WO2019011242A1 - 具有确定颈动脉血压的多功能量测装置 - Google Patents
具有确定颈动脉血压的多功能量测装置 Download PDFInfo
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- WO2019011242A1 WO2019011242A1 PCT/CN2018/095174 CN2018095174W WO2019011242A1 WO 2019011242 A1 WO2019011242 A1 WO 2019011242A1 CN 2018095174 W CN2018095174 W CN 2018095174W WO 2019011242 A1 WO2019011242 A1 WO 2019011242A1
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- sensing unit
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Definitions
- the present invention relates to a blood pressure measuring device, and more particularly to a multifunctional measuring device for determining blood pressure of a carotid artery.
- Cerebrovascular accidents have been among the top five causes of death in China for many years. They are one of the main causes of disability and disability in young and middle-aged people, and they are important enemies of Chinese people's health.
- cerebrovascular diseases ischemic stroke caused by insufficient blood supply to the brain, leading to central nervous system damage, easy to occur in patients from 60 to 70 years old, the risk factors include: porridge Arteriosclerosis, hypertension, diabetes, hyperlipidemia, smoking, family history, etc., while atherosclerosis mainly accounts for 20-25% of carotid stenosis, and small hole infarction related to hypertension 20%, 25% of obstructions caused by arrhythmia associated with atrial fibrillation, and 30% of other unexplained causes.
- carotid stenosis has a statistically significant correlation with ischemic stroke in the ipsilateral brain, and ischemic stroke and other patients with carotid stenosis more than 80%.
- the risk of complications was nearly sixty times higher (92.3% vs. 1.5%) than patients with carotid stenosis less than 80%.
- carotid stenosis will gradually become more serious, and then the damage to the body is relatively greater.
- the cervical Doppler ultrasound scan uses the Doppler effect to detect the hemodynamics of the major arteries in the intracranial arterial ring, and observes the flow state of the blood vessels.
- the carotid artery Doppler ultrasound is limited in engineering or clinical application because of the limitation of the skull. It can only detect a fairly limited part of the carotid artery in the neck. This limitation can be used to penetrate the skull. Le ultrasonic waves to reinforce, but the effect is limited.
- Nuclear magnetic resonance angiography uses a magnetic field to temporarily magnetize hydrogen atoms in human tissues, and then resonates with hydrogen atoms by radio waves to collect signals from coils to generate images. Therefore, NMR angiography uses blood flow velocity and then external magnetic field. The vector properties that are presented determine the vascular conditions to be observed, so that images that are sensitive to blood flow velocity are produced, and if more accurate vascular anatomy is required, it is not as accurate as conventional angiography.
- Carotid angiography is performed by puncture of the femoral artery or other peripheral arteries of the iliac crest, and under the supervision of radiosurgery, the catheter is introduced into the proximal end of the carotid artery, and then the contrast agent is injected, and simultaneously irradiated with rapid interval X-ray, thereby ingesting the intracranial Or the image of the vascular lumen of the head and neck and blood flow.
- the pseudo-negative rate is as high as 40% compared with the pathological sections of carotid angiography and carotid endoscopic curettage.
- carotid stenosis For patients with carotid stenosis, the risk of ischemic stroke and other complications is much higher than in patients with low stenosis. Carotid stenosis is closely related to cerebral blood flow volume, and cerebral blood flow has a great relationship with dementia. In order to prevent the occurrence of stroke and dementia, the clinical detection of carotid stenosis is very important.
- Traditional methods commonly used to diagnose carotid stenosis and cerebral blood flow volume are: carotid digital subtraction angiography, nuclear magnetic resonance angiography, Dubu Le ultrasonic scanning, etc., not only have their limitations, the cost of inspection is high, and it often takes a long time to complete the test.
- Doppler ultrasound In the simplest Doppler ultrasound, it takes at least twenty minutes to complete an inspection. Magnetic resonance magnetic resonance imaging (MRA) and angiography are more time consuming, and angiography and computed tomography, which has become popular in recent years, are more invasive and the risk of developer allergy, so the current traditional diagnosis The method is not suitable for use in rapid screening tests. For older people, those with a history of stroke, or a high-risk group for cardiovascular disease, it is imperative to develop a carotid stenosis detection device or technique that is convenient for rapid screening and for the prevention of stroke and dementia. And there is a high demand for the global medical market.
- MRA Magnetic resonance magnetic resonance imaging
- angiography and computed tomography which has become popular in recent years
- a main object of the present invention is to provide a multifunctional measuring device having a determined blood pressure of a carotid artery, comprising: a heart beat sensing unit disposed at a chest portion for acquiring a heart beat signal a pulse sensing unit disposed at a position of the neck portion relative to the carotid artery to obtain a pulse signal; and a data calculation unit communicating with the heartbeat sensing unit and the pulse sensing unit, the processing is from the a heartbeat sensing unit and a signal from the pulse sensing unit; wherein the data calculating unit obtains a carotid artery by calculating the heartbeat signal from the heartbeat sensing unit and the pulse signal from the pulse sensing unit Mean arterial pressure (MAP).
- MAP Mean arterial pressure
- the heartbeat sensing unit is an acoustic wave sensor.
- the heartbeat sensing unit is disposed at a position of the chest site relative to the aortic outlet, the pulmonary artery outlet, the tricuspid valve, or the circumferential side of the mitral valve.
- the pulse sensing unit is a doppler radar, a piezoelectric pressure sensor, an impedance pressure sensor, a capacitive pressure sensor, an acoustic wave sensor, and an ultrasonic sensor. (ultrasound sensor) or Photoplethysmographic sensor (PPG).
- the pulse sensing unit is disposed at a pulse measuring point of the neck portion, and the pulse measuring point is extrapolated to the left or right horizontal level by 3 ⁇ 0.3 cm as the starting point. Centimeter, from 0 cm from the starting point to a range of 4 cm from the 135 degree angle to the centrifugation direction.
- the mean arterial pressure is obtained using the following formula (I) or formula (II):
- L p is the path length of the pulse from the main artery outlet to the pulse measurement point through the artery
- T PA is the pulse arrival time
- a, b, c and A, B, and C are correction parameters.
- the pulse sensing unit includes a patch having a ligation node.
- the multi-function measuring device further includes a communication module connected to the data computing unit, the communication module is a Bluetooth communication module, a WIFI communication module, an RFID communication module, an NFC communication module, or a Zigbee communication. Module.
- the data calculation unit is disposed in the heartbeat sensing unit, the pulse sensing unit, and/or a portable device.
- the multifunctional measuring device can further acquire heart sound, blood flow sound, pulse wave velocity, and degree of carotid stenosis.
- the multifunctional measuring device of the present invention can be attached to the carotid artery by using a non-invasive electronic patching method by attaching an acoustic wave sensor to the peripheral side of the heart valve and with a plurality of selectable pulse sensing units. On the side, not only the carotid blood pressure and pulse wave velocity can be detected, but also the measurement results of the present invention can be used to diagnose carotid stenosis and cerebral blood flow volume.
- the multifunctional measuring device of the invention is light, portable, portable, and can measure the degree of carotid stenosis in real time and fast, and is suitable for hospitals, home operations, physician diagnosis, nursing centers and research centers, etc. for the elderly There is a high demand in the global medical market for people with a history of stroke or high risk of cardiovascular disease.
- FIG. 1 is a schematic view (1) of the multifunctional measuring device of the present invention.
- FIG. 2 is a schematic view (2) of the multifunctional measuring device of the present invention.
- FIG. 3 is a schematic view showing the use state of the first embodiment of the multi-function measuring device of the present invention.
- Embodiment 4 is a waveform diagram of Embodiment 1 of the multi-function measuring device of the present invention.
- FIG. 5 is a schematic view showing the use state of the second embodiment of the multi-function measuring device of the present invention.
- Fig. 6 is a view showing the heart sound wave of the aortic valve region of the second embodiment of the multifunctional measuring device of the present invention.
- Fig. 7 is a view showing the waveform of the right carotid artery of the second embodiment of the multifunctional measuring device of the present invention.
- 8A and 8B are waveform diagrams of a first embodiment of the present invention.
- Figure 9 is a correlation analysis diagram of Example 1 of the present invention.
- Figure 10 is a correlation analysis diagram (1) of Example 2 of the present invention.
- Figure 11 is a correlation analysis diagram (2) of the example 2 of the multifunctional measuring device of the present invention.
- Figure 12 is a correlation analysis diagram (3) of the example 2 of the multifunctional measuring device of the present invention.
- Fig. 13 is a view showing a waveform image of a third example of the multi-function measuring device of the present invention.
- FIG. 1 is a schematic diagram of a preferred embodiment of the multifunctional measuring device of the present invention, as shown in the figure:
- the main purpose of the present invention is to provide a multi-function measuring device 100 having a determined blood pressure of a carotid artery, comprising: a heartbeat sensing unit 11 disposed at a chest portion for acquiring a heartbeat signal; a pulse sensing unit 12 And a position of the neck portion relative to the carotid artery to obtain a pulse signal; and a data calculation unit 13 communicating with the heartbeat sensing unit 11 and the pulse sensing unit 12 to process the heartbeat The measuring unit 11 and the signal from the pulse sensing unit 12; wherein the data calculating unit 13 obtains the heartbeat signal from the heartbeat sensing unit 11 and the pulse signal from the pulse sensing unit 12 Mean arterial pressure (MAP) of the carotid artery.
