Implantable Medical Device Program Version Restoration
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Solution Overview
Problem
Implantable medical devices face challenges in reverting to previous program versions due to changes in therapy media, electrode configurations, or other state changes, which can lead to errors or ineffective therapy delivery, necessitating a method to assess and restore compatible program versions while ensuring patient safety.
Innovation Solution
The method involves creating and saving restore points based on previous program versions during telemetry sessions, determining compatibility with the current device state, and reverting to a previous program version only if it is safe to do so, ensuring that the therapy medium and configuration are compatible, thereby maintaining therapy efficacy and avoiding potential harm to the patient.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the implantable medical device reverts to a previous program version, then the device can recover from errors or dissatisfaction with current operation, but the device may become incompatible with current therapy media, electrode configurations, or device state changes
Solution Approach 1:
The system performs preliminary compatibility assessment before reverting to a previous program version. The determination step evaluates whether the device can successfully operate with the restored program version by checking compatibility with current therapy media, electrode configurations, and device state, preventing unsafe restorations before they occur
Solution Approach 2:
The patent introduces an external programmer as an intermediary between the implantable medical device and the program version restoration process. The external programmer manages the complexity of compatibility assessment and coordinates the restoration process, acting as a mediator that ensures safe and compatible program version recovery
2Reliability
If the device stores multiple program versions for restoration, then the device can recover from various problematic conditions, but the device complexity and memory requirements increase
Solution Approach 1:
The patent extracts the complex task of managing multiple program versions and their compatibility assessments from the implantable medical device and places it in the external programmer. This allows the implantable device to maintain simpler internal storage while still achieving comprehensive restoration capabilities through the external system's management
3Object-affected harmful factors
If the device automatically reverts to a previous program version upon detecting errors, then patient safety is improved, but the device may revert to an incompatible configuration causing therapy failure
Solution Approach 1:
The system performs preliminary anti-action by assessing compatibility before allowing program version restoration. The determination step proactively identifies and prevents incompatible restorations that would cause therapy failure, countering potential harmful effects before they can occur
Solution Approach 2:
The patent implements feedback mechanisms where the device monitors for problematic conditions and automatically triggers compatibility assessment before restoration. The system receives feedback about device state and therapy delivery status, and uses this feedback to determine whether program version restoration is safe and appropriate
Data Source
AI summary
Various embodiments concern reprogramming an implantable medical device by an external programmer to operate using a second program version, the second program version replacing a first program version in controlling operation of the implantable medical device. It can be determined whether the implantable medical device will be able to operate using the first program version to deliver therapy according to the first program version if the implantable medical device was to revert back to using the first program version. The implantable medical device can then revert to operational programming from the second program version to the first program version, the first program version saved in memory of the implantable medical device as a restore point while the implantable medical device operates according to the second program version between the reprogramming and reverting of the implantable medical device.