WO2019011241A1 - 颈动脉血压侦测装置 - Google Patents

颈动脉血压侦测装置 Download PDF

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Publication number
WO2019011241A1
WO2019011241A1 PCT/CN2018/095173 CN2018095173W WO2019011241A1 WO 2019011241 A1 WO2019011241 A1 WO 2019011241A1 CN 2018095173 W CN2018095173 W CN 2018095173W WO 2019011241 A1 WO2019011241 A1 WO 2019011241A1
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Prior art keywords
sensing unit
detecting device
carotid
blood pressure
pressure detecting
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PCT/CN2018/095173
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English (en)
French (fr)
Inventor
林世明
Original Assignee
林世明
深禾医学科技股份有限公司
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Application filed by 林世明, 深禾医学科技股份有限公司 filed Critical 林世明
Priority to CN201880003176.9A priority Critical patent/CN109640806A/zh
Priority to SG11202000226RA priority patent/SG11202000226RA/en
Priority to US16/630,663 priority patent/US11690523B2/en
Publication of WO2019011241A1 publication Critical patent/WO2019011241A1/zh

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    • A61B5/02—Detecting, 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
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/0245—Detecting, measuring or recording pulse rate or heart rate by using sensing means generating electric signals, i.e. ECG signals
    • A—HUMAN NECESSITIES
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    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
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    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002—Monitoring the patient using a local or closed circuit, e.g. in a room or building
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    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
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    • A61B5/021—Measuring pressure in heart or blood vessels
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    • A61B5/021—Measuring pressure in heart or blood vessels
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    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
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    • A61B5/683—Means for maintaining contact with the body
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    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
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Definitions

  • the invention relates to a blood pressure detecting device, in particular to a carotid blood pressure detecting device for detecting blood pressure of a carotid artery.
  • the carotid artery is the main source artery of blood supply to the brain, and is also a good site for atherosclerotic cerebrova. Carotid atherosclerosis may cause brain ischemia and even cause severe stroke. Therefore, carotid atherosclerosis is an important risk factor for cerebrovascular disease. The presence and extent of carotid atherosclerosis can also reflect the existence and extent of systemic arteriosclerosis to some extent. In addition, the carotid artery is superficial and easy to detect, so it is a window for clinically found arteriosclerosis.
  • Cerebrovascular accident also known as stroke, is caused by insufficient blood supply to the brain, which causes damage to the central nervous system. It is easy to occur in patients from 60 to 70 years old. Risk factors for ischemic stroke, in addition to high blood pressure, diabetes, hyperlipidemia, smoking, family history, etc., atherosclerosis is the most common factor. According to the literature, atherosclerosis mainly accounts for 20% of carotid stenosis obstruction; while small hole infarction related to hypertension accounts for about 20%; arrhythmia associated with atrial fibrillation accounts for 25% of obstruction; The blocking caused by unknown reasons is 30%.
  • Carotid stenosis is closely related to cerebral blood flow volume, and cerebral blood flow is closely related to dementia.
  • clinical detection of carotid stenosis is very important.
  • Traditional methods commonly used to diagnose carotid stenosis and cerebral blood flow volume include carotid digital angiography, magnetic resonance angiography, and Doppler. Ultrasound scanning, etc.
  • these methods often take a long time to complete the tests, and each has its limitations, so they are not suitable for rapid screening tests. Further development of rapid screening methods or techniques will become a very important topic in the prevention of stroke and dementia.
  • Carotid Doppler ultrasound has many limitations in engineering or clinical applications. Because of the skull limitation, only the carotid artery can be detected in a fairly limited part of the neck, although it can be used to penetrate the skull. Le supersonic to reinforce, but the effect is limited. The comparison of angiography on clinical surgical treatment found that the literature compared the results of angiography and carotid endoscopic curettage, and found that the former's false negative rate was as high as 40%. In the case of nuclear magnetic resonance angiography, the vascular condition to be observed is determined by the vector characteristics exhibited by the blood flow velocity in the applied magnetic field. However, it produces images that are sensitive to blood flow velocity, and if you need to observe more accurate vascular anatomy, it is not as accurate as traditional angiography.
  • 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, clinical detection of carotid stenosis is very important. Traditional methods commonly used to diagnose carotid stenosis and cerebral blood flow volume include carotid angiography, magnetic resonance angiography, and Doppler ultrasound. Scanning, etc. The above-mentioned commonly used clinical methods for assessing carotid stenosis have several limitations, and their clinical application takes a considerable amount of time.
  • Doppler ultrasound it takes at least twenty minutes to complete an examination, as for nuclear magnetics.
  • Resonance nuclear magnetic imaging MRA and angiography are more time consuming; the latter is more invasive and the risk of developer allergy.
  • Computed tomography which has become popular in recent years, is also at risk of the same radiation agents and developers.
  • how can you find a screening method for rapid assessment of carotid blood flow, and a device for detecting the degree of carotid stenosis, for stroke patients with stroke risk factors, or even stroke precursors, such as temporary Patients with a transient ischemic attack are even more urgent today.
  • the present invention provides a carotid blood pressure detecting device, comprising: a first sensing unit disposed on a first position of the neck near the carotid artery; and a second sensing unit disposed on the a second position on the neck portion adjacent to the carotid artery; and a controller coupled, coupled, or coupled to the first sensing unit and the second sensing unit, the controller via the first sensing
  • the pulse wave data measured by the unit and the pulse wave data measured by the second sensing unit obtain an average arterial pressure of the segment between the first position and the second position of the carotid artery.
  • the mean arterial pressure is obtained according to the following formula: Where MAP is the mean arterial pressure, l p is the path length between the first position and the second position, and t pa is the time when the pulse wave arrives at the second position from the first position, a, b, and c To correct the parameters.
  • MAP is the mean arterial pressure
  • l p is the path length between the first position and the second position
  • t pa is the time when the pulse wave arrives at the second position from the first position
  • the carotid blood pressure detecting device comprises a patch, and the first sensing unit and the second sensing unit are disposed on the patch.
  • the patch is provided with a throat positioning hole or a throat positioning mark, and the first sensing unit and the second sensing unit are disposed in pairs on the throat positioning hole or the one side position of the throat positioning mark.
  • the first sensing unit is disposed on the patch at a starting point position of the throat positioning hole or the left or right side of the throat positioning mark of 2.7 cm to 3.3 cm, and the starting point position is the starting point position and the throat node Positioning hole or the knuckle positioning mark is offset from a position of 135 degrees in the upward angle by 0 cm to 4 cm, and the second sensing unit is disposed at the starting point position and the throat position is positioned
  • the hole or the knot positioning mark is offset from the line 135 degrees in the upward direction by a distance of 0 cm to 4 cm but does not overlap the first sensing unit.
