Implantable Cardiac Device Risk Stratification

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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 individual risk levels, leading to inefficient use and potential device failure due to battery longevity issues, and there is a lack of stratification in risk evaluation for conditions like sudden cardiac death (SCD), ventricular fibrillation (VF), and ventricular tachycardia (VT).

Innovation Solution

A stratification system for evaluating and diagnosing cardiac patients to identify higher-risk individuals earlier in the disease progression, providing a prophylactic device with defibrillation therapy only, and implementing a device with a predetermined expiration date to ensure safety and timely replacement, along with a rechargeable battery system for extended life and efficient charging.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a one-size-fits-all approach is used for implantable cardiac defibrillators, then device versatility is improved, but device complexity and cost increase unnecessarily

Engineering Contradiction:
Improvedevice versatilityVSAvoiddevice complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent segments the device into different types based on patient risk stratification. Primary prevention devices are offered to high-risk patients, while secondary prevention devices are offered to patients who have survived cardiac arrest. This segmentation allows each device type to be optimized for its specific indication, reducing unnecessary complexity and cost for patients who do not need advanced features.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies local quality by tailoring device features to specific patient needs and risk levels. High-risk patients receive devices with advanced monitoring and intervention capabilities, while lower-risk patients receive simpler devices. This ensures that device complexity is localized to where it is most needed, rather than being uniformly applied to all patients.

Inventive Principle:
Principle #3Local quality

2Adaptability or versatility

If current ICDs are designed to treat multiple cardiac conditions, then adaptability is improved, but device complexity and manufacturing cost increase

Engineering Contradiction:
Improvetreatment capabilityVSAvoidmanufacturing cost
Core Design Contradiction:
Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

The patent segments treatment capabilities into different device types based on the specific cardiac conditions being treated. Devices are designed with specific therapeutic capabilities matched to patient needs, such as defibrillation for ventricular arrhythmias or pacing for bradycardia. This segmentation allows each device to be manufactured with optimized features for its intended use, reducing overall manufacturing complexity and cost.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies local quality by providing specific treatment capabilities only where needed. Rather than equipping all devices with every possible cardiac therapy option, each device is configured with the specific therapies required for its target patient population. This reduces manufacturing complexity and cost while maintaining adequate treatment capability for each indication.

Inventive Principle:
Principle #3Local quality

3Reliability

If implantable devices are used for prophylactic treatment of sudden cardiac death, then patient safety is improved, but device longevity and reliability challenges arise

Engineering Contradiction:
Improvepatient safetyVSAvoiddevice longevity
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent applies preliminary action by implementing risk stratification and patient selection criteria before device implantation. By identifying high-risk patients who will benefit most from prophylactic treatment, the system ensures that devices are implanted in the most appropriate candidates, maximizing the likelihood of device longevity and reliability through proper patient matching and monitoring.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements feedback mechanisms through continuous monitoring of device performance and patient status. This allows for real-time adjustment of device settings and monitoring parameters to maintain optimal reliability and safety over the device's operational life, addressing longevity challenges through adaptive management rather than relying solely on fixed design specifications.

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS9144686B2Implantable medical device with external access for recharging and data communication
Publication Date: 2015.09.29 NEUROCARDIAC INNOVATIONS LLC
  • US9144686B2 patent drawing
  • US9144686B2 patent drawing
  • US9144686B2 patent drawing

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 power sources can include rechargeable batteries. The housing can include receptacles that receive a probe that mechanically and electrically connects to circuitry to recharge the device and receive data from the device.