WO2016029546A1 - 血压测量辅助装置和血压测量设备及其设计方法 - Google Patents

血压测量辅助装置和血压测量设备及其设计方法 Download PDF

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WO2016029546A1
WO2016029546A1 PCT/CN2014/090433 CN2014090433W WO2016029546A1 WO 2016029546 A1 WO2016029546 A1 WO 2016029546A1 CN 2014090433 W CN2014090433 W CN 2014090433W WO 2016029546 A1 WO2016029546 A1 WO 2016029546A1
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module
blood pressure
signal
audio
pressure
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English (en)
French (fr)
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周嘉璐
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Priority to US15/507,338 priority Critical patent/US20170290519A1/en
Priority to EP14900906.0A priority patent/EP3187106A4/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/022—Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
    • A61B5/02225—Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers using the oscillometric method
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/022—Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
    • A61B5/02208—Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers using the Korotkoff method
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16Z—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR
    • G16Z99/00—Subject matter not provided for in other main groups of this subclass
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/02141—Details of apparatus construction, e.g. pump units or housings therefor, cuff pressurising systems, arrangements of fluid conduits or circuits

Definitions

  • the invention relates to the field of blood pressure monitoring, in particular to a blood pressure measuring auxiliary device, a blood pressure measuring device and a design method thereof.
  • the current sphygmomanometers are based on two methods of measurement: auscultation and oscillometric methods.
  • Auscultation is the main method used in clinical medicine.
  • the mercury sphygmomanometer used by doctors is designed by auscultation.
  • the auscultation method is to determine the blood pressure value by using a stethoscope to listen to the blood flow of the radial artery in conjunction with the corresponding pressure when the sphygmomanometer cuff is deflated.
  • the scale indicated by the mercury column is the systolic pressure; when the pulsation sound suddenly weakens or disappears, the scale indicated by the mercury column is the diastolic pressure.
  • Auscultation is medically known as the gold standard for blood pressure measurement because of its high measurement accuracy.
  • the oscillometric method determines the blood pressure value by measuring the amplitude of the pulse wave combined with the corresponding cuff pressure. Due to the simple implementation of the principle, an electronic sphygmomanometer that uses the oscillometric method to measure blood pressure is a mainstream product on the market. For example, most OMRON electronic sphygmomanometers use the oscillometric method. Many studies have found that the accuracy of oscillometric methods is sometimes poor.
  • the deviation of a certain sphygmomanometer and a mercury sphygmomanometer can be up to 16mmHg or more, as shown in Figure 1, the frequency of deviation measurement for the brand sphygmomanometer. distributed.
  • a source of inaccuracy in the oscillometric method may be related to the measurement principle itself.
  • the auscultation method In the auscultation method, during the deflation of the cuff airbag, the blood cannot flow until the pressure drops to the systolic pressure, so the human ear cannot hear the pulsating sound of the blood flow.
  • the oscillometric method the oscillating wave still exists before the blood pressure drops to the systolic pressure, but the amplitude is smaller.
  • the amplitude of the oscillation wave In the process of deflation of the cuff or pressure drop of the airbag, the amplitude of the oscillation wave is continuous before and after the systolic pressure and the diastolic pressure. This is not like a clear boundary in auscultation that has a pulsating sound change from scratch.
  • the oscillometric method can only establish a certain empirical correlation between the amplitude of the oscillation and the blood pressure value through a large number of individual samples. This average association based on a large number of individual samples does not apply to all individuals, which leads to large errors in blood pressure measurements for a certain percentage of the population. This error is not due to the quality of the sphygmomanometer itself, but is inherently flawed in the measurement principle.
  • amplitude parameter method also known as the 'normalized method'. It normalizes the amplitude of the pulse wave vibration signal to the maximum amplitude of the signal, and identifies the systolic and diastolic pressures by determining the normalized parameters of systolic and diastolic pressure, as shown in FIG.
  • As is the amplitude of the pulse wave corresponding to the systolic pressure
  • Am is the amplitude of the pulse wave corresponding to the mean pressure
  • Ad is the amplitude of the pulse wave corresponding to the diastolic pressure
  • As/Am is the normalized value of the systolic pressure Pd
  • Ad/Am is The normalized value of diastolic blood pressure Ps
  • Pc is the cuff pressure
  • the abscissa represents the continuous decrease of the pressure in the cuff during deflation.
  • As/Am C1
  • the systolic pressure Ps, the diastolic pressure Pd, and the average pressure Pm can be obtained.
  • the amplitude parameter of general systolic blood pressure is 0.46 ⁇ 0.64, and the amplitude parameter of diastolic blood pressure is 0.43 ⁇ 0.73.
  • the principle of oscillometric method can be referenced--Liu Jianqiang, Wang Yongcai. Design of electronic sphygmomanometer system based on oscillometric method[J]. Embedded System Applications, 2010(4): 62-65.).
  • sphygmomanometer manufacturers use different amplitude parameters, which also results in a large difference between the measurements of different manufacturers using the same oscillometric method.
  • the amplitude parameters corresponding to each measurement individual may be different, and the sphygmomanometer does not use unused parameters for each person.
  • the sphygmomanometers currently designed using these two methods collect data through the sphygmomanometer itself, perform calculations, and only inform the user by display or voice.
  • the sphygmomanometer directly determines the blood pressure value during the measurement process or directly by the sphygmomanometer, or directly judges the blood pressure value by directly listening to the visual inspection, and does not assist the user in judging the blood pressure value by displaying the original data.
  • the visualization of the raw data during the measurement process will have a good auxiliary effect on the determination of the blood pressure value, which is conducive to improving the accuracy of the judgment of the blood pressure value.
  • the saved raw data is useful for repeatedly determining the blood pressure value, and can make a trend analysis of the user's blood pressure status, and the current sphygmomanometer can generally only record the most recently measured blood pressure values, and can not be on the sphygmomanometer. Do further analysis and display trend graphs.
  • the design concept of the present invention is that the original data in the blood pressure measurement process is completely collected and stored, and the data is processed correspondingly, and displayed numerically and/or graphically. This helps the user to make a more accurate judgment of the blood pressure value.
  • the pressure value and the pulsation sound Korean sound, Korotkoff sound
  • the oscillometric method in combination with the blood pressure value determined by the auscultation method (or the blood pressure value obtained by other methods with higher accuracy)
  • the parameters used to improve the accuracy of the oscillometric method are used to improve the accuracy of the oscillometric method.
  • the user when using the existing sphygmomanometer product for measurement, the user cannot obtain the original data, and can only manually read the blood pressure value manually, or automatically determine and display the blood pressure value by the sphygmomanometer, which is used to determine the blood pressure value.
  • the original data cannot be extracted by the user, and the above design concept cannot be realized.
  • the acquisition of raw data for existing sphygmomanometer products is also a technical problem to be solved by the present invention.
  • the present invention provides a measurement aid for blood pressure measurement
  • the main function is to collect and output the corresponding pressure signal when using the existing sphygmomanometer product (the pressure signal can not be directly obtained from the existing sphygmomanometer product), thus providing the necessary data analysis.
  • Data Sources The main function is to collect and output the corresponding pressure signal when using the existing sphygmomanometer product (the pressure signal can not be directly obtained from the existing sphygmomanometer product), thus providing the necessary data analysis.
  • the measurement aid is configured to be connectable to a compression device of the sphygmomanometer and includes a sensing module and a communication module.
  • the pressurizing device referred to in the present specification refers to a member for supplying pressure to a measurement site and capable of performing a pressurization/decompression operation, such as an air pump, a deflation valve, a trachea, and a cuff airbag in an electronic sphygmomanometer. Combination, or a combination of manual inflatable balls, trachea, and cuff airbags in a mercury sphygmomanometer.
  • the sensing module is configured to sense a pressure at a connection between the measuring auxiliary device and the pressing device and output a pressure signal to the communication module;
  • the communication module is configured to receive the pressure signal and transmit the signal to a terminal device.
  • the terminal device mentioned in this specification refers to a device that can realize data transmission with an external device through a wired or wireless connection and can save the received data.
  • it is a device capable of performing data analysis, processing, and the like on the received data, and further outputting data or analyzing and processing the data (such as graphics, sound, etc.), such as a mobile phone or a computer.
  • Smart devices or wearable devices such as tablets, wristbands, and watches.
