MR Conditional Status Flags in Implantable Medical Devices
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Solution Overview
Problem
Current methods for determining if an implanted medical device is magnetic resonance (MR) conditional are time-consuming, costly, and lack efficient updating, often requiring multiple physician interactions and unnecessary procedures, leading to patients being denied potentially life-saving MRI scans due to uncertainty about the device's safety in MRI environments.
Innovation Solution
Implementing a system where MR conditional status is programmed and updated at the time of implantation or later, with flags indicating the device's safety conditions, and periodically uploading this information to a central database, allowing rapid querying by radiologists to ensure safe MRI procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional methods are used to determine MR conditional status, then physicians can assess device safety, but the process is time-consuming and costly
Solution Approach 1:
The system pre-determines and stores MR conditional status information in the implantable medical device at the time of implantation. This preliminary action eliminates the need for physicians to perform time-consuming assessments later, as the status is already programmed into the device memory.
Solution Approach 2:
The patent creates a digital copy of the MR conditional status information that is stored in the implantable medical device and can be retrieved by radiologists. This copying approach replaces the need for physicians to manually assess and write memos, significantly reducing time requirements.
2Reliability
If physicians manually determine MR conditional status, then accurate assessment is possible, but the process is costly and involves unbillable tasks
Solution Approach 1:
The implantable medical device autonomously stores and provides its own MR conditional status information without requiring physician intervention. The device serves itself by maintaining its safety status in memory and making it available to radiologists through automated queries, eliminating unbillable manual assessment tasks.
Solution Approach 2:
The system establishes a feedback loop where the implantable medical device automatically updates its status information in a central database, which then provides feedback to radiologists. This automated feedback mechanism replaces costly manual communication between physicians and radiologists.
3Stability of the object's composition
If MR conditional status is not updated periodically, then device information remains stable, but the status may not reflect current device state
Solution Approach 1:
The system implements continuous updating of MR conditional status information in the implantable medical device and central database. This continuous action ensures that the status information always reflects the current device state, including any changes from lead replacements or other modifications, while maintaining data consistency through structured storage.
4Reliability
If radiologists call implanting physicians for MR conditional status, then accurate information can be obtained, but it takes up physician staff time and is not billable
Solution Approach 1:
The patent introduces an intermediary system consisting of the implantable medical device's memory and a central database that stores MR conditional status information. This intermediary allows radiologists to access accurate status information directly without contacting implanting physicians, eliminating the time consumption and lack of billing for staff time.
Solution Approach 2:
The system creates a copy of the MR conditional status information that is stored in both the implantable medical device and central database. This copy can be quickly retrieved by radiologists through automated queries, replacing the time-consuming process of calling physicians and manually reviewing their notes.
Data Source
AI summary
A method for determining if an implantable medical device (IMD) in a patient is magnetic resonance conditional. Embodiments include a Home Monitoring Service Center (HMSC) that indicates if the IMD is MR conditional and what those conditions are. The IMD includes memory with flags, enabling a physician to set a flag to “MR conditional” if the IMD is MR conditional, if there are no abandoned leads in the patient, and if there are no other hardware in the patient that are not MR conditionally approved. In embodiments, the flags indicate safe for 1.5 T, 3.0 T, 1.5 & 3.0 T, up to 2 W/Kg, up to 4 W/Kg, with/without exclusion zone, and date flags are set. During home monitoring, the HMSC reads out a status of the MR conditional flags and the date last confirmed. If the patient needs an MRI scan, physician queries HMSC to determine MR conditional status.