WO2018113442A1 - Continuous ambulatory blood pressure monitoring device and method based on pulse wave transit - Google Patents

Continuous ambulatory blood pressure monitoring device and method based on pulse wave transit Download PDF

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WO2018113442A1
WO2018113442A1 PCT/CN2017/110340 CN2017110340W WO2018113442A1 WO 2018113442 A1 WO2018113442 A1 WO 2018113442A1 CN 2017110340 W CN2017110340 W CN 2017110340W WO 2018113442 A1 WO2018113442 A1 WO 2018113442A1
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pulse wave
signal
pwtt
electrocardiographic
blood pressure
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PCT/CN2017/110340
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French (fr)
Chinese (zh)
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闵卫东
冯秀丽
潘朋
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天津普仁万合信息技术有限公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021Measuring pressure in heart or blood vessels
    • A61B5/02108Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics
    • A61B5/02125Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics of pulse wave propagation time
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements 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
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6824Arm or wrist
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/72Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235Details of waveform analysis

Definitions

  • the invention belongs to the field of non-invasive dynamic blood pressure continuous monitoring technology, and particularly relates to a device and a method for realizing continuous monitoring of dynamic blood pressure by obtaining pulse wave transit time and speed.
  • Cardiovascular and cerebrovascular diseases are the leading cause of death worldwide.
  • the prevalence of cardiovascular disease in China is on the rise.
  • As of the end of 2014 there were approximately 290 million cardiovascular patients in the country (China Cardiovascular Disease Report 2014).
  • Hypertension is the most common cardiovascular disease, with clinical manifestations of increased systemic arterial pressure.
  • Arterial pressure includes systolic blood pressure (SBP) and diastolic blood pressure (DBP), and the mean value of arterial blood pressure during a cardiac cycle is called mean arterial pressure (MAP).
  • SBP systolic blood pressure
  • DBP diastolic blood pressure
  • MAP mean arterial pressure
  • There are many factors that cause hypertension such as heredity (about 40%), disease, or external factors such as nervousness, excessive long-term sodium intake, smoking, obesity, alcoholism, and lack of exercise.
  • Invasive methods mostly require the insertion of a catheter into a blood vessel for continuous monitoring of arterial blood pressure. This method can accurately measure arterial pressure, but the risk factor and the cost of care are high. This method is not a common method.
  • Most non-invasive blood pressure measurement products currently on the market use auscultation (Korotkoff's Sound) and Oscillography. Both methods require wearing an inflatable cuff and applying pressure to the arteries to obtain blood pressure values.
  • the oscillometric method is widely used in electronic sphygmomanometers. After inflation and pressure, the built-in chip and pressure sensing components of the machine make judgments on the changes of the shock wave, and obtain systolic blood pressure and diastolic blood pressure.
  • a blood pressure measurement takes about 1 minute.
  • the size of the cuff for measurement also needs to be replaced according to individual differences, otherwise it will affect the measurement results. Therefore, Existing non-invasive blood pressure measurements are not suitable for hypertensive patients who frequently and repeatedly monitor blood pressure changes over a long period of time. For users who require continuous blood pressure monitoring, long-term pressure on the wearing position can cause localized skin congestion, and the wearer may affect the quality of sleep due to cuff inflation during nighttime use.
  • PWV pulse wave velocity
  • a complete pulse wave is mainly composed of two pressure waves, which are the pressure wave generated by ventricular contraction ejection and the pressure wave generated by the rapid expansion of the ascending aorta by the ascending aorta. Therefore, the pulse wave has the property of mechanical wave and is extremely fast.
  • the speed is transmitted from the heart along the arterial tree.
  • the energy conversion that occurs when the pulse wave is conducted is mainly the energy conversion between the kinetic energy of the pulse wave conduction and the elastic potential energy of the arterial cavity.
  • PWV 2 E h/2r ⁇ (E is Young's modulus, h is the thickness of the artery wall, r is the intravascular radius, ⁇ is Blood density) It can be seen that the Young's modulus represents that the blood vessel elasticity is proportional to PWV and the worse the arterial elasticity is, the faster the pulse wave conduction speed is.
  • PWV blood pressure
  • the radial artery is the more commonly used blood pressure measurement site. Therefore, the calculation of blood pressure using the pulse velocity of the heart to the radial artery is more suitable for the needs of most people.
  • the location of the radial artery is not suitable for long-term wearing of measuring instruments, so the use of the heart-radial artery is more suitable.
  • the brachial artery pulse wave can be obtained by directly measuring the strongest point of the radial artery pulse, and processed together with the ECG signal to obtain the pulse wave conduction velocity.
  • the relationship between changes in Pwv and changes in systolic blood pressure is more obvious, but the feedback on diastolic blood pressure cannot rely solely on pwv. It also needs to consider changes in parameters such as viscous elasticity of blood vessels, blood vessel diameter, blood density, compliance, and swelling. Impact.
  • the Windkessel vascular elastic cavity model provides a suitable theoretical background for changes in vascular parameters.
  • the Windkessel model sees the cardiovascular system as an equivalent circuit.
  • the power source generates a periodic potential difference, which represents the function of the heart, q represents the blood flow;
  • L is the inductance, which represents the inertia of the blood flowing in the artery, and the larger the value, the slower the blood flow velocity and the blood density ⁇ ;
  • R is the electrical resistance, which also represents the microcirculatory system with the greatest peripheral resistance in the cardiovascular cycle;
  • C1 and C2 are capacitors, representing the arterial vessels at all levels, C1 near the current source represents the aorta, C2 represents the arterial branch, and the capacitance value
  • the size reflects the swelling of the blood vessel, and the larger the value, the better the expansion of the blood vessel; on the other hand, hemodynamics proposes the concept of vascular dilatation, which is compatible with the end of the diastolic phase of the arterial vessel.
  • PWV L/PWTT.
  • L is the distance between the two arterial pulse wave detection points
  • PWTT is the pulse wave transit time.
  • the prior art such as the Chinese patent CN100413464C and the German patent DE10061189A1, obtains the PWTT by reflecting the time difference between the landmark points of the heart ejection at the same time for the two-point pulse wave, and directly calculates the blood pressure by using the PWTT instead of the PWV.
  • this method ignores the effect of the distance L between two points of the peripheral measurement point on the blood pressure calculation.
  • the size of L will vary due to individual differences in population. Therefore, only fitting the PWTT to fit the blood pressure value will cause a large error.
  • Inflatable cuff pressurization device cannot achieve true continuous dynamic blood pressure detection
  • Photoelectric components are biased due to factors such as different skin color at the detection site, scars, excessive thickness of the stratum corneum, and tight adhesion to the skin;
  • the pressure sensor obtains the absolute pressure value of the pulse wave, and the method requires high amplitude of the pulse wave, but the signal amplitude is affected by the difference of subcutaneous fat and externally applied pressure, and the accuracy of the result;
  • the problem to be solved by the present invention is to design a continuous dynamic blood pressure monitoring device and method based on pulse wave conduction, and realize continuous dynamic blood pressure monitoring based on pulse wave transit time (PWTT) and pulse wave velocity (PWV), non-invasive and non-inflatable. Cuff, portable, and highly adaptable, accurate and scalable.
  • PWTT pulse wave transit time
  • PWV pulse wave velocity
  • the pulse wave is a waveform formed by cardiac ejection and diastolic pulsation (vibration) propagating along the aorta to the peripheral artery.
  • the heart-phrenic pulse wave velocity refers to the pulse wave of the same cardiac cycle and myocardial beating.
  • the sensor receives the signal change of the brachial artery vascular force, and calculates the relationship between the pulse wave transit time and the heart-to-arterial measurement point distance and the pulse wave conduction velocity, after being processed by the internal computer chip of the sphygmomanometer Measuring the systolic and diastolic blood pressure of the human body, this method can also be used to detect arteriosclerosis between two different arterial measurement points of the human body.
  • a continuous dynamic blood pressure monitoring device based on pulse wave conduction wherein the monitoring device is in the form of a wristwatch, and the main body casing (101) is provided with an electrocardiographic signal acquisition module (104), and the wristband (102) is provided with a wrist artery at the wrist
  • the pulse wave signal acquisition module (103), the ECG signal acquisition module (104) and the pulse wave signal acquisition module (103) are signally connected to the control module (105).
  • control module includes an amplification module (106), a filtering module (107), an AD converter (108), a blood pressure calculation module (109), which are sequentially connected, the amplification module (106) and the ECG signal.
  • the acquisition module (104) is coupled to the pulse wave signal acquisition module (103).
  • the ECG signal acquisition module (104) includes an electrocardiographic upper electrode sheet (201) on the upper cover of the main body case, and an electrocardiographic lower electrode piece (202) and an electrocardiographic ground electrode on the bottom surface of the main body case for closely contacting the skin.
  • the sheet (203), the electrocardiographic upper electrode sheet (201), the electrocardiographic lower electrode sheet (202), and the electrocardiographic ground sheet (203) are connected to the control module (105).
  • the ECG signal acquisition module (104) includes an upper electrode (401) for adhering to the underside of the left clavicle. And a lower electrode (402) above the left nipple, and a transmission line interface (206) on the main body casing (101) connected to the control module (105), the upper electrode (401) and the lower electrode (402) pass An ECG data transmission line (403) is coupled to the transmission line interface (206).
  • the ECG signal acquisition module (104) includes a manual ECG signal acquisition module and an automatic ECG signal acquisition module;
  • the manual ECG signal acquisition module includes an electrocardiographic upper electrode sheet (201) on a cover of the main body case, and an electrocardiographic lower electrode piece (202) and an electrocardiographic ground piece (203) located on the bottom surface of the main body case for closely contacting the skin.
  • the electrocardiographic upper electrode sheet (201), the electrocardiographic lower electrode sheet (202), and the electrocardiographic ground electrode sheet (203) are connected to the control module (105);
  • the automatic electrocardiographic signal acquisition module includes an upper electrode (401) for being placed under the left clavicle and a lower electrode (402) above the left nipple, and is connected to the control module (105) on the main body casing (101).
  • the transmission line interface (206), the upper electrode (401) and the lower electrode (402) are connected to the transmission line interface (206) through an electrocardiographic data transmission line (403), and it should be noted that for the heart on the right side In the human body, the upper electrode (401) is placed just below the right clavicle, and the lower electrode (402) is placed just above the right nipple.
  • a continuous dynamic blood pressure monitoring method based on pulse wave conduction comprising:
  • the diastolic pressure PWTT DBP is calculated based on the systolic pressure PWTT SBP and the duration of the diastolic phase.
  • the interval of acquiring the pulse wave signal in the step (1) is 2 ms.
  • step (2) is:
  • Td The diastolic duration Td [Td0, Td1, ... Tdn] is calculated by the signal s3.
  • PWTT SBP exp(pt1*PWTT)+pt2;
  • pt1, pt2 are fitting parameters that are combined with user-related parameters.
  • PWTT DBP Td * exp ⁇ PWTT SBP / (pt3 ⁇ PWTT) 2 ⁇ - hr1 * heart rate;
  • Td is the length of the diastolic period
  • pt1 and pt2 are the fitting parameters for combining the relevant parameters of the user.
  • a simple monitoring method for continuous dynamic blood pressure calibration values based on pulse wave conduction comprising:
  • the diastolic pressure PWTT DBP is calculated based on the systolic pressure PWTT SBP and the duration of the diastolic phase.
  • the interval between the synchronous acquisition of the ECG signal and the pulse wave signal in the step (1) is 2 ms.
  • step (2) is:
  • PWTT SBP exp(pt1*hrPWTT)+pt2;
  • pt1, pt2 are fitting parameters that are combined with user-related parameters.
  • PWTT DBP Td * exp ⁇ PWTT SBP / (pt3 ⁇ hrPWTT) 2 ⁇ - hr1 * heart rate;
  • Td is the length of the diastolic period
  • pt1 and pt2 are the fitting parameters for combining the relevant parameters of the user.
  • a continuous dynamic blood pressure monitoring method based on pulse wave conduction comprising:
  • the diastolic pressure PWV DBP is calculated based on the systolic pressure PWV SBP and the diastolic duration TD.
  • the personal parameters in the step (1) include a height height, a body weight BMI, an age Age, a smoking condition, and a medication state of the subject.
  • the interval between the synchronous acquisition of the ECG signal and the pulse wave signal in the step (2) is 2 ms.
  • step (3) is:
  • hrPWV (h1*height-5.085)/hrPWTT;
  • PWV SBP gen1 ⁇ sex+pw1 ⁇ hrPWV+bm1 ⁇ BMI+age1 ⁇ age+Sm1*sponder+drug1* medication;
  • gen1, pw1, bm1, age1, Sm1, and drug1 are fitting parameters that combine user-related parameters.
  • step (6) calculates the calculation formula of step (6).
  • the RC 2 value is obtained by fitting the parameters.
  • the present invention has the beneficial effects that the present invention provides a non-invasive continuous blood pressure monitoring device and method, and realizes a miniaturization, portability, no cuff inflation and pressure, and a continuous blood pressure measuring device and method.
  • the device not only does not require a pneumatic cuff to achieve the function of a sphygmomanometer, but also enables long-term continuous monitoring of blood pressure changes, and it can be worn on the wrist like a watch, and can be flexibly applied to various life scenes.
  • the method of continuous blood pressure monitoring of the present invention is based on hemodynamics and the influencing factors of vascular parameters in the vascular elastic cavity model, so that the results of long-term continuous blood pressure measurement are more reliable.
  • FIG. 1 is a schematic structural view of a device in an embodiment of the present invention.
