CN101401732B - Ultrasonic measurement analytical system for bone substance density - Google Patents
Ultrasonic measurement analytical system for bone substance density Download PDFInfo
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Abstract
The invention discloses an ultrasound bone density measuring and analyzing system. The system comprises an ultrasound parameter measuring apparatus, a communication interface and a human machine interaction device, wherein the ultrasound parameter measuring apparatus comprises transmitting unit consisting of a pulse generator, a high-voltage pulse excitation module and a transmitting probe, an ultrasound receiving unit consisting of a receiving probe, a simulation pretreatment module, a gain adjustable amplifier, a phrase comparator, a high-speed ADC and an asynchronous FIFO, and a central processor, a power supply control module and a structural body. the human machine interaction device controls the ultrasound parameter measuring apparatus through the communication interface to measure the width of a calcaneus of a detected person, the transmission speed of an ultrasound wave in the calcaneus, broadband ultrasonic attenuation to calculate the bone intensity indexes and the bone density, so a medical report can be made according to diagnostic standards of osteoporosis and a special data base can be built for long term use. The system adopts wet or dry coupling and other technologies to improve the precision and accuracy of measure and has the advantages of easy carrying, low cost, no damage caused by radiation and can be use in long term monitoring of bone condition of the detected person.
Description
Affiliated field
The present invention relates to ultrasonic sensor technology and information analytical technology and the application on medical apparatus and instruments thereof, the ultrasonic measurement analytical system for compact bone substance density of particularly a kind of diagnosis of osteoporosis and monitoring.
Background technology
Osteoporosis is a kind of whole body dysostosis disease of serious harm human health.According to estimates, at present the whole world 200,000,000 people that have an appointment suffer from osteoporosis, and China also has 9,000 ten thousand people of surpassing to suffer from osteoporosis, and these numerals are in continuous growth.Simultaneously, osteoporosis constantly runs off with bone ore deposit composition and bone matrix equal proportion ground, the sclerotin attenuation, the density of bone and downgrade, bone strength descends, bone fragility increases and the risk of fractures degree raises, and (the especially fracture of lumbar vertebra, hip and wrist) be feature, and the slow lasting for years and without any symptom, fracture is first signal of trouble osteoporosis of bone loss.Therefore, osteoporosis is called as " epidemic diseases of mourning in silence ", belongs to one of human subhealth state class disease.The early diagnosis of osteoporosis, prevention and treatment monitoring become the difficult problem of international medical community and the focus of the interior research of world wide.
Osteoporosis is a feature with the density and the downgrade of bone, in numerous inspection means of osteoporosis, bone density measurement with its effectively, accurately, characteristics such as convenient, not damaged and diagnostic criteria quantification become the best quantitative approach of current diagnosis osteoporosis, prediction osteoporotic fracture and monitoring natural history or pharmaceutical intervention curative effect.
At present, existing in the world multiple bone density measurement method is as x-ray optical density method (RA), single photon absorptiometry (SPA), two-photon absorption method (DPA), dual energy X-ray absorptiometry (DEXA), quantitative CT method (QCT), quantitative ultrasound method (QUS) etc.
The RA method mainly calculates that by the difference of observing and contrast bone and standard body X-ray film bone density changes, thrown by the X line influences bigger according to condition and observer's subjective judgment, be mainly used in the observation of osteoporosis concurrency fracture, should not be used for bone density and accurately measure, the RA method is eliminated; Above SPA method is similar substantially with DPA method principle, and the photon that utilizes radioactive substance to produce is measured bone density by the osseous tissue absorptance, and its equipment is simple, cheap, but accuracy and repeatability are relatively poor, radiation damage is arranged, and need the professional and technical personnel to operate;
DEXA method principle is similar to the DPA method, just irradiation source changes the X ray tube into, produce the X ray of high and low two kinds of energy, obviously shorten sweep time, and the application of C-scan arm makes the DEXA method can measure the bone density of each section of whole body, precision and accuracy are higher than photon absorption, radiation dose is little, become the international goldstandard of measuring bone density, prediction fracture incidence rate, but instrument cost is higher, the inspection fee costliness can not reflect the structural information of bone;
The QCT method is a computed tomography method, has good resolution, but the testing cost costliness, radiation dose is also bigger.
Ultrasonic technique has been widely used in medical instruments field, uses such as the maturation of ultrasonic imaging technique on B ultrasonic instrument, color ultrasound instrument etc.Quantitative ultrasound method (Quantitative Ultrasound, QUS) utilize hyperacoustic reflection and penetrate decay and measure the bone density of surrounding bones such as calcaneus, hipbone, tibia and phalanges, its major parameter is velocity of ultrasonic sound SOS and broadband ultrasonic attenuation BUA, and the radiationless damage of ultrasound wave.
The QUS method can not only reflect bone amount information, can also reflect the structural information (being shape, size, bone trabecula spacing and the connection thereof of bone) and the elasticity of bone.The quantitative ultrasound method becomes the generaI investigation screening technique of osteoporosis first-selection with advantages such as its radiationless damage, good reproducibility, portable, simple to operate and cheapnesss.External existing multiple ultrasonic bone density instrument product comes out, but its technology externally blocks, and what diagnosing osteoporosis used is external standard, and particularly price is high, is difficult in domestic applying.
