Bioreactor for intravascular stent degradation and fatigue performance test and test method thereof

Abstract

The invention discloses a bioreactor for intravascular stent degradation and fatigue performance test and a test method thereof. The bioreactor comprises a biofermentation tank, wherein a first inletof the biofermentation tank is sequentially connected with one ends of a culture cavity, a loop test device, a four-way valve and a three-way valve through a pulse flowing pipeline; the rest two endsof the three-way valve are respectively connected with one ends of a metering pump and a peristaltic pump through the pulse flow pipeline; the pulse flow pipeline arranged at the other ends of the metering pump and the peristaltic pump are connected to the biofermentation tank through the four-way valve; a vascular substitute is arranged in the culture cavity; the two ends of the vascular substitute are respectively connected with the biofermentation tank and a first loop test device; an intravascular stent is arranged inside the vascular substitute. The metering pump and the peristaltic pumpare used for providing pulse flow for the intravascular stent in vitro degradation experiments and fatigue test; the biofermentation tank is used for providing a fluid environment more similar to theenvironment inside the body, so that the in vitro degradation and fatigue performance test of the intravascular stent at different blood pressure pulse features and flow rates can be realized.

Description

technical field [0001] The invention belongs to the technical field of medical devices, and in particular relates to a bioreactor for testing vascular stent degradation and fatigue performance and a testing method thereof. Background technique [0002] Coronary atherosclerosis can cause stenosis or blockage of the vascular lumen, resulting in heart disease caused by myocardial ischemia, hypoxia or necrosis, namely "coronary heart disease". Cardiovascular and cerebrovascular diseases have been recognized all over the world as one of the most serious diseases that endanger people's life and health, and the morbidity and mortality of coronary heart disease rank first among all kinds of diseases. Vascular stent implantation is an effective and common method for the treatment of coronary heart disease. [0003] With the rapid development of science and technology, vascular stents have mainly experienced the development process of bare metal stents, drug-loaded stents and degrada...

AI Technical Summary

Problems solved by technology

Functional effect: The change of flow and pressure with time is approximately a sinusoidal function, and the flow Q t =(A sin(ωt)+A)+Q m (Q t is the flow rate at a certain moment; ΔQ=2A is the flow difference; Q m For a steady flow, the average flow ), pressure P t =(B sin(ωt)+B)+P m (P t is the pressure at a certain moment; ΔP=2B is the pulse pressure, P m For stable pulse pressure, the average pulse pressure ), the pulsation source adopted by the above device cannot adjust the average flow at the same time Stable pulse pressure P m and pulse pressure ΔP, resulting in the adjustment of the sine function unable to meet the test requirements; the increase of the pulsation frequency, due to the hysteresis of the low pressure of the loop, will cause the next cycle of pulsation to start when the low pressure of the loop does not reach the predetermined value, which cannot meet the requirements of the corrosion test. Pressure requirements, so the above devices cannot simulate accelerated corrosion tests at high frequencies; the above devices are only tested for a single support, and cannot simultaneously achieve independent adjustment of multi-channel flow and pressure characteristics

Therefore, although the above devices can generate pulsating flow, they cannot meet the matching requirements of the stent for pulse pressure, stable pulse pressure, and average flow rate, and cannot achieve multi-channel independent adjustment and high-frequency testing requirements.

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