Implantable Cardiac Device Risk Stratification and Segmentation
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Solution Overview
Problem
Current implantable cardiac defibrillators (ICDs) are often over-engineered for patients, providing unnecessary features and costing more than needed, with a one-size-fits-all approach that doesn't account for varying risk levels of cardiac patients, leading to inefficient use and economic waste. Additionally, existing devices rely on battery depletion for replacement, which can result in prolonged exposure to potential component failures.
Innovation Solution
A stratified system for evaluating cardiac patient risk levels, providing a prophylactic device with defibrillation-only therapy for lower-risk patients and a more comprehensive device for higher-risk patients, with a built-in expiration mechanism to ensure timely replacement and prevent device failure, along with a rechargeable battery system for extended use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a one-size-fits-all approach is used for implantable cardiac defibrillators, then device versatility and comprehensive arrhythmia coverage are improved, but device complexity and cost increase unnecessarily for lower-risk patients
Solution Approach 1:
The patent segments the cardiac device market into different risk stratification categories (primary prevention, secondary prevention, tertiary prevention) and provides tailored device configurations for each segment. This allows patients with lower risk levels to receive simplified devices with essential defibrillation capabilities only, while high-risk patients receive comprehensive multi-functional devices, thereby reducing unnecessary complexity and cost for most patients.
2Adaptability or versatility
If current ICDs are designed to treat multiple cardiac conditions, then treatment comprehensiveness is improved, but device complexity and manufacturing cost increase
Solution Approach 1:
The patent applies segmentation by creating distinct device versions for different patient risk categories. Standard ICDs are designed with essential defibrillation functionality for primary prevention patients, while advanced ICDs with additional pacing and cardioversion capabilities are reserved for secondary and tertiary prevention patients who have demonstrated arrhythmias. This segmentation reduces manufacturing complexity and cost for the majority of patients who only need basic defibrillation protection.
3Duration of action of stationary object
If battery depletion is used as the replacement trigger, then device longevity is improved, but reliability decreases due to prolonged exposure to potential component failures
Solution Approach 1:
The patent implements preliminary action by establishing a predetermined replacement timeline based on device manufacturing date and risk stratification category, rather than waiting for battery depletion. This proactive approach ensures devices are replaced before potential component failures can occur, maintaining patient safety while extending the practical operational lifespan. The system automatically tracks device age and triggers replacement notifications before the battery actually depletes.
4Reliability
If comprehensive arrhythmia treatment features are provided to all patients, then patient safety is improved, but economic waste increases due to unnecessary features
Solution Approach 1:
The patent applies local quality by customizing device features to match individual patient risk profiles and clinical needs. Patients in the primary prevention category receive standardized ICDs with essential defibrillation capabilities, while patients in secondary and tertiary prevention categories receive advanced ICDs with additional pacing, cardioversion, and arrhythmia management features. This localized customization ensures patients receive exactly the features they need for their specific risk level, eliminating economic waste from unnecessary features while maintaining adequate safety for all patients.
Data Source
AI summary
Embodiments relate to an implantable cardiac system, including a housing, electronic circuitry for controlling one or more of power management, processing unit, information memory and management circuit, sensing and simulation output. The system also includes diagnosis and treatment software for diagnosing health issues, diagnosing mechanical issues, determining therapy output and manage patient health indicators over time, a power supply system including at least one rechargeable battery, a recharging system, an alarm (or alert) system to inform patient of energy level and integrity of system, communication circuitry, one or more electrodes for delivering therapeutic signal to a heart and one or more electrodes for from delivering electrocardiogram signal from the heart to the electronic circuitry. The present embodiments further include a body orientation unit to determine body position and use same to control therapy.