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

A fatigue performance testing and bioreactor technology, applied in the field of medical devices, can solve the problems of accelerated corrosion testing, inability to adjust at the same time, and inability to achieve independent adjustment of multi-channel flow and pressure characteristics at the same time, so as to solve the low pressure lag and satisfy the test desired effect

Active Publication Date: 2018-05-01
成都格登特科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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 o

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Example 1 Degradation performance test of multi-channel independent regulation under high frequency

[0046] 1. Sterilize the device.

[0047] First multi-way joint 1, first throttle valve 2, blood vessel substitute 4, culture chamber 5, second throttle valve 9, second multi-way joint 10, first four-way valve 11, first three-way valve 12 , back pressure valve 14, filter 15, liquid return bottle 16, second three-way valve 17, second four-way valve 20, third throttle valve 23, pulsating flow pipeline 24, biological fermentation tank 25, shut-off valve 7- 3 Perform high-temperature sterilization at 120°C for 25 minutes; use the pulsating flow pipeline 24 to connect the pressure gauge 13, flow meter 7-1, and pressure transmitter 7-2 in sequence, connect the first metering pump 18 and the second metering pump 19 in parallel and then connect them in series To the loop, start the first metering pump 18 and the second metering pump 19, utilize 75% alcohol to soak and sterilize...

Embodiment 2

[0078] Steady flow test with independent regulation of multiple channels

[0079] 1. Equipment Sterilization

[0080] First multi-way joint 1, first throttle valve 2, blood vessel substitute 4, culture chamber 5, second throttle valve 9, second multi-way joint 10, first four-way valve 11, back pressure valve 14, filter Device 15, liquid return bottle 16, pulsating flow pipeline 24, biological fermentation tank 25, and stop valve 7-3 were sterilized at 120°C for 25 minutes; the pulsating flow pipeline 24 was used to connect the pressure gauge 13, flowmeter 7-1, pressure For the transmitter 7-2, start the peristaltic pump 21, soak and sterilize the circuit with 75% alcohol, and then rinse the circuit with sterile PBS solution and 1% double-antibody mixture for 5 times (change the liquid every 20 minutes). Put it on the ultra-clean workbench after sterilization.

[0081] 2. In the ultra-clean workbench, install the blood vessel substitute 4 into the culture chamber 5, expand th...

Embodiment 3

[0103] Vascular stent radial fatigue test

[0104]1. Sterilize the device. First throttle valve 2, second throttle valve 9, blood vessel substitute 4, culture chamber 5, first four-way valve 11, back pressure valve 14, filter 15, liquid return bottle 16, second three-way valve 17 , the second four-way valve 20, the third throttle valve 23, the pulsating flow pipeline 24, and the biological fermentation tank 25 were sterilized at 120°C for 25 minutes; the pulsating flow pipeline 24 was used to connect the pressure gauge 13, the flow meter 7-1, For the pressure transmitter 7-2, connect the second metering pump 19 in series to the circuit, start the second metering pump 19, soak and sterilize the circuit with 75% alcohol, and then rinse with sterile PBS solution and 1% double-antibody mixture Loop 5 times (change the liquid every 20 minutes). Put it on the ultra-clean workbench after sterilization.

[0105] 2. Install the vascular substitute 4 into the culture chamber 5 in the...

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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...

Claims

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Application Information

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IPC IPC(8): C12M3/00C12M1/34C12Q1/02G01D21/02
Inventor 王玲史鑫郝志岩王莹莹李涤尘周功耀
Owner 成都格登特科技有限公司
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