DEVICE FOR MEASURING A RADIAL DISPATCH PULSE SHAFT AND APPLICATION METHOD FOR IT

Abstract

A device for measuring a radial displacement pulse wave and an application method for it are provided. The device for measuring a radial displacement pulse wave comprises a housing, an airbag, a pressure control module, a displacement sensing module, and a computing unit. The housing has a transparent section. The airbag is located below the transparent section, and the displacement sensing module is located above the transparent section. The pressure control module controls the internal pressure of the airbag to set the airbag's penetration depth against the subject's skin. A measurement signal from the displacement sensing module passes through the transparent section and the airbag to measure a dynamic distance between the subject's skin and the displacement sensing module caused by arterial pulses.The computing unit controls the pressure control module and the displacement detection module respectively, receives and records the dynamic distance and receives a radial displacement pulse wave.

Description

REFERENCE TO RELATED REGISTRATION

[0001] This application claims priority from US patent application No. 18 / 098,729, filed on January 19, 2023, entitled "Chinese Pulse Wave Measuring Device and Application Method Therefor", the entire contents of which are hereby incorporated by reference. BACKGROUND Technical area

[0002] The present disclosure relates to a system for measuring physiological characteristics and a method for its use, in particular a device for measuring a radial displacement pulse wave and a method for its application. State of the art

[0003] Pulse waves are used to assess the function and health of the cardiovascular system. Depending on the characteristics of the measurement, pulse waves can be classified into pressure pulse waves, vascular volume pulse waves, photoplethysmography (PPG) pulse waves, and vascular radial displacement pulse waves.

[0004] The pressure pulse waves mentioned above are typically measured using piezoelectric, strain gauge, film-type, or other piezoresistive pressure sensors. These sensors indirectly measure the pressure caused by vascular expansion. In use, the pressure sensor is placed between an airbag and the skin. As the airbag, attached to the skin, expands, it presses downward on the blood vessel beneath it. As the pulse wave changes the diameter of the blood vessel, the vessel compresses the pressure sensor and the airbag above it. Therefore, the pressure sensor can indirectly measure the pressure pulse wave of the blood vessel based on the change in vessel diameter.Common problems with pulse wave measurement using this method include a small dynamic measurement range, a low signal-to-noise ratio, complex calibration methods for the pressure sensor, and poor reproducibility of the measurement results.

[0005] The vascular volume pulse waves mentioned above are typically measured using a cuff airbag as the measuring device, and a pressure sensor is used to measure the pressure inside the cuff airbag. In this procedure, the cuff airbag is placed over a blood vessel, and the airbag is gradually inflated and pressurized. A pressure sensor then measures changes in the airbag's internal pressure. The measurement result is the integration of the diameter changes of all blood vessels located beneath the airbag and their conversion into a change in the airbag's internal pressure. One problem with this measurement technique is that when the air in the airbag is compressed, the details of the vascular volume pulse wave disappear, and only the amplitude of the vascular volume pulse wave remains available as a reference.

[0006] The photoplethysmography (PPG) pulse wave described above is obtained by a PPG sensor, which detects changes in the intensity of light reflected by blood vessels beneath the skin. A common problem with this measurement technique is that physiological variations at the measurement site (such as the thickness of the subcutaneous tissue or the tissue's light absorption characteristics) can influence the PPG pulse wave measurement results.

[0007] The aforementioned vascular radial displacement pulse wave can also be measured by ultrasound echo imaging. However, complex calculations and calibrations are often required to achieve good image resolution and contrast in order to estimate the change in vascular radial displacement. CONTENT OF THE PRESENT DISCLOSURE

[0008] To solve the aforementioned problems, one aspect of the present disclosure relates to a device for measuring a radial displacement pulse wave, which serves to measure a radial displacement pulse wave of an artery at a measurement site of a subject. The device for measuring a radial displacement pulse wave comprises a housing, a transparent airbag, a pressure control module, a displacement sensing module, and a computing unit.

[0009] The housing features a transparent section, which includes a hole or a first transparent plate. A transparent airbag is positioned below this transparent section, and the primary material of the transparent airbag is one resistant to strain deformation. The pressure control module is configured to regulate the internal pressure of the transparent airbag to control downward pressure exerted by the airbag on the measurement site, thereby amplifying an arterial pulse signal. The displacement sensing module is positioned above the transparent section. The displacement sensing module is configured to detect the arterial pulses and measure the dynamic distance between the skin at the measurement site and the displacement sensing module, caused by the arterial pulses, to obtain the radial displacement pulse wave.The processing unit is connected to the pressure control module and the displacement sensing module via communication channels. The processing unit is configured to transmit control signals to both the pressure control module and the displacement sensing module, and to receive information from both modules in order to perform calculations.

[0010] According to one embodiment of the present disclosure, a main material of the transparent airbag comprises polymethyl methacrylate, cellulose acetate, nylon-66 polyamide resin, nylon-6 polyamide resin, polybutylene terephthalate, polyethylene terephthalate, polyphenylene oxide, polycarbonate, ethylene-vinyl acetate copolymer, polyethylene, polypropylene, polyvinyl chloride, polyoxymethylene or polyurethane.

[0011] According to one embodiment of the present disclosure, if the transparent section is the hole, the transparent airbag further comprises a transparent window that overlaps the transparent section of the housing. The transparent window comprises a second transparent plate.

[0012] According to one embodiment of the present disclosure, an antireflective coating is arranged on an outer surface of the transparent window.

[0013] According to one embodiment of the present disclosure, an area of ​​the second transparent plate is larger than an area of ​​the hole, so that if an internal pressure of the transparent airbag is too high, the second transparent plate rests against a bottom of the hole and is prevented from being pressed towards a top of the hole.

[0014] According to one embodiment of the present disclosure, the transparent airbag further comprises a contact section configured to fit snugly against the skin of the subject's measurement site, wherein a material of the contact section is a soft, stretchable and deformable thermoplastic elastomer material comprising at least one of the following materials: thermoplastic polyurethane, polyolefin elastomer, dynamically vulcanized polyolefin elastomer, polystyrene elastomer, polyether ester elastomer, polyamide elastomer and polyvinyl chloride.

[0015] According to one embodiment of the present disclosure, a reflective layer or a dichroic layer is arranged on an inner surface of the contact section.

[0016] According to one embodiment of the present disclosure, the device for measuring a radial displacement pulse wave in the present disclosure further comprises a support section configured to accommodate a limb segment of the subject, the measuring point being located within an interior of the support section. The support section comprises a soft inner layer and a hard outer layer. The soft inner layer comprises the transparent airbag. The hard outer layer is arranged outside the soft inner layer to form, together with the soft inner layer, the interior of the support section. During a measurement operation of the radial displacement pulse wave, the hard outer layer maintains a fixed distance between the displacement sensing module and the furthest position on the hard outer layer relative to the displacement sensing module.

[0017] According to one embodiment of the present disclosure, the soft inner layer further comprises a plurality of auxiliary airbags, and the internal pressure of the auxiliary airbags is controlled by the pressure control module.

[0018] According to one embodiment of the present disclosure, the pressure control module comprises a pressure sensor and a pressure adjustment module. The pressure sensor is configured to detect the internal pressure of the transparent airbag. The pressure adjustment module is configured to adjust the internal pressure of the transparent airbag and includes a pump.

[0019] According to one embodiment of the present disclosure, the pressure adjustment module further comprises a pulse width modulation circuit configured to adjust the speed of a motor of the pump.

[0020] According to one embodiment of the present disclosure, the displacement detection module comprises a transmitter and a receiver. The transmitter and the receiver are aligned with the transparent section, and the transparent section and the transparent airbag are configured such that a measurement signal emitted by the transmitter passes through the transparent section and the transparent airbag.

[0021] According to one embodiment of the present disclosure, the displacement detection module comprises a photoelectric displacement sensor.

[0022] According to one embodiment of the present disclosure, the photoelectric displacement sensor comprises a distance measuring device selected from the group consisting of: a laser displacement sensor, a fiber optic displacement sensor, a three-dimensional laser displacement sensor, a time-of-flight (TOF) distance sensor, a three-dimensional time-of-flight (3D TOF) distance array sensor, a laser Doppler anemometer, a laser Doppler velocimeter, a laser Doppler vibrometer, a Michelson interferometer, or a laser interferometer.

[0023] According to one embodiment of the present disclosure, the displacement detection module further comprises a filter.

[0024] According to one embodiment of the present disclosure, the device for measuring a radial displacement pulse wave further comprises a scanning position control module that is communicatively connected to the computing unit and is configured to control the displacement sensing module to perform distance measurement within the measuring point. The scanning position control module comprises a single-axis position controller or a dual-axis position controller.

[0025] Another aspect of the present disclosure relates to a device for measuring a radial displacement pulse wave, which serves to measure a radial displacement pulse wave of an artery at a measurement point of a subject. The device for measuring a radial displacement pulse wave comprises a housing, a non-transparent airbag, a pressure control module, a displacement sensing module, and a computing unit.

[0026] The housing has a transparent section, which includes a hole or a first transparent plate. A non-transparent airbag is located below the transparent section, and the primary material of the non-transparent airbag is a material resistant to strain deformation. The non-transparent airbag includes a transparent window that overlaps the transparent section of the housing, and this transparent window also includes a transparent material resistant to strain deformation, or a second transparent plate. The pressure control module is configured to control an internal pressure of the non-transparent airbag to control a downward pressure exerted by the non-transparent airbag on the measurement site, thereby amplifying a pulse wave signal from the artery. The displacement sensing module is located above the transparent section.The displacement sensing module is configured to detect the arterial pulse and measure the dynamic distance between the skin at the measurement site and the displacement sensing module caused by the arterial pulse to obtain the radial displacement pulse wave. The processing unit is communicatively connected to the pressure control module and the displacement sensing module. The processing unit is configured to transmit control signals to both the pressure control module and the displacement sensing module, and to receive information from both modules to perform calculations.

[0027] According to one embodiment of the present disclosure, the transparent material resistant to strain deformation of the main material of the non-transparent airbag comprises polymethyl methacrylate, cellulose acetate, nylon-66 polyamide resin, nylon-6 polyamide resin, polybutylene terephthalate, polyethylene terephthalate, polyphenylene oxide, polycarbonate, ethylene-vinyl acetate copolymer, polyethylene, polypropylene, polyvinyl chloride, polyoxymethylene, polyurethane, glass, quartz, polystyrene or acrylonitrile-butadiene-styrene copolymer.

[0028] According to one embodiment of the present disclosure, the transparent material resistant to strain deformation of the transparent window comprises polymethyl methacrylate, cellulose acetate, nylon-66 polyamide resin, nylon-6 polyamide resin, polybutylene terephthalate, polyethylene terephthalate, polyphenylene oxide, polycarbonate, ethylene-vinyl acetate copolymer, polyethylene, polypropylene, polyvinyl chloride, polyoxymethylene, polyurethane, glass, quartz, polystyrene or acrylonitrile-butadiene-styrene copolymer.

[0029] According to one embodiment of the present disclosure, an antireflective coating is arranged on an outer surface of the transparent window.

[0030] According to one embodiment of the present disclosure, the transparent window is the second transparent plate, where the transparent section is the hole.

[0031] According to one embodiment of the present disclosure, an area of ​​the second transparent plate is larger than an area of ​​the hole, so that if an internal pressure of the transparent airbag is too high, the second transparent plate rests against a bottom of the hole and is prevented from being pressed towards a top of the hole.

[0032] According to one embodiment of the present disclosure, an antireflective coating is arranged on an outer surface of the transparent window.

[0033] According to one embodiment of the present disclosure, the non-transparent airbag further comprises a contact section. The contact section is configured to fit snugly against the skin at the subject's measurement site, and the contact section material is a soft, stretchable, and deformable thermoplastic elastomer. The elastomer material comprises at least one of the following: thermoplastic polyurethane, polyolefin elastomer, dynamically vulcanized polyolefin elastomer, polystyrene elastomer, polyether ester elastomer, polyamide elastomer, and polyvinyl chloride.

[0034] According to one embodiment of the present disclosure, a reflective layer or a dichroic layer is arranged on an inner surface of the contact section.

[0035] According to one embodiment of the present disclosure, the device for measuring a radial displacement pulse wave in the present disclosure further comprises a support section configured to accommodate a limb segment of the subject, the measuring point being located within an interior of the support section. The support section comprises a soft inner layer and a hard outer layer. The soft inner layer comprises the transparent airbag. The hard outer layer is arranged outside the soft inner layer to form, together with the soft inner layer, the interior of the support section. During a measurement operation of the radial displacement pulse wave, the hard outer layer maintains a fixed distance between the displacement sensing module and the furthest position on the hard outer layer relative to the displacement sensing module.

[0036] According to one embodiment of the present disclosure, the soft inner layer further comprises a plurality of auxiliary airbags, and the internal pressure of the auxiliary airbags is controlled by the pressure control module.

[0037] According to one embodiment of the present disclosure, the pressure control module comprises a pressure sensor and a pressure adjustment module. The pressure sensor is configured to detect the internal pressure of the transparent airbag. The pressure adjustment module is configured to adjust the internal pressure of the transparent airbag and includes a pump.

[0038] According to one embodiment of the present disclosure, the pressure adjustment module further comprises a pulse width modulation circuit configured to adjust the speed of a motor of the pump.