  • the carotid blood pressure detecting device includes a communication module connected to the controller.
  • 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.
  • controller is connected, coupled, or coupled to a mobile device or a wearable device via the communication module to access data of the controller via the mobile device or the wearable device.
  • the first sensing unit is a Doppler Radar, a Pressure Sensor, an Acoustic Wave Sensor, an Ultrasound Sensor, or a Light Volume Description Signal Sensor (Photoplethysmographic Sensor) ).
  • the second sensing unit is a Doppler Radar, a Pressure Sensor, an Acoustic Wave Sensor, an Ultrasound Sensor, or a Light Volume Description Signal Sensor (Photoplethysmographic Sensor) ).
  • the distance between the first sensing unit and the second sensing unit is between 1 cm and 4 cm.
  • the first sensing unit is disposed at a starting point position of the subject from the middle of the lips to the most convex point of the neck and further to the left by 2.7 cm to 3.3 cm, and the starting point position is the starting point position.
  • the position of the line 135 degrees in the upward direction is offset from 0 cm to 4 cm but does not overlap the first sensing unit.
  • the invention effectively utilizes the sensor to detect the arterial pressure of the carotid artery, and can screen the elderly patients in real time to confirm whether the patient suffers from carotid stenosis and other related lesions.
  • the present invention can be used for rapid screening tests, and the conventional methods such as digital subtraction angiography, magnetic resonance angiography, and Doppler ultrasound scanning can effectively reduce the time required for detection.
  • FIG. 1 is a flow chart (1) of a carotid blood pressure detecting device of the present invention.
  • FIG. 2 is a flow chart (2) of the carotid blood pressure detecting device of the present invention.
  • Fig. 3 is a schematic view showing the state of use of the carotid blood pressure detecting device of the present invention.
  • Fig. 4 is a schematic view showing the state of use of the first embodiment of the present invention.
  • Fig. 5 is a schematic view showing the state of use of the second embodiment of the present invention.
  • Fig. 6 is a schematic view showing the state of use of the third embodiment of the present invention.
  • Figure 7 is a schematic diagram (1) showing the distribution of the correlation between the present invention and a commercially available product.
  • Figure 8 is a schematic diagram (2) showing the distribution of the correlation between the present invention and a commercially available product.
  • Figure 9 is a schematic diagram (3) showing the distribution of the correlation between the present invention and a commercially available product.
  • Figure 10 is a schematic diagram showing the distribution of the correlation between the present invention and a commercially available product (4).
  • Figure 11 is a schematic view showing the waveform of a three-centimeter separation distance of the sensor of the present invention.
  • FIG. 1 a flow chart of the carotid blood pressure detecting device of the present invention, as shown in the figure:
  • the present invention provides a carotid blood pressure detecting device 100.
  • the carotid blood pressure detecting device 100 can be configured in conjunction with the mobile device 200 or the wearable device 300 to access the carotid blood pressure detecting device via the mobile device 200 or the wearable device 300. 100 measured data and process the data.
  • the carotid blood pressure detecting device 100 includes a first sensing unit 11 , a second sensing unit 12 , a controller 13 connected to the first sensing unit 11 and the second sensing unit 12 , And a communication module 14.
  • the first sensing unit 11 and the second sensing unit 12 may be, but are not limited to, Doppler Radar, Pressure Sensor, Acoustic Wave. Sensors, Ultrasound Sensors, Photoplethysmographic Sensors, or the like, are not limited in the present invention.
  • the controller 13 is connected, coupled, or coupled to the first sensing unit 11 and the second sensing unit 12 for cooperation with the first sensing unit 11 and the second sensing unit 12, The sensing data is acquired via the first sensing unit 11 and the second sensing unit 12 .
  • the controller 13 can be a microprocessor, a digital signal processor (DSP), a programmable controller, an application specific integrated circuit (ASIC) or the like. A combination of these devices.
  • the controller 13 described herein may be a system-on-chip (SoC), a system-in package (SiP), or a plurality of chips having different functions or
  • SoC system-on-chip
  • SiP system-in package
  • the integrated circuit formed by the components is not limited in the present invention.
  • the controller 13 can be configured with an amplitude filter 131 and an analog-to-digital converter 132 for performing signals. Pre-processing, the sensor signal is converted into a digital signal and then calculated.
  • the communication module 14 is configured to be paired with the mobile device 200 or the wearable device configuration 300 to configure the data obtained by the access controller 13 or the output controller 13 to be operated through the mobile device 200 or the wearable device 300. The results obtained afterwards.
  • the communication module 14 can communicate by wired or wireless transmission.
  • the wireless transmission mode can be, for example but not limited to, Bluetooth, WLAN, Radio Frequency Identification (RFID), Near Field Communication (NFC). ), Zigbee, etc. or other communication means are not limited in the present invention.
  • FIG. 3 is a schematic diagram of the state of use of the carotid blood pressure detecting device of the present invention, as shown in the figure:
  • the carotid artery responsible for blood flow to the skull and neck is divided into left and right sides, and there are three main branches.
  • the common carotid artery branched from the aorta branches into the external carotid artery and the inner carotid artery A11 (external carotd artery) and the inner neck.
  • Arterial carotid artery A12 internal carotid artery.
  • the external carotid artery A11 serves as the main source of facial blood flow distribution, in which the facial artery is responsible for the blood supply to most of the face.
  • the internal maxillary artery is responsible for deep blood flow in the face and the transverse facial artery.
  • the other branch of the common carotid A1 is the internal carotid artery A12, which is primarily responsible for supplying blood flow to the brain tissue.
  • the source of facial blood flow distribution should also understand the mutual communication between the internal and external carotid arteries (A11, A12), that is, the anatomical anastomosis of the external carotid artery A11 and the internal carotid artery A12; that is, part of the facial blood flow may pass through the above traffic.
  • the external carotid artery A11 can communicate with the internal carotid artery A12 by the internal maxillary artery or with the facial artery by the facial artery.
  • the external carotid artery A11 has an important correlation with the internal carotid artery A12 which directly causes brain stroke to cause stroke. It contains three correlations: first, most porridge
  • the atherosclerotic plaque is distributed in the shunt of internal and external carotid artery traffic, so the external carotid artery A11 is narrow, and the adjacent internal carotid artery A12 will also have continuous atherosclerotic plaque, even affecting the original total carotid A1 blood flow.
  • the internal carotid artery A12 and the external carotid artery A11 have anatomical communication, and when the internal carotid artery A12 is narrow, a so-called blood phenomenon occurs, so that the blood flow on the ipsilateral face is lowered.
