Phrenic Nerve Stimulation for Heart Failure Pressure Reduction

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Solution Overview

Problem

Current treatments for heart failure, including pacemakers, defibrillators, and CRTs, do not effectively improve the quality of life for all patients, and existing therapies for heart failure and sleep apnea have limitations such as patient compliance issues and potential exacerbation of heart failure symptoms, particularly in diastolic heart failure patients.

Innovation Solution

Phrenic nerve and diaphragm stimulation to modulate intrathoracic pressure, reducing sympathetic nerve activation and improving cardiac output, lung volume, and blood gas levels, which can be achieved through various stimulation modalities including low-level stimulation, breath augmentation, and synchronized stimulation with respiratory or cardiac cycles.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current treatments for heart failure (pacemakers, defibrillators, CRTs) are used, then cardiac rhythm control is improved, but quality of life and functional improvement are limited for many patients

Engineering Contradiction:

Improvecardiac rhythm controlVSAvoidquality of life

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent applies parameter changes by modifying intrathoracic pressure dynamics through diaphragm stimulation. This changes the hemodynamic parameters (atrial pressure, ventricular filling pressure, cardiac output) to improve both rhythm control reliability and quality of life. The stimulation alters the pressure-volume relationship in the thoracic cavity, creating beneficial hemodynamic effects that complement existing rhythm management therapies.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The diaphragm stimulation device serves multiple functions: it improves cardiac rhythm control, enhances quality of life, reduces hospitalizations, and provides therapeutic benefits for both systolic and diastolic heart failure. This multi-functionality resolves the contradiction by addressing both reliability and ease of operation through a single integrated therapy.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Reliability

If positive pressure ventilation is used to treat sleep apnea, then airway patency is improved, but heart failure symptoms may be exacerbated

Engineering Contradiction:

Improveairway patencyVSAvoidheart failure symptoms

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

Instead of using positive pressure ventilation that pushes air into the airway, the patent uses negative pressure generation through diaphragm stimulation to create suction that draws air into the lungs. This inverted approach maintains airway patency while avoiding the harmful effects of positive pressure on heart failure patients by creating negative intrathoracic pressure during inspiration.

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The patent changes the pressure parameter from positive to negative by using diaphragm stimulation to generate negative intrathoracic pressure. This parameter inversion resolves the contradiction by maintaining airway patency through negative pressure mechanisms that do not exacerbate heart failure symptoms, unlike positive pressure ventilation.

Inventive Principle:

Principle #35Parameter changes

3Productivity

If phrenic nerve stimulation is used to reduce intrathoracic pressure, then cardiac output is improved, but device complexity increases

Engineering Contradiction:

Improvecardiac outputVSAvoidstimulation device

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The patent integrates phrenic nerve stimulation functionality into existing cardiac rhythm management devices, allowing the same device to perform both pacing/defibrillation and diaphragm stimulation. This multi-functionality reduces overall device complexity while maintaining the cardiac output benefits of intrathoracic pressure reduction.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent combines the phrenic nerve stimulation system with existing cardiac management devices, merging multiple therapeutic functions into a single integrated system. This consolidation reduces the number of separate devices needed, simplifying the overall treatment approach while preserving the cardiac output improvement benefits.

Inventive Principle:

Principle #5Merging (Combining)

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

This approach reduces hospitalization due to pulmonary congestion, improves cardiac output, and remodels cardiac tissue, offering a supplementary treatment for heart failure and sleep apnea that complements existing therapies.

Implementation Method 1

stimulation is provided to the diaphragm or phrenic nerve to elicit a diaphragm response

Methodology Applied

Scientific EffectPhrenic nerve stimulation:

Implementation Method 2

elicit a diaphragm response to thereby provide a therapeutic effect

Methodology Applied

Scientific EffectDiaphragm contraction:

Data Source

PatentUS11497915B2Devices and methods for reducing intrathoracic pressure

Publication Date: 2022.11.15 RMX LLC

AI summary

Devices and methods are provided to treat acute and chronic heart failure by using one or more implantable or non-implantable sensors along with phrenic nerve stimulation to reduce intrathoracic pressure and thereby reduce pulmonary artery, atrial, and ventricular pressures leading to reduced complications and hospitalization.