Fetal Heart Rate Simulation System for Realistic EFM Training

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Solution Overview

Problem

Current fetal monitoring simulation systems lack realism, as they do not allow clinicians to practice using actual electronic fetal monitoring (EFM) devices, limiting their ability to interact with and interpret fetal heart rate data during simulated crisis situations.

Innovation Solution

A system that simulates fetal heart rate and uterine activity using a device with a bladder, deformable material, and a Doppler probe, where a processor controls a solenoid or digital flow valve to mimic fetal heartbeats and contractions, allowing realistic training on actual EFM devices.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If computer screen simulation is used to simulate fetal monitoring, then training coverage can be provided, but realism and clinical interaction capability deteriorate

Engineering Contradiction:
Improvetraining coverageVSAvoidrealism
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent creates a physical copy of the fetal monitoring system by placing actual EFM sensors on a pregnant woman's abdomen and connecting them to a real monitor, rather than using virtual screen-based simulation. This allows trainees to practice with authentic clinical equipment while maintaining patient safety through controlled simulation conditions.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The system serves multiple functions simultaneously: it provides realistic clinical training for multiple trainees, ensures patient safety through controlled simulation, and allows repetition of clinical scenarios. The same physical setup can be used for different training purposes and with different patient scenarios.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If actual EFM devices are used for training, then realism and clinical interaction improve, but patient safety risks and complexity increase

Engineering Contradiction:
ImproverealismVSAvoidpatient safety risks
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system prepares the simulation environment in advance by selecting a pregnant woman who has already reached full term, ensuring the fetus is viable and the pregnancy is stable. All necessary equipment is set up beforehand, and the simulation is conducted under controlled conditions with medical supervision ready, thereby minimizing risks before the training session begins.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system incorporates multiple safety buffers: the simulation is conducted with a stable full-term pregnancy where the fetus can tolerate brief monitoring periods, the actual EFM equipment is used in a controlled clinical setting, and medical professionals are present to immediately address any complications. These pre-arranged safety measures cushion against potential harms.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Object-affected harmful factors

If Doppler ultrasound is used to measure fetal heart rate, then noninvasive measurement is achieved, but direct coupling requirement increases device complexity

Engineering Contradiction:
ImproveinvasivenessVSAvoidcoupling requirement
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent uses coupling gel as an intermediary substance between the Doppler ultrasound probe and the pregnant woman's skin. This gel eliminates air gaps that would block ultrasound waves, enabling effective noninvasive fetal heart rate measurement without requiring direct skin-to-probe contact, thus simplifying the coupling requirement while maintaining noninvasiveness.

Inventive Principle:
Principle #24Intermediary (Mediator)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enhances the realism and utility of simulation-based training for clinicians by providing a realistic simulation of fetal heart rate and uterine activity on actual EFM devices, improving their ability to interact with clinical monitors during training.

Implementation Method 1

Fetal heart rate (FHR) Doppler ultrasound probes measure the change in frequency of ultrasonic waves as they reflect off of moving tissues within the body. According to the Doppler Effect, the frequency of the reflected waves is shifted higher or lower (depending on the direction of the movement) when the waves reflect off of a moving object within the body.

Methodology Applied
Scientific EffectDoppler Effect: Doppler Effect

Implementation Method 2

Ultrasonic waves are transmitted by piezoelectric generators in the FHR probe and the reflected waves are detected by transducers in the same probe.

Methodology Applied
Scientific EffectUltrasonic waves: Ultrasound

Implementation Method 3

Ultrasonic waves are transmitted by piezoelectric generators in the FHR probe

Methodology Applied
Scientific EffectPiezoelectric effect: Piezoelectric Effect

Data Source

PatentUS10360816B2System and method for simulating fetal heart rate for noninvasive intra-partum fetal monitoring
Publication Date: 2019.07.23 LAERDAL MEDICAL AS
  • US10360816B2 patent drawing
  • US10360816B2 patent drawing
  • US10360816B2 patent drawing

AI summary

A method and apparatus to simulate a fetal heart rate to train clinicians in using a Doppler probe. The apparatus includes an enclosure housing a bladder, with a piece of deformable material to be placed in contact with the bladder and the Doppler probe. The bladder is selectively pressurized by a source of compressed gas, the flow being controlled by a flow valve. A pressure release valve is provided to reduce pressure in the bladder. A pressure sensor monitors the bladder pressure. The flow valve may be controlled by a software run on a processor to achieve pre-determined bladder pressures to mimic a fetal heart rate.