医療機器ハードウェア・イン・ザ・ループ（HIL）向け合成生理生体信号生成システム

VitalSimulator In Silico Simulation Architecture

Computational Physiology Engine and Hardware Signal Generator

Central System: Physiological Physics Engine - Multi-Compartment Human Model

Clinical IoMT Nodes

• Lumped-Parameter Hemodynamic Core
• 3D Cellular Electrophysiology
• Respiratory Mechanics Twin
• Precision DAC Signal Injector
• Target Medical Device Under Test

Architectural Layers & Regulatory Standards

• Multi-Compartment Hemodynamic Modeling (Nonlinear ODE Solver / 21-Compartment Circulatory Twin): Numerical solution of Navier-Stokes and Windkessel differential equations simulating pressure drops across cardiac chambers and vascular beds.
• Cellular Cardiac Electrophysiology (Bidomain Reaction-Diffusion Solver / GPU Finite Element Acceleration): Biophysical simulations of ion channel kinetics (ten Tusscher-Panfilov model) producing authentic 12-lead ECG surface potentials.
• Synthetic Respiratory Dynamics (Two-Compartment Viscoelastic Lung Model / PaO2/PaCO2 Blood Gas Simulator): Simulation of airway resistance, lung compliance, alveolar gas exchange, and ventilator patient-asynchrony events.
• Hardware-in-the-Loop (HIL) Physical Injection (24-Bit Precision DAC / High-CMRR Bio-Impedance Synthesizer): Converting computational waveforms into calibrated microvolt biopotentials and pneumatic pressure waves for physical device inputs.

Key Metrics: < 10 µV (ECG Voltage Resolution) | 100 kHz (Waveform Synthesis Rate) | ASME V&V 40 (Verification Standard) | Zero (Human Clinical Exposure Risk)