  • the external carotid artery A11 is responsible for 12% of the celebral blood flaw, so the neck blood flow caused by the external carotid artery A11 stenosis is decreased, and the ipsilateral intracranial blood flow is also insufficient. Relevant.
  • the blood flow caused by the stenosis of the external carotid artery A11 should be also related to the stenosis of the internal carotid artery A12. According to the above principle, if the information of the blood flow pulse and blood flow sound of the neck can be obtained, the stenosis of the carotid artery can be detected.
  • the first sensing unit 11 and the second sensing unit 12 are respectively disposed on the neck at a first position and a second position near the carotid artery.
  • the first position may be the position of the total carotid artery A1 outlet (ie, the branch position of the external carotid artery A11 and the internal carotid artery A12), or any position on the total carotid artery A1.
  • the second position may be any position on the total carotid artery A1 that does not overlap the first position, and the portion depends on the position of the affected part corresponding to the affected part.
  • the flow rate of the total carotid artery A1 can directly evaluate the possibility of atherosclerosis of the external carotid artery A11 and the internal carotid artery A12. If the state of the external carotid artery A11 or the state of the internal carotid artery A12 is to be evaluated separately, the first sensing unit 11 and the second sensing unit 12 can adjust their positions as needed. In addition to performing calculus sensing through two sets of sensors (the first sensing unit 11 and the second sensing unit 12), the present invention does not exclude setting a third group or even more groups of sensors to evaluate the carotid artery. The flow rate, and the pattern of blood flow, to further obtain the relative integrity of the carotid artery and its branches.
  • the carotid blood pressure detecting device includes a patch 20 on which the patch 20 is disposed.
  • the first sensing unit 11 and the second sensing unit 12 are symmetrically disposed on the patch 20 and are appropriately spaced to be attached thereto. Attached to the neck corresponds to the first position and the second position of the carotid artery.
  • the first sensing unit 11 and the second sensing unit 12 are coupled to the patch 20 in a fixed design to enable the first sensing unit 11 and the second sensing unit.
  • Unit 12 maintains a fixed spacing.
  • the patch 20 may be provided with an adjustable structure (for example, a buried trench or a track) to adjust the first sensing unit 11 and the second sensing unit 12 according to actual conditions.
  • the interval is not limited in the present invention.
  • the first sensing unit 11 of the patch 20 can be aligned to the left or right side of the topmost position of the throat 2.7 cm to 3.3 cm. Starting point position P, and tilting the patch so that the connection between the second sensing unit 12 and the first sensing unit and the connection between the starting point position P and the topmost position of the throat are 135 degrees (upward).
  • the carotid blood pressure detecting device includes a patch 30, and the patch 30 is disposed on the patch 30.
  • the first sensing unit 11 and the second sensing unit 12 are disposed on the patch 30, and the first sensing unit 11 and the second sensing unit 12 are disposed in pairs on the throat.
  • the one side of the aperture 31 is maintained at an appropriate spacing therebetween so that it conforms to the first and second positions of the carotid artery when attached to the neck.
  • the first sensing unit 11 and the second sensing unit 12 are coupled to the patch 30 in a fixed design to enable the first sensing unit 11 and the second sensing unit.
  • the patch 30 can be provided with an adjustable structure (for example, a buried trench or a track) to adjust the first sensing unit 11 and the second sensing unit 12 according to actual conditions.
  • the interval is not limited in the present invention.
  • the first sensing unit 11 is disposed on the patch 30 on the left or right side of the throat positioning hole 31 by 2.7 cm to 3.3.
  • the starting point position P of the centimeter, and the starting point position P is offset from the starting point position P by 135 degrees in the direction of the upward angle of the throat positioning hole 31 by 0 cm to 4 cm
  • the second The sensing unit 12 is disposed at a position offset from the starting point position by a distance of 135 degrees from the starting point position to the throat positioning hole 31 or the throat positioning mark 41 by an angle of 135 degrees, but with the first A position where the sensing unit 11 does not overlap.
  • the carotid blood pressure detecting device includes a patch 40 , and the patch 40 is disposed on the patch 40 .
  • the first sensing unit 11 and the second sensing unit 12 are disposed on the patch 40.
  • the first sensing unit 11 and the second sensing unit 12 are disposed in pairs on the throat.
  • the marker 41 is in a single-sided position with a suitable spacing therebetween for attachment to the neck corresponding to the first and second positions of the carotid artery.
  • the first sensing unit 11 and the second sensing unit 12 are coupled to the patch 40 in a fixed design to enable the first sensing unit 11 and the second sensing unit.
  • Unit 12 maintains a fixed spacing.
  • the patch 40 can be provided with an adjustable structure (for example, a buried trench or a track) to adjust the first sensing unit 11 and the second sensing unit 12 according to actual conditions. The interval is not limited in the present invention.
  • the first sensing unit 11 is disposed on the patch 40 on the left or right side of the stenosis positioning mark 41 by 2.7 cm to 3.3.
  • the starting point position P of the centimeter is offset from the starting point position P by 0 cm to 4 cm in the direction of the 135 degree angle between the starting point position P and the knot positioning hole 31 or the throat positioning mark 41.
  • the second sensing unit 12 is disposed at a position offset from the starting point position P by a distance of 135 degrees from the starting point position P to the larynical positioning mark 41 by an angle of 135 degrees, but with The position where the first sensing unit 11 does not overlap.
  • 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 distance between the two arterial sensors, ie the distance.
  • PWV pulse wave velocity
  • ⁇ 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, so the elasticity and pulse wave velocity are functions of the artery. Conducted pulse wave formation measures the basis of 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 uses the first sensing unit 11 and the second 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).
  • 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.
  • equation (d) is for the pulse arrival time, and the parameter Lt describes the path of the pressure pulse through the artery:
  • the aforementioned mean arterial pressure is obtained via the following formula (I):
  • l p is the path length between the first position and the second position
  • t pa is the time when the pulse wave arrives at the second position from the first position
  • 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):
  • l p is the path length between the first position and the second position
  • t pa is the time when the pulse wave arrives at the second position from the first position
  • 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 average arterial pressure is obtained by calculating the time difference between the first position and the second position in the pulse wave response.
  • the time when the pulse wave reaches the second position from the first position is obtained via a time difference between a peak value of the first sensing unit 11 and a peak value of the second sensing unit 12.
  • the time when the pulse wave reaches the second position from the first position can also be detected as a time trigger condition through the troughs of the signals of the first sensing unit 11 and the second sensing unit 12 The time difference is obtained, which is not limited in the present invention.
  • the blood flow velocity between the first position and the second position (target segment) on the carotid artery can be obtained, and the mean arterial pressure (MAP) can be calculated based on the blood flow velocity.
