CN102178571B - Device and method for measuring modification degree of bioprosthesis valve by utilizing sound wave - Google Patents

Device and method for measuring modification degree of bioprosthesis valve by utilizing sound wave Download PDF

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CN102178571B
CN102178571B CN 201110085210 CN201110085210A CN102178571B CN 102178571 B CN102178571 B CN 102178571B CN 201110085210 CN201110085210 CN 201110085210 CN 201110085210 A CN201110085210 A CN 201110085210A CN 102178571 B CN102178571 B CN 102178571B
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sound wave
measurement
chamber
testing sample
modification degree
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CN102178571A (en
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陈大凯
李�雨
陈国明
陈诚
刘翔
王云蕾
林韶烨
乐承筠
罗七一
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Chengdu Xintuo Biotechnology Co.,Ltd.
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Shanghai Microport Medical Group Co Ltd
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Abstract

The invention relates to a device and method for measuring modification degree of a bioprosthesis valve by utilizing sound wave. The device comprises a sound wave generator, a speaker, a sound wave conduction device, a sample clip, a UV meter and the like. The device adopts the method for measuring the sound absorption rate or porosity of the bioprosthesis valve by utilizing the sound wave aiming at the structure change in the modification process of the pericardial material. The sound wave measuring equipment has the characteristics of rapidness, accuracy and large scanning area, thus avoiding adoption of the detection method which has the defects of time consumption and small scanning area so as to reflect the modification result of the pericardial material in real time and rapidly adjust the modified configuration process flow of the pericardial material.

Description

Utilize the device and method of acoustic measurement bioprosthesis valve modification degree
Technical field
The invention belongs to the detection of curable product, particularly a kind of apparatus and method of utilizing acoustic measurement bioprosthesis valve modification degree.
Background technology
In the preparation process of artificial bio-prosthetic valve, it is low that bioprosthetic valve itself exists mechanical strength, easily degrades and shortcoming such as inefficacy, and the method that therefore often needs to modify (or modification) by chemical crosslinking improves its stability.In addition, bioprosthesis valve has only by modifying to change its surface property and organizational structure could improve its service life in the process of implant into body.The common chemical cross-linking agent is glutaraldehyde, and it can improve the intensity of valve (being pericardium) material, improves physics and the chemical property of pericardium material.Because glutaraldehyde is a kind of homotype bi-functional cross-linking agent, two aldehyde radical can be respectively forms Schiff alkali with the primary amino radical of two identical or different molecules, and two molecules are connect with five carbon bridgings.When glutaraldehyde takes place when crosslinked with biological material in water miscible system, situation is complicated, and the aldehyde radical of glutaraldehyde monomer can generate Schiff alkali and form in the tropocollagen molecule crosslinked with the lysine of collagen composition in the biomaterial or the amino reaction of E2 of hydroxylysine residue; Simultaneously, because of glutaraldehyde polymer that the long-chain that aldol condensation generates takes place in aqueous solution also and the E2 amino of aforementioned amino acid residue react and form between tropocollagen molecule crosslinkedly, even form crosslinked between collagen microfibrils.Glutaraldehyde has hydrophilic and hydrophobic mixed characteristic, can infiltrate soon in the aqueous medium and cell membrane of biological material, so can be at short notice cross-linked material effectively.But concentration is unsuitable high, because of the glutaraldehyde of high concentration can quick crosslinked organization material surface portion and form one deck protection barrier, stop further crosslinkedly, and this also is accompanied by the variation of the porosity (or acoustic absorptivity) of pericardium material.
In the bioprosthesis valve modifying process, because needing to use number of chemical reagent handles, in case wherein a certain step overtreating or undertreatment, all will have influence on follow-up treatment process, comprising temperature, chemical agent concentration, the change of pH value etc., these processes are technological processes of a configurationization, so require in processing procedure, mensuration are real-time made in the structural change (namely modifying or the modification degree) that the pericardium material takes place after process physics and chemical modification.For example, because in the bioprosthesis valve that causes of cross-linking agent between the collagen protein and the crosslinked action between the elastin laminin, thereby need determine the modification degree of valve after crosslinking Treatment by certain measurement means.