Look into new by retrieval, the patent No. be WO 03/032840 A2's " Ultrasoundmeasurement techniques for bone analysis " mainly estimate bone strength by the sound wave that bone is passed in measurement, by the non-linear material situation (as elasticity, how much degree of enclosing) of estimating bone of the acoustics of measuring bone.Advantage has been to use surface wave method, transmission beam method, back scattering method and bounce technique to obtain the velocity of ultrasonic sound SOS and the ultrasonic attenuation of bone, uses the second harmonic component analytical technology to analyze ultrasound echo signal, and the ultrasound information of contained bone is abundant.But described measuring technique is not carried out uncoupling to ultrasonic transmission on the interface and is handled, energy measurement bone density not, and experiment research just.The patent No. be CN 101199429A's " method and apparatus of ultrasonic bone assessment " a kind of method and apparatus that is used for the multiple character of bone is done the Position Research object heel bone area-of-interest of ultrasound wave assessment is disclosed.The patent No. be CN 1846631A's " ultrasonic bone evaluation apparatus " disclose a kind ofly to come the person under inspection is carried out the device that bone is estimated by the velocity of sound in the ultrasonic measurement person under inspection bone, a kind of structure composition of bone evaluation apparatus and the method for acoustic velocity measutement in the bone being carried out temperature correction have mainly been set forth in this invention.More than two inventions do not relate to the concrete technical characterictic that ultrasonic bone density is measured.The patent No. be CN2891973's " ultrasonic bone density measurement analysis device " disclose a kind of measurement velocity of ultrasonic sound SOS and ultrasonic amplitude and decay and judge osteoporotic device, between probe and tested position contact surface, do not use coupling process to the interface sound waves uncoupling, the just a kind of realization on the hardware frame, technical scheme lacks concrete analysis and enforcement in the device, and certainty of measurement and accuracy can't guarantee.
Summary of the invention
The objective of the invention is: at the deficiency of at present domestic and international technology and method, the ultrasonic measurement analytical system for compact bone substance density of a kind of diagnosis of osteoporosis and monitoring is proposed, this system adopts transmitting probe and the coaxial installation of receiving transducer (ultrasonic transducer) that machinery and electrical characteristic are mated fully to carry out hyperacoustic transmitting and receiving, between transmitting probe and receiving transducer and measured's contact surface, adopt dry type coupling or wet type coupling that sound wave is better propagated between different medium, improve certainty of measurement and accuracy.Velocity of ultrasonic sound, broadband ultrasonic attenuation and the bone density of measured's calcaneus can accurately be measured by this system, according to corresponding diagnostic criteria osteoporosis diagnosed and monitored.
Technical scheme of the present invention is: a kind of ultrasonic measurement analytical system for compact bone substance density, comprise the ultrasound parameter measuring instrument, the ultrasound parameter measuring instrument comprises ultrasound emission unit, ultrasonic receiving element, central processing unit, power management module and structural body, and described central processing unit is electrically connected with ultrasound emission unit, ultrasonic receiving element, power management module and structural body are interactive respectively;
Described ultrasound emission unit comprises transmitting probe in order to launch the ultrasound wave of certain bandwidth;
Described ultrasonic receiving element comprises receiving transducer, simulation pretreatment module, gain adjustable amplifier and the high-speed ADC of mutual electrical connection in order to receive the ultrasound wave that penetrates calcaneus in measured's heel portion of ultrasound emission unit emission;
Described central processing unit is in order to control ultrasound emission unit, ultrasonic receiving element, power management module and structural body, and the signal that ultrasonic receiving element obtains handled and calculate, simultaneously, data after central processing unit will be handled upload to the human-computer interaction device by communication interface, and operation response is carried out in the instruction that the human-computer interaction device issues;
Described power management module is in order to provide each unit operate as normal of ultrasound parameter measuring instrument required voltage and current, and providing overvoltage, low pressure and electric leakage safeguard protection to the ultrasound parameter measuring instrument, power management module is electrically connected with the 220V alternating current by the power line with single-phase three-prong plug;
Described communication interface is in order to be electrically connected the central processing unit in the ultrasound parameter measuring instrument with the human-computer interaction device is interactive;
Described human-computer interaction device is in order to issuing operational order to central processing unit, and the data that central processing unit is uploaded are calculated and analyzed, show, preserve or print simultaneously measure, analysis result;
Particularly: described ultrasound parameter measuring instrument carries RS 232 serial ports and USB interface, and communication interface is in order to be electrically connected the central processing unit in the ultrasound parameter measuring instrument with the human-computer interaction device is interactive;
Described ultrasound emission unit also comprises high-voltage pulse excitation module and pulse generator, the high-voltage pulse excitation module is come the ultrasound wave of the certain bandwidth of stimulated emission probe emission in order to the high pressure negative pulse that excites certain amplitude, comprise D.C. regulated power supply module, high back voltage transistors, RC charge-discharge circuit and shunt inductance tuning circuit, D.C. regulated power supply module output voltage linearity is adjustable, scope is 0～500V, linear regulation voltage 0～5V, output current 5mA;
Described pulse generator comprises oscillation source and auxiliary circuit, produce frequency and transmitting probe and the consistent pulse train of receiving transducer mid frequency, this pulse train excites the high pressure negative pulse of certain amplitude in order to cooperate the high-voltage pulse excitation module, the amplitude of the high pressure negative pulse that is excited is adjustable between 12V～500V, pulse width is lower than 1us, and 1us is half of transmitting probe and receiving transducer mid frequency inverse;
