Three-dimensional pulse wave non-invasive blood pressure monitoring device and method

Abstract

The invention discloses a three-dimensional pulse wave non-invasive blood pressure monitoring device and method. The device comprises a liquid bag, an ultrasonic area array transducer, a pressurizing part, a wearing part and a control part. Wherein the liquid bag, the ultrasonic area array transducer and the pressurizing part are arranged on the inner side of the wearing part in a stacked mode, so that preset pressure is applied through the pressurizing part, the inner side of the liquid bag is tightly attached to the skin surface, ultrasonic waves are transmitted or received within a preset range through the ultrasonic area array transducer, and therefore three-dimensional space pulsation information of a user is obtained. The control part is arranged on the wearing part, is connected with the ultrasonic area array transducer and is used for processing information so as to output a blood pressure monitoring result. According to the device, the liquid bag is tightly and flexibly attached to the surface of the skin of the human body through the pressurizing part, the pulse pulsation of the three-dimensional space is measured through the ultrasonic area array technology, and the data size and the fineness are higher.

Description

Technical Field

[0001] The present invention relates to a three-dimensional pulse wave non-invasive blood pressure monitoring device and also to a corresponding three-dimensional pulse wave non-invasive blood pressure monitoring method, belonging to the technical field of medical equipment. Background Art

[0002] As a crucial physiological parameter, accurate and continuous blood pressure monitoring is crucial for early disease diagnosis, treatment efficacy assessment, and daily health management. While traditional blood pressure measurement methods, such as the oscillometric method using a cuff or the Korotkoff sound method, are relatively accurate, they are inherently intermittent and can cause a degree of discomfort during measurement, making them difficult to meet the needs of long-term, continuous, or nighttime blood pressure monitoring.

[0003] To overcome the limitations of traditional methods, a variety of non-invasive continuous blood pressure monitoring technologies have been developed, including but not limited to pulse wave transit time (PTT), plethysmography, and single-point pulse wave-based measurement methods. However, these existing technologies generally suffer from the following technical deficiencies in practical applications, limiting their measurement accuracy, stability, and user experience:

[0004] (1) Limited ultrasonic echo signal quality: When existing blood pressure monitoring devices use ultrasound to measure the skin surface or blood vessel pulsation, they often suffer from severe ultrasonic echo signal attenuation and low signal-to-noise ratio due to factors such as poor coupling between the sensor and the skin, the presence of small air gaps, and the complexity of human tissue structure. This in turn affects the accuracy and stability of the measurement data. High-quality raw signals are the basis for accurate measurement, and existing technologies show significant shortcomings in this regard.

[0005] (2) Sound velocity error: In technologies that rely on ultrasound to measure blood pressure, the propagation speed of sound waves in different human tissues is not constant but is affected by individual differences (such as tissue density, elasticity, and water content). This individual difference in sound velocity can lead to errors in the measurement results, thereby reducing the accuracy and reliability of blood pressure data. Existing technologies often find it difficult to effectively correct or avoid this type of systematic error caused by changes in sound velocity.

[0006] (3) Incomplete acquisition of pulse wave information: Most blood pressure monitoring devices can only obtain single-point or two-dimensional (planar) pulse wave information of the blood vessels. This limited data dimension cannot fully capture the complex pulsation characteristics of the blood vessel wall in three-dimensional space, such as the directionality of the pulsation and the deformation of different cross-sections. This limits the ability to conduct in-depth analysis of vascular health status and may also affect the accuracy of blood pressure calculations based on pulse wave morphology.

[0007] (4) Wearing position sensitivity: Existing blood pressure monitoring devices are generally highly sensitive to wearing position and angle. If the user fails to accurately align or maintain stability when wearing the device, it is very likely to cause measurement failure, data deviation, or poor repeatability. This not only affects the user experience, but also reduces the universality of the device and its usability in non-professional environments.

[0008] Therefore, there is an urgent need to provide a non-invasive blood pressure monitoring device with an improved design to solve the above technical problems. Summary of the Invention

[0009] The primary technical problem to be solved by the present invention is to provide a three-dimensional pulse wave non-invasive blood pressure monitoring device.

[0010] Another technical problem to be solved by the present invention is to provide a three-dimensional pulse wave non-invasive blood pressure monitoring method.