Several modes below existing in the prior art are measured the structural change through the bioprosthesis valve (hereinafter to be referred as valve) that causes after pentanedial decoration or the modification, determine to modify or the modification degree.
As document Gilberto Goissis, Domingo Marcolino Braile, N é lly CristinaCarnevalli, Vladimir Aparecido Ramirez.Materials Research.2009,12:113-119 is disclosed, adopt determine with dsc method the pericardium material after through the glutaraldehyde modification structural change and the variation of the water absorption rate that causes.
Document Beatriz Arenaz for another example, Marian Mart í n Maestro, Pilar Fern á ndez, Javier Turnay, Nieves Olmo, Jes ú s Sen é n, Javier Gil Mur, Mar í a AntoniaLizarbe, Eduardo Jorge-Herrero.Biomaterials.2004,25:3359-3368 puts down in writing, and it adopts the degree of modification after the method for X-ray diffraction has been observed the modification of pericardium material process glutaraldehyde.
Yet measured variation all is subjected to the degree of cross linking influence in the bioprosthesis valve in above-mentioned two pieces of documents, and the size of porosity reflects the size of the degree of cross linking simultaneously, and both are positively related.The technical problem that exists in these prior aries is that the area of measuring samples is too little, and they all are randomizations, can't characterize the whole degree of cross linking feature of bioprosthesis valve.In addition, there are shortcomings such as expensive, complicated operation, sample test time be long in the employed instrument of these existing measuring techniques.
Summary of the invention
The object of the present invention is to provide a kind of device that utilizes acoustic measurement artificial bio-prosthetic valve membrane porosity, to overcome the above-mentioned defective that prior art exists.
For this reason, the present invention proposes employing acoustic measurement bioprosthesis valve modification degree methods.Acoustic measurement equipment has fast, accurately, characteristics that scan area is big, adopt existing detection method consuming time and that scan area is little thereby replaced, in the hope of reflecting the modification result of artificial bio-prosthetic valve in real time, the configuration metallization processes flow process of quick adjustment bioprosthesis valve modification.
Sound comes from the vibration of object, and it causes the vibration of contiguous air and form sound wave, and in air dielectric to around propagate.When sound imports construction material (for example valvular tissue) surface into, an acoustic energy part is reflected, part penetrable material, also has one one because the vibration of construction material or sound when propagating therein and the surrounding medium friction, change into heat energy by acoustic energy, acoustic energy is depleted, and namely usually said sound is by absorbed.
Owing to porous, membrane action or the resonance effect of bioprosthesis valve incident acoustic energy had Absorption.Sound-absorbing material will with the acoustic characteristic impedance coupling of on every side sound bearing medium, enter sound-absorbing material with making the acoustic energy areflexia, and incident acoustic energy be absorbed substantially.
Sound wave of the present invention is measured apparatus and method and just is being based on that above-mentioned principle makes.
Specifically, the present invention proposes a kind of device that utilizes acoustic measurement bioprosthesis valve modification degree, this device comprises: sonic generator, described sonic generator can be launched the measurement sound wave that is fit to measure the artificial bio-prosthetic valve membrane porosity; Speaker, the outfan coupling of its input and sonic generator; The sound wave conduction device, place one to measure chamber, to be imported in the described measurement chamber by the measurement sound wave that speaker sends by described sound wave conduction device, the sound wave output port of described sound wave conduction device is in the face of the testing sample setting, thereby will measure the sonic guide testing sample, the other end of described sound wave conduction device and VU meter coupling simultaneously; Wherein VU meter also is of coupled connections with sonic generator; And specimen holder, be used for fixedly testing sample.
Specimen holder can be two snap ring structures, be used between two snap ring structures fixedly testing sample, and the inner surface of the periphery of described pair of snap ring structure and described measurement chamber is slidingly matched.Specimen holder can further include an elastic support, and this elastic support can arch upward testing sample or force testing sample to keep open and flat towards the surface of sound wave conduction device direction at least towards described sound wave conduction device direction.
