Implantable Pulse Generator Electrode Vector Validation
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Solution Overview
Problem
In implantable cardiac rhythm management systems with multiple electrodes, clinicians face challenges in ensuring that only valid electrode pairs are used for pacing, sensing, or shocking, as the complexity of multiple electrodes can lead to confusion and errors if an electrode is missing or non-operational, potentially resulting in inappropriate programming.
Innovation Solution
A medical system that includes an external communication device and an external programmer device configured to interrogate an implantable pulse generator, which automatically detects the presence or absence of electrodes on stimulation leads by measuring impedance and provides a listing of valid electrode pairs, preventing the programming of invalid vectors and alerting clinicians to missing or non-operational electrodes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple electrodes are used on stimulation leads to provide flexibility in vector selection, then the adaptability of the system is improved, but the device complexity increases and the difficulty of detecting and measuring electrode presence worsens
Solution Approach 1:
The system performs preliminary detection of electrode presence and configuration status before allowing vector programming. The pulse generator automatically tests each electrode pair and stores the results, so that when the clinician attempts to program a vector, the system has already prepared the validity information to prevent programming errors.
Solution Approach 2:
The system provides feedback to the clinician through the programmer interface, displaying which electrode pairs are valid and which are invalid based on detected electrode presence. This feedback mechanism guides the clinician to select only from valid vectors, preventing programming errors while maintaining the flexibility of multiple electrode options.
2Ease of operation
If the clinician manually programs electrode vectors without automatic validation, then the ease of operation is improved, but the reliability of the system worsens due to potential programming errors
Solution Approach 1:
The system applies preliminary anti-action by detecting invalid electrode configurations and blocking the programming of vectors that would use missing or non-operational electrodes. The pulse generator prevents the programmer from storing invalid vector configurations, thereby counteracting potential programming errors before they can occur.
Solution Approach 2:
The system performs self-service by automatically detecting electrode presence and determining valid electrode pairs without requiring manual verification by the clinician. The pulse generator autonomously tests electrodes and provides this information to the programmer, reducing the burden on the clinician while ensuring accuracy.
3Reliability
If the system provides comprehensive electrode detection and validation, then the reliability of electrical stimulation delivery is improved, but the extent of automation required increases the device complexity
Solution Approach 1:
The system segments the electrode detection process into distinct functional modules: impedance measurement circuits test individual electrode pairs, the microprocessor analyzes the results to determine electrode presence, and the programmer interface presents valid vectors to the clinician. This segmentation allows complex automatic detection to be achieved through coordinated simpler subsystems.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system effectively reduces programming errors by ensuring only valid electrode pairs are used, thereby preventing the use of missing or non-functional electrodes, enhancing the reliability and safety of electrical stimulation delivery in cardiac rhythm management systems.
Implementation Method 1
delivering a series of sub-threshold pulses of current and measuring impedance and determining if the measured impedance falls within a predefined range of impedance values
Data Source
AI summary
In one aspect a system includes an external communication device configured to interrogate a pulse generator, an external programmer device communicatively coupled to the external communication device; the external programmer device configured to receive a listing of valid electrode pairs from the pulse generator through the external communication device, the external programmer device configured to prevent a pacing, sensing, or shocking vector from being programmed by the user if a pair of electrodes needed for the vector are not included within the listing of valid electrode pairs. In another aspect a system includes an implantable medical device configured to detect the presence or absence of electrodes on an implanted stimulation lead coupled to the implantable medical device and to generate a valid electrode pair listing, the implantable medical device configured to compare the programmed electrode pairs with the valid electrode pair listing and to execute a corrective action procedure if one or more of the programmed electrode pairs are not included within the valid electrode pair listing. Other embodiments are also included herein.