WO2020258352A1 - 一种脉搏检测装置及其制作方法 - Google Patents

一种脉搏检测装置及其制作方法 Download PDF

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WO2020258352A1
WO2020258352A1 PCT/CN2019/094407 CN2019094407W WO2020258352A1 WO 2020258352 A1 WO2020258352 A1 WO 2020258352A1 CN 2019094407 W CN2019094407 W CN 2019094407W WO 2020258352 A1 WO2020258352 A1 WO 2020258352A1
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sensor
detection device
pulse detection
measurement site
static pressure
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French (fr)
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方鹏
彭雨辉
林宛华
李光林
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Shenzhen Institute of Advanced Technology of CAS
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Shenzhen Institute of Advanced Technology of CAS
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6824—Arm or wrist
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6831—Straps, bands or harnesses
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
    • G01L1/00—Measuring force or stress, in general
    • G01L1/16—Measuring force or stress, in general using properties of piezoelectric devices
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
    • G01L1/00—Measuring force or stress, in general
    • G01L1/18—Measuring force or stress, in general using properties of piezo-resistive materials, i.e. materials of which the ohmic resistance varies according to changes in magnitude or direction of force applied to the material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors

Definitions

  • the present invention relates to the technical field of medical devices, in particular to a pulse detection device and a manufacturing method thereof.
  • pulse diagnosis is used to detect the pulse wave.
  • the pulse is caused by the contraction of the heart to eject blood into the blood vessel, which causes the vessel diameter to expand.
  • the cardiovascular physiological state can be understood, such as heart rate analysis, blood pressure estimation, and disease diagnosis And so on, has very important physiological significance.
  • pulse wave detection technologies mainly include photo-capacitance pulse sensors, piezoresistive pulse sensors, piezoelectric pulse sensors, photoplethysmography, pressure detection methods, etc.
  • Photocapacitive pulse sensor The main components of this method are LED lights and photosensitive sensors.
  • the LED lights emit a beam of light to the blood vessels.
  • the light transmittance changes due to the blood flow in the blood vessels, and the photosensitive sensor receives
  • the pulse wave waveform is obtained by recording the change of light intensity.
  • Piezoresistive pulse sensor The sensing material of a piezoresistive sensor is generally a piezoresistor or a strain resistance. When this type of material is deformed by an external force, the resistance of the material will change accordingly. Placing the sensor at the sensing site with strong pulse pulse will cause the sensing material to be deformed when the pulse is pulsed, so that the pulse wave waveform can be obtained by detecting the resistance change of the piezoresistive sensor.
  • Piezoelectric pulse sensor The sensing material of piezoelectric sensor is piezoelectric material, generally piezoelectric electret, PVDF (polyvinylidene fluoride) and other piezoelectric materials. This type of material has many holes inside, and the surface is polarized with a polarization charge. When squeezed by an external force, the holes inside the material are compressed, and the electric dipole moment changes, which changes the surface charge of the material. The pulse wave waveform can be obtained by detecting the surface charge of the material.
  • Photoplethysmography The principle of this method is to detect changes in blood transmittance in blood vessels, thereby indirectly obtaining pulse wave signals.
  • the signal detected by this method is very weak, and optical noise is everywhere in the environment, which will greatly interfere with the signal collected by the sensor. And the slight change in the degree of adhesion between the sensor and the skin can also cause huge interference in the final result.
  • this method will cause the light emitted by the LED lamp to be absorbed for users with dark skin or tattoos at the measurement site, resulting in the photosensitive sensor not receiving the light signal after passing through the blood vessel.
  • Pressure detection method uses a piezoresistive sensor or a piezoelectric sensor to detect the pressure signal of the blood against the blood vessel wall.
  • the basic principle of a piezoresistive sensor is that when the sensor is affected by an external force, the varistor inside the sensor deforms, which causes the resistance value to change, and the pulse wave waveform is obtained by detecting the resistance value change.
  • Piezoresistive sensors have low linearity and low measurement accuracy, making it difficult to obtain accurate pulse wave signals, and are generally suitable for measuring static pressure, but not suitable for detecting the dynamic pressure of pulse waves.
  • the basic principle of a piezoelectric sensor is that when the sensor is affected by an external force, the electric dipole moment inside the piezoelectric material in the sensor changes, resulting in a change in the amount of surface charge of the material, and the surface charge of the piezoelectric material is detected to obtain the pulse wave Waveform.
  • Piezoelectric materials are suitable for detecting dynamic forces, but an external device is required to fix the sensor during measurement, so that the piezoelectric material is squeezed when the pressure of the pulse wave changes. Therefore, such sensors are usually equipped with external fixing devices.
  • the purpose of the present invention is to overcome the above-mentioned defects of the prior art and provide a pulse detection device and a manufacturing method thereof, which combine the collected static pressure of the measurement site and the dynamic signal of the pulse wave to perform pulse detection.