To measure chamber as impedance matching box, the acoustic impedance between the sound bearing medium that is used for regulating testing sample and measuring chamber.Can described speaker be docked with described impedance matching box by laser weld, thereby constitute described measurement chamber jointly.Between described speaker and described sonic generator, a power amplifier can also be set.
The inside of measuring chamber is that sound wave is airtight, and each inner surface of measuring in the chamber all is made of sound wave total reflection material.
Described device can also comprise the scale that is slidingly matched with described VU meter, and this scale is used in reference to the distance between the surface of the other end that described sound wave conduction device is shown and described testing sample.
Away from an end place of testing sample and/or in the side that described specimen holder is measured chamber dorsad at least one sound wave antireflection device is set also what measure sound wave conduction device described in the chamber.
Described device can also comprise to the device of measuring the chamber evacuation with to measuring the device that is introduced as the protective gas of sound bearing medium in the chamber.
In addition, the invention allows for a kind of acoustic measurement bioprosthesis valve modification degree methods of utilizing, described method comprises the steps: that (a) places testing sample in the airtight measurement chamber of sound, (b) to the measurement sound wave of testing sample emission preset frequency, (c) by measuring acoustic absorptivity α or the porosity of testing sample, determine the modification degree of sample.
Described method can also comprise: repeating step (a) to (c) also records each measurement result, compares each measurement result or compares with standard value, to determine the modification degree of sample.When acoustic absorptivity is in the scope of 0.05≤α≤0.2, show that the modification degree is good
Described method can also comprise the steps: airtight measurement chamber evacuation, charges into the protective gas as sound bearing medium then in the described measurement chamber.
Description of drawings
Fig. 1 is the apparatus structure sketch map of acoustic measurement artificial bio-prosthetic valve membrane porosity of the present invention;
Fig. 2 is the perspective view of uncovered specimen holder in the acoustic measurement device of the present invention;
Fig. 3 has the perspective view that covers specimen holder in the acoustic measurement device of the present invention;
Fig. 4 is the sketch map of another embodiment of acoustic measurement device of the present invention.
Fig. 5 is the flow chart of acoustic measurement method of the present invention.
The present invention is described in detail hereinafter with reference to accompanying drawing, wherein shows exemplary embodiment of the present invention.But the present invention can different forms implement, and can not be interpreted as the various specific embodiment that are limited to here explanation.But, these embodiments are provided, thereby make the disclosure more fully with comprehensive, to those skilled in the art, express scope of the present invention more fully.In full, element or key element that same Reference numeral is corresponding same.For key element identical in each accompanying drawing with no longer repeat specification.
The specific embodiment
Before in detail explaining embodiments of the present invention, it should be understood that the present invention in actual applications is not limited to propose in the following description or in the accompanying drawings the structure of diagrammatic each parts and the details of layout.The present invention can be other embodiment, and can put into practice in every way or implement.And, it should be understood that employed wording and term are for purpose of description in this article, and should being considered limiting property.As employed " comprising " and " comprising " in this article with and the use of distortion mean and comprise item and its equivalent and the extra item of listing thereafter.Further, it should be understood that such as term " left side ", " right side ", "up" and "down" etc. all be for convenience of description, do not constitute the restriction effect, and can replace each other.
Below in conjunction with the specific embodiment the preferred embodiments of the present invention are described.
The modification degree of bioprosthesis valve in modifying process measured in the variation of the sound absorption qualities that the variation of the three-dimensional pore space structure that this device takes place in modifying process by bioprosthesis valve causes, more pore space structure will cause bigger porosity or acoustic absorptivity, and vice versa.
Specifically, the present invention proposes a kind of device that utilizes acoustic measurement bioprosthesis valve modification degree, this device comprises measures chamber 9, sonic generator 1, power amplifier 2, impedance tuner 3, specimen holder 4, VU meter 5, speaker 6, sound wave conduction device 7, scale 8 etc.
