IMD Exposure Mode Configuration for MRI Safety
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Solution Overview
Problem
Implantable medical devices (IMDs) face operational issues and tissue damage due to exposure to disruptive energy fields from medical procedures like MRI scans, leading to improper therapy delivery and tissue heating, as they inappropriately detect induced energy as physiological signals or fail to detect actual signals.
Innovation Solution
The IMD is selectively configurable to operate in an exposure mode, supporting manual, automatic, or semi-automatic options for enabling and disabling this mode, allowing flexibility in clinical workflows and reducing adverse effects from disruptive energy fields.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the IMD operates in normal mode during exposure to disruptive energy fields, then the device maintains full functionality for therapy delivery and signal detection, but the device may inappropriately detect induced energy as physiological signals or fail to detect actual signals, leading to improper therapy delivery
Solution Approach 1:
The IMD dynamically switches between normal operating mode and exposure operating mode based on detection of disruptive energy fields. The device transitions from full functionality to modified functionality automatically, allowing it to adapt to changing environmental conditions while maintaining reliability through mode-specific operational characteristics
Solution Approach 2:
The device changes its operational parameters by switching between different operating modes. In exposure mode, the IMD modifies its signal detection thresholds, therapy delivery parameters, and operational characteristics to account for the presence of disruptive energy fields, thereby maintaining reliable operation under adverse conditions
2Reliability
If the IMD enables exposure operating mode to protect against disruptive energy fields, then the device reduces risk of tissue damage and improper therapy delivery, but the device loses full functionality and requires manual intervention to enable/disable mode
Solution Approach 1:
The IMD automatically detects the presence of disruptive energy fields and self-transitions into exposure operating mode without requiring manual intervention. The device monitors its own operational environment and autonomously adjusts its mode to maintain safety, eliminating the need for user awareness or manual switching while preserving full functionality when safe
3Adaptability or versatility
If the IMD supports multiple programming options for exposure mode, then the device provides flexibility in clinical workflows and user preference accommodation, but the device complexity increases
Solution Approach 1:
The programming options are segmented into distinct categories (manual mode, automatic mode, and hybrid modes with various combinations of automatic enabling/disabling). Each programming option represents a discrete configuration that can be independently selected, allowing clinicians to choose the appropriate level of automation and control without overwhelming complexity
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
This configuration reduces the risk of improper therapy delivery and tissue damage by allowing the IMD to function with reduced or modified functionality during exposure to disruptive energy fields, ensuring more accurate signal detection and safer operation.
Implementation Method 1
The disruptive energy field may induce energy on one or more of the implantable leads coupled to the IMD
Implementation Method 2
the induced energy on the leads may result in stimulation or heating of the tissue and/or nerve site adjacent to the electrodes of the leads or adjacent to the housing of the IMD
Data Source
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AI summary
An IMD is selectively configurable to support a plurality of programming options for enabling and disabling an exposure operating mode of the device. In one example, the IMD may support at least two of a manual exposure mode programming option in which the exposure operating mode is manually enabled and manually disabled, an automatic exposure mode programming option in which the exposure operating mode is automatically enabled and automatically disabled, or a semi-automatic exposure mode programming option in which the exposure operating mode is either automatically enabled and manually disabled or manually enabled and automatically disabled. In this manner, the IMD may support more than one way for enabling and disabling the exposure operating mode to provide flexibility in the clinical workflows associated with programming the IMD into an exposure operating mode for a medical procedure, such as an MRI scan.