- MAP Mean arterial pressure
- carotid artery refers to the artery responsible for blood flow to the skull and neck. It is divided into left and right sides, with three main branches on each side. The common carotid artery from the aorta is branched into the outer neck.
- the external carotid artery and the internal carotid artery, the external carotid artery is mainly the source of facial blood flow, and the internal carotid artery is mainly responsible for supplying blood flow to the brain tissue.
- the carotid artery is superficial and easy to detect, so it is a good window for finding diseases such as arteriosclerosis.
- the "heartbeat sensing unit 11" described herein refers to a combination of components having a function of acquiring a heartbeat signal in real time, which may include hardware or software, or may further be combined with an auxiliary component, such as a sensor that can measure heartbeat, receive and
- the storage of data, the processor for data processing, and other related components are not limited in the present invention.
- the aforementioned related components are, for example but not limited to, a signal booster, a power supply device, a micro control unit, a communication unit, a power unit, a display unit, and the like.
- the foregoing software is, for example but not limited to, data acquisition or feature extraction software, signal amplification amplification software, data calculation analysis software, and the like.
- the heartbeat sensing unit 11 is an acoustic wave sensor that uses an acoustic wave sensor to acquire a sound/sound wave signal (or a heart sound number) of a heart beat, since the heart audio signal corresponds to the operation of the heart valve. Therefore, the heart sound signal can be converted into a heartbeat signal.
- the heartbeat sensing unit 11 can operate independently of the pulse sensing unit 12 and the data calculating unit 13 to obtain the user's heart audio number.
- the frequency, intensity, and correlation of heart sounds can reflect the condition of the heart valve, myocardial function, and blood flow within the heart to further determine whether, for example, irregular heart sounds or other cardiac abnormalities have occurred.
- the heartbeat sensing unit 11 is disposed at a chest portion, the chest portion being opposite to the peripheral side of the heart valve, such as a mitral or tricuspid valve.
- the peripheral side of the atrioventricular valve, or the peripheral side of the aortic outlet or the exit of the pulmonary artery at the exit of the pulmonary artery ie, the aortic valve or the periorbital side of the semilunar valve of the pulmonary valve).
- the "pulse sensing unit 12" described herein refers to a combination of components having a real-time acquisition of a pulse signal function, which may include hardware or software, or may further be combined with an auxiliary component, such as a sensor that may measure a pulse, receive and record data.
- the storage, the processor for data processing, and other related components are not limited in the present invention.
- the aforementioned related components are, for example but not limited to, a signal booster, a power supply device, a micro control unit, a communication unit, a power unit, a display unit, and the like.
- the foregoing software is, for example but not limited to, data acquisition or feature extraction software, signal amplification amplification software, data calculation analysis software, and the like.
- the pulse sensing unit 12 is a pulse wave sensor that converts the pulse wave sensor into a pulse signal by using the obtained pulse wave signal, and the pulse sensing unit 12 is, for example but not limited to: Doppler Doppler radar, piezoelectric pressure sensor, impedance pressure sensor, capacitive pressure sensor, acoustic wave sensor, ultrasonic or photoplethysmography (PPG), or other sensor that can sense pulse signals Wait.
- Doppler Doppler radar piezoelectric pressure sensor, impedance pressure sensor, capacitive pressure sensor, acoustic wave sensor, ultrasonic or photoplethysmography (PPG), or other sensor that can sense pulse signals Wait.
- PPG photoplethysmography
- the pulse sensing unit 12 can also operate independently, for example, can be used to acquire a pulse signal of a user to further determine whether an irregular pulse/heart rhythm symptom occurs.
- the pulse sensing unit 12 is disposed at a position of the neck portion relative to the carotid artery, and the neck portion is not limited to the left carotid artery or the right carotid artery. .
- the pulse sensing unit 12 is disposed at a pulse measuring point of the neck portion, and the optimal position of the pulse measuring point is the most prominent point of the throat (or the middle point of the lip is down to Centering on the most protruding point of the neck, pushing 3 ⁇ 0.3 cm horizontally to the left or right side as the starting point 0 cm, from 0 cm from the starting point to 4 cm in the centrifugal direction at an angle of 135 degrees; Horizontal extrapolation 3 ⁇ 0.3 cm, for example but not limited to: 2.7 cm, 2.8 cm, 2.9 cm, 3 cm, 3.1 cm, 3.2 cm, 3.3 cm, etc., the pulse measurement point range, for example: from the starting point 0 cm to 135 The angle is pushed in the range of 1 cm, 2 cm, 3 cm, or 4 cm in the centrifugal direction.
- the pulse measuring point of the present invention is not limited to the ranges, and the foregoing examples can only measure the preferred pulse signal. Measurement range.
- the pulse sensing unit 12 includes a The patch having the knuckle positioning portion, which may be, for example but not limited to, a positioning hole, a positioning mark or the like having a positioning function, and the present invention does not limit the positioning means.
- the pulse sensing unit 12 of the present invention can further have functions according to different types of pulse wave sensors in addition to the pulse wave and pulse signals of the carotid artery.
- neck blood can be obtained.
- the "data computing unit 13" described herein refers to a combination of components having processing and arithmetic signal functions, which may include hardware or software, or may further be combined with auxiliary components, such as a memory that may include receiving and recording data, for data processing.
- the processor and other related components are not limited by the present invention.
- the aforementioned related components are, for example but not limited to, a signal booster, a power supply device, a micro control unit, a communication unit, a power unit, a display unit, and the like.
- the foregoing software is, for example but not limited to, data acquisition or feature extraction software, signal amplification amplification software, data calculation analysis software, and the like.
- the data calculation unit 13 is connected, coupled, or coupled to the heartbeat sensing unit 11 and the pulse sensing unit 12, and the data calculation unit 13 can process the heartbeat sensing unit 11 and the pulse sensing unit.
- the signals obtained by 12 and/or other data parameters are used to perform various parameters.
- the data calculation unit 13 functions as a pre-device of the sensor (heartbeat sensing unit 11, pulse sensing unit 12), as shown in "FIG. 2", the data calculation unit 13 can be configured with an amplitude filter 131, analog to digital conversion
- the device 132 is configured to perform pre-processing of the signal, and convert the signal of the sensor into a digital signal for operation.
- the data calculation unit 13 communicates with the heartbeat sensing unit 11 and the pulse sensing unit 12 to process signals from the heartbeat sensing unit 11 and from the pulse sensing unit 12, Using the time difference between the heart beat and its corresponding pulse, the mean arterial pressure (MAP) was calculated, and the systolic blood pressure and the diastolic blood pressure were calculated using the average arterial pressure.
- the data calculation unit 13 is disposed on the heartbeat sensing unit 11, the pulse sensing unit 12 or a portable device; In an embodiment, the data calculation unit 13 is disposed on the heartbeat sensing unit 11 or the pulse sensing unit 12 and a portable device.
- the data computing unit 13 can also be coupled to a communication module 14 for pairing with the portable device configuration to access the data computing unit 13 through the portable device configuration. The obtained data or the result obtained by the calculation of the data calculation unit 13 after the operation.
- the "communication” described herein can be communicated by means of wired or wireless transmission.
- the heartbeat sensing unit 11, the pulse sensing unit 12 and the data computing unit 13 can be connected to each other by a line.
- the wireless communication module can be coupled to each other by a wireless communication module, such as but not limited to: a Bluetooth communication module, a WIFI communication module, a radio frequency identification (RFID) communication module, and a near field communication (NFC) communication.
- RFID radio frequency identification
- NFC near field communication
- the communication method of the module, the Zigbee communication module, the wireless local area network (WLAN) communication module, or the like, and the communication method of the present invention are not limited.
- a "portable device” as described herein can be, for example, a handheld device 200, a wearable device 300, a smart mobile device, or other such portable electronic device.
- the multifunctional measuring device 100 of the present invention can be configured in conjunction with the handheld device 200 or the wearable device 300 to access the multifunctional measuring device 100 via the handheld device 200 or the wearable device 300. The measured data is processed and processed.
- the multifunctional measuring device 100 of the present invention can acquire a plurality of physiological data such as carotid blood pressure, heart sound, blood flow sound, pulse wave velocity, carotid stenosis degree and the like.
- blood pressure and "pulse wave velocity/pulse conduction velocity” described herein can be obtained by the following methods:
- the heart pulsates the blood into the aorta, and the aortic wall produces a pulse pressure wave that is transmitted along the vessel wall to the peripheral vessel at a certain speed.
- the conduction velocity of the pulse pressure wave in the artery wall is called the pulse wave velocity (PWV). ).
- Pulse wave velocity has a certain relationship with the biomechanical properties of the arterial wall, the geometric characteristics of blood vessels and the density of blood.
- the size is an early sensitive index reflecting the stiffness of the artery (stenosis).
- the harder (or narrower) the vessel wall, the normal standard index of PWV is 140 mm/ms.
- the pulse wave velocity (PWV) of the carotid artery can be obtained by measuring the pulse wave transit time and distance between two arterial recording sites (such as the aortic exit and the carotid artery).