  • MAP mean arterial pressure
  • the above algorithm can be executed by the controller 13 mounted on the mobile device 200 or the wearable device 300, and can be transmitted through the mobile device 200 or the wearable device, in addition to the calculation performed by the controller 13 of the carotid blood pressure detecting device 100.
  • the controller of 300 performs calculations to reduce the power required by the carotid blood pressure detecting device 100 while miniaturizing the controller 13 of the carotid blood pressure detecting device 100 to reduce the weight of the carotid blood pressure detecting device 100.
  • FIG. 7 is a schematic diagram (1) of the correlation distribution between the present invention and a commercially available product, as shown in the figure:
  • the inventors further performed a plurality of patients who recorded the measurement of carotid artery pressure by the carotid blood pressure detecting device 100 of the present invention, including healthy persons.
  • the inventors simultaneously tested the pulse wave velocity recorded by a commercially available arteriosclerosis apparatus (Fukuda Denshi VS-1500) and performed statistical correlation analysis on the results obtained by the two devices.
  • FIG. 8 are schematic diagrams of the correlation distribution (2), distribution diagram (3), and distribution diagram (4) of the present invention and commercially available products, as shown in the figure:
  • the pulse rate of the carotid blood pressure detecting device 100 of the present invention is commercially available.
  • the pulse rate of the carotid blood pressure detecting device 100 of the present invention is commercially available.
  • the pulse rate of the carotid blood pressure detecting device 100 of the present invention is commercially available during the 30 seconds of simultaneous measurement of carotid pressure measurement by the carotid blood pressure detecting device 100 of the present invention.
  • FIG. 11 is a schematic diagram of a waveform of a three-cm separation distance of the sensor of the present invention, as shown in the figure:
  • the second position of the second sensing unit 12 is fixed.
  • the subject's lips are centered down to the most convex point of the neck, and then the left three centimeters is the starting point; starting from the starting point, the test is performed along the extension direction of the total carotid artery A1 at a distance of 1 cm each time.
  • a total of five tests were performed, with a pitch of 1 cm, a pitch of 2 cm, a pitch of 3 cm, a pitch of 4 cm, and a pitch of 5 cm.
  • the waveforms obtained between 1cm and 4cm can obtain effective peaks.
  • the waveforms obtained in the example of 1cm interval are slightly deviated, most of the peaks can be effectively obtained. In the embodiment where the interval is 2 cm - 4 cm, the waveforms of the plurality of sets of data can be effectively obtained. In the 5 cm embodiment, the waveform is too weak to detect.
  • the detected pulse wave velocity is organized as follows:
  • the sensing structure most suitable for the curvature of the human body must be adjusted so that the sensor fits the skin of the subject, and the waveform must be corrected to some extent.
  • the spacing between the first sensing unit 11 and the second sensing unit 12 is preferably between 1 cm and 4 cm, and the range is not limited in the present invention.
  • the inventors have found that in the preferred embodiment, when the sensing unit (the first sensing unit 11 and the second sensing unit 12) is disposed in the middle of the subject's lips, the convexity of the neck is convex.