Transmitting probe in the described ultrasound emission unit and receiving transducer are the direct contact type ultrasonic transducer based on piezoelectric effect, described transmitting probe has identical electric and mechanical property with receiving transducer, comprise identical mid frequency, bandwidth, wafer size, frame for movement and size, the mid frequency of transmitting probe and receiving transducer be 0.5MHz, frequency band range within 0.3MHz～0.8MHz, output sound intensity is lower than 10mW/cm
2
Fill between described transmitting probe and receiving transducer and the measured's heel portion contact surface or the coating medical ultrasonic coupling agent, to reduce ultrasonic interface loss between air and measured's heel portion, make ultrasound wave effectively transmission between transmitting probe and receiving transducer and measured's heel portion, select wet type coupling or dry type coupling for use according to the soft tissue thickness degree of measured's heel portion;
Described wet type coupling charges and discharge water for the water bag that is clipped between transmitting probe and receiving transducer and the measured's heel portion by the constant temperature supply and drain water system, and guarantees that the water temperature in the water bag is constant in 36 ℃; Described dry type coupling is coating one deck medical ultrasonic coupling agent between transmitting probe and receiving transducer and measured's heel portion contact surface, and medical ultrasonic coupling agent is the aqueous high molecular gel-type preparation;
Described ultrasonic receiving element also comprises phase comparator and asynchronous FIFO, and wherein, phase comparator is a kind of integrated circuit, and the intervalometer that compares to cooperate central processing unit to carry by the phase place to two signals carries out accurate timing;
Described high-speed ADC is 12 above analog-digital conversion ics, more than the switching rate 20MSPS, can satisfy the requirement of the ultrasonic signal that receives being carried out fast fourier transform, and high-speed ADC is electrically connected with phase comparator;
Described asynchronous FIFO is the asynchronous buffer device, the real-time Transmission of data between high-speed ADC that the realization clock zone is different and the human-computer interaction device, and asynchronous FIFO adopts the monolithic or the mode of multi-disc cascade and the data width of high-speed ADC to be complementary;
Described structural body is in order to transmitting probe and coaxial installation of receiving transducer and location, be fixed on the both sides of calcaneus in measured's heel portion, measure the width of measured's calcaneus simultaneously along transmitting probe and receiving transducer coaxial line direction, described structural body comprises in order to place the groove of measured's sole, in order to the gripper shoe at support measured shank back with in order to the location, fixed transmission probe and receiving transducer and the location survey mechanism of measuring width of calcaneus WOB, groove is installed in the location survey mechanism, gripper shoe is installed in the location survey mechanism by guide rail, and gripper shoe is freely adjusted height as required and the angle of inclination makes measured's foot be in comfortable posture;
Described ultrasonic measurement analytical system for compact bone substance density is measured width W OB and the velocity of ultrasonic sound SOS and the broadband ultrasonic attenuation BUA of measured's calcaneus, bone strength index STI and bone density BMD according to velocity of ultrasonic sound SOS that records and broadband ultrasonic attenuation BUA calculating measured, described velocity of ultrasonic sound SOS is compressional wave and shearing wave spread speed synthetic in measured's calcaneus, described broadband ultrasonic attenuation BUA is that ultrasound wave is penetrating measured's the attenuation of calcaneus front and back amplitude on frequency spectrum, and described ultrasonic measurement analytical system for compact bone substance density regularly carries out quality self-assessment to guarantee measurement accuracy.
As a further improvement of existing technologies, the ultrasonic signal be made up of so that receiving transducer is received overvoltage crowbar, filter circuit and primary amplifier of described simulation pretreatment module carries out pretreatment; Described gain adjustable amplifier is a kind of integrated circuit, gain adjustable amplifier is regulated its amplification, the measurement occasion when measured's bone being arranged and do not have measured's bone between transmitting probe and receiving transducer in order to adapt to automatically according to simulation pretreatment module outfan output signal amplitude size; Described communication interface uses RS232 serial ports or CAN-USB interface adapter, and described human-computer interaction device is the desk computer or the notebook computer of band serial ports or USB interface.
" ultrasonic bone density measurement analysis device " discloses a kind of measurement velocity of ultrasonic sound SOS and ultrasonic amplitude and decays and judge osteoporotic device in the beneficial effect prior art, between probe and tested position contact surface, do not use coupling process to the interface sound waves uncoupling, the prior art is a kind of realization on the hardware frame, technical scheme lacks concrete analysis and enforcement in the device, and certainty of measurement and accuracy can't guarantee.With respect to prior art, the invention has the beneficial effects as follows:
Among one, the present invention, transmitting probe in the ultrasound emission unit and receiving transducer are the direct contact type ultrasonic transducer based on piezoelectric effect, transmitting probe has identical electric and mechanical property with receiving transducer, comprise identical mid frequency, bandwidth, wafer size, frame for movement and size, the mid frequency of transmitting probe and receiving transducer be 0.5MHz, frequency band range within 0.3MHz～0.8MHz, output sound intensity is lower than 10mW/cm
2
Fill between transmitting probe and receiving transducer and the measured's heel portion contact surface or the coating medical ultrasonic coupling agent, to reduce ultrasonic interface loss between air and measured's heel portion, make ultrasound wave effectively transmission between transmitting probe and receiving transducer and measured's heel portion, select wet type coupling or dry type coupling for use according to the soft tissue thickness degree of measured's heel portion;