  • Figure 2 is a front elevational view of the wristwatch in the embodiment of the present invention.
  • Figure 3 is a rear view of the wristwatch in the embodiment of the present invention (close to the skin of the wrist);
  • Figure 4 is a cross-sectional view of the device in the embodiment of the present invention worn on the wrist;
  • FIG. 5 is a schematic diagram of manual ECG signal acquisition in the embodiment of the present invention (a calibration operation mode of the simple measurement method);
  • Figure 6 is an accurate measurement wearing diagram (continuous) in the embodiment of the present invention.
  • Figure 7 is a schematic diagram of a left ventricle-aortic PWTT in an embodiment of the present invention.
  • FIG. 8 is a schematic diagram of a pulse wave signal and an electrocardiogram signal in an embodiment of the present invention.
  • FIG. 9 is a schematic diagram of a reduction displacement signal S3 in an embodiment of the present invention.
  • Figure 10 is a diagram showing the definition of the diastolic duration td in the embodiment of the present invention.
  • Figure 11 is a schematic view showing the pulse wave transit time of the heart to the radial artery in the embodiment of the present invention.
  • FIG. 12 is a schematic flow chart of a simple measurement method and a quick calibration simple measurement method in an embodiment of the present invention
  • FIG. 13 is a schematic flow chart of an accurate measurement method in an embodiment of the present invention.
  • FIG. 14 is a schematic diagram of a signal vertex recognition process in an embodiment of the present invention.
  • Fig. 15 is a flow chart showing the calculation of the diastolic duration Td in the embodiment of the present invention.
  • 101 a host shell; 102, a wristband; 103, a pulse wave signal acquisition module; 104, an ECG signal acquisition module;
  • control module 106, amplification module; 107, filter module; 108, AD converter;
  • 109 blood pressure calculation module
  • 110 button control circuit
  • 111 power circuit
  • 112 signal input and output
  • 207 humerus
  • 208 radial artery
  • 209 wrist cross section
  • 301 silicone contact
  • PVDF piezoelectric film 303, sensor housing; 401, upper electrode; 402, lower electrode;
  • the invention establishes a complete mathematical model of the relationship between PWTT, PWV and blood pressure through multiple experimental design and a large number of experimental data fitting, and verifies the relationship between PWTT, PWV and blood pressure, and can realize continuous dynamic blood pressure monitoring.
  • the present invention uses a self-developed "continuous blood pressure monitoring device and method based on pulse wave transit time (PWTT) and pulse wave velocity (PWV)".
  • the pulse wave is a waveform formed by the spread of cardiac ejection and diastolic pulsation (vibration) along the aorta to the peripheral artery.
  • Heart- ⁇ radial pulse wave velocity refers to the speed of the heartbeat pulse wave transmitted to the wrist artery during the same cardiac cycle.
  • the sensor is used to receive the signal changes of the brachial artery vascular force.
  • the systolic blood pressure and diastolic blood pressure of the human body are measured after being processed by the internal computer chip of the sphygmomanometer. This method can also be used to detect arteriosclerosis between two different arterial measurement points in the human body.
  • the device used in the present invention provides two methods for continuous dynamic blood pressure monitoring and a correction method:
  • continuous continuous blood pressure can be obtained by continuously acquiring the pulse wave of a single arterial site (ie, the pulse wave generated by one heartbeat) and decomposing the continuous heart-to-aortic PWTT (fitting the brachial blood pressure value) ).
  • Ii. Accurate monitoring method Continuously acquire the pulse waves of two different arterial beat points at the same time, obtain continuous PWV between the two arteries, and monitor the accurate continuous dynamic blood pressure value (fit the brachial blood pressure value).
  • the present invention provides a rapid correction method for correcting the systolic blood pressure SBP value of a simple measurement method by using a PWTT correction between two different arterial pulse waves by only decomposing a single artery. The accuracy of simple measurement results.
  • the present invention provides a wrist-worn device for non-invasive continuous ambulatory blood pressure detection (shown in Figure 1):
  • the structure of the present invention is shown in FIG. 1 , and the main form of the present invention is a wristwatch, as shown in FIG. 2 and FIG. 3 , which includes a display module 113 , and a main body casing 101 is provided with an electrocardiographic signal acquisition module 104 and a wristband 102 .
  • the dual-channel signals collected by the pulse wave signal acquisition module 103 and the pulse wave signal acquisition module 103 and the pulse wave signal acquisition module 103 pass through each module in the control module 105 (including the amplification module 106, the filter module 107, and the AD converter 108).
  • the blood pressure calculation module 109) obtains a blood pressure value after processing.
  • the present invention is further provided with a button control circuit 110, a power supply circuit 111, and a signal input/output 112 connected to the control module 105.
  • the application example of the present invention uses the pulse-wave transit time (hrPWTT) of the heart-radial artery and its corresponding cardiac-iliac artery pulse wave velocity hrPWV to fit the brachial blood pressure to achieve continuous ambulatory blood pressure monitoring.
  • hrPWTT pulse-wave transit time
  • the acquisition of the arterial pulse wave signal 601 is a prerequisite for calculating the PWTT and PWV.
  • the pulse wave signal acquisition module 103 in this application example includes a pulse wave sensor 204 fastened to the watch band 102, which includes a silicone contact 301, a PVDF piezoelectric film 302 and a sensor housing 303, a connection 204, and a sensor connection line of the control module 105. 205.
  • This application example places the pulse wave sensor 204 in the pulse wave signal acquisition module 103 at the radial artery beat point 208 to obtain a pulse wave signal, that is, a pulse wave 601 of the radial artery (see FIG. 4) by measuring the rate of change of the inner diameter of the artery.
  • the pulse wave sensor (204) in this application example uses a piezoelectric capacitive sensor placed at the radial artery beat point (208) for continuous acquisition of the radial artery pulse wave (601).
  • At least one pulse wave sensor is required to continuously acquire pulse waves of two different arteries at the same time.
  • the pulse wave acquired by this application example is the radial artery pulse wave (501) and the heart pulse wave. Since the heart position is special, the key to measuring the heart pulse wave is to use the ECG signal instead of the pulse wave signal (502).
  • the application center central electrical signal acquisition module (104) includes two sets of electrocardiographic sensors (201-203, 401-402) and an electrocardiographic data transmission line 403, and provides two methods for acquiring ECG signals:
  • Fig. 2 to Fig. 4 using a single lead ECG sensor, including an electrocardiographic upper electrode piece (201) located on the upper surface of the main body case, and an electrocardiographic lower electrode piece (202) located on the bottom surface of the main body case. ) and the electrocardiogram pole piece (203).
  • 202 and 203 are in close contact with the wrist skin, and the other hand touches 201 with any finger to form an electrocardiographic path, and a continuous ECG signal at this moment is obtained, the finger is released, the passage is broken, and the signal is disconnected. (See Figure 5)
  • ECG signal acquisition use chest-mounted ECG sensor, including upper electrode (401) and lower electrode (402), respectively, under the left clavicle and above the left nipple, ECG data transmission line (403)
  • the transmission line interface (206) on the host casing (101) is connected, and the obtained continuous ECG signal can be transmitted to the control module (105) in the host in real time. (See Figure 6)
  • the simple measurement method includes the following points:
  • the key to the simple measurement method is to calculate the pulse wave transit time PWTT (607) transmitted by the pulse wave generated by the cardiac ejection to the aorta.
  • the specific method is to perform a pulse wave (601) of one cycle of acquiring the radial artery. Decomposition, a pulse wave contains the pulse wave (602) generated by left ventricular ejection and the aortic pulse wave (603) formed by aortic compression, calculating the time difference between the two peaks and generating for cardiac ejection.
  • the pulse wave conduction time PWTT (607) transmitted by the pulse wave to the aorta (see Figure 7).
  • Equation 1 The exemplary fitting formula for the systolic pressure PWTT SBP calculation in the simple measurement method is Equation 1:
  • pt1, pt2 are fitting parameters that are combined with user-related parameters, and vary according to changes in individual differences.
  • PWTT DBP Td*exp ⁇ PWTT SBP /(pt3 ⁇ PWTT) 2 ⁇ -hr1*heart rate (Equation 2)
  • Td is the length of diastolic period
  • pt1 and pt2 are the fitting parameters that combine the relevant parameters of the user, and their values change according to the individual differences.
  • the accurate measurement method includes the following points:
  • the key to the accurate measurement method is to calculate the pulse wave transit time hrPWTT transmitted by the pulse wave generated by the cardiac ejection to the radial artery collection point.
  • the specific method is to simultaneously acquire the ECG signal (502) and the radial artery pulse wave (501).
  • the time difference between the calculated R-wave peak in the two-way signal and the valley of the adjacent radial artery pulse wave (501) is hrPWTT.
  • PWV SBP gen1 ⁇ sex+pw1 ⁇ hrPWV+bm1 ⁇ BMI+age1 ⁇ age+Sm1*sponder+drug1* medication
  • gen1, pw1, bm1, age1, Sm1, and drug1 are fitting parameters that combine user-related parameters, and their values change according to individual differences.
  • the present invention provides a method of rapid calibration for simple measurement, that is, using the hrPWTT between the radial artery and the cardiac pulse wave (instead of the electrocardiographic signal), instead of the PWTT obtained by decomposing the radial artery pulse wave in the simple measurement method, Correcting the SBP value of the systolic pressure ensures the accuracy of the simple measurement results.
  • the operation diagram is as shown in FIG. 5, and the process is shown in the flowchart of FIG. 12 in 900-711).
  • the technical solution of the present invention further includes a method for processing the pulse wave signal by the blood pressure calculation module: the signal blood pressure calculation module 109 restores the velocity signal S1 of the pulse waveform signal to the displacement signal S3 (ie, 602) and the displacement signal S3 The method of identifying the peak of each cycle. (Fig. 8, Fig. 9, Fig. 13, Fig. 14)
  • the blood pressure calculation module identifies the apex of the pulse wave signal S1, the main steps of which are shown in Figure 14;
  • the signal analysis processing module normalizes the radial artery pulse wave signal s1 to obtain a pulse wave signal s2;
  • the signal s3 needs to be decomposed using the ⁇ function to obtain the left ventricular pulse wave and the aortic pulse wave recognition, and the peak value of the extracted left ventricular pulse wave and the pulse wave peak of the middle artery are extracted.
  • the valleys V[V 0 , V 1 , ... V n ] of the signal s3 are to be marked.
  • the technical solution of the present invention further includes: a method for extracting a diastolic duration Td[Td0, Td1...Tdn] for each period of the restored displacement signal S3 by the blood pressure calculation module (109) (FIG. 10) .
  • the specific method is shown in Fig. 15; the displacement signal S3 is fitted with the ⁇ function, and the difference signal is calculated to obtain the diastolic duration.
  • the technical solution of the present invention further includes: identifying a time point mark R[R 0 , R 1 , . . . R n ] corresponding to the R wave of the electrocardiogram,
  • the invention provides a non-invasive continuous blood pressure monitoring device and method, and realizes a miniaturization, portability, no cuff inflation and pressure, and a continuous blood pressure measuring device and method.
  • the device not only does not require a pneumatic cuff to achieve the function of a sphygmomanometer, but also enables long-term continuous monitoring of blood pressure changes, and it can be worn on the wrist like a watch, and can be flexibly applied to various life scenes.
  • the method of continuous blood pressure monitoring of the present invention is based on hemodynamics and the influencing factors of vascular parameters in the vascular elastic cavity model, so that the results of long-term continuous blood pressure measurement are more reliable.

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Abstract

A continuous ambulatory blood pressure monitoring device and method based on pulse wave transit time and pulse wave transit velocity. In the continuous ambulatory blood pressure monitoring device, a host housing (101) having a watch shape is equipped with an electrocardiograph signal collecting module (104), a pulse wave signal collecting module (103) is provided on a wristband (102) at the position facing to the wrist radial artery, and the electrocardiograph signal collecting module (104) and the pulse wave signal collecting module (103) signal connect to a control module (105). The continuous ambulatory blood pressure monitoring device and method can obtain pulse waves in real time, and solve the problem of poor heart pulse wave acquisition in vitro. A quick and accurate method for obtaining the time point of cardiac ejection is provided, and the method is an important part of the continuous ambulatory blood pressure monitoring.

Description

一种基于脉搏波传导的连续动态血压监测装置和方法Continuous dynamic blood pressure monitoring device and method based on pulse wave conduction 技术领域Technical field
本发明属于无创动态血压连续监测技术领域,尤其涉及一种通过获得脉搏波传导时间及速度实现动态血压连续监测的装置及方法。The invention belongs to the field of non-invasive dynamic blood pressure continuous monitoring technology, and particularly relates to a device and a method for realizing continuous monitoring of dynamic blood pressure by obtaining pulse wave transit time and speed.
