Implantable Medical Lead Temperature Sensor for MRI RF Heating Mitigation

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Solution Overview

Problem

Implantable medical leads face challenges in managing excessive heating during MRI scans due to induced radiofrequency energy, particularly when routed near the body surface, as existing shielding techniques are inadequate for shallow implantations.

Innovation Solution

Incorporating a temperature sensor within the lead adjacent to the electrode and a signal path for real-time temperature monitoring, with a controller that can activate a switch to shunt electrical current to a heat sink or create an open circuit when temperature thresholds are exceeded, thereby mitigating heating.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the lead is routed near the surface for peripheral nerve stimulation therapy, then accessibility and ease of operation are improved, but exposure to higher levels of RF energy increases causing excessive heating at the electrode

Engineering Contradiction:
ImproveaccessibilityVSAvoidRF energy exposure
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent implements preliminary protective actions by incorporating temperature sensors adjacent to electrodes and establishing monitoring systems before MRI procedures. The system proactively detects temperature changes and can preemptively interrupt stimulation or activate cooling mechanisms to prevent excessive heating before it occurs, rather than merely responding after damage begins.

Inventive Principle:
Principle #10Preliminary action

2Object-affected harmful factors

If conventional shielding techniques are used in leads, then protection against RF energy is improved for deep implantation, but the shielding becomes inadequate when the lead is routed near the body surface

Engineering Contradiction:
ImproveRF energy protectionVSAvoidadaptability to shallow implantation
Core Design Contradiction:
Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The patent implements dynamic adaptation by making the lead system's protective capabilities adjustable based on implantation depth and location. Temperature monitoring thresholds, stimulation interruption criteria, and active cooling activation levels are dynamically adjusted according to whether the lead is positioned deeply or shallowly in the body, allowing the same lead design to adapt to different implantation scenarios rather than requiring fixed shielding parameters.

Inventive Principle:
Principle #15Dynamics

3Reliability

If temperature monitoring is implemented in real-time, then patient safety is improved by detecting excessive heating, but device complexity increases due to additional sensors and control circuitry

Engineering Contradiction:
Improvepatient safetyVSAvoidmonitoring system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent implements multi-functionality by designing temperature sensors and control circuitry that serve multiple purposes: monitoring electrode temperature during stimulation, detecting MRI-induced heating, triggering stimulation interruption, activating cooling mechanisms, and providing data for post-procedure analysis. This consolidates what could be separate complex systems into an integrated multi-functional unit, reducing overall complexity while maintaining comprehensive safety monitoring.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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

Effectively reduces electrode heating during MRI scans by diverting or blocking RF energy, ensuring patient safety and preventing tissue damage.

Implementation Method 1

A temperature sensor may be positioned within the lead and in proximity to the electrode

Methodology Applied
Scientific EffectThermal conduction: Conduction (thermal)

Implementation Method 2

an electrical current is induced onto the electrical conductors of the lead. This electrical current passes through the electrode to generate heating of the electrode to tissue interface

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Implementation Method 3

the implantable medical device or separate probe processing device may trigger a series switch in the conduction path to open to attempt to block conduction of the RF energy and/or may trigger a shunt in parallel to the conduction path to become active to divert some of the RF energy away from the electrode being heated

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentEP3651848B1Methods, implantable medical leads, and related systems to monitor and limit temperature changes in proximity to electrodes
Publication Date: 2024.05.15 MEDTRONIC INC
  • EP3651848B1 patent drawingFigure 1
  • EP3651848B1 patent drawingFigure 2
  • EP3651848B1 patent drawingFigure 3

AI summary

A temperature sensor is included within a lead in proximity to distal electrodes. The temperature sensor measures temperature change at the electrode to tissue interface. Actions can be taken when the temperature exceeds a threshold due to heating from current induced by radio frequency energy from an MRI scan. The actions may include sending a signal via telemetry from the implanted device to an external device to produce an alarm to alert an MRI technician or to instruct the MRI scanner to alter the MRI scan. The actions may include activating a switch in the conduction path of an implanted lead to block some of the RF energy and/or to activate a shunt in the conduction path to divert some of the RF energy. The temperature sensor may be of various forms and may be mounted in various locations within the lead.