CN101625288A - Method and device for testing pulse fatigue of medical stent - Google Patents

Method and device for testing pulse fatigue of medical stent Download PDF

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Publication number
CN101625288A
CN101625288A CN200810128330A CN200810128330A CN101625288A CN 101625288 A CN101625288 A CN 101625288A CN 200810128330 A CN200810128330 A CN 200810128330A CN 200810128330 A CN200810128330 A CN 200810128330A CN 101625288 A CN101625288 A CN 101625288A
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medical stent
pressure
test
fatigue
stent
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CN200810128330A
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CN101625288B (en
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黄研昕
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Abstract

The invention relates to a method and a device for testing pulse fatigue of a medical stent. Generally, the service life of a medical stent finished product is designed to be not less than 10 years. Once the medical stent is implanted to human body, the medical stent can generate the periodic distortion and the deformation under the periodic function of diastolic pressure and systolic pressure for a long period, thereby possibly allowing a medical stent material to gradually generate fatigue damage. Therefore, the method requires that the medical stent has good static mechanical performance and excellent anti-fatigue property. The method and the device for testing the pulse fatigue of the medical stent can simulate the pulse deformation and distortion of the medical stent finished product in the human body, can control the radial deformation degree of the stent finished product through the adjustment of the size of the diastolic pressure and the systolic pressure of an analog test and the mechanical performance of a test tube cavity and can carry out fatigue performance and service life test on a plurality of pairs of the stent finished products in different mounting postures.

