Phrenic Nerve Stimulation for Respiratory Insufficiency

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Solution Overview

Problem

There is a need for an implantable medical device that can automatically deliver electrical stimulation to the right or left phrenic nerve to effectively treat respiratory insufficiencies such as paralysis, apnea, and obstructive sleep apnea, as existing methods lack a reliable and automatic solution for synchronized and robust breathing patterns.

Innovation Solution

An implantable medical device system that includes a housing with electronic circuitry and a connector block for medical electrical leads, which are positioned near the phrenic nerves to deliver electrical stimulation, using electrodes to activate the diaphragm and sense cardiac signals to avoid inadvertent cardiac capture, with a method for selecting optimal electrode pairs and stimulation parameters to achieve normalized breathing patterns.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If electrical stimulation is delivered to the phrenic nerve using existing methods, then respiratory insufficiency is treated, but the breathing pattern is not robust or synchronized

Engineering Contradiction:
Improvebreathing pattern stabilityVSAvoidautomatic control capability
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent employs feedback mechanisms by sensing the patient's intrinsic respiratory cycles and using this information to adjust the timing and parameters of electrical stimulation. The device monitors respiratory signals and modifies stimulation delivery based on the sensed breathing patterns, creating a closed-loop system that achieves synchronized and robust breathing control while operating automatically.

Inventive Principle:
Principle #23Feedback

2Reliability

If electrical stimulation is applied to activate the diaphragm, then respiratory function is improved, but inadvertent cardiac capture may occur

Engineering Contradiction:
Improverespiratory therapy effectivenessVSAvoidcardiac capture risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by using multiple electrode pairs with different spatial orientations and characteristics. Specific electrode pairs are selected based on their local electrical field distribution to preferentially stimulate the phrenic nerve while minimizing current spread to cardiac tissue. The system characterizes each electrode pair's stimulation properties and selects the optimal pair for delivering therapy, thereby achieving localized stimulation that avoids harmful cardiac capture.

Inventive Principle:
Principle #3Local quality

3Reliability

If multiple electrode pairs are used for stimulation, then therapy effectiveness is improved, but device complexity increases

Engineering Contradiction:
Improvestimulation effectivenessVSAvoidelectrode selection system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent implements self-service by enabling the device to automatically characterize and select optimal electrode pairs without requiring manual intervention. The system performs automated threshold testing and impedance measurements to evaluate each electrode pair's suitability for phrenic nerve stimulation. This self-characterization capability allows the device to independently determine the best electrode configuration, reducing the need for complex manual programming while maintaining high therapy effectiveness.

Inventive Principle:
Principle #25Self-service

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 delivers phrenic nerve stimulation, minimizing the risk of cardiac capture and achieving synchronized, normalized breathing patterns, thereby improving ventilatory stability and treating respiratory insufficiencies.

Implementation Method 1

electrical stimulation is delivered to the phrenic nerve in order to prevent the upper airway from collapsing

Methodology Applied
Scientific EffectElectrical stimulation: Electric Field

Implementation Method 2

Muscle contraction is detected through a sensor near the pharyngeal muscle within the pharynx at the onset of inspiration

Methodology Applied
Scientific EffectElectrical signal detection: Electrical Impedance Tomography

Data Source

PatentUS8897879B2Method and apparatus for therapies of the cardiovascular and cardiorenal system
Publication Date: 2014.11.25 MEDTRONIC INC
  • US8897879B2 patent drawing
  • US8897879B2 patent drawing
  • US8897879B2 patent drawing

AI summary

A system and method for controlling respiration depth or respiration rate is provided. A bipolar pair of a plurality of electrodes is selected in a location for stimulating a phrenic nerve. Electrical stimulation is delivered through a medical electrical lead electrode proximate phrenic nerve tissue. Modulating respiration is elicited in response to electrical stimulation of the phrenic nerve.