  • the sensing module includes a pressure sensor through which the pressure at the junction of the measurement aid and the pressurizing device is sensed.
  • the measurement assistance device further includes an operation module, configured to preprocess the pressure signal, For example, analog-to-digital conversion, noise reduction, signal amplification, filtering, etc., and the pre-processed pressure signal is transmitted to the communication module, and transmitted by the communication module to the terminal device.
  • an operation module configured to preprocess the pressure signal, For example, analog-to-digital conversion, noise reduction, signal amplification, filtering, etc., and the pre-processed pressure signal is transmitted to the communication module, and transmitted by the communication module to the terminal device.
  • the operation module determines a blood pressure value by an oscillometric method according to the pressure signal, and transmits the blood pressure value to the communication module, and is transmitted by the communication module to the terminal device.
  • the communication module is wired or wirelessly connected to the terminal.
  • the present invention also provides another measurement aid for blood pressure measurement
  • the main function is to collect and output the corresponding pressure signal and pulsation sound when using the existing sphygmomanometer product (the pressure signal and the pulsation sound when the measurement is not directly obtained from the existing sphygmomanometer product) Data analysis provides the necessary data sources.
  • the measurement assisting device is configured to be connectable with the pressurizing device of the sphygmomanometer, and includes an induction module, a communication module, and an audio collection module;
  • the sensing module is configured to sense a pressure at a connection between the measuring auxiliary device and the pressing device and output a pressure signal to the communication module;
  • the communication module is configured to receive the pressure signal and transmit the signal to a terminal device;
  • the audio collection module is configured to collect sound of the measurement site and output an audio signal to the terminal device.
  • the sensing module includes a pressure sensor, and the pressure at the connection of the measuring auxiliary device and the pressing device is sensed by the pressure sensor.
  • the measurement assistance device further includes an operation module, configured to preprocess the pressure signal, For example, analog-to-digital conversion, noise reduction, signal amplification, filtering, etc., and the pre-processed pressure signal is transmitted to the communication module, and transmitted by the communication module to the terminal device.
  • an operation module configured to preprocess the pressure signal, For example, analog-to-digital conversion, noise reduction, signal amplification, filtering, etc., and the pre-processed pressure signal is transmitted to the communication module, and transmitted by the communication module to the terminal device.
  • the operation module determines a blood pressure value by an oscillometric method according to the pressure signal, and transmits the blood pressure value to the communication module, and is transmitted by the communication module to the terminal device.
  • the audio collection module includes pre-processing the collected sound (such as analog-to-digital conversion, noise reduction, signal amplification, filtering, etc.) ) conversion module.
  • the audio collection module transmits the audio signal to the communication module, and is transmitted by the communication module to the terminal device. At this time, the audio signal is transmitted to the terminal device indirectly through the communication module.
  • the audio collection module transmits the audio signal to the operation module, and the operation module directly or preprocesses the audio signal and transmits the audio signal to the communication module, and the communication module transmits the The terminal device.
  • the audio signal is indirectly transmitted to the terminal device through the operation module and the communication module. And being configurable to preprocess the audio signal by the arithmetic module, Such as analog to digital conversion, noise reduction, signal amplification, filtering and so on.
  • the operation module passes the auscultation method according to the pressure signal and the audio signal, or/and determines the blood pressure value by the oscillometric method according to the pressure signal, and determines the blood pressure determined by the auscultation method or/and the oscillometric method.
  • the value is transmitted to the communication module and transmitted by the communication module to the terminal device.
  • the parameters used in the oscillometric method are adjusted by using the blood pressure value determined by the arithmetic module by the auscultation method as a reference.
  • the adjustment is periodic, may be a time-based period, or may be a period based on the number of measurements or other forms.
  • the operation module stores a plurality of sets of parameters used in the oscillometric method, so that parameters suitable for different users can be selected.
  • the communication module and the audio collection module are wired or wirelessly connected to the terminal.
  • the invention also provides a blood pressure measuring device, comprising:
  • a pressurizing device for pressurizing and decompressing the measurement site
  • a sensing module configured to be coupled to the pressing device to sense a pressure at the connection and output a pressure signal
  • An audio collection module for collecting sound of the measurement site and outputting an audio signal
  • a main control unit configured to be connected to the sensing module and the audio collecting module to receive and process the pressure signal and the audio signal.
  • the main control unit processes the pressure signal and the audio signal, including synchronous storage of the received signal, and the signal itself Analog-to-digital conversion, noise reduction, signal amplification, filtering, and signal-based data extraction, data analysis, data manipulation, and output control.
  • the stored pressure signal and audio signal provide raw data for the basis of auscultation and oscillometric judgment, and can be used repeatedly to provide necessary conditions for multiple judgments.
  • the pressing device includes a pressing assembly that directly acts on the measurement site, and the audio collection module is partially or entirely disposed inside or outside the pressing assembly.
  • the sensing module includes a pressure sensor through which the pressure at the junction with the pressurizing device is sensed.
  • the blood pressure measuring device Also included is an image output module for numerically and/or graphically displaying the pressure signal and/or the audio signal.
  • the digitization and patterning of the pressure signal includes conversion to a corresponding pressure value and generation of a corresponding trend graph, etc., the digitization and patterning of the audio signal including audio amplitude for the audio signal or the processed audio signal , numerical values such as frequency extraction and generation of corresponding trend graphs, etc.
  • the blood pressure measuring device further includes an audio output module for playing the audio signal or the audio formed by the audio signal (if the audio signal has been amplified or noise-reduced, or encoded or transcoded to suit a particular audio format, etc.) . It is realized that the sound is synchronously played on the blood pressure measuring device and the graphical pressure signal and the audio signal are displayed, so that when the blood pressure value is determined by using the auscultation method, the image can be combined for judgment and can be played back multiple times. Judge.
  • the master unit determines blood pressure values by auscultation and/or oscillometric methods and is displayed by the image output module or/and played by the audio output module.
  • the parameters used in the oscillometric method can be adjusted.
  • the parameters used in the oscillometric method are adjusted by a manually entered value or by a blood pressure value determined by the master unit by auscultation.
  • a plurality of sets of parameters used in the oscillometric method can be stored, so that parameters suitable for different users can be selected.
  • the adjustment is periodic, It can be a time-based period, or a period based on the number of measurements or other forms.
  • the main control unit further includes a communication module, configured to perform wired or wireless communication with an external device. For example, if the stored data is uploaded to an external device such as a computer, a server, or a cloud, the judgment of the original data can be extended to different places and multiple people.
  • an external device such as a computer, a server, or a cloud
  • the invention also provides A design method of a blood pressure measuring device, which is designed to provide a sensing module, an audio collecting module, and a main control unit connected to the sensing module and the audio collecting module; the sensing module is used for sensing a measuring part And outputting a pressure signal; the audio collection module is configured to collect sound of the measurement site and output an audio signal; the main control unit receives and processes the pressure signal and the audio signal.
  • the main control unit processes the pressure signal and the audio signal, including synchronous storage of the received signal, and the signal itself Analog-to-digital conversion, noise reduction, signal amplification, filtering, and signal-based data extraction, data analysis, data manipulation, and output control.
  • the stored pressure signal and audio signal provide raw data for the basis of auscultation and oscillometric judgment, and can be used repeatedly to provide necessary conditions for multiple judgments.
  • an image output module is provided for numerically and/or graphically displaying the pressure signal and/or the audio signal.
  • the digitization and patterning of the pressure signal includes conversion to a corresponding pressure value and generation of a corresponding trend graph, etc., the digitization and patterning of the audio signal including audio amplitude for the audio signal or the processed audio signal , numerical values such as frequency extraction and generation of corresponding trend graphs, etc.
  • an audio output module is provided for playing the audio signal or the audio formed by the audio signal (if the audio signal has been amplified or noise-reduced, or encoded or transcoded to accommodate a particular audio format) . It is realized that the sound is synchronously played on the blood pressure measuring device and the graphical pressure signal and the audio signal are displayed, so that when the blood pressure value is determined by using the auscultation method, the image can be combined for judgment and can be played back multiple times. Judge.
  • the blood pressure value is determined in the following manner:
  • Method 1 the main control unit determines the blood pressure value by auscultation according to the pressure signal and the audio signal;
  • Mode 3 The main control unit determines the blood pressure value by the oscillometric method according to the pressure signal, and the measured blood pressure value can be obtained immediately, wherein the parameters used in the oscillometric method can be adjusted to adapt to different personal situations.
