Vagus Nerve Stimulation Device Using Heart Rate Histograms
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Solution Overview
Problem
Current Vagus Nerve Stimulation (VNS) therapies for patients at risk of heart failure lack effective long-term adaptation mechanisms, relying on empirical adjustments by physicians and failing to account for changes in patient condition over time.
Innovation Solution
An active implantable medical device that automatically adjusts VNS therapy parameters based on a retrospective analysis of physiological activity over a month, comparing intrinsic and reference heart rates to determine the patient's condition and triggering alerts or parameter modifications as needed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If VNS therapy parameters are adjusted empirically by physicians during control visits, then the therapy can be customized to patient needs, but the adjustment frequency is insufficient to capture long-term changes in patient condition
Solution Approach 1:
The system continuously monitors physiological parameters (heart rate, activity level) and automatically adjusts VNS therapy parameters based on the detected changes in patient condition, creating a closed-loop feedback system that eliminates the need for frequent manual physician visits
Solution Approach 2:
The implantable device autonomously adapts therapy parameters by analyzing its own collected physiological data and comparing intrinsic heart rate with reference heart rate derived from activity sensors, enabling the system to self-adjust without external intervention
2Adaptability or versatility
If dynamic modification of VNS therapy is made based on instantaneous activity sensors, then the therapy adapts to current patient activity, but the long-term evolution of patient condition is not accounted for
Solution Approach 1:
The system combines instantaneous activity sensor data with long-term physiological monitoring data, merging short-term activity information with historical trends to comprehensively assess both current and evolving patient condition for optimized therapy adjustment
Solution Approach 2:
The system performs preliminary analysis of long-term physiological trends by continuously collecting and storing data, preparing the foundation for detecting condition evolution before clinical symptoms manifest, enabling proactive therapy adjustment
3Reliability
If multiple sensors and continuous monitoring are implemented to track patient condition, then long-term adaptation is achieved, but device complexity increases
Solution Approach 1:
The implantable device performs multiple functions using integrated components: it monitors heart rate, tracks activity level, compares intrinsic and reference heart rates, and adjusts VNS therapy parameters, allowing a single device to handle all aspects of long-term adaptation without requiring separate specialized systems
Data Source
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AI summary
The device includes a VNS pulse generator, a sensor for the patient's current activity level, and means for collecting successive values of the patient's current intrinsic heart rate (HRint). A reference heart rate (HRref) is calculated based on the patient's current activity. A first histogram is then constructed from the reference heart rate (HRref) values calculated by the computing means over a predefined monitoring period, and a second histogram is constructed from the intrinsic heart rate (HRint) values collected over the same monitoring period. The first and second histograms are compared to produce an index representative of the patient's condition at the end of the monitoring period.