Leadless Pacemaker ROM Fallback for RAM Corruption
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Solution Overview
Problem
Implantable medical devices, particularly leadless pacemakers, face challenges in maintaining complex functionalities while ensuring longevity and safely managing worst-case reset conditions, which can lead to suboptimal or unsafe therapy delivery, especially in multi-device systems.
Innovation Solution
The device incorporates a processor that switches to ROM-based operation in case of irreparable RAM corruption, using a state element and ROM sub-unit to determine therapy output, ensuring safe and reliable therapy delivery even in worst-case scenarios.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If the device uses a small battery capacity due to highly restricted device size, then the device can be miniaturized for intracardiac implantation, but the device longevity is reduced
Solution Approach 1:
The patent changes the operational parameters of the device by switching from RAM-based operation to ROM-based operation during worst-case reset conditions. This parameter change allows the device to maintain functionality with reduced power consumption, thereby extending device longevity without increasing device size or battery capacity.
2Adaptability or versatility
If the device supports complex functionalities in a small form factor, then the device can provide comprehensive cardiac pacing and monitoring, but the device complexity increases
Solution Approach 1:
The patent segments the memory system into separate ROM and RAM components, each serving distinct functions. The ROM stores critical pacing algorithms and safety fallback behaviors, while the RAM stores patient-specific programming and operational data. This segmentation allows the device to maintain complex functionalities through modular organization, reducing overall device complexity by separating permanent algorithms from variable data.
3Reliability
If the device administers high amplitude long pulse width pacing output during worst-case resets, then the therapy effectiveness is improved, but the energy demand increases
Solution Approach 1:
The patent changes the pacing output parameters (amplitude and pulse width) based on the operational mode. During normal operation, the device uses patient-specific parameters from RAM. During worst-case reset conditions, the device switches to pre-defined safe fallback parameters stored in ROM, which are optimized to balance therapy effectiveness with reduced energy demand, preventing excessive energy consumption while maintaining reliable pacing.
4Reliability
If the device uses ROM-based operation during worst-case resets, then the therapy delivery safety is improved, but the adaptability to patient-specific needs is reduced
Solution Approach 1:
The patent applies preliminary action by pre-storing safe fallback pacing algorithms and parameters in the ROM memory before any corruption occurs. These pre-defined algorithms include conservative pacing parameters that ensure patient safety during worst-case reset conditions. This preliminary preparation allows the device to quickly switch to safe operation without needing to re-adapt to patient-specific needs, thereby maintaining both safety and basic adaptability.
Data Source
AI summary
An implantable medical device, for example an implantable leadless pacemaker, is disclosed comprising a processor, a therapy signal generator, for example a pacing signal generator, as well as a communication unit and a memory unit, wherein the memory unit is configured to exchange data with the processor, wherein the memory unit comprises a ROM sub-unit, a second memory sub-unit and a state element, wherein the state element is configured to be set to one state of a first state and at least one second state, wherein the second memory sub-unit comprises a RAM, wherein the communication unit is configured to receive information comprising a state input information from an external computing device and to transmit at least one data corresponding to this information to the processor, wherein the processor is configured to set the state of the state element.