Active Medical Device for Selective Hypopnea Treatment

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Solution Overview

Problem

Current techniques for diagnosing and treating sleep-disordered breathing, particularly hypopneas, face challenges in real-time detection and targeted therapy, leading to excessive treatment and potential disruption of sleep, as they often apply therapy too late or incorrectly, resulting in reduced effectiveness over time.

Innovation Solution

An active medical device that analyzes and classifies ventilatory drops in real-time using multiple criteria, such as episode history, event severity, physiological origin, sleep stage, and treatment efficacy, to accurately identify hypopneas and apply tailored therapy only when necessary, thereby reducing unnecessary treatments and improving therapy relevance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of time

If therapy is applied as soon as a respiratory drop is detected, then early treatment of hypopnea is achieved, but unnecessary treatment is applied to non-hypopnea events

Engineering Contradiction:
Improvetreatment delayVSAvoidtreatment accuracy
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The system performs preliminary classification of respiratory drops using multiple criteria (amplitude, duration, shape, episode history) before initiating therapy. This preliminary action filters out non-hypopnea events early in the detection process, preventing unnecessary treatment while maintaining early intervention for true hypopneas.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system uses feedback from multiple sensor signals (respiratory flow, oxygen saturation, heart rate, movement) to continuously refine the classification of respiratory events. This multi-parameter feedback loop enables accurate real-time discrimination between hypopneas and non-hypopnea events, ensuring therapy is applied only when appropriate.

Inventive Principle:
Principle #23Feedback

2Reliability

If all respiratory drop events are treated preventively, then potential hypopneas are treated early, but sleep is disrupted by excessive treatment

Engineering Contradiction:
Improvetreatment coverageVSAvoidsleep disruption
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system applies different treatment strategies to different types of respiratory events based on their classified characteristics. By analyzing local features of each respiratory drop (amplitude, duration, morphology, episode context), the system selectively applies therapy only to events meeting hypopnea criteria, avoiding sleep disruption from unnecessary treatment while maintaining comprehensive coverage for true hypopneas.

Inventive Principle:
Principle #3Local quality

3Reliability

If therapy is applied after confirming hypopnea criteria, then treatment accuracy is improved, but treatment is delayed until after the event

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidtreatment timing
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system performs preliminary classification using multiple criteria (amplitude threshold, duration threshold, episode history, signal morphology) to identify high-probability hypopnea events before confirmation. This allows early therapy initiation for events that meet multiple preliminary criteria, reducing treatment delay while maintaining high accuracy through the multi-criteria filtering process.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP3017752B1Active medical device for selective, early treatment of hypopnoea
Publication Date: 2022.11.02 SORIN CRM
  • EP3017752B1 patent drawingFigure 1
  • EP3017752B1 patent drawingFigure 2a~2b
  • EP3017752B1 patent drawingFigure 3~4

AI summary

The device includes means for measuring respiratory activity and detecting (20) an event of a drop in respiratory flow below a predetermined threshold. Discriminatory means (22, 40, 50, 70, 80, 90, 100, 102) analyze various parameters of this event in real time and determine whether they meet predefined criteria, so as to assign the event an indicator of a priori hypopnea. Anti-hypopnea therapy (28) is selectively triggered upon detection of the respiratory drop, but only in the event of a routine occurrence indicating a priori hypopnea.The criteria may include: history of intervals between successive events constituting episodes of hypopnea; severity of the current event; conformity of a profile of the current event with a reference profile; physiological, obstructive or central origin of the event; current sleep stage of the patient; and history of the degree of effectiveness of therapies applied.