背景技术Background technique
心脑血管疾病是全球范围造成死亡的最主要原因。中国心血管病患病率处于持续上升阶段。截止2014年末,全国大约有心血管病患者2.9亿(《中国心血管病报告2014》)。高血压是最常见的心血管疾病,以体循环动脉压增高为主要表现的临床综合征。动脉压包括收缩压(SBP)和舒张压(DBP),一个心动周期过程中动脉血压的平均值称为平均动脉压(MAP)。高血压的发病因素有很多,如遗传(大约占40%)、疾病、或外界因素,如神经紧张、长期钠摄入量过大、吸烟、肥胖、酗酒、缺乏运动等。长期高血压会改变动脉脉管的结构进而影响心脏、脑、肾等靶器官的生理功能,最终导致这些器官功能的衰竭。因此高血压患者有必要主动监测自身的血压变化并积极治疗。高血压的诊断和治疗都需要对患者进行定期的血压测量,其测量要符合3个条件:第一,分别测3次血压;第二,3次测量血压不能是同一天;第三,收缩压≥140mmHg,舒张压≥90mmHg。对于已经诊断为高血压的患者则需要每天测量血压。血压测量的方法分为侵入性法(invasive)和非侵入性(non-invasive)法。侵入法大多需要将导管***血管用于连续监测动脉血压,此方法能够精确测量动脉压,但是危险系数和且护理成本皆很高,此方法并不是常用方法。目前市场上的大部分无创血压测量产品采用的是听诊法(Korotkoff‘s Sound)和示波法(Oscillography)。这两种方法都需要佩戴充气式袖带,并对动脉血管施加压力获得血压数值。示波法广泛用于电子血压计,通过充气加压后,机器内置的芯片和压力感应元器件对震荡波的变化做出判断,得到收缩压和舒张压。但由于电子血压计始终与人耳听力有所差别,因此多次测量后结果时有不准,有时会出现较大误差。至今,使用听诊法和水银柱血压计测量的血压值仍是医疗机构诊断高血压病患的黄金参考标准。然而,听诊法对使用者的操作方法有一定要求。首先,袖带佩戴的位置需符合操作说明的要求,且听诊器的放置位置也有一定要求,如果操作不当,结果也会出现较大误差。对于不同的操作者,因个体差异造成听力有所不同,测量结果也会有差异。无论使用哪种方法,都无法避免充气加压造成的不舒适感。通常,一次血压测量需要用时1分钟左右。此外,测量用的袖带的尺寸长短也需要根据个体差异进行更换,否则也会对测量结果造成影响。因此, 现有的非入侵血压测量法都不适合频繁多次和需要长期连续监控血压变化的高血压患者。对于需要连续血压监控的使用者来说,长期对佩戴位置施加压力会造成局部皮肤充血,且在夜晚使用时佩戴者会因袖带充气而影响睡眠质量。Cardiovascular and cerebrovascular diseases are the leading cause of death worldwide. The prevalence of cardiovascular disease in China is on the rise. As of the end of 2014, there were approximately 290 million cardiovascular patients in the country (China Cardiovascular Disease Report 2014). Hypertension is the most common cardiovascular disease, with clinical manifestations of increased systemic arterial pressure. Arterial pressure includes systolic blood pressure (SBP) and diastolic blood pressure (DBP), and the mean value of arterial blood pressure during a cardiac cycle is called mean arterial pressure (MAP). There are many factors that cause hypertension, such as heredity (about 40%), disease, or external factors such as nervousness, excessive long-term sodium intake, smoking, obesity, alcoholism, and lack of exercise. Long-term hypertension can change the structure of the arterial vasculature and affect the physiological functions of the target organs such as the heart, brain and kidney, and eventually lead to the failure of these organs. Therefore, it is necessary for patients with hypertension to actively monitor their blood pressure changes and actively treat them. The diagnosis and treatment of hypertension require regular blood pressure measurement of the patient. The measurement should meet three conditions: first, three times blood pressure; second, three times blood pressure cannot be the same day; third, systolic blood pressure ≥140mmHg, diastolic blood pressure ≥90mmHg. For patients who have been diagnosed with high blood pressure, blood pressure is measured daily. Methods of blood pressure measurement are divided into invasive and non-invasive methods. Invasive methods mostly require the insertion of a catheter into a blood vessel for continuous monitoring of arterial blood pressure. This method can accurately measure arterial pressure, but the risk factor and the cost of care are high. This method is not a common method. Most non-invasive blood pressure measurement products currently on the market use auscultation (Korotkoff's Sound) and Oscillography. Both methods require wearing an inflatable cuff and applying pressure to the arteries to obtain blood pressure values. The oscillometric method is widely used in electronic sphygmomanometers. After inflation and pressure, the built-in chip and pressure sensing components of the machine make judgments on the changes of the shock wave, and obtain systolic blood pressure and diastolic blood pressure. However, since the electronic sphygmomanometer always differs from the human ear hearing, the results are not accurate after multiple measurements, and sometimes there is a large error. To date, blood pressure values measured using auscultation and mercury column sphygmomanometers are still the gold reference standard for medical institutions to diagnose hypertension. However, auscultation has certain requirements for the user's method of operation. First of all, the position of the cuff should be in accordance with the requirements of the operating instructions, and the position of the stethoscope is also required. If the operation is not correct, the result will also have a large error. For different operators, hearing differences may vary due to individual differences, and measurement results may vary. No matter which method is used, the discomfort caused by inflation and pressurization cannot be avoided. Usually, a blood pressure measurement takes about 1 minute. In addition, the size of the cuff for measurement also needs to be replaced according to individual differences, otherwise it will affect the measurement results. Therefore, Existing non-invasive blood pressure measurements are not suitable for hypertensive patients who frequently and repeatedly monitor blood pressure changes over a long period of time. For users who require continuous blood pressure monitoring, long-term pressure on the wearing position can cause localized skin congestion, and the wearer may affect the quality of sleep due to cuff inflation during nighttime use.
近些年,使用脉搏波速间接测量血压的方法被多次提出,血流动力学领域的有大量文献研究指出,脉搏波传导速度(pulse wave velocity,pwv)与血压和血管性质存在相关性,与血压之间存在某种的关系。PWV指的是脉搏波在动脉***的两个既定点间的传播速度。普遍意义上的PWV的计算公式如下:PWV=L/PWTT。其中,L为两个动脉脉搏波检测点的距离,PWTT为脉搏波传导时间。In recent years, methods for indirectly measuring blood pressure using pulse wave velocity have been proposed many times. A large number of literature studies in the field of hemodynamics have pointed out that pulse wave velocity (pwv) is related to blood pressure and blood vessel properties, and There is a relationship between blood pressure. PWV refers to the speed at which pulse waves travel between two established points of the arterial system. The general formula for calculating PWV is as follows: PWV=L/PWTT. Where L is the distance between the two arterial pulse wave detection points, and PWTT is the pulse wave transit time.
一个完整的脉搏波主要由两个压力波构成,分别是于心室收缩射血产生的压力波和升主动脉接受射血迅速膨胀产生的压力波,因此,脉搏波具有机械波的性质并以极快的速度从心脏出发沿动脉树传导。脉搏波在传导时发生的能量转换主要是脉搏波传导时的动能和动脉腔弹性势能之间的能量转换。根据血流动力学中Moens-Korteweg提出的PWV与血管性质关系的公式:PWV2=E h/2r·ρ(E为杨氏模量,h为动脉壁厚度,r为血管内半径,ρ为血液密度)可以看出,杨氏模量代表血管弹性与PWV成正比且动脉弹性越差的情况下,脉搏波的传导速度越快。进一步对关于血流动力学中杨氏模量的公式E=ΔP·Dd/(ΔD·h)(其中,h为动脉壁厚度,ΔP为血压变化,Dd为舒张期末血管直径,ΔD为血管直径变化)进行分析可见,血管弹性与血压尤其收缩压变化有直接关系,因此血流动力学方面证实了pwv与血管内压存在关系为:PWV2=ΔP·Dd/ΔD·2rρ;另一方面,从Moens-Korteweg和杨氏模量的公式中的参数可以看出,动脉内径、厚度、血液密度、动脉的粘滞弹性和心脏的收缩和舒张等都在一定程度上影响脉搏波的传导速度,也间接的影响了动脉内压。A complete pulse wave is mainly composed of two pressure waves, which are the pressure wave generated by ventricular contraction ejection and the pressure wave generated by the rapid expansion of the ascending aorta by the ascending aorta. Therefore, the pulse wave has the property of mechanical wave and is extremely fast. The speed is transmitted from the heart along the arterial tree. The energy conversion that occurs when the pulse wave is conducted is mainly the energy conversion between the kinetic energy of the pulse wave conduction and the elastic potential energy of the arterial cavity. According to the relationship between PWV and vascular properties proposed by Moens-Korteweg in hemodynamics: PWV 2 =E h/2r·ρ (E is Young's modulus, h is the thickness of the artery wall, r is the intravascular radius, ρ is Blood density) It can be seen that the Young's modulus represents that the blood vessel elasticity is proportional to PWV and the worse the arterial elasticity is, the faster the pulse wave conduction speed is. Further to the formula E=ΔP·Dd/(ΔD·h) for the Young's modulus in hemodynamics (where h is the thickness of the artery wall, ΔP is the change in blood pressure, Dd is the diameter of the end-diastolic blood vessel, and ΔD is the diameter of the blood vessel According to the analysis, the vascular elasticity is directly related to the changes of blood pressure, especially systolic blood pressure, so hemodynamics confirmed that the relationship between pwv and intravascular pressure is: PWV 2 = ΔP · Dd / ΔD · 2rρ; From the parameters in the formula of Moens-Korteweg and Young's modulus, it can be seen that the inner diameter, thickness, blood density, viscous elasticity of the artery, and contraction and relaxation of the heart all affect the conduction velocity of the pulse wave to some extent. It also indirectly affects intra-arterial pressure.
PWV有很多种,如颈-股脉搏波速、臂-踝脉搏波速等,但这些方法更适用于主动脉压计算。对于大多数人群来说,肱动脉则是更常用的血压测量位点。因此,对于使用心脏至肱动脉的脉搏波速计算血压更适用于大多人群的需求。然而,肱动脉的位置并不适合长期佩戴测量仪器,故使用心脏-桡动脉较为适合。通过对ECG信号R波的识别,可以对提取心脏射血时间点。对于桡动脉脉搏波获取的方法,可以通过对桡动脉脉搏最强点直接测量获得桡动脉脉搏波,并与ECG信号共同处理,获得脉搏波传导速度。Pwv的变化与收缩压变化的对应关系较为明显,但对舒张压的反馈不能仅仅依靠pwv,还需要考虑血管的粘滞弹性、血管直径、血液密度、顺应性、膨胀性等参数的变化对血压的影响。There are many types of PWV, such as neck-strand pulse wave velocity, arm-踝 pulse wave velocity, etc., but these methods are more suitable for aortic pressure calculation. For most people, the radial artery is the more commonly used blood pressure measurement site. Therefore, the calculation of blood pressure using the pulse velocity of the heart to the radial artery is more suitable for the needs of most people. However, the location of the radial artery is not suitable for long-term wearing of measuring instruments, so the use of the heart-radial artery is more suitable. By identifying the R wave of the ECG signal, the time point of the ejection of the heart can be extracted. For the method of acquiring brachial artery pulse wave, the brachial artery pulse wave can be obtained by directly measuring the strongest point of the radial artery pulse, and processed together with the ECG signal to obtain the pulse wave conduction velocity. The relationship between changes in Pwv and changes in systolic blood pressure is more obvious, but the feedback on diastolic blood pressure cannot rely solely on pwv. It also needs to consider changes in parameters such as viscous elasticity of blood vessels, blood vessel diameter, blood density, compliance, and swelling. Impact.
在血流动力学中Windkessel血管弹性腔模型为血管参数的变化提供适合的理论背景。Windkessel模型将心血管***看做一个等效电路。电源产生周期性电势差,代表了心脏的功 能,q代表血流;L为电感,代表了动脉中流淌的血液受到的惯性,其数值越大,血流速度越慢,且与血液密度ρ有关;R为电阻,也代表了心血管循环中外周阻力最大的微循环***;C1、C2均为电容,代表了各级动脉血管,靠近电流源的C1代表主动脉,C2代表动脉分支,电容值的大小反映了血管的膨胀性,其值越大,代表血管的膨胀性越好,;另一方面,血流动力学提出了血管膨胀性(Distensibility)的概念,其与动脉血管在舒张期末的顺应性有关。血管膨胀性定义了动脉血管直径随血管壁受到的压力变化而变化的关系。其公式为:Distensibility=ΔD/ΔP·Dd(其中,ΔD代表了血管直径在心脏收缩和舒张期的差值;Dd为舒张期末血管直径)。由于Windkessel模型中电容与膨胀性性质相同,故C=ΔD/ΔP·Dd。另一方面,Bramwell-Hill在血流动力学的研究中提出了PWV与血压变化的关系表达式:PWV2=ΔP·V/(ΔV·ρ)(其中,h为动脉壁厚度,ΔP为压力变化,ΔV为容积变化,V为基线容积)。同理可证,运用PWV和Windkessel相关公式之间的关系,可以推算其他相关血管参数并通过采样得到回归方程
Figure PCTCN2017110340-appb-000001
(其中R为血液流动的血管阻力,阻力越大引起的压力下降越显著;C为血管顺应性,是反应动脉血管对血液积聚能量的度量;td为舒张期的时间。)进而得到更精准的血压数值。
In hemodynamics, the Windkessel vascular elastic cavity model provides a suitable theoretical background for changes in vascular parameters. The Windkessel model sees the cardiovascular system as an equivalent circuit. The power source generates a periodic potential difference, which represents the function of the heart, q represents the blood flow; L is the inductance, which represents the inertia of the blood flowing in the artery, and the larger the value, the slower the blood flow velocity and the blood density ρ; R is the electrical resistance, which also represents the microcirculatory system with the greatest peripheral resistance in the cardiovascular cycle; C1 and C2 are capacitors, representing the arterial vessels at all levels, C1 near the current source represents the aorta, C2 represents the arterial branch, and the capacitance value The size reflects the swelling of the blood vessel, and the larger the value, the better the expansion of the blood vessel; on the other hand, hemodynamics proposes the concept of vascular dilatation, which is compatible with the end of the diastolic phase of the arterial vessel. Sexually relevant. Vascular expansion defines the relationship between the diameter of an artery and the pressure changes experienced by the vessel wall. Its formula is: Distensibility = ΔD / ΔP · Dd (where ΔD represents the difference in blood vessel diameter between systolic and diastolic phases; Dd is the diameter of the end diastolic blood vessel). Since the capacitance and expansion properties are the same in the Windkessel model, C = ΔD / ΔP · Dd. On the other hand, Bramwell-Hill proposed a relationship between PWV and blood pressure changes in hemodynamic studies: PWV 2 = ΔP · V / (ΔV · ρ) (where h is the thickness of the artery wall and ΔP is the pressure Change, ΔV is the volume change, and V is the baseline volume). Similarly, it can be proved that by using the relationship between PWV and Windkessel related formulas, other relevant vascular parameters can be extrapolated and regression equations can be obtained by sampling.