Please refer to Fig. 1, at least one is measured chamber 9 and is used for placing testing sample 14, and described measurement chamber should keep the sound wave seal of its inner body after putting into testing sample 14, thereby makes sound wave in the described measurement chamber only propagate in this chamber and do not leak.The cross sectional shape of described measurement chamber 9 can be any suitable plane geometric shape, but the airtight regular geometric shapes of sound wave that is conducive to such as circular, oval or square preferably.Preferably, a side that only keeps this chamber can be opened, in order to sample is imported wherein.Other sides of chamber can be prior complete closed some sidewalls or miscellaneous part or assemblies good or that be sealed connected together by other existing sealing means.Preferably, the inner surface of other all sides of the described measurement chamber except the side that makes the sample importing all is made of sound wave total reflection material, for example, by the formations such as steel plate (for example wolfram steel plate), quartz glass or other sound wave total reflection alloy materials of densification.When each side of described measurement chamber 9 is made of above-mentioned sound wave total reflection material, can omit the shell of described measurement chamber.When the sidewall of described measurement chamber or shell are made by other materials, preferably, pass through existing technology in these inside surface of side wall, apply or through coating process one deck sound wave total reflection material is set at least and be coated with (plating) layer, for example, Teflon, polyurethane are in order to make these inner surfacies can keep the sound wave of measuring in the chamber is carried out total reflection.Described sound wave total reflection material layer or be coated with (plating) layer itself or together constituted impedance tuner 3 in this device with shell is used for the impedance matching between the sound bearing medium (being generally air) of adjusting detected materials and chamber.Generally, described impedance tuner 3 has configured when measuring device of the present invention dispatches from the factory, and need not to do further to adjust in measuring process.Preferably, can actual needs such as size per sample regulate the cross section of impedance tuner 3, perhaps be equipped with the impedance tuner of different size.
Another side at described measurement chamber, preferably in the side relative with the importing side of testing sample sound wave conduction device 7 is set, described sound wave conduction device 7 can be conventional horn-like microphone or at least one acoustic waveguide tube, is used for sound wave is imported described measurement chamber 9.The inside and outside surface of described sound wave conduction device or acoustic waveguide tube preferably also is made of sound wave total reflection material coating.Preferably, locate with described sound wave conduction device or acoustic waveguide tube one antireflection device 10 to be set coaxially in the rear end (right side among Fig. 1) of described sound wave conduction device or acoustic waveguide tube, be used for to measure sound wave that chamber 9 transmits towards testing sample direction (for example left direction among Fig. 1) total reflection.Preferably, described antireflection device 10 is by constituting with impedance tuner 3 identical materials, perhaps constituted by other sound wave total reflection materials, also can use to apply the sound wave total reflection identical with the sidewall of measuring chamber at other materials and be coated with (plating) and layer constitute described antireflection device 10.Not oversize when described measurement chamber, during for example smaller or equal to 0.5 meter, also can need not to arrange described antireflection device 10.
Described sound wave conduction device 7 and speaker 6 couplings import in the described sound wave conduction device 7 in order to will measure with sound wave by the outfan of speaker.Can be input in the sound wave conduction device 7 by the sound wave that the method for any routine is exported speaker 6.The input of speaker 6 connects power amplifier 2, and this power amplifier 2 will input to speaker 6 after will amplifying from the sound wave of sonic generator 1.Usually, the preferred sine-wave generator that uses of sonic generator 1, the sine wave that its optional audible frequency scope is 1~100000Hz preferably uses the sound wave of 1600~8000Hz wave-length coverage, more preferably 2000Hz.When sonic generator 1 self has the power amplification function, just do not need to set up power amplifier 2 for measuring device of the present invention again, and can directly export satisfactory measurement sound wave to speaker 6.Ideally, when sonic generator 1 can directly produce when measuring required sound wave, except power amplifier, can also omit speaker 6.That is, sonic generator 1 and sound wave conduction device 7 directly are coupled.
Can adopt the existing conventional product for speaker 6 and power amplifier 2, as long as the sound wave that they can the coincidence measurement bioprosthesis valve requires.Power amplifier 2 and sonic generator 1 can be distinguished setting separately in addition, perhaps power amplifier can be arranged on the outer surface of measuring chamber 9 or other suitable positions.