[0039] According to one embodiment of the present disclosure, the displacement sensing module comprises a transmitter and a receiver. The transmitter and the receiver are aligned with the transparent section, and the transparent section and the transparent window are configured such that a measurement signal emitted by the transmitter passes through the transparent section and the transparent window.

[0040] According to one embodiment of the present disclosure, the displacement detection module comprises a photoelectric displacement sensor.

[0041] According to one embodiment of the present disclosure, the photoelectric displacement sensor comprises a distance measuring device selected from the group consisting of: a laser displacement sensor, a fiber optic displacement sensor, a three-dimensional laser displacement sensor, a time-of-flight (TOF) distance sensor, a three-dimensional time-of-flight (3D TOF) distance array sensor, a laser Doppler anemometer, a laser Doppler velocimeter, a laser Doppler vibrometer, a Michelson interferometer, or a laser interferometer.

[0042] According to one embodiment of the present disclosure, the displacement detection module further comprises a filter.

[0043] According to one embodiment of the present disclosure, the device for measuring a radial displacement pulse wave in the present disclosure further comprises a scanning position control module which is communicatively connected to the computing unit and is configured to control the displacement detection module to perform a distance measurement at the measuring point. The scanning position control module comprises a single-axis position controller or a dual-axis position controller.

[0044] Another aspect of the present disclosure relates to a method for optimizing the measurement conditions for a vascular radial displacement pulse wave. In this method, a Y-axis is defined substantially perpendicular to the direction of the artery and substantially parallel to the surface of the skin at the measurement site. The method comprises: using the device described above for measuring a radial displacement pulse wave; placing the transparent or non-transparent airbag on the skin at the subject's measurement site; positioning the displacement sensing module at a starting position, wherein the displacement sensing module is a point-type displacement sensor or a matrix-type displacement sensor; maintaining pressure of the transparent or non-transparent airbag at an initial pressure and pressing the transparent or non-transparent airbag against the measurement site to a first depth;Scanning the displacement detection module on the surface of the measurement site along the Y-axis to a first measurement position where a maximum amplitude signal of the vascular radial displacement pulse wave of the artery is found; maintaining the displacement detection module at the first measurement position and adjusting the pressure of the transparent or non-transparent airbag to find a second pressure at which a maximum signal of the vascular radial displacement pulse wave of the artery is obtained; and maintaining the pressure of the transparent or non-transparent airbag at this second pressure, pressing the transparent or non-transparent airbag against the measurement site to a second depth. The first measurement position and the second depth serve as measurement conditions for the vascular radial displacement pulse wave of the artery.

[0045] According to one embodiment of the present disclosure, the first pressure is obtained by gradually increasing the pressure of the transparent airbag or the non-transparent airbag in order to press the measuring point vertically with the transparent airbag or the non-transparent airbag until the first pressure is applied when a maximum amplitude signal of a vascular volume pulse wave of the artery is found.

[0046] According to one embodiment of the present disclosure, the method for optimizing the measurement conditions for a vascular radial displacement pulse wave in the present disclosure further comprises scanning the displacement detection module along the direction of the artery up to a second measurement position, at which a local maximum signal of the vascular radial displacement pulse wave of the artery is obtained. The second measurement position replaces the first measurement position as the measurement condition for the vascular radial displacement pulse wave of the artery.

[0047] Another aspect of the present disclosure relates to a method for optimizing the measurement conditions for a vascular radial displacement pulse wave. The method comprises: identifying a first measurement position above an artery at a measurement site of a subject; using the device described above to measure a radial displacement pulse wave; placing the transparent or non-transparent airbag on the skin of the subject's measurement site; aligning the displacement detection module with the first measurement position, wherein the displacement detection module is a point-type displacement sensor or a matrix-type displacement sensor;Gradually increasing the pressure of the transparent or non-transparent airbag to press the measurement site vertically against it until a measurement pressure is applied when a maximum signal of the vascular radial displacement pulse wave of the artery is found; maintaining the pressure of the transparent or non-transparent airbag at a measurement pressure and pressing the transparent or non-transparent airbag against the measurement site to a measurement depth. The initial measurement position and the measurement depth serve as the measurement conditions for the vascular radial displacement pulse wave of the artery.

[0048] According to one embodiment of the present disclosure, the method for optimizing the measurement conditions for a vascular radial displacement pulse wave in the present disclosure further comprises scanning the displacement detection module along the direction of the artery up to a second measurement position, at which a local maximum signal of the vascular radial displacement pulse wave of the artery is obtained. The second measurement position replaces the first measurement position as the measurement condition for the vascular radial displacement pulse wave of the artery.

[0049] Another aspect of the present disclosure relates to a method for optimizing the measurement conditions for a vascular radial displacement pulse wave. The method comprises: using the device described above to measure a radial displacement pulse wave; placing the transparent or non-transparent airbag on the skin at the subject's measurement site; maintaining pressure on the transparent or non-transparent airbag at an initial pressure; and moving the displacement sensing module over the measurement site. The displacement sensing module is a matrix-type displacement sensor, and the matrix-type displacement sensor has a measurement area that intersects one direction of the blood vessel. Among the point-type displacement sensors within the measurement area, one sensor is identified that corresponds to a maximum amplitude signal, indicating that this displacement sensor is at a first measurement position.The pressure of the transparent or non-transparent airbag is then adjusted so that a second pressure is reached when a maximum signal of the vascular radial displacement pulse wave of the artery is obtained. The pressure of the transparent or non-transparent airbag is maintained at this second pressure to press the airbag against the measurement site to a second depth. The first measurement position and the second depth serve as the measurement conditions for the vascular radial displacement pulse wave of the artery.

[0050] According to one embodiment of the present disclosure, the first pressure is obtained by gradually increasing the pressure of the transparent airbag or the non-transparent airbag in order to press the measuring point vertically with the transparent airbag or the non-transparent airbag until the first pressure is applied when a maximum amplitude signal of a vascular volume pulse wave of the artery is found.

[0051] According to one embodiment of the present disclosure, the method for optimizing the measurement conditions for a vascular radial displacement pulse wave in the present disclosure further comprises scanning the displacement detection module along the direction of the artery up to a second measurement position, at which a local maximum signal of the vascular radial displacement pulse wave of the artery is obtained. The second measurement position replaces the first measurement position as the measurement condition for the vascular radial displacement pulse wave of the artery.

[0052] Another aspect of the present disclosure relates to a method for measuring blood pressure. The method comprises: using the device described above to measure a radial displacement pulse wave; placing the transparent or non-transparent airbag at the measurement site; locating the artery at the subject's measurement site by using the method described above to optimize the measurement conditions for a vascular radial displacement pulse wave in order to measure the artery's vascular radial displacement pulse wave; gradually increasing the pressure of the transparent or non-transparent airbag until the artery's vascular radial displacement pulse wave appears and then disappears;Gradual release of the pressure of the transparent or non-transparent airbag until the vascular radial displacement pulse wave of the artery begins to appear, wherein the pressure of the transparent or non-transparent airbag at this time is the systolic pressure of the artery; and continued gradual release of the pressure of the transparent or non-transparent airbag until the vascular radial displacement pulse wave of the artery begins to disappear, wherein the pressure of the transparent or non-transparent airbag at this time is the diastolic pressure of the artery.

[0053] Another aspect of the present disclosure relates to a method for measuring pulse wave velocity (PWV). The method comprises: measuring a proximal radial displacement pulse wave at a proximal measurement position of a proximal arterial segment of a subject, located closer to the heart, using the radial displacement pulse wave measuring device described above, while simultaneously recording an electrocardiogram (ECG); simultaneously recording a vascular radial displacement pulse wave at the proximal arterial segment and the ECG of the subject in order to obtain a delay time T1 of the proximal radial displacement pulse wave of the proximal arterial segment relative to the R-wave of the ECG;Measuring a distal radial displacement pulse wave at a distal measurement position of a distal arterial segment of the subject, which is farther from the heart, using the radial displacement pulse wave measuring device described above, while simultaneously recording an electrocardiogram (ECG); simultaneously recording a vascular radial displacement pulse wave at the distal arterial segment and the subject's ECG to obtain a delay time T2 of the distal radial displacement pulse wave of the distal arterial segment relative to the R-wave of the ECG; calculating a delay time difference ΔT = T2 - T1; measuring a distance ΔD between the proximal arterial segment and the distal arterial segment; and calculating a pulse wave velocity as PWV = ΔD / ΔT.

[0054] According to one embodiment of the present disclosure, the proximal measurement position and the distal measurement position are the first measurement position found by using the above-described method for optimizing the measurement conditions for a vascular radial displacement pulse wave, or the second measurement position found by using the above-described method for optimizing the measurement conditions for a vascular radial displacement pulse wave.

[0055] Another aspect of the present disclosure relates to a method for measuring pulse wave velocity (PWV). The method comprises: measuring a proximal radial displacement pulse wave at a proximal measurement position of a proximal arterial segment of a subject that is closer to the heart, without recording an electrocardiogram (ECG); simultaneously measuring a distal radial displacement pulse wave at a distal measurement position of a distal arterial segment of the subject that is farther from the heart, without recording an electrocardiogram (ECG), wherein the proximal measurement position and the distal measurement position utilize one or two of the radial displacement pulse wave measuring devices described above to simultaneously measure the proximal radial displacement pulse wave and the distal radial displacement pulse wave;Calculate a delay time difference ΔT between the proximal radial displacement pulse wave and the distal radial displacement pulse wave; measure a distance ΔD between the proximal arterial segment and the distal arterial segment; and calculate the pulse wave velocity PWV = ΔD / ΔT.

[0056] According to one embodiment of the present disclosure, the proximal measurement position and the distal measurement position are the first measurement position found by using the above-described method for optimizing the measurement conditions for a vascular radial displacement pulse wave, or the second measurement position found by using the above-described method for optimizing the measurement conditions for a vascular radial displacement pulse wave.

[0057] Another aspect of the present disclosure relates to a method for the continuous measurement of blood pressure. The method comprises: using the blood pressure measurement method described above to measure a subject's diastolic pressure under an initial condition and a corresponding first compression depth of the transparent or non-transparent airbag at the measurement site, and to measure a subject's systolic pressure under the initial condition and a corresponding second compression depth of the transparent or non-transparent airbag at the measurement site, wherein a difference between the first compression depth and the second compression depth is a vascular diameter R of the subject; calculating a change in the subject's vascular diameter ΔR from a time-dependent waveform of the subject's radial displacement pulse wave;Using the above-described procedure for measuring pulse wave velocity to determine the subject's pulse wave velocity (PWV); determining the subject's blood density (ρ); calculating the change in blood pressure (ΔP) using the following Branwell-Hill formula: ΔP = ρ × PWV; 2 (ΔR / R); and calculating a real-time systolic pressure (= initial systolic pressure + ΔP) and a real-time diastolic pressure (= initial diastolic pressure + ΔP) of the subject.

[0058] The device described above for measuring a radial displacement pulse wave offers the following technical advantages. First, the device can directly measure vascular radial displacement pulse waves and provides more accurate results compared to conventional pressure pulse wave measurement methods. Second, the device has high accuracy with a resolution of less than 100 micrometers, providing detailed pulse wave information that is beneficial for various pulse wave analysis applications. Third, the device can be applied to many non-invasive measurement techniques, offering convenience and stability, real-time measurement results and waveform displays, and the possibility of continuous long-term monitoring.With these advantages, the device for measuring a radial displacement pulse wave has a wide range of applications in the fields of cardiovascular medicine and biomedicine, thereby supporting improved personalized healthcare and health monitoring. BRIEF DESCRIPTION OF THE DRAWINGS Fig. Figure 1 is a schematic functional block diagram of a device for measuring a radial displacement pulse wave according to an embodiment of the present disclosure. Fig. Figure 2 is a schematic cross-sectional diagram of a support section of a device for measuring a radial displacement pulse wave according to an embodiment of the present disclosure. Fig.Figure 3A is a schematic diagram illustrating an operating sequence for the automatic localization of a measurement point of a radial displacement pulse wave using a scanning position control module 140 according to an embodiment of the present disclosure, wherein the displacement detection module 130 is a point-type displacement sensor. Fig. Figure 3B is a schematic diagram illustrating an operating procedure for manually locating a measurement point of a radial displacement pulse wave according to another embodiment of the present disclosure, wherein the displacement detection module 130 is a point-type displacement sensor. Fig.Figure 3C is a schematic diagram illustrating an operating sequence for locating a measurement point of a radial displacement pulse wave according to a further embodiment of the present disclosure, wherein the displacement detection module 130 is a linear matrix-type displacement sensor. Fig. Figure 4 is a schematic diagram illustrating waveform changes of a vascular volume pulse wave and a radial displacement pulse wave with respect to pressure and time according to an embodiment of the present disclosure. Fig. Figure 5 is a schematic diagram illustrating a process for measuring blood pressure using the [information missing]. Fig. 1 illustrated device for measuring a radial displacement pulse wave 100. Fig. Figure 6A is a schematic enlarged view of a radial displacement pulse wave during period III (t2-t3) in Fig. 4. Fig.6B is a diagram illustrating a change in the intervals between beats over time. Fig. 6C is a spectral distribution diagram of RRI obtained by performing a discrete Fourier transform (DFT) on heart rate variability (HRV). Fig. Figure 7A is a schematic diagram for measuring pulse wave velocity with ECG support according to an embodiment of the present disclosure. Fig. Figure 7B is a schematic diagram for the simultaneous use of two devices for measuring a pulse wave for measuring the pulse wave velocity according to an embodiment of the present disclosure. Fig. 7C is a flowchart of a procedure for measuring pulse wave velocity using the in Fig. 7A presented approach. Fig.Figure 8 is a flowchart of a procedure for the continuous measurement of blood pressure. Reference symbol list: 100 Device for measuring a radial displacement pulse wave 110 Airbag 110a Measuring section 112 Transparent window 114 Contact section 120 Pressure control module 122 Pressure sensor 124 Pressure adjustment module 130 Displacement Detection Module 130a emitted signal 130b Reflected signal 132 channels 134 recipients 136 filters 140 Scanning Position Control Module 150 computing units 151 Power supply module 152 memory module 153 Communication module 154 Operating module 155 Display module 156 Processing module 157 Control module 158 Analysis module 160 measuring point 200 support section 210 Hard outer layer 212 furthest position 220 Soft inner layer 230 case 232 Transparent section 240 limb section 250 artery 305-850 steps D1, D2, D3, D4, D5 Depth MD distance P1, P2, P3, P4, P5 Print R R-wave R1 valley point R2 summit T1 Delay time of the proximal radial displacement pulse wave T2 Delay time of the distal radial displacement pulse wave ΔT delay time difference DETAILED DESCRIPTION