Figure PCTCN2017110340-appb-000001
(where R is the vascular resistance of blood flow, the greater the resistance, the more significant the pressure drop; C is vascular compliance, which is a measure of the energy accumulated by the arterial blood vessels; t d is the time of diastole.) Blood pressure value.
普遍意义上的PWV的计算公式如下:PWV=L/PWTT。其中,L为两个动脉脉搏波检测点的距离,PWTT为脉搏波传导时间。现有技术如中国专利CN100413464C和德国专利DE10061189A1,通过对于两点脉搏波反映心脏射血同一时刻的标志点之间的时间差得到PWTT,并直接使用PWTT代替PWV计算血压。然而,此方法忽略了外周测量点两点之间的距离L对血压计算的影响。由于人群个体差异的影响,L的大小会有差异性。因此,仅适用PWTT拟合血压值会造成较大的误差。The general formula for calculating PWV is as follows: PWV=L/PWTT. Where L is the distance between the two arterial pulse wave detection points, and PWTT is the pulse wave transit time. The prior art, such as the Chinese patent CN100413464C and the German patent DE10061189A1, obtains the PWTT by reflecting the time difference between the landmark points of the heart ejection at the same time for the two-point pulse wave, and directly calculates the blood pressure by using the PWTT instead of the PWV. However, this method ignores the effect of the distance L between two points of the peripheral measurement point on the blood pressure calculation. The size of L will vary due to individual differences in population. Therefore, only fitting the PWTT to fit the blood pressure value will cause a large error.
虽然现有技术中一些专利(如CN201110218935、CN201410537675、CN1524490A)也有使用脉搏波信号计算血压,但都使用充气、加压的方式获取脉搏波,并不是真正意义上的连续动态血压监测,极少有专利能够实现真正的连续动态血压监测。Although some patents in the prior art (such as CN201110218935, CN201410537675, CN1524490A) also use pulse wave signals to calculate blood pressure, they all use pneumatic and pressurized methods to obtain pulse waves, which is not a continuous dynamic blood pressure monitoring in the true sense. The patent enables true continuous dynamic blood pressure monitoring.
现有技术中还有一些其他专利(如CN201110218935、CN201610078117、CN1524490A)中提到使用压力传感器获取对脉搏波的绝对压力值,其方法对脉搏波的幅值要求高,但信号幅度会受到皮下脂肪和外部施加压力的不同等因素影响其结果的准确性。There are some other patents in the prior art (such as CN201110218935, CN201610078117, CN1524490A) that use a pressure sensor to obtain the absolute pressure value of the pulse wave. The method requires a high amplitude of the pulse wave, but the signal amplitude is subject to subcutaneous fat. Factors such as the difference in pressure applied externally affect the accuracy of the results.
综上所述,现有技术的主要问题在于:In summary, the main problems of the prior art are:
1)充气袖带加压的装置不能实现真正意义的连续动态血压检测;1) Inflatable cuff pressurization device cannot achieve true continuous dynamic blood pressure detection;
2)对于脉搏波采集的两测量点之间距离L的测算方法有些难度,现有技术没有提及确切 的解决方案;2) It is somewhat difficult to measure the distance L between two measurement points of pulse wave acquisition. The prior art does not mention the exact s solution;
3)现有技术对没有确切说明心血管相关参数在使用PWV计算血压时的影响,其采样结果获得对应的血压数值差异度大,所获得的拟合曲线与实际情况偏差较大;3) The prior art does not specify the influence of cardiovascular related parameters on the calculation of blood pressure using PWV, and the sampling result obtains a corresponding difference in blood pressure values, and the obtained fitting curve deviates greatly from the actual situation;
4)光电元件因探测部位皮肤颜色不同、瘢痕、角质层过厚、与皮肤贴合不紧密等因素的影响导致结果偏差;4) Photoelectric components are biased due to factors such as different skin color at the detection site, scars, excessive thickness of the stratum corneum, and tight adhesion to the skin;
5)压力传感器获取对脉搏波的绝对压力值,其方法对脉搏波的幅值要求高,但信号幅度会受到皮下脂肪和外部施加压力的不同等因素影响其结果的准确性;5) The pressure sensor obtains the absolute pressure value of the pulse wave, and the method requires high amplitude of the pulse wave, but the signal amplitude is affected by the difference of subcutaneous fat and externally applied pressure, and the accuracy of the result;
6)现有技术对于PWV计算收缩压和舒张压的关系没有清楚的说明,特别对于舒张压的计算方法比较模糊。6) The prior art does not clearly explain the relationship between systolic blood pressure and diastolic blood pressure for PWV calculation, especially for the calculation method of diastolic blood pressure.
发明内容Summary of the invention
本发明要解决的问题是设计一种基于脉搏波传导的连续动态血压监测装置和方法,基于脉搏波传导时间(PWTT)及脉搏波传导速度(PWV)实现连续动态血压监测,无创、无充气式袖带、便携、且具有很强的自适应性、准确性和可扩展性。The problem to be solved by the present invention is to design a continuous dynamic blood pressure monitoring device and method based on pulse wave conduction, and realize continuous dynamic blood pressure monitoring based on pulse wave transit time (PWTT) and pulse wave velocity (PWV), non-invasive and non-inflatable. Cuff, portable, and highly adaptable, accurate and scalable.
本发明的关键技术在于:脉搏波是心脏射血和舒张的搏动(振动)沿主动脉向外周动脉血管传播而形成的波形,心脏—桡动脉脉搏波速是指同一心动周期,心肌搏动的脉搏波传导至手腕桡动脉的速度,运用传感器接收桡动脉血管受力发生的信号变化,通过计算脉搏波传导时间及心脏至动脉测量点距离的关系及脉搏波传导速度,经血压计内部电脑芯片处理后测量人体的收缩压、舒张压,此方法还可以用于检测人体两个不同动脉测量点之间的动脉硬化情况。The key technology of the present invention is that the pulse wave is a waveform formed by cardiac ejection and diastolic pulsation (vibration) propagating along the aorta to the peripheral artery. The heart-phrenic pulse wave velocity refers to the pulse wave of the same cardiac cycle and myocardial beating. The speed of conduction to the brachial artery of the wrist, the sensor receives the signal change of the brachial artery vascular force, and calculates the relationship between the pulse wave transit time and the heart-to-arterial measurement point distance and the pulse wave conduction velocity, after being processed by the internal computer chip of the sphygmomanometer Measuring the systolic and diastolic blood pressure of the human body, this method can also be used to detect arteriosclerosis between two different arterial measurement points of the human body.
基于上述关键技术,本发明采取的技术方案为:Based on the above key technologies, the technical solution adopted by the present invention is:
一种基于脉搏波传导的连续动态血压监测装置,所述监测装置为腕表形态,主机壳(101)上配有心电信号采集模块(104),腕带(102)对应手腕桡动脉处配有脉搏波信号采集模块(103),所述心电信号采集模块(104)和脉搏波信号采集模块(103)信号连接控制模块(105)。A continuous dynamic blood pressure monitoring device based on pulse wave conduction, wherein the monitoring device is in the form of a wristwatch, and the main body casing (101) is provided with an electrocardiographic signal acquisition module (104), and the wristband (102) is provided with a wrist artery at the wrist The pulse wave signal acquisition module (103), the ECG signal acquisition module (104) and the pulse wave signal acquisition module (103) are signally connected to the control module (105).
进一步的,所述控制模块包括依次连接的放大模块(106)、滤波模块(107)、AD转换器(108)、血压计算模块(109),所述放大模块(106)与所述心电信号采集模块(104)和脉搏波信号采集模块(103)信号连接。Further, the control module includes an amplification module (106), a filtering module (107), an AD converter (108), a blood pressure calculation module (109), which are sequentially connected, the amplification module (106) and the ECG signal. The acquisition module (104) is coupled to the pulse wave signal acquisition module (103).
进一步的,心电信号采集模块(104)包括位于主机壳上盖的心电上电极片(201)以及位于主机壳底面用于紧贴皮肤的心电下电极片(202)和心电地极片(203),所述心电上电极片(201)、心电下电极片(202)、心电地极片(203)与控制模块(105)连接。Further, the ECG signal acquisition module (104) includes an electrocardiographic upper electrode sheet (201) on the upper cover of the main body case, and an electrocardiographic lower electrode piece (202) and an electrocardiographic ground electrode on the bottom surface of the main body case for closely contacting the skin. The sheet (203), the electrocardiographic upper electrode sheet (201), the electrocardiographic lower electrode sheet (202), and the electrocardiographic ground sheet (203) are connected to the control module (105).
进一步的,所述心电信号采集模块(104)包括用于紧贴左锁骨下方的上贴电极(401) 和左***上方的下贴电极(402),以及位于主机壳(101)上与控制模块(105)连接的传输线接口(206),所述上贴电极(401)和下贴电极(402)通过心电数据传输线(403)连接所述传输线接口(206)。Further, the ECG signal acquisition module (104) includes an upper electrode (401) for adhering to the underside of the left clavicle. And a lower electrode (402) above the left nipple, and a transmission line interface (206) on the main body casing (101) connected to the control module (105), the upper electrode (401) and the lower electrode (402) pass An ECG data transmission line (403) is coupled to the transmission line interface (206).
进一步的,所述心电信号采集模块(104)包括手动心电信号采集模块和自动心电信号采集模块;Further, the ECG signal acquisition module (104) includes a manual ECG signal acquisition module and an automatic ECG signal acquisition module;
所述手动心电信号采集模块包括位于主机壳上盖的心电上电极片(201)以及位于主机壳底面用于紧贴皮肤的心电下电极片(202)和心电地极片(203),所述心电上电极片(201)、心电下电极片(202)、心电地极片(203)与控制模块(105)连接;The manual ECG signal acquisition module includes an electrocardiographic upper electrode sheet (201) on a cover of the main body case, and an electrocardiographic lower electrode piece (202) and an electrocardiographic ground piece (203) located on the bottom surface of the main body case for closely contacting the skin. The electrocardiographic upper electrode sheet (201), the electrocardiographic lower electrode sheet (202), and the electrocardiographic ground electrode sheet (203) are connected to the control module (105);
所述自动心电信号采集模块包括用于紧贴左锁骨下方的上贴电极(401)和左***上方的下贴电极(402),以及位于主机壳(101)上与控制模块(105)连接的的传输线接口(206),所述上贴电极(401)和下贴电极(402)通过心电数据传输线(403)连接所述传输线接口(206),需要说明的是,对于心脏在右边的人体,上贴电极(401)紧贴右锁骨下方,下贴电极(402)紧贴右***上方。The automatic electrocardiographic signal acquisition module includes an upper electrode (401) for being placed under the left clavicle and a lower electrode (402) above the left nipple, and is connected to the control module (105) on the main body casing (101). The transmission line interface (206), the upper electrode (401) and the lower electrode (402) are connected to the transmission line interface (206) through an electrocardiographic data transmission line (403), and it should be noted that for the heart on the right side In the human body, the upper electrode (401) is placed just below the right clavicle, and the lower electrode (402) is placed just above the right nipple.
进一步的,所述脉搏波信号采集模块(103)包括紧固在腕带(102)上的脉搏波传感器(204)、以及连接脉搏波传感器(204)和控制模块(105)的传感器连接线(205),所述脉搏波传感器(204)包括设置于传感器外壳(303)的PVDF压电薄膜(302)和硅胶触头(301)。Further, the pulse wave signal acquisition module (103) includes a pulse wave sensor (204) fastened on the wristband (102), and a sensor connection line connecting the pulse wave sensor (204) and the control module (105) ( 205) The pulse wave sensor (204) includes a PVDF piezoelectric film (302) and a silicone contact (301) disposed on the sensor housing (303).
本发明的另一方面,还提出了基于脉搏波传导的连续动态血压简易监测法,包括:In another aspect of the invention, a continuous dynamic blood pressure monitoring method based on pulse wave conduction is also proposed, comprising:
(1)通过脉搏波传感器连续获得桡动脉搏动点的一个周期的脉搏波信号S1并发送至控制模块;(1) continuously obtaining a pulse wave signal S1 of one cycle of the radial artery beat point by the pulse wave sensor and transmitting it to the control module;
(2)对信号S1进行分解得到左心室脉搏波和主动脉脉搏波,同时得到舒张期时长;(2) Decomposing the signal S1 to obtain a left ventricular pulse wave and an aortic pulse wave, and at the same time obtaining a diastolic duration;
(3)计算左心室脉搏波和主动脉脉搏波波峰之间的时间差PWTT;(3) calculating the time difference PWTT between the left ventricular pulse wave and the aortic pulse wave peak;
(4)根据PWTT计算收缩压PWTTSBP(4) Calculate the systolic pressure PWTT SBP according to PWTT;
(5)根据收缩压PWTTSBP和舒张期时长计算舒张压PWTTDBP(5) The diastolic pressure PWTT DBP is calculated based on the systolic pressure PWTT SBP and the duration of the diastolic phase.