A kind of alternate embodiments of the present invention is to connect and compose described measurement chamber 9 with described speaker 6 and described impedance tuner 3 are airtight.Specifically, described impedance tuner 3 is made of the steel plate materials of densification, and described speaker 6 docks keep sound wave seal as encapsulant with the respective side of impedance tuner 3 by laser weld and/or by elastane.Also can adopt other existing sonic seal modes that speaker 6 is docked with impedance tuner 3, thereby make the inner surface of speaker 6 and the inner surface of impedance tuner 3 constitute measurement chamber 9 jointly.
One end of sound wave conduction device 7 (left end among Fig. 1) is arranged to face with testing sample, and the other end (right-hand member among Fig. 1) also is of coupled connections with VU meter 5 except with speaker coupling is connected.According to actual needs, sound wave conduction device 7 can have the length in the scope from several centimetres to several meters, and for example 0.5-10 rice is preferably 0.5 meter to 5 meters scope.Preferably, as shown in Figure 1, when speaker 6 and impedance tuner 3 together constituted described measurement chamber 9, sound wave conduction device 7 mated with speaker 6 when passing speaker and is connected, in order to acoustic duct is gone into sound wave conduction device 7.In addition, similar with aforesaid hermetically-sealed construction, when sound wave conduction device 7 passes speaker 6, should keep the sound wave seal that connects between them.Simultaneously, an end that passes the sound wave conduction device 7 of speaker 6 is connected with VU meter 5 couplings to measuring outside extension of chamber, so that with the echo of detected materials after absorbing along with the importing side of incident acoustic wave in the opposite direction (among Fig. 1 to the right direction) enter sound wave conduction device 7, thereby sound wave conduction device 7 in the formation standing wave.VU meter 5 can be the acoustic measurement devices such as VU meter of measuring sound wave acoustic absorptivity or porosity.
VU meter 5 also is coupled with sonic generator 1 coupling.Preferably by data wire with sonic generator 1 and VU meter 5 (not shown) that is of coupled connections, so as to coordinate and 5 pairs of control VU meters via the measurement of the emission sound wave of sonic generator and/or power amplifier with in emission intermittently or afterwards to the measurement of reflective sound wave, thereby maximum and the minima of the standing wave sound press that the measurement incidence wave forms in sound wave conduction device 7 when sonic generator 1 emission measurement pulsed sound, and maximum and the minima of the standing wave sound press that in sound wave conduction device 7, forms at the echo of the measurements interpulse period of sonic generator 1 after detected materials absorbs, and calculate the acoustic absorptivity of material by the formula that this paper illustrates later.When using power amplifier 2, preferably between sonic generator 1, power amplifier 2 and VU meter 5, pass through data wire connection (not shown) coupled to each other, to realize above-mentioned identical coordination and control function.
In addition, preferably, VU meter 5 can with a scale 8 coupling, be used to refer to the other end that described sound wave conduction device 7 is shown and the distance between the testing sample.VU meter 5 can be slidably mounted on the scale 8, or by wheel etc., it can be slided at scale 8, move along the horizontal direction among Fig. 1 in order to drive sound wave conduction device 7, make can regulate sound wave conduction device 7 in measuring chamber the end and testing sample 14 between apart from d.This distance can be according to actual needs, by slip VU meter 5 and then push away/draw sound wave conduction device 7 and regulate.
Referring now to accompanying drawing 2 and 3 specimen holder 4 is described.Shape per sample, specimen holder 4 are divided into lid and two kinds of uncovereds.The operation principle of specimen holder 4 can similar piston operation principle, namely specimen holder 4 is complementary by the inner surface of sonic seal and described measurement chamber 9 circumferentially, and can be free to slide in measuring chamber 9 by lubricated wet goods lubriation material.For example, can guarantee the periphery of specimen holder 4 and the sound wave seal between measurement chamber 9 inner surfacies by elasticity O RunddichtringO (for example sealing ring that is constituted by nitrile rubber or silica gel etc.).Preferably, the shape of the neighboring of specimen holder matches with the cross sectional shape of the inner surface of measuring chamber 9, in order to realize the sound wave seal better.
