Automated Cardiac Screening System for S-ICD Patient Selection
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for screening patients for implantable cardiac stimulation devices are time-consuming and cumbersome, particularly the pre-screening tool for the S-ICD System, which requires manual comparison of ECGs to printed shapes, necessitating a more efficient and automated approach.
Innovation Solution
An automated screening system using cutaneous electrodes to capture cardiac signals, employing multiple methods for calculating heart rates, including surface ECG analysis, pulse oximetry, blood pressure monitoring, and heart sound analysis, to determine patient suitability for implantable devices by comparing rates from different analysis methods and adjusting electrode placement or patient posture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If manual comparison of ECGs to printed shapes is used for screening, then screening accuracy can be maintained through visual inspection, but screening time is significantly increased and the process becomes cumbersome
Solution Approach 1:
The patent replaces the manual visual inspection process with an automated computational system. The screening device uses operational circuitry to automatically calculate beat rates from ECG signals and compare them to reference values, eliminating the need for manual visual comparison of ECGs to printed shapes. This substitution of mechanical/manual operations with automated electronic processing resolves the contradiction by maintaining accuracy through systematic calculation while dramatically reducing screening time.
Solution Approach 2:
The screening device performs self-assessment by automatically analyzing its own captured ECG signals without requiring external manual intervention. The operational circuitry independently calculates beat rates, compares them to predetermined criteria, and determines screening results autonomously. This self-service capability allows the system to maintain high accuracy through consistent automated processing while eliminating the time loss associated with manual screening procedures.
2Measurement precision
If multiple methods are used to calculate beat rate for accurate screening, then screening accuracy is improved, but device complexity increases
Solution Approach 1:
The screening device incorporates multiple beat rate calculation methods within a single universal system. The operational circuitry can select from various algorithms including R-wave detection, QRS complex analysis, and other ECG feature-based methods. This multi-functional approach allows the device to maintain high measurement accuracy by choosing the most appropriate method for each patient's specific ECG characteristics without requiring separate dedicated devices for each method, thus managing complexity through integration.
Solution Approach 2:
The device manages complexity by dynamically changing operational parameters based on the specific ECG signal characteristics. The system can adjust which calculation method is used, modify filtering parameters, and change analysis thresholds according to the detected signal quality and patient-specific features. This parameter adaptability allows accurate beat rate measurement across diverse patient populations while keeping the device design flexible rather than requiring fixed complex hardware for every possible scenario.
3Productivity
If automated screening is implemented, then screening efficiency and productivity are improved, but the extent of automation requires validation to ensure reliability
Solution Approach 1:
The screening device incorporates feedback mechanisms where the automated system's beat rate calculations are validated against predetermined clinical criteria and reference ranges. The operational circuitry compares calculated beat rates to expected physiological ranges and can flag anomalies for review. This feedback loop ensures that automated screening maintains high productivity while preserving reliability by systematically verifying results against established medical standards before final determination.
Solution Approach 2:
The device performs preliminary validation of automated screening results by comparing calculated beat rates against predetermined criteria before finalizing the screening outcome. This preliminary action includes checking whether calculated values fall within expected ranges, verifying signal quality thresholds are met, and preparing results for clinical interpretation. By performing these validation steps automatically as part of the screening process, the system maintains high productivity while ensuring reliability through systematic pre-validation of automated results.
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 significantly reduces screening time by automating the comparison of cardiac rates from different methods, providing a quicker and more accurate assessment of patient suitability for implantable devices, potentially reducing the need for manual screening.
Implementation Method 1
applying a set of cutaneous electrodes on a patient to transcutaneously capture a cardiac signal
Data Source
AI summary
Automated pre-implant screening for candidate recipients of implantable medical devices. A set of cutaneous electrodes placed on a patient transcutaneously capture a cardiac signal using a screening device coupled to the electrodes. A first beat rate may be determined by identifying individual R-waves, QRS complexes or cardiac cycles from the captured cardiac signal using the cutaneous electrodes. A second beat rate may be calculated using one of several different methods, for example, by optical measurement, by monitoring heart sounds, by a second electric cardiac signal analysis, or by using an implanted device. The rates are compared to one another and, if a match is identified, the patient is deemed well suited to receive a particular device.