[0011] In order to achieve the above technical objectives, the present invention adopts the following technical solutions:

[0012] According to a first aspect of an embodiment of the present invention, there is provided a three-dimensional pulse wave non-invasive blood pressure monitoring device, comprising:

[0013] a liquid sac, wherein the inner side of the liquid sac is used to contact with human skin;

[0014] An ultrasonic array transducer is disposed outside the liquid capsule and is used to transmit or receive ultrasonic waves within a preset range, thereby obtaining the user's three-dimensional spatial pulsation information;

[0015] a pressurizing portion, disposed on the outer side of the ultrasonic array transducer, for applying a preset pressure to the ultrasonic array transducer, so that the inner side of the liquid sac is in close contact with the skin surface;

[0016] a wearing portion, disposed on the outer side of the pressurizing portion and used for being worn on human tissue;

[0017] The control unit is arranged on the wearable part and connected to the ultrasonic array transducer, and is used to receive the three-dimensional spatial pulsation information sent by the ultrasonic array transducer, and calculate the blood pressure based on a preset algorithm, thereby outputting the blood pressure monitoring result.

[0018] Preferably, the liquid capsule is made of a thin film with high acoustic impedance, is arc-shaped or ring-shaped as a whole, and is filled with a liquid medium having acoustic properties similar to those of human tissue.

[0019] Preferably, the ultrasonic area array transducer includes a plurality of ultrasonic transducer units, and the plurality of ultrasonic transducer units are arranged in an area array along the outside of the liquid sac so as to be arranged together into an arc or a ring.

[0020] Preferably, the ultrasonic transducer unit is a rigid two-dimensional ultrasonic phased array transducer or a flexible curved surface transducer.

[0021] Preferably, the pressurizing unit includes:

[0022] An airbag is arranged on the outside of the ultrasonic array transducer and has an inflation port and a deflation port;

[0023] an air pump connected to the inflation port of the airbag, for inflating the airbag to expand the airbag, thereby applying a preset pressure to the ultrasonic array transducer;

[0024] Wherein, a solenoid valve is provided at the air release port, and the solenoid valve is connected to the control unit so that the opening of the solenoid valve is controlled by the control unit, thereby automatically adjusting the expansion degree of the airbag.

[0025] Preferably, the control unit further includes a sound velocity correction unit, which compares the propagation speed of ultrasound in a standard medium with the propagation speed of ultrasound in human tissue to calculate a sound velocity correction factor, and performs data correction on the three-dimensional spatial pulsation information based on the sound velocity correction factor.

[0026] Preferably, the control unit calculates the blood pressure monitoring result through the following steps:

[0027] receiving three-dimensional spatial pulsation information sent by the ultrasonic array transducer;

[0028] Digitally processing the three-dimensional spatial pulsation information to form digital data;

[0029] Preprocessing the digitized data to form preprocessed data;

[0030] Performing three-dimensional reconstruction on the pre-processed data using a three-dimensional ultrasound imaging algorithm to generate pulsation waveform data of the arterial blood vessel in three-dimensional space;

[0031] Based on the pulse waveform data and in combination with the user's multiple physiological parameters, a model calculation is performed using a preset algorithm model to output a blood pressure monitoring result corresponding to the user;

[0032] Among them, the multiple physiological parameters include at least: pulse wave conduction velocity, pulse wave morphological characteristics and vascular elastic modulus; the blood pressure monitoring results include at least: systolic pressure, diastolic pressure and mean arterial pressure; the algorithm model includes at least a machine learning model or a neural network model.

[0033] Preferably, the three-dimensional pulse wave non-invasive blood pressure monitoring device further comprises:

[0034] an alarm, disposed on the wearable portion and connected to the control portion, for issuing an alarm based on a preset abnormal blood pressure threshold;

[0035] A display is connected to the controller and is used to display the blood pressure monitoring results.