- the formula is: Where t is the time difference between the two waveforms, ie the propagation time; L is the path length of the pulse wave through the artery (eg the distance between the aortic outlet and the carotid artery measurement site).
- PWV pulse wave velocity
- each contraction of the left ventricle forms a pressure pulse through the artery to the end of the blood vessel.
- the rate of pulse conduction depends on the stiffness of the artery, as shown in equation (a):
- ⁇ is the density of blood.
- the elasticity of the carotid artery is based on the effect of the intravascular and extravascular pressure on the arterial wall. This pressure is based on the viscoelasticity of the vessel geometry and the vessel wall. Typically, the effect of external pressure on the wall is negligible, and therefore, the rate of elasticity and pulse wave conduction is the function of the artery, and the transmitted pulse wave formation is the basis for measuring carotid stenosis.
- Pulse wave velocity and diastolic pressure are the most correlated with mean arterial pressure, as in equation (b):
- the slope a and the constant pwv0 are specific parameters of the subject.
- the present invention utilizes the heartbeat sensing unit 11 and the pulse sensing unit 12 to monitor a known parameter, pulse arrival time (PAT).
- PAT pulse arrival time
- the numerical measurement of the arrival time of each pulse wave is the sum of two different time intervals, the speed is determined by the vascular transit time (VTT) and the pre-ejection period (PEP).
- VTT vascular transit time
- PEP pre-ejection period
- the vascular transit time is the time during which the pressure pulse experiences the arterial path
- the pre-ejection period is the interval between the complex wave crests and the time interval between the opening of the aortic valve.
- the pre-ejection period includes the motor delay period and the left ventricular isovolumic contraction, such as equation (d) for the pulse arrival time, and parameter L for the path of the pressure pulse through the artery:
- the aforementioned mean arterial pressure is obtained via the following formula (I):
- the pulse length of L P from the main artery outlet to the pulse measurement point passes through the path length of the artery, T PA is the pulse arrival time, and a, b and c are correction parameters.
- the aforementioned correction parameters are a better adjustment of the algorithm based on the database built by the target subject population.
- the aforementioned mean arterial pressure is obtained via the following formula (II):
- the pulse length of L P from the main artery outlet to the pulse measurement point passes through the path length of the artery, T PA is the pulse arrival time, and A, B and C are the correction parameters.
- the aforementioned correction parameters are a better adjustment of the algorithm based on the database built by the target subject population.
- the mean arterial pressure is obtained by calculating the time difference between the chest site and the neck portion in response to the pulse wave response.
- the pulse arrival time is obtained via a time difference between the peak value of the heartbeat sensing unit 11 and the peak value of the pulse sensing unit 12.
- the pulse arrival time can also be obtained by detecting the time difference between the heartbeat sensing unit 11 and the trough of the pulse sensing unit 12 as a time trigger condition, which is not provided in the present invention. limit.
- the pulse wave velocity between the chest portion and the neck portion can be obtained, and the mean arterial pressure (MAP) of the carotid artery can be obtained based on the pulse wave velocity calculation.
- MAP mean arterial pressure
- the severity of atherosclerosis in the affected area can be assessed, and relevant data can be tracked by caregivers in real time.
- the above algorithm can be executed through the program installed on the handheld device 200 or the wearable device 300, and can be executed through the handheld device 200 or worn, in addition to the calculation by the data calculation unit 13 of the multi-function measurement device 100.
- the controller of the device 300 performs calculations to reduce the power required by the multi-function measuring device 100 while minimizing the data calculating unit 13 of the multi-function measuring device 100, reducing the weight of the multi-function measuring device 100.
- the heart sound refers to the sound of the heart, and refers to various sounds generated when the heart operates, and the medical field often utilizes the cardiac cycle, when the heart valve is opened and closed.
- the resulting sound for example, the first heart sound (S1) produced by the beginning of the systole, usually emitted by the mitral and tricuspid valves; and the second heart sound (S2) produced by the beginning of the diastolic phase, usually Caused by the closure of the aortic valve. Therefore, the heart audio signal can be used to understand the cardiac cycle and convert to a heartbeat signal.
- the heartbeat sensing unit 11 is an acoustic wave sensor disposed at a chest portion, and the chest portion is at a circumferential position relative to the aortic outlet, the pulmonary artery outlet, the tricuspid valve, or the mitral valve.
- the heartbeat sensing unit 11 can be used to acquire a pulsed area noise/unused sound by attaching to the position of the pulsed area, and the information can be used to assist in diagnosing valvular heart disease, such as mitral stenosis and insufficiency, three Mitral stenosis and insufficiency, aortic stenosis and insufficiency, pulmonary valve disease.
- the "stenosis of the carotid artery” described herein can be obtained by:
- the carotid artery has three main branches, the total carotid artery, the external carotid artery and the internal carotid artery.
- the source of facial blood flow distribution must also understand the mutual communication between the internal and external carotid arteries, that is, the anatomical communication between the external carotid artery and the internal carotid artery ( Anatomical anastomosis), that is, part of the facial blood flow may pass through the internal carotid artery through the above traffic, for example, the external carotid artery may communicate with the internal carotid artery by the internal maxillary artery; or the facial carotid artery ( Facial artery).
- the multifunctional measuring device 100 of the present invention achieves the function of detecting the stenosis of the carotid artery by acquiring relevant information of the blood flow pulse of the neck according to the above principle.
- the Peak systolic velocity (PSV) is used as the standard for judging the degree of carotid stenosis.
- the classification is shown in Table 1.
- the pulse sensing unit 12 is disposed at a position of the neck portion relative to the carotid artery.
- the pulse sensing unit 12 is disposed at a pulse measurement point of the neck portion, and the optimal position of the pulse measurement point is Centering on the most prominent point of the larynx (or from the middle point of the lip down to the most prominent point in the neck), push 3 ⁇ 0.3 cm horizontally to the left or right side as the starting point 0 cm, from the starting point 0 cm to a range of 135 degrees to within 4 cm of the centrifugation direction; wherein the level is extrapolated by 3 ⁇ 0.3 cm such as, but not limited to, 2.7 cm, 2.8 cm, 2.9 cm, 3 cm, 3.1 cm, 3.2 cm, 3.3 cm, etc.
- the pulse measuring point range is, for example, a range of 1 cm, 2 cm,
- the male subject's optimal position of the pulse measurement point is centered at the most prominent point of the larynx (or from the middle point of the lip down to the most prominent point of the neck), to the left or
- the horizontal thrust of the right side is 3 ⁇ 0.3 cm and the position of 3 cm is extrapolated to the centrifugal direction at an angle of 135 degrees;
- the optimal position of the pulse measurement point of the female subject is the most prominent point of the throat (or the middle of the lips) Centering down to the most prominent point in the neck, push 3 cm horizontally to the left or right side and push 3 cm to the centrifuge at 135 degrees.
- the pulse sensing unit 12 is disposed at a neck portion at any position relative to the left or right carotid artery.
- the position of the pulse sensing unit 12 may correspond to an affected part or a high-risk part of the subject, such as but not limited to: the pulse sensing unit 12 is disposed relative to the left carotid artery or The neck portion of the common carotid artery of the right carotid artery, the pulse sensing unit 12 is disposed at a position of the total carotid artery exit relative to the left or right carotid artery (ie, the branch position of the external carotid artery and the internal carotid artery) The neck part.
- the flow rate of the total carotid artery can directly evaluate the possibility of atherosclerosis of the external carotid artery and the internal carotid artery. If the state of the external carotid artery or the state of the internal carotid artery is to be evaluated separately, the pulse sensing unit 12 can adjust its setting position as needed. In addition, in addition to performing the carotid sensing by the pulse sensing unit 12, the present invention does not exclude setting a plurality of sets of sensors to evaluate the carotid blood flow sound wave, pulse wave velocity, and pulse wave mode. Analyze, or other desired physiological parameters, to further obtain data on the relative integrity of the carotid artery and its branches.
- FIG. 3 Please refer to "Fig. 3" and “Fig. 4" below, which are respectively used as a schematic diagram of the use state and waveform diagram of the multifunctional measuring device of the present invention, as shown in the figure:
- the multi-function measuring device 100 of the present embodiment includes a heartbeat sensing unit 11, a pulse sensing unit 12, and a data calculating unit 13, wherein the data calculating unit 13 is executed by a program installed in a handheld device 200.
- the heartbeat sensing unit 11, the pulse sensing unit 12, and the data computing unit 13 wirelessly communicate with each other via Bluetooth.
- the heartbeat sensing unit 11 includes an acoustic wave sensor and a patch, so that the heartbeat sensing unit 11 can be attached to a position of the chest of the subject relative to the aortic outlet to obtain a heart sound, a heartbeat signal, and the like.
- the pulse sensing unit 12 includes a pressure sensor and a patch 121 attached to a position of the neck of the subject relative to the total carotid artery exit of the right carotid artery to obtain a carotid pulse wave. Type and pulse signal.
- the obtained waveform image is shown in FIG. 4, the lower curve is the blood flow sound wave of the aortic exit, the upper curve is the right carotid artery blood flow pulse wave, and the dotted line part of the image is the first obtained by the heart beat sensing unit 11.
