CN1035153C - Test method for fatigue of artificial cardiac valve and apparatus thereof - Google Patents

Test method for fatigue of artificial cardiac valve and apparatus thereof Download PDF

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Publication number
CN1035153C
CN1035153C CN91104142A CN91104142A CN1035153C CN 1035153 C CN1035153 C CN 1035153C CN 91104142 A CN91104142 A CN 91104142A CN 91104142 A CN91104142 A CN 91104142A CN 1035153 C CN1035153 C CN 1035153C
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valve
main shaft
fatigue life
electric motors
linear electric
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CN91104142A
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CN1068031A (en
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席葆树
裴兆宏
祖佩贞
李守彦
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Tsinghua University
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Tsinghua University
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Abstract

The present invention relates to a method and a device for testing the fatigue life of an artificial heart valve. The method of the present invention comprises the steps that the total load on a valve is used as a monitoring parameter; driving frequency, vibration amplitude and pressure behind the valve are regulated; the load waveform of the valve after the valve is accelerated is the same as physiology. The device for realizing the method comprises a driving part, a main body part and a monitoring part, wherein the main body part is composed of a linear motor, an experiment segment and a circulation circuit; the linear motor is positioned above the device. The driving signals of a waveform generator and a direct current power amplifier make the linear motor drive a connecting rod and a valve frame to reciprocate through a main shaft disk. The device has the advantages of compact and reasonable structure, convenient movement, good sealing performance, no noise and low energy consumption.