The wet type coupling charges and discharge water for the water bag that is clipped between transmitting probe and receiving transducer and the measured's heel portion by the constant temperature supply and drain water system, and guarantees that the water temperature in the water bag is constant in 36 ℃; The dry type coupling is coating one deck medical ultrasonic coupling agent between transmitting probe and receiving transducer and measured's heel portion contact surface, and medical ultrasonic coupling agent is the aqueous high molecular gel-type preparation;
Structural body is in order to transmitting probe and coaxial installation of receiving transducer and location, be fixed on the both sides of calcaneus in measured's heel portion, measure the width of measured's calcaneus simultaneously along transmitting probe and receiving transducer coaxial line direction, structural body comprises in order to place the groove of measured's sole, in order to the gripper shoe at support measured shank back with in order to the location, fixed transmission probe and receiving transducer and the location survey mechanism of measuring width of calcaneus WOB, groove is installed in the location survey mechanism, gripper shoe is installed in the location survey mechanism by guide rail, and gripper shoe is freely adjusted height as required and the angle of inclination makes measured's foot be in comfortable posture;
With respect to prior art, the present invention adopts transmitting probe and the coaxial installation of receiving transducer (ultrasonic transducer) that machinery and electrical characteristic are mated fully to carry out hyperacoustic transmitting and receiving, between transmitting probe and receiving transducer and measured's contact surface, adopt dry type coupling or wet type coupling that sound wave is better propagated between different medium, improve certainty of measurement and accuracy; And selecting mid frequency for use is 0.5MHz, transmitting probe and the receiving transducer of bandwidth in 0.3MHz～0.8MHz scope, and the broadband ultrasonic attenuation BUA and the frequency of bone are linear substantially in this frequency band range, and measurement accuracy is higher;
Two, among the present invention, the ultrasound emission unit also comprises the high-voltage pulse excitation module and the pulse generator of mutual electrical connection, the high-voltage pulse excitation module is come the ultrasound wave of the certain bandwidth of stimulated emission probe emission in order to the high pressure negative pulse that excites certain amplitude, comprise D.C. regulated power supply module, high back voltage transistors, RC charge-discharge circuit and shunt inductance tuning circuit, D.C. regulated power supply module output voltage linearity is adjustable, scope is 0～500V, linear regulation voltage 0～5V, output current 5mA;
Pulse generator comprises oscillation source and auxiliary circuit, produce frequency and transmitting probe and the consistent pulse train of receiving transducer mid frequency, pulse train excites the high pressure negative pulse of certain amplitude in order to cooperate the high-voltage pulse excitation module, the amplitude of the high pressure negative pulse that is excited is adjustable between 12V～500V, pulse width is lower than 1us, and 1us is half of transmitting probe and receiving transducer mid frequency inverse;
The ultrasonic signal that the simulation pretreatment module is made up of so that receiving transducer is received overvoltage crowbar, filter circuit and primary amplifier carries out pretreatment;
Gain adjustable amplifier is a kind of integrated circuit, gain adjustable amplifier is regulated its amplification, the measurement occasion when measured's bone being arranged and do not have measured's bone between transmitting probe and receiving transducer in order to adapt to automatically according to simulation pretreatment module outfan output signal amplitude size;
With respect to prior art, the present invention adopts multistage adjustable amplification and noise cancellation technology, it is adjustable between 12V～500V to launch the required pulse amplitude of ultrasound wave, and its pulse width is lower than 1us, 1us is half of transmitting probe and receiving transducer mid frequency inverse, makes the better effects if of transmitting probe excitation ultrasound ripple; Use gain adjustable amplifier that the signal that receiving transducer receives is carried out the Gain Adjustable processing and amplifying, adapt to and improve certainty of measurement when different measuring requires;
Three, among the present invention, ultrasonic receiving element also comprises phase comparator and asynchronous FIFO, and phase comparator is a kind of integrated circuit, and the intervalometer that compares to cooperate central processing unit to carry by the phase place to two signals carries out accurate timing;
High-speed ADC is 12 above analog-digital conversion ics, more than the switching rate 20MSPS, can satisfy the requirement of the ultrasonic signal that receives being carried out fast fourier transform, and high-speed ADC is electrically connected with phase comparator;
Asynchronous FIFO is the asynchronous buffer device, the real-time Transmission of data between high-speed ADC that the realization clock zone is different and the human-computer interaction device, and asynchronous FIFO adopts the monolithic or the mode of multi-disc cascade and the data width of high-speed ADC to be complementary;
The present invention adopts phase comparator to improve accuracy of timekeeping, adopt high-speed AD converter realization data to gather fast, adopt asynchronous FIFO to realize the real-time Transmission of data between different clock-domains, use fast fourier transform method that signal is carried out spectrum analysis to calculate broadband ultrasonic attenuation, these The Application of Technology obviously improve the certainty of measurement and the repeatability of velocity of ultrasonic sound and broadband ultrasonic attenuation, reflect the density and the structure of measured's bone simultaneously;
They are four years old, among the present invention, structural body is in order to transmitting probe and coaxial installation of receiving transducer and location, be fixed on the both sides of measured's heel portion calcaneus, measure the width of measured's calcaneus simultaneously along transmitting probe and receiving transducer coaxial line direction, structural body comprises in order to place the groove of measured's sole, in order to the gripper shoe at support measured shank back with in order to the location, fixed transmission probe and receiving transducer and the location survey mechanism of measuring width of calcaneus WOB, groove is installed in the location survey mechanism, gripper shoe is installed in the location survey mechanism by guide rail, and gripper shoe is freely adjusted height as required and the angle of inclination makes measured's foot be in comfortable posture;
