Sacrificial Conductor for Predictive Lead Failure
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Solution Overview
Problem
Implantable medical device leads are prone to fatigue damage and failure due to repeated flexing and axial stresses, particularly at stress concentration points, which can lead to kinking and crushing, and the trend towards smaller, more fragile leads increases the need for robust designs that can withstand numerous cycles and stresses.
Innovation Solution
Incorporating a sacrificial conductor within the medical device lead that is configured to fail at a lower stress than the primary lead conductor, allowing for predictive failure detection through periodic electrical property measurements by the pulse generator, thereby enabling timely replacement or reconfiguration of the lead to minimize performance impact.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Weight of moving object
If the lead size is decreased to make less invasive products, then the invasiveness is reduced, but the lead becomes more fragile and susceptible to fatigue damage
Solution Approach 1:
The sacrificial conductor is installed in advance within the lead body, positioned to fail before the main conductor under stress conditions. This preliminary protective element is pre-configured to detect and indicate potential failure modes before they affect the primary conductor, allowing proactive monitoring and replacement.
Solution Approach 2:
The sacrificial conductor acts as an intermediary element between the external stress environment and the main conductor. It absorbs and indicates mechanical stresses through controlled failure, protecting the main conductor from direct exposure to fatigue damage while providing detectable warning signals.
2Adaptability or versatility
If the lead follows narrow and tortuous paths to navigate tight bends, then the lead can reach difficult locations, but stress concentration points increase
Solution Approach 1:
The sacrificial conductor is pre-positioned within the lead body to intercept and indicate stress concentrations that occur during navigation through tortuous paths. This allows the lead to navigate difficult anatomy while the sacrificial element monitors and warns of stress accumulation before it compromises the main conductor.
Solution Approach 2:
The sacrificial conductor serves as a mediator that absorbs and signals the mechanical stresses encountered during lead navigation through narrow and tortuous paths. It protects the main conductor from the full impact of bending and flexing stresses by providing a sacrificial failure mode that can be detected and monitored.
3Duration of action of moving object
If the lead undergoes numerous flex cycles during normal daily activity, then the lead remains functional for extended periods, but fatigue damage accumulates
Solution Approach 1:
The sacrificial conductor is installed in advance to fail before the main conductor under repeated flexing conditions. It provides a preliminary warning mechanism that detects fatigue accumulation through controlled failure, allowing the lead to remain functional longer while providing early indication of approaching fatigue limits.
Solution Approach 2:
The sacrificial conductor provides feedback about the cumulative stress and fatigue experienced by the lead during normal daily activity. Through periodic electrical property measurements, the system receives information about the lead's mechanical history and fatigue state, enabling proactive monitoring and replacement before main conductor failure occurs.
4Reliability
If periodic electrical property measurements are performed to detect sacrificial conductor failure, then early warning capability is improved, but device complexity increases
Solution Approach 1:
The pulse generator performs periodic electrical property measurements of the sacrificial conductor and uses this feedback to detect failure. The measurement system monitors changes in electrical properties such as impedance or continuity, providing feedback about the sacrificial conductor's integrity and enabling early warning of potential main conductor failure.
Solution Approach 2:
The sacrificial conductor is electrically coupled to the pulse generator, allowing the existing device to monitor its own health through periodic measurements. The lead system essentially monitors itself by using the pulse generator's built-in measurement capabilities to detect sacrificial conductor failure without requiring external monitoring equipment.
Data Source
AI summary
A medical device lead includes a lead body having a proximal end and a distal end. The proximal end is configured for connection to a pulse generator. One or more electrodes are at a distal end of the lead body, and a lead conductor extends through the lead body and is electrically coupled to at least one of the one or more electrodes. The conductor is configured to deliver electrical signals between the proximal end and the at least one of the one or more electrodes. A sacrificial conductor extends through the lead body adjacent to lead conductor and is configured to fail at a lower stress than the lead conductor.