Description

A kind of Cardiac valve prosthesis fatigue life test device
The technical field of the invention is the biomechanics measurement technology.
The world of the present invention, domestic prior art situation:
Human heart is the maincenter of blood circulation, and it promotes blood and flow in blood vessel with contraction, the diastole of rhythmicity.Human heart is made up of four chambers, between ventricle and atrium, valve is arranged all between ventricle and the outlet conduit, and cardiac valve is simple check (non-return) valve, opens and closes passively along with the diastole of heart, contraction.Because various geneogenous defectives or because the invasion and attack of rheumatism, cardiac valve can suffer damage and lose normal unidirectional non-return function.Along with the development of biomedical engineering, can make patient recover work capacity with made heart valved prosthesis pathological changes valve now.Therefore the quality of artificial valve's performance, the length in life-span directly influences patient's safety.Because the cycle of zoopery and clinical experiment is very long, the fatigue life and the mechanical property of evaluation and comparison prosthetic heart valve mainly realize by the extracorporeal simulating experiment device.According to the home and abroad interrelated data because the calcification of bioprosthetic valve, perforation, the lobe leaf is torn because the wearing and tearing of mechanical prosthetic valve, reason such as rupture and block, the death that is caused and again operation accounted for a big chunk in the valve failure.Especially bioprosthetic valve, since material character, reasons such as structural design and manufacturing process, and its problem fatigue life is more outstanding, has become the current subject matter that influences the bioprosthetic valve development.
The external acceleration simulation of Cardiac valve prosthesis fatigue life test can shorten research cycle greatly, can accumulate the valve durability data of considerable amount in one long period.In development process, can differentiate the quality of structural design, material selection and the treatment process of prosthetic heart valve early.As far back as the sixties just the someone be engaged in the research work of this respect, set up the different analogue experiment installation of structure successively, more representational is the laboratory table of R.E Clark and M.W Swanson, experimental provision fatigue life of the Rowan Ash company of " rotating disc type " experimental provision of H.Reul and Britain.But the blood circulation of these analogue experiment installations is fairly simple, and it is similar to physiological condition only to control pressure gradient, and the STRESS VARIATION that does not have consideration under high frequency situations after the acceleration, to produce.Valve big many of suffered power that under force rate normal physiological conditions suffered under the acceleration situation, move, so Cardiac valve prosthesis measurement result fatigue life on these analog, mostly be far smaller than actual life in vivo, and on different analogue experiment installations, same valve carried out fatigue experiment gained data very big-difference is also arranged.Existing analogue experiment installation majority all is a mechanical drive mode, wears no resistance, and noise is big, and the life-span of device itself is shorter, can't long time continuous working.
The present invention is the problem that exists in existing artificial valve's fatigue life test in order to solve, and the assay device of a kind of Cardiac valve prosthesis fatigue life of invention, its eminency is to make prosthetic heart valve quicken suffered load in back and body physiological conditional likelihood, make result of experiment under the external artificial condition like this, can reflect intravital situation to a certain extent, prediction prosthetic heart valve working condition and the life-span in vivo.
Basic point of the present invention is: with the full payload on the valve as monitoring parameter, promptly by regulating the compliance and the impedance of closed circuit 30, regulate drive waveforms, frequency and amplitude make and quicken under the suffered full payload of back prosthetic heart valve and the physiological condition (72 times/minute) suffered full payload (Fig. 6) is similar.The inventive system comprises main part, drive part and monitoring part (see figure 1).Main part is by linear electric motors 1, experimental section 2, and closed circuit 30, main shaft 3, main shaft disk 4, link rod 5 and valve frame 6 are formed.The top that linear electric motors 1 are placed in this device be support 7 above, motor shaft and main shaft 3 are one, its lower end links to each other with main shaft disk 4.Closed circuit 30 adopts Unit 2 two parameter models.Six experimental sections are independent separately, and a link rod 5 and valve frame 6 are all arranged within each experimental section.Valve experimental section 2 is paired to be that centrosymmetry distributes with main shaft 3.Drive part is the power source of this device, includes power supply 8, random wave generator 9 and amplidyne 10.Through main shaft 3, main shaft disk 4 drive link rods 5 and valve frame 6 move back and forth in experimental section 2 tested valve are opened and closed by drive linear electric motors 1.Monitoring partly comprises: the lobe that is installed between main shaft disk 4 and the link rod 5 carries measuring transducer; Be installed on pressure measxurement pick off 29 and the displacement monitoring pick off 25 that is installed on linear electric motors axle upper end on experimental section 2 walls of valve below.