  • the blood pressure value is determined by auscultation To further improve the accuracy of the auscultation.
  • the blood pressure measuring device includes a plurality of sets of parameters used in the oscillometric method.
  • the parameters used in the oscillometric method are adjusted to improve the oscillometric method by using a manually input value or a blood pressure value determined by the main control unit by auscultation. Precision.
  • the adjustment is periodic, It can be a time-based period, or a period based on the number of measurements or other forms.
  • a communication module is provided for wired or wireless communication with an external device
  • an external device such as a computer, a server, or a cloud
  • the judgment of the original data can be extended to different places and multiple people.
  • the original data can be played back synchronously and the blood pressure can be manually determined.
  • the existing sphygmomanometer calculates (judges) the blood pressure value in the process of measurement, whether it is manual, automatic or semi-automatic, and directly tells the measured person the blood pressure value.
  • the product and method of the present invention separates the measurement of the raw data from the determination of the blood pressure, records the raw data during the measurement, and analyzes the raw data by various forms to obtain the blood pressure value after the measurement is completed.
  • the stored raw data can be analyzed multiple times by different devices and different people to get more accurate blood pressure values. Taking the traditional auscultation method as an example, it is difficult to judge the sound while the eye is gazing at the pressure gauge in the process of pressurizing and decompressing the cuff airbag.
  • the original data after the original data is recorded, it can be listened to multiple times, listened to by many people, and listened to by a professional; when the sampling sound is small, the volume can be turned up, and when the noise of the sampled sound is too large, The noise reduction process is performed first.
  • the visualization of the original data, especially the visualization of the sound helps to determine blood pressure in the auscultation.
  • the traditional auscultation method it is judged by the human ear directly listening to the sound, or the machine judges according to the sound, all in the process of pressurizing or decompressing the pressing device.
  • the sound is visualized and can be simultaneously displayed during the sound playback, which plays a role in the sound assisted judgment, reduces the difficulty in the manual auscultation method, and improves the accuracy of the automatic auscultation method.
  • the visualization of the sound allows people to judge the sound from the use of only the ear to the ear and the eye, reducing the difficulty of judging the sound of the pulsation of the blood vessel.
  • the visual sound also allows people to have a pre-judgment before playing a certain sound. For example, the sound intensity or frequency of the next second can be seen when the sound is played to a certain position.
  • each individual has parameters that are adapted to each individual according to the calibration settings, thereby improving the accuracy of the oscillometric method.
  • Figure 1 is a frequency distribution diagram of measurement deviation of a brand sphygmomanometer
  • Figure 2 is a graph of the normalized value curve of the amplitude parameter method
  • Figure 3 is a schematic view of a blood pressure measuring auxiliary device of the present invention, and shows a blood pressure meter and a mobile phone which can be used together with the same;
  • Figure 4 is a schematic view showing the structure of an access unit of the blood pressure measurement assisting device shown in Figure 3;
  • Figure 5 is a schematic view showing the connection of the blood pressure measuring auxiliary device shown in Figure 3 with a blood pressure meter and a mobile phone;
  • Figure 6 is a schematic view of a sphygmomanometer based on the present invention.
  • FIG. 7 is a schematic structural diagram of a host system of the sphygmomanometer shown in FIG. 6;
  • Figure 8 is a schematic illustration of an operational interface of the sphygmomanometer shown in Figure 6;
  • Figure 9 is another schematic view of the operational interface shown in Figure 8.
  • the blood pressure measurement assisting device and the blood pressure measuring device of the present invention will be further described below by way of specific embodiments. The objects, features, design methods and effects of the present invention are fully understood.
  • This embodiment is based on the present invention, a measurement aid for blood pressure measurement, which is mainly solved When users use existing sphygmomanometer products for measurements, they are unable to obtain raw data.
  • an upper arm type electronic sphygmomanometer is used as an example, but it is not limited to an upper arm type electronic sphygmomanometer, and a different sphygmomanometer such as a mercury sphygmomanometer or a wrist type electronic sphygmomanometer and other sphygmomanometers for different measurement sites may be used.
  • the sphygmomanometer used only needs to have a pressurizing device.
  • the solid line frame is a measurement aid device based on the present invention, which is used in combination with the upper arm type electronic sphygmomanometer 5, wherein the measurement aid device comprises: Access component 1, microphone 2, air tube 3, stethoscope 4.
  • the microphone 2 is connected to the stethoscope 4 through the trachea 3, and the microphone 2 has an earphone plug connected to the mobile phone 6 at one end, thereby forming an audio collection module.
  • the mobile phone 6 is used as the terminal device, but not limited to the use of the mobile phone, and a smart device such as a computer, a tablet computer, or the like, or a new wearable device such as a wristband or a watch may be used.
  • access component 1 The utility model comprises an arithmetic module (such as a single chip microcomputer), an air inlet and an air outlet, a communication module and a pressure sensor; the air inlet, the air outlet and the port connecting the pressure sensor in the access part 1 are a three-way structure.
  • the communication module is used to perform wireless connection with the mobile phone 6 to implement data transmission. It is also possible to connect the data cable to the data port of the mobile phone 6, such as a USB port, by means of a wired connection.
  • the access member 1 When blood pressure measurement is required, as shown in Fig. 5, the access member 1 is connected to the air tube of the upper arm type electronic sphygmomanometer 5, and the microphone 2 is connected to one end.
  • the headphone plug is plugged into the headphone jack of the phone 6.
  • the upper arm type electronic sphygmomanometer 5 is used in its normal use mode, and the cuff is bound to the upper arm radial artery, and the stethoscope 4 needs to be placed on the inside of the cuff to fit close to the radial artery.
  • the measurement procedure of the upper arm type electronic sphygmomanometer 5 is performed, and the measurement site is pressurized and decompressed.
  • the pressure sensor of the access component 1 will sense the pressure in the air pipe and output a pressure signal, and the pressure signal is converted, amplified, and filtered by the arithmetic module (the arithmetic module may not be used, and the output of the pressure sensor at this time)
  • the signal is directly transmitted by the communication module to the mobile phone 6), and the pre-processed pressure signal is transmitted to the mobile phone 6 through the communication module, and at the same time, the microphone 2 collects the sound of the radial artery transmitted through the stethoscope 4 and the trachea 3, and passes through the earphone.
  • the plug is delivered to the handset 6.
  • a conversion module for preprocessing the audio signal may be added at the output end of the microphone 2, such as signal amplification, noise reduction, digital-to-analog conversion, filtering, etc., and the output through the earphone plug is pre- The processed audio signal.
  • the acquisition and transmission of pressure and audio signals to the measurement site during the measurement of the existing sphygmomanometer product is achieved.
  • the components in the box in Figure 3 there are also a variety of combinations, such as the microphone 2 can be placed in the stethoscope 4, and then connected to the earphone plug through the conductive wire, at this time without the use of the trachea 3 or other sound transmission medium.
  • the connection between the earphone plug and the mobile phone 6 may be a direct connection or an indirect connection, such as setting a headphone jack on the access part 1, inserting the earphone plug into the access part 1, through the wired part of the access part 1 and the mobile phone 6
  • the wireless connection transmits the audio signal.
  • the audio signal is directly transmitted to the mobile phone 6 through the communication module; (2) since the access component 1 can simultaneously receive the pressure signal and the audio signal, it can be in the arithmetic module.
  • the pre-processing of the audio signal (such as the conversion module described above) is implemented, and the pre-processed audio signal is transmitted to the communication module and transmitted to the mobile phone 6 by the communication module.
  • the function of the computing module can be extended as needed to alleviate the data processing pressure of the terminal device, and even the terminal device is only used as an output device for images and sounds, and the processing of the data can be handled by the arithmetic module, as described above.
  • the blood pressure value is also determined by the oscillometric method or the auscultation method according to the received signal, and then transmitted to the terminal device through the communication module.
  • the data can also be transmitted to an external device through a wired or wireless connection with the mobile phone 6, such as uploading the stored data to an external device such as a computer, a server, a cloud, etc., sharing on the external device or directly playing back on the external device.
  • an external device such as a computer, a server, a cloud, etc.
