Implanted Lead Insulation Damage Detection System
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Solution Overview
Problem
Current lead extraction techniques face challenges in safely and effectively removing pacing leads with compromised insulation layers, which can lead to further damage during removal and increased risk of injury to the patient.
Innovation Solution
A device comprising a separator to free the lead from surrounding tissue, a sensor to detect electrical parameters associated with the lead's insulation layer, and a controller to alert physicians of irregularities, ensuring safe removal by identifying and addressing damaged insulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If lead extraction is performed using mechanical traction or energy devices, then the lead can be removed from the body, but the damaged insulation layer may tear further or unravel, causing injury to the patient
Solution Approach 1:
The patent applies preliminary action by detecting insulation layer damage before lead extraction begins. The sensor system identifies compromised insulation segments, and the controller pre-plans the extraction path and force application points to avoid further damage. This allows the extraction process to proceed with knowledge of where the insulation is weak, preventing catastrophic failure during removal.
Solution Approach 2:
The patent implements feedback by continuously monitoring the lead's condition during extraction using sensors that detect insulation integrity, electrical continuity, and mechanical stress. The controller receives real-time data and adjusts extraction forces or halts the process when damage is detected, preventing further injury while still enabling safe removal of the lead.
2Productivity
If the insulation layer is damaged and not detected, then the lead can be extracted, but undetected damage may lead to patient injury during removal
Solution Approach 1:
The patent performs preliminary inspection of the insulation layer using sensors before extraction begins. The controller analyzes the insulation condition and identifies damaged segments in advance, creating a safety map that guides the extraction process. This allows rapid extraction to proceed while avoiding areas of compromised insulation, maintaining both speed and safety.
Solution Approach 2:
The patent introduces an intermediary detection system between the lead and the extraction forces. The sensors act as intermediaries that detect insulation damage and communicate this information to the controller, which then mediates the extraction process by adjusting forces or routing to avoid damaged areas, preventing injury while maintaining extraction efficiency.
3Reliability
If a sensor system is added to detect insulation abnormalities, then patient safety is improved, but device complexity increases
Solution Approach 1:
The patent applies universality by designing the sensor system to serve multiple functions: detecting insulation damage, monitoring lead position, and assessing tissue adhesion. The controller integrates multiple detection capabilities into a single unified system, reducing overall device complexity while maintaining comprehensive safety monitoring throughout the extraction process.
Solution Approach 2:
The patent merges the detection and control functions into an integrated system. The sensors are combined with the controller and extraction mechanism into a unified device that automatically processes detection data and adjusts extraction parameters. This consolidation reduces the number of separate components and simplifies the overall device architecture while maintaining high reliability.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution enables quick and accurate detection of damaged insulation layers, allowing for remedial action to prevent patient injury and ensure safe extraction of pacing leads.
Implementation Method 1
a sensor to sense an electrical parameter associated with the lead to determine a condition of an insulation layer of the lead
Data Source
AI summary
A system is provided to determine whether an insulating layer of an implanted lead is damaged.