[0036] According to a second aspect of an embodiment of the present invention, a three-dimensional pulse wave non-invasive blood pressure monitoring method is provided, comprising the following steps:

[0037] Wearing the three-dimensional pulse wave non-invasive blood pressure monitoring device on human tissue;

[0038] Controlling the pressurizing part to continuously apply pressure to the ultrasonic array transducer until a preset pressure value is reached, thereby making the inner side of the liquid sac fit tightly against the skin surface;

[0039] Controlling the ultrasonic array transducer to emit ultrasonic pulses within a preset range so that the ultrasonic pulses pass through the fluid pocket and reach the skin surface and arterial walls; and receiving reflected echo signals through the ultrasonic array transducer to obtain three-dimensional spatial pulsation information of the user based on the echo signals at multiple angles.

[0040] The controller receives the three-dimensional spatial pulse information sent by the ultrasonic array transducer, calculates the blood pressure using a preset algorithm, and outputs the blood pressure monitoring result;

[0041] The blood pressure monitoring result is displayed on a display.

[0042] Preferably, the three-dimensional pulse wave non-invasive blood pressure monitoring method further includes:

[0043] The blood pressure monitoring results are synchronized and stored with the smart terminal APP or cloud platform so that users can view historical monitoring data at any time.

[0044] Compared with the prior art, the present invention has the following technical effects:

[0045] (1) The embodiments of the present invention utilize a liquid sac-like structure composed of a high-acoustic-impedance thin film that can fit tightly and flexibly onto the surface of human skin. This design significantly optimizes the acoustic coupling interface of ultrasound, effectively reducing the attenuation and scattering of ultrasound signals during transmission, and lowering the interference of ambient noise, resulting in significantly better ultrasound echo signal quality than existing technologies. High-quality raw data provides a solid foundation for subsequent precise analysis and blood pressure calculation, thereby ensuring the accuracy and reliability of measurement results.

[0046] (2) The embodiments of the present invention address the inherent problem that the propagation speed of ultrasound waves in human tissue is affected by individual differences, by providing a compatible or integrated correction scheme for measuring sound velocity differences using standard solutions. The sound velocity correction factor can effectively correct for sound velocity propagation errors caused by differences in human tissue density, elasticity, etc., thereby significantly improving the accuracy and reliability of blood pressure measurements, solving the long-standing problem of individual differences leading to inaccurate measurements in the prior art, and making the measurement results more universal and clinically valuable.

[0047] (3) The present invention innovatively uses ultrasonic array technology to measure pulse pulsation in three dimensions. This enables the system to obtain complete, multi-dimensional pulsation information of the blood vessel wall in three dimensions, including pulsation direction, intensity distribution, and changes in blood vessel cross-section. The data volume and precision far exceed the information provided by existing single-point or two-dimensional pulse wave measurement technologies. This comprehensive three-dimensional pulsation data provides unprecedented data support for clinicians to conduct more in-depth vascular health assessments, disease diagnosis, and physiological research.

[0048] (4) The combination of area array imaging technology and a back gas bag and pump to apply stable pre-pressure significantly reduces the accuracy requirements for the user's wearing position. Users can wear the device more conveniently and tolerantly, and are less likely to experience measurement failures or inaccurate data due to wearing position deviations. This significantly improves the user experience, lowers the operational threshold, and expands the applicable population and universality of the device, making it more suitable for home self-monitoring and use by non-professionals.

[0049] (5) The embodiments of the present invention can achieve high-precision, high-stability continuous non-invasive blood pressure monitoring. By providing continuous and accurate blood pressure data, the present invention provides a revolutionary solution for the management of chronic diseases (such as hypertension), home health monitoring, and real-time clinical monitoring. This comprehensive advantage gives the present invention broad application prospects and significant social benefits in the medical and health field. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] Figure 1 A schematic cross-sectional view of a three-dimensional pulse wave non-invasive blood pressure monitoring device provided by the first embodiment of the present invention;

[0051] Figure 2 A schematic cross-sectional view of another three-dimensional pulse wave non-invasive blood pressure monitoring device provided by the first embodiment of the present invention;

[0052] Figure 3 This is a schematic structural diagram of an ultrasonic array transducer in the first embodiment of the present invention;

[0053] Figure 4 This is another structural schematic diagram of the ultrasonic array transducer in the first embodiment of the present invention;

[0054] Figure 5 This is a flow chart of a three-dimensional pulse wave non-invasive blood pressure monitoring method provided by the second embodiment of the present invention. DETAILED DESCRIPTION

[0055] The technical content of the present invention is described in detail below with reference to the accompanying drawings and specific embodiments.