[0059] Accordingly, the present disclosure relates to a device for measuring a radial displacement pulse wave and an application method therefor. The device for measuring a radial displacement pulse wave can directly measure the waveform of a vascular radial displacement pulse wave through a coordinated design of the airbag, the pressure control module, and the displacement sensing module, with a measurement accuracy of less than 100 micrometers. Therefore, the device can provide many details of the waveform of the vascular radial displacement pulse wave for various application analyses of the radial displacement pulse wave. The following describes the measurement of blood pressure, heart rate variability, pulse wave velocity, and continuous blood pressure measurement.These measurement methods are merely some examples of the applications of the device for measuring a radial displacement pulse wave, and the application methods of the device for measuring a radial displacement pulse wave are not limited to them.

[0060] Definition of the coordinate axis directions: The XY plane is essentially parallel to the skin surface of a subject, the X-axis is essentially parallel to the direction of a blood vessel in the subject, and the Y-axis is essentially perpendicular to the direction of the blood vessel. Therefore, the Z-axis is essentially perpendicular to the skin surface of the subject. The definitions of the X-axis, Y-axis, and Z-axis mentioned in the following descriptions are the same as those defined above. Device for measuring a radial displacement pulse wave

[0061] Fig.Figure 1 is a schematic functional block diagram of a device for measuring a radial displacement pulse wave according to an embodiment of the present disclosure. As in Fig. Figure 1 shows a device for measuring a radial displacement pulse wave 100 comprising an airbag 110, a pressure control module 120, a displacement detection module 130, a scanning position control module 140, and a computing unit 150. The pressure control module 120, the displacement detection module 130, and the scanning position control module 140 are each communicatively connected to the computing unit 150.

[0062] Fig.Figure 2 is a schematic cross-sectional diagram of a support section of a device for measuring a radial displacement pulse wave according to an embodiment of the present disclosure. To connect the airbag 110 and a measuring point 160 of a subject stably and tightly, to fix a relative position between the displacement detection module 130 and the measuring point 160 of the subject, and to effectively reduce noise caused by changes in posture or body shake of the subject, a support section for the device for measuring a radial displacement pulse wave 100 is developed to improve the accuracy of the pulse wave measurement. As shown in Figure 2, the airbag 110 and a measuring point 160 of the subject are stably and tightly connected, to fix a relative position between the displacement detection module 130 and the measuring point 160 of the subject, and to effectively reduce noise caused by changes in posture or body shake of the subject. Fig.As shown in Figure 2, the device for measuring a radial displacement pulse wave 100 further comprises a support section 200 and a housing 230. The support section 200 comprises a hard outer layer 210 and a soft inner layer 220, and the housing 230 has a transparent section 232. In the device for measuring a radial displacement pulse wave 100, the airbag 110 is arranged below the transparent section 232 (outside the housing 230), and the displacement sensing module 130 is arranged above the transparent section 232 (inside the housing 230). The computing unit 150, the pressure control module 120, and the scanning position control module 140 can optionally be enclosed inside or outside the housing 230. For the sake of simplicity, in Figure 2, the following is shown: Fig. 2 only the displacement detection module 130 within the housing 230 is shown. If the support section 200 and the housing 230, as in Fig. As shown in Figure 2, the airbag 110 is located between the measuring point 160 of the subject and the housing 230, and the displacement detection module 130 is aligned with the transparent section 232 of the housing 230, so that an emitted signal 130a and a reflected signal 130b from the displacement detection module 130 can pass through the transparent section 232.

[0063] The following components of the device for measuring a radial displacement pulse wave 100 are described individually.

[0064] As in Fig. 1 and Fig.As shown in Figure 2, the airbag 110 has three functions. The first function is to generate downward pressure to compress the subcutaneous tissue. The second function is to allow a measurement signal from the displacement detection module 130 (i.e., the emitted signal 130a and the reflected signal 130b) to pass through an interior space of the airbag 110 and be reflected back to the displacement detection module 130. The third function is that, when the airbag 110 is firmly in place against the skin, it can serve as a space to accommodate the expansion of the artery's diameter with each heartbeat.

[0065] A principal material of the Airbag 110 may consist of an available transparent polymer material that is resistant to strain deformation, or of an available non-transparent polymer material that is resistant to strain deformation. In the present disclosure, the term "non-transparent" includes opaque and semi-transparent materials. The transparent or non-transparent polymer material may be, but is not limited to: polymethyl methacrylate (PMMA), cellulose acetate (CA), nylon 66 polyamide resin (PA-66), nylon 6 polyamide resin (PA-6), polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polyphenylene oxide (PPO), polycarbonate (PC), ethylene-vinyl acetate copolymer (EVA), polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyoxymethylene (POM), or polyurethane (PU).

[0066] If the airbag 110 is made of a transparent polymer material, a measurement signal from the displacement detection module 130 (i.e., the emitted signal 130a and the reflected signal 130b) can pass through a main material of the airbag 110. If a transparent section 232 of the housing 230, as in Fig.As shown in Figure 2, a hole is provided to increase the permeability of the measurement signal of the displacement sensing module 130 through the main material of the airbag 110, or to reduce the refraction and reflection of the measurement signal of the displacement sensing module 130 through the main material of the airbag 110, which could impair the measurement accuracy. Furthermore, an upper section of the airbag 110, made of transparent polymer material, can include a transparent window 112 made of a deformation-resistant transparent plate. An area of ​​the transparent plate of the transparent window 112 is larger than an area of ​​the hole of the transparent section 232 to prevent the transparent plate of the transparent window 112 from being forced into the interior of the housing 230 when the pressure of the airbag 110 is too high. During use, the transparent window 112 of the airbag 110 must be aligned with the transparent section 232 of the housing 230 (i.e.h. the transparent window 112 and the transparent section 232 overlap at least partially), to allow the measurement signal of the displacement detection module 130 (i.e., the emitted signal 130a and the reflected signal 130b) to pass vertically through the transparent window 112 made from the transparent plate and into the interior of the airbag 110. If the transparent section 232 of the housing 230, as in . Fig.Since the transparent window 112, which is resistant to deformation, is shown in Figure 2, the airbag 110, made of transparent polymer material, does not require a transparent window 112 made of a transparent plate. Furthermore, regardless of whether the transparent section 232 of the housing 230 is a hole or a transparent plate, because the housing 230 is located above the airbag 110, the housing 230 can also serve as a limiting plate to restrict the upward expansion of the airbag 110 during inflation. This keeps the transparent window 112, which contacts the transparent section 232, in a flat state, and the increased pressure in the airbag 110 is almost completely utilized to press the measuring point 160 of the subject downwards against a contact section 114 of the airbag 110.

[0067] However, if the airbag 110 is made of a non-transparent polymer material, a measurement signal from the displacement sensing module 130 cannot easily, or can only partially, pass through the main material of the airbag 110. Therefore, the airbag 110 must have at least one transparent window 112 to allow the measurement signal from the displacement sensing module 130 to pass through. During use, the transparent window 112 of the airbag 110 must also be aligned with the transparent section 232 of the housing 230 (i.e., the transparent window 112 and the transparent section 232 must overlap at least partially) to allow the measurement signal from the displacement sensing module 130 (i.e., the emitted signal 130a and the reflected signal 130b) to pass through the transparent window 112 and the transparent section 232 and enter an interior space of the airbag 110. If the transparent section 232 of the housing 230, as in Fig.As shown in Figure 2, where a hole is present, the transparent window 112 of the airbag 110, which is made of non-transparent polymer material, must consist of a deformation-resistant transparent plate, wherein the area of ​​the transparent plate of the transparent window 112 is larger than the area of ​​the hole of the transparent section 232, in order to prevent the transparent plate of the transparent window 112 from being forced into the interior of the housing 230 when the internal pressure of the airbag 110 is too high. The remaining aspects are similar to the situation in which the airbag 110 is made of the transparent polymer material, and therefore the details are not repeated. If the transparent section 232 of the housing 230, as shown in Figure 2, is made of a transparent polymer material, the transparent window 112 must be made of a transparent plate that is resistant to deformation. Fig.As shown in Figure 2, a transparent plate resistant to deformation is used. The transparent material used for the transparent window 112 of the airbag 110, which is made of non-transparent polymer material, is not limited to the transparent plate and can also be a transparent material resistant to tensile deformation. The transparent material resistant to tensile deformation can be, for example, but is not limited to, polymethyl methacrylate, cellulose acetate, nylon-66 polyamide resin, nylon-6 polyamide resin, polybutylene terephthalate, polyethylene terephthalate, polyphenylene oxide, polycarbonate, ethylene-vinyl acetate copolymer, polyethylene, polypropylene, polyvinyl chloride, polyoxymethylene, or polyurethane. The remaining aspects are similar to the situation where the airbag 110 is made of the transparent polymer material, and therefore the details are not repeated.

[0068] Therefore, in Fig.2, regardless of whether the transparent window 112 of the airbag 110 is formed from a transparent plate or the transparent section 232 of the housing 230, both limit upward expansion of the airbag 110, so that the increased pressure in the airbag 110 is almost completely utilized to push the measuring point 160 of the subject downwards through a contact section 114 of the airbag 110. This allows the vascular radial displacement generated by pulse beats to be maximized, which facilitates measurement by the displacement sensing module 130.

[0069] The deformation-resistant transparent plate forming the transparent window 112 or the transparent section 232 may be made of, but is not limited to, glass, quartz, polystyrene (PS), acrylonitrile butadiene styrene (ABS), or the same transparent material used for the airbag. The transparent window 112 and the transparent section 232 may be made of the same material or of different materials. According to some embodiments, the transparent section 232 of the housing 230 and the transparent window 112 of the airbag 110 may also be integrated into a single structure, provided a high-hardness transparent plate is used.

[0070] According to further embodiments, an anti-reflective coating can be applied to an outer surface of the transparent window 112, which faces the outer side of the airbag 110, in order to increase the transmittance of the measurement signal of the displacement detection module 130 through the transparent window 112, thereby reducing noise caused by partial reflection of the measurement signal from the transparent window 112. The anti-reflective coating can also improve the wear resistance of the transparent window 112.

[0071] Since the main material of the airbag 110 is a material resistant to tensile deformation, the amplitude of the reflective surface of the skin or the airbag can be reduced at the point where the airbag is in firm contact with the skin. To reduce the lateral stress on the material while maintaining downward pressure in the airbag, a soft polymer material with stretchable and deformable properties can be used locally. The airbag 110 can further comprise a contact section 114, as shown in Fig. 1 and Fig. 2 shown. The contact section 114 serves to touch a skin surface of the measuring point 160 of the subject, and the skin of the measuring point 160 may move due to pulse beats of an artery 250 located under the skin (see Fig.2) move up and down. Therefore, the contact section 114 can be made of a soft polymer material (with a hardness in the Shore range of 20C to 72D) that is stretchable and deformable to help reduce the lateral stress exerted on the constantly moving skin of the measuring point 160. In cooperation with the main body of the airbag 110 and its transparent window 112, both of which are resistant to deformation, the soft and elastic contact section 114 can effectively transmit the downward pressure of the airbag 110 to the measuring point 160.Alternatively, the airbag 110 can be made entirely of the same material as the airbag, which is resistant to strain deformation. After inflation, an elastic layer of air with a compressible volume within the airbag 110 can serve as an elastic buffer for pulse beats, while reducing lateral stresses in the material. This allows the displacement sensing module 130 to more easily detect a measurement signal corresponding to the vascular radial displacement caused by pulse beats. The contact section 114 can be transparent, semi-transparent, or opaque. The polymer material mentioned above can be the same as the main airbag material or, for example, a thermoplastic elastomer (TPE).The available thermoplastic elastomer can be, for example, thermoplastic polyurethane (TPU), polyolefin elastomer (TPO), dynamically vulcanized polyolefin elastomer (TPV), polystyrene-based elastomer (TPS / TPR), polyether ester elastomer (TPEE), polyamide-based elastomer (TPA), or polyvinyl chloride (PVC).

