Implantable Device Parameter Adjustment Using Predictive Biomarker Data
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Solution Overview
Problem
Implantable medical devices often deliver unnecessary shocks to patients due to inaccurate sensing of cardiac activity, leading to patient distress and battery depletion, as they err on the side of safety over comfort.
Innovation Solution
The use of predictive markers like Endothelin-1 (ET-1) concentrations to set programming parameters for implantable medical devices, adjusting the level of stringency in arrhythmia detection and therapy administration based on sensed ET-1 levels to reduce unnecessary shocks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the device uses stringent arrhythmia detection criteria to ensure patient safety, then false positive shocks are reduced, but necessary therapy for high-risk patients may be delayed
Solution Approach 1:
The patent implements dynamic adjustment of detection stringency based on real-time ET-1 marker levels. When ET-1 is elevated indicating high arrhythmia risk, the device automatically reduces detection stringency and shortens therapy thresholds. When ET-1 is normal, the device maintains standard detection criteria. This dynamic adaptation resolves the contradiction by making detection criteria flexible rather than fixed, allowing the system to optimize between false positives and therapy delays based on current physiological state.
Solution Approach 2:
The system changes key detection parameters (stringency level, therapy thresholds, sensing windows) based on ET-1 concentration measurements. Specifically, the device adjusts the arrhythmia detection module's stringency parameter and therapy delivery thresholds according to the biomarker level. This parameter adaptation allows the same hardware to operate under different detection regimes, resolving the trade-off between reliability and response time.
2Reliability
If the device delivers therapy aggressively to ensure patient safety, then life-threatening arrhythmias are treated promptly, but unnecessary shocks cause patient distress and battery depletion
Solution Approach 1:
The device performs preliminary assessment of arrhythmia risk using ET-1 biomarker measurements before committing to aggressive therapy delivery. By measuring ET-1 levels in advance, the system predicts the likelihood of true arrhythmia events and pre-configures appropriate therapy thresholds. This preliminary risk stratification prevents aggressive therapy delivery when risk is low, thereby conserving battery energy while maintaining readiness for high-risk patients.
Solution Approach 2:
The system incorporates feedback from ET-1 biomarker measurements to continuously adjust therapy delivery parameters. The device monitors biomarker levels and uses this information to modulate therapy aggressiveness dynamically. When ET-1 indicates low risk, the device raises therapy thresholds to prevent unnecessary shocks. When ET-1 indicates high risk, the device lowers thresholds to ensure prompt treatment. This feedback loop resolves the contradiction by making therapy delivery adaptive rather than fixed.
Data Source
AI summary
Embodiments of the invention are related to systems and methods for setting parameters of implantable medical devices, amongst other things. In an embodiment, the invention includes a method for programming an implantable medical device including sensing concentrations of a predictive marker such as ET-1 in a patient, selecting programming parameter values based on the sensed concentrations of the predictive marker, and implementing the selected programming parameter values. In an embodiment the invention includes a method for detecting arrhythmia in a patient including sensing concentrations of the predictive marker in a patient, selecting a level of stringency to be used in an arrhythmia detection module based on the sensed concentrations of the predictive marker, sensing electrical signals in the patient, and evaluating the sensed electrical signals for indicia of an arrhythmia using the arrhythmia detection module. Other embodiments are also included herein.