Endovascular Phrenic Nerve Pacing to Prevent Diaphragm Atrophy

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Solution Overview

Problem

Current methods for mechanical ventilation in ICU patients lead to rapid diaphragmatic muscle atrophy, ventilator dependence, and increased healthcare costs due to prolonged use of positive pressure mechanical ventilation, which interferes with neural activation and induces muscle dysfunction.

Innovation Solution

A minimally invasive transvascular diaphragm pacing system using disposable endovascular electrodes for phrenic nerve stimulation, synchronized with ventilator breaths to prevent or reverse diaphragm disuse atrophy, allowing for early weaning from mechanical ventilation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional phrenic nerve stimulation systems are used, then diaphragm pacing can be achieved, but the procedure is highly invasive requiring surgical implantation of nerve cuffs

Engineering Contradiction:
Improvediaphragm pacing effectivenessVSAvoidimplantation invasiveness
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent uses the superior vena cava as an intermediary pathway to deliver electrodes to the phrenic nerve. Instead of directly exposing and cuffing the nerve through surgical dissection, electrodes are introduced through the venous system, using the blood vessels as a conduit to reach the target site with minimal external incisions.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical surgical approach (direct nerve exposure and cuffing) with an endovascular delivery system. The electrodes are delivered through catheters navigated through the venous system, substituting open surgical mechanics with minimally invasive percutaneous access and vascular navigation.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If conventional diaphragmatic pacing with laparoscopic electrode implantation is used, then diaphragm stimulation can be achieved, but the procedure is time-consuming and requires incisions

Engineering Contradiction:
Improvediaphragm stimulation effectivenessVSAvoidimplantation procedure time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent uses the venous system as an intermediary delivery pathway, allowing electrodes to be positioned near the diaphragm and phrenic nerve without requiring laparoscopic dissection. This vascular route provides direct access to the target area through naturally occurring anatomical pathways.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent extracts the electrode delivery from the complex laparoscopic surgical procedure and separates it into a distinct endovascular component. The electrodes are delivered through the venous system independently of abdominal cavity access, simplifying and accelerating the overall implantation process.

Inventive Principle:
Principle #2Taking out (Extraction)

3Reliability

If prolonged positive pressure mechanical ventilation is used, then ventilatory assistance can be provided, but diaphragmatic muscle atrophy occurs rapidly

Engineering Contradiction:
Improveventilatory support effectivenessVSAvoiddiaphragm functional duration
Core Design Contradiction:
ReliabilityVSDuration of action of moving object

Solution Approach 1:

The patent applies diaphragm pacing during the early period of mechanical ventilation before significant atrophy develops. By providing neuromuscular stimulation in advance, the system prevents the onset of disuse atrophy rather than attempting to reverse established muscle loss, maintaining diaphragmatic responsiveness and function.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses intermittent phrenic nerve stimulation delivered in synchronized bursts rather than continuous stimulation. This periodic activation pattern provides sufficient diaphragm contraction to prevent atrophy while allowing rest periods, mimicking natural respiratory patterns and reducing metabolic demand during mechanical ventilation.

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 or reverses diaphragmatic atrophy, reducing ventilator dependence and associated complications, enabling earlier weaning from mechanical ventilation and lowering healthcare costs by maintaining diaphragmatic function and reducing ventilator-induced lung injuries.

Implementation Method 1

at least one endovascular electrode configured to transmit a stimulation signal delivered thereto... The stimulation signal has one or more stimulation parameters... configured to recruit a phrenic nerve of the patient

Methodology Applied
Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Data Source

PatentEP2863987B1Transvascular diaphragm pacing systems
Publication Date: 2023.08.02 LUNGPACER MEDICAL INC
  • EP2863987B1 patent drawingFigure 1
  • EP2863987B1 patent drawingFigure 2
  • EP2863987B1 patent drawingFigure 3A

AI summary

Transvascular diaphragm pacing systems (TDPS) and methods are disclosed for providing respiratory therapy to a patient. The TDPS can provide rapid insertion and deployment of endovascular pacing electrodes in critically ill patients who require intubation and invasive PPMV in order to support the physiological requirements of the human ventilatory system. The systems and methods make best use of the contractile properties of the diaphragm muscle and prevent muscle disuse and muscle atrophy. This can be carried out by engaging the phrenic nerves using patterned functional electrical stimulation applied to endovascular electrodes that are temporarily and reversibly inserted in central veins of the patient, such as the left subclavian vein and the superior vena cava. The TDPS can be designed to seamlessly interface with any commercially available positive-pressure ventilatory assistance/support equipment such as is commonly in use in hospital intensive care units (ICU) for treating critically ill patients with breathing insufficiencies, pain, trauma, sepsis or neurological diseases or deficits.