The ultrasound parameter measuring instrument carries RS232 serial ports and USB interface, communication interface uses RS232 serial ports or CAN-USB interface adapter, the human-computer interaction device is the desk computer or the notebook computer of band serial ports or USB interface, and communication interface is electrically connected the ultrasound parameter measuring instrument with the human-computer interaction device is interactive;
Structural design of the present invention is followed the ergonomics principle, and structural designs such as groove that employing can freely be adjusted in location survey mechanism and gripper shoe make operator and measured be in comfortable position; Simultaneously, system interface is abundant, and RS232 serial ports and CAN-USB interface are arranged, and the human-computer interaction device who helps being not limited to desk computer and notebook computer is integrated in the system, uses the CAN-USB interface to help the system integration and longer-distance transfer of data; Measuring Time of the present invention is short, is no more than 30 seconds, when the human-computer interaction device uses notebook computer, can form portable measurement analytical system for compact bone substance density;
They are five years old, among the present invention, ultrasonic measurement analytical system for compact bone substance density is measured width W OB and the velocity of ultrasonic sound SOS and the broadband ultrasonic attenuation BUA of measured's calcaneus, bone strength index STI and bone density BMD according to velocity of ultrasonic sound SOS that records and broadband ultrasonic attenuation BUA calculating measured, velocity of ultrasonic sound SOS is compressional wave and shearing wave spread speed synthetic in measured's calcaneus, broadband ultrasonic attenuation BUA is that ultrasound wave is penetrating measured's the attenuation of calcaneus front and back amplitude on frequency spectrum, and ultrasonic measurement analytical system for compact bone substance density regularly carries out quality self-assessment to guarantee measurement accuracy;
The present invention calculates measured's bone strength index STI, bone density BMD standard deviation T value and the Z value with respect to matched group, the inorganic salt in introducing constitutional index (BMI) and the body composition analysis and the ratio of non-fatty material improve sclerotin status monitoring accuracy rate, change application software and can also be used for bone-age determination.
In addition, the present invention selects to be rich in the calcaneus of spongy bone as the measuring point, the bone turnover rate of spongy bone is higher 8 times than the bone turnover rate of cortical bone, it is higher than cortical bone to osteoporosis sensitivity, measurement and diagnostic accuracy are higher, and its surrounding soft tissue is thinner, and is little to the measurement result influence, and it is convenient to measure; And, the present invention adopts the quantitative ultrasound method (QUS) of Non-ionizing radiation to measure the human body bone density, the early diagnosis, prevention and the curative effect monitoring that are used for osteoporosis, overcome employing dual energy X-ray absorptiometry ionizing radiation such as (DEXA) method radiation damage, cost height, take up an area of shortcomings such as face amount is big, be applicable to the different crowd that comprises child and anemia of pregnant woman, be fit to community or domestic.
Description of drawings
The present invention is described further below in conjunction with drawings and Examples.
Fig. 1 is a population structure sketch map of the present invention;
Fig. 2 is the theory diagram of ultrasound parameter measuring instrument among the present invention;
Fig. 3 is the sketch map of ultrasonic coupling process among the present invention;
Fig. 4 is a workflow diagram of the present invention.
The specific embodiment
Fig. 1 is a population structure sketch map of the present invention.The 1st, ultrasound parameter measuring instrument, the 2nd, communication interface, the 3rd, human-computer interaction device.Wherein, ultrasound parameter measuring instrument 1 is made up of ultrasound emission unit 11, ultrasonic receiving element 13, central processing unit 14, power management module 15 and structural body 16, and power management module 15 is electrically connected with the 220V alternating current by the power line with single-phase three-prong plug.
Ultrasound parameter measuring instrument 1 is electrically connected with human-computer interaction device 3 by communication interface 2 forms ultrasonic measurement analytical system for compact bone substance density, width of calcaneus WOB, velocity of ultrasonic sound SOS, the broadband ultrasonic attenuation BUA of calcaneus 121 in this systematic survey measured heel portion 12, analyze, calculate bone density BMD, bone strength STI, T value, Z value by human-computer interaction device 3, whether osteoporosis reaches that its sclerotin state is monitored according to corresponding diagnostic criteria diagnosis measured.
Fig. 2 is the theory diagram of ultrasound parameter measuring instrument among the present invention.Form ultrasound emission unit 11 to launch the ultrasound wave of certain bandwidth by transmitting probe 111, high-voltage pulse excitation module 112 and the pulse generator 113 of mutual electrical connection.Receiving transducer 131, simulation pretreatment module 132, gain adjustable amplifier 133, phase comparator 134, high-speed ADC 135 and asynchronous FIFO 136 by mutual electrical connection are formed ultrasonic receiving element 13 to receive the ultrasound wave that penetrates calcaneus 121 measured's heel portion 12 of 11 emissions from the ultrasound emission unit.
By groove 161, the structural body 16 that location survey mechanism 162 and gripper shoe 163 are formed is with transmitting probe 111 and receiving transducer 131 coaxial installation and location, fixing both sides of calcaneus 121 in measured's heel portion 12, measure the width of measured's calcaneus 121 simultaneously along transmitting probe 111 and receiving transducer 131 coaxial line directions, wherein, groove 161 is in order to place measured's sole, gripper shoe 163 is in order to support measured's shank back, location survey mechanism 162 makes it to aim at measured's calcaneus 121 and contact the width W OB that fixes transmitting probe 111 and receiving transducer 131 and measure calcaneus 121 with it in order to location transmitting probe 111 and receiving transducer 131.Groove 161 is installed in the location survey mechanism 162, and gripper shoe 163 is installed in the location survey mechanism 162 by guide rail, and gripper shoe 163 is freely adjusted height as required and the angle of inclination makes measured's foot be in comfortable posture.