  • This embodiment is an electronic sphygmomanometer based on the present invention, which integrates pressure control, signal/data acquisition, signal/data processing, signal/data analysis, signal/data viewing, and human-computer interaction.
  • the upper arm type electronic sphygmomanometer 7 of the present embodiment is not limited to the upper arm type electronic sphygmomanometer, It can also be designed with different pressures or other types of sphygmomanometers for different measurement sites.
  • the main unit 10, the gas line 8 and the cuff air bag 9 are included, and the main unit 10 includes a button 11 and a touch display screen 12.
  • a stethoscope (not shown) is attached to the inside of the cuff air bag 9, and a microphone (not shown) is mounted in the cavity of the stethoscope (it is also possible to use only a microphone, not a stethoscope).
  • the conductive wire connected to the main body 10 of the microphone is embedded in the gas line 8, so that the appearance is not much different from that of a general upper arm type sphygmomanometer.
  • FIG. 7 it is a system architecture of the host 10, wherein the main processor is mainly responsible for: controlling the air pump and the deflation valve in the pressurizing device; and performing pressure signals and audio signals respectively input by the pressure sensing module and the audio collecting module. Processing (amplification, noise reduction, analog-to-digital conversion, filtering, etc.) and simultaneous storage to the data storage module; determining blood pressure values by oscillometric and/or auscultation; controlling audio and image output; receiving commands from the button module, performing the device Control, parameter adjustment, data playback, etc.
  • the user's key input may be a physical button or a touch to the touch screen. In this embodiment, a combination of the two is used.
  • the pressure sensing module senses the pressure through the pressure sensor, and can directly send the pressure signal outputted by the pressure sensor to the main processor for processing, or set the pressure signal to preprocess the pressure signal in the pressure sensing module.
  • the communication module is further included in the architecture for implementing the wired or/and wireless communication between the host 10 and the external device.
  • the communication module in this embodiment uses a wireless protocol to implement data transmission or sharing with the external device.
  • FIG. 8 it is the upper arm type electronic sphygmomanometer 7 An operation interface in which a graph of audio amplitude, oscillating wave and pressure value as a function of time is displayed from top to bottom, and a blood pressure value calculated by the main processor according to the auscultation method (this value can also be set to be measured After the broadcast directly by voice). It is also possible to display the blood pressure value determined by the oscillometric method or to simultaneously display the blood pressure value determined by the auscultation method and the oscillometric method.
  • the leftmost vertical line A in each graph indicates the time point corresponding to the systolic pressure determined according to the auscultation method, and the rightmost vertical line B indicates the time point corresponding to the diastolic pressure.
  • Figure 9 is a diagram showing the state of the interface of Figure 8 during data playback.
  • the vertical line C in the middle moves along the time axis along with the playback progress, and the audio amplitude curve passed by the vertical line C can help the user to make a more accurate judgment on the sound heard by the ear.
  • the graphics of the audio signal can be not only in the time domain, but also in the frequency domain or both.
  • the graphic is not limited to a graph, but may be a column chart or the like. It can also be set to pause, continue, and set the loop playback between two time points during the playback of the sound.
  • the blood pressure value obtained by the main processor through the oscillometric method is also available. (or a more accurate blood pressure value obtained by other means)