  • a pulse detection device includes a pressing structure, a wristband structure, a composite sensor and a wrist rest structure, wherein:
  • the pressing structure is used to apply static pressure to the measurement site and set it at a position close to the measurement site according to the use state of the pulse detection device;
  • the composite sensor includes a piezoelectric sensor and a piezoresistive sensor, the piezoresistive sensor is used to sense the static pressure applied to the measurement site, and the piezoelectric sensor is used to sense the static pressure applied to the measurement site.
  • Dynamic pressure signal ;
  • the wristband structure is used to fix the pressing structure on the wrist;
  • the wrist rest structure is used to provide the adhesion force between the pulse detection device and the sensing site.
  • the piezoresistive sensor is connected to the pressing structure, and the piezoelectric sensor is attached to the piezoresistive sensor.
  • the piezoelectric sensor is a sensor based on a flexible piezoelectric electret.
  • the piezoelectric sensor includes a flexible piezoelectric electret film, two metal electrodes respectively arranged on the upper and lower surfaces of the flexible piezoelectric electret film, and a flexible piezoelectric sensor wrapped with two metal electrodes.
  • the encapsulation protection layer of the electret film, the encapsulation protection layer transmits the pulse signal from the measurement site to the flexible piezoelectric electret film.
  • the flexible piezoelectric electret film is a single-layer porous film, or a multilayer porous film superimposed in parallel or in series.
  • the piezoresistive sensor is a piezoresistive pressure sensor or a strain pressure sensor.
  • the pressing structure is a mechanical screw structure, including a mechanical knob and a screw connected to the mechanical knob, and the mechanical knob is used to control the screwing in and out of the screw to control the alignment measurement position. The amount of static pressure applied by the point.
  • a manufacturing method of a pulse detection device includes the following steps:
  • the piezoresistive sensor is used to sense the static pressure applied to the measurement site, and the piezoelectric sensor is used to sense the static pressure applied to the measurement site Dynamic pressure signal;
  • the preset wrist rest structure is obtained to provide the adhesion force between the pulse detection device and the sensing site.
  • the pressing structure is a mechanical spiral structure, including a mechanical knob and a screw connected to the mechanical knob, and the mechanical knob is used to control the screwing in and out of the screw to control the measurement position. The amount of static pressure applied.
  • a pulse detection method includes the following steps:
  • the piezoresistive sensor senses the static pressure applied to the measurement site, and the piezoelectric sensor senses the dynamic pressure signal when the static pressure is applied to the measurement site;
  • the pulse wave signal of the measurement site is obtained based on the sensed static pressure and dynamic pressure signal.
  • the piezoelectric-piezoresistive composite sensor is used to detect the pulse wave signal, which not only overcomes the complex structure of the photoplethysmography detection method, the difficult design and production, the low reliability, and the easy to be affected by ambient light.
  • the shortcomings of inaccurate results, etc. have overcome the shortcomings of low repeatability of pressure detection method and unreliable detection principle.
  • the sensing structure and fixing the composite sensor on the wrist it can greatly reduce the artifact interference of the human body's micro-motion to the detection signal, and ensure the stability of the detection signal.
  • the sensing structure can fix the measurement site, and solves the problem of inaccurate measurement results caused by the small movement between the composite sensor and the skin surface.
  • Metal electrodes and wires are formed on the surface of the piezoelectric electret film of the present invention, and a piezoelectric sensing unit is formed in the area with the metal electrodes.
  • the manufacturing process adopted is simple and suitable for machine flow production.
  • the overall structure of the present invention is relatively simple, has strong portability, and can detect dynamic-static combined pressure signals in many fields.
  • Fig. 1 is a front view of a pulse detection device according to an embodiment of the present invention
  • Figure 2 is a side view of the pulse detection device of Figure 1;
  • Fig. 3 is a schematic diagram of a composite sensor according to an embodiment of the present invention.
  • Fig. 4 is a schematic diagram of a piezoelectric sensor according to an embodiment of the present invention.
  • Fig. 5 is a flowchart of a manufacturing method of a pulse detection device according to an embodiment of the present invention.
  • a pulse detection device which adopts the flat tension method (or arterial tension method) to detect the pulse wave.
  • the pressure of blood on the tube wall can be decomposed into a horizontal force component and a vertical force component.
  • the embodiment of the present invention is based on the principle of the flat tension method, which is applied externally The pressure compresses the blood vessel to a flat state. At this time, the pressure of the blood on the tube wall is only in the vertical direction.
  • the collected pulse wave waveform is closest to the true pulse wave waveform, and the data is more accurate, which is beneficial to subsequent analysis and application.
