Vagus Nerve Stimulation Poincaré Plot for Real-Time Autonomic Assessment

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Solution Overview

Problem

Current vagus nerve stimulation therapies for congestive heart failure lack real-time monitoring and adjustment capabilities, leading to inefficiencies in titrating therapeutic doses and increasing the risk of side effects like tachycardia and bradycardia.

Innovation Solution

A system that includes a vagus nerve stimulation device, a processor, and a display to record and analyze ECG profiles during stimulation and non-stimulation periods, generating real-time heart rate variability data and Poincaré plots to visually indicate autonomic engagement, allowing for immediate adjustments to stimulation parameters.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If vagus nerve stimulation intensity is gradually increased over time through titration, then patient comfort is improved and side effects are reduced, but treatment duration is extended and productivity decreases

Engineering Contradiction:
Improveside effectsVSAvoidtitration speed
Core Design Contradiction:
Object-affected harmful factorsVSProductivity

Solution Approach 1:

The system continuously monitors heart rate variability and autonomic engagement metrics during VNS therapy, providing real-time feedback to automatically adjust stimulation intensity. This closed-loop control enables faster titration by dynamically optimizing the balance between therapeutic efficacy and side effect prevention, resolving the contradiction between safe gradual escalation and treatment efficiency.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system performs self-adjustment of stimulation parameters based on real-time physiological monitoring and pre-programmed algorithms. The automated titration process eliminates the need for frequent manual physician adjustments, enabling faster intensity escalation while maintaining safety through continuous autonomic engagement assessment.

Inventive Principle:
Principle #25Self-service

2Measurement precision

If real-time monitoring of heart rate variability is implemented, then autonomic engagement assessment is improved and therapy optimization is enabled, but device complexity increases

Engineering Contradiction:
Improveautonomic engagement assessmentVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system integrates multiple functions including ECG signal acquisition, heart rate variability analysis, autonomic engagement calculation, and automated stimulation adjustment within a single integrated platform. This multi-functionality reduces overall system complexity by eliminating the need for separate monitoring and control devices, while maintaining high measurement precision for therapeutic optimization.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentEP3793668B1PoincarÉ display to assess autonomic engagement responsive to vagus nerve stimulation
Publication Date: 2024.09.25 LIVANOVA USA INC
  • EP3793668B1 patent drawingFigure 1
  • EP3793668B1 patent drawingFigure 1A
  • EP3793668B1 patent drawingFigure 2

AI summary

A system includes a vagus nerve stimulation (VNS) device configured to deliver a vagus nerve stimulation signal having an ON-period status and an OFF-period status, and a processor and a non-transitory computer readable memory. The memory stores instructions that, when executed by the processor, cause the system to synchronously record a first ECG profile of during the ON-period status and a second ECG profile during the OFF-period status, determine heart rate dynamics from the first and second ECG profiles, the heart rate dynamics including a plurality of R-R intervals in each ECG profile, generate display data configured to be displayed on a display, and transmit the display data to the display. The display data includes the R-R intervals for each of the first and second ECG profiles. The display data further includes a Poincaré plot.