Phrenic Nerve Stimulation Timing for Mandatory Ventilator Breaths

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Solution Overview

Problem

Current medical practices face challenges in effectively preventing or reducing ventilator-induced diaphragmatic dysfunction (VIDD) due to the lack of integration with mechanical ventilators, difficulty in distinguishing between different ventilation modes, and the need for a system that can differentiate between patient-initiated and ventilator-controlled breaths to optimize diaphragm pacing.

Innovation Solution

A percutaneous electrical phrenic nerve stimulation system (PEPNS) that integrates with mechanical ventilators to detect and differentiate between various ventilation modes, providing electrical stimulation only during mandatory breaths and ceasing stimulation during patient-initiated breaths, using an instrumented wye sensor and stimulator/controller to monitor and adjust diaphragm pacing based on work of breathing (WOB) measurements.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If electrical stimulation is provided continuously to prevent diaphragm atrophy, then diaphragm activity is maintained, but patient discomfort increases and spontaneous breathing is inhibited

Engineering Contradiction:
Improvediaphragm activity maintenanceVSAvoidpatient discomfort
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system applies electrical stimulation periodically only during mandatory ventilator breaths rather than continuously. The controller detects mandatory breaths through flow sensor signals and delivers stimulation pulses synchronized with these breaths, allowing the diaphragm to remain active during stimulation while remaining quiescent during spontaneous breaths, thereby preventing atrophy without causing discomfort

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The system dynamically adjusts stimulation delivery based on real-time detection of breath type. The controller monitors flow signals to distinguish between mandatory and spontaneous breaths, enabling the stimulation to adapt its timing and intensity to match the patient's breathing pattern, thus optimizing therapeutic effect while minimizing discomfort

Inventive Principle:
Principle #15Dynamics

2Reliability

If electrical stimulation is provided during all breaths including spontaneous breaths, then diaphragm atrophy is prevented, but patient agitation and discomfort increase

Engineering Contradiction:
Improvediaphragm atrophy preventionVSAvoidpatient agitation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system provides stimulation only during mandatory breaths by detecting characteristic flow patterns. During spontaneous breaths, no stimulation is delivered, allowing the patient to breathe naturally without interference. This periodic stimulation approach maintains diaphragm function during necessary ventilator support while avoiding agitation during patient-initiated breathing

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The system uses flow sensor feedback to detect the type of breath being delivered. By monitoring the flow signal characteristics, the controller can distinguish between mandatory and spontaneous breaths and adjust stimulation delivery accordingly, preventing patient agitation by avoiding stimulation during spontaneous breathing efforts

Inventive Principle:
Principle #23Feedback

3Productivity

If the system integrates with mechanical ventilators to detect ventilation modes, then stimulation timing is optimized, but device complexity increases

Engineering Contradiction:
Improvestimulation timing optimizationVSAvoidsystem integration complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The system uses an instrumented wye sensor as an intermediary component that connects to the existing ventilator circuit without requiring deep integration with the ventilator's control system. The wye sensor passively detects flow patterns and provides signals to the stimulator controller, enabling optimized stimulation timing while minimizing complexity by avoiding direct communication protocols or complex interfacing with the ventilator

Inventive Principle:
Principle #24Intermediary (Mediator)

4Productivity

If the system differentiates between mandatory and spontaneous breaths, then stimulation is provided only when needed, but measurement precision requirements increase

Engineering Contradiction:
Improvebreath type differentiation efficiencyVSAvoidbreath detection accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The system exploits the periodic nature of mandatory ventilator breaths to establish a reference pattern. By detecting the regular timing and flow characteristics of mandatory breaths, the system can identify deviations that indicate spontaneous breathing efforts, enabling reliable breath type differentiation through pattern recognition rather than requiring high-precision absolute measurements

Inventive Principle:
Principle #19Periodic action

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

The system effectively prevents VIDD by ensuring diaphragm activity during mandatory breaths while allowing the patient to breathe spontaneously, reducing patient discomfort and accelerating weaning from mechanical ventilation, thereby decreasing healthcare costs and morbidity.

Implementation Method 1

delivering electrical stimulus to a patient's phrenic nerve effective to activate the patient's diaphragm

Methodology Applied
Scientific EffectElectrical stimulation: Electric Field

Implementation Method 2

measuring a flow signal and a pressure signal and calculating a work of breathing (WOB) for the patient based upon the flow signal and the pressure signal

Methodology Applied
Scientific EffectPressure measurement: Pressure Gradient

Data Source

PatentEP3648835B1Percutaneous electrical phrenic nerve stimulation system
Publication Date: 2025.11.05 STIMDIA MEDICAL INC
  • EP3648835B1 patent drawingFigure 1a
  • EP3648835B1 patent drawingFigure 1b
  • EP3648835B1 patent drawingFigure 2

AI summary

A percutaneous electrical phrenic nerve stimulation (PEPNS) system that measures the patient Work of Breathing (WOB) of each type of ventilator breath and determines when to deliver electrical stimulus based upon the measured WOB. The PEPNS system alters its behavior based upon the type and origin of the ventilator breath delivered and provides warnings for certain identified interactions between the ventilator and the patient.