  • the pulse detection device includes a wristband structure, a pressing structure, and a sensing structure as a whole, wherein the wristband structure is used to fix the pressing structure at a fixed position of the wrist to prevent relative sliding between the sensor and the skin surface;
  • the structure is used to control the application of appropriate pressure to the sensing site;
  • the sensing structure is used to detect the static pressure of the sensing site and the dynamic signal of the pulse wave.
  • the pulse wave detection device provided by the embodiment of the present invention includes a pressing structure 100, a wristband structure 200, a wrist rest structure 300, and a sensing structure 400 (or a composite sensor).
  • the pressing structure 100 is used for clamping and positioning.
  • a spiral structure can be used, including a mechanical knob and a screw connected to the mechanical knob.
  • the screw is a stick-like object for screwing in and out. Because the pulse point is on the outside of the wrist, according to In the use state of the pulse detection device, the pressing structure is designed at a side position, so that it can be conveniently placed at a suitable pulse wave measurement site.
  • pressing structure 100 may also adopt other structural designs, for example, an electric knob or other types.
  • the wristband structure 200 is used to fix the entire pulse detection device on the wrist to prevent the sensing site from shifting and reduce the relative movement between the sensor and the skin.
  • the wrist support structure 300 is designed to fit the shape of the wrist. For example, a softer material is used to better fit the arm, so that the sensing site can fit smoothly.
  • the sensing structure 400 applies pressure by pressing the structure 100 to closely adhere to the skin surface.
  • the sensing structure 400 is a piezoelectric-piezoresistive composite sensor, including a piezoresistive sensor 401 and a piezoelectric sensor 402.
  • the piezoresistive sensor 401 is connected to the pressing structure 100, and the piezoelectric sensor 402 is attached. On the piezoresistive sensor 401, it is in direct contact with the skin.
  • the piezoresistive sensor 401 collects the static pressure applied externally on the skin surface, and is connected to the piezoresistive sensor signal collection module (not shown) to obtain the current static pressure value.
  • the piezoelectric sensor 402 collects the pulse wave dynamic pressure, connects the piezoelectric signal acquisition module and the signal processing module (not shown), and records the pulse wave signal in real time.
  • the sensing structure 400 detects externally applied static pressure and the dynamic force of the pulse wave, and applies the detection result to blood pressure estimation.
  • the sensing system measures the applied static pressure through a piezoresistive sensor, and measures the pulse wave dynamic force signal through a piezoelectric sensor, combining the advantages of the two sensors to achieve high-precision measurement.
  • the piezoelectric sensor is a piezoelectric unit based on a piezoelectric electret, as shown in FIG. 4, it includes a detection layer 600 (or piezoelectric sensing layer), an encapsulation protection layer 500, and an encapsulation protection layer 700 .
  • the detection layer 600 includes a flexible piezoelectric electret film 601 and two metal electrodes 602 and 603 respectively arranged on the upper and lower surfaces of the flexible piezoelectric electret film 601. One ends of the metal electrodes 602 and 603 are respectively connected to wires 604 and 605. .
  • the piezoelectric electret film 601 is a flexible material, and the piezoelectric electret is a flexible material, including but not limited to polypropylene (PP), polyethylene terephthalate (Polyethylene terephthalate). , PET), polyethylene naphthalate (PEN) and other materials.
  • PP polypropylene
  • Polyethylene terephthalate Polyethylene terephthalate
  • PET PET
  • PEN polyethylene naphthalate
  • the flexible piezoelectric electret film 601 can be cut into a circular shape.
  • the flexible piezoelectric electret film 601 is a closed film made of piezoelectric electret with multiple holes inside. A large number of positive and negative charges are deposited on the upper and lower surfaces of the holes, or a flexible piezoelectric electret.
  • the pole body 601 is a multi-layer porous film superimposed by folding to enhance the overall piezoelectric coefficient and improve the signal-to-noise ratio.
  • the flexible piezoelectric electret film 601 has metal electrodes 602 and 603 on the upper and lower surfaces to obtain the amount of charge change generated when the flexible piezoelectric electret film 601 deforms, in order to better measure the piezoelectric sensor layer
  • the two metal electrodes in this embodiment are equipped with wires 604 and 605.
  • the metal electrodes on the upper and lower surfaces can be further connected to a charge amplifier (the charge amplifier can be set in the piezoelectric Signal acquisition module or signal processing module) to convert the change in charge generated when the electret is deformed into a change in voltage (or the amount of potential change).
  • the flexible piezoelectric electret film 601, the metal electrodes 602, 603 on the upper and lower surfaces, and the wires 604, 605 of the two metal electrodes form a piezoelectric sensor to realize force-electric conversion.
  • the piezoelectric sensor may also be other types of piezoelectric sensors based on piezoelectric semiconductor materials or polymer piezoelectric materials.
