Implantable Device Lead Verification via Signal Analysis

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Solution Overview

Problem

Active implantable medical devices that deliver both cardiac and peripheral therapies face risks due to probe connection errors, where identical connectors for different probes can lead to incorrect targeting of therapies, potentially causing adverse effects such as tachycardia or fibrillation.

Innovation Solution

The device includes means to verify the connection configuration of probes before initiating therapy, inhibiting delivery if incompatible, and automatically identifies and configures the correct coupling of leads to their respective circuits, ensuring safe and accurate delivery of cardiac and peripheral therapies.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If identical connectors are used for all probes to simplify design and production, then device complexity is reduced and manufacturing is easier, but the risk of probe connection errors increases leading to incorrect therapy delivery

Engineering Contradiction:
Improveconnector design complexityVSAvoidprobe connection accuracy
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The system performs preliminary detection of cardiac signals on each probe before therapy delivery. The control unit analyzes whether cardiac signals are present on probes connected to peripheral therapy circuits, and only allows peripheral therapy when no cardiac signals are detected, preventing incorrect therapy delivery due to connection errors

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system continuously monitors and analyzes signals on all probes during operation. The control unit receives feedback from signal analysis on peripheral therapy circuits and adjusts therapy delivery accordingly - blocking peripheral therapy when cardiac signals are detected and enabling it when only peripheral signals are present

Inventive Principle:
Principle #23Feedback

2Adaptability or versatility

If the device allows both cardiac and peripheral therapies with identical connectors, then adaptability and versatility are improved, but the risk of harmful effects from incorrect probe targeting increases

Engineering Contradiction:
Improvetherapy type flexibilityVSAvoidadverse effects from incorrect therapy
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The system applies preliminary anti-action by detecting the presence of cardiac signals on peripheral therapy circuits before allowing peripheral therapy delivery. When cardiac signals are detected, the control unit blocks peripheral therapy output, preventing the harmful effect of delivering peripheral therapy to cardiac tissue which could cause tachycardia or fibrillation

Inventive Principle:
Principle #9Preliminary anti-action

Solution Approach 2:

The control unit acts as an intermediary between the therapy circuits and the probes. It analyzes signals from all probes and mediates therapy delivery by enabling or blocking cardiac and peripheral therapies based on signal analysis, ensuring that therapy is delivered only to the correct target

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP3042692B1Implantable medical device for cardiac and peripheral therapy with means for allowing or inhibiting therapy based on sensed signals
Publication Date: 2017.11.22 SORIN CRM
  • EP3042692B1 patent drawingFigure 1~2
  • EP3042692B1 patent drawingFigure 3
  • EP3042692B1 patent drawingFigure 4

AI summary

The device includes a cardiac therapy circuit with a terminal receiving a heart sensing/stimulation lead, and a peripheral therapy circuit with a peripheral organ sensing/stimulation lead. It includes means (30) for verifying the connection configuration of the leads to the terminals of the respective cardiac therapy and peripheral therapy circuits, operating by analyzing the signals collected at these terminals to reveal the presence or absence of a cardiac signal and delivering in response a command to activate or inhibit the cardiac and peripheral therapy circuits.