The uncovered specimen holder is suitable for harder sample, and namely sample thickness is thicker, and perhaps sample is difficult for producing fold or distortion in fixing or measuring process.Specimen holder 4 is used for fixing testing sample towards the surface of sound wave conduction device 7.Concrete fixed form can adopt the buckle connected mode, namely as shown in Figure 2, two each other the snap ring of nested fastening (A, B) between fixing testing sample 14, arrange in the face of sound wave conduction device 7 in order to a surface of sample can directly be exposed to measure in the chamber 9.(A, B) diameter of the outer snap ring A in or profile should be slightly less than diameter or the cross sectional shape of measuring chamber to two snap rings, so that the snap ring that carries sample can be written into smoothly to be measured in the chamber, also maintenance is slidingly matched with the inwall of measuring chamber.In addition, the periphery of snap ring A can also further arrange outside, and elastic sealing ring for example is in order to keep measuring the sound wave seal of chamber 9.
When testing sample thinner or testing sample fixing or measure during when fold or deformation very easily take place, preferably use specimen holder that add a cover or that lid is arranged.As shown in Figure 3, described have cover specimen holder 4 with surface that testing sample contacts between a supporter or supporting construction 15 are set, this supporting construction 15 can be steel disc or iron plate etc., preferably this supporter has elasticity, thereby sample can be arched upward or forces sample to keep open and flat towards the surface of sound wave conduction device direction at least towards the direction of sound wave conduction device 7, in order to guarantee the accuracy measured.Can one handle 16 be set in the outside (left side among Fig. 3) of supporting construction 15, in order to support sample by external force auxiliary support structure 15.
The shape of covering that can also be designed to have sphere or convex surfaces at a side and the wall of interior snap ring B one-body moldedly, with this sphere or convex surfaces as described support body supports testing sample.But can also use other similarly fixing or deformation structure as described supporter.
Preferably, in order guarantee to measure the sound airtight performance in the chamber better, in the outside of specimen holder 4 (left end among Fig. 1), i.e. handle 16 1 ends, can also arrange one with sound wave conduction device 7 rear ends on the antireflection device 10 similar antireflection devices 13 that arrange.The diameter of antireflection device 13 or cross section can be slightly larger than the sample inlet of measuring chamber, so that complete airtight measurement chamber.Also can make antireflection device 13 and specimen holder together servo-actuated entering measure chamber 9, this moment need by and the inwall of the aforementioned similar sealing means neighboring that keeps the antireflection device and measurement chamber 9 between the sound wave seal.
In addition, can also be near the entrance of the measurement chamber 9 of specimen holder one side, projection or block (not shown) are set measuring chamber inner wall, excessively enter the measurement chamber in order to prevent specimen holder 4.
Have again, can also be by the diameter of nested fastening snap ring each other described in the above-mentioned embodiment being arranged than the slightly larger in diameter of measuring chamber, oppositely be socketed on the sample inlet of measuring chamber in order to will fix the snap ring of sample, and guarantee sound wave seal between snap ring inwall and the measurement chamber outer wall simultaneously.A surface of testing sample can be arranged in the face of sound wave conduction device 7 too in this way.Certainly, the outside (left side among Fig. 1) that is preferably in snap ring or sample arranges a sealing device, and for example, the sleeve (not shown) of the slightly larger in diameter of a described snap ring of being made by the steel plate materials of densification of ratio is as antireflection device 13.In addition, can also supporter same as the previously described embodiments be set for testing sample, to keep the planarization on testing sample surface.
In considering measuring process, may cause airborne oxygen and pericardium material generation Oxidation as sound bearing medium owing to measure the chamber heating, and then when having influence on the degree of accuracy that the porosity of pericardium material or acoustic absorptivity are measured, can consider to use nitrogen or carbon dioxide to wait to replace air, can stop effectively like this or the generation of inhibited oxidation effect, thus can the proper extension Measuring Time.But in this case, need to increase other necessary ancillary equipment, such as, import protective gas in the chamber as the device 12 of sound bearing medium (as nitrogen or carbon dioxide etc.) etc. to the device 11 of measuring the chamber evacuation and to measuring.Fig. 4 shows this embodiment.