[0072] According to some embodiments, an inner surface of the contact section 114 facing the airbag 110 can, for example, be smooth, or a reflective or dichroic layer can additionally be formed on the inner surface of the contact section 114. For example, if a red laser light source is used, a dichroic layer coated on the inner surface of the contact section 114 of the airbag 110 can reflect red laser light while allowing other visible light to pass through, thereby increasing the reflection intensity of the measurement signal (i.e., the red laser) and facilitating alignment with an alignment mark located below the contact section 114. Therefore, the reflection intensity and the uniformity (rather than scattering) of the measurement signal emitted by the displacement sensing module 130 on the inner surface of the contact section 114 can be increased.The contact section 114 can also be semi-transparent to simultaneously improve the reflection intensity of the measurement signal and to facilitate alignment with an alignment mark or reflective sticker located below the contact section 114.

[0073] The in Fig.The pressure control module 120 shown controls the internal pressure of the airbag 110 by inflating and increasing the pressure or deflating and decreasing the pressure of the airbag 110 in order to adjust the downward compression depth of the airbag 110 against the measuring point 160. According to some embodiments, the pressure control module 120 can include a pressure sensor 122 and a pressure adjustment module 124 (including a pump, an air line, and an air valve) that are interconnected. The pressure sensor 122 is configured to detect the internal pressure of the airbag 110 and can thus be used to measure a vascular volume pulse wave of the subject. Two ends of the air line of the pressure adjustment module 124 are connected to the pump and the airbag 110, respectively, and the air valve is installed at a suitable position in the air line.Thus, the amount of gas entering and exiting the airbag 110 can be controlled quickly and precisely by controlling the direction of rotation (forward or reverse) of a motor in the pump, using a pulse-width modulation (PWM) circuit to adjust the speed of the motor in the pump, using two motors in the pump, one responsible for air intake and one for air delivery, or by combining these methods with the circuitry of the air valve. This allows the internal pressure of the airbag 110 to be controlled quickly and precisely by controlling the downward compression depth of the airbag 110 along a Z-axis on the skin surface of measuring point 160 of the subject.Accordingly, the aforementioned pump, in combination with the air valve, the PWM circuit, or both together with the detection of a maximum amplitude of the vascular volume pulse wave, enables a rapid determination of the required airbag pressure, thereby allowing an approximately suitable pressure depth of the airbag 110 on the skin of the subject to be quickly determined for the detection of a vascular radial displacement pulse wave.

[0074] The displacement sensing module 130 shown in Figures 1 and 2 is configured to measure a distance in the Z-axis direction from the displacement sensing module 130 to a skin surface at the measurement site 160 of the subject (if the contact section 114 of the airbag 110 is made of a transparent material) or a distance in the Z-axis direction from the displacement sensing module 130 to the contact section 114 of the airbag 110 (if the contact section 114 of the airbag 110 is made of an opaque material). Thus, the displacement sensing module 130 can measure a vascular radial displacement pulse wave of the subject, which is hereinafter simply referred to as the radial displacement pulse wave.

[0075] The displacement sensing module 130 can be any available displacement sensor comprising a transmitter 132 for emitting a measurement signal and a receiver 134 for receiving the reflected measurement signal. The displacement sensing module 130 can be classified based on the shape of its maximum detectable area. The displacement sensing module 130 can be a point-type displacement sensor or a matrix-type displacement sensor formed by arranging multiple point-type displacement sensors, such as a linear or area-like matrix-type displacement sensor.The measurement resolution of the displacement sensing module 130 can be less than 100 micrometers; for example, the displacement sensing module 130 can have a resolution of 100 micrometers, 90 micrometers, 80 micrometers, 70 micrometers, 60 micrometers, 50 micrometers, 40 micrometers, 30 micrometers, 20 micrometers, 10 micrometers, 1 micrometer or less than 1 micrometer.

[0076] The displacement sensor can, for example, be a photoelectric displacement sensor that performs distance measurement using light sources (i.e., the aforementioned transmitter 132) of different wavelengths. The photoelectric displacement sensor can, for example, be a laser displacement sensor, a fiber optic displacement sensor, a three-dimensional laser displacement sensor (3D laser displacement sensor), such as a binocular depth CCD combined with a programmable structured light sectioning system, a time-of-flight (TOF) distance sensor, a three-dimensional time-of-flight (3D TOF) distance array sensor, a laser Doppler anemometer, a laser Doppler velocimeter, a laser Doppler vibrometer, a Michelson interferometer, or a laser interferometer.

[0077] According to some embodiments, the displacement detection module 130 may further include a filter 136 configured to remove various disturbances mixed into the measurement signal, thereby further increasing the signal-to-noise ratio of the measurement signal.

[0078] The in Fig.The scanning position control module 140, as shown, is configured to control the displacement sensing module 130, causing it to move over the subject's measurement site 160. It also controls the displacement sensing module 130 to perform distance measurement scans within a range of the measurement site 160. By combining coordinates determined by the position control module with the amplitude of the radial displacement pulse wave measured at each specific location by the displacement sensing module 130, the position of a blood vessel within the subject's measurement site 160 can be located, or a measurement site with a better signal-to-noise ratio along the blood vessel's direction can be identified to obtain an optimal radial displacement pulse wave measurement signal. Therefore, the scanning position control module 140 is an optional module and can be omitted.If the scanning position control module 140 is not provided, a user can manually move the displacement sensing module 130 to the subject's measurement point 160 to perform distance measurement scans at measurement point 160, or manually locate the position where the pulse beats are strongest and attach a reflective sticker so that a laser light source is aligned with the reflective sticker. The displacement sensing module 130 can be a photoelectric displacement sensor with a point-type, line-type, or area-type sensing area. According to some embodiments, the scanning position control module 140 can, for example, include a single-axis position controller or dual-axis position controllers (such as an XY dual-axis motion platform or a cylindrical coordinate motion mechanism).

[0079] The in Fig.The computing unit 150 shown in Figure 1 comprises several modules formed by a variety of hardware circuits that are electrically interconnected. The computing unit 150 can be any available machine with computing capacity, such as various types of computers, microprocessors, cloud computing units, mobile computing devices, or edge computing devices for artificial intelligence. According to some embodiments, the computing unit 150 comprises a power module 151, a memory module 152, a communication module 153, an operator module 154, a display module 155, and a processing module 156, which are electrically or communicatively interconnected. Some of these modules can also be integrated into a single chip.

[0080] The power module 151 provides the electrical energy required by the computing unit 150. The power module 151 can be an alternating current (AC) power source (e.g., power from a power plant via a standard wall socket) or a direct current (DC) power source (e.g., various dry-cell or rechargeable batteries).

[0081] The memory module 152 can be any available volatile or non-volatile data storage device to store all data generated during the measurement process of the displacement acquisition module 130.

[0082] The communication module 153 is communicatively connected to the aforementioned pressure control module 120, displacement detection module 130, and scanning position control module 140 in order to transmit control signals from the processing unit 150 to the pressure control module 120, displacement detection module 130, and scanning position control module 140, respectively, or to receive information transmitted by the pressure control module 120, displacement detection module 130, and scanning position control module 140 for calculation and analysis by an analysis module 158 or for storage in the storage module 152. The communication module 153 can also be communicatively connected to a cloud database, a cloud computing center, or both, in order to obtain reference data for pulse wave interpretation and to perform analysis and calculation to enable subsequent pulse wave interpretation.The cloud database can contain, for example, an acupuncture meridian database, a pulse chart comparison database, a Chinese herbal medicine database, a pulse wave analysis database, a vascular elasticity database, a pulse wave velocity (PWV) database, a continuous blood pressure analysis database, cloud-based artificial intelligence calculations, or various other databases related to pulse wave analysis to improve the accuracy of pulse wave interpretation results; however, this is not limited to such databases. The Communication Module 153 can also transmit the received monitoring data to a cloud computing center to perform data analysis and calculations to generate interpretation results.

[0083] The operating module 154 provides a user interface for the radial displacement pulse wave measuring device 100, enabling a user to issue control commands through the operating module 154 to operate the pressure control module 120, the displacement detection module 130, and the scanning position control module 140. The user interface can also be displayed on a remote display device via the communication module 153 to facilitate remote control required for telemedicine applications.

[0084] The processing module 156 can include a control module 157 and an analysis module 158. The control module 157 is responsible for providing control commands to the pressure control module 120, the displacement detection module 130, and the scanning position control module 140. The analysis module 158 is responsible for performing calculations and analyses on the information transmitted by the pressure control module 120, the displacement detection module 130, and the scanning position control module 140. The radial displacement pulse wave measurement signal received from the displacement detection module 130 simultaneously contains a Z-axis displacement caused by pulse beats (i.e., a dynamic alternating current (AC) signal) and a Z-axis displacement caused by the downward pressure of the airbag 110 on the measuring point 160 (i.e., a downward pressure depth along the Z-axis, which represents a static direct current (DC) signal).At this point, if only the Z-axis displacement caused by the downward pressure of the airbag 110 against the measuring point 160 is to be clearly measured, the analysis module 158 of the computing unit 150 can be used to filter out the dynamic Z-axis displacement caused by the pulse beats from the obtained measurement signal of the radial displacement pulse wave, leaving only the static Z-axis displacement caused by the downward pressure of the airbag 110 against the measuring point 160. Using this static DC signal, it is convenient to determine the Z-axis downward pressure depth and the corresponding pressure value of the airbag 110, which provide a maximum signal-to-noise ratio of the pulse wave signal and can serve as a target for the pressure control module 120.Therefore, the accuracy and repeatability of the measurement signal determination can be improved, thereby facilitating the detection of the radial displacement pulse wave signal of the subject's blood vessels.

[0085] The display module 155 is configured to show a user interface of the control module 157, to display information transmitted from the pressure control module 120, the displacement detection module 130, and the scanning position control module 140 to the analysis module 158, and to display the analysis results generated by the analysis module 158 based on this information. If the display module 155 is located remotely, the aforementioned information can also be displayed on the remotely located display module 155 via the communication module 153, thus facilitating telemedicine.

[0086] The support section 200 in Fig.2 is attached to the housing 230. An interior of the support section 200 is configured to accommodate a limb segment 240 of the subject, on which the measuring point 160 is located. Furthermore, an artery 250 runs under the skin of the measuring point 160 and enables the displacement detection module 130 to measure a radial displacement pulse wave of the artery 250. The support section 200 comprises a hard outer layer 210 and a soft inner layer 220. The hard outer layer 210 is essentially cylindrical in shape, and the soft inner layer 220 is generally formed by an extension of the airbag 110.

[0087] The hard outer layer 210 of the support section 200 allows a fixed distance MD between the displacement sensing module 130 and a furthest position 212 on the hard outer layer 210 relative to the displacement sensing module 130 to be established, so that a continuous, stable measurement reference can be maintained during the pulse wave measurement process. Therefore, the material of the hard outer layer 210 must possess a certain mechanical strength to ensure that the aforementioned distance MD can continue to be maintained as a fixed value after the support section 200 has been correctly attached to the subject and the airbag 110 has been pressurized. According to some embodiments, it is easier to maintain the distance MD as a fixed value if the airbag 110 is distributed only over the upper half of the hard outer layer 210.

[0088] The structural design of the hard outer layer 210 can vary depending on the shape of the limb segment where the measuring point 160 of the subject is located. Therefore, Fig.Figure 2 merely represents a simplified schematic diagram, and the actual structure of the hard outer layer 210 should not be limited to it. For example, the hard outer layer 210 may have a design similar to a metal watch strap and clasp, with the length of the metal strap being adjustable, which facilitates attachment to the limb segment where the measuring point 160 is located and also allows for convenient storage and portability. If the hard outer layer 210 adopts a structural design of an annular, leaf-like hard shell, the perimeter of the hard outer layer 210 is fixed, and the limb segment where the subject's measuring point 160 is located can pass directly through the hard outer layer 210.Alternatively, the hard outer layer 210 can adopt a structural design of two or more annular, leaf-like hard shells, together with suitable fastening elements for the hard outer layer (such as fasteners) to fix overlapping sections between different annular, leaf-like hard shells. Alternatively, the hard outer layer 210 can also be designed as a C-shaped structure, with the wrist being placed into the structure through an opening in the C-shape during measurement, with a soft inner layer 220 attached to the inside of the opening.

[0089] As described above, the soft inner layer 220 is essentially formed by the airbag 110, so the internal gas pressure of the soft inner layer 220 can also be controlled by the pressure control module 120. Accordingly, the opening size of the hard outer layer 210 can be more easily adjusted, allowing the support section 200 to more comfortably accommodate limbs of different sizes where the measuring point 160 is located, thus facilitating pulse wave measurement. Similarly, the structural design of the soft inner layer 220 can vary depending on the shape of the limb section where the measuring point 160 of the subject is located. Therefore, Fig.Figure 2 merely represents a simplified schematic diagram, and the actual structure of the soft inner layer 220 should not be limited to it. For example, the soft inner layer 220 can be formed directly by a cylindrical airbag 110. Alternatively, the soft inner layer 220 can be formed by a sheet-like airbag 110, with two side ends of the airbag 110 overlapping and fixed by suitable fastening elements of the soft inner layer (such as hook-and-loop fasteners). Furthermore, the soft inner layer 220 can consist of only a measuring section 110a (including the transparent window 112 and the contact section 114 of the airbag 110), as shown in Figure 2. Fig. Sections 2 shown can be retained, while other sections of the airbag 110 can be omitted.