  • the point is the center and then the left or right is about 3 cm from the starting point position, and the starting point position is offset from the starting point position by 135 degrees in the direction of the uppermost point of the line between the starting point and the offset of 0 to 4
  • the setting position of the centimeter can be effectively obtained by the pulse wave of the subject on most of the wave patterns on the waveform map.
  • the starting point position may specifically be the position of the subject from the middle of the lip to the most convex point of the neck and then to the left or right of 2.7 cm to 3.3 cm, for example, 2.7 cm, 2.8 cm. 2.9 cm, 3.0 cm, 3.1 cm, 3.2 cm or 3.3 cm, which is not limited in the present invention.
  • the present invention effectively utilizes a sensor to detect arterial pressure of the carotid artery, and can screen elderly patients in real time to confirm whether the patient suffers from carotid stenosis and other related lesions.
  • the invention can be used for rapid screening test, and the traditional methods such as carotid digital angiography, nuclear magnetic resonance angiography, and Doppler ultrasound scanning can effectively reduce the time required for detection.

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Abstract

一种颈动脉血压侦测装置（100），包括一第一感测单元（11）、一第二感测单元（12）、以及一连接、耦接、或耦合至该第一感测单元（11）、及该第二感测单元（12）的控制器（13）。该第一感测单元（11）设置于颈部上靠近颈动脉的第一位置上。该第二感测单元（12）设置于该颈部上靠近该颈动脉的第二位置上。该控制器（13）经由该第一感测单元（11）测量到的脉波数据以及经由该第二感测单元（12）测量到的脉波数据获得该颈动脉的该第一位置及该第二位置之间区段的平均动脉压（MAP）。

Description

颈动脉血压侦测装置 技术领域
本发明有关于一种血压侦测装置，特别指一种用以侦测颈动脉血压的颈动脉血压侦测装置。
背景技术
颈动脉(carotid artery)是脑部血液供应的主要源动脉，也是粥状动脉硬化(atherosclerotic cerebrova)的好发部位，颈动脉硬化可能导致脑部缺血，甚至引起严重的脑中风(stroke)，因此，颈动脉硬化是脑血管病的重要危险因素，颈动脉硬化的存在与程度在某种程度上也能够反映全身大动脉硬化的存在和程度。另外，颈动脉位置表浅，易于探测，因此是临床发现动脉硬化的窗口。
脑血管疾病(cerebrovascular accident)又称脑中风，肇因于脑部供血量不足，导致中枢神经的损害，其易好发于六十到七十岁的病患。造成缺血性脑中风的危险因素，除了高血压、糖尿病、高血脂、抽烟、家族病史等等，粥状动脉硬化为最常见的因素。根据文献，粥状动脉硬化主要为颈动脉狭窄的阻塞约占20％；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％。此外，文献上屡屡报告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；同时颈动脉狭窄超过百分之八十的病患，之后产生缺血性脑中风及其他并发症的机会，比低于百分之八十的病患高出许多，将近增加六十倍(92.3％与1.5％)；同一个研究也发现，随着时间的进展，颈动脉狭窄会逐渐严重，而症状也相对更厉害。由此可见为了预防脑中风的发生，临床上颈动脉狭窄的侦测与定量十分重要。如果能够发展一个快速筛检的检查方法或技术，将成为预防脑中风的相当重要课题。
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，通常用于诊断颈动脉狭窄和脑血流容积的传统方法包括颈动脉数字减血管造影、核磁共振血管造影、都卜勒超声扫描等。然而，这些方法往往需要花费很长的时间完成检测，而且各有其局限性，因此，它们不适合用于快速筛选测试。进一步发展快速筛选方法或技术，将成为中风和痴呆预防的一个非常重要的课题。
颈动脉都卜勒超音波在工程技术上或临床应用上具有诸多限制，因为颅骨限制，只能检测到颈动脉位于颈部相当受限一部份，这一点虽然可以用穿透头颅骨都卜勒超音波来补强，但效果毕竟有限。有关血管摄影对临床手术处理的比较方面发现，文献比较血管摄影以及颈动脉内皮刮除术的手术结果病理切片，发现前者的漏诊率(false negative rate)竟高达40％。而核磁共振血管摄影，利用血流速度在外加磁场中所表现的向量特性，决定所要观察的血管条件。不过其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。
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，通常用于诊断颈动脉狭窄和脑血流容积的传统方法包括颈动脉血管摄影、核磁共振血管摄影、都卜勒超音波扫描等。上述常用的评估颈动脉狭窄的临床方法，都具若干局限性，而其临床应用需耗用相当时间，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；而后者更有侵袭性以及显影剂过敏的风险。近年来逐渐普及的计算机断层血管摄影(computed tomography)也有同样辐射剂以及显影剂的危险。同样，因而如何能找到一个快速评估颈动 脉血流的筛检性方法，及颈动脉狭窄程度的检测仪器，对于已经中风的病患或是有中风危险因子，或是甚至中风前兆，例如暂时性缺血发作(transient ischemic attack)的病患，在今日更为当务之急。
本发明的目的在于提供一种利用传感器检测颈动脉血压的创新技术，用以测量并筛检颈动脉狭窄，并将其制成适合应用于高龄用户的医疗检测装置。
为达到上述目的，本发明提供一种颈动脉血压侦测装置，包括：一第一感测单元，设置于颈部上靠近颈动脉的第一位置上；一第二感测单元，设置于该颈部上靠近该颈动脉的第二位置上；以及一控制器，连接、耦接、或耦合至该第一感测单元、及该第二感测单元，该控制器经由该第一感测单元测量到的脉波数据以及经由该第二感测单元测量到的脉波数据获得该颈动脉的该第一位置及该第二位置之间区段的平均动脉压。
进一步地，该平均动脉压依据以下的公式获得：
Figure PCTCN2018095173-appb-000001
其中，MAP为该平均动脉压，l p为该第一位置及该第二位置之间的路径长度，t pa为脉波自该第一位置抵达该第二位置的时间，a、b及c为校正参数。
进一步地，该平均动脉压依据以下的公式获得：
Figure PCTCN2018095173-appb-000002
其中，MAP为该平均动脉压，l p为该第一位置及该第二位置之间的路径长度，t pa为脉波自该第一位置抵达该第二位置的时间，A、B及C为校正参数。
进一步地，该颈动脉血压侦测装置包含有一贴片，该贴片上设置有该第一感测单元及该第二感测单元。
进一步地，该贴片上设置一喉结定位孔或一喉结定位标记，该第一感测单元及该第二感测单元成对设置于该喉结定位孔或该喉结定位标记的单侧位置上。
