged for mimicking a color of the fetus, wherein the color setting arrangement is arranged for mimicking the color of the fetus considering the fetal input data elements; a limb movement arrangement arranged for mimicking movement of a limb of the fetus, wherein the limb movement arrangement is arranged for mimicking the movement of a limb of the fetus considering the fetus input data elements; an umbilical blood flow arrangement arranged for mimicking a blood flow and heartbeat of the fetus, wherein the blood flow arrangement is arranged for mimicking the blood flow and heartbeat of the fetus considering the fetus input data elements; and a heart rate arrangement arranged for mimicking the heartbeat, including its sound.

7. The simulation device according to claim 6, wherein the blood flow arrangement comprises at least one of: a pump for mimicking the heart of a fetus, the pump selected from the group consisting of an indenter pump, a piston pump, and a peristaltic pump, the pump configured with a stroke volume selected from a configurable stroke volume and a pre-set stroke volume, the pump configured to operate at a pump frequency selected from a pre-seat pump frequency and a configurable pump frequency; a flow line, attached to provide fluid flow to the pump, for mimicking an umbilical cord and couplable to an artificial womb environment; a valve, provided in the flow line, to build up pressure in the flow line and the pump, wherein in a first position of the valve the flow line is blocked for fluid flow; and at least one sensor selected from a flow sensor configured to measure flow in the flow line and a pressure sensor arranged for detecting a pressure in the flow line or the pump.

8. The simulation device according to claim 6 or 7, wherein the physical fetal model is arranged for allowing the limb to be moved by application of an external force to the limb, wherein the limb movement arrangement is arranged for outputting limb data elements and wherein the fetal output data elements are further associated with the limb data elements.19LEGAL\81273831\39. The simulation device according to claim 6, wherein the physical fetal model comprises an internal skeleton and wherein at least one of sensor arrangement, the breathing reflex arrangement, the color setting arrangement, the limb movement arrangement, and blood flow arrangement are attached to the skeleton.

10. A fetal manikin comprising: a skeleton covered by a flexible skin; at least one temperature sensor at least partially enclosed by the flexible skin; at least one airflow sensor disposed in an airway of the fetal manikin; at least one pump within the fetal manikin configured to pump fluid through a tube coupled to an umbilicus of the fetal manikin, the pump selected from an indenter pump, a piston pump, and a peristaltic pump; and at least one sensor within the manikin adapted to measure flow or pressure from the pump.

11. The fetal manikin of claim 10 further comprising: at least one color change device of the fetal manikin configured to mimic cyanosis; and at least one color change device configured to interface to an external fetal cerebral oxygenation sensor.

12. The fetal manikin of claim 10 or 11 further comprising: at least one limb actuator coupled to provide movement of limbs of the fetal manikin.

13. The fetal manikin of claim 10 or 11 , further comprising a computer configured with a digital twin mathematical model.20LEGAL\81273831\3

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