Embodiment below with reference to above-mentioned measuring device further describes measuring method of the present invention.
The present invention with an end face of the acoustic waveguide tube of the sound wave conduction device 7 shown in Fig. 1 to the detected materials setting, produce the sound wave of particular measurement frequency by sonic generator (source of sound) and be input in the described measurement chamber simulation one plane wave sound field in the acoustic waveguide tube of sound wave conduction device 7 via amplifier, speaker, sound wave conduction device at the other end.After detected materials sound-absorbing and reflection, in acoustic waveguide tube, form standing wave at incident plane wave, measure maximum and the minimum of standing wave sound press under each audio frequency.
The sound absorbing capabilities of material can be represented with acoustic absorptivity α.Incide the sound wave of material surface, a part is reflected, and a part penetrates material internal and is absorbed.Ratio by the acoustic energy of absorbed and incident acoustic energy is called acoustic absorptivity or acoustic absorptivity.For total reflection surface, α=0; For the hypersorption surface, α=1; The absorptivity of general material is between 0 to 1.
After the maximum and minimum of measuring standing wave sound press under each audio frequency, converse the reflectance of material by following each formula again, and then obtain acoustic absorptivity.
Pi=(Pi_max+Pi_min)/2 (formula 1)
Pr=(Pr_max+Pr_min)/2 (formula 2)
R=Pr/Pi (formula 3)
α=1-(R) 2(formula 4)
Wherein, Pi_max is the maximum of incidence wave sound press, Pi_min is the minima of incidence wave sound press, Pr_max is the maximum of echo sound press, Pr_min is the minima of echo sound press, and Pi is the maximum of sound wave conduction device standing internal wave sound press, and Pr is the minima of sound wave conduction device standing internal wave sound press, R is the reflectance of artificial bio-prosthetic valve, and α is the acoustic absorptivity of artificial bio-prosthetic valve.
Preferably, VU meter 5 is designed to directly to demonstrate the value of acoustic absorptivity α of detected materials or porosity etc.
Describe concrete measuring method in detail referring now to Fig. 5.
At first, with testing sample, for example be fixed on the specimen holder 4 without bioprosthesis valve 14 physics or chemical modification or physics or chemical modification, and import and measure in the chamber 9 (step 100).Open sonic generator 1, power amplifier 2, VU meter 3.Regulate audible frequency and the power amplifier 2 of sonic generator as required.The measurement sound wave of preset frequency is imported measurement chamber 9 in the face of testing sample emission (step 102) by speaker 6 and sound wave conduction device 7.As required, regulate the end of sound wave conduction device in measuring chamber and the distance between the print to be measured along scale 8 slip VU meters 5, thus definite audio scan scope.During predetermined time, for example in 5 seconds to 1 minute, preferably in second, measure the acoustic absorptivity α (step 104) of detected materials by VU meter 5 at 5-10, or during the certain hour scope, determine the meansigma methods of α.
Alternatively; by reference to the accompanying drawings 4, if desired to measuring the chamber evacuation and injecting other protective gas as sound bearing medium, then can be before the step 102 of emission measurement sound wave; for example after importing sample, to measuring the chamber evacuation and injecting protective gas.
Behind the acoustic absorptivity of the sample of in advance measuring unprocessed mistake, will compare through sample acoustic absorptivity and the untreated sample acoustic absorptivity of physics or chemical modification processing back measurement, thereby determine whether modified effect comes up to the expectation.
The α value of the valve that experiment showed, unprocessed mistake by the present inventor is usually between 0.3-0.4.Further experiment confirm when the value of measured α during at 0.05-0.2, shows that the modified effect of bioprosthesis valve is good.Otherwise, show that modification or modification effect are not enough or cross modification.In addition, the value of α also depends on selected artificial valve's material category, and for example, when the cardiac valve of selecting pig or cattle for use during as raw material, the α value in its each stage can be slightly different each other.
Disposablely be, can also be separated into several airtight capacitors of sound each other with measuring chamber 9, and the sound wave that will have identical or different frequency imports in each capacitor by identical or different sound wave conduction device, be used for different samples is measured simultaneously, perhaps the standing wave that same sample is under the different frequency is measured, to determine the acoustic absorptivity of sample under the different frequency.
