Remote MRI Certificate Verification for Active Implant Systems

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Solution Overview

Problem

The current process for determining MRI suitability of active implants is time-consuming for both patients and physicians, requiring in-person visits and inefficient administrative actions.

Innovation Solution

A computer-implemented method and system that allows for remote verification and management of MRI-certificate status for active implant systems, utilizing a remote monitoring system to verify compliance and update the certificate status of the implant system.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If the current in-office programming device method is used to verify MRI suitability, then the MRI-certificate can be issued or renewed, but the process is time-consuming for both patients and physicians

Engineering Contradiction:
Improveefficiency of MRI-certificate verificationVSAvoidtime required for MRI suitability verification
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The patent replaces the mechanical in-office programming device with a wireless communication system. The implantable medical device transmits technical data directly to the remote monitoring system via wireless communication, eliminating the need for physical in-person visits and manual data extraction through programming devices. This substitution dramatically reduces the time required for MRI suitability verification while maintaining comprehensive checking capabilities.

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

Solution Approach 2:

The patent introduces a remote monitoring system as an intermediary between the implantable medical device and the certification authority. This intermediary automatically receives, processes, and verifies MRI suitability data from the implantable device, performing the verification function remotely without requiring patient presence at the physician's office. The intermediary streamlines the workflow by consolidating data collection, verification, and certificate management in one automated system.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the patient must present in-person to the doctor for MRI suitability verification, then the doctor can directly assess the implant conditions, but the patient and physician experience inefficient workflow and time loss

Engineering Contradiction:
Improveaccuracy of MRI suitability assessmentVSAvoidconvenience of MRI-certificate process
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The implantable medical device performs self-service by automatically storing and transmitting its own technical data (model, serial number, lead information, impedance values) to the remote monitoring system. This eliminates the need for manual data extraction through programming devices and reduces the burden on both patients and physicians. The device essentially certifies itself by providing all necessary verification data automatically.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The remote monitoring system serves multiple functions: it acts as a data receiver, verification system, certificate manager, and communication hub. By consolidating these functions into a single universal system, the patent eliminates the need for separate in-person visits for data extraction, verification, and certificate issuance, thereby improving convenience while maintaining reliability through comprehensive automated checking.

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

3Reliability

If comprehensive verification of implant conditions is performed to ensure MRI safety, then patient safety is ensured, but the verification process becomes more complex and time-consuming

Engineering Contradiction:
Improvesafety of MRI procedure for implant patientsVSAvoidcomplexity of MRI suitability verification process
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The implantable medical device is pre-configured with all necessary technical data (model information, serial number, lead details, impedance values) stored in its memory before the MRI procedure. This preliminary preparation ensures that when verification is needed, all required information is already available and can be transmitted automatically to the remote monitoring system, eliminating the need for complex real-time assessment procedures during the verification process.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The remote monitoring system automatically receives data from the implantable device, compares it against MRI safety criteria, and provides immediate feedback on MRI suitability. This automated feedback loop performs comprehensive safety checks (impedance verification, lead integrity, device configuration) without requiring complex manual assessment procedures. The system either confirms MRI safety or identifies specific issues that need attention, simplifying the overall verification process while maintaining thorough safety checking.

Inventive Principle:
Principle #23Feedback

Data Source

PatentEP4664474A1Method and system for managing a MRI-certificate of an active implant system
Publication Date: 2025.12.17 BIOTRONIK SE & CO KG
  • EP4664474A1 patent drawingFigure 1
  • EP4664474A1 patent drawingFigure 2
  • EP4664474A1 patent drawing

AI summary

The invention relates to a computer-implemented method for performing an administrative action (18) concerning a MRI-certificate (10) of the active implant system (12), comprising the steps of providing (S1) the active implant system (12), said active implant system (12) comprising an implantable medical device (12a) and electrode leads (12b) connected to the implantable medical device (12a), transmitting (S2) technical and/or medical data (14) acquired by the active implant system (12), in particular via a relay device (28), to a remote monitoring system (16), based on the technical and/or medical data (14) acquired by the active implant system (12), verifying (S3) a MRI-compliance of the active implant system (12), and based on a result of the verification, performing an administrative action (18) concerning the MRI-certificate (10) of the active implant system (12). Furthermore, the invention relates to a system for performing an administrative action (18) concerning a MRI-certificate (10) of the active implant system (12).