[0056] The present invention provides a three-dimensional pulse wave noninvasive blood pressure monitoring device designed to effectively overcome a series of technical challenges encountered in the prior art, including poor ultrasonic echo signal quality, large sound velocity errors, incomplete pulse wave information acquisition, and sensitivity to wearer position. The technical solutions proposed in the present invention are expected to enable more accurate, comprehensive, stable, and convenient noninvasive continuous blood pressure monitoring, thereby providing a reliable and efficient new tool for clinical diagnosis, disease management, and daily health monitoring.

[0057] First embodiment

[0058] like Figure 1 and Figure 2 As shown, the first embodiment of the present invention provides a three-dimensional pulse wave non-invasive blood pressure monitoring device, including a liquid capsule 1, an ultrasonic array transducer 2, a pressurizing portion 3, a wearing portion 4, a control portion 5 and a display portion 6. The liquid capsule 1, the ultrasonic array transducer 2 and the pressurizing portion 3 are stacked on the inner side of the wearing portion 4, so that a preset pressure is applied by the pressurizing portion 3 to make the inner side of the liquid capsule 1 fit tightly with the skin surface, and the ultrasonic array transducer 2 is used to transmit or receive ultrasonic waves within a preset range (for example, a 360° range) to obtain the user's three-dimensional spatial pulsation information. The control portion 5 is provided on the wearing portion 4 for performing information processing to output the blood pressure monitoring results. The display portion 6 is used to receive the blood pressure monitoring results and display them on the screen.

[0059] In this embodiment, the liquid capsule 1 is made of a thin film with high acoustic impedance and is in an arc or ring shape (e.g. Figure 1 and Figure 2 As shown in the figure, the interior is filled with a liquid medium 11 having acoustic properties similar to those of human tissue. Specifically, the film constituting the liquid capsule can be made of medical-grade polyurethane (TPU) or silicone materials, which have excellent biocompatibility, high elastic modulus and high acoustic impedance. The thickness of the film can be controlled between 0.05 and 0.1 mm to ensure sufficient flexibility and acoustic transparency. The liquid filled inside can be physiological saline or medical ultrasonic coupling agent, which have acoustic properties similar to those of human tissue, can ensure good acoustic matching, and further improve the transmission efficiency of ultrasonic signals.

[0060] It is understood that the high elasticity of the film allows the liquid capsule 1 to adhere tightly and flexibly to the surface of human skin, thus forming an excellent acoustic coupling interface. This design minimizes the attenuation and scattering of ultrasound waves caused by air gaps or irregular contact during propagation, significantly improving the quality of the ultrasonic echo signal. Furthermore, the combination of the high-acoustic-impedance film and the liquid filling optimizes the transmission efficiency of ultrasonic energy, directly resolving signal quality issues caused by poor coupling in the prior art. Furthermore, the interface between the high-acoustic-impedance film and the skin also provides excellent echoes, far exceeding the echo quality of direct ultrasound measurements of blood vessels.

[0061] like Figure 3 As shown, in this embodiment, the ultrasonic array transducer 2 includes a plurality of ultrasonic transducer units 21, and the plurality of ultrasonic transducer units 21 are arranged in an array along the outside of the liquid capsule 1 to form an arc or ring shape (refer to Figure 1 and Figure 2 As shown in FIG. 1 , it is understood that the annular ultrasonic array transducer 2 is capable of transmitting or receiving ultrasonic waves within a 360° range of human tissue 10 (e.g., the wrist, neck, or chest); whereas the arc-shaped ultrasonic array transducer 2 is capable of transmitting or receiving ultrasonic waves within a certain arc range, and the specific configuration can be adaptively selected based on needs. Furthermore, preferably, the shape of the ultrasonic array transducer 2 corresponds to the shape of the aforementioned liquid sac 1.

[0062] Preferably, a rigid two-dimensional ultrasonic phased array transducer with a frequency range of 5 to 10 MHz can be used. This frequency range can take into account both penetration depth and image resolution, and is suitable for monitoring superficial blood vessels. The number of array elements can be designed to be 64x64 or 128x128 to ensure sufficient spatial resolution and imaging range. Moreover, it is understandable that the rigid two-dimensional ultrasonic phased array transducer has higher mechanical stability and durability, lower mass production cost, and longer service life. In addition, if Figure 4 As shown, in order to better adapt to the physiological curvature of the human body's wrist, neck or chest, the ultrasonic transducer unit 21 can also be designed as a flexible curved surface structure to maximize the contact area and optimize the acoustic coupling effect.