The assay device of the artificial cardiac valve of the present invention fatigue life has following characteristics compared with the prior art:
1. novel, design meticulous, Rational Parameters, the compact and symmetry of apparatus structure, experimental machine and monitoring instrument package unit are integrated, conveniently moving, floor space is little.
2. closed circuit 30 and experimental section 2 are rational in infrastructure, can simulate the compliance and the impedance of Arterial system, significantly reduce the generation water hammer, good seal performance, and it is easy to change lobe, and mounting or dismounting are convenient, are convenient to observe.
3. linear electric motors 1 and main shaft 3 are positioned at the top of device, therefore can not produce because the below drives the sealing that brings and the contradiction of friction, and noiseless, energy consumption is low.
4. the monitoring to the valve motion is converted into displacement monitoring, frequency and pressure, realizes control automatically easily.
5. test symmetric 6 valves 16 simultaneously, by same drive shaft, so their amplitude, frequency is identical, as long as the pressure adjusting is identical behind the lobe, lobe carries just identical, is convenient to comparison.
6. the valve full payload can be by changing driving frequency, amplitude, and pressure is regulated behind the lobe, can make to quicken under the running status full payload near physiological condition.
7. whole device does not have mechanical transmission component, and frictional force is very little, excellent in durability, and corrosion resistance and good guarantees that cycle frequency can reach 2000 times/minute, promptly more than the 33Hz under valve standard-sized sheet, the full cut-off condition.Can work reliably continuously for a long time.
8. this device has accumulator and power supply can work under the grid cut-off situation.
Accompanying drawing:
Fig. 1. a kind of Cardiac valve prosthesis fatigue life test device block diagram.
Fig. 2. a kind of Cardiac valve prosthesis fatigue life test apparatus main body structure front elevational schematic.
Fig. 3. the agent structure schematic top plan view.
Fig. 4. the closed circuit sketch map.
Fig. 5. the structure of the linear motion actuator sketch map.
Fig. 6. the load waveform under 72 times/minute hearts rate.
Fig. 7 viewing system structural representation.
Detailed structure below in conjunction with description of drawings apparatus of the present invention.
The present invention points out to act on the power on the valve under high frequency situations after the acceleration, also should consider inertia force except that pressure gradient, and its total force is:
F=Fm+F q+F ΔP
The inertia force that the inertia mass of Fm---valve moving component causes.
F Δ P---pressure gradient acts on the power on the valve.
F q---fluid inertia acts on the power on the valve.And square being directly proportional of inertia force and motion frequency, i.e. (Fm+F q) ∝ f 2, f is a heart rate.Inertia force Fm and Fq are very little when being low frequency under physiologic frequency, are very little amounts with respect to pressure gradient.Physiological system is that its inertia and compliance are in good balance in the work of pulsating flow optimum state.After quickening, the active force that the inertia of valve moving component and fluid inertia cause will sharply increase, and inertia force and pressure gradient constitute the full payload on the valve together.And on the experimental provision of prior art, only consider under pressure gradient and the physiological condition similarly, so must make valve after acceleration, it is very big to load, soon because of stressed excessive destruction, so the test result of valve fatigue life is far smaller than actual life in vivo.The similar problem of the suffered load of prosthetic heart valve under suffered load that this problem is actual when relating to how to guarantee external accelerated tests on the prosthetic heart valve structure and the body physiological condition.For the maximum stress of prosthetic heart valve under the distribution that makes maximum stress and the physiological condition distributes similar, we can adjust the compliance and the impedance of closed circuit system, change flow and pressure gradient by valve, selecting suitable drive waveforms to drive linear electric motors makes it according to certain waveform, frequency and amplitude motion, make the approximate physiological condition of switching campaign of heart lobe, the characteristics of motion of then quickening the back system can be near the rule of normal physiological conditions, aortic pressure waveform when pressure waveform is near normal physiological conditions behind the lobe, valve do not produce water attack when opening and closing.
Cardiac valve prosthesis fatigue life test device of the present invention, it partly constitutes (see figure 1) by drive part, main part, monitoring.Its drive part is a power source, and it is by power supply 8, and random wave generator 9 and amplidyne 10 are formed.Main part comprises linear electric motors 1 experimental section 2, closed circuit 30, main shaft 3, main shaft disk 4, link rod 5 and valve frame 6 (seeing Fig. 2 .3).Closed circuit 30 adopts Unit 2 two parameter model (see figure 4)s, and it is by air-capacitor C 111, C 212, antivibrator R 113, R 214 and experimental section 2 form.Valve experimental section 2 is independent separately, and experimental section 2 is paired, is symmetrically distributed with main shaft 3, and this device adopts 6 valve experimental sections.Link rod 5 upper ends connect with main shaft disk 4, and valve 16 is installed on the valve frame 6 of link rod 5 lower ends, produce needed waveform by AWG (Arbitrary Waveform Generator) 9, after amplidyne 10 amplifies, drive