  • the piezoresistive sensor is a rigid packaged sensing unit, which is packaged but not limited to pressure sensors such as piezoresistors and strain gauge pressure sensors.
  • the basic process of pulse detection is that the pressing structure 100 controls the entry and exit of a stick-like object to achieve a fixed pressure on the sensing site, and the process of applying pressure from small to large, the pulse wave
  • the pressure change on the skin surface changes from small to large, and then decreases when it reaches a peak.
  • the appropriate static pressure for the pulse measurement point is adjusted, so that the pulse wave has the greatest pressure on the skin surface, and the piezoelectric sensor 402 has the largest output signal amplitude.
  • the applied static pressure is an appropriate value, the blood vessel reaches an approximately flat state, and the blood pressure on the blood vessel wall is all vertical force.
  • the piezoresistive sensor 401 measures the magnitude of the static pressure currently applied. The magnitude of the static pressure at this time is close to the average blood pressure.
  • the piezoelectric sensor 402 detects the dynamic signal of the pulse wave, extracts the peak and valley values of the pulse wave, and finally The pressure value, pulse wave peak value and pulse wave trough value estimate blood pressure.
  • the present invention also provides a manufacturing method of a pulse detection device, as shown in Fig. 5, including:
  • Step S510 Obtain a preset piezoelectric sensor and a piezoresistive sensor to form a piezoelectric-piezoresistive composite sensor.
  • the preset conditions include the size and shape of the flexible piezoelectric electret film. For example, shear the piezoelectric electret film to match the sensitive area of the piezoelectric electret sensor and the piezoresistive sensor.
  • a buffer layer can be further filled between the piezoelectric electret sensor and the piezoresistive sensor.
  • Step S520 Obtain the preset pressing structure and wristband structure.
  • the relative position of the pressing structure and the wristband structure, as well as the length and elasticity of the wristband, are set.
  • Step S530 connect the pressing structure to the composite sensor.
