Implantable 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 RF energy, particularly when routed near the body surface, as existing techniques are inadequate in preventing overheating at the electrode-tissue interface.

Innovation Solution

Incorporating a temperature sensor within the implantable medical lead adjacent to the electrode with a signal path to a processing unit that monitors temperature changes and takes action to limit heating, such as triggering alarms, blocking RF energy, or diverting it via telemetry or shunts, when thresholds are exceeded.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

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

Engineering Contradiction:
Improveaccessibility of lead implantationVSAvoidRF energy exposure and heating
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by implementing temperature monitoring and protective measures before excessive heating occurs. The system continuously monitors temperature at the electrode-tissue interface and takes preventive action (such as alerting the MRI operator or adjusting stimulation parameters) before dangerous heating levels are reached, rather than responding after damage occurs.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements feedback by using temperature sensors to continuously monitor the temperature at the electrode-tissue interface during MRI scans. This temperature information is fed back to the control system, which then adjusts stimulation parameters or alerts operators when temperature thresholds are approached, creating a closed-loop control system that dynamically responds to actual thermal conditions.

Inventive Principle:
Principle #23Feedback

2Object-affected harmful factors

If traditional shielding techniques are used to block RF energy, then the heating problem is reduced for deep implants, but the effectiveness is insufficient for shallow leads near the body surface

Engineering Contradiction:
Improveheating reductionVSAvoidprotection effectiveness
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent uses temperature sensors as intermediary devices that directly monitor the thermal condition at the electrode-tissue interface. Rather than relying solely on passive shielding structures, the temperature sensors provide direct measurement feedback, enabling active control and adjustment of stimulation parameters to prevent excessive heating in shallow leads.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces passive mechanical shielding approaches with an active electronic control system. Instead of relying solely on physical barriers (shields, chokes) to block RF energy, the system uses electronic temperature monitoring and dynamic adjustment of stimulation parameters to actively manage and prevent excessive heating, providing more reliable protection for shallow leads.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Object-affected harmful factors

If temperature monitoring is implemented to detect excessive heating, then patient safety is improved, but the device complexity and manufacturing cost increase

Engineering Contradiction:
Improvetemperature control and patient safetyVSAvoidsystem complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent applies universality by designing temperature sensors that can be integrated into existing lead structures without requiring completely separate monitoring systems. The same sensor infrastructure supports both temperature monitoring and can inform adjustments to stimulation therapy, allowing one system to serve multiple protective and therapeutic functions.

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

Solution Approach 2:

The patent implements nesting by integrating temperature sensors within the existing lead structure, placing them in close proximity to the electrodes where temperature monitoring is most critical. This nested arrangement allows the monitoring function to be embedded within the existing implantable device architecture rather than requiring separate external monitoring equipment.

Inventive Principle:
Principle #7Nested doll (Nesting)

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 heating at the electrode-tissue interface during MRI scans by detecting and mitigating excessive temperature increases, ensuring patient safety and system functionality.

Implementation Method 1

A temperature sensor may be positioned within the lead and in proximity to the electrode and may have a signal path back to a temperature probe processor

Methodology Applied
Scientific EffectTemperature sensing:

Implementation Method 2

The implantable medical device may also trigger a series switch in the conduction path to open to attempt to block conduction of the RF energy

Methodology Applied
Scientific EffectElectromagnetic blocking:

Implementation Method 3

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 EffectElectromagnetic shunting:

Data Source

PatentUS12053625B2Methods, implantable medical leads, and related systems to monitor and limit temperature changes in proximty to electrodes
Publication Date: 2024.08.06 MEDTRONIC INC
  • US12053625B2 patent drawing
  • US12053625B2 patent drawing
  • US12053625B2 patent drawing

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.