External Diaphragm Pacemaker Synchronization with Ventilator

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Solution Overview

Problem

Current mechanical ventilation methods cause ventilator-induced diaphragmatic dysfunction (VIDD), leading to diaphragm muscle weakness and atrophy, complicating weaning from breathing machines and increasing ICU stays and medical costs, with existing external diaphragm pacemakers unable to effectively synchronize with mechanical ventilation.

Innovation Solution

An external diaphragm pacemaker device coupled with a ventilator that captures and processes electrical activity of the diaphragm (EAdi) signals to adjust stimulation frequency and trigger ventilator modes, ensuring synchronized diaphragmatic pacing and reduced positive pressure ventilation, thereby enhancing diaphragmatic involvement and reducing VIDD.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If mechanical ventilation is used to save lives of patients with respiratory failure, then life-saving effectiveness is improved, but ventilator-induced diaphragmatic dysfunction (VIDD) occurs causing diaphragm muscle weakness and atrophy

Engineering Contradiction:
Improvelife-saving effectivenessVSAvoiddiaphragm muscle weakness and atrophy
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The external diaphragm pacemaker delivers electrical stimulation to the phrenic nerve before complete diaphragm dysfunction occurs during mechanical ventilation, maintaining diaphragm muscle activation and preventing atrophy. The pacemaker is activated concurrently with mechanical ventilation to ensure continuous diaphragm engagement.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The external diaphragm pacemaker acts as an intermediary device between the mechanical ventilator and the diaphragm muscle. It translates ventilator operation into targeted electrical stimulation of the phrenic nerve, ensuring the diaphragm remains actively engaged during mechanical ventilation without direct mechanical interaction with the lung.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If external diaphragm pacemaker is used to stimulate diaphragm muscle, then diaphragmatic function is improved, but synchronization with mechanical ventilation is difficult to achieve

Engineering Contradiction:
Improvediaphragmatic functionVSAvoidsynchronization complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system uses feedback from the ventilator's operation status to automatically adjust the diaphragm pacemaker's stimulation timing and intensity. The ventilator provides operational signals that the pacemaker uses to synchronize its electrical stimulation with the mechanical ventilation cycles, eliminating complex manual coordination.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The external diaphragm pacemaker is designed to work with multiple types of mechanical ventilators and ventilation modes through universal communication interfaces and standardized synchronization protocols. This multi-functionality allows the same device to adapt to different clinical scenarios without requiring device-specific customization.

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

3Productivity

If mechanical ventilation provides sufficient respiratory support, then respiratory failure is treated effectively, but extended ICU stays and increased medical costs occur due to VIDD

Engineering Contradiction:
Improverespiratory support effectivenessVSAvoidICU stay duration
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The diaphragm pacemaker provides continuous electrical stimulation to the phrenic nerve throughout the mechanical ventilation period, ensuring uninterrupted diaphragm muscle activation. This continuous useful action prevents the disuse atrophy that would otherwise occur during extended mechanical ventilation, enabling earlier weaning and discharge.

Inventive Principle:
Principle #20Continuity of useful 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

Enables intelligent synchronization between diaphragmatic pacing and mechanical ventilation, reducing VIDD, VILI, and VAP complications, allowing for more effective treatment of critically ill patients and potentially shorter ICU stays with reduced drug use and financial burdens.

Implementation Method 1

an EAdi acquisition module for capturing EAdi signals from the diaphragm muscle

Methodology Applied
Scientific EffectElectrical activity detection: Electrical Impedance Tomography

Implementation Method 2

stimulate the phrenic nerve by electrical impulses, causing continuous and rhythmic muscle contractions of the diaphragm

Methodology Applied
Scientific EffectElectrical stimulation: Electromagnetic Induction

Data Source

PatentEP2918303B1Device for external diaphragm pacing and synergistic aspiration with respirator
Publication Date: 2020.05.27 ZHANG HONGXUAN
  • EP2918303B1 patent drawingFigure 1~2
  • EP2918303B1 patent drawingFigure 3~4
  • EP2918303B1 patent drawingFigure 5~6

AI summary

The present invention discloses a method for synchronized ventilation using an external diaphragm pacemaker and a ventilator, which includes the following steps: (1) filtrating captured EAdi signal to reduce the noises, (2) assessing the absolute peak value a of the EAdi signal and : if a <0.5µV, adjust the external diaphragm pacemaker to issue a stimulus current at a frequency of 10-12 beats per minute, and at the same time trigger the ventilator to perform ventilation in an assisted ventilation mode; if 0.5 ≤ a ≤ 1.0µV, adjust the external diaphragm, pacemaker to issue a stimulus current at a frequency of 5-8 beats per minute, and at the same time trigger the ventilator to perform ventilation in an assisted ventilation mode; if 1.0 < a ≤2.0µV, adjust the external diaphragm pacemaker to issue a stimulus current at a frequency of 3-4 beats per minute and at the same time trigger the ventilator to perform ventilation in an assisted ventilation mode. The present invention also discloses a device which couples an external diaphragm pacemaker to ventilator. The present invention brings the external diaphragm pacemaker into the application of mechanical ventilation in the emergency room and intensive care unit.