进一步的,步骤(1)中采集脉搏波信号的间隔为2ms。Further, the interval of acquiring the pulse wave signal in the step (1) is 2 ms.
进一步的,步骤(2)的具体方法为:Further, the specific method of step (2) is:
(201)识别信号S1中每个周期的顶点;(201) identifying a vertex of each period in the signal S1;
(202)对信号S1正则化得到信号S2;(202) Regularizing the signal S1 to obtain a signal S2;
(203)对信号S2累加得到位移信号S3;(203) accumulating the signal S2 to obtain a displacement signal S3;
(204)用β函数对信号S3进行分解得到左心室脉搏波和主动脉脉搏波;(204) Decomposing the signal S3 by the β function to obtain a left ventricular pulse wave and an aortic pulse wave;
(205)通过信号s3计算舒张期时长Td[Td0,Td1,...Tdn]。 (205) The diastolic duration Td [Td0, Td1, ... Tdn] is calculated by the signal s3.
进一步的,步骤(4)所述收缩压PWTTSBP计算的拟合公式为:Further, the fitting formula of the systolic pressure PWTT SBP calculated in the step (4) is:
PWTTSBP=exp(pt1*PWTT)+pt2;PWTT SBP = exp(pt1*PWTT)+pt2;
其中,pt1,pt2为为结合用户相关参数的拟合参数。Where pt1, pt2 are fitting parameters that are combined with user-related parameters.
进一步的,步骤(5)所述舒张压PWTTDBP计算的拟合公式为:Further, the fitting formula of the diastolic pressure PWTT DBP calculation in the step (5) is:
PWTTDBP=Td*exp{PWTTSBP/(pt3·PWTT)2}-hr1*心率;PWTT DBP = Td * exp {PWTT SBP / (pt3 · PWTT) 2} - hr1 * heart rate;
其中,Td是舒张期时长;pt1、pt2为为结合用户相关参数的拟合参数。Wherein, Td is the length of the diastolic period; pt1 and pt2 are the fitting parameters for combining the relevant parameters of the user.
本发明的另一方面,还提出了基于脉搏波传导的连续动态血压校准值简易监测法,包括:In another aspect of the invention, a simple monitoring method for continuous dynamic blood pressure calibration values based on pulse wave conduction is also proposed, comprising:
(1)通过脉搏波传感器和手动心电信号采集模块连续同步采集心电信号和脉搏波信号s1并发送至控制模块;(1) continuously collecting the ECG signal and the pulse wave signal s1 by the pulse wave sensor and the manual ECG signal acquisition module and transmitting the signal to the control module;
(2)得到心-桡脉搏波传导时间hrPWTT;(2) obtaining a heart-桡 pulse wave transit time hrPWTT;
(3)根据hrPWTT计算收缩压PWTTSBP(3) Calculate the systolic pressure PWTT SBP according to hrPWTT;
(4)根据收缩压PWTTSBP和舒张期时长计算舒张压PWTTDBP(4) The diastolic pressure PWTT DBP is calculated based on the systolic pressure PWTT SBP and the duration of the diastolic phase.
进一步的,步骤(1)中同步采集心电信号和脉搏波信号的间隔为2ms。Further, the interval between the synchronous acquisition of the ECG signal and the pulse wave signal in the step (1) is 2 ms.
进一步的,步骤(2)的具体方法为:Further, the specific method of step (2) is:
(201)识别信号S1中每个周期的顶点;(201) identifying a vertex of each period in the signal S1;
(202)对信号S1正则化得到信号S2;(202) Regularizing the signal S1 to obtain a signal S2;
(203)对信号S2累加得到位移信号S3;(203) accumulating the signal S2 to obtain a displacement signal S3;
(204)提取信号S3中波谷值[V0,V1,...Vn];(204) extracting the valley value [V0, V1, ... Vn] in the signal S3;
(205)识别心电信号的R波并标记为[R0,R1,...Rn];(205) identifying the R wave of the electrocardiographic signal and marking it as [R0, R1, ... Rn];
(206)处理同一心跳周期的P[V0,V1,...Vn]和R波[R0,R1,...Rn]的时间差,得到心-桡脉搏波传导时间hrPWTT。(206) The time difference between P[V0, V1, ... Vn] and the R wave [R0, R1, ... Rn] of the same heartbeat cycle is processed to obtain a heart-pulse pulse wave transit time hrPWTT.
进一步的,步骤(3)所述收缩压PWTTSBP计算的拟合公式为:Further, the fitting formula of the systolic pressure PWTT SBP calculated in the step (3) is:
PWTTSBP=exp(pt1*hrPWTT)+pt2;PWTT SBP = exp(pt1*hrPWTT)+pt2;
其中,pt1,pt2为为结合用户相关参数的拟合参数。Where pt1, pt2 are fitting parameters that are combined with user-related parameters.
进一步的,步骤(4)所述舒张压PWTTDBP计算的拟合公式为:Further, the fitting formula of the diastolic pressure PWTT DBP calculation in the step (4) is:
PWTTDBP=Td*exp{PWTTSBP/(pt3·hrPWTT)2}-hr1*心率;PWTT DBP = Td * exp {PWTT SBP / (pt3 · hrPWTT) 2} - hr1 * heart rate;
其中,Td是舒张期时长;pt1、pt2为为结合用户相关参数的拟合参数。Wherein, Td is the length of the diastolic period; pt1 and pt2 are the fitting parameters for combining the relevant parameters of the user.
本发明的另一方面,还提供了基于脉搏波传导的连续动态血压精确监测法,包括: In another aspect of the invention, a continuous dynamic blood pressure monitoring method based on pulse wave conduction is also provided, comprising:
(1)获取被测者个人参数;(1) Obtain the personal parameters of the test subject;
(2)通过脉搏波传感器和心电信号采集模块连续同步采集心电信号ECG、脉搏波信号s1并发送至控制模块;(2) continuously acquiring the ECG signal ECG and the pulse wave signal s1 through the pulse wave sensor and the ECG signal acquisition module and transmitting the signal to the control module;
(3)得到心-桡脉搏波传导时间hrPWTT以及舒张期时长TD;(3) obtaining cardiac-桡 pulse wave transit time hrPWTT and diastolic duration TD;
(4)根据心-桡脉搏波传导时间hrPWTT计算心-桡脉搏波传导速度hrPWV;(4) Calculating the heart-桡 pulse wave velocity hrPWV according to the heart-桡 pulse wave transit time hrPWTT;
(5)根据心-桡脉搏波传导速度hrPWV计算收缩压PWVSBP(5) Calculate systolic pressure PWV SBP according to heart-桡 pulse wave velocity hrPWV;
(6)根据收缩压PWVSBP以及舒张期时长TD计算舒张压PWVDBP(6) The diastolic pressure PWV DBP is calculated based on the systolic pressure PWV SBP and the diastolic duration TD.
进一步的,步骤(1)所述个人参数包括被测者的身高height,体重BMI,年龄Age,吸烟情况和服药情况。Further, the personal parameters in the step (1) include a height height, a body weight BMI, an age Age, a smoking condition, and a medication state of the subject.
进一步的,步骤(2)中同步采集心电信号和脉搏波信号的间隔为2ms。Further, the interval between the synchronous acquisition of the ECG signal and the pulse wave signal in the step (2) is 2 ms.
进一步的,步骤(3)的具体过程为:Further, the specific process of step (3) is:
(201)识别信号S1中每个周期的顶点;(201) identifying a vertex of each period in the signal S1;
(202)对信号S1正则化得到信号S2;(202) Regularizing the signal S1 to obtain a signal S2;
(203)对信号S2累加得到位移信号S3;(203) accumulating the signal S2 to obtain a displacement signal S3;
(204)通过信号s3计算舒张期时长Td[Td0,Td1,...Tdn];(204) calculating the diastolic duration Td [Td0, Td1, ... Tdn] by the signal s3;
(205)提取信号S3中波谷值[V0,V1,...Vn];(205) extracting the valley value [V0, V1, ... Vn] in the signal S3;
(206)识别心电信号的R波并标记为[R0,R1,...Rn];(206) identifying the R wave of the electrocardiographic signal and marking it as [R0, R1, ... Rn];
(207)处理同一心跳周期的P[V0,V1,...Vn]和R波[R0,R1,...Rn]的时间差,得到心-桡脉搏波传导时间hrPWTT。(207) The time difference between P[V0, V1, ... Vn] and the R wave [R0, R1, ... Rn] of the same heartbeat cycle is processed, and the heart-桡 pulse wave transit time hrPWTT is obtained.
进一步的,步骤(4)计算hrPWV的公式如下:Further, the formula for calculating hrPWV in step (4) is as follows:
hrPWV=(h1*身高-5.085)/hrPWTT;hrPWV=(h1*height-5.085)/hrPWTT;
其中,h1为拟合参数。Where h1 is the fitting parameter.
进一步的,步骤(5)计算收缩压PWVSBP的公式如下:Further, the formula for calculating the systolic pressure PWV SBP in step (5) is as follows:
PWVSBP=gen1×性别+pw1×hrPWV+bm1×BMI+age1×年龄+Sm1*吸烟者+drug1*服药者;PWV SBP =gen1×sex+pw1×hrPWV+bm1×BMI+age1×age+Sm1*sponder+drug1* medication;
其中,gen1、pw1、bm1、age1、Sm1、drug1为结合用户相关参数的拟合参数。Among them, gen1, pw1, bm1, age1, Sm1, and drug1 are fitting parameters that combine user-related parameters.
进一步的,步骤(6)的计算公式为: Further, the calculation formula of step (6) is:
Figure PCTCN2017110340-appb-000002
Figure PCTCN2017110340-appb-000002
其中,
Figure PCTCN2017110340-appb-000003
通过位移信号s3得到,RC2值通过拟合参数获得。
among them,
Figure PCTCN2017110340-appb-000003
Obtained from the displacement signal s 3 , the RC 2 value is obtained by fitting the parameters.
针对现有技术,本发明的有益效果为:本发明提供了一种无创连续血压监测装置及方法,实现了一种小型化、便携、无需袖带充气加压、且连续血压测量装置及方法。该设备不仅无需充气袖带就可以实现血压计的功能,同时能够实现长期连续监测血压变化,且只需如手表般佩戴于腕部,灵活运用于各种生活场景。本发明在连续血压监测的方法基于血流动力学和血管弹性腔模型中血管参数的影响因素,使长期连续血压测量的结果更加可靠。In view of the prior art, the present invention has the beneficial effects that the present invention provides a non-invasive continuous blood pressure monitoring device and method, and realizes a miniaturization, portability, no cuff inflation and pressure, and a continuous blood pressure measuring device and method. The device not only does not require a pneumatic cuff to achieve the function of a sphygmomanometer, but also enables long-term continuous monitoring of blood pressure changes, and it can be worn on the wrist like a watch, and can be flexibly applied to various life scenes. The method of continuous blood pressure monitoring of the present invention is based on hemodynamics and the influencing factors of vascular parameters in the vascular elastic cavity model, so that the results of long-term continuous blood pressure measurement are more reliable.
附图说明DRAWINGS
图1是本发明实施例中的装置结构示意图;1 is a schematic structural view of a device in an embodiment of the present invention;
图2是本发明实施例中的腕表正面图;Figure 2 is a front elevational view of the wristwatch in the embodiment of the present invention;
图3是本发明实施例中的腕表背面图(紧贴腕部皮肤);Figure 3 is a rear view of the wristwatch in the embodiment of the present invention (close to the skin of the wrist);
图4是本发明实施例中的装置佩戴在手腕的截面图;Figure 4 is a cross-sectional view of the device in the embodiment of the present invention worn on the wrist;
图5是本发明实施例中的手动心电信号采集示意图(简易测量法的校准操作方式);5 is a schematic diagram of manual ECG signal acquisition in the embodiment of the present invention (a calibration operation mode of the simple measurement method);
图6是本发明实施例中的精确测量法佩戴图(连续);Figure 6 is an accurate measurement wearing diagram (continuous) in the embodiment of the present invention;
图7是本发明实施例中的左心室-主动脉PWTT示意图;Figure 7 is a schematic diagram of a left ventricle-aortic PWTT in an embodiment of the present invention;
图8是本发明实施例中的脉搏波信号和心电信号示意图;8 is a schematic diagram of a pulse wave signal and an electrocardiogram signal in an embodiment of the present invention;
图9是本发明实施例中的还原位移信号S3示意图;9 is a schematic diagram of a reduction displacement signal S3 in an embodiment of the present invention;
图10是本发明实施例中的舒张期时长td定义图;Figure 10 is a diagram showing the definition of the diastolic duration td in the embodiment of the present invention;
图11是本发明实施例中的心脏至桡动脉的脉搏波传导时间示意图;Figure 11 is a schematic view showing the pulse wave transit time of the heart to the radial artery in the embodiment of the present invention;
图12是本发明实施例中的简易测量法及快速校准简易测量法流程示意图;12 is a schematic flow chart of a simple measurement method and a quick calibration simple measurement method in an embodiment of the present invention;
图13是本发明实施例中的精确测量法的流程示意图;13 is a schematic flow chart of an accurate measurement method in an embodiment of the present invention;
图14是本发明实施例中的信号顶点识别流程示意图;14 is a schematic diagram of a signal vertex recognition process in an embodiment of the present invention;
图15是本发明实施例中的舒张期时长Td计算流程示意图。Fig. 15 is a flow chart showing the calculation of the diastolic duration Td in the embodiment of the present invention.