- T PA pulse wave arrival time
- the distance of the point is regarded as the path length (L p ) of the pulse wave passing through the artery, and the data calculating unit 13 can further calculate the results of the carotid blood pressure and the pulse wave velocity.
- FIG. 5" Please refer to "FIG. 5", "FIG. 6" and “FIG. 7" together, which are respectively used as a schematic diagram of the use state of the multifunctional measuring device of the present invention, aortic valve heart sound wave map and right carotid artery wave.
- the multi-function measuring device 100 of the present embodiment includes a heartbeat sensing unit 11, a pulse sensing unit 12, and a data calculating unit 13, wherein the data calculating unit 13 is installed in the heartbeat sensing unit 11 in a line connection manner.
- the heartbeat sensing unit 11 and the data computing unit 13 and the pulse sensing unit 12 communicate wirelessly via Bluetooth.
- the heartbeat sensing unit 11 includes an acoustic wave sensor, a display unit 15 and a patch, so that the heartbeat sensing unit 11 can be attached to the position of the chest of the subject relative to the exit of the aorta to obtain the heart sound and the heart.
- the display unit 15 can display information such as a heart sound wave type, a calculation result of the data calculation unit 13, and the like.
- the waveform pattern obtained by the heart beat sensing unit 11 is as shown in FIG. 6.
- the pulse sensing unit 12 includes an acoustic wave sensor and a patch 121 having a throat positioning portion 122.
- the throat positioning portion 122 is a hole for the user to align the throat positioning portion 122 of the patch 121 with the throat.
- the pulse sensing unit 12 is attached to the neck of the subject relative to the total carotid artery of the left or right carotid artery to obtain a carotid pulse wave pattern and a pulse signal, etc., in this embodiment, the right carotid artery is used.
- the waveform pattern obtained as an example is shown in Fig. 7.
- carotid blood flow sound can also be obtained to provide clinical diagnosis of carotid blood flow without abnormalities such as noise or abnormal sound. situation.
- the data calculation unit 13 obtains the pulse wave arrival by obtaining the time difference between the pulse peaks corresponding to the first heart sound wave peak (indicating the start of the systole period) obtained by the heart beat sensing unit 11 and the pulse sensing unit 12 Time (T PA ), and the distance from the aortic outlet to the pulse measurement point is taken as the path length (L p ) of the pulse wave through the artery to further calculate the carotid blood pressure and pulse wave velocity.
- Comparative Example 1 used a traditional clinical detection technique, Mindray Color Doppler Ultrasound Diagnostic System, to detect the right carotid artery by manual real-time measurement and record the test data.
- Comparative Example 2 A commercially available arteriosclerosis/sphygmomanometer recorded carotid blood flow sound waves.
- FIG. 8A and FIG. 8B Please refer to “FIG. 8A and FIG. 8B" and “FIG. 9" together, and the waveform image and correlation analysis diagrams of the first embodiment and the comparative example 1 are respectively shown, as shown in the figure:
- Example 1 uses both Example 1 and the conventional ultrasound diagnostic system (ie, Comparative Example 1) to measure 25 subjects including healthy or likely carotid stenosis by using two sensor screens (see figure 8A and 8B), the correlation between the pulse wave velocity obtained in Example 1 and the peak shrinkage speed recorded in Comparative Example 1 was analyzed.
- Example 1 and Comparative Example 1 were performed simultaneously in 30 seconds, including recording about 25 aortic pulse wave velocities from the aortic valve region to the carotid artery, and the results showed that the pulse wave velocity obtained in Example 1 and the comparative example were compared. 1
- the carotid pulse wave velocity obtained by the present invention can be utilized as a means for discriminating the degree of carotid stenosis, as shown in Table 2.
- FIG. 10 Please refer to "FIG. 10", “FIG. 11” and “FIG. 12" together, which are the correlation analysis diagrams (1), (2), and (3) of Example 1 and Comparative Example 2, respectively. Show:
- Example 1 the carotid pulse waves recorded in Example 1 and the carotid blood flow sound waves recorded in the commercially available arteriosclerosis instrument (ie, Comparative Example 2) were analyzed. Statistical correlation analysis was performed on the pulse wave velocity results obtained by the two devices.
- the carotid pulse wave velocity obtained by the present invention has a significant correlation with the commercially available arteriosclerosis apparatus. Therefore, the measurement results of the present invention can be used to determine the degree of carotid stenosis and the calculation of carotid blood pressure.
- FIG. 13 shows the carotid waveform image of the pulse sensing unit 12 of the present invention set at different pulse measuring points.
- the male subject and the female subject are measured by using the first embodiment, except that the pulse measuring point of the pulse sensing unit 12 is attached to the most prominent point of the subject's throat and extrapolated to the right side.
- a -0.3 points 3 cm
- B 0 points 3 cm
- a +0.3 points 3.3 cm
- the external point of the throat is 3 cm from the most prominent point of the throat.
- B 0 cm that is, B 0 point
- B 1 point push 1 cm
- B 2 point 2 cm
- B 3 point 3 cm
- B 4 points push 4 cm
- B 5 points 5 cm
- carotid pulse can be obtained at B 0 (Fig. 13 lower curve), B 1 point, B 2 point, B 3 point (Fig. 13 upper curve) and B 4 point.
- B 3 the signal at B 3 is better
- B 4 the signal at B 4 is weaker
- the signal at B 5 is more difficult to measure the pulse signal. It is speculated that B 4 and B 5 are affected by cartilage structure and hinder the carotid artery. Acquisition of the wave signal.
- the multifunctional measuring device of the present invention can be attached to the aortic outlet, the pulmonary artery outlet, the tricuspid valve or the circumferential side of the mitral valve by means of a sonic sensor by means of a non-invasive electronic patch. It can be attached to the peripheral side of the carotid artery with a variety of optional pulse sensing units, which can not only detect carotid blood pressure and pulse wave velocity, but also further use the measurement results of the present invention to diagnose carotid stenosis and cerebral blood flow volume. .
- the multifunctional measuring device of the invention is light, portable, portable, and can measure the degree of carotid stenosis in real time and fast, and is suitable for hospitals, home operations, physician diagnosis, nursing centers and research centers, etc. for the elderly There is a high demand in the global medical market for people with a history of stroke or high risk of cardiovascular disease.
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Abstract
一种具有确定颈动脉血压的多功能量测装置,包括一心搏感测单元(11),其设于胸口部位,藉以获取心搏讯号;一脉搏感测单元(12),其设置于颈部部位相对于颈动脉的位置,藉以获取脉搏讯号;及一数据计算单元(13),其与该心搏感测单元(11)及该脉搏感测单元(12)通讯,处理来自该心搏感测单元(11)及来自该脉搏感测单元(12)的讯号,并进一步获得颈动脉的平均动脉压。该量测装置不仅可侦测颈动脉血压及脉波速度,更可进一步利用量测结果判别颈动脉狭窄与脑血流容积,快速筛检心血管疾病高风险族群的颈动脉狭窄程度。
Description
本发明关于一种血压量测装置,特别关于一种用以确定颈动脉血压的多功能量测装置。
脑血管疾病(cerebrovascular accident)长年位居我国前五大死因,更是造成青壮年人口失能与残障的主因之一,是国人健康的重要敌人。在脑血管疾病中,缺血性脑中风(stroke)肇因于脑部供血量不足,导致中枢神经的损害,易好发于六十到七十岁的病患,其危险因素包括:粥状动脉硬化、高血压、糖尿病、高血脂、抽烟、家族病史等等,而粥状动脉硬化主要为颈动脉狭窄的阻塞约占20-25%、而与高血压有关的小洞性梗塞约占20%、跟心房颤动有关的心律不整所造成的阻塞占25%、其他不明原因所造成的阻塞则为30%。
在各项危险因素中,颈动脉狭窄与之后同侧大脑的缺血性脑中风有相当强的统计学相关性,且颈动脉狭窄程度超过80%的病患之后产生缺血性脑中风及其他并发症的风险,相较于颈动脉狭窄程度低于80%的病患高出将近六十倍(92.3%与1.5%)。此外,随着时间的进展,颈动脉狭窄会逐渐严重,之后对于身体的损伤亦相对更大。
由此可知,为预防脑中风的发生,临床上颈动脉的狭窄的侦测与定量十分重要。传统颈动脉狭窄的诊断方法,一般常用有都卜勒超音波扫描、核磁共振血管摄影、颈动脉血管摄影等方法,分别简述如下:
颈部都卜勒超音波扫描利用都卜勒效应来检测颅内底动脉环上各个主要动脉血流动力学,可对血管的流动状态进行观察。然而,颈动脉都卜勒超音波因为颅骨限制,故在工程技术上或临床应用上有所局限,只能检测到颈动脉位于颈部相当受限一部分,此限制虽可用穿透头颅骨都卜勒超音波来补强,但效果有限。
核磁共振血管摄影利用磁场将人体组织中的氢原子暂时磁化,再藉由无线电波与氢原子共振作用,以线圈收集组织讯号而产生影像,因此,核磁共振血管摄影利用血流速度再外加磁场中所表现的向量特性,决定所要观察的血管条件,故所产生的是对血流速度敏感的影像,如果需要观察更精确的血管解剖构造时,并不如传统的血管摄影精确。
颈动脉血管摄影是经由鼠蹊部的股动脉或其他外围动脉穿刺后,在放射线透视监视下,把导管导入颈动脉近端,再注射对比剂,并同时用快速间隔X光照射,藉以摄取颅内或头颈部血管内腔的影像及血流情况。血管摄影虽可获得较精确的血管构造影像,但有文献指出,颈动脉血管摄影与颈动脉内皮刮除术的手术结果病理切片相较下,伪阴性率高达40%。
发明内容
对于颈动脉狭窄患者而言,罹患缺血性中风和其他并发症的机率要远远高于狭窄程度低的病人。颈动脉狭窄与脑血流容积密切相关,脑血流量则与痴呆症有很大的关系。为了防止中风和痴呆的发生,颈动脉狭窄的临床检测是非常重要的,常用于诊断颈动脉狭窄和脑血流容积的传统方法如:颈动脉数位减影血管造影、核磁共振血管摄影、都卜勒超音波扫描等,不仅各有其局限性、检查费用高昂,且往往需要花费相当长的时间完成检测,以最简便的都卜勒超音波而论,完成一次检查至少需要二十分钟,至于核磁共振核磁摄影(MRA)以及血管摄影则更为耗时,而血管摄影及近年来逐渐普及的计算机断层血管摄影(computed tomography)更有侵袭性以及显影剂过敏的风险,因此,现行的传统诊断方法并不适合用于快速筛选测试。对于年长者、有中风病史或是心血管疾病高风险族群而言,发展一种方便且适用于快速筛检的颈动脉狭窄侦测装置或技术,对于脑中风和痴呆症的预防乃当务之急,且对于全球医疗市场亦具有相当高的需求性。
有鉴于此,为解决上述问题,本发明的主要目的在于提供一种具有确定颈动脉血压的多功能量测装置,其包括:一心搏感测单元,其 设于胸口部位,藉以获取心搏讯号;一脉搏感测单元,其设置于颈部部位相对于颈动脉的位置,藉以获取脉搏讯号;及一数据计算单元,其与该心搏感测单元及该脉搏感测单元通讯,处理来自该心搏感测单元及来自该脉搏感测单元的讯号;其中,该数据计算单元藉由计算来自该心搏感测单元的该心搏讯号及来自该脉搏感测单元的该脉搏讯号获得颈动脉的平均动脉压(mean arterial pressure,MAP)。