[0063] As will be appreciated, the embodiments of the present invention innovatively employ ultrasonic area array technology to measure pulse pulsation in three dimensions. This enables the system to acquire complete, multi-dimensional pulsation information about the vessel wall in three dimensions, including pulsation direction, intensity distribution, and changes in vessel cross-section. The data volume and precision far exceed those provided by existing single-point or two-dimensional pulse wave measurement technologies. This comprehensive three-dimensional pulsation data provides unprecedented data support for clinicians to conduct more in-depth vascular health assessments, disease diagnosis, and physiological research.

[0064] like Figure 1 and Figure 2 As shown, in this embodiment, the pressurizing portion 3 is arranged on the outside of the ultrasonic array transducer 2 and is used to apply a preset pressure to the ultrasonic array transducer 2, so that the inner side of the liquid sac 1 is in close contact with the skin surface. Specifically, the pressurizing portion 3 includes an airbag 31 and an air pump 32. The airbag 31 is arranged on the outside of the ultrasonic array transducer 2 and has an inflation port 311 and an deflation port 312. The air pump 32 is connected to the inflation port 311 of the airbag 31 and is used to inflate the airbag 31 to expand the airbag 31, thereby applying a preset pressure to the ultrasonic array transducer 2. In addition, the deflation port 312 is provided with a solenoid valve 313. Opening the solenoid valve 313 can deflate the airbag 31, so that the gas in the airbag 31 is directly emptied when not in use, thereby improving wearing comfort.

[0065] It is understood that by controlling the inflation volume of the air pump 32, the system can be precisely controlled and maintained operating under a stable pre-pressure. In this embodiment, the air pump 32 is a piezoelectric pump that can be built into the wearable portion 4. In addition, the air pump 32 and the solenoid valve 313 are both connected to the controller 5, so that the controller 5 can control the start and stop of the air pump 32, thereby automatically controlling the inflation volume; and the controller 5 controls the opening of the solenoid valve 313, thereby automatically controlling the deflation operation. Stable pre-pressure ensures that the liquid sac 1 is in constant close contact with the skin, providing constant external conditions for stable ultrasonic measurement, thereby significantly improving the repeatability and accuracy of the measurement results. This solves the problem of inaccurate wearing position of existing devices. By actively applying and stabilizing pressure, the standardization of measurement conditions is ensured, and measurement errors caused by user wearing differences are reduced. This significantly improves the user experience, lowers the operating threshold, and expands the applicable population and universality of the system, making it more suitable for home self-monitoring and use by non-professionals.

[0066] Furthermore, it should be noted that, in this embodiment, the pressurizing portion 3 is configured as a combination of an airbag 31 and an air pump 32, which is merely a preferred embodiment. In other embodiments, other structures may be substituted. For example, by combining a piston rod with a piston chamber, the piston rod's expansion and contraction (e.g., using a lead screw or linear motor) can be used to control the pressure within the piston chamber, thereby applying a predetermined pressure to the ultrasonic array transducer 2.

[0067] like Figure 1 and Figure 2As shown, the wearing portion 4 is disposed outside the pressurizing portion 3 and is intended to be worn on human tissue 10. Specifically, the shape and size of the wearing portion 4 can be adapted to suit individual needs. For example, if worn on the wrist, the wearing portion 4 can be designed as a bracelet; if worn around the neck, the wearing portion 4 can be designed as an elastic collar; if worn around the chest, the wearing portion 4 can be designed as a flexible bandage with Velcro fastened at both ends.

[0068] In addition, it should be noted that the wearing part 4 in this embodiment can be worn on human tissue for a long time. When blood pressure needs to be measured, the airbag 31 is inflated by the air pump 32 so that the airbag 31 remains in a filled state, thereby enabling continuous and uninterrupted non-invasive blood pressure monitoring of the user.