[0090] According to some embodiments, the soft inner layer 220, in addition to the airbag 110, can include a plurality of independent auxiliary airbags to accommodate a wider range of sizes and shapes of the limb section 240 where the measuring point 160 is located. The pressure of each auxiliary airbag can be independently controlled by the pressure control module 120, enabling each independent airbag to easily fill the remaining irregular spaces between the inside of the support section 200 and the limb section. Method for localizing the measurement point of the radial displacement pulse wave

[0091] The following describes a method for measuring pulse waves using the aforementioned device for measuring a radial displacement pulse wave 100. If the device for measuring a radial displacement pulse wave 100 includes the scanning position control module 140, the movement of the displacement detection module 130 can be automatically controlled at a suitable downward compression depth of the airbag in order to scan the measurement point 160 of the subject and locate an optimal measurement position within the measurement point 160. Please see Figures 3A and 3B.

[0092] Fig. Figure 3A is a schematic diagram illustrating a process for automatically locating a measurement point of a radial displacement pulse wave using the scanning position control module 140 according to an embodiment of the present disclosure, wherein the displacement detection module 130 is a point-type displacement sensor.

[0093] In step 310 of Fig. 3A The airbag 110 of the device for measuring a radial displacement pulse wave 100 is first placed at the measuring point 160 of the subject, thereby bringing the contact section 114 of the airbag 110 into contact with the skin of the measuring point 160. By detecting the maximum amplitude of the vascular volume pulse wave, the downward compression depth of the airbag 110 can be roughly adjusted to a depth at which the vascular pulses can be detected even before the displacement detection module 130 is aligned with the blood vessel, thus accelerating the entire measurement process.

[0094] In step 320, the pressure control module 120 is used to gradually increase the internal pressure of the airbag 110. When the pressure sensor 122 in the pressure control module 120 detects that the signal generated by the pulses has reached its maximum value, i.e., when the amplitude of the vascular volume pulse wave reaches its maximum, a rough downward compression depth is identified, and the pressure control module 120 stops applying pressure to the airbag 110 to maintain its internal pressure. According to some embodiments, step 320 can be skipped, and step 330a can be executed directly.

[0095] In step 330a, a starting position (coordinate) is first selected at measuring point 160 of the subject. The point-type displacement sensor is then moved by the scanning position control module 140 to a position above the starting position, which serves as the starting point for scanning. The distance between the point-type displacement sensor and measuring point 160 is then measured.

[0096] In step 340a, the scanning position control module 140 is used to scan the point-type displacement sensor along a direction perpendicular to the vascular direction, i.e., along the Y-axis. Within a specific area, the amplitude of the radial displacement pulse wave initially increases gradually and then decreases. The position along the Y-axis at which the amplitude of the radial displacement pulse wave reaches its maximum is identified, which corresponds to the location of the blood vessel and is referred to as the first measurement position.

[0097] In step 350a, the scanning position control module 140 is used to align the point-type displacement sensor with the first measurement position.

[0098] In step 360, the pressure of airbag 110 is adjusted until the maximum amplitude signal of the radial displacement pulse wave is obtained at the first measurement position, thereby generating a radial displacement pulse wave measurement signal with an improved signal-to-noise ratio. At this point, the pressure of airbag 110 corresponds to the optimal measurement pressure, and the downward compression depth of airbag 110 at measurement point 160 corresponds to the optimal measurement depth. Therefore, after completion of step 360, the process for locating the measurement point of the pulse wave can be concluded.

[0099] However, step 370 can be performed if there are special requirements (for example, specific pulse measurement positions are emphasized in traditional Chinese medicine) or if the detected vascular radial displacement pulse wave has an insufficient signal-to-noise ratio. In step 370, the scanning position control module 140 is used to scan along the vascular direction, i.e., along the X-axis, to locate the position where the radial displacement pulse wave signal shows a local maximum (the second measurement position). Once located, the second measurement position serves as the measurement site for the radial displacement pulse wave.

[0100] If the device for measuring a radial displacement pulse wave 100 does not include the scanning position control module 140, or if the scanning position control module 140 is not to be used, the movement of the point-type displacement sensor can be manually controlled to perform a scan over the measuring point 160 of the subject and to locate an optimal measuring position within the measuring point 160. Since the movement of the point-type displacement sensor is manually controlled, the first half of the manual control process differs from the first half of the automatic control process. Please refer to Fig. 3B.

[0101] Next, please refer to Fig. 3B. Fig.Figure 3B is a schematic diagram illustrating an operating procedure for manually locating the measurement point of the radial displacement pulse wave according to another embodiment of the present disclosure, in which the displacement sensing module 130 is a point-type displacement sensor. Since the measurement point must first be located manually, it is preferable that at least the transparent window 112 and the contact section 114 of the airbag 110 be made of transparent materials. Alternatively, the main body of the airbag 110, the transparent window 112, and the contact section 114 can all be made of transparent materials, or openings can be formed in the visible areas of the support section 200 and the housing 230, or these components can be made of transparent materials to facilitate visual identification of the measurement point by the user.In step 305, the function of the scanning position control module 140 is replaced by a manual operation. After the user has manually touched the artery at the measuring point 160 where the pulse is felt, the position of the artery within the measuring point 160 (the first measuring position) can be directly identified. In this step, if the contact section 114 is transparent or semi-transparent, a reflective patch that reflects the measurement signal can be applied to the skin surface at the position of the artery. The measurement signal emitted by the displacement detection module 130 is then aligned with the reflective patch before the subsequent steps 310, 350a, 360, and 370 are performed. Since the subsequent steps 310, 350a, 360, and 370 are identical or similar to those in [reference missing], the following steps are performed: Fig. Since the processes described in section 3A are not detailed, the descriptions are omitted here.

[0102] Next, please refer to Fig. 3C. Fig. Figure 3C is a schematic diagram illustrating an operating sequence for locating the measurement point of the radial displacement pulse wave according to another embodiment of the present disclosure, in which the displacement detection module 130 is a linear space displacement sensor. The Fig. The process shown in 3C is similar to that of Fig.3A, except that the linear space displacement sensor is formed by arranging several point-type displacement sensors in a linear configuration. Therefore, the scanning process along the Y-axis to locate the first measurement position can be omitted. Accordingly, only the slightly different steps 330c and 340c are described below, while the remaining steps are not repeated. Furthermore, step 320 can also be skipped, and step 330c can be performed directly to measure the radial displacement pulse wave.

[0103] In step 330c, the scanning position control module 140 or a manual operation can be used to align the linear measurement range of the linear ray displacement sensor directly parallel to the Y-axis and over the position of the artery. In step 340c, the internal pressure of the airbag is adjusted incrementally while observing which point-type displacement sensor within the linear ray displacement sensor detects the maximum signal value of the radial displacement pulse wave. This allows the determination that the corresponding point-type displacement sensor is positioned over the artery, meaning that the first measurement position has been located and the subsequent step 360 can be performed directly.

[0104] When using an area-like array displacement sensor, the scan steps along the X-axis and Y-axis for locating the position with the maximum signal (i.e., the starting position and the first measurement position) can be omitted. The area-like array displacement sensor can be positioned directly above measurement point 160, and the point-type displacement sensor within the area-like array displacement sensor, which detects the maximum radial displacement pulse wave signal, can be identified. Once the optimal signal-to-noise ratio measurement depth is found, this indicates that this point-type displacement sensor is positioned above the aforementioned second measurement position. Thus, the measurement signal obtained by this point-type displacement sensor can be used for subsequent applications.Therefore, when using both an area-like array displacement sensor and a linear array displacement sensor, the device for measuring a radial displacement pulse wave 100 can select the use of the scanning position control module 140 based on the actual requirements.

[0105] As described above, the cooperation between the airbag 110 and the pressure control module 120 enables the airbag 110 to control the downward pressure depth along the Z-axis at the measuring point 160, allowing the displacement detection module 130 to locate an optimal pulse wave measurement depth along the Z-axis with a better signal-to-noise ratio. Once the airbag 110 has been pressed against the measuring point 160, the scanning position control module 140 enables the displacement detection module 130 to locate an optimal pulse wave measurement position on the XY plane with a better signal-to-noise ratio. Therefore, the device for measuring a radial displacement pulse wave 100 within the measuring point 160 of the subject can easily locate an optimal measurement position with a better signal-to-noise ratio to obtain an improved radial displacement pulse wave signal. Analysis of pulse waveforms in response to pressure variations.

[0106] Fig. Figure 4 is a schematic diagram showing waveforms of a vascular volume pulse wave and a radial displacement pulse wave, which change with pressure and time according to one embodiment of the present disclosure. Fig.Figure 4 represents time on the horizontal axis, and the vertical axis is divided into four segments from top to bottom: Valve, Pump, Pressure, and Depth. The curve in the uppermost Valve segment shows the on / off state of the valve over time. The curve in the Pump segment shows the on / off state of the pump over time. The curve in the Pressure segment shows the real-time change in the internal pressure of the airbag 110, corresponding to the vascular volume pulse wave measured by the Pressure Sensor 122. The curve in the lower Depth segment shows the real-time change in the downward pressure of the airbag 110 along the Z-axis at the measuring point, corresponding to the radial displacement pulse wave measured by the Displacement Detection Module 130. Please refer to both Fig. 4 as well as Table 1 below for a detailed description of the waveform changes during different time intervals (t0-t1, t1-t2, t2-t3 and t3-t4) along the time axis. Table 1: Relationship between the pressure and depth in Figure 4 and the corresponding signals of the radial displacement pulse wave. period Timeline Compression depth Airbag pressure Amplitude signal of the radial displacement pulse wave Period I t0 D1 P1=0 None t1 D5 P5 None Period II D4 P4 Begins to appear t2 D3 P3 Maximum Period III t3 D3 P3 Maximum Period IV D2 P2 It begins to disappear t4 0 P1 =0 None

[0107] During period I (t0-t1), the air valve is closed to stop the deflation of airbag 110, and the pump is activated to inflate airbag 110, thereby continuously and gradually increasing its internal pressure. During this gradual pressure increase process up to P5, the signals of the vascular volume pulse wave and the radial displacement pulse wave can be observed transitioning from being absent, then gradually increasing, subsequently decreasing, and finally disappearing. In this way, the maximum pressure at which airbag 110 should deflate can be determined as P5. The operation in period I is an optional step that can be omitted.The internal pressure of the airbag can be directly adjusted, and variations in the amplitude of the vascular radial displacement pulse wave and the compression depth can be detected to obtain a pulse wave signal of the vascular radial displacement pulse wave with an optimized signal-to-noise ratio.

[0108] In the second period (t1-t2), the pump is switched off at time t1 to stop the inflation of airbag 110, and the valve is opened to gradually deflate airbag 110. As the pressure of airbag 110 decreases to P4 and the pressure depth reaches D4, signals from both the vascular volume pulse wave and the radial displacement pulse wave begin to appear. As the pressure of airbag 110 continues to decrease gradually, at time t2, the pressure P3 and pressure depth D3 reach their peak, and the amplitude of the radial displacement pulse wave reaches its maximum value. At this moment, the amplitude of the vascular volume pulse wave is also near its maximum value. Therefore, pressure P3 and pressure depth D3 are considered optimal conditions for measuring the radial displacement pulse wave.At time t2, the valve is also closed to maintain this state for a certain period, during which the vascular volume pulse wave, the radial displacement pulse wave, or both can be monitored and recorded if necessary. Since the pressure P3 and pressure depth D3 required to achieve the maximum amplitude of the vascular volume pulse wave (related to the vascular volume change) and the maximum amplitude of the radial displacement pulse wave (related to the vascular diameter change) are not necessarily identical, the appropriate pressure P3 and pressure depth D3 to be maintained during this phase can be determined based on the actual measurement requirements.

[0109] In the third period (t2-t3) the airbag pressure at P3 and the airbag pressure depth at D3 are maintained so that the vascular volume pulse wave, the radial displacement pulse wave or both can be monitored and recorded if necessary.

[0110] In the fourth period (t3 to t4), after the monitoring and recording performed during the third period at time t3 is completed, the valve opens to allow airbag 110 to gradually release its pressure. When the pressure of airbag 110 drops to P2 and the penetration depth D2 is reached, both the vascular volume pulse wave and the radial displacement pulse wave signals disappear. Airbag 110 then continues to deflate until its pressure reaches zero, marking the end time t4.

[0111] By comparing the vascular volume pulse wave in the pressure segment and the radial displacement pulse wave in the depth segment during the third period (t2-t3), it can be observed that the radial displacement pulse wave exhibits more waveform detail. Therefore, it can be used for more comprehensive data analysis to obtain multiple physiological parameters, thus enabling its application in a broader range of physiological monitoring fields. Examples are provided below. Methods for measuring blood pressure

[0112] The following describes how to perform a blood pressure measurement. To measure blood pressure, the measurement site (160 mmHg) of the subject can be, for example, the radial artery on the inside of the wrist or the brachial artery on the inside of the upper arm near the elbow joint.