于一较佳实施例,该心搏感测单元是一种声波传感器。
于一较佳实施例,该心搏感测单元设置于胸口部位的相对于主动脉出口、肺动脉出口、三尖瓣或二尖瓣周侧的位置。
于一较佳实施例,该脉搏感测单元是都卜勒雷达(doppler radar)、压电压力传感器(Piezoelectric sensor)、阻抗压力传感器、电容压力传感器、声波传感器(acoustic wave sensor)、超音波传感器(ultrasound sensor)或光体积描述信号仪(Photoplethysmographic sensor,PPG)。
于一较佳实施例,该脉搏感测单元设置于颈部部位的脉搏量测点,该脉搏量测点以喉结最突点向左侧或右侧水平外推3±0.3厘米为起始点0厘米,自起始点0厘米至以135度角往离心方向4厘米内的范围。
于一较佳实施例,该平均动脉压是利用如下公式(I)或公式(II)获得:
其中,L
p为主动脉出口至该脉搏量测点脉波经过动脉的路径长度,T
PA为脉波抵达时间(pulse arrival time),a、b、c及A、B、C为校正参数。
于一较佳实施例,该脉搏感测单元包含一具有喉结定位部的贴片。
于一较佳实施例,该多功能量测装置更进一步包含有一连接至该数据计算单元的通讯模块,该通讯模块为蓝牙通讯模块、WIFI通讯模块、RFID通讯模块、NFC通讯模块、或Zigbee通讯模块。
于一较佳实施例,该数据计算单元设置于该心搏感测单元、该脉搏感测单元及/或一便携设备。
于一较佳实施例,该多功能量测装置可进一步获取心音、血流声、脉波速度、颈动脉狭窄程度。
本发明的多功能量测装置可利用非侵入性的电子贴片方式藉由以声波传感器贴附于心瓣周侧的位置,并搭配多种可选择的脉搏感测单元贴附于颈动脉周侧,不仅可侦测颈动脉血压及脉波速度,更可进一步利用本发明的量测结果诊断颈动脉狭窄与脑血流容积。本发明的多功能量测装置体积轻便、可手持、可携带,且可实时、快速量测颈动脉狭窄程度,适用于医院、居家行动、医师诊断、看护中心及研究中心等,对于年长者、有中风病史或心血管疾病高风险族群等在全球医疗市场上有相当高的需求性。
图1为本发明多功能量测装置的示意图(一)。
图2为本发明多功能量测装置的示意图(二)。
图3为本发明多功能量测装置实施例1的使用状态示意图。
图4为本发明多功能量测装置实施例1的波型图。
图5为本发明多功能量测装置实施例2的使用状态示意图。
图6为本发明多功能量测装置实施例2的主动脉瓣区心音声波图。
图7为本发明多功能量测装置实施例2的右颈动脉波型图。
图8A、图8B为本发明示例1的波型影像图。
图9为本发明示例1的相关性分析图。
图10为本发明示例2的相关性分析图(一)。
图11为本发明多功能量测装置示例2的相关性分析图(二)。
图12为本发明多功能量测装置示例2的相关性分析图(三)。
图13为本发明多功能量测装置示例3的波型影像图。
附图标记:
100 多功能量测装置
11 心搏感测单元
12 脉搏感测单元
121 贴片
122 喉结定位部
13 数据计算单元
131 振幅滤波器
132 模拟数字转换器
14 通讯模块
15 显示单元
200 手持式装置
300 穿戴式装置
有关本发明的详细说明及技术内容,现就配合图式说明如下。再者,本发明中的图式,为说明方便,其比例未必照实际比例绘制,该等图式及其比例并非用以限制本发明的范围,在此先行叙明。
本文中所称的“包含或包括”意指不排除一或多个其他组件、步骤、操作和/或元素的存在或添加至所述的组件、步骤、操作和/或元素。“一”意指该物的语法对象为一或一个以上(即,至少为一)。
下文中,将进一步以详细说明及实施例描述本发明,然而,应理解这些实施例仅用于帮助可更加容易理解本发明,而非用以限制本发明的范围。
以下请一并参照“图1”及“图2”,其所示为本发明多功能量测装置较佳实施例的示意图,如图所示:
本发明的主要目的在于提供一种具有确定颈动脉血压的多功能量测装置100,其包括:一心搏感测单元11,其设于胸口部位,藉以 获取心搏讯号;一脉搏感测单元12,其设置于颈部部位相对于颈动脉的位置,藉以获取脉搏讯号;及一数据计算单元13,其与该心搏感测单元11及该脉搏感测单元12通讯,处理来自该心搏感测单元11及来自该脉搏感测单元12的讯号;其中,该数据计算单元13藉由计算来自该心搏感测单元11的该心搏讯号及来自该脉搏感测单元12的该脉搏讯号获得颈动脉的平均动脉压(mean arterial pressure,MAP)。
本文所述的“颈动脉”指负责头颅和颈部血流的动脉,其分成左右两边,每边有三段主要的分支,从主动脉分流上来的总颈动脉(common carotid artery)分支成外颈动脉(External Carotid Artery)和内颈动脉(internal carotid artery),外颈动脉主要为面部血流的来源,内颈动脉主要负责供应脑部组织血流。颈动脉位置表浅,易于探测,因此是发现动脉硬化等疾病的良好窗口。
本文所述的“心搏感测单元11”指具有实时获取心搏讯号功能的组件组合,其中可包含硬件或软件,或是进一步结合辅助件,例如可包含量测心搏的传感器、接收并记录数据的储存器、用于数据处理的处理器及其他相关组件,本发明不予限定。前述相关组件例如但不限于:讯号增幅器、供电装置、微控制单元、通讯单元、功率单元、显示单元等。前述软件例如但不限于:数据采集或特征提取软件、讯号增幅扩增软件、数据演算分析软件等。前述辅助件例如但不限于:贴片、电子贴片、手持式辅助件等。于一较佳实施例中,该心搏感测单元11是一种声波传感器,即利用声波传感器获取心脏搏动的声音/声波讯号(或称心音频号),由于心音频号对应为心脏瓣膜的运作,故心音讯号可被转换为心搏讯号。此外,由于心音可反应心脏瓣膜的运作情形,故该心搏感测单元11除可与脉搏感测单元12及数据计算单元13进行通讯外,亦可独立运作用以获取用户心音频号,利用心音的频率、强度和相互关系可以反应出心脏瓣膜、心肌功能及心脏内血流的状况,以进一步判定是否出现例如不规则心音或其他心脏异常情形。关于该心搏感测单元11的设置位置,于一较佳实施例中,该 心搏感测单元11设置于胸口部位,该胸口部位相对于心瓣周侧,例如二尖瓣或三尖瓣的房室瓣周侧,或是主动脉出口或肺动脉出口的离心动脉出口周侧(亦即主动脉瓣或肺动脉瓣的半月瓣周侧)。
本文所述的“脉搏感测单元12”指具有实时获取脉搏讯号功能的组件组合,其中可包含硬件或软件,或是进一步结合辅助件,例如可包含量测脉搏的传感器、接收并记录数据的储存器、用于数据处理的处理器及其他相关组件,本发明不予限定。前述相关组件例如但不限于:讯号增幅器、供电装置、微控制单元、通讯单元、功率单元、显示单元等。前述软件例如但不限于:数据采集或特征提取软件、讯号增幅扩增软件、数据演算分析软件等。前述辅助件例如但不限于:贴片、电子贴片、手持式辅助件等。于一较佳实施例中,该脉搏感测单元12是一种脉波传感器,其利用所获得的脉波讯号将其转换为脉搏讯号,该脉搏感测单元12例如但不限于:都卜勒雷达(Doppler radar)、压电压力传感器(Piezoelectric sensor)、阻抗压力传感器、电容压力传感器、声波传感器、超音波或光体积描述信号仪(Photoplethysmography,PPG)、或其他可感测脉波讯号的传感器等。该脉搏感测单元12除可与心搏感测单元11及数据计算单元13进行通讯外,亦可独立运作,例如可用于获取用户脉波讯号,以进一步判定是否出现不规则脉搏/心律的症状。关于该脉搏感测单元12的设置位置,于一较佳实施例中,该脉搏感测单元12设置于颈部部位相对于颈动脉的位置,该颈部部位不限于左颈动脉或右颈动脉。于一更佳实施例中,该脉搏感测单元12设置于颈部部位的脉搏量测点,该脉搏量测点的最适位置以喉节最突点(或是以嘴唇中间点往下至颈部最突点)为中心,向左侧或右侧水平外推3±0.3厘米为起始点0厘米,自起始点0厘米至以135度角往离心方向4厘米内的范围;其中,该水平外推3±0.3厘米例如但不限于:2.7厘米、2.8厘米、2.9厘米、3厘米、3.1厘米、3.2厘米、3.3厘米等,该脉搏量测点范围例如:自起始点0厘米至以135度角往离心方向上推1厘米、2厘米、3厘米、或4厘米内的范围,然而,本发明的脉搏量测点不限于该等范围, 前述示例仅可量测到较佳脉搏讯号的量测范围。此外,为便于使用者将该脉搏感测单元12设置于颈部相对于颈动脉的位置上(即颈部脉搏量测点),于一较佳实施例中,该脉搏感测单元12包含一具有喉结定位部的贴片,该喉结定位部可以例如但不限于:定位孔、定位标记或其他类此具有定位功能的设置,本发明对于定位手段不予限定。更进一步地,本发明的脉搏感测单元12除可获取颈动脉的脉波及脉搏讯号外,依据不同种类的脉波传感器可具有进一步的功能,例如:若使用声波传感器,则可获得颈部血流声;若使用都卜勒雷达,则可获得颈部血流/脉波传导速度;该设置的优势在于,该脉搏感测单元12不仅可监测颈动脉脉搏,还可实时量测颈动脉血流变化。
本文所述的“数据计算单元13”指具有处理及运算讯号功能的组件组合,其中可包含硬件或软件,或是进一步结合辅助件,例如可包含接收并记录数据的储存器、用于数据处理的处理器及其他相关组件,本发明不予限定。前述相关组件例如但不限于:讯号增幅器、供电装置、微控制单元、通讯单元、功率单元、显示单元等。前述软件例如但不限于:数据采集或特征提取软件、讯号增幅扩增软件、数据演算分析软件等。该数据计算单元13与该心搏感测单元11及该脉搏感测单元12连接、耦接、或耦合进行通讯,该数据计算单元13可处理该心搏感测单元11及该脉搏感测单元12所获得的讯号及/或其他数据参数,进行各种参数的运算。该数据计算单元13作为传感器(心搏感测单元11、脉搏感测单元12)的前置装置,如“图2”所示,该数据计算单元13可以配置有振幅滤波器131、模拟数字转换器132,用以进行讯号的预处理,将传感器的讯号转换为数字讯号后进行运算。于一较佳实施例中,该数据计算单元13与该心搏感测单元11及该脉搏感测单元12通讯,处理来自该心搏感测单元11及来自该脉搏感测单元12的讯号,利用心搏及其所对应脉搏的时间差,计算出平均动脉压(mean arterial pressure,MAP),再利用平均动脉压推算出使用者的收缩压及舒张压。关于该数据计算单元13的设置位置,于一较佳实施例中,该数据计算单元13设置于该心搏感测单元11、该脉搏感 测单元12或一便携设备上;于另一较佳实施例中,该数据计算单元13设置于该心搏感测单元11或该脉搏感测单元12以及一便携设备上。于一较佳实施例中,该数据计算单元13还可与一通讯模块14连接,该通讯模块14用以与该便携设备配置进行配对,以透过该便携设备配置存取该数据计算单元13所获得的数据或输出该数据计算单元13经运算后所获得的结果。