  • the pressing structure is connected with the piezoresistive sensor to obtain a composite sensor that can be used to detect static pressure and dynamic signals, thereby improving the accuracy of detecting tactile signals, and at the same time providing a data source for subsequent applications such as blood pressure estimation and disease pre-diagnosis.
  • the sensor unit proposed in the present invention can change the corresponding size parameters for heart sound signal extraction, and can also be used in other places where a combination of dynamic and static pressure signals needs to be detected.
  • the present invention proposes a pulse detection device based on the flat tension method by combining the piezoelectric sensor and the piezoresistive sensor to avoid the inaccurate detection results caused by the measurement principle of the photoplethysmography method and the harsh conditions of the use scene.
  • it also solves the shortcomings of traditional piezoelectric sensors that have large output amplitude errors during repeated measurements. While meeting the accuracy of the measurement results, it does not require high measurement conditions, can detect in real time, and is simple and convenient to use.
  • the pulse detection device of the present invention can accurately measure small signals such as pulse.
  • piezoelectric electret sensing technology has come out, and its material properties have been continuously improved, and its sensitivity can meet the measurement of small signals such as human pulse waves.
  • the manufacturing process and technology of the pulse detection device of the present invention are simple and clear, and technically easy to accomplish.

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Abstract

一种脉搏检测装置及其制作方法，脉搏检测装置包括按压结构（100）、腕带结构（200）、复合传感器（400）和腕托结构（300），其中按压结构（100）用于向测量位点施加静态压力并根据脉搏检测装置的使用状态设置在靠近测量位点的位置；复合传感器（400）包括压电传感器（402）和压阻传感器（401），压阻传感器（401）用于感测施加到测量位点的静态压力，压电传感器（402）用于感测对测量位点施加静态压力情况下的动态压力信号；腕带结构（200）用于将按压结构（100）固定在腕部；腕托结构（300）用于提供脉搏检测装置和传感位点之间的贴合力。脉搏检测装置通过同时检测施加的静态压力和脉搏波的动态压力信号能够实现准确测量。

Description

一种脉搏检测装置及其制作方法 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种脉搏检测装置及其制作方法。
背景技术
传统中医中有脉诊检测脉搏波，脉搏是由心脏收缩喷射血液进入血管中，使得血管管径扩张，通过对脉搏波的分析可以了解心血管生理状态，如心率分析、血压估算和疾病预诊断等，具有非常重要的生理意义。
在现有技术中，脉搏波检测技术主要包括光电容式脉搏传感器、压阻式脉搏传感器、压电式脉搏传感器、光电容积描记法和压力检测法等。
光电容式脉搏传感器：该方法主要原件为LED灯和光敏传感器，通过LED灯发射一束光到血管处，光经过血管时，由于血管内血液的流动，导致透光率发生变化，光敏传感器接收经过血管后的光，通过记录光强度的变化得到脉搏波波形。
压阻式脉搏传感器：压阻式传感器的传感材料一般为压敏电阻或应变电阻，这类材料在受到外力产生形变时，材料的阻值会发生相应变化。将传感器放置在脉搏搏动较强的传感位点，脉搏搏动时造成传感材料发生形变，从而通过检测压阻传感器的电阻变化来得到脉搏波波形。