  • the amplitude parameter method in the oscillometric method is taken as an example.
  • the parameters C1 and C2 vary from person to person, and can be adjusted according to individual circumstances to improve the measurement accuracy for individuals. This adjustment can be modified directly through the operator interface (not shown), such as parameters C1 and C2, but this may require a professional to implement effectively.
  • it can be set to input a blood pressure value that is confirmed to be accurate after confirmation (such as a blood pressure value determined by auscultation), and the blood pressure value and the oscilloscope input by the dedicated APP.
  • the blood pressure values determined by the method are compared, and the parameters are adjusted according to the comparison result, so that the parameter adjustment can be easily performed without a professional.
  • the parameters used in the oscillometric method (such as C1 and C2 in the amplitude parameter method) can also be automatically calibrated based on the blood pressure value determined by the auscultation method. This calibration can also be set to periodic, such as set to a period of time or Automatic calibration after a certain number of times.
  • the avatar icons at the lower left of the operation interface in Fig. 6 and Fig. 7 can be used to switch users, and each user has its own parameter group, which satisfies the use of multiple people.
  • the sphygmomanometer of the present embodiment is also the same as the ordinary electronic sphygmomanometer, and the sphygmomanometer automatically performs the charge and discharge operation of the cuff airbag while recording the measured data.
  • the blood pressure value determined by the oscillometric method and/or the auscultation method is automatically displayed, and the recorded pressure value and sound data can also be played back on the host, and the blood pressure value is determined by auscultation.
  • the sphygmomanometer in the embodiment can be realized by compiling the corresponding APP on the mobile phone (or computer, tablet, etc.) as the terminal device.
  • the mobile phone is roughly equivalent to the host 10 in the present embodiment, except that the mobile phone cannot control the pressurizing device.

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Abstract

一种血压测量辅助装置和血压测量设备及其设计方法，其是基于在血压测量过程中，记录测量的压力值和搏动声，从而能够对记录的压力值和声音进行回放，提高了听诊法的准确性；并可调整示波法中使用的参数，提高了示波法的精度。血压测量辅助装置被设置为可与血压计（5）的加压装置连接，并包括感应模块（1）、通讯模块和音频采集模块（2）。感应模块（1）用于感应血压测量辅助装置与加压装置连接处的压力并输出压力信号至通讯模块。通讯模块用于接收压力信号，并传送至终端设备（6）。音频采集模块（2）用于采集测定部位的声音并输出音频信号至终端设备（6）。

Description

血压测量辅助装置和血压测量设备及其设计方法
技术领域
本发明涉及血压监测领域，尤其涉及一种血压测量辅助装置和一种血压测量设备及其设计方法。
背景技术
目前市面上的血压计主要基于两种测量方法：听诊法和示波法。
听诊法是在临床医疗上主要使用的方法。医生使用的水银血压计就是通过听诊法设计的。听诊法是通过在血压计袖带气囊放气时用听诊器去听肱动脉的血液流动的声音结合对应的压力来判断血压值。当听诊器中出现第一声搏动声，此时水银柱所指刻度即为收缩压；当搏动声突然变弱或消失，此时水银柱所指刻度即为舒张压。听诊法由于其测量准确性高，在医学上被称作血压测量的黄金标准。一般对其他类型的血压计测量准确性的研究都是通过和使用水银血压计的听诊法进行对照研究的。但是听诊法在电子血压计的使用上还有很大的局限性，主要是因为电子设备对声音的辨别能力在某些方面比人耳要弱。听诊法需要判断声音的强弱（搏动声的高低）和频率（是搏动声还是噪音），使用听诊法的电子血压计由于设计难度和成本的缘故不太普及，抗噪音干扰能力差。使用听诊法的水银血压计（或者其他非水银介质）使用上也不太方便，比如很难自己给自己测量，需要专业训练，测量的时候耳朵和眼睛要高度同步才能捕捉到声音变化和对应的压强值，并且数据不能自动记录等。
示波法通过测量脉搏振荡波的幅度结合对应的袖带压强来判断血压值。由于原理实现简单，使用示波法测量血压的电子血压计是市场上的主流产品，比如大部分欧姆龙的电子血压计都使用示波法。很多研究对比发现示波法准确度有时会很差。根据美国疾控中心对某主流品牌血压计产品的检测报告显示，其某款血压计跟水银血压计对照测量偏差最高可达16mmHg以上，如图1所示，为该品牌血压计测量偏差的频率分布。示波法的一个不准确性的来源可能与测量原理本身有关。
在听诊法中，袖带气囊放气的过程中，当压强下降到收缩压以前，血液是不能流动的，所以人耳听不到血液流动的搏动声。而示波法中，在血压下降到收缩压以前，振荡波还是存在的，只是幅度要小一些。而在袖带放气或者气囊压力下降的过程中，振荡波的变化幅度在收缩压和舒张压的前后是连续的。这并不像听诊法中存在一个搏动声音变化从无到有的清晰界限。所以示波法只能够通过大量的个体样本在振荡幅度变化和血压值之间建立某种经验关联。这种基于大量个体样本建立的平均关联，并不适用于所有个体，这就导致了对于一定比例的人群，血压值测量的误差很大。这种误差并不是血压计本身的质量引起的，而是测量原理内在的缺陷。
示波法中比较常用的一种方法是幅度参数法，又称'归一法'。它是将脉搏波振动信号的幅值与信号的最大幅值相比进行归一化处理，通过确定收缩压和舒张压的归一化参数来识别收缩压与舒张压，如图2所示。其中As为收缩压对应的脉搏波幅度，Am为平均压所对应的脉搏波的幅度，Ad为舒张压对应的脉搏波幅度，As／Am为收缩压Pd的归一化值，Ad／Am为舒张压Ps的归一化值，Pc为袖带压力，横坐标代表放气过程中袖带内压力的不断减小。As／Am=C1，Ad／Am=C2，分别对应收缩压和舒张压的位置。根据测得的脉搏波幅值和对应的静压力，就可以得出收缩压Ps、舒张压Pd和平均压Pm。一般收缩压的幅度参数为0.46～0.64，舒张压的幅度参数为0.43～0.73（示波法原理可参考--刘坚强，王永才.基于示波法的电子血压计系统设计[J].单片机与嵌入式系统应用，2010(4):62-65.）。不同血压计厂商会使用不同的幅度参数，这也导致即使不同厂家使用了相同的示波法，其测量值也可能会有挺大区别。每个测量个体对应的幅度参数可能都是不一样的，血压计并没有针对每个人采用不用的参数。
