Artificial Heart Valves Accelerated Fatigue Life Testing

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Artificial heart valve accelerated fatigue life test is to simulate the long-term cyclical load of the valve in the physiological environment of the human body, and predict its durability after implantation through accelerated experiments. With the rapid development of biomedical engineering technology, artificial heart valves have become the preferred solution for the treatment of severe heart valve diseases, and valves need to withstand about 40 million opening and closing cycles per year in the human body, which means that valves with a design life of 25 years must withstand more than 1 billion fatigue loads. The test can complete the fatigue assessment equivalent to decades of clinical use in a matter of weeks through an accelerated mechanism under laboratory conditions, providing critical data support for product design validation, material selection and process optimization. At the level of clinical application, this test is directly related to the safety and quality of life of patients, and any leaflet tear, stent rupture or connector failure can lead to catastrophic consequences, so regulatory agencies in various countries have listed this test as a mandatory verification item that must be passed before artificial heart valve products can be marketed.

Inspection items and scope

The accelerated fatigue life test of artificial heart valves covers several key detection dimensions: first, the valve fatigue performance test, which mainly evaluates the tear resistance and deformation characteristics of the valve material during the periodic opening and closing of the valve; The second is the structural integrity test of the support, which focuses on monitoring the fatigue strength of the support structure under long-term alternating stress. The durability test of the suture ring is also included to verify the mechanical reliability of the connection between the suture ring and the valve body. The test scope should cover common types such as aortic valves and mitral valves of different specifications, and the test conditions should simulate physiological temperature (37±2°C), pulsation frequency (corresponding to heart rate 60-120 beats/min) and pressure differential environment. For the two-leaf mechanical valve, the wear characteristics of the blade pivot mechanism need to be additionally tested, while for the biological valve, the calcification trend of the tissue material and the degradation of collagen fibers need to be focused.

Testing instruments and equipment

Implementing the accelerated fatigue life test of artificial heart valves requires a professional testing platform: the core equipment is the cardiovascular valve fatigue test system, which usually consists of a pulsating flow generator, a test chamber, a pressure sensor, a flow meter and a temperature control unit. The pulsating flow generator needs to be able to produce cardiac output (usually 2-7L/min) that conforms to the physiological waveform, and the test chamber needs to be transparent to observe the valve motion in real time. Supporting instruments include high-frequency pressure sensors (measuring range -50 to 300 mmHg with an accuracy ±1%), laser displacement sensors (monitoring valve leaf microdeformations), and high-resolution high-speed camera systems (recording valve dynamics). The environmental simulation unit needs to maintain the test solution (usually a mixture of saline and glycerol) at a constant temperature of 37°C, and is equipped with bubble detection and elimination devices to ensure test safety. The data acquisition system should have multi-channel synchronous acquisition capability, and the sampling frequency should not be less than 1kHz.

Importance of Accelerated Fatigue Life Testing for Artificial Heart Valves

Standard testing methods and processes

The standard testing process follows strict protocols: the system is first calibrated to verify the accuracy of the pressure and flow sensors and confirm that the viscosity of the test liquid meets the requirements (about 3.5 cP). Install the valve under test into the test chamber to ensure it is in a physiologically anatomical position and to remove air bubbles in the chamber. After starting the system, the test frequency is increased according to the stages, and the initial stage is run for 24 hours at 600-800 times/min as the running-in period, and then gradually increases to the accelerated test frequency of 1200-1500 times/minute. Shutdown checks every 24 hours during testing, including visual inspection of lobe integrity, measurement of pressure gradient changes, recording of effective orifice area (EOA) and other parameters. Detailed functional evaluation is required every 50 million cycles, including static leak testing and dynamic performance analysis. The entire test cycle needs to be continued until 400 million cycles (equivalent to 10 years of clinical use) or functional failure occurs, and all abnormalities need to be recorded as the number of cycles and failure mode at the time of occurrence.

Relevant technical standards and specifications

Artificial heart valve accelerated fatigue life testing must strictly follow international common technical standards: ISO 5840-1 "Cardiovascular Implants - Heart Valve Prostheses" is the core guiding standard, which details the acceleration factor calculation method, test medium requirements and acceptance criteria for fatigue testing. ISO 5840-3 specifically sets out supplementary testing requirements for transcatheter implantable heart valves. The U.S. Food and Drug Administration (FDA) guideline document requires a test sample size of no less than 6 and the test duration should be equivalent to 380 million cycles (corresponding to 10 years of clinical use).

The European standard EN 12006-3 specifies the calibration methods and validation procedures for test systems.

In addition, ASTM F1842 provides a standard method for evaluating valve hydrodynamic properties, while ISO 5910 sets out specific technical requirements for fatigue testing equipment for cardiovascular implants. Together, these standards form a complete system of technical specifications, ensuring that the test results are scientific and comparable.

Criteria for judging test results

The test results are judged based on multi-dimensional performance indicators: the primary criterion is structural integrity, which requires that there is no tear, perforation or delamination of the valve leaf after the test is completed, no cracks or permanent deformation of the bracket structure, and no loosening of the connection part. In terms of functional performance, the added value of steady-state leakage shall not exceed 50% of the initial value, the average translobe pressure difference shall not exceed 25% of the initial value, and the effective orifice area (EOA) decrease shall be controlled within 15%. For mechanical lobes, the change of blade motion should be within the range of ±5°, and there is no jamming. biological valves need to meet the tissue degeneration requirements of less than 10% of the calcified area. Failure criteria include visible impairment affecting function, a sudden increase in pressure gradient of more than 50%, a reflux fraction greater than 20%, or a clinically unacceptable hemolytic marker (plasma hemoglobin >10 mg/dL). The final test report should include individual data and statistical analysis of all samples, demonstrating a 95% confidence level over the target lifetime.

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