该第一感测单元设置于该贴片上该喉结定位孔或该喉结定位标记左侧或右侧2.7厘米至3.3厘米的起始点位置，并由该起始点位置以该起始点位置与该喉结定位孔或该喉结定位标记之间联机朝上夹角135度的方向偏移0厘米至4厘米的位置，该第二感测单元设置于由该起始点位置以该起始点位置与该喉结定位孔或该喉结定位标记之间联机朝上夹角135度的方向偏移0厘米至4厘米但与该第一感测单元不重叠的位置。
进一步地，该颈动脉血压侦测装置包含有一连接至该控制器的通讯模块。
进一步地，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。
进一步地，该控制器经由该通讯模块连接、耦接、或耦合至一行动装置或一穿戴式装置，以经由该行动装置或该穿戴式装置存取该控制器的数据。
进一步地，该第一感测单元为都卜勒雷达(Doppler Radar)、压力传感器(Pressure Sensor)、声波传感器(Acoustic Wave Sensor)、超声波传感器(Ultrasound Sensor)、或光体积描述信号传感器(Photoplethysmographic Sensor)。
进一步地，该第二感测单元为都卜勒雷达(Doppler Radar)、压力传感器(Pressure Sensor)、声波传感器(Acoustic Wave Sensor)、超声波传感器(Ultrasound Sensor)、或光体积描述信号传感器(Photoplethysmographic Sensor)。
进一步地，该第一感测单元及该第二感测单元的间距介于1㎝至4㎝之间。
进一步地，该第一感测单元设置于受测者嘴唇中间往下至颈部最凸点为中心再往左2.7厘米至3.3厘米的起始点位置，并由该起始点位置以该起始点位置与该最凸点之间联机朝上夹角135度的方向偏移0厘米至4厘米的位置，该第二感测单元设置于由该起始点位置以 该起始点位置与该最凸点之间联机朝上夹角135度的方向偏移0厘米至4厘米但与该第一感测单元不重叠的位置。
对具有中风病史或是心血管疾病高危险群的病患使用者而言，在全球医疗产品市场上，发展方便的颈动脉狭窄方法，有相当的需求性，研发创新型的颈动脉狭窄的方法与仪器，在世界上的先进国家长期一直受到高度的重视。本发明有效利用传感器检测颈动脉的动脉压力，可实时对高龄患者进行筛检以确认患者是否罹患颈动脉狭窄等相关病灶。此外，本发明可以用于快速筛检测试，相较于颈动脉数字减血管造影、磁共振血管造影、多普勒超声扫描等传统方法可以有效的减少检测所需耗费的时间。
附图说明
图1为本发明颈动脉血压侦测装置的流程图(一)。
图2为本发明颈动脉血压侦测装置的流程图(二)。
图3为本发明颈动脉血压侦测装置的使用状态示意图。
图4为本发明第一实施例的使用状态示意图。
图5为本发明第二实施例的使用状态示意图。
图6为本发明第三实施例的使用状态示意图。
图7为本发明与市售产品的相关性分布示意图(一)。
图8为本发明与市售产品的相关性分布示意图(二)。
图9为本发明与市售产品的相关性分布示意图(三)。
图10为本发明与市售产品的相关性分布示意图(四)。
图11为本发明传感器三厘米间隔距离的波型示意图。
附图标记：
100       颈动脉血压侦测装置
11        第一感测单元
12        第二感测单元
13        控制器
131       振幅滤波器
132       模拟数字转换器
14        通讯模块
20        贴片
30        贴片
31        喉结定位孔
40        贴片
41        喉结定位标记
200       行动装置
300       穿戴式装置
P         起始点位置
A1        总颈动脉
A11       外颈动脉
A12       内颈动脉
具体实施方式
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创作的范围，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)。
请先参阅图1，本发明颈动脉血压侦测装置的流程图，如图所示：
本发明提供一种颈动脉血压侦测装置100，该颈动脉血压侦测装置100可以配合行动装置200或穿戴式装置300配置，经由行动装置200或穿戴式装置300存取颈动脉血压侦测装置100所测量到的数据，并将该等数据进行处理。
所述的颈动脉血压侦测装置100包括一第一感测单元11、一第二感测单元12、一连接至该第一感测单元11及该第二感测单元12的控制器13、以及一通讯模块14。
所述的第一感测单元11及第二感测单元12于一较佳实施例中可以为但不限定于都卜勒雷达(Doppler Radar)、压力传感器(Pressure Sensor)、声波传感器(Acoustic Wave Sensor)、超声波传感器(Ultrasound Sensor)、光体积描述信号传感器(Photoplethysmographic Sensor)、或其他类此的传感器，于本发明中不予以限制。
所述的控制器13连接、耦接、或耦合至该第一感测单元11及该第二感测单元12，用以协同该第一感测单元11及该第二感测单元12工作，以经由该第一感测单元11及该第二感测单元12获取感测数据。所述的控制器13可以为微处理器(Microprocessor)、数字信号处理器(Digital Signal Processor，DSP)、可程序化控制器、特殊应用集成电路(Application Specific Integrated Circuits，ASIC)或其他类似装置或这些装置的组合。在此所述的控制器13可以为系统单芯片(System on Chip,SoC)、系统级封装(System in Package,SiP)所构成的独立芯片、或是可以由多个分别具有不同功能的芯片或组件所构成的集成电路，于本发明中不予以限制。作为传感器(第一感测单元11、第二感测单元12)的前置装置，如图2所示，该控制器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。
所述的通讯模块14用以与该行动装置200或穿戴式装置配置300进行配对，以透过该行动装置200或穿戴式装置300配置访问控制器13所获得的数据或输出控制器13经运算后所获得的结果。该通讯模块14可以透过有线或无线的传输方式进行通讯，无线的传输方式例如可以为但不限定于蓝牙(Bluetooth)、无线局域网络(WLAN)、射频识别(RFID)、近场通讯(NFC)、紫蜂(Zigbee)等或其他类此的通讯方式，于本发明中不予以限制。
请一并参阅图3，为本发明颈动脉血压侦测装置的使用状态示意图，如图所示：
负责头颅和颈部血流的颈动脉分成左右两边，而有三段主要的分支，从主动脉分流上来的总颈动脉A1(common carotid artery)分支成 外颈动脉A11(external carotd artery)和内颈动脉A12(internal carotid artery)。
外颈动脉A11作为面部血流分布的主要来源，其中颜面动脉(facial artery)负责绝大部分脸部的血流供应。另外内上额骨动脉(internal maxillary artery)负责脸部深层血流，以及水平面动脉(transverse facial artery)。
总颈动脉A1的另一个分支是内颈动脉A12，主要负责供应脑部组织血流。面部血流分布的来源同时要了解内外颈动脉(A11、A12)的互相交通，即外颈动脉A11和内颈动脉A12的解剖交流(anatomical anastomosis)；亦即部分面部血流可能透过上述交通自内颈动脉A12而过，例如外颈动脉A11可由内颚动脉(internal maxillary artery)与内颈动脉A12交流；或是由面颈动脉(facial artery)与眼动脉交流。
面部血流主要是来自外颈动脉A11，外颈动脉A11与直接供应脑组织容易引起脑中风的内颈动脉A12具有重要的相关性，其包含有三点相关性：第一、大部分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A11狭窄，邻近的内颈动脉A12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A1血流；第二、如上所述内颈动脉A12和外颈动脉A11有解剖交流，在内颈动脉A12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A11原本即负责头颅内血流(celebral blood flaw)的百分之十二，因而外颈动脉A11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。所以预期因为外颈动脉A11狭窄造成的血流降低，应该也与同一侧内颈动脉A12狭窄，有相当相关性。根据上述原理，若能取得颈部血流脉波与血流音的信息，即可侦测颈动脉的狭窄状况。