Fig. 3 is the sketch map of ultrasonic coupling process among the present invention.In order to reduce ultrasonic interface loss between air and measured's heel portion as far as possible, make ultrasound wave more effectively transmission between transmitting probe 111 and receiving transducer 131 and measured's heel portion 12, the present invention uses ultrasonic coupling process, comprises wet type coupling and dry type coupling.Wherein, the wet type coupling is respectively to press from both sides a thin transparent water bag 41 between transmitting probe 111 and receiving transducer 131 and measured's heel portion 12 contact surfaces, and constant temperature supply and drain water system 42 charges and discharge water for water bag 41, and guarantees that the water temperature in the water bag 41 is constant in 36 ℃; The dry type coupling is to fill between transmitting probe 111 and receiving transducer 131 and measured's heel portion 12 contact surfaces or coating one deck medical ultrasonic coupling agent 51, and medical ultrasonic coupling agent 51 is the aqueous high molecular gel-type preparation.Can judge that the soft tissue thickness degree of measured's heel portion 12 selects for use wet type to be coupled or dry type is coupled according to range estimation and constitutional index (BMI).
Fig. 4 is a workflow diagram of the present invention.The system works flow process is as follows:
Step 100: ultrasound parameter measuring instrument 1 and human-computer interaction device 3 are connected with the mains, and they are electrically connected, start by communication interface 2;
Step 200: whether check system has mechanical breakdown and electrical safety hidden danger, then can not enter step 400;
Step 300: then maintenance is arranged, get rid of potential safety hazard and re-use;
Step 400: human-computer interaction device 3 sends initialization command by communication interface 2 to ultrasound parameter measuring instrument 1, and with each unit in the ultrasound parameter measuring instrument 1 and module hardware initialization, system carries out quality self-assessment, and all normally then can begin to measure;
Step 500: input measured essential information in human-computer interaction device 3, measured's essential information comprises: name, age, height (H), body weight (W), constitutional index (BMI, BMI=H/W
2, unit: kg/m
2), the native place, have or not osteoporosis or fracture medical history, tested foot (left side/right side), preservation information to set up measured's information bank in order to subsequent query with analyze and use;
Step 600: according to measured's heel portion 12 soft tissue thickness degree select for use wet type coupling or dry type coupling with coaxial mounted transmitting probe 111 and receiving transducer 131 respectively with measured's calcaneus 121 couplings, and transmitting probe 111 and receiving transducer 131 be positioned to measured's calcaneus 121 positions, measure measured's calcaneus 121 width W OB, the ultrasound wave of the certain bandwidth of ultrasound emission unit 11 emissions penetrates measured's calcaneus 121, ultrasonic receiving element 13 receives and handles ultrasonic signal, and 14 pairs of data of central processing unit are carried out computing and upload the data among the human-computer interaction device 3;
Step 700: human-computer interaction device 3 calculates, analyze the measurement data that ultrasound parameter measuring instrument 1 is uploaded, calculate measured's width of calcaneus WOB, velocity of ultrasonic sound SOS and broadband ultrasonic attenuation BUA, calculate bone strength index STI and bone density BMD according to velocity of ultrasonic sound SOS and broadband ultrasonic attenuation BUA, select corresponding bone density reference database to calculate T value and Z value according to measured's essential information by the specialist system in the ultrasonic measurement analytical system for compact bone substance density, introducing inorganic salt and the ratio of non-fatty material in constitutional index (BMI) and the body composition analysis assists bone density BMD to contrast whether osteoporosis of diagnosis of osteoporosis standard diagnostics measured, provide the fracture risk early warning, and show, preserve or print simultaneously and measure, analysis result, set up complete measured's information bank in order to subsequent applications, the measurement back location survey mechanism 162 that finishes resets into the original state of spacing maximum with transmitting probe 111 and receiving transducer 131, and the tester shifts out foot (left side/right side).
Embodiment:
Ultrasound parameter measuring instrument 1 and human-computer interaction device 3 are connected with the mains, and by communication interface 2 they are electrically connected, start, whether check system has mechanical breakdown and electrical safety hidden danger, then can not prepare to measure.
Human-computer interaction device 3 sends initialization command by the central processing unit 14 of communication interface 2 in ultrasound parameter measuring instrument 1, with each unit and the module initialization in the ultrasound parameter measuring instrument 1, power management module 15 provides operate as normal required voltage and current for ultrasound parameter measuring instrument 1 each unit, system carries out quality self-assessment, and all normally then can begin to measure.
Input measured essential information on human-computer interaction device 3 is preserved to set up measured's information bank and is used in order to subsequent query and analysis.Location survey mechanism 162 in the structural body 16 resets into transmitting probe 111 and receiving transducer 131 original state of spacing maximum, the tester is placed on sole (left side/right side) in the groove 161, adjusting gripper shoe 163 makes it just support measured's shank back, make measuring process comfortable, easily, adjust heel, calcaneus 121 is just between the coaxial transmitting probe 111 and receiving transducer 131 that is installed in the location survey mechanism 162 in this moment measured heel portion 12, and uses 36 ℃ of water of constant temperature or medical ultrasonic coupling agent to be coupled between transmitting probe 111 and receiving transducer 131 and measured's heel contact surface.Send measuring command by human-computer interaction device 3, begin to measure, location survey mechanism 162 closely contacts transmitting probe 111 with measured's heel portion 12 respectively by the medical ultrasonic coupling agent 51 in water bag 41 in the wet type coupling or the dry type coupling with receiving transducer 131, and measurement measured calcaneus 121 width W OB, in human-computer interaction device 3, survey WOB value is done follow-up Nonlinear Processing, to eliminate the influence of soft tissue.It is that 0.5MHz, pulsewidth 1us, amplitude adjustable high pressure negative pulse between 12V～500V makes transmitting probe 111 resonance with the excitation ultrasound ripple that high-voltage pulse excitation module 112 and pulse generator 113 collaborative works produce frequency.