本文所述的“通讯”可以透过有线或无线的传输方式进行通讯,例如该心搏感测单元11、该脉搏感测单元12及该数据计算单元13之间可以藉由线路互相连接,亦可藉由无线通信模块进行彼此间的耦合通讯等,前述无线的通讯模块例如但不限于:蓝牙(Bluetooth)通讯模块、WIFI通讯模块、射频识别(RFID)通讯模块、近场通讯(NFC)通讯模块、紫蜂(Zigbee)通讯模块、无线局域网络(WLAN)通讯模块等或其他类此的通讯方式,本发明对通讯方式不予限定。
本文所述的“便携设备”可以为例如手持式装置200、穿戴式装置300、智能型行动装置或其他类此的便于携带的电子装置。于一较佳实施例中,本发明的多功能量测装置100可以配合手持式装置200或穿戴式装置300配置,经由手持式装置200或穿戴式装置300存取多功能量测装置100所量测到的数据,并将该等数据进行处理。
本发明的多功能量测装置100可获取颈动脉血压、心音、血流声、脉波速度、颈动脉狭窄程度等多项生理数据。
本文所述的“血压”、“脉波速度/脉波传导速度”可以利用以下方式获得:
心脏将血液搏动性地射入主动脉,主动脉壁产生脉搏压力波,并以一定的速度沿血管壁向外周血管传导,这种脉搏压力波在动脉壁的传导速度叫脉波传导速度(PWV)。
脉波速度(PWV)与动脉壁的生物力学特性、血管的几何特性及血液的密度等因素有一定的关系,其大小是反映动脉僵硬度(狭窄度)的早期敏感指标,数值越大,表示血管壁越硬(或越狭窄),PWV的正常标准指数为140mm/ms。
颈动脉的脉波速度(PWV)可通过测量两个动脉记录部位(如主动脉出口与颈动脉)之间的脉搏波传导时间和距离求得,计算公式为:
其中,t为两个波形的时间差,即传播时间;L是脉波经过动脉的路径长度(如主动脉出口与颈动脉量测部位的距离)。
颈动脉的脉波速度(PWV)增大,表示颈动脉硬度增高(或狭窄度增大),顺应性差;反之,则血管硬度低顺应性佳。年龄和血压是PWV最重要的影响因素。降压治疗仍是目前已知最有效的降低PWV的方法。
此外,颈动脉脉波速度算法的概念是基于其与压力间的关系。每次心动周期,每次左心室的收缩都会形成一个压力脉波通过动脉到达血管末稍,脉波传导的速度取决于动脉的弹性(stiffness of artery),如方程式(a)表示:
在方程式(a)中,ρ是血液的密度。颈动脉的弹性是基于血管内外压差(transmural pressure)在动脉壁的作用。这个压力是根据由于血管几何和血管壁的黏弹性。典型地,外部压力在壁上的作用是可忽略,因此,弹性和脉波传导速度是动脉的功能,其所传导的脉波形成量测颈动脉狭窄的基础。
脉波传导和动脉血压,形成的基础非侵入式血压量测的相关性。而脉波传导速度和舒张压与平均动脉压相关性最大,如方程式(b):
PWV=fcn(MAP)……方程式(b)。
脉波传导速度和平均动脉压之间的关系是可以用线性模型精凖的叙述。脉波传导速度和平均动脉压的关系,如方程式(c):
PWV(t)=a·MAP(t)+pwv
0……方程式(c)
其中的斜率a和常数pwv0是受测者的特定参数。为了追迹病人脉搏压力速度,本发明利用心搏感测单元11及脉搏感测单元12监测一个已知的参数,即脉波抵达时间(pulse arrival time,PAT)。藉由测 量,每个脉波抵达时间的数值量测是由两个不同的时间间隔总和,速度决定于血管运输时间(vascular transit time,VTT)和射血前期(pre-ejection period,PEP),血管运输时间是压力脉搏在经历动脉路径的时间,射血前期是复合波波峰之间的间隔和主动脉瓣的开启的时间间隔。射血前期包含电机延迟期和左心室等容收缩期(isovolumic contraction),如方程式(d)针对脉波抵达时间,参数L叙述压力脉波经过动脉的路径:
假定射血前期于被监控期间不变,脉波抵达时间的改变将直接地导致血管运输时间改变,这两个参数和平均动脉压的改变将会有关联。为了得到脉波抵达时间和平均动脉压之间的关系,和平均动脉压与脉波传导速度之间的线性关系,其表现就像是方程式(b)必须被抽象和限定在量测脉波延迟时间在单独量测脉波抵达时间,如方程式(e):
于一较佳实施例中,前述平均动脉压是经由如下公式(I)获得:
其中L
P为主动脉出口至脉搏量测点的脉波经过动脉的路径长度(path length),T
PA为脉波抵达时间(pulse arrival time),a、b及c为校正参数。前述校正参数是以目标受测族群所建置的数据库进行算法的较佳调整。
于一较佳实施例中,前述平均动脉压是经由如下公式(II)获得:
其中L
P为主动脉出口至脉搏量测点的脉波经过动脉的路径长度(path length),T
PA为脉波抵达时间(pulse arrival time),A、B及C为校正参数。前述校正参数是以目标受测族群所建置的数据库进行算法的较佳调整。
其中,该平均动脉压藉由该胸口部位及该颈部部位于脉波响应的时间差计算而获得。于一较佳实施例中,脉波抵达时间(pulse arrival time)经由心搏感测单元11的波峰值与脉搏感测单元12的波峰值之间的时间差而获得。于另一较佳实施例中,脉波抵达时间亦可透过心搏感测单元11以及脉搏感测单元12讯号的波谷作为时间触发条件侦测其间的时间差而获得,于本发明中不予以限制。
经由上述的算法,可以取得胸口部位及颈部部位之间(目标区段)的脉波波速、并基于脉波波速计算获得颈动脉的平均动脉压(MAP)。经由分析平均动脉压的指数,可评估患部粥状动脉硬化的严重程度,相关的数据亦可供照护人员进行实时性的追踪。
上述的算法除了可以经由多功能量测装置100的数据计算单元13执行运算外,亦可以透过安装于手持式装置200或穿戴式装置300上的程序执行,并透过手持式装置200或穿戴式装置300的控制器进行运算,以减少多功能量测装置100所需的功率,同时让多功能量测装置100的数据计算单元13得以微型化,减轻多功能量测装置100的重量。
本文所述的“心音”可以利用如后所述的方式获得:心音指心脏的声音,泛指心脏运作时所产生的各种声音,医学领域上常利用心动周期中,心脏瓣膜开启与关闭时所产生的声音,例如:心缩期起始产生的第一心音(S1),通常由二尖瓣和三尖瓣处发出;及心舒期起始产生的第二心音(S2),通常因大动脉的瓣膜关闭所发出。因此,可利用心音频号来了解心动周期而转换为心搏讯号。于一较佳实施例中,该心搏感测单元11一设置于胸口部位的声波传感器,该胸口部位是相对于主动脉出口、肺动脉出口、三尖瓣或二尖瓣的周侧位置,故该心搏感测单元11藉由附接于脉瓣区位置,可用于获取脉瓣区杂音/异 音,该些信息可用于协助诊断瓣膜性心脏病,诸如二尖瓣狭窄及闭锁不全、三尖瓣狭窄及闭锁不全、主动脉狭窄及闭锁不全、肺动脉瓣疾病等。
本文所述的“颈动脉的狭窄”可以利用以下方式获得:
颈动脉具有总颈动脉、外颈动脉及内颈动脉等三段主要分支,面部血流分布的来源同时要了解内、外颈动脉的互相交通,即外颈动脉和内颈动脉的解剖交流(anatomical anastomosis),亦即部份面部血流可能透过上述交通自内颈动脉而过,例如:外颈动脉可由内颚动脉(internal maxillary artery)与内颈动脉交流;或是由面颈动脉(facial artery)与眼动脉交通。虽然面部血流主要是来自外颈动脉,但其与直接供应脑组织容易引起脑中风的内颈动脉依然有重要的相关性,相关性主要有三点,第一,大部份的粥状动脉硬化斑块分布在内外颈动脉交通的分流之处,所以外颈动脉狭窄,邻近的内颈动脉也会有连续的动脉硬化斑块影响,甚至影响到原本的总颈动脉血流;第二,如上所述,内颈动脉和外颈动脉有解剖交流,故在内颈动脉狭窄时,发生所谓的血流盗取现象(steal phenomenon),使得同侧脸部血流下降;第三,外颈动脉原本即负责头颅内血流(cerebral blood flow)的百分之十二,因而外颈动脉狭窄引起的颈部血流下降,也与同侧的颅内血流不足有相关性,所以预期外颈动脉狭窄造成的血流降低,应与同一侧内颈动脉狭窄,有相当相关性。因此,本发明的多功能量测装置100根据上述原理,藉由获取颈部血流脉波的相关信息,达到侦测颈动脉的狭窄状况的功效。传统以颈动脉脉波峰值收缩波速度(Peak systolic velocity,PSV)作为判别颈动脉狭窄程度的标准,分类如表1所示。
表1
本发明为了获取颈动脉脉波速度及其他参数,该脉搏感测单元12设置于颈部部位相对于颈动脉的位置上。为便于使用者操作寻找较适的颈动脉量测位置,于一较佳实施例中,该脉搏感测单元12设置于颈部部位的脉搏量测点,该脉搏量测点的最适位置以喉节最突点(或是以嘴唇中间点往下至颈部最突点)为中心,向左侧或右侧水平外推3±0.3厘米为起始点0厘米,自起始点0厘米至以135度角往离心方向4厘米内之范围;其中,该水平外推3±0.3厘米例如但不限于:2.7厘米、2.8厘米、2.9厘米、3厘米、3.1厘米、3.2厘米、3.3厘米等,该脉搏量测点范围例如:自起始点0厘米至以135度角往离心方向上推1厘米、2厘米、3厘米、或4厘米内的范围,然而,本发明的脉搏量测点不限于该等范围,前述示例仅可量测到较佳脉搏讯号的量测范围。于一更佳实施例中,男性受测者该脉搏量测点的最适位置以喉节最突点(或是以嘴唇中间点往下至颈部最突点)为中心,向左侧或右侧水平外推3±0.3厘米并以135度角往离心方向外推3厘米的位点;女性受测者该脉搏量测点的最适位置以喉节最突点(或是以嘴唇中间点往下至颈部最突点)为中心,向左侧或右侧水平外推3厘米并以135度角往离心方向外推3厘米的位点。于一较佳实施例中,该脉搏感测单元12设置在相对于左颈动脉或右颈动脉的任一位置的颈部部位。于一较佳实施例,该脉搏感测单元12的设置位置可以对应于受测者的患部或高风险部位而定,例如但不限于:该脉搏感测单元12设置在相对于左颈动脉或右颈动脉的总颈动脉上的颈部部位、该脉搏感测单元12设置在相对于左颈动脉或右颈动脉的总颈动脉出口位置(亦即外颈动脉及内颈动脉的分支位置)的颈部部位。由于外颈动脉及内颈动脉均为总颈动脉的分支,故总颈动脉的流速可直接评估外颈动脉及内颈动脉粥状动脉硬化的可能性。若欲单独评估外颈动脉的状态或内颈动脉的状态,该脉搏感测单元12可视需求调整其设置位置。此外,本发明除可透过该脉搏感测单元12进行演算颈动脉感测之外,本发明亦不排除设定多组传感器分区段评估颈动脉血 流声波、脉波速度、脉波波型分析、或其他所需的生理参数,以进一步获得颈动脉及其分支相对完整的评估数据。