为了检测颈动脉的流速、及血流声，该第一感测单元11及该第二感测单元12分别设置于颈部上靠近颈动脉的第一位置以及第二位置上。于一较佳实施例中，该第一位置可以为总颈动脉A1出口的位置(亦即外颈动脉A11及内颈动脉A12的分支位置)、或是在总颈动脉 A1上的任一位置，该第二位置可以为总颈动脉A1上与该第一位置互不重叠的任一位置上，此部分视受测者对应于患部可能的所在位置而定。由于外颈动脉A11及内颈动脉A12均为总颈动脉A1的分支，总颈动脉A1的流速可直接评估外颈动脉A11及内颈动脉A12粥状动脉硬化的可能性。若欲单独评估外颈动脉A11的状态或内颈动脉A12的状态，该第一感测单元11及该第二感测单元12可视需求调整其位置。除了透过两组传感器(该第一感测单元11及该第二感测单元12)进行演算感测之外，本发明亦不排除设定第三组甚至更多组传感器分区段评估颈动脉的流速、及血流声的态样，以进一步获得颈动脉及其分支相对完整的评估数据。
请一并参阅图4，为本发明第一实施例的使用状态示意图，如图所示：本实施例中，该颈动脉血压侦测装置包含有一贴片20，该贴片20上设置有该第一感测单元11及该第二感测单元12，其中该第一感测单元11及该第二感测单元12对称设置于该贴片20上，并于其间保持适当间距，使其贴附于颈部时对应于颈动脉的第一位置及第二位置上。于一较佳实施例中，该第一感测单元11及该第二感测单元12以固定式的设计结合于该贴布20上，使该第一感测单元11及该第二感测单元12保持固定间距。于另一较佳实施例中，该贴布20上可设置有可调整结构(例如埋设沟槽、或设置轨道)，以配合实际状况需求调整第一感测单元11及第二感测单元12的间隔，于本发明中不予以限制。又于一较佳实施例中，于贴覆该贴片20时，可将该贴片20的该第一感测单元11对准至该喉结最顶部位置左侧或右侧2.7厘米至3.3厘米的起始点位置P，并令该贴片倾斜使该第二感测单元12与该第一感测单元之间的联机与该起始点位置P与该喉结最顶部位置之间联机的夹角为135度(朝上)。在此需叙明的是，由于图式是以正面的方式示意，而脖子的表面是呈曲面的，因此于图式中无法明确表示其夹角为135度角，该等图式并非用以限制本发明的范围，在此先行叙明。
请一并参阅图5，为本发明第二实施例的使用状态示意图，如图所示：本实施例中，该颈动脉血压侦测装置包含有一贴片30，该贴片30上设置有该第一感测单元11及该第二感测单元12，其中该贴片30上设置一喉结定位孔31，该第一感测单元11及该第二感测单元12成对设置于该喉结定位孔31的单侧位置上，并于其间保持适当间距，使其贴附于颈部时对应于颈动脉的第一位置及第二位置上。于一较佳实施例中，该第一感测单元11及该第二感测单元12以固定式的设计结合于该贴布30上，使该第一感测单元11及该第二感测单元12保持固定间距。于另一较佳实施例中，该贴布30上可设置有可调整结构(例如埋设沟槽、或设置轨道)，以配合实际状况需求调整第一感测单元11及第二感测单元12的间隔，于本发明中不予以限制。
为了获取最佳的检测数据，请一并参阅图3，于较佳实施例中，该第一感测单元11设置于该贴片30上该喉结定位孔31左侧或右侧2.7厘米至3.3厘米的起始点位置P，并由该起始点位置P以该起始点位置P与该喉结定位孔31之间联机朝上夹角135度的方向偏移0厘米至4厘米的位置，该第二感测单元12设置于由该起始点位置以该起始点位置与该喉结定位孔31或该喉结定位标记41之间联机朝上夹角135度的方向偏移0厘米至4厘米但与该第一感测单元11不重叠的位置。在此需叙明的是，由于图式是以正面的方式示意，而脖子的表面是呈曲面的，因此于图式中无法明确表示其夹角为135度角，该等图式并非用以限制本发明的范围，在此先行叙明。
请一并参阅图6，为本发明第三实施例的使用状态示意图，如图所示：本实施例中，该颈动脉血压侦测装置包含有一贴片40，该贴片40上设置有该第一感测单元11及该第二感测单元12，其中该贴片40上设置一喉结定位标记41，该第一感测单元11及该第二感测单元12成对设置于该喉结定位标记41的单侧位置上，并于其间保持适当间距，使其贴附于颈部时对应于颈动脉的第一位置及第二位置上。于一较佳实施例中，该第一感测单元11及该第二感测单元12以固定式的设计结合于该贴布40上，使该第一感测单元11及该第二感测单 元12保持固定间距。于另一较佳实施例中，该贴布40上可设置有可调整结构(例如埋设沟槽、或设置轨道)，以配合实际状况需求调整第一感测单元11及第二感测单元12的间隔，于本发明中不予以限制。
为了获取最佳的检测数据，请一并参阅图3，于较佳实施例中，该第一感测单元11设置于该贴片40上该喉结定位标记41左侧或右侧2.7厘米至3.3厘米的起始点位置P，并由该起始点位置P以该起始点位置P与该喉结定位孔31或该喉结定位标记41之间联机朝上夹角135度的方向偏移0厘米至4厘米的位置，该第二感测单元12设置于由该起始点位置P以该起始点位置P与该喉结定位标记41之间联机朝上夹角135度的方向偏移0厘米至4厘米但与该第一感测单元11不重叠的位置。在此需叙明的是，由于图式是以正面的方式示意，而脖子的表面是呈曲面的，因此于图式中无法明确表示其夹角为135度角，该等图式并非用以限制本发明的范围，在此先行叙明。
以下针对算法的部分进行说明：
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搏波传导速度(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：
Figure PCTCN2018095173-appb-000003
其中，t为两个波形的时间差，即传播时间；L是两个动脉传感器间的距离，即距离。
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，颈动脉波速度算法的概念是基于压力和脉波传导速度(PWV)两者的关系。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：
Figure PCTCN2018095173-appb-000004
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。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，本发明利用第一感测单元11及第二感测单元12监测一个已知的参数，脉波抵达时间(pulse arrival time,PAT)。通过测量，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Lt叙述压力脉波经过动脉的路径：
Figure PCTCN2018095173-appb-000005
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)：
Figure PCTCN2018095173-appb-000006
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：
平均动脉压
Figure PCTCN2018095173-appb-000007
其中l p为该第一位置及该第二位置之间的路径长度(path length)，t pa为脉波自该第一位置抵达该第二位置之时间，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。
于另一较佳实施例中，前述平均动脉压是经由如下公式(II)获得：
平均动脉压
Figure PCTCN2018095173-appb-000008
其中l p为该第一位置及该第二位置之间的路径长度(path length)，t pa为脉波自该第一位置抵达该第二位置之时间，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，该平均动脉压通过该第一位置及该第二位置于脉波响应的时间差计算而获得。于一较佳实施例中，脉波自该第一位置抵达该第二位置之时间经由第一感测单元11的波峰值与第二感测单元12的波峰值之间的时间差而获得。于另一较佳实施例中，脉波自该第一位置抵达该第二位置之时间亦可透过第一感测单元11以及第二感测单元 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，可以取得颈动脉上第一位置及第二位置之间(目标区段)的血流流速、并基于血流流速计算获得平均动脉压(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颈动脉血压侦测装置100的控制器13执行运算外，亦可以透过安装于行动装置200或穿戴式装置300上的程序执行，并透过行动装置200或穿戴式装置300的控制器进行运算，以减少颈动脉血压侦测装置100所需的功率，同时让颈动脉血压侦测装置100的控制器13得以微型化，减轻颈动脉血压侦测装置100的重量。
