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Publication Number
US-12290677-B2
Publication Date
2025-05-06
Expiration Date
Abstract
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.
Core Innovation
An implantable component of a medical device includes read-only memory (ROM) and non-volatile memory (NVM). The implantable component determines that it has experienced a safety critical fault and, in response, purposely corrupts a memory block of the NVM.
After purposely corrupting the memory block, the implantable component automatically forces itself into a locked mode. The locked mode prevents execution of a run-time program stored in the implantable component, and the document describes restart and ROM code execution to validate the NVM, determine whether the NVM is corrupt, and prevent re-execution of the run-time program when the NVM is corrupt.
The document further describes NVM validation that determines corrupt memory blocks, including CRC-based detection of corrupt NVM. When a safety-critical fault is detected during operation, fault information is stored and a dedicated NVM lock memory block is purposely corrupted, and the implant remains in ROM/locked mode until unlocked by a clinician via an external or secondary device with limited NVM read/write access.
Claims Coverage
The relevant claims provided include three independent claims, each centered on a safety response that purposely corrupts an NVM memory block and places the implantable component into a locked mode to prevent execution or re-execution of a run-time program. Across the independent claims, the main inventive features are organized around fault detection using an integrated diagnostic mechanism or runtime execution, intentional NVM corruption, restart and ROM validation of NVM, and locked-mode behavior that prevents run-time program execution.
Purposeful NVM memory block corruption upon detecting a safety critical fault
The implantable component determines that it has experienced a safety critical fault, and in response purposely corrupts a memory block of the non-volatile memory (NVM).
Locked mode that prevents execution of a run-time program
In response to the safety critical fault, the implantable component automatically forces itself into a locked mode, wherein the locked mode prevents execution of a run-time program stored in the implantable component.
Restart and NVM validation with anti-reexecution prevention
An implantable medical device restarts in response to detection of the safety critical fault, initiates a locked mode including validation of the NVM, determines that the NVM is corrupt, and in response prevents re-execution of the run-time program.
Indefinite execution of ROM code when NVM is corrupt
The instructions cause the processor to automatically restart, determine whether the NVM is corrupt, and in response to determining that the NVM is corrupt, indefinitely execute code stored in read-only memory (ROM) of the implantable medical device.
Overall, the independent claims cover detecting a safety critical fault in an implantable medical device, purposely corrupting an NVM memory block, and using restart and ROM-based NVM validation to enter a locked mode that prevents execution or re-execution of a run-time program, including indefinite ROM code execution when NVM is corrupt.
Stated Advantages
Forces the implantable component into a locked mode that prevents execution of a run-time program.
When NVM is corrupt, prevents re-execution of the run-time program.
Indefinitely executes code stored in read-only memory (ROM) when the NVM is corrupt.
Maintains the implant in ROM/locked mode until unlocked by a clinician via an external or secondary device with limited NVM read/write access.
Documented Applications
A cochlear implant example is described, including implant components, safety-critical fault handling, ROM code for validating NVM (including CRC-based corrupt NVM detection), purposely corrupting a dedicated NVM lock memory block, and remaining in ROM/locked mode until clinician unlocking.
The concepts are extended to other implants including spinal cord stimulators.
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