Implantable Device Composite Index for Clinical Status Assessment
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Solution Overview
Problem
Medical practitioners lack a convenient and objective tool to assess the effectiveness of multisite pacing therapy on patient exercise performance status between routine visits, relying on subjective patient reports or clinical tests that provide limited retrospective insights.
Innovation Solution
A multisite active implantable medical device equipped with both physiologic and physical sensors that analyze and memorize data to generate a composite index of clinical status, allowing for objective evaluation of patient exercise performance over time, using multiple linearization and threshold-based segmentation to identify significant changes in metabolic and activity parameters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If medical practitioners rely on subjective patient reports or clinical tests to assess therapy effectiveness, then patient exercise performance status can be evaluated, but the assessment lacks objectivity and provides limited retrospective insights
Solution Approach 1:
The device continuously collects and stores physiological data (ventilation, activity level, heart rate) in memory before practitioner visits occur. This preliminary data accumulation enables objective retrospective assessment of patient status evolution between visits, eliminating the need to rely solely on subjective patient reports at the time of evaluation.
Solution Approach 2:
The device provides automated feedback to practitioners through generated reports that objectively present collected physiological data. This feedback mechanism transforms subjective patient reports into objective measured data, allowing practitioners to assess therapy effectiveness with precision and gain retrospective insights into patient status changes over time.
2Adaptability or versatility
If a multisite device uses both physiologic and physical sensors to assess patient status, then comprehensive data on metabolic needs and activity level is obtained, but the device complexity increases
Solution Approach 1:
The device merges physiologic sensors (measuring ventilation, heart rate) with physical sensors (measuring activity level, acceleration) into a single integrated system. This combination allows comprehensive assessment of both metabolic needs and physical activity simultaneously, enabling the device to adapt pacing rate responses to multiple physiological parameters without requiring separate independent systems.
Solution Approach 2:
The sensor system is designed with multi-functionality, where the same sensor array serves multiple purposes: assessing metabolic needs, monitoring activity level, detecting patient status changes, and providing data for therapy adjustment. This universal approach reduces overall system complexity compared to having separate specialized systems for each function.
3Measurement precision
If the device continuously monitors and analyzes patient data between visits, then objective assessment of clinical status evolution is enabled, but the data processing and analysis complexity increases
Solution Approach 1:
The data analysis process is segmented into distinct functional modules: data collection from sensors, data storage in memory, automated analysis algorithms, and report generation. This segmentation allows complex continuous monitoring to be broken down into manageable processing stages, reducing overall analysis complexity while maintaining precise clinical status assessment capability.
Solution Approach 2:
The device performs self-service through automated data analysis and report generation without requiring external intervention between visits. The embedded algorithms automatically process collected physiological data, identify clinically significant changes, and generate assessment reports, reducing the burden on practitioners while providing continuous objective monitoring of patient status evolution.
Data Source
AI summary
An active implantable medical device, preferably a device for pacing, resynchronization, defibrillation and/or cardioversion of a patient, that includes functionality that assists in the diagnosis of the patient's clinical status. This devices comprises circuits (10, 12) for measuring one physiologic parameter, preferably minute ventilation (VE), and circuits (14, 16) for measuring a physical parameter, preferably acceleration (G), control logic (18) for discriminating between activity and rest phases of the patient, and analysis circuits (20-28), to process and combine these signals and memorize (store in memory) the obtained results in the form of a data history. The analysis will establish characteristics providing, for successive dates, representative values, for a given period of time, of the physical signal and physiologic signal during activity phases of the patient, and/or of the physiologic signal during rest phases. These circuits search for remarkable dates for each of the characteristics and allocate specific indices of clinical status respective to each of the periods comprised between the remarkable dates, then combined the specific thus obtained into one single composite index.