Receiving transducer 131 receives the ultrasonic simulation signal of launching from transmitting probe 111 that ultrasound wave produced that penetrates calcaneus 121 measured's heel portion 12; the ultrasonic simulation signal that 132 pairs of pretreatment module of simulation receive carries out overvoltage protection; pretreatment such as filtering and elementary amplification; according to simulation pretreatment module 132 outfan output signal amplitude sizes; automatically 133 pairs of ultrasonic simulation signals of gain adjustable amplifier of regulating amplification carry out secondary and amplify; phase comparator 134 is gathered and the accurate Calculation interval signal with high-speed ADC 135 collaborative works; the data that 136 pairs of high-speed ADCs 135 of asynchronous FIFO collect are carried out buffer memory and are transferred among the human-computer interaction device 3 with the data in real time of realization with different clock-domains; above each unit of operational order control and module work that central processing unit 14 response human-computer interaction devices 3 issue are carried out computing to data.
Human-computer interaction device 3 calculates, analyzes the measurement data that ultrasound parameter measuring instrument 1 is uploaded, and calculates velocity of ultrasonic sound SOS and broadband ultrasonic attenuation BUA, and wherein broadband ultrasonic attenuation BUA is normalized result, and unit is: dB/MHzcm.Human-computer interaction device 3 calculates bone strength index STI and bone density BMD according to velocity of ultrasonic sound SOS and broadband ultrasonic attenuation BUA, select corresponding bone density reference database to calculate T value and Z value according to measured's essential information by specialist system, introducing inorganic salt and the ratio of non-fatty material in constitutional index (BMI) and the body composition analysis assists bone density BMD to contrast whether osteoporosis of diagnosis of osteoporosis standard diagnostics, provide the early warning of measured's fracture risk, demonstration is also preserved measurement, analysis result, sets up complete measured's information bank in order to subsequent applications.Can also carry out long term monitoring to estimate measured's bone loss rate or osteoporosis treatment effect.
Whole measuring process is finished in about 30 seconds, measures the back location survey mechanism 162 that finishes transmitting probe 111 and receiving transducer 131 are reset into the original state of spacing maximum, and the tester shifts out foot (left side/right side).
Obviously, those skilled in the art can carry out various changes and modification to the present invention and not break away from the spirit and scope of the present invention.Like this, if of the present invention these are revised and modification belongs within the scope of claim of the present invention and equivalent technologies thereof, then the present invention also is intended to comprise these changes and modification interior.
Claims (4)
1. ultrasonic measurement analytical system for compact bone substance density, comprise ultrasound parameter measuring instrument (1), described ultrasound parameter measuring instrument (1) comprises ultrasound emission unit (11), ultrasonic receiving element (13), central processing unit (14), power management module (15) and structural body (16), and described central processing unit (14) is electrically connected with ultrasound emission unit (11), ultrasonic receiving element (13), power management module (15) and structural body (16) are interactive respectively;
Described ultrasound emission unit (11) comprises transmitting probe (111) in order to launch the ultrasound wave of certain bandwidth;
Described ultrasonic receiving element (13) is in order to receive the ultrasound wave that penetrates calcaneus (121) in measured's heel portion (12) of ultrasound emission unit (11) emission, and described ultrasonic receiving element (13) comprises receiving transducer (131), simulation pretreatment module (132), gain adjustable amplifier (133) and the high-speed ADC (135) of mutual electrical connection;
Described central processing unit (14) is in order to control ultrasound emission unit (11), ultrasonic receiving element (13), power management module (15) and structural body (16), and the signal that ultrasonic receiving element (13) obtains handled and calculate, simultaneously, data after described central processing unit (14) will be handled upload to human-computer interaction device (3) by communication interface (2), and operation response is carried out in the instruction that human-computer interaction device (3) issues;
Described power management module (15) is in order to provide each unit operate as normal of ultrasound parameter measuring instrument (1) required voltage and current, and providing overvoltage, low pressure and electric leakage safeguard protection to ultrasound parameter measuring instrument (1), described power management module (15) is electrically connected with the 220V alternating current by the power line with single-phase three-prong plug;
Described human-computer interaction device (3) is in order to issuing operational order to central processing unit (14), and the data that central processing unit (14) is uploaded are calculated, analyzed, show, preserve or print simultaneously measure, analysis result;
It is characterized in that: described ultrasound parameter measuring instrument (1) carries RS232 serial ports and USB interface, and described communication interface (2) is in order to be electrically connected the central processing unit (14) in the ultrasound parameter measuring instrument (1) with human-computer interaction device (3) is interactive;
Described ultrasound emission unit (11) also comprises the high-voltage pulse excitation module (112) and the pulse generator (113) of mutual electrical connection, described high-voltage pulse excitation module (112) is come the ultrasound wave of the certain bandwidth of stimulated emission probe (111) emission in order to the high pressure negative pulse that excites certain amplitude, described ultrasound emission unit (11) comprises the D.C. regulated power supply module, high back voltage transistors, RC charge-discharge circuit and shunt inductance tuning circuit, described D.C. regulated power supply module output voltage linearity is adjustable, scope is 0～500V, linear regulation voltage 0～5V, output current 5mA;