linear electric motors 1 by main shaft 3, and main shaft disk 4 drives link rod 5.When valve frame 6 moved upward, valve 16 was opened under the liquid inertia effect, when valve frame 6 moves downward, because liquid resistance is closed valve 16.And promote liquid and move downward, liquid flows to corresponding separately air-capacitor C from each experimental section 2 111 and needle valve type antivibrator R 113, import fluid reservoir 17 again, in this fluid reservoir 17 big air-capacitor C is arranged 212, dividing plate 18 with holes is arranged with the waterproof wave under it, again through adjustable damper R 2Each experimental section is returned in 14 shuntings.Pressure is that pressure gradient passes through antivibrator R behind the lobe 113 regulate, and can change in 0~100mgHg scope, can satisfy physiological scope.Waveform generator 9 can provide selected arbitrarily drive waveforms, guarantees the motion of linear electric motors 1, makes the approximate physiological condition of switching campaign of heart lobe.By adjusting pressure behind the lobe and drive the frequency of signal, amplitude and waveform make and quicken under the running status on the valve 16 the full payload curve near the full payload curve under the normal cardiac rate, i.e. load waveform (see figure 6) under 72 times/minute hearts rate.Linear electric motors 1 are installed on the top (see figure 2) of support 7, its structure (see figure 5), and it is by motor shaft 3 (motor shaft and main shaft are one), bobbin 19, coil 20, magnetic conductor 21, permanent magnet 22 is formed, and there is stainless steel cage 23 its outside, and whole moving component adopts titanium alloy material, therefore in light weight, Hz-KHz is wide, and fatigue performance is good, adopt centre pilot, radial force is little, and it is little to rub, energy consumption is low, and motion is steady, noiseless.
Monitoring system comprises that lobe carries measurement, pressure measxurement three parts behind valve displacement measurement and the lobe.
It is the change curve of measuring valves 16 suffered load in motor process with strain-type force sensor 24 that lobe carries measurement.This pick off 24 is installed in the junction (see figure 2) of valve link rod 5 and main shaft disk 4, and valve 16 is stressed to be delivered on the force cell 24 by link rod 5, and the output of force cell 24 is valve 16 and link rod 5, valve frame 6 suffered full payload sizes.In order to obtain valve 16 suffered load, the dynamic loading of link rod 5 valve framves 6 must be deducted, we at first do not adorn valve 16 when adjusting for this reason, force cell 24 with two performance unanimities, be installed on symmetric two link rods 5, the dynamic loading of valve frame 6 and link rod 5 when measuring different frequencies, because it is symmetrical fully, subtracting each other the back dynamic loading is zero, tested valve 16 is installed on a valve frame 6 then, another does not adorn valve 16, obtains the change curve of valve 16 suffered load after the output of two force cells 24 is subtracted each other when different frequency.By adjusting the lobe afterload and driving signal, make the load when load approaches normal cardiac rate when quickening operation.These force cell 24 mounting or dismounting are very convenient, when dynamometry, pick off 24 installed, and after complete machine is adjusted, pull down force transducer 24, and device normally moves.
Pressure measxurement is with pressure transducer 29, opens pressure tap on valve 16 back experimental section 2 sidewalls, links through medical mini three links valve and experimental section 2, records pressure variation behind the lobe.Utilize medical mini three links valve, pressure transducer 29 is communicated with experimental section 2 when pressure measurement, communicate and return to zero with atmosphere during not pressure measurement.
The detection of displacement signal: the motion of linear electric motors 1 is to measure by displacement transducer 25.This displacement transducer 25 is installed in the upper end (see figure 2) of linear electric motors 1, adopts the photo-electric principle, the variation that utilizes electric current that light-sensitive element produces and the proportional principle of light-receiving area to detect displacement.The line source that slit sends is sheltered from a part by the axle head of linear electric motors 1, shine on the light-sensitive element, when the upper and lower motion of linear electric motors 1 axle head, the luminous flux that light-sensitive element is experienced changes, be directly proportional with linear electric motors 1 reciprocating amplitude, the electric current variation that light-sensitive element produced has promptly reflected linear electric motors 1 amplitude variations.This displacement transducer 25 is simple in structure, does not have mechanical drive disk assembly, and not wearing and tearing are fit to the requirement of long-term continuous operation.
The assay device of Cardiac valve prosthesis of the present invention fatigue life is to quicken near under the physiological condition in suffered load, and guarantees valve 16 standard-sized sheet full cut-offs in each circulation.Be provided with the viewing system (see figure 7).Reflecting mirror 26 is housed below valve experimental section 2, be radiated on the valve 16 with stroboscopic lamp 28, when the flashing rate of adjustment stroboscopic lamp 28 and valve motion frequency have certain difference, by inspection section 27 can be clearly seen that valve 16 slowly open and close process, whether standard-sized sheet, close, motion conditions such as whether valve 16 damages, whether distortion, lobe leaf shake, and by the picture recording system its situation of change is noted.

