Accelerated Heart Valve Testing System
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Solution Overview
Problem
Current methods for accelerated life testing of prosthetic heart valves, as outlined in ISO 5840-3:2013, require extensive testing cycles to ensure durability, which can be time-consuming and may lead to unrepresentative results due to overstress, and lack efficient visualization and adjustment capabilities.
Innovation Solution
The development of a system and method for accelerated life testing of prosthetic heart valves that includes a chamber assembly with adjustable return flow orifices, pressure sensors, and a machine vision system, allowing for high-speed testing, minimal pressure overshoot, and visual observation, while replicating physiological conditions and meeting ISO test requirements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If accelerated life testing is performed with high cycle rates to reduce test duration, then productivity is improved, but measurement precision deteriorates due to overstress and unrepresentative results
Solution Approach 1:
The system dynamically adjusts the pressure waveform in real-time during testing. The computer-controlled pressure source modifies pressure parameters based on feedback from sensors and vision systems, allowing the test to maintain physiological representativeness even at accelerated cycle rates. This dynamic adaptation prevents overstress while achieving faster test completion.
Solution Approach 2:
The system incorporates multiple feedback mechanisms including pressure sensors that monitor transvalvular pressure differentials, vision systems that track valve motion, and computer-controlled adjustments. This closed-loop feedback ensures that accelerated testing maintains physiological accuracy by detecting and correcting deviations from representative valve behavior in real-time.
2Reliability
If traditional pulsatile flow testers are used to meet ISO requirements, then reliability is improved, but loss of time increases due to extended test durations
Solution Approach 1:
The system changes key test parameters including pressure waveform characteristics, cycle frequency, and flow rates to achieve accelerated testing. By carefully controlling these parameter changes while maintaining physiological relationships, the system achieves ISO compliance in shorter durations. The computer-controlled pressure source enables precise parameter manipulation that traditional fixed-parameter testers cannot achieve.
Solution Approach 2:
The system uses periodic pressure waveforms that replicate physiological cardiac cycles but at accelerated frequencies. The pressure source generates repeating pressure patterns that simulate normal heart function, ensuring that each cycle represents a valid physiological event even at higher rates, thereby maintaining reliability while reducing total test time.
3Productivity
If high pressure differentials are applied during testing to accelerate wear, then productivity is improved, but object-generated harmful factors increase due to overstress and artificial failure modes
Solution Approach 1:
The system applies pressure differentials that are partially elevated compared to normal physiological conditions, but not excessively so. The computer-controlled pressure source adjusts pressure to achieve accelerated testing while maintaining pressure gradients that represent actual valve operating conditions, preventing artificial failure modes caused by excessive stress.
Solution Approach 2:
The pressure differential is dynamically adjusted during each cardiac cycle and across different test phases. The system modifies pressure parameters in real-time based on valve position, flow conditions, and accumulated cycle counts, ensuring that acceleration is achieved without sustained overstress that would create artificial failure artifacts.
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 enables efficient, high-speed testing that meets ISO requirements with minimal overstress, allows for visual analysis, and is configurable to simulate physiological conditions, thereby shortening test duration and improving the accuracy of valve durability assessment.
Implementation Method 1
an oscillating fluid pump having an interior volume that is changeable
Implementation Method 2
a first pressure sensor configured to measure a liquid pressure within the proximal interior space and a second pressure sensor configured to measure a liquid pressure within the distal interior space
Data Source
AI summary
This document provides systems and methods for testing of various kinds of valves. For example, this document provides systems and methods for accelerated life testing of prosthetic heart valves.