Described pulse generator (113) comprises oscillation source and auxiliary circuit, produce frequency and transmitting probe (111) and the consistent pulse train of receiving transducer (131) mid frequency, described pulse train excites the high pressure negative pulse of certain amplitude in order to cooperate high-voltage pulse excitation module (112), the amplitude of the high pressure negative pulse that is excited is adjustable between 12V～500V, pulse width is lower than 1us, and 1us is half of transmitting probe (111) and receiving transducer (131) mid frequency inverse;
Transmitting probe (111) in the described ultrasound emission unit (11) and receiving transducer (131) are the direct contact type ultrasonic transducer based on piezoelectric effect, described transmitting probe (111) has identical electric and mechanical property with receiving transducer (131), comprise identical mid frequency, bandwidth, wafer size, frame for movement and size, the mid frequency of described transmitting probe (111) and receiving transducer (131) be 0.5MHz, frequency band range within 0.3MHz～0.8MHz, output sound intensity is lower than 10mW/cm
2
Fill between described transmitting probe (111) and receiving transducer (131) and measured's heel portion (12) contact surface or the coating medical ultrasonic coupling agent, to reduce ultrasonic interface loss between air and measured's heel portion (12), make ultrasound wave effectively transmission between transmitting probe (111) and receiving transducer (131) and measured's heel portion (12), select wet type coupling or dry type coupling for use according to the soft tissue thickness degree of measured's heel portion (12);
Described wet type coupling charges and discharge water for the water bag (41) that is clipped between transmitting probe (111) and receiving transducer (131) and the measured's heel portion (12) by constant temperature supply and drain water system (42), and guarantees that the water temperature in the water bag (41) is constant in 36 ℃; Described dry type coupling is to fill between transmitting probe (111) and receiving transducer (131) and measured's heel portion (12) contact surface or coating one deck medical ultrasonic coupling agent (51), and medical ultrasonic coupling agent (51) is the aqueous high molecular gel-type preparation;
Described ultrasonic receiving element (13) also comprises phase comparator (134) and asynchronous FIFO (136), described phase comparator (134) is a kind of integrated circuit, and the intervalometer that compares to cooperate central processing unit (14) to carry by the phase place to two signals carries out accurate timing;
Described high-speed ADC (135) is 12 above analog-digital conversion ics, more than the switching rate 20MSPS, can satisfy the requirement of the ultrasonic signal that receives being carried out fast fourier transform, and high-speed ADC (135) is electrically connected with phase comparator (134);
Described asynchronous FIFO (136) is the asynchronous buffer device, the real-time Transmission of data between high-speed ADC (135) that the realization clock zone is different and the human-computer interaction device (3), asynchronous FIFO (136) adopt the monolithic or the mode of multi-disc cascade and the data width of high-speed ADC (135) to be complementary;
Described structural body (16) is in order to transmitting probe (111) and coaxial installation of receiving transducer (131) and location, be fixed on the both sides of calcaneus (121) in measured's heel portion (12), measure the width of measured's calcaneus (121) simultaneously along transmitting probe (111) and receiving transducer (131) coaxial line direction, described structural body (16) comprises in order to place the groove (161) of measured's sole, in order to the gripper shoe (163) at support measured shank back with in order to the location, fixed transmission probe (111) and receiving transducer (131) and the location survey mechanism (162) of measuring width of calcaneus WOB, described groove (161) is installed in the location survey mechanism (162), described gripper shoe (163) is installed in the location survey mechanism (162) by guide rail, and described gripper shoe (163) is freely adjusted height as required and the angle of inclination makes measured's foot be in comfortable posture;
Described ultrasonic measurement analytical system for compact bone substance density is measured width W OB and the velocity of ultrasonic sound SOS and the broadband ultrasonic attenuation BUA of measured's calcaneus (121), bone strength index STI and bone density BMD according to velocity of ultrasonic sound SOS that records and broadband ultrasonic attenuation BUA calculating measured, described velocity of ultrasonic sound SOS is compressional wave and shearing wave spread speed synthetic in measured's calcaneus (121), described broadband ultrasonic attenuation BUA is that ultrasound wave is penetrating the attenuation of measured's calcaneus (121) front and back amplitude on frequency spectrum, and described ultrasonic measurement analytical system for compact bone substance density regularly carries out quality self-assessment to guarantee measurement accuracy.
2. ultrasonic measurement analytical system for compact bone substance density according to claim 1 is characterized in that: the ultrasonic signal that described simulation pretreatment module (132) is made up of so that receiving transducer (131) is received overvoltage crowbar, filter circuit and primary amplifier carries out pretreatment.
3. ultrasonic measurement analytical system for compact bone substance density according to claim 1, it is characterized in that: described gain adjustable amplifier (133) is a kind of integrated circuit, gain adjustable amplifier (133) is regulated its amplification, the measurement occasion when bone being arranged and do not have bone between described transmitting probe (111) and receiving transducer (131) in order to adapt to automatically according to simulation pretreatment module (132) outfan output signal amplitude size.
4. ultrasonic measurement analytical system for compact bone substance density according to claim 1, it is characterized in that: described communication interface (2) uses RS232 serial ports or CAN-USB interface adapter, and described human-computer interaction device (3) is the desk computer or the notebook computer of band serial ports or USB interface.
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