[0069] like Figure 1 and Figure 2 As shown, the control unit 5 is provided on the wearable portion 4 and connected to the ultrasonic array transducer 2, and is used to receive the three-dimensional spatial pulse information sent by the ultrasonic array transducer and calculate the blood pressure based on a preset algorithm, thereby outputting the blood pressure monitoring result. Specifically, in this embodiment, the control unit 5 calculates the blood pressure monitoring result through the following steps:

[0070] ① Receive the three-dimensional spatial pulsation information sent by the ultrasonic array transducer 2.

[0071] ②Digitally process the three-dimensional spatial pulsation information to form digital data.

[0072] ③Perform preprocessing operations such as denoising and filtering on the digital data to form preprocessed data.

[0073] ④ Using a 3D ultrasound imaging algorithm, such as voxel rendering or surface reconstruction, to perform 3D reconstruction on the preprocessed data to generate pulsation waveform data of the arterial blood vessels in 3D space. This pulsation waveform data contains at least information about the deformation of the blood vessel wall at different depths and cross-sections.

[0074] ⑤ Based on the pulse waveform data and combined with the user's various physiological parameters, the preset algorithm model is used for model calculation to output the user's corresponding blood pressure monitoring results.

[0075] The multiple physiological parameters include at least pulse wave velocity, pulse wave morphology (e.g., waveform steepness, reflected wave intensity), and vascular elastic modulus. The algorithm model includes at least a machine learning model or a neural network model. The ultimately calculated blood pressure monitoring results include at least systolic, diastolic, and mean arterial pressure data.

[0076] In addition, preferably, the control unit 5 also has a sound velocity correction unit. Specifically, during system initialization or periodic calibration, the ultrasonic probe can be placed in a standard solution with a known sound velocity (such as pure water or a specific colloid) for measurement to obtain the propagation speed of ultrasonic waves in the standard medium. By comparing with the sound velocity measured in human tissue, a sound velocity correction factor is calculated. When actual measurements are performed on the human body, the correction factor is applied to the pulse wave data processing and blood pressure calculation process through the sound velocity correction unit to effectively eliminate or significantly reduce the measurement error caused by the difference in sound velocity of human tissue, thereby ensuring the accuracy of the blood pressure data.

[0077] like Figure 1 and Figure 2 As shown, after the control unit 5 calculates the user's blood pressure monitoring result through a preset algorithm, the blood pressure monitoring result is sent to the display unit 6 for intuitive interface display to the user.

[0078] And, as Figure 1 and Figure 2 As shown, preferably, the three-dimensional pulse wave non-invasive blood pressure monitoring device also includes an alarm 7. The alarm 7 is provided on the wearing portion 4 and connected to the control portion 5. When the user's blood pressure value exceeds a preset blood pressure abnormality threshold, it emits an audible and visual alarm to remind the user to pay attention or seek medical attention in time.

[0079] Second embodiment

[0080] like Figure 5 As shown, based on the above-mentioned first embodiment, the second embodiment of the present invention provides a three-dimensional pulse wave non-invasive blood pressure monitoring method, which specifically includes the following steps:

[0081] S10: Wearing a three-dimensional pulse wave non-invasive blood pressure monitoring device on human tissue.

[0082] S20: Apply and maintain a stable preload.

[0083] Specifically, the air pump 32 is controlled to inflate air into the airbag 31 , so that the airbag 31 continuously applies pressure to the ultrasonic array transducer 2 until a preset pressure value is reached, so that the inner side of the liquid bag 1 is closely fitted to the skin surface.

[0084] S30: Collecting the user's three-dimensional spatial pulsation information.

[0085] Specifically, the ultrasonic array transducer 2 is first controlled to emit ultrasonic pulses within a preset range (e.g., 360°), allowing the ultrasonic pulses to pass through the fluid sac 1 and reach the skin surface and arterial wall. The ultrasonic array transducer 2 then receives the reflected echo signal. The arterial pulsation causes subtle vibrations on the surface of the fluid sac 1, which are precisely captured by the ultrasound and converted into raw three-dimensional pulse wave data.

[0086] It can be understood that, in this embodiment, the user's three-dimensional spatial pulsation information is obtained based on three-dimensional pulse wave data from multiple angles.

[0087] S40: Output the user's blood pressure monitoring results.