[0113] Fig.5 is a schematic flowchart illustrating the process of blood pressure measurement using the [method / method - context needed]. Fig. Figure 1 illustrates the device for measuring a radial displacement pulse wave. After the first or second measurement position of the radial displacement pulse wave has been located using the method described above, the displacement detection module 130 is aligned with the first or second measurement position to perform a blood pressure measurement. Although both vascular volume pulse waves and radial displacement pulse waves can be used for blood pressure measurement, the signal of the radial displacement pulse wave is clearer than that of the vascular volume pulse wave. Therefore, the radial displacement pulse wave will primarily be used as the basis for determining blood pressure in the following discussion.

[0114] Step 510 generally corresponds to the first period (stage I), which is in Fig.As shown in Figure 4 and Table 1. In step 510, the pressure control module 120 gradually increases the internal pressure of the airbag 110 until the signal amplitude of the radial displacement pulse wave appears and then disappears.

[0115] Step 520 generally corresponds to the period from time t1 to time t2 during the second stage (stage II), which is described in Fig.As shown in Figure 4 and Table 1, that is, from the time when the airbag 110 reaches a pressure P4 and a penetration depth D4, until the time when the airbag 110 reaches a pressure P3 and a penetration depth D3. In step 520, the pressure control module 120 gradually reduces the internal pressure of the airbag 110. When the signal amplitude of the radial displacement pulse wave begins to reappear, the static DC voltage signal of the vascular volume pulse wave, obtained by the pressure sensor 122 of the pressure control module 120, represents the internal pressure value (P4) of the airbag 110, which corresponds to the systolic blood pressure (P4) of the subject, after the dynamic signal of the vascular volume pulse wave caused by the heartbeat has been filtered out.

[0116] Step 530 generally corresponds to the period from time t3 to time t4 during the fourth stage (stage IV), which is in Fig.As shown in Figure 4 and Table 1, that is, from the time when the airbag 110 reaches a pressure P3 and a penetration depth D3, until the time when the airbag 110 reaches a pressure P2 and a penetration depth D2. In step 530, the pressure control module 120 continues the gradual reduction of the internal pressure of the airbag 110. When the signal amplitude of the radial displacement pulse wave begins to disappear again, the static DC voltage signal of the vascular volume pulse wave, obtained by the pressure sensor 122 of the pressure control module 120, represents the internal pressure value (P2) of the airbag 110, which corresponds to the diastolic blood pressure (P2) of the subject, after the dynamic signal of the vascular volume pulse wave caused by the heartbeat has been filtered out. Measurement of heart rate variability and its use

[0117] Fig.Figure 6A is an enlarged schematic diagram of the radial displacement pulse wave during the third stage (stage III) from time t2 to t3, which is shown in Fig. 4 is shown. Fig. 6A, since the peak positions of the radial displacement pulse wave are clearly identifiable, these peak positions can be used to simulate the R-wave peaks in a conventional electrocardiogram (ECG) to extract beat-to-beat interval (RR interval, RRI) data. By recording the radial displacement pulse wave signals for one minute and calculating the number of detected peaks, the heart rate per minute can be obtained. Fig. 6A represents the distance between two adjacent peaks on the radial displacement pulse wave curve, the heart rate interval.

[0118] Heart rate variability (HRV) refers to the variability in the time intervals between successive heartbeats. Under normal conditions, heartbeats do not occur at perfectly regular intervals but exhibit slight variations known as heart rate variability. Therefore, HRV analysis is a method for measuring the degree of variation in continuous beat-to-beat intervals. When using the device for measuring a radial displacement pulse wave 100 to measure heart rate variability, the measurement area 160 can be selected from a region with relatively thin subcutaneous tissue, such as the styloid process of the wrist and its anterior or posterior aspect, the earlobe or auricular artery, the palmar artery, the sole of the foot, or the toes, where a blood vessel can be located to obtain a radial displacement pulse wave with a more pronounced peak.

[0119] Heart rate variability (HRV) analysis can be divided into two types. The first type is time-domain analysis, which typically continuously measures electrocardiogram (ECG) waveforms and directly calculates and analyzes the dispersion of the corresponding beat-to-beat intervals. Common examples include:

[0120] SDNN (Standard Deviation of NN Intervals): typically refers to the standard deviation of normal beat-to-beat intervals over a 24-hour period, expressed in milliseconds (ms).

[0121] SDANN (Standard Deviation of Mean NN Intervals): typically refers to dividing the continuous recording into five-minute segments, calculating the mean NN interval for each segment, and then calculating the standard deviation of these averages, expressed in milliseconds (ms).

[0122] A more detailed explanation is given below using SDNN as an example. SDNN is a measure of the overall activity of the autonomic nervous system, reflecting the combined activity of the sympathetic and parasympathetic nervous systems and representing the body's ability to regulate physiological processes. SDNN is the standard deviation of RR intervals (RRI) within a given time period, as each RRI is not necessarily identical. The unit of measurement for SDNN is milliseconds (ms). The standard deviation of the RRI describes the degree of dispersion of each RRI around its mean value. The greater the dispersion, the larger the standard deviation. Conversely, if all RRIs are identical, the standard deviation of the RRI is 0. After calculating all RRIs from the HRV recording, the relationship between RR intervals (RRI) and time can be derived, as shown in Fig.6B shown. SDNN can be calculated using equations (1) and (2) below. SDNN=1N−1∑i=1N(RRiRR¯)2 RR¯=1N∑i=1NRRi+1 where RRi represents the i-th RR interval (RRI), N represents the total number of measured RRIs, and RR represents the average of all RRIs. The variable i is a positive integer.

[0123] The second method is frequency domain analysis, which uses a discrete Fourier transform (DFT) to convert the time series of beat-to-beat intervals into the frequency domain and expresses the results in terms of power spectral density or spectral distribution, as in Fig.Figure 6C shows this. Typically, spectral analysis of heart rate variability (HRV) signals requires a stable recording of 200 to 500 consecutive RRIs, corresponding to several minutes of recording time. The RRI spectrum is generally below 1 Hz; for example, multiple RRI spectral peaks can be observed in the range of 0 to 0.4 Hz, including the ultra-low frequency (ULF: ≤ 0.003 Hz), very low frequency (VLF: 0.0033–0.04 Hz), low frequency (LF: 0.04–0.15 Hz), and high frequency (HF: 0.15–0.40 Hz). Among these, the HF band usually reflects parasympathetic nervous system activity, the LF band is influenced by both the sympathetic and parasympathetic nervous systems, and the LF / HF ratio reflects the balance between sympathetic and parasympathetic nervous system activity. Methods for measuring pulse wave velocity

[0124] Pulse wave velocity (PWV) refers to the speed at which fluctuations in arterial blood propagate through the blood vessels. These fluctuations are caused by pressure waves generated during the ventricular contraction of the heart and propagated along the arterial system. Therefore, PWV can reflect the elasticity and stiffness of the arteries. PWV is inversely proportional to the viscoelasticity of the arterial walls, meaning that the stiffer the arteries, the faster the PWV; conversely, the softer the arteries, the slower the PWV.

[0125] The interpretation of pulse wave velocity (PWV) should consider factors such as age, sex, pre-existing conditions, and risk factors. Generally, the normal PWV of the aorta is approximately 5–7 m / s, while a PWV greater than 10 m / s indicates significant arterial stiffness. PWV is closely associated with the incidence and mortality of cardiovascular disease; therefore, PWV can serve as an important indicator for assessing cardiovascular risk and prognosis, including conditions such as coronary artery disease, atherosclerosis, or connective tissue disorders.

[0126] The measurement of pulse wave velocity (PWV) is primarily performed by simultaneously recording pressure waveforms at two different locations along the arterial system. These two locations comprise a proximal location near the heart and a distal location further away from the heart. By simultaneously recording the waveforms at the proximal and distal locations, the delay time ΔT (= T2 - T1) of the distal waveform relative to the proximal waveform can be directly measured. After measuring the distance ΔD between the proximal and distal locations, the PWV can be calculated according to equation (3) below. PWV=ΔD / ΔT

[0127] There are two methods for measuring the delay time ΔT. The first method uses two displacement detection modules 130, and the second method combines an electrocardiogram (ECG) with a single displacement detection module 130.

[0128] Fig.Figure 7A is a schematic diagram of the simultaneous use of two pulse wave measuring devices for measuring the pulse wave velocity according to an embodiment of the present disclosure. Fig. 7A Two devices for measuring a radial displacement pulse wave 100 are used directly to record the proximal radial displacement pulse wave and the distal radial displacement pulse wave simultaneously, thereby allowing the delay time ΔT between the proximal and distal radial displacement pulse waves to be measured directly, based either on the valley-to-valley or the peak-to-peak alignment. Fig.Figure 7A shows the valley-to-valley delay time ΔT. If one of the two devices for measuring a radial displacement pulse wave 100 uses a manually aligned displacement sensing module 130 for alignment with the measuring point 160, the scanning position control module 140 can be omitted, leaving only the airbag 110, the pressure control module 120, the displacement sensing module 130, and the computing unit 150 in the device for measuring a radial displacement pulse wave 100. Furthermore, the two devices for measuring a radial displacement pulse wave 100 can share a single computing unit 150, thus eliminating the need for one of the computing units 150.

[0129] Fig. Figure 7B is a schematic diagram for measuring pulse wave velocity using an electrocardiogram (ECG) according to an embodiment of the present disclosure. Fig.7B The R-wave peak of the ECG is used as a temporal reference to align the proximal and distal pulse waves. In the upper part (I) of the Fig. 7B defines the delay time of the trough of the proximal radial displacement pulse wave relative to the R-wave peak of the ECG as T1. In the lower part (II) of the Fig. In section 7B, the delay time of the trough of the distal radial displacement pulse wave relative to the R-wave peak of the ECG is defined as T2. The time difference between T1 and T2 is defined as the delay time ΔT. The delay time ΔT measured by the two methods described above represents the pulse transit time (PTT).

[0130] The distance ΔD between the proximal and distal sites can be measured directly using a flexible measuring tape to determine the distance between the two measurement positions. Alternatively, the sum of the distances from the heart to each of the two measurement positions can be measured and multiplied by a coefficient. The proximal and distal sites can include, for example, the carotid artery, femoral artery, brachial artery, radial artery, ankle artery, digital artery, or posterior tibial artery, and the measurement positions are defined according to the specific measurement requirements. Different combinations of proximal and distal positions allow for the calculation of different pulse wave velocities.

[0131] Fig. 7C is a flowchart illustrating the procedure for measuring pulse wave velocity using the in Fig. 7A illustrates the approach shown.

[0132] In step 710, one of the devices for measuring a radial displacement pulse wave 100 is placed at the first measurement position of the proximal artery. The alignment of the device with the target artery to be measured is performed either automatically or manually according to the instructions in Fig. 3A or Fig. The procedure described in section 3B is followed. The vascular radial displacement pulse wave at the first measurement position of the artery is then recorded.

[0133] In step 720, another device for measuring a radial displacement pulse wave 100 is placed at the second measurement position of the distal artery. The alignment of the device with the target artery to be measured is performed either automatically or manually according to the instructions in Fig. 3A or Fig. The procedure described in section 3B is followed. The vascular radial displacement pulse wave at the second measurement position of the artery is then recorded.

[0134] In step 730, the signals of the vascular radial displacement pulse wave obtained in steps 710 and 720 are simultaneously acquired to obtain the pulse wave delay time ΔT. This step 730 can be repeated multiple times within a specific time period to obtain the successive delay times ΔTi for each pulse wave during that period, that is, the successive pulse transit times (PTTi).

[0135] In step 740, the distance ΔD between the first and second measurement positions is measured. Various displacement sensors, such as point-type, linear matrix-type, or planar matrix-type sensors, can be used to measure the distance ΔD. When using point-type displacement sensors, the distance ΔD can be measured using a measuring tape to determine the length between the two point-type displacement sensors, one at the first position and the other at the second.

[0136] According to some embodiments, when using a linear or planar optical displacement sensor, only one optical displacement sensor is required to simultaneously measure the radial displacement pulse waves at two positions by utilizing two non-adjacent sensors within the optical displacement sensor at a known distance. Since the measurement signal of the optical displacement sensor is typically a laser beam, the distance between these two positions within the scan area can be estimated by configuring the scan area of ​​the optical displacement sensor to cover both the first and second measurement positions. This estimation is achieved by using the two non-adjacent sensors at a known distance and applying simple geometric proportional calculations.

[0137] In step 750, based on the successive pulse transit times (PTTi) obtained in step 730 and the distance ΔD obtained in step 740, the successive pulse wave velocities are calculated using the formula: ΔD / ΔTi = ΔD / PTTi. Continuous blood pressure monitoring

[0138] Currently, conventional cuff-based blood pressure monitors on the market determine systolic and diastolic pressure by detecting vascular volume pulse waves. While convenient, these devices provide inaccurate readings and cannot deliver real-time blood pressure measurement. Furthermore, portable continuous blood pressure monitors typically estimate blood pressure based on the correlation between pulse transit time (PTT) and blood pressure using the Branwell-Hill formula. However, conventional methods for calculating continuous blood pressure using the Branwell-Hill formula suffer from inaccuracies in the real-time estimation of vascular diameter and insufficient sensitivity in pulse wave detection. These shortcomings lead to errors in the calculation of pulse transit time and, consequently, to an inaccurate continuous blood pressure reading derived from the Branwell-Hill formula.Accordingly, one embodiment of the present disclosure provides a continuous blood pressure measuring device that can improve the accuracy of vascular diameter measurement and increase the sensitivity of pulse wave detection, thereby increasing the measurement accuracy of portable continuous blood pressure measuring devices.