其中:among them:
101、主机壳;102、腕带;103、脉搏波信号采集模块;104、心电信号采集模块;101, a host shell; 102, a wristband; 103, a pulse wave signal acquisition module; 104, an ECG signal acquisition module;
105、控制模块;106、放大模块;107、滤波模块;108、AD转换器;105, control module; 106, amplification module; 107, filter module; 108, AD converter;
109、血压计算模块;110、按键控制电路;111、电源电路;112、信号输入输出; 109, blood pressure calculation module; 110, button control circuit; 111, power circuit; 112, signal input and output;
113、显示模块;201、心电上电极片;202、心电下电极片;203、心电地极片;113, display module; 201, ECG upper electrode sheet; 202, ECG lower electrode sheet; 203, electrocardiogram pole piece;
204、脉搏传感器;205、传感器连接线;206、胸贴式心电数据传输线接口;204, pulse sensor; 205, sensor connection line; 206, chest-mounted ECG data transmission line interface;
207、桡骨;208、桡动脉;209、手腕横截面;301、硅胶触头;207, humerus; 208, radial artery; 209, wrist cross section; 301, silicone contact;
302、PVDF压电薄膜;303、传感器外壳;401、上贴电极;402、下贴电极;302, PVDF piezoelectric film; 303, sensor housing; 401, upper electrode; 402, lower electrode;
403、心电数据传输线;404、心脏。403, ECG data transmission line; 404, heart.
具体实施方式detailed description
下面结合具体实施例对本发明做进一步说明。The invention will be further described below in conjunction with specific embodiments.
本发明通过多次实验设计和大量实验数据拟合,建立了一套完整的PWTT、PWV与血压关系的数学模型,验证了PWTT、PWV和血压的关系,并可以实现连续动态血压监测。本发明使用了自主研发的“基于脉搏波传导时间(PWTT)及脉搏波传导速度(PWV)的连续血压监测装置及方法”。脉搏波是心脏射血和舒张的搏动(振动)沿主动脉向外周动脉血管传播而形成的波形。心脏—桡动脉脉搏波速是指同一心动周期,心肌搏动的脉搏波传导至手腕桡动脉的速度。运用传感器接收桡动脉血管受力发生的信号变化,通过计算脉搏波传导时间及心脏至动脉测量点距离的关系及脉搏波传导速度,经血压计内部电脑芯片处理后测量人体的收缩压、舒张压,此方法还可以用于检测人体两个不同动脉测量点之间的动脉硬化情况。The invention establishes a complete mathematical model of the relationship between PWTT, PWV and blood pressure through multiple experimental design and a large number of experimental data fitting, and verifies the relationship between PWTT, PWV and blood pressure, and can realize continuous dynamic blood pressure monitoring. The present invention uses a self-developed "continuous blood pressure monitoring device and method based on pulse wave transit time (PWTT) and pulse wave velocity (PWV)". The pulse wave is a waveform formed by the spread of cardiac ejection and diastolic pulsation (vibration) along the aorta to the peripheral artery. Heart-桡 radial pulse wave velocity refers to the speed of the heartbeat pulse wave transmitted to the wrist artery during the same cardiac cycle. The sensor is used to receive the signal changes of the brachial artery vascular force. By calculating the relationship between the pulse wave transit time and the heart-to-arterial measurement point distance and the pulse wave conduction velocity, the systolic blood pressure and diastolic blood pressure of the human body are measured after being processed by the internal computer chip of the sphygmomanometer. This method can also be used to detect arteriosclerosis between two different arterial measurement points in the human body.
本发明所用装置提供了两种连续动态血压监测的方法和一种校正方法:The device used in the present invention provides two methods for continuous dynamic blood pressure monitoring and a correction method:
i.简易监测法:可以只连续获取单一动脉位点的脉搏波(即一次心跳产生的脉搏波)分解出连续的心脏至主动脉的PWTT便可得到连续的血压值(拟合肱动脉血压值)。i. Simple monitoring method: continuous continuous blood pressure can be obtained by continuously acquiring the pulse wave of a single arterial site (ie, the pulse wave generated by one heartbeat) and decomposing the continuous heart-to-aortic PWTT (fitting the brachial blood pressure value) ).
ii.精确监测法:连续获取同一时刻获取两个不同动脉搏动点的脉搏波,获得连续的两动脉间的PWV,可以监测到精确的连续动态血压值(拟合肱动脉血压值)。Ii. Accurate monitoring method: Continuously acquire the pulse waves of two different arterial beat points at the same time, obtain continuous PWV between the two arteries, and monitor the accurate continuous dynamic blood pressure value (fit the brachial blood pressure value).
iii.本发明针对简易测量法提供了一种用快速校正方法,即使用两个不同动脉脉搏波之间PWTT校正仅通过分解单个动脉得到的PWTT,校正简易测量法的收缩压SBP值,保证了简易测量结果的准确性。Iii. The present invention provides a rapid correction method for correcting the systolic blood pressure SBP value of a simple measurement method by using a PWTT correction between two different arterial pulse waves by only decomposing a single artery. The accuracy of simple measurement results.
因此,综上所述:Therefore, in summary:
一、本发明提供一种无创连续动态血压检测的腕式佩戴装置(如图1所示):1. The present invention provides a wrist-worn device for non-invasive continuous ambulatory blood pressure detection (shown in Figure 1):
本发明的结构如图1所示,而本发明的主要形态为腕表,见图2、图3:包括配有显示模块113,其主机壳101上配有心电信号采集模块104,腕带102配有脉搏波信号采集模块103,心电信号采集模块104和脉搏波信号采集模块103采集到的双路信号经过控制模块105中的各个模块(包括放大模块106、滤波模块107、AD转换器108、血压计算模块109)处理后得到血压值。 The structure of the present invention is shown in FIG. 1 , and the main form of the present invention is a wristwatch, as shown in FIG. 2 and FIG. 3 , which includes a display module 113 , and a main body casing 101 is provided with an electrocardiographic signal acquisition module 104 and a wristband 102 . The dual-channel signals collected by the pulse wave signal acquisition module 103 and the pulse wave signal acquisition module 103 and the pulse wave signal acquisition module 103 pass through each module in the control module 105 (including the amplification module 106, the filter module 107, and the AD converter 108). The blood pressure calculation module 109) obtains a blood pressure value after processing.
本发明还设有与控制模块105连接的按键控制电路110、电源电路111、信号输入输出112。The present invention is further provided with a button control circuit 110, a power supply circuit 111, and a signal input/output 112 connected to the control module 105.
本发明的应用实例使用了心脏-桡动脉的脉搏波传导时间(hrPWTT)及其对应的心脏-桡动脉脉搏波传导速度hrPWV,拟合肱动脉血压,实现连续动态血压监测。The application example of the present invention uses the pulse-wave transit time (hrPWTT) of the heart-radial artery and its corresponding cardiac-iliac artery pulse wave velocity hrPWV to fit the brachial blood pressure to achieve continuous ambulatory blood pressure monitoring.
采集动脉脉搏波信号601是计算PWTT和PWV的前提。The acquisition of the arterial pulse wave signal 601 is a prerequisite for calculating the PWTT and PWV.
本应用实例中脉搏波信号采集模块103包括:紧固在表带102的脉搏波传感器204其包括硅胶触头301、PVDF压电薄膜302和传感器外壳303、连接204和控制模块105的传感器连接线205。The pulse wave signal acquisition module 103 in this application example includes a pulse wave sensor 204 fastened to the watch band 102, which includes a silicone contact 301, a PVDF piezoelectric film 302 and a sensor housing 303, a connection 204, and a sensor connection line of the control module 105. 205.
本应用实例将脉搏波信号采集模块103中的脉搏波传感器204放置在桡动脉搏动点208利用测量动脉内径变化速度的方法获得脉搏波信号,即桡动脉的脉搏波601(见图4)。This application example places the pulse wave sensor 204 in the pulse wave signal acquisition module 103 at the radial artery beat point 208 to obtain a pulse wave signal, that is, a pulse wave 601 of the radial artery (see FIG. 4) by measuring the rate of change of the inner diameter of the artery.
二、本发明提供的两种连续血压监测方法中,不同方法都需要脉搏波的获取:2. In the two consecutive blood pressure monitoring methods provided by the present invention, different methods require pulse wave acquisition:
i.简易监测法:只需要一个脉搏波传感器(204)并连续获得同一个动脉搏动点的脉搏波。本应用实例中的脉搏波传感器(204)选用压电式电容传感器放置于桡动脉搏动点(208)用于连续获取桡动脉脉搏波(601)。i. Simple monitoring method: only one pulse wave sensor (204) is needed and the pulse wave of the same arterial beat point is continuously obtained. The pulse wave sensor (204) in this application example uses a piezoelectric capacitive sensor placed at the radial artery beat point (208) for continuous acquisition of the radial artery pulse wave (601).
ii.精确监测法:需要至少一个脉搏波传感器,连续获取同一时刻两个不同动脉的脉搏波。本应用实例获取的脉搏波为桡动脉脉搏波(501)和心脏脉搏波,由于心脏位置特殊,测得心脏脉搏波的关键是使用心电信号代替脉搏波信号(502)。Ii. Accurate monitoring method: At least one pulse wave sensor is required to continuously acquire pulse waves of two different arteries at the same time. The pulse wave acquired by this application example is the radial artery pulse wave (501) and the heart pulse wave. Since the heart position is special, the key to measuring the heart pulse wave is to use the ECG signal instead of the pulse wave signal (502).
本应用实例中心电信号采集模块(104)包括两组心电传感器(201-203,401-402)和心电数据传输线403,并提供了两种心电信号的获取方法:The application center central electrical signal acquisition module (104) includes two sets of electrocardiographic sensors (201-203, 401-402) and an electrocardiographic data transmission line 403, and provides two methods for acquiring ECG signals:
i.手动心电信号采集:(图2至图4)使用单导联心电传感器,包括位于主机壳上盖的心电上电极片(201)位于主机壳底面的心电下电极片(202)和心电地极片(203)。操作时202与203紧贴于手腕皮肤,另一手任意手指接触201,即可构成心电通路,获得此时刻的连续心电信号,手指松开,通路断开,信号断开。(见图5)i. Manual ECG signal acquisition: (Fig. 2 to Fig. 4) using a single lead ECG sensor, including an electrocardiographic upper electrode piece (201) located on the upper surface of the main body case, and an electrocardiographic lower electrode piece (202) located on the bottom surface of the main body case. ) and the electrocardiogram pole piece (203). During operation, 202 and 203 are in close contact with the wrist skin, and the other hand touches 201 with any finger to form an electrocardiographic path, and a continuous ECG signal at this moment is obtained, the finger is released, the passage is broken, and the signal is disconnected. (See Figure 5)
ii.自动心电信号采集:使用胸贴式心电传感器,包括上贴电极(401)和下贴电极(402),分别紧贴于左锁骨下方和左***上方,心电数据传输线(403)连接主机壳(101)上的传输线接口(206),获取到的连续心电信号可以实时传输至主机内的控制模块(105)。(见图6)Ii. Automatic ECG signal acquisition: use chest-mounted ECG sensor, including upper electrode (401) and lower electrode (402), respectively, under the left clavicle and above the left nipple, ECG data transmission line (403) The transmission line interface (206) on the host casing (101) is connected, and the obtained continuous ECG signal can be transmitted to the control module (105) in the host in real time. (See Figure 6)
三、本发明实施例实现连续监测动态血压的方法中,简易测量法包括以下几点:3. In the method for continuously monitoring the dynamic blood pressure in the embodiment of the present invention, the simple measurement method includes the following points:
i.简易测量法的关键是计算心脏射血产生的脉搏波传导至主动脉的脉搏波传导时间PWTT(607),具体实施方法为对获取桡动脉的一个周期的脉搏波(601)进行 分解,一个脉搏波包含了左心室射血时产生的脉搏波(602)和主动脉受压膨胀形成的主动脉脉搏波(603),计算两个波峰之间的时间差及为心脏射血产生的脉搏波传导至主动脉的脉搏波传导时间PWTT(607)(见图7)。i. The key to the simple measurement method is to calculate the pulse wave transit time PWTT (607) transmitted by the pulse wave generated by the cardiac ejection to the aorta. The specific method is to perform a pulse wave (601) of one cycle of acquiring the radial artery. Decomposition, a pulse wave contains the pulse wave (602) generated by left ventricular ejection and the aortic pulse wave (603) formed by aortic compression, calculating the time difference between the two peaks and generating for cardiac ejection. The pulse wave conduction time PWTT (607) transmitted by the pulse wave to the aorta (see Figure 7).
ii.简易测量法中收缩压PWTTSBP计算的示例性拟合公式为公式1:Ii. The exemplary fitting formula for the systolic pressure PWTT SBP calculation in the simple measurement method is Equation 1:
PWTTSBP=exp(pt1*PWTT)+pt2     (公式1)PWTT SBP =exp(pt1*PWTT)+pt2 (Equation 1)
其中,pt1,pt2为为结合用户相关参数的拟合参数,根据个体差异的变化而变化。Where pt1, pt2 are fitting parameters that are combined with user-related parameters, and vary according to changes in individual differences.
iii.简易测量法中收舒张压PWTTDBP计算的示例性拟合公式为公式2:Iii. The simple fitting method for the diastolic pressure PWTT DBP calculation is based on the formula 2:
PWTTDBP=Td*exp{PWTTSBP/(pt3·PWTT)2}-hr1*心率   (公式2)PWTT DBP =Td*exp{PWTT SBP /(pt3·PWTT) 2 }-hr1*heart rate (Equation 2)
其中,Td是舒张期时长;pt1、pt2为为结合用户相关参数的拟合参数,根据个体差异的不同其值相应发生变化。Among them, Td is the length of diastolic period; pt1 and pt2 are the fitting parameters that combine the relevant parameters of the user, and their values change according to the individual differences.
