Medical Device Circuit Leak Testing for Reservoir Bag Compliance
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Solution Overview
Problem
The accuracy of leak testing in medical device circuits is uncertain due to varying deformation characteristics of reservoir bags, which affect pressure changes during the pressure decay process.
Innovation Solution
A method for leak testing that determines the compliance characteristic of a reservoir bag, adjusts the wait time based on this characteristic, and measures pressure changes before and after the wait time to accurately assess leaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the pressure decay method is used for leak testing in circuits with different reservoir bags, then the testing process is simplified, but the accuracy of test results deteriorates due to varying compliance characteristics
Solution Approach 1:
The patent changes the testing parameters (wait time, pressurization level) based on the measured compliance characteristics of the reservoir bag. By dynamically adjusting these parameters rather than using fixed values, the system maintains high accuracy across different reservoir bag types while keeping the testing process straightforward.
Solution Approach 2:
The patent performs a preliminary compliance test on the reservoir bag before conducting the leak test. This preliminary measurement of compliance characteristics allows the system to adapt subsequent testing parameters to match the specific reservoir bag being tested, ensuring accurate results without requiring manual configuration.
2Device complexity
If a fixed wait time is used in the pressure decay method, then the testing procedure is standardized, but the reliability of test results deteriorates due to different deformation characteristics of various reservoir bags
Solution Approach 1:
The patent makes the wait time dynamic by calculating it based on the measured compliance characteristics of the reservoir bag. Instead of using a fixed predetermined wait time, the system adjusts the wait time to match the specific deformation behavior of each reservoir bag, thereby improving reliability while maintaining procedural simplicity through automated calculation.
3Adaptability or versatility
If additional system software configuration is performed for different reservoir bags, then the adaptability to different reservoir bag types is improved, but the device complexity increases
Solution Approach 1:
The patent enables the testing system to automatically determine the reservoir bag's compliance characteristics and adjust testing parameters without requiring manual software configuration. The system serves itself by measuring and adapting to different reservoir bag types through automated compliance testing and parameter calculation, thereby maintaining high adaptability while minimizing user burden and complexity.
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 method adapts to different reservoir bags, ensuring accurate and reliable leak testing results without additional system software configuration, enhancing safety and performance of medical devices.
Implementation Method 1
different reservoir bags have different deformation characteristics (or compliance characteristics) after being pressurized
Data Source
AI summary
The present disclosure relates to the technical field of medical devices, and in particular to a method for leak testing in a circuit of a medical device, a device, and a storage medium, the circuit including a reservoir bag, the method including: pressurizing the circuit; determining a compliance characteristic of the reservoir bag; stopping pressurizing the circuit, and determining a wait time of the circuit on the basis of the compliance characteristic of the reservoir bag; and determining a change in gas pressure in the circuit before and after the wait time, thereby testing whether the circuit is leaking.