Implantable Lead Safety Element for MRI RF Interference
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Solution Overview
Problem
Conventional implantable electrical stimulation systems are incompatible with magnetic resonance imaging (MRI) due to RF pulses causing tissue damage and premature failure of electronic components.
Innovation Solution
Incorporating a safety element along the lead body of the implantable electrical stimulation system to reduce damage from RF irradiation, including a heat dissipating safety element and shunting undesired electrical signals, thereby protecting patient tissue and electronic components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional implantable electrical stimulation systems are used, then the systems can provide therapeutic electrical stimulation, but the systems are incompatible with MRI due to RF pulses causing tissue damage and electronic component failure
Solution Approach 1:
A safety element is introduced as an intermediary component between the RF field and the lead conductors. This safety element acts as a mediator that intercepts and manages the harmful RF-induced currents and heating, preventing them from reaching and damaging the electrodes and surrounding tissue during MRI procedures.
Solution Approach 2:
The safety element utilizes the harmful RF-induced currents and converts them into a beneficial protective function. By providing a controlled path for these currents through the safety element, the harmful energy is dissipated safely without causing tissue damage, effectively transforming the harmful RF exposure into a protected state.
2Device complexity
If conventional leads without safety elements are used, then the lead structure remains simple, but the lead causes tissue heating and induced electrical signals during RF irradiation
Solution Approach 1:
The safety element serves as a mediator component inserted into the lead structure. It provides a controlled interface between the RF field and the lead conductors, managing the thermal and electrical effects without significantly complicating the overall lead design.
Solution Approach 2:
The safety element alters the electrical and thermal parameters of the lead system during RF exposure. By changing the impedance characteristics and providing thermal management, the safety element modifies how RF energy interacts with the lead, reducing temperature rise and induced signals while maintaining structural simplicity.
3Ease of operation
If conventional leads are used during MRI, then the lead can function normally, but electronic components experience premature failure due to induced currents
Solution Approach 1:
The safety element acts as a protective intermediary that shields electronic components from harmful RF-induced currents during MRI. It provides a controlled path for these currents, preventing them from reaching and damaging the electronic components while allowing the lead to function normally during the procedure.
Solution Approach 2:
The safety element provides beforehand protection against RF-induced currents that would otherwise cause premature failure of electronic components. By being in place before MRI exposure, it cushions and protects the vulnerable electronic components from the harmful effects of RF irradiation, extending their operational lifespan.
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 effectively mitigates tissue heating and induced electrical signals during MRI procedures, ensuring the safety and functionality of the implantable electrical stimulation systems.
Implementation Method 1
heat dissipating safety element... reduce damage to patient tissue adjacent to the plurality of electrodes due to heating
Implementation Method 2
shunting undesired electrical signals... reduce damage to patient tissue adjacent to the plurality of electrodes due to heating, induced electrical signals
Data Source
AI summary
An implantable lead includes a lead body and at least one safety element. The lead body has a distal end and a proximal end. The lead body defines at least one lumen extending along at least a portion of the lead body. The lead body includes a plurality of electrodes disposed on the distal end of the lead body, a plurality of terminals disposed on the proximal end of the lead body, and a plurality of conductors disposed in the lead body, each conductor electrically coupling at least one of the electrodes to at least one of the terminals. The at least one safety element is disposed along at least a portion of the lead body and is configured and arranged to reduce damage to patient tissue adjacent to the plurality of electrodes due to heating, induced electrical signals, or both when the lead is exposed to radio frequency irradiation.