Implantable Medical Device Exposure Mode Adaptation for MRI Fields
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Solution Overview
Problem
Implantable medical devices (IMDs) face improper operation, damage, and thermal injury due to exposure to disruptive energy fields during medical procedures like MRI scans, leading to incorrect therapy delivery and tissue heating.
Innovation Solution
IMDs automatically determine parameters for an exposure operating mode based on stored information about sensed physiological events and therapy, allowing them to adapt their functionality to minimize disruptive energy field interference.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the IMD operates in a disruptive energy field without parameter adaptation, then the device structure remains simple, but the reliability deteriorates due to improper operation and incorrect therapy delivery
Solution Approach 1:
The patent pre-configures multiple operating modes (first operating mode for normal operation, second operating mode for disruptive energy field exposure) before the IMD is exposed to disruptive energy fields. The device automatically transitions between these pre-defined modes based on detected conditions, eliminating the need for complex real-time parameter calculations during exposure.
Solution Approach 2:
The IMD automatically detects exposure to disruptive energy fields and self-transitions to the appropriate operating mode without requiring external programming or manual intervention. The device monitors its own operational parameters and autonomously adjusts its configuration to maintain proper function during exposure.
2Adaptability or versatility
If the IMD uses fixed operating parameters, then the ease of operation is improved, but the adaptability deteriorates when exposed to different disruptive energy field conditions
Solution Approach 1:
The patent implements dynamic operating modes that automatically adjust device parameters based on the detected disruptive energy field conditions. The IMD transitions between a first operating mode (for normal conditions) and a second operating mode (for disruptive energy field exposure), with parameters such as sensing thresholds and therapy delivery settings being dynamically modified to maintain proper function.
Solution Approach 2:
The device automatically detects exposure conditions and self-configures the appropriate operating parameters without requiring manual programming. The IMD monitors its own operational state and autonomously transitions between operating modes, eliminating the need for clinicians to manually reprogram the device before each exposure.
3Reliability
If the IMD delivers therapy based on induced energy detection, then the sensing function is active, but the harmful factors increase due to incorrect therapy delivery
Solution Approach 1:
The patent pre-configures the second operating mode with specific parameters designed to prevent incorrect therapy delivery during disruptive energy field exposure. Before exposure occurs, the device is programmed with adjusted sensing thresholds and therapy delivery criteria that account for the presence of induced energy, ensuring that therapy is only delivered when truly indicated.
Solution Approach 2:
The IMD continuously monitors physiological signals and compares them against adjusted thresholds specific to the second operating mode. The device uses feedback from the sensed signals to determine whether therapy delivery is appropriate, taking into account the presence of disruptive energy fields and adjusting its response accordingly to avoid inappropriate therapy.
4Object-affected harmful factors
If the IMD operates with standard parameters during exposure, then the device complexity is low, but the temperature increases causing thermal damage to adjacent tissue
Solution Approach 1:
The patent pre-configures the second operating mode with parameters specifically designed to minimize thermal effects during disruptive energy field exposure. Before exposure occurs, the device adjusts parameters such as pulse width, amplitude, and duty cycle to reduce the risk of tissue heating and thermal damage to adjacent structures.
Solution Approach 2:
The IMD dynamically adjusts its therapy delivery parameters when transitioning to the second operating mode during disruptive energy field exposure. The device modifies stimulation characteristics in real-time to minimize energy deposition and reduce the risk of thermal effects, with parameters being actively controlled rather than fixed.
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 adaptation reduces the risk of improper therapy delivery and tissue damage by configuring the IMD to operate more effectively in disruptive energy fields, enhancing safety and reducing the need for manual programming.
Implementation Method 1
The IMD may be exposed to the disruptive energy field for any of a number of reasons. For example, one or more medical procedures may need to be performed on the patient within which the IMD is implanted for purposes of diagnostics or therapy. For example, the patient may need to have a magnetic resonance imaging (MRI) scan
Implementation Method 2
The disruptive energy field may induce energy on one or more of the implantable leads coupled to the IMD. The IMD may inappropriately detect the induced energy on the leads as physiological signals.
Data Source
AI summary
An implantable medical device (IMD) automatically determines at least a portion of the parameters and, in some instances all of the parameters, of an exposure operating mode based on stored information regarding sensed physiological events or therapy provided over a predetermined period of time. The IMD may configure itself to operate in accordance with the automatically determined parameters of the exposure operating mode in response to detecting a disruptive energy field. Alternatively, the IMD may provide the automatically determined parameters of the exposure operating mode to a physician as suggested or recommended parameters for the exposure operating mode. In other instances, the automatically determined parameters may be compared to parameters received manually via telemetry and, if differences exist or occur, a physician or patient may be notified and/or the manual parameters may be overridden by the automatically determined parameters.