另一方面，目前使用这两种方法设计的血压计都是通过血压计本身采集数据，进行计算，只把结果通过显示或者语音告知使用者。血压计在测量过程中或是血压计直接判断血压值，或是人直接耳听目测直接判断血压值，而没有通过展示原始数据辅助用户判断血压值。而测量过程中原始数据的可视化，对于判断血压值会有很好的辅助作用，有利于提高对于血压值判断的准确性。并且保存下来的原始数据，有利于重复判断血压值，以及可以对使用者的血压状况做趋势性分析，而目前的血压计一般只能记录最近测量的若干个血压值，也无法在血压计上做进一步分析和显示趋势图。
发明内容
有鉴于现有技术的上述缺陷，本发明的设计构思在于，将血压测量过程中的原始数据完整的采集并存储下来，将数据进行相应处理后，数值化地和/或图形化的显示出来，从而帮助使用者对血压值进行更准确的判断。如在血压测量中记录压力值和搏动声（柯氏音, Korotkoff sound ），从而通过反复听取上述声音记录来提高听诊法的准确性，并可结合由听诊法确定的血压值（或是由其他方式获得的准确度较高的血压值），来调整示波法中使用的参数，从而提高示波法的精度。
另一方面，使用者在使用现有血压计产品进行测量时，无法获得原始数据，只能人工即时读取血压值，或由血压计自动判断并显示出血压值，其中用于判断血压值的原始数据，对于用户来说是无法提取的，从而无法实现上述的设计构思。为此针对现有血压计产品的原始数据的获取也是本发明需要解决的技术问题。
为实现上述目的，本发明提供了 一种用于血压测量的测量辅助装置 ，其主要作用是，在使用现有血压计产品进行测量时，采集并输出相应的压力信号（无法直接从现有血压计产品中获取测量时的压力信号），从而为数据分析提供了必要的数据来源。
所述测量辅助装置被设置为可与血压计的加压装置连接，并包括感应模块和通讯模块。 本说明书中所提到的加压装置，是指用于向测定部位提供压力，并可进行加压/减压操作的部件，如电子血压计中的气泵、泄气阀、气管、袖带气囊的组合，或水银血压计中手动充气球、气管、袖带气囊的组合等。
所述感应模块用于感应所述测量辅助装置与所述加压装置连接处的压力并输出压力信号至所述通讯模块；
所述通讯模块用于接收所述压力信号，并传送至终端设备。
本说明书中所提到的终端设备，是指能通过有线或无线连接方式实现与外部设备的数据传输，并可保存接收到的数据的设备。优选地，是在以上基础上还能对接收到的数据进行数据分析、处理等操作，并进一步将数据或分析和处理后的数据进行输出（如图形、声音等）的设备，如手机、电脑、平板电脑、手环、手表等智能设备或可穿戴设备。
进一步地， 所述感应模块包括压力传感器，通过所述压力传感器感应所述测量辅助装置与所述加压装置连接处的压力。
进一步地，所述测量辅助装置还包括运算模块，用于对所述压力信号进行预处理， 如模数转换、降噪、信号放大、滤波等， 并将预处理后的所述压力信号传送至所述通讯模块，由所述通信模块传送至所述终端设备。
进一步地，所述运算模块根据所述压力信号通过示波法确定血压值，并将所述血压值传送至所述通讯模块，由所述通信模块传送至所述终端设备。
所述通讯模块有线连接或无线连接所述终端。
本发明还提供了另 一种用于血压测量的测量辅助装置 ，其主要作用是，在使用现有血压计产品进行测量时，采集并输出相应的压力信号和搏动声（无法直接从现有血压计产品中获取测量时的压力信号和搏动声），从而为数据分析提供了必要的数据来源。
所述测量辅助装置被设置为可与血压计的加压装置连接，并包括感应模块、通讯模块和音频采集模块；
所述感应模块用于感应所述测量辅助装置与所述加压装置连接处的压力并输出压力信号至所述通讯模块；
所述通讯模块用于接收所述压力信号，并传送至终端设备；
所述音频采集模块用于采集测定部位的声音并输出音频信号至所述终端设备。
进一步地，所述感应模块包括压力传感器，通过所述压力传感器感应所述测量辅助装置与所述加压装置连接处的压力。
进一步地，所述测量辅助装置还包括运算模块，用于对所述压力信号进行预处理， 如模数转换、降噪、信号放大、滤波等， 并将预处理后的所述压力信号传送至所述通讯模块，由所述通信模块传送至所述终端设备。
进一步地，所述运算模块根据所述压力信号通过示波法确定血压值，并将所述血压值传送至所述通讯模块，由所述通信模块传送至所述终端设备。
进一步地，所述音频采集模块包括对采集到的声音进行预处理（ 如模数转换、降噪、信号放大、滤波等 ）的转换模块。
进一步地，所述音频采集模块将所述音频信号传送至所述通讯模块，由所述通讯模块传送至所述终端设备。此时，所述音频信号是通过所述通讯模块间接地传送至所述终端设备的。
进一步地，所述音频采集模块将所述音频信号传送至所述运算模块，由所述运算模块直接或对所述音频信号进行预处理后传送至所述通讯模块，由所述通讯模块传送至所述终端设备。此时，所述音频信号是依次通过所述运算模块和所述通讯模块间接地传送至所述终端设备的。并且在可设置为由运算模块对所述音频信号进行预处理， 如模数转换、降噪、信号放大、滤波等。
进一步地，所述运算模块根据所述压力信号和所述音频信号通过听诊法，或/和根据所述压力信号通过示波法确定血压值，并将由听诊法或/和示波法确定的血压值传送至所述通讯模块，由所述通信模块传送至所述终端设备。
进一步地，以所述运算模块通过听诊法 确定的血压值为基准，对示波法中使用的参数进行调整。
进一步地，所述调整是周期性的，可以是基于时间的周期，也可以是基于测量次数的周期或其他形式。
进一步地，所述运算模块存储多组所述示波法中使用的参数，从而可以针对不同使用者选用与其相适应的参数。
进一步地，所述通讯模块和所述音频采集模块有线连接或无线连接所述终端。
本发明还提供了一种血压测量设备，其包括：
加压装置，用于向测定部位加压和减压；
感应模块，用于与所述加压装置连接以感应连接处的压力并输出压力信号；
音频采集模块，用于采集测定部位的声音并输出音频信号；
主控单元，用于与所述感应模块和所述音频采集模块连接，以接收和处理所述压力信号和所述音频信号。所述主控单元对于所述压力信号和所述音频信号的处理，包括对于接收到的信号进行同步存储，以及对信号本身的 模数转换、降噪、信号放大、滤波，以及基于信号的数据提取、数据分析、数据运算和输出控制。存储的压力信号和音频信号，提供了作为听诊法和示波法判断依据的原始数据，并可反复使用，为多次判断提供了必要条件。
进一步地， 所述加压装置包括直接作用于测定部位的施压组件，所述音频采集模块部分或全部安置在所述施压组件的内部或外侧。
进一步地， 所述感应模块包括压力传感器，通过所述压力传感器感应其与所述加压装置连接处的压力。
进一步地，所述血压测量设备 还包括图像输出模块，用于数值化地和/或图形化地显示所述压力信号和/或所述音频信号。 所述压力信号的数值化和图形化包括转换为对应的压力值和生成相应的趋势图等，所述音频信号的数值化和图形化包括对于所述音频信号或经过处理的音频信号的音频幅度、频率等的数值提取和生成相应的趋势图等。
进一步地，所述血压测量设备 还包括音频输出模块，用于播放所述音频信号或所述音频信号经处理形成的音频 （如所述音频信号已经过放大或降噪处理，或是为适应特定的音频格式而进行的编码或转码处理等） 。实现了在所述血压测量设备上同步地播放声音和显示图形化后的压力信号和音频信号，从而在使用听诊法确定血压值时，还可结合图像来进行判断，并可通过回放来多次判断。
进一步地， 所述主控单元通过听诊法和/或示波法确定血压值，并由所述图像输出模块显示或/和所述音频输出模块播放。
进一步地， 能够调整示波法中使用的参数 。
进一步地， 以手动输入的数值，或以所述主控单元通过听诊法确定的血压值为基准，对所述示波法中使用的参数进行调整。
进一步地，可存储多组 所述示波法中使用的参数，从而可以针对不同使用者选用与其相适应的参数。
进一步地，当以所述主控单元通过听诊法确定的血压值为基准，对所述示波法中使用的参数进行调整时，所述调整是周期性的， 可以是基于时间的周期，也可以是基于测量次数的周期或其他形式 。
进一步地， 所述主控单元还包括通信模块，用于与外部设备进行有线或无线通信 ，如将存储的数据上传到电脑、服务器、云端等外部设备，从而对于原始数据的判断可扩展到异地和多人。
本发明还提供了 一种血压测量设备的设计方法，其设计思想是，设置感应模块、音频采集模块，以及与所述感应模块和所述音频采集模块相连接的主控单元；所述感应模块用于感应测定部位的压力并输出压力信号；所述音频采集模块用于采集测定部位的声音并输出音频信号；所述主控单元接收和处理所述压力信号和所述音频信号。所述主控单元对于所述压力信号和所述音频信号的处理，包括对于接收到的信号进行同步存储，以及对信号本身的 模数转换、降噪、信号放大、滤波，以及基于信号的数据提取、数据分析、数据运算和输出控制。存储的压力信号和音频信号，提供了作为听诊法和示波法判断依据的原始数据，并可反复使用，为多次判断提供了必要条件。
进一步地，设置图像输出模块，用于数值化地和/或图形化地显示所述压力信号和/或所述音频信号。 所述压力信号的数值化和图形化包括转换为对应的压力值和生成相应的趋势图等，所述音频信号的数值化和图形化包括对于所述音频信号或经过处理的音频信号的音频幅度、频率等的数值提取和生成相应的趋势图等。
进一步地，设置音频输出模块，用于播放所述音频信号或所述音频信号经处理形成的音频 （如所述音频信号已经过放大或降噪处理，或是为适应特定的音频格式而进行的编码或转码处理） 。实现了在所述血压测量设备上同步地播放声音和显示图形化后的压力信号和音频信号，从而在使用听诊法确定血压值时，还可结合图像来进行判断，并可通过回放来多次判断。
进一步地，采用以下方式确定血压值：
方式1、所述主控单元根据所述压力信号和所述音频信号，通过听诊法确定血压值；
方式2、 根据 基于所述压力信号和所述音频信号而得到的所述图像输出模块输出的图像和所述音频输出模块输出的声音，人为通过听诊法确定血压值；
方式3、所述主控单元根据所述压力信号通过示波法确定血压值，可即时获得测定的血压值，其中示波法中使用的参数可以调整，以适应不同的个人情况。
进一步地， 所述方式 1 和 2 中，由所述主控单元对所述音频信号进行处理后，再通过听诊法确定血压值 ，从而进一步提高听诊法的准确性。