I.实施例1:
以下请一并参照“图3”及“图4”,其所示分别为本发明多功能量测装置的使用状态示意图及波型图,如图所示:
本实施例的多功能量测装置100包括一心搏感测单元11、一脉搏感测单元12及一数据计算单元13,其中该数据计算单元13以安装于一手持式装置200的程序执行,该心搏感测单元11、该脉搏感测单元12及该数据计算单元13间以蓝牙进行无线通信。
该心搏感测单元11包含一声波传感器及一贴片,使该心搏感测单元11可贴附于受测者胸口相对于主动脉出口的位置,以获取心音及心搏讯号等。
该脉搏感测单元12包含一压力传感器及一贴片121,该脉搏感测单元12贴附于受测者颈部相对于右颈动脉的总颈动脉出口的位置,以获取颈动脉脉波波型及脉搏讯号等。
所获得的波型影像如图4所示,下方曲线为主动脉出口的血流声波,上方曲线为右颈动脉血流脉波,影像中虚线部分为该心搏感测单元11获得的第一心音波峰(表示心缩期起始)与该脉搏感测单元12获得的脉波波峰,对应心动周期后的时间差,即为脉波抵达时间(T
PA),主动脉出口至该脉搏量测点的距离视为脉波经过动脉的路径长度(L
p),该数据计算单元13可进一步计算出颈动脉血压及脉波传导速度等结果。
II.实施例2:
以下请一并参照“图5”、“图6”及“图7”,其所示分别为本发明多功能量测装置的使用状态示意图、主动脉瓣区心音声波图及右颈动脉波型图,如图所示:
本实施例的多功能量测装置100包括一心搏感测单元11、一脉搏感测单元12及一数据计算单元13,其中该数据计算单元13以线 路连接方式安装于该心搏感测单元11中,该心搏感测单元11及该数据计算单元13与该脉搏感测单元12间以蓝牙进行无线通信。
该心搏感测单元11包含一声波传感器、一显示单元15及一贴片,使该心搏感测单元11可贴附于受测者胸口相对于主动脉出口的位置,以获取心音及心搏讯号等,该显示单元15可显示例如:心音波型、该数据计算单元13的计算结果等信息。该心搏感测单元11所获得的波型图如图6所示。
该脉搏感测单元12包含一声波传感器及一具有喉结定位部122的贴片121,该喉结定位部122是一孔洞,便于使用者将该贴片121的喉结定位部122对准喉结后,该脉搏感测单元12贴附于受测者颈部相对于左颈动脉或右颈动脉的总颈动脉的位置上,以获取颈动脉脉波波型及脉搏讯号等,本实施例以右颈动脉为例所获得的波型图如图7所示。使用声波传感器作为该脉搏感测单元12的侦测器的优势在于,除可获得脉搏数据以外,亦可获得颈动脉血流声,以提供临床诊断颈动脉血流是否有杂音或异音等异常状况。
该数据计算单元13藉由该心搏感测单元11获得的第一心音波峰(表示心缩期起始)与该脉搏感测单元12获得相对应的脉搏波峰间的时间差,获得脉波抵达时间(T
PA),而主动脉出口至该脉搏量测点的距离视为脉波经过动脉的路径长度(L
p),以进一步计算出颈动脉血压及脉波传导速度。
[比较例1及2]
比较例1使用传统临床检测技术,迈瑞(Mindray)彩色都卜勒超声波诊断系统,以手动实时量测方式检测右颈动脉,并记录检测数据。
比较例2市售动脉硬化仪/脉波记录仪(Sphygmomanometer)记录颈动脉血流声波。
[示例1]
以下请一并参照“图8A及图8B”及“图9”,其所示分别为实施例1与比较例1的波型影像图及相关性分析图,如图所示:
将本发明与相似产品进行比对,以进行确效验证。本示例同时使用实施例1及传统超声波诊断系统(即比较例1),对25位包括健康或可能患有颈动脉狭窄的受测者进行量测,藉由使用两个传感器的屏幕(如图8A及图8B所示),以分析实施例1获得的脉波速度与比较例1记录的峰值收缩速度之间的相关性。
在30秒内同时进行实施例1和比较例1的量测,包括记录从主动脉瓣区到颈动脉约25个主动脉脉波速度,结果显示,实施例1获得的脉波速度与比较例1获得的峰值收缩速度间呈现显着相关性(相关系数R=0.897),实施例1的动脉脉波速度散布图显示出一线性趋势线(如图9所示)。
因此,可利用本发明所获得的颈动脉脉波速度以作为颈动脉狭窄程度的判别方式,如表2所示。
表2
[示例2]
请一并参阅“图10”、“图11”及“图12”,其分别为实施例1与比较例2的相关性分析图(一)、(二)、及(三),如图所示:
在进行多名患者的测试中,针对不同人数的组群进行测试,同时分析了实施例1记录的颈动脉脉波与市售动脉硬化仪(即比较例2)记录的颈动脉血流声波,并将两装置所获得的脉波速度结果进行统计的相关性分析。
于5人的群组中,如图10所示,在同步记录颈动脉压测量的30秒期间,实施例1所测得的脉波速度与比较例2获得的脉波速度显着相关(相关系数R=0.967),图中可看出明显的线性关系。
于10人的群组中,如图11所示,在同步记录颈动脉压测量的30秒期间,实施例1所测得的脉波速度与比较例2获得的脉波速度显着相关(相关系数R=0.968),图中可看出明显的线性关系。
于11人的群组中,如图12所示,在同步记录颈动脉压测量的30秒期间,实施例1所测得的脉波速度与比较例2获得的脉波速度显着相关(相关系数R=0.950),图中可看出明显的线性关系。
本发明所获得的颈动脉脉波速度与市售动脉硬化仪比较下,具有显着相关性,因此,可利用本发明的量测结果进行颈动脉狭窄程度的判定与颈动脉血压的计算。
[示例3]
以下请参照“图13”,其所示为本发明的脉搏感测单元12设置于不同脉搏量测点的颈动脉波型影像图。
本示例使用实施例1分别对男性受测者及女性受测者进行量测,惟其中脉搏感测单元12的脉搏量测点贴附于受测者喉节最突点向右侧水平外推2.7厘米(下称A
-0.3点)、3厘米(下称B
0点)、3.3厘米(下称A
+0.3点),以及以喉节最突点向右侧水平外推3厘米为起始点0厘米(即B
0点),以及距起始点以135度角往离心方向上推1厘米(下称B
1点)、2厘米(下称B
2点)、3厘米(下称B
3点)、4厘米(下称B
4点)、5厘米(下称B
5点)的位点。
结果显示,男性受测者在A
-0.3点、A
0点及A
+0.3点皆可获取良好颈动脉脉波讯号,而女性受测者在A
-0.3点、A
0点及A
+0.3点亦可获取颈动脉脉波讯号,但A
-0.3点及A
+0.3点讯号较弱,A
0点讯号较佳。
此外,无论男女性受测者,在B
0点(如图13下方曲线)、B
1点、B
2点、B
3点(如图13上方曲线)及B
4点皆可获取颈动脉脉波讯号,其中以B
3点的讯号较佳,B
4点的讯号较弱,B
5点则较难量测到脉波讯号,推测B
4点及B
5点受软骨结构影响而阻碍颈动脉脉波讯号的获取。
综上所述,本发明的多功能量测装置可利用非侵入性的电子贴片方式藉由以声波传感器贴附于主动脉出口、肺动脉出口、三尖瓣或二 尖瓣周侧的位置,并搭配多种可选择的脉搏感测单元贴附于颈动脉周侧,不仅可侦测颈动脉血压及脉波速度,更可进一步利用本发明的量测结果诊断颈动脉狭窄与脑血流容积。本发明的多功能量测装置体积轻便、可手持、可携带,且可实时、快速量测颈动脉狭窄程度,适用于医院、居家行动、医师诊断、看护中心及研究中心等,对于年长者、有中风病史或心血管疾病高风险族群等在全球医疗市场上有相当高的需求性。
以上已将本发明做一详细说明,惟以上所述者,仅惟本发明的一较佳实施例而已,当不能以此限定本发明实施的范围,即凡依本发明申请专利范围所作的均等变化与修饰,皆应仍属本发明的专利涵盖范围内。
Claims (10)
- 一种具有确定颈动脉血压的多功能量测装置,其特征在于,包括:一心搏感测单元,设于胸口部位,藉以获取心搏讯号;一脉搏感测单元,设置于颈部部位相对于颈动脉的位置,藉以获取脉搏讯号;及一数据计算单元,与该心搏感测单元及该脉搏感测单元通讯,处理来自该心搏感测单元及来自该脉搏感测单元的讯号;其中,该数据计算单元藉由计算来自该心搏感测单元的该心搏讯号及来自该脉搏感测单元的该脉搏讯号获得颈动脉的平均动脉压。
- 根据权利要求1所述的具有确定颈动脉血压的多功能量测装置,其特征在于,该心搏感测单元为一种声波传感器。
- 根据权利要求2所述的具有确定颈动脉血压的多功能量测装置,其特征在于,该心搏感测单元设置于胸口部位的相对于主动脉出口、肺动脉出口、三尖瓣或二尖瓣周侧的位置。
- 根据权利要求2所述的具有确定颈动脉血压的多功能量测装置,其特征在于,该脉搏感测单元为都卜勒雷达、压电压力传感器、阻抗压力传感器、电容压力传感器、声波传感器、超音波传感器或光体积描述信号仪。
- 根据权利要求4所述的具有确定颈动脉血压的多功能量测装置,其特征在于,该脉搏感测单元设置于颈部部位的脉搏量测点,该脉搏量测点以喉结最突点向左侧或右侧水平外推3±0.3厘米为起始点0厘米,自起始点0厘米至以135度角往离心方向4厘米内的范围。
- 根据权利要求5所述的具有确定颈动脉血压的多功能量测装置,其特征在于,该脉搏感测单元包含一具有喉结定位部的贴片。
- 根据权利要求6所述的具有确定颈动脉血压的多功能量测装置,其特征在于,还包含有一连接至该数据计算单元的通讯模块,该通讯模块为蓝牙通讯模块、WIFI通讯模块、RFID通讯模块、NFC通讯模块、或Zigbee通讯模块。
- 根据权利要求8所述的具有确定颈动脉血压的多功能量测装置,其特征在于,该数据计算单元设置于该心搏感测单元、该脉搏感测单元及/或一便携设备。
- 根据权利要求1至9任一项所述的具有确定颈动脉血压的多功能量测装置,其特征在于,可进一步获取心音、血流声、脉波速度、颈动脉狭窄程度。
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US16/630,620 US20210022624A1 (en) | 2017-07-13 | 2018-07-10 | Multifunctional measuring device capable of determining carotid blood pressure |
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PCT/CN2018/095173 WO2019011241A1 (zh) | 2017-07-13 | 2018-07-10 | 颈动脉血压侦测装置 |
PCT/CN2018/095174 WO2019011242A1 (zh) | 2017-07-13 | 2018-07-10 | 具有确定颈动脉血压的多功能量测装置 |
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