In addition, if possible, the also direct porosity of measuring samples, but not acoustic absorptivity perhaps by certain conversion method, is converted to measured acoustic absorptivity the expression-form of porosity.Vice versa.
Measuring device of the present invention can also be used for other material or the porosity of sample or the measurement of acoustic absorptivity.
Though described various preferred implementations, those skilled in the art can understand, under situation about not departing from by spirit of the present invention and protection domain, can carry out suitable change or modification.

Claims (12)

1. device that utilizes acoustic measurement bioprosthesis valve modification degree comprises:
Sonic generator, described sonic generator can be launched the measurement sound wave that is fit to measure the artificial bio-prosthetic valve membrane porosity;
Speaker, the outfan coupling of its input and sonic generator;
The sound wave conduction device, place one for the airtight measurement chamber of sound wave, to be imported in the described measurement chamber by the measurement sound wave that speaker sends by described sound wave conduction device, the sound wave output port of described sound wave conduction device is faced the testing sample setting, thereby will measure the sonic guide testing sample;
VU meter is of coupled connections with the other end coupling of described sound wave conduction device and with described sonic generator; And
Specimen holder is used for fixedly testing sample.
2. the device that utilizes acoustic measurement bioprosthesis valve modification degree as claimed in claim 1, wherein said specimen holder is two snap ring structures, be used between two snap ring structures fixedly testing sample, and the inner surface of the periphery of described pair of snap ring structure and described measurement chamber is slidingly matched.
3. the device that utilizes acoustic measurement bioprosthesis valve modification degree as claimed in claim 2, described specimen holder further comprises elastic support, and this elastic support can arch upward testing sample or force testing sample to keep open and flat towards the surface of sound wave conduction device direction at least towards described sound wave conduction device direction.
4. the device that utilizes acoustic measurement bioprosthesis valve modification degree as claimed in claim 1, wherein, described measurement chamber is impedance matching box, is used for regulating the acoustic impedance between the sound bearing medium of testing sample and measurement chamber.
5. the device that utilizes acoustic measurement bioprosthesis valve modification degree as claimed in claim 4 wherein, docks described speaker by laser weld with described impedance matching box, constitutes described measurement chamber jointly; And between described speaker and described sonic generator, a power amplifier is set also.
6. the device that utilizes acoustic measurement bioprosthesis valve modification degree as claimed in claim 5, each inner surface of wherein measuring in the chamber all is made of sound wave total reflection material.
7. the device that utilizes acoustic measurement bioprosthesis valve modification degree as claimed in claim 1, also comprise the scale that is slidingly matched with described VU meter, this scale is used in reference to the distance between the surface of described output port that described sound wave conduction device is shown and described testing sample.
8. the device that utilizes acoustic measurement bioprosthesis valve modification degree as claimed in claim 1 also arranges at least one sound wave antireflection device at sound wave conduction device described in the described measurement chamber away from an end place of testing sample and/or in the side that described specimen holder is measured chamber dorsad.
9. the device that utilizes acoustic measurement bioprosthesis valve modification degree as claimed in claim 1 wherein, also comprises to the device of measurement chamber evacuation with to measuring the device that is introduced as the protective gas of sound bearing medium in the chamber.
10. one kind is utilized acoustic measurement bioprosthesis valve modification degree methods, comprises the steps:
(a) testing sample is placed in the airtight measurement chamber of sound,
(b) to the measurement sound wave of testing sample emission preset frequency,
(c) by measuring acoustic absorptivity α or the porosity of testing sample, determine the modification degree of sample.
11. the method as claim 10, also comprise: repeating step (a) to (c) also records each measurement result, compare each measurement result or compare with standard value, to determine the modification degree of sample, wherein when acoustic absorptivity is in the scope of 0.05≤α≤0.2, show that the modification degree is good.
12. as the method for claim 10 or 11, (b) also comprises the steps: before in step
With airtight measurement chamber evacuation, charge into the protective gas as sound bearing medium then in the described measurement chamber.
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