Implantable Device Locking for Safety Critical Faults
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Solution Overview
Problem
Existing medical devices lack a robust mechanism to automatically detect and respond to safety critical faults, potentially leading to harmful situations for the device user.
Innovation Solution
The implementation of a method within implantable medical devices to automatically detect safety critical faults, restart the device, and enter a locked mode that prevents execution of the run-time program, ensuring the device operates in a safe state until further assessment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If the device continues operation after a safety critical fault, then productivity is maintained, but safety and reliability deteriorate
Solution Approach 1:
The system performs preliminary validation of the run-time program in non-volatile memory before execution. A safety mechanism checks the integrity of the program stored in non-volatile memory prior to allowing the device to operate, preventing execution of potentially harmful corrupted code while maintaining normal operation when valid
Solution Approach 2:
An intermediary safety mechanism is introduced between the run-time program and the processor. This intermediary validates the program code from non-volatile memory before allowing execution, acting as a mediator that prevents corrupted programs from causing safety issues while allowing legitimate programs to execute normally
2Reliability
If the device enters locked mode after safety critical fault, then reliability improves, but productivity decreases
Solution Approach 1:
The system uses a disposable locked mode state that is easily entered and exited. When a safety critical fault occurs, the device transitions to a locked mode that prevents further execution of the problematic run-time program. This locked state acts as a temporary, easily reversible safety measure that protects the patient while allowing for subsequent clinical evaluation and program reconfiguration
3Reliability
If automatic fault detection and locking is implemented, then safety improves, but device complexity increases
Solution Approach 1:
The device performs self-diagnosis and self-protection through automatic fault detection mechanisms. The implantable component monitors its own operation, detects safety critical faults, and automatically enters locked mode without external intervention. This self-service approach improves safety while minimizing the need for complex external monitoring systems
Data Source
AI summary
Presented herein are techniques for electronically locking an electronic device in response to detection of a safety critical fault. As used herein, a “safety critical fault” is a fault having a potential to cause harm to an individual using the device. In particular, an electronic device in accordance with certain embodiments presented herein is configured to determine when the electronic device has experienced a safety critical fault. In response, the electronic device automatically restarts itself and, following restart, is automatically forced into a locked mode. The locked mode prevents execution of a run-time program stored in the electronic device.