压电式脉搏传感器：压电式传感器的传感材料为压电材料，一般有压电驻极体、PVDF(聚偏氟乙烯)等压电材料。这类材料内部有许多孔洞，表面通过极化附有极化电荷。在受到外力挤压时，材料内部的孔洞被压缩，电偶极矩发生变化，使材料的表面电荷量发生改变，通过检测材料的表面电荷量可以得到脉搏波波形。
光电容积描记法：该方法的原理是检测血管中血液透光率的变化，从而间接得到脉搏波信号。这种方法检测到的信号本身就很微弱，而光噪声在环境中无处不在，会极大的干扰传感器采集到的信号。而且传感器和皮肤贴合程度的微弱变化也会导致最终结果的巨大干扰。除此之外，该方法 对肤色较黑或测量位点有纹身的使用者，会导致LED灯发出的光被吸收，导致光敏传感器接收不到经过血管之后的光信号。
压力检测法：该方法利用压阻传感器或压电传感器检测血液对血管壁的压力信号。压阻传感器的基本原理是，当传感器受到外力影响时，传感器内部的压敏电阻发生形变，从而导致电阻值发生变化，通过检测电阻值变化得到脉搏波波形。压阻传感器线性度不高，测量精度低，难以得到准确的脉搏波信号，且一般适用于测量静态压力，不适合检测脉搏波这种动态压力。压电传感器的基本原理是，当传感器受到外力影响时，传感器中的压电材料内部的电偶极矩发生变化，从而导致材料表面电荷量发生变化，检测压电材料的表面电荷从而得到脉搏波波形。压电材料适合检测动态力，但是测量时需要外部装置固定传感器，以达到压电材料在受到脉搏波压力变化时，材料被挤压，因此这种传感器通常会配有外部固定装置。而通过对血管模型分析发现，血管在受到不同外部固定装置的压力时，扁平程度不一样，传感器会得到不同的信号幅值。该方法在不同外部压力的情况下得到不同的脉搏波波形，难以进行后续分析应用。
因此，需要对现有技术进行改进，提供具有压电传感器和压阻传感器的复合传感单元的脉搏检测装置。
发明内容
本发明的目的在于克服上述现有技术的缺陷，提供一种脉搏检测装置及其制作方法，结合采集的测量位点的静态压力和脉搏波的动态信号来进行脉搏检测。
根据本发明的第一方面，提供了一种脉搏检测装置。该脉搏检测装置包括按压结构、腕带结构、复合传感器和腕托结构，其中：
所述按压结构用于向测量位点施加静态压力并根据该脉搏检测装置的使用状态设置在靠近测量位点的位置；
所述复合传感器包括压电传感器和压阻传感器，所述压阻传感器用于感测施加到测量位点的静态压力，所述压电传感器用于感测对测量位点施加静态压力情况下的动态压力信号；
所述腕带结构用于将所述按压结构固定在腕部；
所述腕托结构用于提供该脉搏检测装置和传感位点之间的贴合力。
在一个实施例中，所述压阻传感器与所述按压结构相连，所述压电传 感器贴附在所述压阻传感器上。
在一个实施例中，所述压电传感器是基于柔性压电驻极体的传感器。
在一个实施例中，所述压电传感器包括柔性压电驻极体薄膜、分别设置在所述柔性压电驻极体薄膜上下表面的两金属电极，以及包裹附有两金属电极的柔性压电驻极体薄膜的封装保护层，所述封装保护层将脉搏信号从测量位点传递到所述柔性压电驻极体薄膜。
在一个实施例中，所述柔性压电驻极体薄膜为单层多孔膜，或由多层多孔膜通过并联或串联方式叠加而成。
在一个实施例中，所述压阻传感器是压敏电阻式压力传感器或应变式压力传感器。
在一个实施例中，所述按压结构为是机械式螺旋结构，包括机械旋钮以及与该机械旋钮连接的螺杆，所述机械旋钮用于控制所述螺杆的旋进旋出，以控制对测量位点施加的静态压力大小。
根据本发明的第二方面，提供一种脉搏检测装置的制作方法。该方法包括以下步骤：
获取预设的按压结构，并根据该脉搏检测装置的使用状态将所述按压结构设置在靠近测量位点的位置，以向测量位点施加静态压力；
获取预设的压电传感器和压阻传感器构成复合传感器，所述压阻传感器用于感测施加到测量位点的静态压力，所述压电传感器用于感测对测量位点施加静态压力情况下的动态压力信号；
获取预设的腕带结构，以将所述按压结构固定在腕部；
获取预设的腕托结构，以提供该脉搏检测装置和传感位点之间的贴合力。
在一个实施例中，所述按压结构是机械式螺旋结构，包括机械旋钮以及与该机械旋钮连接的螺杆，所述机械旋钮用于控制所述螺杆的旋进旋出，以控制对测量位点所施加的静态压力大小。
根据本发明的第三方面，提供一种脉搏检测方法。该方法包括以下步骤：
通过所述按压结构控制施加到测量位点的静态压力；
所述压阻传感器感测施加到测量位点的静态压力，所述压电传感器感测对测量位点施加静态压力情况下的动态压力信号；
基于所感测的静态压力和动态压力信号获得测量位点的脉搏波信号。
与现有技术相比，本发明的优点在于：
1)、基于扁平张力法，采用压电-压阻复合传感器，检测脉搏波信号，既克服了光电容积描记法检测方法结构复杂、设计制作难度大、可靠性低、易受环境光影响、检测结果不准确等缺点，又克服了压力检测法可重复性低、检测原理不可靠等缺点。
2)、通过设计传感结构，将复合传感器固定在手腕上，可大幅度降低人体微动作对检测信号的伪迹干扰，保证了检测信号的稳定性。传感结构能固定测量位点，解决了复合传感器与皮肤表面产生微小移动而造成测量结果不准确的问题。
3)、本发明的压电驻极体薄膜表面形成金属电极和导线，在具有金属电极的区域形成压电传感单元，采用的制作流程简单，适合机器流水生产。
4)、本发明整体结构相对简单，可移植性强，能够检测较多领域的动态-静态相结合的压力信号。
附图说明
以下附图仅对本发明作示意性的说明和解释，并不用于限定本发明的范围，其中：
图1是根据本发明一个实施例的脉搏检测装置的正面视图；
图2是图1的脉搏检测装置的侧面视图；
图3是根据本发明一个实施例的复合传感器的示意图；
