Surgical Insufflator Monitoring Device
Clinical-grade flow monitoring system for 20+ human laparoscopic surgeries with full medical certification
Image represents the actual instrumentation developed for this project. Technical details have been abstracted for confidentiality purposes.
Challenge
Insufflator algorithms are proprietary, yet understanding their real-world behaviour during human surgery is critical. The device would sit directly in the gas supply path where failure could harm patients. Medical device requirements demand extensive safety documentation, ethics approval, and EMC compliance with zero-failure deployment in operating rooms.
Solution
Clinical-grade in-line monitoring system developed through mathematical modelling, FMEA analysis, and full medical certification. Successfully deployed across 20+ human surgeries. Complete project management from technical design through ethics approval, clinical collaboration, commissioning, and data analysis.
Key Technical Features
- • Mathematical modelling of surgical environment eliminating trial-and-error approach
- • Literature review, surgeon experience, and FMEA integration for risk minimisation
- • Custom bidirectional thermal mass flow sensor design from commercial sensors
- • Disassembly and reconfiguration of single-direction sensors into dual-flow system
- • Bespoke PCB design with ADC, power control, and microcontroller (C/C++)
- • Medical-grade component selection for EMC, power, and surgical environment compliance
- • Medical-grade power supply unit meeting surgery environment specifications
- • Off-the-shelf validated components: tubing, valves, filters, electronic buses
- • Comprehensive safety testing: robustness, leakage, EMC (external certification)
- • Complete medical documentation: requirements, specifications, FMEA, SOPs
- • Ethics committee approval and clinical collaboration protocols
- • Standard Operating Procedure (SOP) for research nurse operation
- • On-site commissioning with surgeon collaboration and operating room attendance
- • Research nurse training and remote support throughout trial period
- • Offline data collection with Python-based comprehensive analysis
- • Successfully recorded insufflator behaviour across 20+ diverse surgical procedures
Applications
Surgical Research
Understanding proprietary insufflator algorithms during actual surgery
Medical Device Development
Data-driven design of improved surgical gas delivery systems
Clinical Protocol Optimisation
Evidence-based refinement of pressure management strategies
Safety Analysis
Real-world validation of insufflator performance across procedures