Implantable Medical Device Lead Integrity Report
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Solution Overview
Problem
Implantable medical devices face challenges in diagnosing potential conditions with electrode leads due to intermittent or continuous changes in lead impedance, which can affect sensing and stimulation integrity, and existing solutions do not provide a comprehensive and clinically actionable report for such conditions.
Innovation Solution
A method and system that combine impedance trend data with additional diagnostic data, such as non-sustained episode and sensing integrity data, into a single report to indicate possible conditions with the electrode lead, allowing for clinically actionable information to be provided to users.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple separate diagnostic data sets (impedance trends, non-sustained episodes, sensing integrity counts) are monitored separately, then comprehensive diagnostic information is collected, but the complexity of analyzing and interpreting lead conditions increases
Solution Approach 1:
The patent combines multiple separate diagnostic data sets (impedance trend data, non-sustained episode data, sensing integrity count data) into a single integrated lead integrity report. This consolidation maintains comprehensive diagnostic information while simplifying analysis by presenting all relevant data in one unified report with consistent formatting and correlated time stamps, directly resolving the contradiction between diagnostic completeness and report complexity.
2Measurement precision
If detailed diagnostic data is provided for lead conditions, then diagnosis accuracy improves, but the time required to review and interpret the data increases
Solution Approach 1:
The patent pre-processes and organizes diagnostic data before presentation, correlating impedance trends with non-sustained episodes and sensing integrity counts by time stamps, and pre-formatting the integrated report with consistent units and scales. This preliminary organization allows clinicians to review comprehensive diagnostic information efficiently without manual data correlation, resolving the contradiction between diagnostic precision and review time.
3Reliability
If impedance measurements are continuously monitored to detect lead conditions, then lead integrity is better monitored, but energy consumption of the implantable device increases
Solution Approach 1:
The patent implements continuous impedance monitoring with automatic trend analysis that compares current measurements against historical data and thresholds, enabling the device to maintain reliable lead monitoring while managing energy consumption through efficient measurement strategies and intelligent data processing that only flags significant changes for detailed reporting.
Data Source
AI summary
In general, the disclosure relates to techniques for providing a combination of stored diagnostic information, including impedance trend data, into one displayable report that may be used to diagnose a possible condition with an implantable medical electrode lead. One example device includes a processor that is configured to obtain impedance trend data for an electrical path, the electrical path comprising a plurality of electrodes, and to obtain additional diagnostic data that is associated with the electrical path, the additional diagnostic data being distinct from the impedance trend data. The device is further configured to combine both the impedance trend data and the additional diagnostic data into a displayable report that indicates whether there is a possible condition with the electrical path. The additional diagnostic data may include non-sustained episode data, sensing integrity data, pacing threshold, and/or electrogram data (such as P-wave amplitude and/or R-wave amplitude data).