IMD MRI Mode ATP Therapy for Arrhythmia Management

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Solution Overview

Problem

Magnetic resonance imaging (MRI) environments interfere with the operation of implantable medical devices (IMDs) due to strong magnetic fields and RF energy, preventing proper detection and treatment of tachyarrhythmias by saturating power supply components and disrupting the charging of high voltage capacitors.

Innovation Solution

The IMD system operates in various modes, including an MRI mode where sensors are deactivated, and upon detection of distress, transitions to a stat therapy mode to deliver antitachyarrhythmia pacing (ATP) therapy, reverting to normal mode once outside the MRI field to deliver shock therapy if necessary.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the IMD operates in normal mode with sensors active for tachyarrhythmia detection, then arrhythmia management capability is maintained, but the device becomes vulnerable to MRI electromagnetic field interference that can saturate power supply components and disrupt capacitor charging

Engineering Contradiction:
Improvearrhythmia management capabilityVSAvoidMRI electromagnetic field interference
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The IMD dynamically transitions between operational modes (normal mode, MRI mode, stat therapy mode) based on the detection of MRI electromagnetic field presence. The system adjusts sensor operation and therapy delivery capabilities in real-time to adapt to changing environmental conditions, thereby maintaining reliability while avoiding harmful interference.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes operational parameters by deactivating sensors and ignoring sensor signals when in MRI mode, and by switching to ATP therapy mode when distress is detected. This parameter adjustment allows the device to function reliably in the presence of strong electromagnetic fields that would otherwise cause saturation of power supply components.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If the IMD deactivates sensors to avoid MRI interference, then protection from electromagnetic field saturation is achieved, but tachyarrhythmia detection capability is temporarily lost

Engineering Contradiction:
Improveprotection from electromagnetic field saturationVSAvoidtachyarrhythmia detection capability
Core Design Contradiction:
Object-affected harmful factorsVSMeasurement precision

Solution Approach 1:

The system uses an intermediary control mechanism that monitors for MRI field presence and mediates between sensor operation and therapy delivery. When MRI fields are detected, the intermediary deactivates sensors to prevent saturation while maintaining the ability to deliver therapy through alternative means (ATP pacing) when distress is detected.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system performs preliminary detection of MRI electromagnetic field presence before full sensor operation begins. This preliminary action allows the device to preemptively deactivate sensors and enter protective MRI mode, preventing interference while maintaining readiness to provide therapy through alternative pathways.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If the IMD uses ATP therapy during MRI procedures, then continued arrhythmia management is achieved without shock therapy, but the device must carefully manage operational modes to ensure safety

Engineering Contradiction:
Improvecontinued arrhythmia managementVSAvoidoperational mode management
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The operational mode management is segmented into distinct states: normal mode for standard operation, MRI mode for protective operation during scanning, and stat therapy mode for emergency treatment. This segmentation simplifies the control logic by providing clear, discrete transitions between well-defined states, each with specific sensor and therapy delivery rules.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system automatically monitors for MRI field presence and transitions to appropriate operational modes without external intervention. The device self-manages its operational state by detecting electromagnetic field characteristics and autonomously adjusting sensor operation and therapy delivery capabilities, reducing the complexity of external control.

Inventive Principle:
Principle #25Self-service

4Speed

If the IMD transitions to stat therapy mode upon detecting distress during MRI, then immediate treatment capability is restored, but the system must rapidly switch from sensor-deactivated MRI mode to therapy-delivery mode

Engineering Contradiction:
Improvetherapy delivery speedVSAvoidrapid mode transition
Core Design Contradiction:
SpeedVSDevice complexity

Solution Approach 1:

The system maintains preliminary monitoring of physiological parameters and MRI field characteristics even during MRI mode operation. This preliminary action ensures that when distress occurs, the device can immediately transition to stat therapy mode without delay, as all necessary detection and decision-making infrastructure remains in place and ready for rapid activation.

Inventive Principle:
Principle #10Preliminary action

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

Ensures continued arrhythmia management during MRI procedures by using ATP therapy within the MRI environment and shock therapy post-procedure, maintaining effective treatment of tachyarrhythmias while minimizing interference from MRI electromagnetic fields.

Implementation Method 1

MRI systems employ the use of a magnetic coil having a magnetic field strength of between about 0.2 to 3 Teslas

Methodology Applied
Scientific EffectMagnetic field: Magnetic Field

Implementation Method 2

the body tissue is briefly exposed to RF pulses of electromagnetic energy in a plane perpendicular to the magnetic field

Methodology Applied
Scientific EffectRF electromagnetic energy: Electromagnetic Induction

Implementation Method 3

the presence of strong magnetic fields and RF energy during an MRI scan may prevent the charging of a high voltage capacitor within the pulse generator

Methodology Applied
Scientific EffectMagnetic saturation: Magnetic Saturation

Data Source

PatentEP2398553B1Systems for providing arrhythmia therapy in MRI environments
Publication Date: 2015.07.22 CARDIAC PACEMAKERS INC
  • EP2398553B1 patent drawingFigure 1
  • EP2398553B1 patent drawingFigure 2
  • EP2398553B1 patent drawingFigure 3

AI summary

Systems and methods for arrhythmia therapy in MRI environments are disclosed. Various systems disclosed utilize ATP therapy rather than ventricular shocks when patients are subjected to electromagnetic fields in an MRI scanner bore and shock therapy is not available. As the patient is moved out from within the scanner bore and away from the MRI scanner, the magnetic fields diminish in strength eventually allowing a high voltage capacitor within the IMD to charge if necessary. The system may detect when the electromagnetic fields no longer interfere with the shock therapy and will transition the IMD back to a normal operational mode where shock therapy can be delivered. Then, if the arrhythmia still exists, the system will carry out all of the system's prescribed operations, including the delivery of electric shocks to treat the arrhythmia.