四、本实施例实现连续监测动态血压的方法中,精确测量法包括以下几点:4. In the method for continuously monitoring the dynamic blood pressure in the embodiment, the accurate measurement method includes the following points:
i.精确测量法的必须获取被测者的身高height,体重BMI,年龄Age,吸烟情况和服药情况。i. Accurate measurement must obtain the height, weight BMI, age Age, smoking status and medication status of the subject.
ii.精确测量法的关键是计算心脏射血产生的脉搏波传导至桡动脉采集点的脉搏波传导时间hrPWTT,具体实施方法是同时采集获取心电信号(502)和桡动脉脉搏波(501),计算的双路信号中R波波峰和其后相邻的桡动脉脉搏波(501)的波谷之间的时间差,即为hrPWTT。Ii. The key to the accurate measurement method is to calculate the pulse wave transit time hrPWTT transmitted by the pulse wave generated by the cardiac ejection to the radial artery collection point. The specific method is to simultaneously acquire the ECG signal (502) and the radial artery pulse wave (501). The time difference between the calculated R-wave peak in the two-way signal and the valley of the adjacent radial artery pulse wave (501) is hrPWTT.
iii.精确测量法的计算心脏射血产生的脉搏波传导至桡动脉采集点的脉搏波传导速度hrPWV是通过表达式:Iii. Accurate measurement method The pulse wave velocity hrPWV generated by the pulse wave generated by cardiac ejection to the radial artery collection point is expressed by the expression:
hrPWV=(h1*身高-5.085)/hrPWTT   (公式3)hrPWV=(h1*height-5.085)/hrPWTT (Equation 3)
其中,心脏至桡动脉的距离的拟合公式为L=h1*身高-5.085,其中,h1为拟合参数,根据个体差异的不同其值相应发生变化。The fitting formula of the distance from the heart to the radial artery is L=h1*the height-5.085, wherein h1 is a fitting parameter, and the value changes correspondingly according to the individual difference.
精确测量法中收缩压PWVSBP计算的示例性拟合公式为 An exemplary fitting formula for the calculation of systolic pressure PWV SBP in the accurate measurement method is
i.关于PWV的收缩压SBP的示例性拟合公式为:i. An exemplary fitting formula for the systolic pressure SBP of PWV is:
PWVSBP=gen1×性别+pw1×hrPWV+bm1×BMI+age1×年龄+Sm1*吸烟者+drug1*服药者     (公式4)PWV SBP =gen1×sex+pw1×hrPWV+bm1×BMI+age1×age+Sm1*sponder+drug1* medication (Formula 4)
其中,gen1、pw1、bm1、age1、Sm1、drug1为结合用户相关参数的拟合参数,根据个体差异的不同其值相应发生变化。Among them, gen1, pw1, bm1, age1, Sm1, and drug1 are fitting parameters that combine user-related parameters, and their values change according to individual differences.
ii.关于PWV的舒张压DBP的示例性拟合公式为:Ii. An exemplary fitting formula for the diastolic blood pressure DBP of PWV is:
Figure PCTCN2017110340-appb-000004
Figure PCTCN2017110340-appb-000004
其中,
Figure PCTCN2017110340-appb-000005
我们可以通过位移信号s3得到,RC2值通过拟合参数获得。
among them,
Figure PCTCN2017110340-appb-000005
We can get this by the displacement signal s 3 and the RC 2 value is obtained by fitting the parameters.
五、本发明为简易测量法提供了一种快速校准的方法,即使用桡动脉和心脏脉搏波(心电信号代替)之间hrPWTT,代替简易测量法中通过分解桡动脉脉搏波得到的PWTT,校正收缩压SBP值,保证了简易测量结果的准确性。(操作图如图5所示,过程见图12的流程图中900-711)。5. The present invention provides a method of rapid calibration for simple measurement, that is, using the hrPWTT between the radial artery and the cardiac pulse wave (instead of the electrocardiographic signal), instead of the PWTT obtained by decomposing the radial artery pulse wave in the simple measurement method, Correcting the SBP value of the systolic pressure ensures the accuracy of the simple measurement results. (The operation diagram is as shown in FIG. 5, and the process is shown in the flowchart of FIG. 12 in 900-711).
六、本发明的技术方案还包括血压计算模块对脉搏波信号处理的方法:所述信号血压计算模块109中将脉搏波形信号的速度信号S1还原位移信号S3(即602)并对位移信号S3中每个周期的峰值进行识别的方法。(图8、图9、图13、图14)The technical solution of the present invention further includes a method for processing the pulse wave signal by the blood pressure calculation module: the signal blood pressure calculation module 109 restores the velocity signal S1 of the pulse waveform signal to the displacement signal S3 (ie, 602) and the displacement signal S3 The method of identifying the peak of each cycle. (Fig. 8, Fig. 9, Fig. 13, Fig. 14)
i.血压计算模块对脉搏波信号S1的顶点进行识别,其主要步骤见图14;i. The blood pressure calculation module identifies the apex of the pulse wave signal S1, the main steps of which are shown in Figure 14;
ii.通过信号分析处理模块将桡动脉脉搏波信号s1正则化处理得到脉搏波信号s2;Ii. The signal analysis processing module normalizes the radial artery pulse wave signal s1 to obtain a pulse wave signal s2;
iii.对s2累加
Figure PCTCN2017110340-appb-000006
还原位移信号S3,反映血管半径受心脏射血和舒张因素的影响发生的变化。(如图9所示)、
Iii. Accumulating s 2
Figure PCTCN2017110340-appb-000006
The displacement signal S3 is restored to reflect changes in the vascular radius that are affected by cardiac ejection and relaxation factors. (as shown in Figure 9),
iv.简易测量法中需要对信号s3使用β函数进行分解,得到左心室脉搏波和主动脉脉搏波识别,并识别提取信号左心室脉搏波的波峰值和中动脉的脉搏波波峰值。精确测量法中需标记信号s3的波谷V[V0,V1,…Vn]。 Iv. In the simple measurement method, the signal s3 needs to be decomposed using the β function to obtain the left ventricular pulse wave and the aortic pulse wave recognition, and the peak value of the extracted left ventricular pulse wave and the pulse wave peak of the middle artery are extracted. In the accurate measurement method, the valleys V[V 0 , V 1 , ... V n ] of the signal s3 are to be marked.
七、本发明的技术方案还包括:所述血压计算模块(109)对还原后的位移信号S3中每个周期提取心脏舒张期时长Td[Td0,Td1...Tdn]的方法(图10)。具体方法见图15;用β函数拟合位移信号S3,计算差值信号,得到舒张期时长。7. The technical solution of the present invention further includes: a method for extracting a diastolic duration Td[Td0, Td1...Tdn] for each period of the restored displacement signal S3 by the blood pressure calculation module (109) (FIG. 10) . The specific method is shown in Fig. 15; the displacement signal S3 is fitted with the β function, and the difference signal is calculated to obtain the diastolic duration.
八、本发明的技术方案还包括:识别心电R波对应的时间点标记R[R0,R1,…Rn],8. The technical solution of the present invention further includes: identifying a time point mark R[R 0 , R 1 , . . . R n ] corresponding to the R wave of the electrocardiogram,
以及处理同一心跳周期内的双路信号(即,脉搏波信号S3和ECG)中已经标记的P[P0,P1,…Pn]和R[R0,R1,…Rn]之间的时间差,得到心脏-桡动脉的脉搏波传导时间hrPWTT,如图11。And processing the already labeled P[P 0 , P 1 , . . . P n ] and R[R 0 , R 1 , . . . R n ] in the two-way signals (ie, the pulse wave signals S3 and ECG) in the same heartbeat period. The time difference between the two, the pulse-wave transit time hrPWTT of the heart-radial artery is obtained, as shown in Fig. 11.
本发明提供了一种无创连续血压监测装置及方法,实现了一种小型化、便携、无需袖带充气加压、且连续血压测量装置及方法。该设备不仅无需充气袖带就可以实现血压计的功能,同时能够实现长期连续监测血压变化,且只需如手表般佩戴于腕部,灵活运用于各种生活场景。本发明在连续血压监测的方法基于血流动力学和血管弹性腔模型中血管参数的影响因素,使长期连续血压测量的结果更加可靠。The invention provides a non-invasive continuous blood pressure monitoring device and method, and realizes a miniaturization, portability, no cuff inflation and pressure, and a continuous blood pressure measuring device and method. The device not only does not require a pneumatic cuff to achieve the function of a sphygmomanometer, but also enables long-term continuous monitoring of blood pressure changes, and it can be worn on the wrist like a watch, and can be flexibly applied to various life scenes. The method of continuous blood pressure monitoring of the present invention is based on hemodynamics and the influencing factors of vascular parameters in the vascular elastic cavity model, so that the results of long-term continuous blood pressure measurement are more reliable.
以上所述仅为本发明的具体实施例而已,并不用于限定本发明的保护范围,凡在本发明的精神和原则之内,所做的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。 The above description is only for the specific embodiments of the present invention, and is not intended to limit the scope of the present invention. Any modifications, equivalent substitutions, improvements, etc., which are included in the spirit and principles of the present invention, should be included in Within the scope of protection of the present invention.

Claims (22)

  1. 一种基于脉搏波传导的连续动态血压监测装置,所述监测装置为腕表形态,主机壳(101)上配有心电信号采集模块(104),腕带(102)对应手腕桡动脉处配有脉搏波信号采集模块(103),所述心电信号采集模块(104)和脉搏波信号采集模块(103)信号连接控制模块(105)。A continuous dynamic blood pressure monitoring device based on pulse wave conduction, wherein the monitoring device is in the form of a wristwatch, and the main body casing (101) is provided with an electrocardiographic signal acquisition module (104), and the wristband (102) is provided with a wrist artery at the wrist The pulse wave signal acquisition module (103), the ECG signal acquisition module (104) and the pulse wave signal acquisition module (103) are signally connected to the control module (105).
  2. 根据权利要求1所述的装置,其特征在于,所述控制模块包括依次连接的放大模块(106)、滤波模块(107)、AD转换器(108)、血压计算模块(109),所述放大模块(106)与所述心电信号采集模块(104)和脉搏波信号采集模块(103)信号连接。The device according to claim 1, wherein the control module comprises an amplification module (106), a filtering module (107), an AD converter (108), and a blood pressure calculation module (109) connected in sequence, the amplification The module (106) is in signal connection with the ECG signal acquisition module (104) and the pulse wave signal acquisition module (103).
  3. 根据权利要求1所述的装置,其特征在于,心电信号采集模块(104)包括位于主机壳上盖的心电上电极片(201)以及位于主机壳底面用于紧贴皮肤的心电下电极片(202)和心电地极片(203),所述心电上电极片(201)、心电下电极片(202)、心电地极片(203)与控制模块(105)连接。The device according to claim 1, wherein the electrocardiographic signal acquisition module (104) comprises an electrocardiographic upper electrode tab (201) located on the cover of the main body case and an electrocardiogram located on the bottom surface of the main body case for adhering to the skin. The electrode sheet (202) and the electrocardiographic pole piece (203), the electrocardiographic upper electrode sheet (201), the electrocardiographic lower electrode sheet (202), and the electrocardiographic ground sheet (203) are connected to the control module (105). .
  4. 根据权利要求1所述的装置,其特征在于,所述心电信号采集模块(104)包括用于紧贴左锁骨下方的上贴电极(401)和左***上方的下贴电极(402),以及位于主机壳(101)上与控制模块(105)连接的传输线接口(206),所述上贴电极(401)和下贴电极(402)通过心电数据传输线(403)连接所述传输线接口(206)。The device according to claim 1, wherein said electrocardiographic signal acquisition module (104) includes an upper electrode (401) for abutting under the left clavicle and a lower electrode (402) above the left nipple. And a transmission line interface (206) connected to the control module (105) on the main body casing (101), wherein the upper bonding electrode (401) and the lower bonding electrode (402) are connected to the transmission line interface through an electrocardiographic data transmission line (403) (206).
  5. 根据权利要求1所述的装置,其特征在于,所述心电信号采集模块(104)包括手动心电信号采集模块和自动心电信号采集模块;The device according to claim 1, wherein the ECG signal acquisition module (104) comprises a manual ECG signal acquisition module and an automatic ECG signal acquisition module;
    所述手动心电信号采集模块包括位于主机壳上盖的心电上电极片(201)以及位于主机壳底面用于紧贴皮肤的心电下电极片(202)和心电地极片(203),所述心电上电极片(201)、心电下电极片(202)、心电地极片(203)与控制模块(105)连接;The manual ECG signal acquisition module includes an electrocardiographic upper electrode sheet (201) on a cover of the main body case, and an electrocardiographic lower electrode piece (202) and an electrocardiographic ground piece (203) located on the bottom surface of the main body case for closely contacting the skin. The electrocardiographic upper electrode sheet (201), the electrocardiographic lower electrode sheet (202), and the electrocardiographic ground electrode sheet (203) are connected to the control module (105);
    所述自动心电信号采集模块包括用于紧贴左锁骨下方的上贴电极(401)和左***上方的下贴电极(402),以及位于主机壳(101)上与控制模块(105)连接的的传输线接口(206),所述上贴电极(401)和下贴电极(402)通过心电数据传输线(403)连接所述传输线接口(206),需要说明的是,对于心脏在右边的人体,上贴电极(401)紧贴右锁骨下方,下贴电极(402)紧贴右***上方。The automatic electrocardiographic signal acquisition module includes an upper electrode (401) for being placed under the left clavicle and a lower electrode (402) above the left nipple, and is connected to the control module (105) on the main body casing (101). The transmission line interface (206), the upper electrode (401) and the lower electrode (402) are connected to the transmission line interface (206) through an electrocardiographic data transmission line (403), and it should be noted that for the heart on the right side In the human body, the upper electrode (401) is placed just below the right clavicle, and the lower electrode (402) is placed just above the right nipple.