Claims (6)

1. a Cardiac valve prosthesis fatigue life test device is characterized in that this device by main part, and drive part and monitoring part are formed,
Its main part comprises, linear electric motors 1, experimental section 2, closed circuit 30, main shaft 3, main shaft disk 4, the top that link rod 5, valve frame 6, linear electric motors 1 are positioned at this device be support 7 above, linear electric motors axle and main shaft 3 are one, the lower end of main shaft 3 and main shaft disk 4 are connected, and a link rod 5 and valve frame 6 are all arranged in each experimental section 2, and the upper end of link rod 5 is connected with main shaft disk, valve 16 is installed on the valve frame 6 of link rod 5 lower ends, and valve experimental section 2 is independent separately to be that centrosymmetry distributes with main shaft 3 all;
Drive part is the power source of this device, includes power supply 8, random wave generator 9 and amplidyne 10, and through main shaft 3, main shaft disk 4 drives link rod 5 and valve frame 6 moves back and forth in experimental section 2 by drive linear electric motors 1;
The monitoring part comprises that lobe carries measurement, pressure measxurement behind valve displacement measurement and the lobe, it is with strain-type force sensor 24 that lobe carries test, this pick off is installed between link rod 5 and the main shaft disk 4, the valve displacement measurement is with optical displacement sensor 25, be installed in the upper end of linear electric motors 1, pressure is measured with pressure transducer 29 behind the lobe.
2. according to the said a kind of Cardiac valve prosthesis fatigue life test device of claim 1
It is characterized in that force cell 24 with two performance unanimities, be installed between symmetric two link rods 5 and the main shaft disk 4, two symmetric valve frame 6 one of them valve framves 6 are installed tested valve 16, another does not adorn valve 16, and the change curve that obtains valve 16 suffered full payloads is subtracted each other in two force cell 24 outputs when different frequency.
3. according to the said a kind of Cardiac valve prosthesis fatigue life test device of claim 1, it is characterized in that said closed circuit is Unit 2 two parameter closed circuits 30, it comprises air-capacitor C 111, needle valve type antivibrator R 113, fluid reservoir 17, big air-capacitor C 212, antivibrator R 214, C 1, R 1Corresponding with experimental section 2 separately, big air-capacitor C 212 are positioned at the top of fluid reservoir 17 dividing plates 18 with holes, R 214 are positioned at the top of fluid reservoir 17 concentric drums and adjustable.
4. according to the said a kind of Cardiac valve prosthesis fatigue life test device of claim 1, it is characterized in that said linear electric motors 1, it is by motor shaft, coil rack 19, coil 20, magnetic conductor 21, permanent magnet 22 is formed, there is stainless steel cage 23 its outside, and whole moving component is a titanium alloy material, adopts centre pilot.
5. according to the said a kind of Cardiac valve prosthesis fatigue life test device of claim 1, it is characterized in that the drive system of this device has 36 overhead accumulators and power supply 8, when unexpected outage, guarantee the continuous operate as normal of drive system.
6. require 1 said a kind of Cardiac valve prosthesis fatigue life test device according to power, it is characterized in that on this device viewing system being arranged, by reflecting mirror 26, stroboscopic lamp 28, inspection section 27 can be observed lobe leaf motion conditions.
CN91104142A 1991-06-26 1991-06-26 Test method for fatigue of artificial cardiac valve and apparatus thereof Expired - Fee Related CN1035153C (en)

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CN91104142A CN1035153C (en) 1991-06-26 1991-06-26 Test method for fatigue of artificial cardiac valve and apparatus thereof

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Application Number Priority Date Filing Date Title
CN91104142A CN1035153C (en) 1991-06-26 1991-06-26 Test method for fatigue of artificial cardiac valve and apparatus thereof

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CN1035153C true CN1035153C (en) 1997-06-18

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CN102293691A (en) * 2010-06-24 2011-12-28 苏州爱尔博生物医学工程产品研发有限公司 Portable artificial cardiac valve in-vitro performance testing and circulating system simulation device
CN103622763B (en) * 2012-08-28 2015-07-08 苏州爱尔博生物医学工程产品研发有限公司 Valve fatigue-life testing device
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US9913718B2 (en) * 2014-06-17 2018-03-13 Ta Instruments-Waters L.L.C. System for testing valves
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CN110269726B (en) * 2019-06-27 2021-07-23 西安医学院第二附属医院 Mechanical heart valve simulation detection device
CN111358596A (en) * 2020-03-09 2020-07-03 科凯(南通)生命科学有限公司 Multimode parallel valve fatigue life testing arrangement
CN111982667B (en) * 2020-08-17 2023-06-13 四川大学 Heart valve clamp
CN115105251A (en) * 2021-03-22 2022-09-27 上海微创心通医疗科技有限公司 Valve durability testing device
CN117705560B (en) * 2024-02-06 2024-04-19 圣塔菲医疗科技(常州)有限公司 Real-time abrasion test device for cardiovascular implant

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