Fail-Safe Mode for Implantable Medical Device Remote Programming
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Solution Overview
Problem
Remote programming of implantable medical devices can result in improper operation due to programming session failures, data corruption, or other adverse events, potentially leading to unnecessary or inappropriate therapies for patients.
Innovation Solution
A fail-safe mode is implemented to prevent improper operation by notifying personnel of session failures, modifying programming parameters to revert to default settings, and delivering therapies to ensure patient safety, including the use of notification devices and processors within the medical device system to invoke fail-safe operations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If remote programming session is initiated to modify therapy parameters, then patient care flexibility is improved, but risk of improper operation due to programming failure increases
Solution Approach 1:
The system performs preliminary actions by creating a reversible copy of programming parameters before making changes. The local programmer stores original parameters and can restore them if the remote programming session fails, preventing improper operation while allowing flexible remote modification.
Solution Approach 2:
The system implements feedback mechanisms where the local programmer monitors the remote programming session and detects failures. When a failure is detected, the system automatically triggers parameter restoration to maintain proper device operation.
2Ease of operation
If programming parameters are modified remotely, then ease of operation is improved, but risk of data corruption increases
Solution Approach 1:
The system creates a copy of the original programming parameters before remote modification. The local programmer stores this backup copy and uses it to restore parameters if data corruption occurs during remote programming, ensuring data integrity while enabling easy remote operation.
Solution Approach 2:
The system prepares protective measures in advance by storing backup parameters before remote programming begins. This cushioning mechanism ensures that if data corruption occurs, the original parameters can be restored, preventing loss of critical information.
3Reliability
If fail-safe operations are implemented to prevent improper operation, then reliability is improved, but device complexity increases
Solution Approach 1:
The local programmer serves as an intermediary between the remote programmer and the implantable medical device. It handles the complex fail-safe operations including parameter backup, failure detection, and restoration, thereby protecting the simple IMD structure while ensuring reliable operation.
Solution Approach 2:
The system implements self-service fail-safe mechanisms where the local programmer automatically detects programming failures and restores parameters without requiring external intervention. This automation maintains reliability while minimizing the need for complex manual procedures.
Data Source
AI summary
In general, the invention is directed to a system with a fail-safe mode for remote programming of medical devices, such as implantable medical devices (IMDs). During a remote programming session, an adverse event, such as a programming session failure, may prevent proper completion of a programming or result in improper programming due to data corruption or other factors. If a programming session is not completed correctly, the IMD is susceptible to improper operation, possibly exposing a patient to delivery of unnecessary or inappropriate therapies. A fail-safe mode reduces the likelihood of improper operation following a programming session failure. The fail-safe mode defines one or more fail-safe operations designed to preserve proper operation of the IMD. In some embodiments, the fail-safe operations include notifying a person concerning the failure of the programming session, modifying programming parameters within the implantable medical device, and delivering a therapy to a patient.