  6. 根据权利要求1所述的装置,其特征在于,所述脉搏波信号采集模块(103)包括紧固在腕带(102)上的脉搏波传感器(204)、以及连接脉搏波传感器(204)和控制模块(105)的传感器连接线(205),所述脉搏波传感器(204)包括设置于传感器外壳(303)的PVDF压电薄膜(302)和硅胶触头(301)。The device according to claim 1, wherein said pulse wave signal acquisition module (103) comprises a pulse wave sensor (204) fastened to the wristband (102), and a connected pulse wave sensor (204) and A sensor connection line (205) of the control module (105), the pulse wave sensor (204) includes a PVDF piezoelectric film (302) and a silicone contact (301) disposed on the sensor housing (303).
  7. 基于脉搏波传导的连续动态血压简易监测法,其特征在于,包括: A continuous dynamic blood pressure simple monitoring method based on pulse wave conduction, which comprises:
    (1)通过脉搏波传感器连续获得桡动脉搏动点的一个周期的脉搏波信号S1并发送至控制模块;(1) continuously obtaining a pulse wave signal S1 of one cycle of the radial artery beat point by the pulse wave sensor and transmitting it to the control module;
    (2)对信号S1进行分解得到左心室脉搏波和主动脉脉搏波,同时得到舒张期时长;(2) Decomposing the signal S1 to obtain a left ventricular pulse wave and an aortic pulse wave, and at the same time obtaining a diastolic duration;
    (3)计算左心室脉搏波和主动脉脉搏波波峰之间的时间差PWTT;(3) calculating the time difference PWTT between the left ventricular pulse wave and the aortic pulse wave peak;
    (4)根据PWTT计算收缩压PWTTSBP(4) Calculate the systolic pressure PWTT SBP according to PWTT;
    (5)根据收缩压PWTTSBP和舒张期时长计算舒张压PWTTDBP(5) The diastolic pressure PWTT DBP is calculated based on the systolic pressure PWTT SBP and the duration of the diastolic phase.
  8. 根据权利要求7所述的方法,其特征在于,步骤(1)中采集脉搏波信号的间隔为2ms。The method according to claim 7, wherein the interval of acquiring the pulse wave signals in the step (1) is 2 ms.
  9. 根据权利要求7所述的方法,其特征在于,步骤(2)的具体方法为:The method according to claim 7, wherein the specific method of step (2) is:
    (201)识别信号S1中每个周期的顶点;(201) identifying a vertex of each period in the signal S1;
    (202)对信号S1正则化得到信号S2;(202) Regularizing the signal S1 to obtain a signal S2;
    (203)对信号S2累加得到位移信号S3;(203) accumulating the signal S2 to obtain a displacement signal S3;
    (204)用β函数对信号S3进行分解得到左心室脉搏波和主动脉脉搏波;(204) Decomposing the signal S3 by the β function to obtain a left ventricular pulse wave and an aortic pulse wave;
    (205)通过信号s3计算舒张期时长Td[Td0,Td1,...Tdn]。(205) The diastolic duration Td [Td0, Td1, ... Tdn] is calculated by the signal s3.
  10. 根据权利要求7所述的方法,其特征在于,步骤(4)所述收缩压PWTTSBP计算的拟合公式为:The method according to claim 7, wherein the fitting formula of the systolic pressure PWTT SBP calculated in the step (4) is:
    PWTTSBP=exp(pt1*PWTT)+pt2;PWTT SBP = exp(pt1*PWTT)+pt2;
    其中,pt1,pt2为为结合用户相关参数的拟合参数。Where pt1, pt2 are fitting parameters that are combined with user-related parameters.
  11. 根据权利要求7所述的方法,其特征在于,步骤(5)所述舒张压PWTTDBP计算的拟合公式为:The method according to claim 7, wherein the fitting formula of the diastolic pressure PWTT DBP calculation in the step (5) is:
    PWTTDBP=Td*exp{PWTTSBP/(pt3·PWTT)2}-hr1*心率;PWTT DBP = Td * exp {PWTT SBP / (pt3 · PWTT) 2} - hr1 * heart rate;
    其中,Td是舒张期时长;pt1、pt2为为结合用户相关参数的拟合参数。Wherein, Td is the length of the diastolic period; pt1 and pt2 are the fitting parameters for combining the relevant parameters of the user.
  12. 基于脉搏波传导的连续动态血压校准值简易监测法,其特征在于,包括:A simple monitoring method for continuous dynamic blood pressure calibration values based on pulse wave conduction, characterized in that it comprises:
    (1)通过脉搏波传感器和手动心电信号采集模块连续同步采集心电信号和脉搏波信号s1并发送至控制模块;(1) continuously collecting the ECG signal and the pulse wave signal s1 by the pulse wave sensor and the manual ECG signal acquisition module and transmitting the signal to the control module;
    (2)得到心-桡脉搏波传导时间hrPWTT;(2) obtaining a heart-桡 pulse wave transit time hrPWTT;
    (3)根据hrPWTT计算收缩压PWTTSBP(3) Calculate the systolic pressure PWTT SBP according to hrPWTT;
    (4)根据收缩压PWTTSBP和舒张期时长计算舒张压PWTTDBP(4) The diastolic pressure PWTT DBP is calculated based on the systolic pressure PWTT SBP and the duration of the diastolic phase.
  13. 根据权利要求12所述的方法,其特征在于,步骤(1)中同步采集心电信号和脉搏波信号的间隔为2ms。 The method according to claim 12, wherein the interval between the synchronous acquisition of the electrocardiographic signal and the pulse wave signal in step (1) is 2 ms.
  14. 根据权利要求12所述的方法,其特征在于,步骤(2)的具体方法为:The method according to claim 12, wherein the specific method of step (2) is:
    (201)识别信号S1中每个周期的顶点;(201) identifying a vertex of each period in the signal S1;
    (202)对信号S1正则化得到信号S2;(202) Regularizing the signal S1 to obtain a signal S2;
    (203)对信号S2累加得到位移信号S3;(203) accumulating the signal S2 to obtain a displacement signal S3;
    (204)提取信号S3中波谷值[V0,V1,...Vn];(204) extracting the valley value [V0, V1, ... Vn] in the signal S3;
    (205)识别心电信号的R波并标记为[R0,R1,...Rn];(205) identifying the R wave of the electrocardiographic signal and marking it as [R0, R1, ... Rn];
    (206)处理同一心跳周期的P[V0,V1,...Vn]和R波[R0,R1,...Rn]的时间差,得到心-桡脉搏波传导时间hrPWTT。(206) The time difference between P[V0, V1, ... Vn] and the R wave [R0, R1, ... Rn] of the same heartbeat cycle is processed to obtain a heart-pulse pulse wave transit time hrPWTT.
  15. 根据权利要求12所述的方法,其特征在于,步骤(3)所述收缩压PWTTSBP计算的拟合公式为:The method according to claim 12, wherein the fitting formula of the systolic pressure PWTT SBP calculated in the step (3) is:
    PWTTSBP=exp(pt1*hrPWTT)+pt2;PWTT SBP = exp(pt1*hrPWTT)+pt2;
    其中,pt1,pt2为为结合用户相关参数的拟合参数。Where pt1, pt2 are fitting parameters that are combined with user-related parameters.
  16. 根据权利要求12所述的方法,其特征在于,步骤(4)所述舒张压PWTTDBP计算的拟合公式为:The method according to claim 12, wherein the fitting formula of the diastolic pressure PWTT DBP calculation in the step (4) is:
    PWTTDBP=Td*exp{PWTTSBP/(pt3·hrPWTT)2}-hr1*心率;PWTT DBP = Td * exp {PWTT SBP / (pt3 · hrPWTT) 2} - hr1 * heart rate;
    其中,Td是舒张期时长;pt1、pt2为为结合用户相关参数的拟合参数。Wherein, Td is the length of the diastolic period; pt1 and pt2 are the fitting parameters for combining the relevant parameters of the user.
  17. 基于脉搏波传导的连续动态血压精确监测法,其特征在于,包括:A continuous dynamic blood pressure accurate monitoring method based on pulse wave conduction, which comprises:
    (1)获取被测者个人参数;(1) Obtain the personal parameters of the test subject;
    (2)通过脉搏波传感器和心电信号采集模块连续同步采集心电信号ECG、脉搏波信号s1并发送至控制模块;(2) continuously acquiring the ECG signal ECG and the pulse wave signal s1 through the pulse wave sensor and the ECG signal acquisition module and transmitting the signal to the control module;
    (3)得到心-桡脉搏波传导时间hrPWTT以及舒张期时长TD;(3) obtaining cardiac-桡 pulse wave transit time hrPWTT and diastolic duration TD;
    (4)根据心-桡脉搏波传导时间hrPWTT计算心-桡脉搏波传导速度hrPWV;(4) Calculating the heart-桡 pulse wave velocity hrPWV according to the heart-桡 pulse wave transit time hrPWTT;
    (5)根据心-桡脉搏波传导速度hrPWV计算收缩压PWVSBP(5) Calculate systolic pressure PWV SBP according to heart-桡 pulse wave velocity hrPWV;
    (6)根据收缩压PWVSBP以及舒张期时长TD计算舒张压PWVDBP(6) The diastolic pressure PWV DBP is calculated based on the systolic pressure PWV SBP and the diastolic duration TD.
  18. 根据权利要求17所述的方法,其特征在于,步骤(1)所述个人参数包括被测者的身高height,体重BMI,年龄Age,吸烟情况和服药情况。The method according to claim 17, wherein the personal parameter of the step (1) comprises a height height, a body weight BMI, an age Age, a smoking condition, and a medication situation of the subject.
  19. 根据权利要求17所述的方法,其特征在于,步骤(2)中同步采集心电信号和脉搏波信号的间隔为2ms。 The method according to claim 17, wherein the interval between the synchronous acquisition of the electrocardiographic signal and the pulse wave signal in step (2) is 2 ms.
  20. 根据权利要求17所述的方法,其特征在于,步骤(3)的具体过程为:The method according to claim 17, wherein the specific process of step (3) is:
    (201)识别信号S1中每个周期的顶点;(201) identifying a vertex of each period in the signal S1;
    (202)对信号S1正则化得到信号S2;(202) Regularizing the signal S1 to obtain a signal S2;
    (203)对信号S2累加得到位移信号S3;(203) accumulating the signal S2 to obtain a displacement signal S3;
    (204)通过信号s3计算舒张期时长Td[Td0,Td1,...Tdn];(204) calculating the diastolic duration Td [Td0, Td1, ... Tdn] by the signal s3;
    (205)提取信号S3中波谷值[V0,V1,...Vn];(205) extracting the valley value [V0, V1, ... Vn] in the signal S3;
    (206)识别心电信号的R波并标记为[R0,R1,...Rn];(206) identifying the R wave of the electrocardiographic signal and marking it as [R0, R1, ... Rn];
    (207)处理同一心跳周期的P[V0,V1,...Vn]和R波[R0,R1,...Rn]的时间差,得到心-桡脉搏波传导时间hrPWTT。(207) The time difference between P[V0, V1, ... Vn] and the R wave [R0, R1, ... Rn] of the same heartbeat cycle is processed, and the heart-桡 pulse wave transit time hrPWTT is obtained.
  21. 根据权利要求17所述的方法,其特征在于,步骤(4)计算hrPWV的公式如下:The method of claim 17, wherein the formula for calculating hrPWV in step (4) is as follows:
    hrPWV=(h1*身高-5.085)/hrPWTT;hrPWV=(h1*height-5.085)/hrPWTT;
    其中,h1为拟合参数。Where h1 is the fitting parameter.
  22. 根据权利要求17所述的方法,其特征在于,,步骤(5)计算收缩压PWVSBP的公式如下:The method according to claim 17, wherein the formula for calculating the systolic pressure PWV SBP in the step (5) is as follows:
    PWVSBP=gen1×性别+pw1×hrPWV+bm1×BMI+age1×年龄+Sm1*吸烟者+drug1*服药者;PWV SBP =gen1×sex+pw1×hrPWV+bm1×BMI+age1×age+Sm1*sponder+drug1* medication;
    其中,gen1、pw1、bm1、age1、Sm1、drug1为结合用户相关参数的拟合参数。Among them, gen1, pw1, bm1, age1, Sm1, and drug1 are fitting parameters that combine user-related parameters.
    进一步的,步骤(6)的计算公式为:Further, the calculation formula of step (6) is:
    Figure PCTCN2017110340-appb-100001
    Figure PCTCN2017110340-appb-100001
    其中,
    Figure PCTCN2017110340-appb-100002
    通过位移信号s3得到,RC2值通过拟合参数获得。
    among them,
    Figure PCTCN2017110340-appb-100002
    Obtained from the displacement signal s 3 , the RC 2 value is obtained by fitting the parameters.
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