进一步地，所述血压测量设备包括多组所述示波法中使用的参数。
进一步地，所述方式3中，以手动输入的数值，或以所述主控单元通过听诊法确定的血压值为基准，对所述示波法中使用的参数进行调整，以提高示波法的精度。
进一步地，当以所述主控单元通过听诊法确定的血压值为基准，对所述示波法中使用的参数进行调整时，所述调整是周期性的， 可以是基于时间的周期，也可以是基于测量次数的周期或其他形式 。
进一步地， 设置通信模块，用于与外部设备进行有线或无线通信 ，如将存储的数据上传到电脑、服务器、云端等外部设备，从而对于原始数据的判断可扩展到异地和多人。
本发明的 血压测量辅助装置具有以下优点：
1 、结构简单，连接方便；
2 、解决了现有血压计产品在测量时，用户无法获得原始数据的问题；
3 、为原始数据的存储、分析以及根据原始数据进行可视化判断提供了必要的数据来源；
4 、适用性强，可直接使用日常生活中的智能设备，如手机、电脑、平板电脑等，或者手环、手表等新型可穿戴设备作为终端设备；
5 、使现有血压计产品能与智能设备连接，并向其传输数据，为其功能拓展提供了必要的前提。
本发明的血压测量设备及其设计方法具有以下优点 ：
1 、先测量后判断，原始数据可以同步回放，人工判断血压。
现有的血压计无论是人工、自动和半自动都是在测量的过程中计算（判断）血压值，将血压值直接告诉被测人。本发明的产品和方法将原始数据的测量跟血压的判断计算进行分离，测量过程中记录原始数据，测量结束后通过多种形式分析原始数据得到血压值。存储的原始数据可以被不同设备，不同人进行多次分析，从而得到更准确的血压值。以传统听诊法为例，在袖带气囊加压减压的过程中要在眼睛注视压强计的同时对声音进行判断，比较困难。而本发明的产品和方法中，将原始数据记录以后，可以多次听、多人听、交由专业人士听；当采样声音小时，可以将音量调高，当采样声音中噪音太大时可以先对进行降噪处理。
2 、对原始数据的可视化，尤其对声音的可视化帮助在听诊法中判断血压。
传统听诊法中或靠人耳直接听声音判断，或是机器根据声音判断，都是在加压装置加压或者减压的过程中进行的。在本发明中将声音可视化，并且可以在声音回放时同步展示，起到对声音辅助判断的作用，降低人工听诊法中的难度，提高自动听诊法的精度。声音的可视化让人们对声音的判断从只使用耳朵转变到耳朵和眼睛并用，降低了对血管搏动声音判断的难度。可视化的声音同时可以让人们在播放到某个声音之前有一个预判断，比如下一秒的声音强弱幅度或者频率可以在声音播放到某一位置时就可以看到。
3 、对示波法中对使用的参数，根据个人情况进行定制校准和动态校准，做到因人而异，从而提高精度。
现有血压计中，示波法使用的参数是固定的，或者是简单的分组。本发明的产品和方法中，每个个体都会有根据校正设置适合每个个体的参数，从而提高示波法的精度。
附图说明
图1是 某品牌血压计测量偏差的频率分布图 ；
图2是幅度参数法归一化值曲线坐标图 ；
图3是本发明的一种血压测量辅助装置示意图，同时示出了可与其配合使用的血压计和手机；
图4是图3所示的血压测量辅助装置的接入部件的结构示意图
图5是图3所示的血压测量辅助装置与血压计和手机的连接示意图；
图6是基于本发明的一种血压计的示意图；
图7是图6所示的血压计的主机系统架构示意图；
图8是图6所示的血压计的一种操作界面的示意图；
图9是图8所示的操作界面的另一个示意图。
具体实施方式
以下通过具体实施例来进一步说明本发明的血压测量辅助装置和血压测量设备， 以充分地了解本发明的目的、特征、设计方法和效果。
实施例一
本实施例是基于本发明的一种用于血压测量的测量辅助装置，主要是解决 使用者在使用现有血压计产品进行测量时，无法获得原始数据的问题。 本实施例中使用上臂式电子血压计为例，但不限于上臂式电子血压计，也可以采用水银血压计、腕式电子血压计等不同加压方式和针对不同测定部位的其他血压计，所采用的血压计只需具有加压装置即可。
如图3所示，实线框内是基于本发明的一种测量辅助装置，其与上臂式电子血压计5配合使用，其中测量辅助装置包括： 接入部件1、麦克风2、气管3、听诊器4。麦克风2通过气管3与听诊器4相连，麦克风2一端带有连接手机6的耳机插头，从而组成了音频采集模块 。在本实施例中采用手机6作为终端设备，但不限于使用手机，也可以采用电脑、平板电脑或等日常使用的智能设备，或者手环、手表等新型可穿戴设备。
如图4所示， 接入部件1 包括运算模块（如单片机）、进气口和出气口、通信模块和压力传感器；接入部件1中进气口、出气口和连接压力传感器的端口是一个三通结构。在本实施例中，采用通信模块与手机6进行无线连接，实现数据传送。也可以采用有线连接的方式，加设数据线连接到手机6的数据端口，如USB端口。
当需要进行血压测量时，如图5所示，将 接入部件1 接入上臂式电子血压计5的气管中，将 麦克风2一端 的耳机插头插入手机6的耳机插孔。上臂式电子血压计5按其正常使用方式使用，将袖带绑定在上臂肱动脉处，同时需要将听诊器4放置在袖带内侧紧贴肱动脉处。执行上臂式电子血压计5的测量程序，对测定部位进行加压和减压。在此过程中，接入部件1的压力传感器将感应到的气管中的压力并输出压力信号，压力信号经运算模块进行转换、放大、滤波后（也可不使用运算模块，此时压力传感器的输出信号直接由通信模块传送至手机6），将预处理后的压力信号通过通信模块传送到手机6，与此同时麦克风2采集到经过听诊器4及气管3传递的肱动脉处的声音，并通过耳机插头传送至手机6。类似于压力信号的预处理，也可以在麦克风2的输出端增加用于预处理音频信号的转换模块，如进行信号放大、降噪、数模转换、滤波等处理，通过耳机插头输出的是预处理后的音频信号。
从而通过测量辅助装置，实现了在现有血压计产品测量过程中对于测定部位的压力和音频信号的采集和传送。
另一方面，图3中方框内的 组件 还可以有多种组合方式，如麦克风2可以放置在听诊器4中，再通过导电线接耳机插头，此时不需要使用气管3或者其他声音传导介质。耳机插头和手机6的连接可以是直接连接，也可以是间接连接，如在接入部件1上设置耳机插孔，将耳机插头插入接入部件1，通过接入部件1与手机6的有线或无线连接传输音频信号，此时也有两种方式：(1)音频信号直接通过通讯模块传送至手机6；（2）由于接入部件1可以同时接收压力信号和音频信号，所以可以在运算模块中实现对音频信号的预处理（如上述的转换模块），再将预处理后的音频信号传送至通信模块，在由通信模块传送至手机6。
同时运算模块的功能可根据需要进行扩展，来减轻终端设备的数据处理压力，甚至是只将终端设备作为图像和声音的输出设备，对于数据的处理都可交由运算模块进行处理，如上述的对于压力信号和音频信号的预处理，还根据接收到的信号通过示波法或听诊法确定血压值，再通过通信模块传送至终端设备。
所以在手机6上专用APP所实现的大部分功能（如数据同步存储、数据处理和计算、示波法判定、示波法参数存储和调整等）均可以通过在运算模块中设置相应的功能模块实现，手机6仅负责显示和人机交互。
还可以通过与手机6的有线或无线连接，将其中的数据传输到外部设备，如将存储的数据上传到电脑、服务器、云端等外部设备，在外部设备上进行共享或直接在外部设备上回放，从而对于血压值的判断不再受限于时间、人数和物理距离。
实施例二
本实施例是基于本发明的一种电子血压计，集压力控制、信号/数据采集、信号/数据处理、信号/数据分析、信号/数据视听、人机交互等于一体。
如图6所示，是本实施例的 上臂式电子 血压计7，但不限于上臂式电子血压计， 也可设计为与之具有不同加压方式或针对不同测定部位的其他类型的血压计 。其中包括主机10、气体管路8和袖带气囊9，主机10上包括按键11和触摸显示屏12。听诊器（未示出）固定在袖带气囊9内侧，麦克风（未示出）装置在听诊器的腔体里（也可以只使用麦克风，不装置听诊器）。麦克风连接至主机10的导电线内嵌在气体管路8里，从而外观上与一般的上臂式血压计并无太大区别。
如图7所示，是主机10的系统架构，其中主处理器主要负责：控制加压装置中的气泵和泄气阀；对分别由压力感应模块和音频采集模块传入的压力信号和音频信号进行处理（放大、降噪、模数转换、滤波等）和同步存储到数据存储模块；通过示波法和/或听诊法确定血压值；控制音频和图像的输出；接收按键模块的指令，进行设备控制、参数调整、数据回放等等操作。其中使用者的按键输入（按键模块的接收端）可以是采用物理按键，也可以是对触摸显示屏的触控，本实施例中使用两者相结合的方式。
压力感应模块通过压力传感器感应压力，其可以直接将压力传感器输出的压力信号送入主处理器进行处理，或是在压力感应模块内设置如实施例一中的运算模块对压力信号进行预处理。
架构中还包括了通信模块，其用于实现主机10与外部设备进行有线或/和无线通信，本实施例中的通信模块使用无线协议来实现与外部设备的数据传输或共享。
以下对于本实施中血压计的操作界面做进一步说明，需要指出的是界面的设定不限于以下的示例，可以在现有技术的基础上实现诸多变化。下述示例旨在进一步反映原始数据的可视化对于血压测量和判断的有益效果。
如图8所示，是上臂式电子 血压计7 的一种操作界面，其中由上至下分别显示了音频幅度、振荡波及压力值随时间变化的曲线图，以及由主处理器根据听诊法计算得到的血压值（该值也可以设置为在测量后直接用语音播报）。同样也可以显示由示波法确定的血压值，或同时显示由听诊法和示波法确定的血压值。各曲线图中最左边的竖线A标示了根据听诊法确定的收缩压对应的时间点，最右边的竖线B标示了舒张压对应的时间点。
图9是图8中界面在进行数据回放时的状态。随着音频的播放，操作界面中，位于中间的竖线C会随着播放进度沿时间轴移动，竖线C经过的音频幅度曲线可以帮助使用者来对耳朵听到的声音做更准确的判断。另外，音频信号的图形化不仅可以是时域的，也可以是频域的或二者皆有。图形也不限于是曲线图，也可以是柱形图等。还可以设置在声音的回放过程中可随时进行暂停、继续、设置在两个时间点间循环播放等操作。