Description

Testing pulse fatigue of medical stent method and device
Technical field
The technical field of the invention is the biomechanics measuring technique, relates to a kind of medical stent finished product fatigue test method and device.
Background technology
The medical stent technology is to be widely used in clinical high-tech engineering in medicine technology after conduit intervention diagnosis and therapy technology.Medical stent can be divided into endovascular stent and non-lumen of vessels inner support two big classes, is the thin tube-like structure, inserts in the ill tube chamber and provides mechanical support power to pathological lumen, to recover the function of pathological lumen.From international coverage, usually medical stent finished product designed life is for being not less than 10 years.Behind the medical stent implant into body, long-term under the period effects of diastolic pressure and systolic pressure, produce periodically torsional deformation, may make support progressively produce fatigue breakdown.Therefore, medical stent not only should have good static mechanical performance, also should have good fatigue resistance.The quality of medical stent performance, the length in life-span directly influences patient's safety.State food medicine Supervision Bureau had carried out the quality system special examination to endovascular stent manufacturing enterprise in 2006, and the result shows that quality causes anxiety.Wherein, the problem that support check aspect exists mainly is, part support finished product main performance, safety index are not listed check in, and Interventions Requested mainly are outward appearance, size, and all support finished products all do not carry out durability test etc.All there is the report support that the case of fatigue breakdown takes place in human body both at home and abroad, causes death or operation again.The fatigue behaviour of support finished product and life-span then are the important technology parameters that is related to patient's life, and its detection method and technology are to become the subject matter that the homemade support of influence develops in a healthy way.
Summary of the invention
The objective of the invention is to produce the problem that enterprise can't carry out the medical stent life tests in order to solve state's inner support, and a kind of medical stent that can make of invention is in analogue body under the physiological condition, alternate load and torsional deformation are born in acceleration, detect the test method and the device in medical stent finished product fatigue behaviour and life-span rapidly.Test method of the present invention and device can be simulated the support finished product and be out of shape in intraluminal pulsation, by regulating the big or small of simulation test diastolic pressure and simulation test systolic pressure and regulating the diameter distortion degree that the mechanical property of testing wall of the lumen can be controlled the support finished product, can install under the attitude to how secondary medical stent finished product and in difference simultaneously and carry out torture test.
Embodiment
The object of the present invention is achieved like this: the medical stent finished product is implanted in the mechanical property test tube chamber identical with blood vessel, controller is opened electrohydraulic servo valve, connects high-voltage energy storage device, and test pressure charges into the test tube chamber immediately, set up the simulation test systolic pressure, test tube chamber and support expansion.Regulate the amount of radial expansion of the pressure set points may command support of high-voltage energy storage device, pressure-sensitive controller The real time measure pressure, after pressure reaches setting value, switch the conducting direction of electrohydraulic servo valve immediately, connect the low pressure accumulator, the developmental tube cavity pressure descends immediately, sets up the simulation test diastolic pressure, shrink at tube chamber resilient force lower carriage, regulate the radial shrinkage amount of the pressure set points may command support of low pressure accumulator.After pressure dropped to setting value, the conducting direction that pressure-sensitive controller switches electrohydraulic servo valve once more charged into high pressure, so moved in circles, and the record cycle index, until the sample fatigure failure or reach the lifetime limitation of regulation.
The radial dilatation of medical stent and contraction cause producing periodically distortion action, its degreeof tortuosity is relevant with the initial installation attitude of support again and directly have influence on fatigue lifetime of support, so, in test, by one group of supplemental restraint system, the initial mounting condition of control medical stent, and bear expansion with this understanding and shrink and to move in circles.
What the present invention utilized high-voltage energy storage device and low pressure accumulator alternately switches anthropomorphic dummy's systemic arterial blood pressure, and constant simulation diastolic pressure and the pulsation of simulation systolic pressure is provided.Simultaneously, by means of the elastic force of test tube chamber, simulation medical stent finished product periodically distortion and deformation state in vivo is with the anti-fatigue performance of check medical stent finished product.During detection, only need medical stent finished product sample is inserted in the test tube chamber by specific attitude, the pressure that pressure-sensitive controller is discerned simulation diastolic pressure and simulation systolic pressure automatically changes, and control is switched alternately automatically after pressure reaches setting value.
Description of drawings
Concrete structure of the present invention is provided by following example and accompanying drawing thereof.Fig. 1 is the structural drawing of the testing pulse fatigue of medical stent device of proposition according to the present invention.
Details and the working condition of the concrete device that the present invention proposes are described below in conjunction with Fig. 1. This device comprises Test tube chamber 2, medical inner support finished product sample 3, pressure-sensitive controller 7, commutation electrohydraulic servo valve 8, high pressure Accumulator 9 and low pressure accumulator 10 form. It is flat that medical inner support finished product sample settles state can be divided into the nothing constraint Straight arrangement state, Constrained wheel 5 and constraint wheel 6 retrain S shape constraint arrangement states, Constrained is crooked settles State, two accumulators communicate with the test tube chamber by the commutation electrohydraulic servo valve. It is constant that high-voltage energy storage device provides The simulation systolic pressure, the low pressure accumulator provides constant simulation diastolic pressure, the volume of accumulator is far longer than pipe The volume in chamber is so pressure replaces lifting interval weak point. The intraluminal pressure of pressure-sensitive controller determination test, when When pressure reached setting value, immediately control commutation electrohydraulic servo valve switched the developmental tube cavity pressure. Although this mode Simple but realized alternate pulsation and the simulation support stress in vivo of simulation systolic pressure and diastolic pressure.

Claims (3)