[0139] The Branwell-Hill formula is a mathematical model that describes the relationship between the change in vascular diameter and pulse wave velocity (PWV). This formula is a modification of the Moens-Korteweg equation, which accounts for the reduction in arterial compliance with increasing pressure as well as the increase in vascular volume (arterial distension) with increasing pressure. The Branwell-Hill formula is expressed in equation (4) as follows: ΔP=ρ(ΔDPTT)2(ΔRR)=ρ×PWV2(ΔRR) where ΔP represents the change in blood pressure, ρ is the blood density, ΔD is the distance between the first and second measurement positions in the pulse wave velocity measurement described above, PTT is the pulse transit time from the first to the second measurement position, ΔR is the change in arterial diameter at the first or second measurement position at the wrist, and R is the arterial diameter at the first or second measurement position at the wrist as a reference. Here, (ΔD / PTT) represents the pulse wave velocity (PWV).

[0140] Therefore, by using a displacement sensor to measure the change in arterial diameter ΔRi for each pulse wave and by applying the pulse wave velocity (PWV) measurement method to determine the PWVi for each pulse wave, the Branwell-Hill formula can be used to estimate the blood pressure change ΔPi for each pulse wave, thus enabling continuous blood pressure measurement. The continuous blood pressure measurement method is described in more detail below.

[0141] Fig. Figure 8 is a flowchart of a procedure for the continuous measurement of blood pressure.

[0142] In step 810, the initial diastolic pressure and the initial systolic pressure are first measured. Following the procedure for measuring blood pressure described in the previous section, the subject's initial diastolic pressure P2 and initial systolic pressure P4 are obtained. Additionally, the first compression depth D2 of the airbag 110 at measuring point 160, when the initial diastolic pressure P2 occurs, and the second compression depth D4 of the airbag 110 at measuring point 160, when the initial systolic pressure P4 occurs, are measured as described in [reference to relevant section]. Fig. As shown in Figure 4 and Table 1, the vascular diameter R can then be obtained by calculating the difference between the second compression depth and the first compression depth, i.e., R = (D4 - D2).

[0143] In step 820, the vascular diameter and the change in vascular diameter are calculated. As in Fig.As shown in Figure 6A, the waveform of the vascular radial displacement pulse wave varies over time. The difference between the peak (R2) and trough (R1) of each radial displacement pulse wave represents the change in vascular diameter ΔR caused by each heartbeat.

[0144] In step 830, the pulse wave velocity (PWV) of each pulse wave is measured according to the pulse wave measurement procedure described in the previous section.

[0145] In step 840, based on the obtained change in vascular diameter ΔR, the vascular diameter R and the pulse wave velocity (PWV) together with the subject's blood density, the Branwell-Hill equation is used to calculate the change in blood pressure ΔP.

[0146] In step 850, based on the initial diastolic pressure P2 and the initial systolic pressure P4 measured in step 810, together with the blood pressure change ΔP obtained in step 840, the real-time diastolic pressure (P2 + ΔP) and the real-time systolic pressure (P4 + ΔP) can be determined.

[0147] Steps 820 to 850 are then repeated over a period of time. This allows for highly accurate continuous blood pressure measurement, thus enabling continuous blood pressure monitoring.

[0148] As described above, the device provided by the combination of the airbag, pressure control module, and displacement sensing module is capable of directly measuring the waveform of the vascular radial displacement pulse wave. Compared to conventional methods for measuring pressure pulse waves, this direct measurement approach yields more accurate results.

[0149] Furthermore, the radial displacement pulse wave (RSW) measuring device boasts a measurement accuracy of less than 100 micrometers, enabling the acquisition of detailed pulse wave characteristics such as waveform, amplitude, and temporal features. High-accuracy measurements are extremely valuable for various pulse wave analysis applications. In addition to commonly measured parameters like blood pressure, heart rate variability, and pulse wave velocity, the RSW measuring device can also perform many other analyses. For example, it can be used to assess the degree of arterial stiffness, measure vascular elasticity, monitor the risk of cardiovascular disease, and investigate hemodynamics.This multifunctional application potential allows the device to be used in a variety of ways in medical and biomedical fields for measuring a radial displacement pulse wave.

[0150] Furthermore, the use of the device described above for measuring a radial displacement pulse wave is a non-invasive measurement method. Therefore, the device can be conveniently used to continuously monitor changes in a subject's pulse waves in real time, providing immediate measurement results and waveform diagrams. Moreover, the portable design allows for continuous and stable monitoring of the subject's pulse waves over extended periods. This is of great value to physicians and researchers, as it helps them better understand the subject's cardiovascular status and make appropriate diagnostic and treatment decisions, thereby supporting improved personalized healthcare.

[0151] In summary, the device described above for measuring a radial displacement pulse wave offers several advantages, including the direct measurement of vascular radial displacement pulse waves, high measurement accuracy, multiple application analyses, non-invasive surgery, and real-time monitoring. These advantages enable the device to be widely used in the fields of cardiovascular medicine and biomedical research. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] US 18 / 098,729

[0001]