请一并参阅图7，为本发明与市售产品的相关性分布示意图(一)，如图所示：
为了解本发明在量测动脉波速上与市售产品的量测结果是否有差异，发明人再进行本发明颈动脉血压侦测装置100记录颈动脉压测量研究的多名患者中，包括健康人和心律失常患者，发明人同时测试了市售动脉硬化仪(Fukuda Denshi VS-1500)记录的脉波速度，并将两装置所获得的结果进行统计的相关性分析。
结果如图7所示，在本发明颈动脉血压侦测装置100同步记录颈动脉压测量的30秒期间，本发明颈动脉血压侦测装置100脉波速度与市售产品获得的脉波速度显著相关[相关系数R＝0.897]，图中可看出明显的线性关系。
请一并参阅图8、图9、图10，为本发明与市售产品的相关性分布示意图(二)、分布示意图(三)、及分布示意图(四)，如图所示：
在进行多名患者的测试中，发明人针对不同人数的组群进行测试，同时测试了市售动脉硬化仪(Fukuda Denshi VS-1500)记录的脉波速度，并将两装置所获得的结果进行统计的相关性分析。
于5人的群组中，如图8所示，在本发明颈动脉血压侦测装置100同步记录颈动脉压测量的30秒期间，本发明颈动脉血压侦测装置100脉波速度与市售产品获得的脉波速度显著相关[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9所示，在本发明颈动脉血压侦测装置100同步记录颈动脉压测量的30秒期间，本发明颈动脉血压侦测装置100脉波速度与市售产品获得的脉波速度显著相关[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10所示，在本发明颈动脉血压侦测装置100同步记录颈动脉压测量的30秒期间，本发明颈动脉血压侦测装置100脉波速度与市售产品获得的脉波速度显著相关[相关系数R＝0.950]，图中可看出明显的线性关系。
以下请一并参阅图3及图11，图11为本发明传感器三厘米间隔距离的波型示意图，如图所示：
发明人针对第一感测单元11及第二感测单元12以不同间距的方式设置于颈部的位置上进行测试，其中，第二感测单元12所设置的第二位置为固定状态，位于受测者嘴唇中间往下至颈部最凸点为中心，再往左三厘米为起始点；由该起始点出发，沿着总颈动脉A1的延伸方向以每次间距1厘米的方式进行测试，共测试五次，分别为间距1厘米、间距2厘米、间距3厘米、间距4厘米、间距5厘米。其中，在1㎝至4㎝之间所获得的波型图均可以取得有效的波峰，于间隔1cm的实施例获得的波型图虽然略有偏差，但大多数的波峰都可以有效的取得。间隔2cm-4cm的实施例中，多组数据的波型均可以有效的取得。5cm的实施例中，波型则是过于微弱而无法侦测。所侦测的脉波速度整理如下表格：
Figure PCTCN2018095173-appb-000009
Figure PCTCN2018095173-appb-000010
在感测过程中，须调整最适合人体弧度的感测结构，使传感器贴合受测者的肌肤，此外波型在一定程度上须进行时间校正。由上述的表格可知，该第一感测单元11及该第二感测单元12的间距较佳介于1㎝至4㎝之间，所述范围于本发明中不欲限制。
经多次测试的结果，发明人发现于较佳实施例中，当感测单元(第一感测单元11、第二感测单元12)设置于受测者嘴唇中间往下至颈部最凸点为中心再往左或往右大致3厘米的起始点位置，并由该起始点位置以该起始点位置与该最凸点之间联机朝上夹角135度的方向偏移0厘米至4厘米的设置位置，受测者脉波于波型图上多数的波峰都可以有效的取得。其中，该起始点位置具体而言可以为受测者嘴唇中间往下至颈部最凸点为中心再往左或往右2.7厘米至3.3厘米之间的位置，例如可以为2.7厘米、2.8厘米、2.9厘米、3.0厘米、3.1厘米、3.2厘米或3.3厘米，于本发明中不予以限制。
综上所述，本发明有效利用传感器检测颈动脉的动脉压力，可实时对高龄患者进行筛检以确认患者是否罹患颈动脉狭窄等相关病灶。此外，本发明可以用于快速筛检测试，相较于颈动脉数字减血管造影、核磁共振血管造影、都卜勒超声扫描等传统方法可以有效的减少检测所需耗费的时间。
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，即凡依本发明权利要求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 (13)

  1. 一种颈动脉血压侦测装置，包括：一第一感测单元，设置于颈部上靠近颈动脉的第一位置上；一第二感测单元，设置于该颈部上靠近该颈动脉的第二位置上；以及一控制器，连接、耦接、或耦合至该第一感测单元、及该第二感测单元，该控制器经由该第一感测单元测量到的脉波数据以及经由该第二感测单元测量到的脉波数据获得该颈动脉的该第一位置及该第二位置之间区段的平均动脉压。
  2. 根据权利要求1所述的颈动脉血压侦测装置，其特征在于，该平均动脉压依据以下的公式获得：
    Figure PCTCN2018095173-appb-100001
    其中，MAP为该平均动脉压，l p为该第一位置及该第二位置之间的路径长度，t pa为脉波自该第一位置抵达该第二位置的时间，a、b及c为校正参数。
  3. 根据权利要求1所述的颈动脉血压侦测装置，其特征在于，该平均动脉压依据以下的公式获得：
    Figure PCTCN2018095173-appb-100002
    其中，MAP为该平均动脉压，l p为该第一位置及该第二位置之间的路径长度，t pa为脉波自该第一位置抵达该第二位置的时间，A、B及C为校正参数。
  4. 根据权利要求1所述的颈动脉血压侦测装置，还包含有一贴片，该贴片上设置有该第一感测单元及该第二感测单元。
  5. 根据权利要求4所述的颈动脉血压侦测装置，其特征在于，该贴片上设置一喉结定位孔或一喉结定位标记，该第一感测单元及该第二感测单元成对设置于该喉结定位孔或该喉结定位标记的单侧位置上。
  6. 根据权利要求5所述的颈动脉血压侦测装置，其特征在于，该第一感测单元设置于该贴片上该喉结定位孔或该喉结定位标记左侧或右侧2.7厘米至3.3厘米的起始点位置，并由该起始点位置以该起始点位置与该喉结定位孔或该喉结定位标记之间联机朝上夹角135度的方向偏移0厘米至4厘米的位置，该第二感测单元设置于由该起始点位置以该起始点位置与该喉结定位孔或该喉结定位标记之间联机朝上夹角135度的方向偏移0厘米至4厘米但与该第一感测单元不重叠的位置。
  7. 根据权利要求1所述的颈动脉血压侦测装置，其特征在于，还包含有一连接至该控制器的通讯模块。
  8. 根据权利要求7所述的颈动脉血压侦测装置，其特征在于，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。
  9. 根据权利要求7所述的颈动脉血压侦测装置，其特征在于，该控制器经由该通讯模块连接、耦接、或耦合至一行动装置或一穿戴式装置，以经由该行动装置或该穿戴式装置存取该控制器的数据。
  10. 根据权利要求1所述的颈动脉血压侦测装置，其特征在于，该第一感测单元为都卜勒雷达、压力传感器、声波传感器、超声波传感器、或光体积描述信号传感器。
  11. 根据权利要求1所述的颈动脉血压侦测装置，其特征在于，该第二感测单元为都卜勒雷达、压力传感器、声波传感器、超声波传感器、或光体积描述信号传感器。
  12. 根据权利要求1至11中任一项所述的颈动脉血压侦测装置，其特征在于，该第一感测单元及该第二感测单元的间距介于1至4之间。
  13. 根据权利要求1所述的颈动脉血压侦测装置，其特征在于，该第一感测单元设置于受测者嘴唇中间往下至颈部最凸点为中心再往左2.7厘米至3.3厘米的起始点位置，并由该起始点位置以该起始点位置与该最凸点之间联机朝上夹角135度的方向偏移0厘米至4厘 米的位置，该第二感测单元设置于由该起始点位置以该起始点位置与该最凸点之间联机朝上夹角135度的方向偏移0厘米至4厘米但与该第一感测单元不重叠的位置。
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