1. testing pulse fatigue of medical stent method, it is characterized in that by external acceleration simulated experiment, simulation medical stent finished product is in intraluminal pulsation distortion circulation, by size of regulating simulation test diastolic pressure and simulation test systolic pressure and the mechanical property of testing tube chamber by adjusting, the radial deformation degree and the rule of control medical stent finished product, radial deformation equals the radial deformation degree of normal physiological conditions.
2. device that is used to realize the said testing pulse fatigue of medical stent method of claim 1, it is characterized in that test unit is by test tube chamber, simulation test systolic pressure (high pressure) accumulator, simulation test diastolic pressure (low pressure) accumulator, the commutation electrohydraulic servo valve, pressure-sensitive controller is formed.Provide simulation test diastolic pressure and the pulsation of simulation test systolic pressure by accumulator, test systolic pressure augmentation test tube chamber, medical stent dilatating and deformable; Utilize the contraction elastic force of test tube chamber to realize compression medical stent, medical stent compression deformation during the test diastolic pressure.Alternately commutation of electrohydraulic servo valve is switched in the automatic identification test tube chamber of pressure-sensitive controller internal pressure and control.
3. according to the described device of claim 2, it is characterized in that can be simultaneously one or many medical stents being carried out torture test, the initial installation attitude of medical stent is divided into straight mounting means, crooked mounting means, S shape mounting means, and under above-mentioned initial mounting condition, carry out the test of medical stent expansion fatigue of contraction simultaneously.
CN2008101283303A 2008-07-08 2008-07-08 Method and device for testing pulse fatigue of medical stent Expired - Fee Related CN101625288B (en)

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Application Number Priority Date Filing Date Title
CN2008101283303A CN101625288B (en) 2008-07-08 2008-07-08 Method and device for testing pulse fatigue of medical stent

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Application Number Priority Date Filing Date Title
CN2008101283303A CN101625288B (en) 2008-07-08 2008-07-08 Method and device for testing pulse fatigue of medical stent

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CN101625288A true CN101625288A (en) 2010-01-13
CN101625288B CN101625288B (en) 2011-04-06

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103604596A (en) * 2013-12-02 2014-02-26 南京林业大学 Extracorporeal testing device of fatigue performance of woven-type non-vessel support
CN103645038A (en) * 2013-11-25 2014-03-19 北京垠海工程技术研究有限责任公司 Bracket fatigue testing machine
CN104122151A (en) * 2014-07-16 2014-10-29 南京林业大学 Woven nonvascular stent fatigue performance testing device and method
CN109580270A (en) * 2019-01-21 2019-04-05 长沙学院 A kind of magnetic suspension capsule robot experimental rig
CN110031204A (en) * 2019-05-16 2019-07-19 昆山丘钛微电子科技有限公司 Antifatigue test fixture
CN112530253A (en) * 2020-11-30 2021-03-19 江苏大学 Human body pulse condition simulator

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100361636C (en) * 2005-06-29 2008-01-16 东南大学 Extracorporeal test device and method for the dilation performance of saccule dilating intravascular rack

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103645038A (en) * 2013-11-25 2014-03-19 北京垠海工程技术研究有限责任公司 Bracket fatigue testing machine
CN103645038B (en) * 2013-11-25 2016-04-13 北京垠海工程技术研究有限责任公司 Stent fatigue test machine
CN103604596A (en) * 2013-12-02 2014-02-26 南京林业大学 Extracorporeal testing device of fatigue performance of woven-type non-vessel support
CN103604596B (en) * 2013-12-02 2016-06-29 南京林业大学 Weaving type non-vessel stent fatigue behaviour testing in vitro device
CN104122151A (en) * 2014-07-16 2014-10-29 南京林业大学 Woven nonvascular stent fatigue performance testing device and method
CN104122151B (en) * 2014-07-16 2016-04-13 南京林业大学 Weaving type non-vessel stent fatigue property test device and method
CN109580270A (en) * 2019-01-21 2019-04-05 长沙学院 A kind of magnetic suspension capsule robot experimental rig
CN109580270B (en) * 2019-01-21 2023-09-19 长沙学院 Magnetic suspension capsule robot test device
CN110031204A (en) * 2019-05-16 2019-07-19 昆山丘钛微电子科技有限公司 Antifatigue test fixture
CN110031204B (en) * 2019-05-16 2024-03-08 昆山丘钛微电子科技有限公司 Anti-fatigue test fixture
CN112530253A (en) * 2020-11-30 2021-03-19 江苏大学 Human body pulse condition simulator

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Granted publication date: 20110406

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