图4是根据本发明一个实施例的压电传感器的示意图；
图5是根据本发明一个实施例的脉搏检测装置的制作方法的流程图。
具体实施方式
为了使本发明的目的、技术方案、设计方法及优点更加清楚明了，以下结合附图通过具体实施例对本发明进一步详细说明。应当理解，此处所描述的具体实施例仅用于解释本发明，并不用于限定本发明。
在本文示出和讨论的所有例子中，任何具体值应被解释为仅仅是示例性的，而不是作为限制。因此，示例性实施例的其它例子可以具有不同的值。
对于相关领域普通技术人员已知的技术、方法和设备可能不作详细讨论，但在适当情况下，所述技术、方法和设备应当被视为说明书的一部分。
根据本发明的一个实施例，提供一种脉搏检测装置，采用扁平张力法(或称动脉张力法)来检测脉搏波。对于近似于圆管形腔体结构的血管，根据力学模型分析，血液对管壁压力可分解为水平方向分力和垂直方向分力，本发明实施例基于扁平张力法的原理是，通过外部施加压力将血管压至扁平状态，此时血液对管壁的压力仅有垂直方向，采集的脉搏波波形最接近脉搏波真实波形，数据更准确，有利于后续分析应用。
本发明实施例提供的脉搏检测装置整体上包括腕带结构、按压结构和传感结构，其中腕带结构用于将按压结构固定在手腕的固定位点，防止传感器和皮肤表面产生相对滑动；按压结构用于控制对传感位点施加适当的压力；传感结构用于检测传感位点的静态压力和检测脉搏波的动态信号。
具体地，参见图1和图2所示，本发明实施例提供的脉搏波检测装置包括按压结构100、腕带结构200、腕托结构300和传感结构400(或称复合传感器)。
按压结构100用于夹紧和定位，例如可以采用螺旋结构，包括机械旋钮以及与机械旋钮连接的螺杆，该螺杆是用于旋进旋出的棍状物体，由于脉搏点在手腕的外侧，根据脉搏检测装置的使用状态将按压结构设计在靠边位置，从而方便放置在合适的脉搏波测量位点。
应理解的是，按压结构100也可采用其他的结构设计，例如，采用电动式旋钮或其他类型等。
腕带结构200用于将整个脉搏检测装置固定在手腕上，防止传感位点发生偏移，减小传感器与皮肤之间发生相对移动。
腕托结构300设计成适合贴合手腕的形状，例如，采用较柔软材质，以更有利于贴合手臂，使传感位点能够平整贴合。
传感结构400通过按压结构100施加压力和皮肤表面紧贴。
例如，参见图3所示，传感结构400是压电-压阻复合传感器，包括压阻传感器401和压电传感器402，其中，压阻传感器401与按压结构100相连，压电传感器402贴附在压阻传感器401上，与皮肤直接接触。压阻传感器401采集外部施加在皮肤表面的静态压力，连接压阻传感器信号采集模块(未示出)，得到当前静态压力数值。压电传感器402采集脉搏波动态压力，连接压电信号采集模块和信号处理模块(未示出)，实时记录脉搏波信号。
在该实施例中，传感结构400检测外部施加的静态压力和脉搏波的动 态力，并将检测结果应用于血压估计。传感系统通过压阻传感器测量施加的静态压力，通过压电传感器测量脉搏波动态力信号，结合两种传感器优点实现高精度测量。
在一个实施例中，压电传感器是基于压电驻极体的压电单元，参见图4所示，包括检测层600(或称压电传感层)、封装保护层500和封装保护层700。
具体地，检测层600包括柔性压电驻极体薄膜601以及分别设置在柔性压电驻极体薄膜601上下表面的两金属电极602、603，金属电极602、603的一端分别连接导线604、605。
在一个实施例中，压电驻极体薄膜601为柔性材料，压电驻极体为柔性材料，包括但不限于聚丙烯(Polypropylene，PP)、聚对苯二甲酸乙二醇酯(Polyethylene terephthalate，PET)、聚萘二甲酸乙二醇酯(Polyethylene naphthalate，PEN)等各类材料。柔性压电驻极体薄膜601可裁剪为圆形。
例如，柔性压电驻极体薄膜601是由压电驻极体制成的一层内部包含有多个孔洞的封闭薄膜，在孔洞的上下表面分别沉积有大量的正负电荷，或者柔性压电驻极体601是多层多孔膜通过折叠方式叠加而成，以增强整体压电系数，提高信噪比。
进一步地，柔性压电驻极体薄膜601上下表面有金属电极602、603，以获取柔性压电驻极体薄膜601在发生形变时产生的电荷变化量，为了更好地测量压电传感层的柔性压电驻极体薄膜在发生形变时产生的电荷变化量，本实施例的两金属电极均设置导线604、605，上下表面的金属电极可进一步连接电荷放大器(电荷放大器可设置于压电信号采集模块或信号处理模块)，以将驻极体发生形变时产生的电荷的变化转化为电压的变化(或称电势变化量)。在压力作用下，压电驻极体的内部孔洞被压缩，内部电偶极矩密度发生变化，引起上下表面补偿电荷发生变化，表面电极将表面电荷的变化引出，实现力信号转为电信号，即柔性压电驻极体薄膜601及其上、下表面的金属电极602、603、以及两金属电极的导线604、605形成压电传感器，实现力-电转换。
在另外的实施例中，压电传感器也可以是基于压电半导体材料或高分子压电材料的其他类型的压电传感器。
在一个实施例中，压阻传感器为硬质封装传感单元，包裹但不限于压敏电阻、应变式压力传感器等压力传感器。
对于图1和图2的实施例，脉搏检测的基本过程是，按压结构100通过控制一棍状物体进出，实现对传感位点施加固定压力，施加压力由小变大的过程，脉搏波对皮肤表面的压力变化由小变大，达到峰值时再变小。通过控制棍状物体的进出，调整对脉搏测量点合适的静态压力，使得脉搏波对皮肤表面压力最大，此时压电传感器402输出信号幅值最大。当施加静态压力为合适值时，血管达到近似扁平状态，血液对血管壁压力全部为垂直方向的力。压阻传感器401测得当前施加的静态压力大小，此时的静态压力大小与血压的平均压接近，压电传感器402检测脉搏波的动态信号，提取脉搏波波形的峰值和谷值，最后由静态压力数值、脉搏波峰值和脉搏波谷值对血压进行估计。
