Neural Stimulation Timing Indicator for Vagus Nerve Capture Verification
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Solution Overview
Problem
Intermittent vagus nerve stimulation makes it difficult for clinicians to verify capture of the vagus nerve, as they cannot determine if laryngeal vibration is caused by the stimulation, leading to patient discomfort and inefficiency in monitoring.
Innovation Solution
An implantable medical device configured to deliver programmed intermittent neural stimulation with alternating ON and OFF times, along with an external device providing a user-perceptible indication of the current timing of the stimulation, allowing clinicians to monitor laryngeal vibrations during stimulation ON times and verify vagus nerve capture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intermittent neural stimulation is delivered to the vagus nerve, then therapy effectiveness is improved, but verification of nerve capture becomes difficult
Solution Approach 1:
The patent implements a feedback mechanism where the external device provides real-time indication of stimulation timing status to the clinician. The INS indicator shows whether the device is in stimulation ON or OFF state, enabling the clinician to verify nerve capture by correlating laryngeal vibration observations with the indicated stimulation timing, thus resolving the verification difficulty while maintaining intermittent therapy effectiveness
Solution Approach 2:
The patent introduces an intermediary indication system (INS indicator on external device) that mediates between the implantable device's internal stimulation state and the clinician's external observation. This intermediary provides the timing information bridge needed to verify nerve capture during intermittent stimulation without disrupting the therapy
2Measurement precision
If physical monitoring of laryngeal vibration is performed continuously, then verification accuracy is improved, but patient comfort deteriorates
Solution Approach 1:
The patent enables periodic verification by providing clinicians with timing information that indicates when stimulation is active. This allows verification to be performed periodically during ON states rather than continuously, reducing patient discomfort from constant physical monitoring while maintaining verification accuracy during the stimulation periods when capture can be confirmed
3Adaptability or versatility
If intermittent stimulation with alternating ON and OFF times is used, then therapy adaptability is improved, but monitoring efficiency deteriorates
Solution Approach 1:
The INS indicator provides immediate feedback about the current stimulation state (ON or OFF), enabling clinicians to efficiently determine during which periods laryngeal vibration should be observed. This feedback mechanism maintains monitoring efficiency despite the complex intermittent timing by providing clear real-time guidance on when verification is relevant
Data Source
AI summary
A method and system for providing an indication of delivery of a neural stimulation therapy is disclosed. In an example, a method may include identifying current timing of an intermittent neural stimulation (INS) programmed in an implantable medical device (IMD) where the programmed INS includes alternating stimulation ON and stimulation OFF times and a timing for delivering stimulation bursts of a plurality of stimulation pulses during the stimulation burst ON times. An indication of the current timing of the INS may be provided using an INS indicator of an external device.