Neurostimulation Titration via ECG Autonomic Feedback
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current vagus nerve stimulation therapy for congestive heart failure requires a titration process to gradually increase stimulation intensity, which can be time-consuming and prone to side effects, necessitating a method to monitor and adjust therapy effectively without excessive tachycardia or bradycardia.
Innovation Solution
A neurostimulation system that monitors electrocardiogram (ECG) data to synchronize with the stimulation delivery schedule, allowing for real-time assessment of heart rate changes and autonomic engagement, enabling immediate adjustments to stimulation parameters to optimize therapy and reduce side effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a titration process is used to gradually increase stimulation intensity, then patient discomfort and side effects are reduced, but the time required to achieve full therapeutic dose is extended
Solution Approach 1:
The system continuously monitors ECG data and automatically detects autonomic engagement based on heart rate changes during stimulation cycles. This real-time feedback allows the system to determine when the patient has adapted to the current intensity level, enabling objective criteria for progression rather than relying solely on time-based titration schedules.
Solution Approach 2:
The patent replaces the manual, time-based titration process with an automated system that uses ECG monitoring and algorithmic analysis to detect autonomic engagement. This substitution of mechanical/time-based progression with physiological signal-based automation resolves the contradiction by allowing rapid intensity increases only when physiological readiness is confirmed.
2Productivity
If stimulation intensity is increased to achieve full therapeutic dose, then therapy efficacy is improved, but side effects such as tachycardia and bradycardia increase
Solution Approach 1:
The system monitors heart rate changes during stimulation cycles and uses this feedback to detect autonomic engagement. When the algorithm detects that the patient has reached the side effect threshold, it provides real-time indicators to the programming system, allowing the physician to adjust intensity before excessive side effects occur.
Solution Approach 2:
The system dynamically adjusts the titration process based on real-time physiological responses. Rather than following a fixed intensity increase schedule, the system adapts the titration rate to the patient's individual response characteristics, allowing faster progression when tolerance is high and slower progression when side effects approach thresholds.
3Measurement precision
If ECG monitoring is implemented to detect autonomic engagement, then titration precision is improved, but device complexity increases
Solution Approach 1:
The patent replaces complex manual assessment of autonomic engagement with an automated algorithm that analyzes ECG data. The system automatically detects heart rate changes, determines autonomic engagement status, and provides real-time indicators, substituting physiological measurement with computational analysis to maintain precision while reducing operational complexity.
Solution Approach 2:
The system performs self-monitoring and self-assessment of titration status by automatically analyzing ECG data and detecting autonomic engagement without requiring external intervention. The algorithm autonomously determines when intensity adjustments are appropriate, reducing the burden on the programming system while maintaining high measurement precision.
Data Source
AI summary
A neurostimulation system comprises a control system configured to monitor a patient receiving neurostimulation therapy. The neurostimulation therapy has a stimulation cycle comprising a stimulation ON period, in which the patient is receiving neurostimulation, and a stimulation OFF period, in which the patient is not receiving neurostimulation. The control system is programmed to receive electrocardiogram (ECG) data from the patient receiving the neurostimulation therapy. The control system is further programmed to monitor a heart rate of the patient based on the ECG data over at least one stimulation cycle of the neurostimulation therapy. The control system is further programmed to generate an indication of signal stability to be displayed to a user based on the received ECG data.