External Device Handling Improper IMD Data
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Solution Overview
Problem
Implantable medical devices (IMDs) face challenges in handling unexpected or corrupted data due to alpha particle radiation, which can flip memory bits and corrupt therapeutic settings or other stored data, leading to inconsistent and unsafe device states.
Innovation Solution
An external device system is configured to communicate with the IMD, determining improper device parameter values and automatically re-programming them with substitute values or purging non-programmable data to maintain a consistent and safe state, by comparing values against allowable ranges or lists and re-programming therapy and sensing parameters as needed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If data is stored in IMD memory, then device functionality is maintained, but data corruption occurs due to alpha particle radiation flipping memory bits
Solution Approach 1:
The patent applies preliminary action by implementing error detection and correction codes during the data storage phase. These codes are预先 embedded in the memory system to detect and correct bit flips caused by alpha particle radiation before they can corrupt therapeutic settings, thereby maintaining data integrity without requiring external intervention.
Solution Approach 2:
The patent introduces an intermediary layer of redundancy and verification mechanisms between the memory bits and the therapeutic settings. This intermediary system uses parity bits, checksums, or more advanced error correction codes to mediate the effect of radiation-induced bit flips, ensuring that corrupted data does not propagate to critical device parameters.
2Reliability
If device parameters are automatically corrected, then device safety is improved, but complexity of data handling increases
Solution Approach 1:
The patent implements self-service by enabling the IMD to automatically detect, flag, and correct corrupted data without requiring external programmer intervention. The device monitors its own memory integrity, identifies bit flips through error detection codes, and triggers automatic correction protocols or safe-state transitions, thereby maintaining safety while managing complexity through automation.
Solution Approach 2:
The patent applies parameter changes by dynamically adjusting device operational parameters based on detected data integrity issues. When corruption is detected, the system automatically modifies parameters such as therapy delivery settings, memory access patterns, or error correction thresholds to maintain safe operation, thereby improving reliability through adaptive parameter management.
3Measurement precision
If corrupted data is detected and corrected, then data accuracy is improved, but processing time increases
Solution Approach 1:
The patent applies preliminary action by pre-calculating and storing error correction codes alongside data during the writing phase. This preliminary encoding allows for rapid detection and correction during reading, as the correction logic is already embedded in the stored data structure, minimizing additional processing time while maintaining high data accuracy.
Solution Approach 2:
The patent replaces complex mechanical or manual data verification processes with electronic error detection and correction circuits. By substituting hardware-based parity checks and correction logic for slower software-based or manual verification methods, the system achieves both high data accuracy and fast processing speeds suitable for implantable device operations.
Data Source
AI summary
A system and method for handling data received from an implantable medical device (IMD) is provided. The method includes communicating a device parameter value of an IMD device parameter from the IMD to an external device and determining, at the external device, that the communicated device parameter value is at an improper value. Additionally, in response to the determining that the communicated device parameter value is at an improper value, automatically performing at least one of re-programming the IMD device parameter with a selected substitute device parameter value, ignoring, or purging non-programmable data.