本发明还提供一种脉搏检测装置的制作方法，参见图5所示，包括：
步骤S510，获取预设的压电传感器和压阻传感器，构成压电-压阻复合传感器。
预设条件包括柔性压电驻极体薄膜的尺寸、形状。例如，对压电驻极体薄膜进行剪切，以使压电驻极体传感器与压阻传感器的敏感区域匹配。此外，压电驻极体传感器和压阻传感器之间还可进一步填充缓冲层。
步骤S520，获取预设的按压结构和腕带结构。
根据脉搏检测装置的使用状态，设置按压结构和腕带结构的相对位置，以及腕带的长度、弹性等。
步骤S530，将按压结构连接到复合传感器。
将按压结构与压阻传感器相连，得到了可用于检测静态压力和动态信号的复合传感器，从而提高了检测触觉信号的准确率，同时为血压估算、疾病预诊断等后续应用提供数据源。
除了人体脉搏波的信号检测本发明提出的传感单元可更改相应尺寸参数进行心音信号提取，也可用在其它需要检测动态-静态压力相结合信号的场所。
综上，本发明提出一种根据扁平张力法，通过将压电传感器和压阻传感器复合构成脉搏检测装置，避免了光电容积描记法由于测量原理而导致检测结果不准确，使用场景条件要求苛刻等缺点，同时解决了传统压电传感器在重复测量时有较大的输出幅值误差的缺点，在满足测量结果准确的同时，对测量条件要求不高，能够实时检测，使用简单方便。
经过论证和预实验，证明本发明的脉搏检测装置能够精确地测量脉搏 等小信号。此外，压电驻极体传感技术已经问世，其材料性能不断得到提高，其灵敏性满足人体脉搏波这种小信号的测量，本发明的脉搏检测装置制作流程和工艺简单明了，在技术上容易实现。
需要说明的是，虽然上文按照特定顺序描述了各个步骤，但是并不意味着必须按照上述特定顺序来执行各个步骤，实际上，这些步骤中的一些可以并发执行，甚至改变顺序，只要能够实现所需要的功能即可。
以上已经描述了本发明的各实施例，上述说明是示例性的，并非穷尽性的，并且也不限于所披露的各实施例。在不偏离所说明的各实施例的范围和精神的情况下，对于本技术领域的普通技术人员来说许多修改和变更都是显而易见的。本文中所用术语的选择，旨在最好地解释各实施例的原理、实际应用或对市场中的技术改进，或者使本技术领域的其它普通技术人员能理解本文披露的各实施例。

Claims (10)

  1. 一种脉搏检测装置，其特征在于，包括按压结构、腕带结构、复合传感器和腕托结构，其中：
    所述按压结构用于向测量位点施加静态压力并根据该脉搏检测装置的使用状态设置在靠近测量位点的位置；
    所述复合传感器包括压电传感器和压阻传感器，所述压阻传感器用于感测施加到测量位点的静态压力，所述压电传感器用于感测对测量位点施加静态压力情况下的动态压力信号；
    所述腕带结构用于将所述按压结构固定在腕部；
    所述腕托结构用于提供该脉搏检测装置和传感位点之间的贴合力。
  2. 根据权利要求1所述的脉搏检测装置，其特征在于，所述压阻传感器与所述按压结构相连，所述压电传感器贴附在所述压阻传感器上。
  3. 根据权利要求1所述的脉搏检测装置，其特征在于，所述压电传感器是基于柔性压电驻极体的传感器。
  4. 根据权利要求3所述的脉搏检测装置，其特征在于，所述压电传感器包括柔性压电驻极体薄膜、分别设置在所述柔性压电驻极体薄膜上下表面的两金属电极，以及包裹附有两金属电极的柔性压电驻极体薄膜的封装保护层，所述封装保护层将脉搏信号从测量位点传递到所述柔性压电驻极体薄膜。
  5. 根据权利要求4所述的脉搏检测装置，其特征在于，所述柔性压电驻极体薄膜为单层多孔膜，或由多层多孔膜通过并联或串联方式叠加而成。
  6. 根据权利要求1所述的脉搏检测装置，其特征在于，所述压阻传感器是压敏电阻式压力传感器或应变式压力传感器。
  7. 根据权利要求1所述的脉搏检测装置，其特征在于，所述按压结构为是机械式螺旋结构，包括机械旋钮以及与该机械旋钮连接的螺杆，所述机械旋钮用于控制所述螺杆的旋进旋出，以控制对测量位点施加的静态压力大小。
  8. 根据权利要求1至7任一项所述的脉搏检测装置的制作方法，包括以下步骤：
    获取预设按压结构，并根据该脉搏检测装置的使用状态将所述按压结 构设置在靠近测量位点的位置，以向测量位点施加静态压力；
    获取预设的压电传感器和压阻传感器构成复合传感器，所述压阻传感器用于感测施加到测量位点的静态压力，所述压电传感器用于感测对测量位点施加静态压力情况下的动态压力信号；
    获取预设的腕带结构，以将所述按压结构固定在腕部；
    获取预设的腕托结构，以提供该脉搏检测装置和传感位点之间的贴合力。
  9. 根据权利要求8所述的脉搏检测设备的制作方法，其特征在于，所述按压结构是机械式螺旋结构，包括机械旋钮以及与该机械旋钮连接的螺杆，所述机械旋钮用于控制所述螺杆的旋进旋出，以控制对测量位点所施加的静态压力大小。
  10. 一种脉搏检测方法，用于权利要求1至7任一项所述的脉搏检测装置，包括以下步骤：
    通过所述按压结构控制施加到测量位点的静态压力；
    所述压阻传感器感测施加到测量位点的静态压力，所述压电传感器感测对测量位点施加静态压力情况下的动态压力信号；
    基于所感测的静态压力和动态压力信号获得测量位点的脉搏波信号。
PCT/CN2019/094407 2019-06-26 2019-07-02 一种脉搏检测装置及其制作方法 Ceased WO2020258352A1 (zh)

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