MRI Sensor Control for Implantable Device Safety

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Solution Overview

Problem

Implantable heart therapy devices, such as cardiac pacemakers and cardiovertors/defibrillators, are adversely affected by strong electromagnetic fields found in MRI scanners, making it unsafe for patients with these implants to undergo MRI examinations, and existing solutions require manual reprogramming that may become outdated over time.

Innovation Solution

An electronic implantable device with a control unit, memory unit, and MRI sensor that automatically selects and applies appropriate control programs and parameters based on detected state parameters, allowing safe operation during MRI scans without the need for immediate reprogramming, and includes features like asynchronous stimulation modes to avoid incorrect signal detection from magnetic fields.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual reprogramming is performed before MRI scans, then safety during MRI is improved, but the device complexity and time required for preparation increase

Engineering Contradiction:
Improvesafety during MRIVSAvoidreprogramming requirement
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The implantable device automatically detects MRI conditions through sensors and autonomously switches to MRI-safe operating modes without requiring external reprogramming. The control unit monitors for MRI environments and self-adjusts device parameters, eliminating the need for manual intervention while maintaining safety.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The device pre-loads multiple operating modes including MRI-safe configurations into its memory before the MRI scan occurs. When MRI conditions are detected, the control unit quickly switches to the pre-prepared MRI mode, avoiding the need for time-consuming reprogramming during the scan.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If manual reprogramming is performed before MRI scans, then safety during MRI is improved, but the time required for preparation and follow-up reprogramming increases

Engineering Contradiction:
Improvesafety during MRIVSAvoidreprogramming time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The device automatically detects MRI conditions through sensors and autonomously switches to MRI-safe operating modes without requiring external reprogramming. The control unit monitors for MRI environments and self-adjusts device parameters, eliminating the need for manual intervention while maintaining safety.

Inventive Principle:
Principle #25Self-service

3Ease of operation

If fixed control programs are used, then device operation is simplified, but the device cannot adapt to changing patient conditions or MRI requirements

Engineering Contradiction:
Improveoperation simplicityVSAvoidadaptability to conditions
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The device employs multiple programmable control modes stored in memory that can be dynamically selected based on detected conditions. The control unit automatically transitions between different operating modes (e.g., normal mode, MRI mode, tachycardia mode) depending on the physiological state or environmental conditions, providing both simplicity and adaptability.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The device continuously monitors physiological parameters and environmental conditions through sensors, and uses this feedback to automatically adjust operating parameters or switch between pre-programmed modes. This closed-loop system maintains simplicity while adapting to changing conditions.

Inventive Principle:
Principle #23Feedback

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

Enables safe operation of implantable devices during MRI scans without the need for pre-examination reprogramming, ensuring consistent safety over time by automatically adjusting settings based on patient-specific conditions and reducing the risk of arrhythmia induction.

Implementation Method 1

an MRI sensor, which is connected to the control unit and which responds to a positioning of the implant (or of a patient with the implant) within or in the immediate vicinity of an MRI device

Methodology Applied
Scientific EffectMagnetic field detection: Magnetic Field

Data Source

PatentUS9867983B2Active implantable device suitable for use in an MRI scanner
Publication Date: 2018.01.16 BIOTRONIK SE & CO KG
  • US9867983B2 patent drawing
  • US9867983B2 patent drawing
  • US9867983B2 patent drawing

AI summary

Embodiments include an implantable device configured to be used in an MRI device, including a control unit, a memory unit, an MRI sensor and a statistics unit. The memory unit includes program information including control programs and/or control parameters that control the function of the control unit, and current state parameters. The MRI sensor is connected to the control unit and responds to a positioning of the implant and/or a patient within or in the immediate vicinity of the MRI device. The statistics unit is connected to the control unit and detects current state parameters present prior to a respective response of the MRI sensor. The control unit selects a control program or control parameters indicated by the state parameters and maintains the control program or control parameters until the MRI sensor indicates a positioning of the implantable device within or in the immediate vicinity of the MRI device.