对于主处理器通过示波法确定的血压值，还可以根据听诊法得到的血压值 （或是由其他方式获得的准确度较高的血压值） 对其进行校准，以示波法中的幅度参数法为例，参数C1和C2因人而异，可以根据个人情况对其进行调整，以提高针对个体的测量精度。这种调整可以直接通过操作界面（未示出）来对示波法中使用的参数进行修改，如参数C1和C2，但这可能需要专业人士才能有效实施。对于一般的使用者，可以设置为，针对某一次的测量，输入经确认后认为是准确的血压值（如人为通过听诊法确定的血压值），由专用APP将输入的血压值和由示波法确定的血压值进行比较，依据比较结果进行参数调整，从而无需专业人士也可简单进行参数调整。也可以以听诊法确定的血压值为基准自动校准示波法中使用的参数（如幅度参数法中的C1和C2），这种校准也可以设置为周期性的，如设定为一段时间或一定次数后进行自动校准。
由于参数的修改是针对个人情况而进行的校准，测量精度一般会高于普通电子血压计上的直接读数。并且在经过校准后，即使不使用听诊器4（不进行听诊法确定血压值），也可以获得相对较为准确的血压值。在图6和图7中操作界面左下方的头像图标可以用于切换用户，每个用户都有各自的参数组，满足了多人使用。
以上界面功能的实施，皆在现有技术的可实现范围内，并且在有数据源的前提下，对于数据的处理和显示的方式多种多样，如对数据进行相关性分析、将图像加入动态元素等等，可以根据实际需要做进一步地设计或改进。
在使用时，本实施例的血压计也与普通电子血压计一样，只需一键启动，血压计自动对袖带气囊进行充放气操作，同时记录测量到的数据。待测量结束后，自动显示由示波法和/或听诊法确定的血压值，也可在主机上回放记录的压力值和声音数据，人为通过听诊法确定血压值。
最后需要指出的是，在实施例一中可以通过在作为终端设备的手机（或电脑、平板电脑等）上编制相应的APP来实现本实施例中血压计的几乎全部功能。此时手机大致相当于本实施中的主机10，区别在于手机不能对加压装置进行控制。
以上详细描述了本发明的较佳具体实施例。应当理解，本领域的普通技术人员无需创造性劳动就可以根据本发明的构思作出诸多修改和变化。因此，凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案，皆应在由权利要求书所确定的保护范围内。

Claims (37)

  1. 一种用于血压测量的测量辅助装置，其特征在于，所述测量辅助装置被设置为可与血压计的加压装置连接，并包括感应模块和通讯模块；
    所述感应模块用于感应所述测量辅助装置与所述加压装置连接处的压力并输出压力信号至所述通讯模块；
    所述通讯模块用于接收所述压力信号，并传送至终端设备。
  2. 如权利要求1所述的测量辅助装置，其特征在于，所述感应模块包括压力传感器，通过所述压力传感器感应所述测量辅助装置与所述加压装置连接处的压力。
  3. 如权利要求1所述的测量辅助装置，其特征在于，还包括运算模块，用于对所述压力信号进行预处理，并将预处理后的所述压力信号传送至所述通讯模块，由所述通信模块传送至所述终端设备。
  4. 如权利要求3所述的测量辅助装置，其特征在于，所述运算模块根据所述压力信号通过示波法确定血压值，并将所述血压值传送至所述通讯模块，由所述通信模块传送至所述终端设备。
  5. 如权利要求1所述的测量辅助装置，其特征在于，所述通讯模块有线连接或无线连接所述终端。
  6. 一种用于血压测量的测量辅助装置，其特征在于，所述测量辅助装置被设置为可与血压计的加压装置连接，并包括感应模块、通讯模块和音频采集模块；
    所述感应模块用于感应所述测量辅助装置与所述加压装置连接处的压力并输出压力信号至所述通讯模块；
    所述通讯模块用于接收所述压力信号，并传送至终端设备；
    所述音频采集模块用于采集测定部位的声音并输出音频信号至所述终端设备。
  7. 如权利要求6所述的测量辅助装置，其特征在于，所述感应模块包括压力传感器，通过所述压力传感器感应所述测量辅助装置与所述加压装置连接处的压力。
  8. 如权利要求7所述的测量辅助装置，其特征在于，还包括运算模块，用于对所述压力信号进行预处理，并将预处理后的所述压力信号传送至所述通讯模块，由所述通信模块传送至所述终端设备。
  9. 如权利要求8所述的测量辅助装置，其特征在于，所述运算模块根据所述压力信号通过示波法确定血压值，并将所述血压值传送至所述通讯模块，由所述通信模块传送至所述终端设备。
  10. 如权利要求6所述的测量辅助装置，其特征在于，所述音频采集模块包括对采集到的声音进行预处理的转换模块。
  11. 如权利要求6所述的测量辅助装置，其特征在于，所述音频采集模块将所述音频信号传送至所述通讯模块，由所述通讯模块传送至所述终端设备。
  12. 如权利要求8所述的测量辅助装置，其特征在于，所述音频采集模块将所述音频信号传送至所述运算模块，由所述运算模块直接或对所述音频信号进行预处理后传送至所述通讯模块，由所述通讯模块传送至所述终端设备。
  13. 如权利要求12所述的测量辅助装置，其特征在于，所述运算模块根据所述压力信号和所述音频信号通过听诊法，或/和根据所述压力信号通过示波法确定血压值，并将由听诊法或/和示波法确定的血压值传送至所述通讯模块，由所述通信模块传送至所述终端设备。
  14. 如权利要求13所述的测量辅助装置，其特征在于，以所述运算模块通过听诊法确定的血压值为基准，对示波法中使用的参数进行调整。
  15. 如权利要求14所述的测量辅助装置，其特征在于，所述调整是周期性的。
  16. 如权利要求14所述的测量辅助装置，其特征在于，所述运算模块存储多组所述示波法中使用的参数。
  17. 如权利要求6所述的测量辅助装置，其特征在于，所述通讯模块和所述音频采集模块有线连接或无线连接所述终端。
  18. 一种血压测量设备，其特征在于，包括
    加压装置，用于向测定部位加压和减压；
    感应模块，用于与所述加压装置连接以感应连接处的压力并输出压力信号；
    音频采集模块，用于采集测定部位的声音并输出音频信号；
    主控单元，用于与所述感应模块和所述音频采集模块连接，以接收和处理所述压力信号和所述音频信号。
  19. 如权利要求18所述的血压测量设备，其特征在于，所述加压装置包括直接作用于测定部位的施压组件，所述音频采集模块部分或全部安置在所述施压组件的内部或外侧。
  20. 如权利要求18所述的血压测量设备，其特征在于，所述感应模块包括压力传感器，通过所述压力传感器感应其与所述加压装置连接处的压力。
  21. 如权利要求18所述的血压测量设备，其特征在于，还包括图像输出模块，用于数值化地和/或图形化地显示所述压力信号和/或所述音频信号。
  22. 如权利要求21所述的血压测量设备，其特征在于，还包括音频输出模块，用于播放所述音频信号或所述音频信号经处理形成的音频。
  23. 如权利要求18-22任一所述的血压测量设备，其特征在于，所述主控单元通过听诊法和/或示波法确定血压值，并由所述图像输出模块显示或/和所述音频输出模块播放。
  24. 如权利要求23所述的血压测量设备，其特征在于，能够调整示波法中使用的参数。
  25. 如权利要求24所述的血压测量设备，其特征在于，以手动输入的数值或以所述主控单元通过听诊法确定的血压值为基准，对所述示波法中使用的参数进行调整。
  26. 如权利要求24所述的血压测量设备，其特征在于，存储多组所述示波法中使用的参数。
  27. 如权利要求25所述的血压测量设备，其特征在于，当以所述主控单元通过听诊法确定的血压值为基准，对所述示波法中使用的参数进行调整时，所述调整是周期性的。
  28. 如权利要求18所述的血压测量设备，其特征在于，所述主控单元还包括通信模块，用于与外部设备进行有线或无线通信。
  29. 一种血压测量设备的设计方法，其特征在于，设置感应模块、音频采集模块，以及与所述感应模块和所述音频采集模块相连接的主控单元；所述感应模块用于感应测定部位的压力并输出压力信号；所述音频采集模块用于采集测定部位的声音并输出音频信号；所述主控单元接收和处理所述压力信号和所述音频信号。
  30. 如权利要求29所述的设计方法，其特征在于，设置图像输出模块，用于数值化地和/或图形化地显示所述压力信号和/或所述音频信号。
  31. 如权利要求30所述的设计方法，其特征在于，设置音频输出模块，用于播放所述音频信号或所述音频信号经处理形成的音频。
  32. 如权利要求29-31任一所述的设计方法，其特征在于，采用以下方式确定血压值：
    方式1、所述主控单元根据所述压力信号和所述音频信号，通过听诊法确定血压值；
    方式2、根据基于所述压力信号和所述音频信号而得到的所述图像输出模块输出的图像和所述音频输出模块输出的声音，人为通过听诊法确定血压值；
    方式3、所述主控单元根据所述压力信号通过示波法确定血压值，其中示波法中使用的参数可以调整。
  33. 如权利要求32所述的设计方法，其特征在于，所述方式1和2中，由所述主控单元对所述音频信号进行处理后，再通过听诊法确定血压值。
  34. 如权利要求32所述的设计方法，其特征在于，所述血压测量设备包括多组所述示波法中使用的参数。
  35. 如权利要求32所述的设计方法，其特征在于，所述方式3中，以手动输入的数值，或以所述主控单元通过听诊法确定的血压值为基准，对所述示波法中使用的参数进行调整。
  36. 如权利要求35所述的设计方法，其特征在于，当以所述主控单元通过听诊法确定的血压值为基准，对所述示波法中使用的参数进行调整时，所述调整是周期性的。
  37. 如权利要求29所述的设计方法，其特征在于，设置通信模块，用于与外部设备进行有线或无线通信。
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