Implantable Cardiac Stimulator With Adaptive Rate-Zone Borders
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Solution Overview
Problem
Existing implantable medical devices require manual reprogramming to adjust programming parameters, leading to potential inadequate decisions and delayed reaction times due to dependence on telemetry systems and clinical user experience.
Innovation Solution
An implantable medical device that adjusts programming parameters based on cardiac interval analysis, determining cardiac rate zones and automatically or manually adjusting borders between these zones to match patient physiology, reducing inadequate decisions and improving therapy efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If manual reprogramming is used to adjust programming parameters, then programming parameters can be adjusted to patient needs, but reaction time is delayed and inadequate decisions may occur due to dependence on telemetry systems and clinical user experience
Solution Approach 1:
The implantable medical device automatically adjusts its own programming parameters by analyzing cardiac intervals and detecting when intervals fall within a band around zone borders. The device autonomously determines when reprogramming is needed and executes the adjustment without requiring external telemetry or clinical user intervention, enabling the device to serve itself in optimizing its programming.
Solution Approach 2:
The device continuously monitors cardiac intervals and uses this feedback to automatically detect when intervals are falling within the band around zone borders, triggering automatic reprogramming. This closed-loop feedback mechanism ensures the device responds immediately to changing patient conditions without delay.
2Ease of operation
If standard programming values are used during initial programming, then device setup is simplified, but inadequate decisions may be made that require iterative manual adjustment
Solution Approach 1:
The device performs preliminary automatic optimization of programming parameters immediately upon implantation by analyzing cardiac intervals and automatically adjusting zone borders. This preliminary action eliminates the need for extensive manual trial-and-error programming while ensuring optimal settings from the start, combining ease of initial setup with high reliability.
Solution Approach 2:
The device automatically optimizes its own programming parameters by analyzing cardiac intervals and adjusting zone borders without requiring iterative manual adjustment by the clinical user. This self-service capability ensures both simplified initial programming and optimal programming decisions from the outset.
3Productivity
If telemetry system is used for monitoring and adjustment, then remote monitoring is enabled, but reaction time depends on usage behavior and clinical user experience
Solution Approach 1:
The device autonomously monitors its own operation through continuous cardiac interval analysis and automatically executes reprogramming when needed, eliminating dependence on telemetry system usage behavior and clinical user experience for timely responses. The device handles monitoring and adjustment independently, ensuring immediate reaction to adverse conditions.
Solution Approach 2:
The device implements continuous internal feedback through cardiac interval monitoring, automatically detecting when reprogramming is needed and executing adjustments immediately. This internal feedback loop replaces the external telemetry-dependent feedback mechanism, eliminating delays related to telemetry usage and user response time.
4Device complexity
If cardiac rate zones are used for operational modes, then therapy delivery is structured, but inadequate decisions occur when cardiac rate is near zone borders
Solution Approach 1:
The device dynamically adjusts the borders between cardiac rate zones based on detected cardiac intervals. When intervals are detected within a band around zone borders, the device automatically reprograms to enlarge the appropriate zone, making the zone boundaries adaptive rather than fixed. This dynamic adjustment eliminates inadequate decisions near borders while preserving the structured operational mode framework.
Solution Approach 2:
The device changes the programming parameters of the cardiac rate zone borders based on detected cardiac intervals. When intervals fall within the band around zone borders, the device automatically modifies the border positions to enlarge the appropriate zone, ensuring reliable operation even when cardiac rate is near original zone borders.
Data Source
AI summary
An implantable medical device for stimulating a human or animal heart. During operation, the device performs the following steps: a) repeatedly detecting a cardiac electric signal; b) determining a duration of a cardiac interval from the detected cardiac electric signal and calculating a theoretic cardiac rate for each interval from the determined duration; c) determining a percentage of cardiac intervals lying within a first band having a predeterminable first width around a border between first and second cardiac rate zones in which the implantable medical device is operated in first and second operational modes, respectively; and d) if the determined percentage exceeds a predeterminable threshold, i) outputting a notification signal being indicative for a recommended adjustment of the border between the first and second cardiac rate zones, or ii) automatically adjusting the border between the first and second cardiac rate zones.