Wand Detection Cable Synchronizing ECG Recording for VNS
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Solution Overview
Problem
Current vagus nerve stimulation (VNS) therapy for congestive heart failure requires a lengthy titration process to reach a full therapeutic dose, and there is a need for systems and methods to monitor physiological responses to VNS effectively without inducing undesirable side effects, such as excessive tachycardia or bradycardia, while synchronizing ECG signal monitoring with stimulation signals indirectly.
Innovation Solution
An assessment system that includes a wand assembly with a detection circuit and a processor to synchronize ECG signal recording with vagus nerve stimulation, allowing for the detection of stimulation signal delivery and monitoring of heart rate dynamics to assess autonomic responses, using a wand assembly with a cable connector to indirectly detect the initiation of stimulation pulses and record ECG signals during ON- and OFF-periods.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a lengthy titration process is used to gradually increase VNS intensity, then patient side effect threshold increases and tolerability improves, but treatment time and productivity deteriorate
Solution Approach 1:
The system continuously monitors ECG signals during VNS titration and provides real-time feedback on heart rate dynamics. This feedback mechanism allows the system to automatically detect when the patient reaches their side effect threshold, enabling more efficient titration decisions without requiring lengthy manual observation periods.
Solution Approach 2:
The patent replaces the manual, time-consuming mechanical process of gradual intensity adjustment with an automated electronic system that uses ECG signal processing and algorithmic control. The automated system can rapidly adjust intensity based on real-time physiological data, substituting the slow mechanical titration process with faster electronic control.
2Measurement precision
If ECG signal monitoring is synchronized with VNS stimulation signals, then measurement precision of physiological response improves, but device complexity increases
Solution Approach 1:
The system uses an intermediary synchronization signal derived from the VNS stimulation waveform to trigger ECG recording. This intermediary mechanism coordinates the ECG monitoring with stimulation delivery without requiring complex direct coupling between the stimulator and ECG recorder, simplifying the overall system architecture while maintaining precise temporal alignment.
3Ease of operation
If indirect detection of stimulation signal initiation is used, then ease of operation improves, but measurement precision may deteriorate
Solution Approach 1:
The system performs preliminary detection of the stimulation signal initiation by monitoring for the characteristic electrical waveform of the VNS pulse before it is delivered to the patient. This preliminary detection allows the system to prepare and synchronize ECG recording in advance, ensuring accurate timing without requiring complex real-time adjustment during stimulation delivery.
Data Source
AI summary
An assessment system is provided for a subject patient implanted with a neurostimulator configured to deliver a stimulation signal having a plurality of ON-periods and OFF-periods. The assessment system includes a wand assembly configured to generate a delivery detection signal indicating delivery of an initiating pulse. The assessment system also includes a processor and a memory associated with the wand. The memory stores instructions that, when executed by the processor, cause the assessment system to record an ECG signal over at least one successive pair of ON- and OFF-periods and determine changes in heart rate dynamics to indicate autonomic response to the stimulation. The wand assembly includes a programming device configured to wirelessly communicate with the neurostimulator and a cable connector configured to form a surface contact with the programming device. The cable connector includes a detection circuit configured to indirectly detect a time of the initiating pulse.