Claims

[1] Device for measuring a radial displacement pulse wave, which serves to measure a radial displacement pulse wave of an artery at a measuring point of a subject, wherein the device for measuring a radial displacement pulse wave comprises the following: a housing with a transparent section, wherein the transparent section comprises a hole or a first transparent plate; a transparent airbag arranged below the transparent section, wherein a main material of the transparent airbag is a material that is resistant to strain deformation; a pressure control module configured to control an internal pressure of the transparent airbag in order to control a downward pressure exerted by the transparent airbag on the measuring point in order to amplify a signal of an arterial pulse; a displacement sensing module positioned above the transparent section and configured to detect the pulses of the artery and measure a dynamic distance between the skin of the measurement site and the displacement sensing module caused by the pulses of the artery in order to obtain the radial displacement pulse wave; and; and a computing unit that is communicatively connected to the pressure control module and the displacement sensing module and is configured to transmit control signals to the pressure control module and the displacement sensing module, respectively, and to receive control signals from the pressure control module and the displacement sensing module, respectively. Receives information transmitted by the displacement detection module in order to perform calculations. [2] Device for measuring a radial displacement pulse wave according to claim 1, wherein a main material of the transparent airbag comprises polymethyl methacrylate, cellulose acetate, nylon-66 polyamide resin, nylon-6 polyamide resin, polybutylene terephthalate, polyethylene terephthalate, polyphenylene oxide, polycarbonate, ethylene-vinyl acetate copolymer, polyethylene, polypropylene, polyvinyl chloride, polyoxymethylene or polyurethane. [3] Device for measuring a radial displacement pulse wave according to claim 1, wherein the transparent airbag, if the transparent section is the hole, further comprises a transparent window that overlaps the transparent section of the housing, the transparent window comprising a second transparent plate. [4] Device for measuring a radial displacement pulse wave according to claim 3, wherein an anti-reflective coating is arranged on an outer surface of the transparent window. [5] Device for measuring a radial displacement pulse wave according to claim 3, wherein an area of ​​the second transparent plate is larger than an area of ​​the hole, so that if an internal pressure of the transparent airbag is too high, the second transparent plate rests against a bottom of the hole and is prevented from being pressed towards a top of the hole. [6] Device for measuring a radial displacement pulse wave according to claim 1, wherein the transparent airbag further comprises a contact section configured to fit snugly against the skin of the subject's measurement site, and wherein a material of the contact section is a soft, stretchable and deformable thermoplastic elastomer material comprising at least one of the following materials: thermoplastic polyurethane, polyolefin elastomer, dynamically vulcanized polyolefin elastomer, polystyrene elastomer, polyether ester elastomer, polyamide elastomer and polyvinyl chloride. [7] Device for measuring a radial displacement pulse wave according to claim 6, wherein a reflective layer or a dichroic layer is arranged on an inner surface of the contact section. [8] Device for measuring a radial displacement pulse wave according to claim 1, further comprising a support section configured to accommodate a limb section of the subject, wherein the measuring point is located in an interior of the support section, the support section comprising: a soft inner layer encompassing the transparent airbag; and a hard outer layer that is positioned outside the soft inner layer to form, together with the soft inner layer, the interior of the load-bearing section, wherein during a measurement process of the radial displacement pulse wave, the hard outer layer maintains a fixed distance between the displacement sensing module and a position furthest away on the hard outer layer relative to the displacement sensing module. [9] Device for measuring a radial displacement pulse wave according to claim 8, wherein the soft inner layer further comprises a plurality of auxiliary airbags and the internal pressure of the auxiliary airbags is controlled by the pressure control module. [10] Device for measuring a radial displacement pulse wave according to claim 1, wherein the pressure control module comprises: a pressure sensor configured to detect the internal pressure of the transparent airbag; and a pressure adjustment module configured to adjust the internal pressure of the transparent airbag, the pressure adjustment module comprising a pump. [11] Device for measuring a radial displacement pulse wave according to claim 10, wherein the pressure adjustment module further comprises a pulse width modulation circuit configured to adjust the speed of a motor of the pump. [12] Device for measuring a radial displacement pulse wave according to claim 1, wherein the displacement detection module comprises a transmitter and a receiver, wherein the transmitter and the receiver are aligned with the transparent section, and wherein the transparent section and the transparent airbag are configured such that a measurement signal emitted by the transmitter passes through the transparent section and the transparent airbag. [13] Device for measuring a radial displacement pulse wave according to claim 1, wherein the displacement detection module comprises a photoelectric displacement sensor. [14] Device for measuring a radial displacement pulse wave according to claim 13, wherein the photoelectric displacement sensor comprises a distance measuring device selected from the group consisting of: a laser displacement sensor, a fiber optic displacement sensor, a three-dimensional laser displacement sensor, a time-of-flight (TOF) distance sensor, a three-dimensional time-of-flight (3D TOF) distance array sensor, a laser Doppler anemometer, a laser Doppler velocimeter, a laser Doppler vibrometer, a Michelson interferometer and a laser interferometer. [15] Device for measuring a radial displacement pulse wave according to claim 1, wherein the displacement detection module further comprises a filter. [16] Device for measuring a radial displacement pulse wave according to claim 1, further comprising a scanning position control module which is communicatively connected to the computing unit and is configured to control the displacement detection module to perform distance measurement and scanning within the measuring point, wherein the scanning position control module comprises a single-axis position controller or a dual-axis position controller. [17] Device for measuring a radial displacement pulse wave, which serves to measure a radial displacement pulse wave of an artery at a measuring point of a subject, wherein the device for measuring a radial displacement pulse wave comprises the following: a housing with a transparent section, wherein the transparent section comprises a hole or a first transparent plate; a non-transparent airbag arranged below the transparent section, wherein a main material of the non-transparent airbag is a material resistant to strain deformation, and wherein the non-transparent airbag comprises a transparent window overlapping the transparent section of the housing, the transparent window comprising a transparent material resistant to strain deformation, or a second transparent plate; a pressure control module configured to control the internal pressure of the transparent airbag in order to control a downward pressure exerted by the transparent airbag on the measuring point in order to amplify a signal of the arterial pulse beats; a displacement sensing module positioned above the transparent section and configured to detect the pulse beats of the artery and measure a dynamic distance between the skin of the measurement site and the displacement sensing module caused by the pulse beats of the artery in order to obtain the radial displacement pulse wave; and a computing unit that is communicatively connected to the pressure control module and the displacement sensing module and is configured to transmit control signals to the pressure control module and the displacement sensing module, respectively, and to receive control signals from the pressure control module and the displacement sensing module, respectively. Receives information sent by the displacement detection module in order to perform calculations. [18] Device for measuring a radial displacement pulse wave according to claim 17, wherein the transparent material of the main material of the non-transparent airbag, which is resistant to strain deformation, comprises polymethyl methacrylate, cellulose acetate, nylon 66 polyamide resin, nylon 6 polyamide resin, polybutylene terephthalate, polyethylene terephthalate, polyethylene terephthalate, polycarbonate, ethylene vinyl acetate copolymer, polyethylene, polypropylene, polyvinyl chloride, polyoxymethylene or polyurethane, glass, quartz, polystyrene or acrylonitrile butadiene styrene copolymer. [19] Device for measuring a radial displacement pulse wave according to claim 17, wherein the transparent material of the transparent window, which is resistant to strain deformation, comprises polymethyl methacrylate, cellulose acetate, nylon-66 polyamide resin, nylon-6 polyamide resin, polybutylene terephthalate, polyethylene terephthalate, polyethylene terephthalate, polycarbonate, ethylene-vinyl acetate copolymer, polyethylene, polypropylene, polyvinyl chloride, polyoxymethylene, polyurethane, glass, quartz, polystyrene or acrylonitrile-butadiene-styrene copolymer. [20] Device for measuring a radial displacement pulse wave according to claim 17, wherein an anti-reflective coating is arranged on an outer surface of the transparent window. [21] Device for measuring a radial displacement pulse wave according to claim 17, wherein, if the transparent section is the hole, the transparent window is the second transparent plate. [22] Device for measuring a radial displacement pulse wave according to claim 21, wherein an area of ​​the second transparent plate is larger than an area of ​​the hole, so that if the internal pressure of the transparent airbag is too high, the second transparent plate rests against a bottom of the hole and is prevented from being pressed towards a top of the hole. [23] Device for measuring a radial displacement pulse wave according to claim 17, wherein an anti-reflective coating is arranged on an outer surface of the transparent window. [24] Device for measuring a radial displacement pulse wave according to claim 17, wherein the non-transparent airbag further comprises a contact section configured to fit snugly against the skin of the subject's measurement site, and wherein a material of the contact section is a soft, stretchable and deformable thermoplastic elastomer material comprising at least one of the following materials: thermoplastic polyurethane, polyolefin elastomer, dynamically vulcanized polyolefin elastomer, polystyrene elastomer, polyether ester elastomer, polyamide elastomer and polyvinyl chloride. [25] Device for measuring a radial displacement pulse wave according to claim 24, wherein a reflective layer or a dichroic layer is arranged on an inner surface of the contact section. [26] Device for measuring a radial displacement pulse wave according to claim 17, further comprising a support section configured to accommodate a limb section of the subject, wherein the measuring point is located in an interior of the support section, the support section comprising: a soft inner layer encompassing the non-transparent airbag; and a hard outer layer arranged outside the soft inner layer to form the interior of the support section together with the soft inner layer, wherein during a measurement process of the radial displacement pulse wave the hard outer layer maintains a fixed distance between the displacement sensing module and a furthest position on the hard outer layer relative to the displacement sensing module. [27] Device for measuring a radial displacement pulse wave according to claim 26, wherein the soft inner layer further comprises a plurality of auxiliary airbags and the internal pressure of the auxiliary airbags is controlled by the pressure control module. [28] Device for measuring a radial displacement pulse wave according to claim 17, wherein the pressure control module comprises: a pressure sensor configured to detect the internal pressure of the non-transparent airbag; and a pressure adjustment module configured to adjust the internal pressure of the non-transparent airbag, the pressure adjustment module comprising a pump. [29] Device for measuring a radial displacement pulse wave according to claim 28, wherein the pressure adjustment module further comprises a pulse width modulation circuit configured to adjust the speed of a motor of the pump. [30] Device for measuring a radial displacement pulse wave according to claim 17, wherein the displacement detection module comprises a transmitter and a receiver, wherein the transmitter and the receiver are aligned with the transparent section, and wherein a measurement signal emitted by the transmitter passes through the transparent section and the transparent window. [31] Device for measuring a radial displacement pulse wave according to claim 17, wherein the displacement detection module comprises a photoelectric displacement sensor. [32] Device for measuring a radial displacement pulse wave according to claim 31, wherein the photoelectric displacement sensor comprises a distance measuring device selected from the group consisting of: a laser displacement sensor, a fiber optic displacement sensor, a three-dimensional laser displacement sensor, a time-of-flight distance sensor, a three-dimensional time-of-flight distance sensor, a laser Doppler distance sensor, a laser Doppler velocity sensor, a laser Doppler vibrometer, a Michelson interferometer or a laser interferometer. [33] Device for measuring a radial displacement pulse wave according to claim 17, wherein the displacement detection module further comprises a filter. [34] Device for measuring a radial displacement pulse wave according to claim 17, further comprising a scanning position control module which is communicatively connected to the computing unit and is configured to control the displacement detection module to perform distance measurement and scanning within the measuring point, wherein the scanning position control module comprises a single-axis position controller or a dual-axis position controller. [35] Method for optimizing the measurement conditions for a vascular radial displacement pulse wave, wherein a Y-axis is essentially perpendicular to the direction of the artery and essentially parallel to the skin surface of the measurement site, comprising: Use of the device for measuring a radial displacement pulse wave according to any one of claims 1 to 34; Placing the transparent airbag or the non-transparent airbag on the skin of the subject's measurement site, wherein the displacement sensing module is in a home position, wherein the displacement sensing module is a point-type displacement sensor or a matrix-type displacement sensor; Maintaining pressure of the transparent or non-transparent airbag at an initial pressure, pressing the transparent or non-transparent airbag against the measuring point to a first depth, and scanning the surface of the measuring point along the Y-axis by the displacement detection module to a first measurement position where a maximum amplitude signal of the vascular radial displacement pulse wave of the artery is found; Maintaining the displacement detection module at the first measurement position, adjusting the pressure of the transparent or non-transparent airbag to find a second pressure at which a maximum signal of the vascular radial displacement pulse wave of the artery is obtained; and Maintaining the pressure of the transparent airbag or the non-transparent airbag during a second pressure, pressing the transparent airbag or the non-transparent airbag against the measuring point to a second depth, wherein the first measuring position and the second depth serve as measuring conditions for the vascular radial displacement pulse wave of the artery. [36] Method for optimizing the measurement conditions for a vascular radial displacement pulse wave according to claim 35, wherein the first pressure is obtained by stepwise increasing the pressure of the transparent airbag or the non-transparent airbag in order to press the measurement site vertically with the transparent airbag or the non-transparent airbag until the first pressure is applied when a maximum amplitude signal of a vascular volume pulse wave of the artery is found. [37] Method for optimizing the measurement conditions for a vascular radial displacement pulse wave according to claim 35, further comprising scanning along the direction of the artery by the displacement detection module until a second measurement position is found at which a local maximum signal of the vascular radial displacement pulse wave of the artery is obtained, wherein the second measurement position replaces the first measurement position as the measurement condition for the vascular radial displacement pulse wave of the artery. [38] Method for optimizing the measurement conditions for a vascular radial displacement pulse wave according to claim 35, wherein the method further comprises: Locating a first measurement position above an artery at a measurement site of a subject; using the device to measure a radial displacement pulse wave according to any one of claims 1 to 34; Placing the transparent airbag or the non-transparent airbag on the skin of the subject's measurement site; Aligning the displacement sensing module with the first measurement position, wherein the displacement sensing module is a point-type displacement sensor or a matrix-type displacement sensor; Gradually increasing the pressure of the transparent or non-transparent airbag to press the measuring point vertically with the transparent or non-transparent airbag until a measuring pressure is applied when a maximum signal of a vascular radial displacement pulse wave of the artery is obtained; maintaining the pressure of the transparent or non-transparent airbag at the measuring pressure; pressing the transparent or non-transparent airbag against the measuring point to a measuring depth, the first measuring position and the measuring depth serving as measuring conditions for the vascular radial displacement pulse wave of the artery. [39] Method for optimizing the measurement conditions for a vascular radial displacement pulse wave according to claim 38, further comprising scanning along the direction of the artery by the displacement detection module until a second measurement position is found at which a local maximum signal of the vascular radial displacement pulse wave of the artery is obtained, wherein the second measurement position replaces the first measurement position as the measurement condition for the vascular radial displacement pulse wave of the artery. [40] Method for optimizing the measurement conditions for a vascular radial displacement pulse wave according to claim 35, wherein the method further comprises: Use of the device for measuring a radial displacement pulse wave according to any one of claims 1 to 34; Placing the transparent airbag or the non-transparent airbag on the skin of the subject's measurement site; Maintaining the pressure of the transparent airbag or the non-transparent airbag at an initial pressure; Moving the displacement detection module over the measuring point, wherein the displacement detection module is a matrix displacement sensor with a measuring range and the measuring range intersects with a direction of the artery; Identifying one of the point-type displacement sensors among the matrix-type displacement sensors that measures a maximum amplitude signal, with the identified sensor being located at a first measurement position; Adjusting the pressure of the transparent or non-transparent airbag to find a second pressure at which a maximum signal of the vascular radial displacement pulse wave of the artery is obtained; and Maintaining the pressure of the transparent airbag or the non-transparent airbag during a second pressure, pressing the transparent airbag or the non-transparent airbag against the measuring point to a second depth, wherein the first measuring position and the second depth serve as measuring conditions for the vascular radial displacement pulse wave of the artery. [41] Method for optimizing the measurement conditions for the vascular radial displacement pulse wave according to claim 40, wherein the first pressure is obtained by stepwise increasing the pressure of the transparent airbag or the non-transparent airbag in order to press the measurement site vertically with the transparent airbag or the non-transparent airbag until the first pressure is applied when a maximum amplitude signal of a vascular volume pulse wave of the artery is found. [42] Method for optimizing the measurement conditions for a vascular radial displacement pulse wave according to claim 40, further comprising scanning along the direction of the artery by the displacement detection module until a second measurement position is found at which a local maximum signal of the vascular radial displacement pulse wave of the artery is obtained, wherein the second measurement position replaces the first measurement position as the measurement condition for the vascular radial displacement pulse wave of the artery. [43] Methods for measuring blood pressure, comprising: Use of the device for measuring a radial displacement pulse wave according to any one of claims 1 to 34; Placing the transparent airbag or the non-transparent airbag on the measuring point; Locating the position of the artery at the measurement site of the subject by using the method for optimizing the measurement conditions for a vascular radial displacement pulse wave according to one of claims 35 to 42, in order to measure the vascular radial displacement pulse wave of the artery; Gradual increase of the pressure of the transparent airbag or the non-transparent airbag until the vascular radial displacement pulse wave of the artery appears and then disappears; Gradual release of the pressure of the transparent or non-transparent airbag until the vascular radial displacement pulse wave of the artery begins to appear, wherein the pressure of the transparent or non-transparent airbag at this time is a systolic pressure of the artery; and continued gradual release of the pressure of the transparent airbag or the non-transparent airbag until the vascular radial displacement pulse wave of the artery begins to disappear, wherein a pressure of the transparent airbag or the non-transparent airbag at this time is a diastolic pressure of the artery. [44] Methods for measuring pulse wave velocity, comprising: Measuring a proximal radial displacement pulse wave at a proximal measurement position of a proximal arterial segment of a subject that is closer to the heart, using the radial displacement pulse wave measuring device according to any one of claims 1 to 34, wherein an electrocardiogram is recorded simultaneously; Simultaneous recording of a vascular radial displacement pulse wave at the proximal arterial segment and the subject's ECG to obtain a delay time T1 of the proximal radial displacement pulse wave relative to an R-wave of the ECG; Measuring a distal radial displacement pulse wave at a distal measurement position of a distal arterial segment of the subject, which is farther from the heart, using the radial displacement pulse wave measurement device, while simultaneously recording the ECG; Simultaneous recording of a vascular radial displacement pulse wave at the distal arterial segment and the subject's ECG to obtain a delay time T2 of the distal radial displacement pulse wave relative to the R-wave of the ECG; Calculating a delay time difference ΔT = T2 - T1; Measuring a distance ΔD between the proximal arterial segment and the distal arterial segment; and Calculating pulse wave velocity (PWV) as PWV = ΔD / ΔT. [45] Method for measuring the pulse wave velocity according to claim 44, wherein the proximal measurement position and the distal measurement position are the first measurement position found by using the method for optimizing the measurement conditions for a vascular radial displacement pulse wave according to claim 35, 36, 38, 40 or 41, or the second measurement position found by using the method for optimizing the measurement conditions for a vascular radial displacement pulse wave according to claim 37, 39 or 42. [46] Methods for measuring pulse wave velocity, comprising: Measuring a proximal radial displacement pulse wave at a proximal measurement position of a proximal arterial segment of a subject that is closer to the heart, without recording an electrocardiogram (ECG); Simultaneous measurement of a distal radial displacement pulse wave at a distal measurement position of a distal arterial segment of the subject that is farther from the heart, without recording the ECG, wherein the proximal measurement position and the distal measurement position are used to simultaneously measure the proximal radial displacement pulse wave and the distal radial displacement pulse wave using one or two of the devices for measuring a radial displacement pulse wave according to any one of claims 1 to 34; Calculating a delay time difference ΔT between the proximal radial displacement pulse wave and the distal radial displacement pulse wave; Measuring a distance ΔD between the proximal arterial segment and the distal arterial segment; and Calculating pulse wave velocity (PWV) as PWV = ΔD / ΔT. [47] Method for measuring the pulse wave velocity according to claim 46, wherein the proximal measurement position and the distal measurement position are the first measurement position found by using the method for optimizing the measurement conditions for a vascular radial displacement pulse wave according to claim 35, 36, 38, 40 or 41, or the second measurement position found by using the method for optimizing the measurement conditions for a vascular radial displacement pulse wave according to claim 37, 39 or 42. [48] ​​Methods for continuous measurement of blood pressure, comprising: Measuring a diastolic pressure of the subject in an initial state and a corresponding first compression depth of the transparent airbag or the non-transparent airbag against the measuring point, and measuring a systolic pressure of the subject in the initial state and a corresponding second compression depth of the transparent airbag or the non-transparent airbag against the measuring point using the method for measuring blood pressure according to claim 43, wherein a difference between the first compression depth and the second compression depth is a vascular diameter R of the subject; Calculating a change in the subject's vascular diameter ΔR based on a waveform of the subject's radial displacement pulse wave over time; Measuring the pulse wave velocity (PWV) of the subject using the pulse wave velocity measurement method according to any one of claims 44 to 47; Determining the blood density ρ of the subject; Calculation of a blood pressure change ΔP using the following Branwell-Hill formula: ΔP=ρ×PWV2(ΔRR); and Calculation of a real-time systolic pressure (= initial systolic pressure + ΔP) and a real-time diastolic pressure (= initial diastolic pressure + ΔP) of the subject.

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