[0088] Specifically, the controller 5 receives the three-dimensional spatial pulsation information transmitted by the ultrasonic array transducer 2, applies corrections based on the correction factor provided by the sound velocity correction unit, and ultimately calculates the blood pressure using a preset algorithm to output a blood pressure monitoring result. The specific calculation method for the blood pressure monitoring result can be found in the description of the first embodiment and will not be repeated here.

[0089] S50: Display the user's blood pressure monitoring result via the display 6.

[0090] In addition, preferably, the method further comprises the following steps:

[0091] S60: Data synchronization and data storage.

[0092] Specifically, after the user's current blood pressure monitoring result is obtained through step S50, the blood pressure monitoring result can be synchronized and stored with the smart terminal APP or cloud platform so that the user can view historical monitoring data at any time.

[0093] In summary, the three-dimensional pulse wave non-invasive blood pressure monitoring device and method provided by the embodiments of the present invention have the following beneficial effects:

[0094] (1) The embodiments of the present invention utilize a liquid sac-like structure composed of a high-acoustic-impedance thin film that can fit tightly and flexibly onto the surface of human skin. This design significantly optimizes the acoustic coupling interface of ultrasound, effectively reducing the attenuation and scattering of ultrasound signals during transmission, and lowering the interference of ambient noise, resulting in significantly better ultrasound echo signal quality than existing technologies. High-quality raw data provides a solid foundation for subsequent precise analysis and blood pressure calculation, thereby ensuring the accuracy and reliability of measurement results.

[0095] (2) The embodiments of the present invention address the inherent problem that the propagation speed of ultrasound waves in human tissue is affected by individual differences, by providing a compatible or integrated correction scheme for measuring sound velocity differences using standard solutions. The sound velocity correction factor can effectively correct for sound velocity propagation errors caused by differences in human tissue density, elasticity, etc., thereby significantly improving the accuracy and reliability of blood pressure measurements, solving the long-standing problem of individual differences leading to inaccurate measurements in the prior art, and making the measurement results more universal and clinically valuable.

[0096] (3) The present invention innovatively uses ultrasonic array technology to measure pulse pulsation in three dimensions. This enables the system to obtain complete, multi-dimensional pulsation information of the blood vessel wall in three dimensions, including pulsation direction, intensity distribution, and changes in blood vessel cross-section. The data volume and precision far exceed the information provided by existing single-point or two-dimensional pulse wave measurement technologies. This comprehensive three-dimensional pulsation data provides unprecedented data support for clinicians to conduct more in-depth vascular health assessments, disease diagnosis, and physiological research.

[0097] (4) The combination of area array imaging technology and a back gas bag and pump to apply stable pre-pressure significantly reduces the accuracy requirements for the user's wearing position. Users can wear the device more conveniently and tolerantly, and are less likely to experience measurement failures or inaccurate data due to wearing position deviations. This significantly improves the user experience, lowers the operational threshold, and expands the applicable population and universality of the device, making it more suitable for home self-monitoring and use by non-professionals.

[0098] (5) The embodiments of the present invention can achieve high-precision, high-stability continuous non-invasive blood pressure monitoring. By providing continuous and accurate blood pressure data, the present invention provides a revolutionary solution for the management of chronic diseases (such as hypertension), home health monitoring, and real-time clinical monitoring. This comprehensive advantage gives the present invention broad application prospects and significant social benefits in the medical and health field.

[0099] It should be noted that the above embodiments are merely examples, and the technical solutions of the various embodiments may be combined and are all within the scope of protection of the present invention.

[0100] It should be noted that the orientation or positional relationship indicated by terms such as "thickness", "depth", "up", "down", and "horizontal" are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be understood as a limitation on the present invention.

[0101] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature identified as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, "plurality" means two or more, unless otherwise specifically defined.

[0102] The above describes in detail the three-dimensional pulse wave non-invasive blood pressure monitoring device and method provided by the present invention. For those skilled in the art, any obvious modification thereof without departing from the essence of the present invention would constitute an infringement of the present invention's patent rights and would result in the corresponding legal liability.

Claims

1. A three-dimensional pulse wave non-invasive blood pressure monitoring device, characterized in that include: a liquid sac, wherein the inner side of the liquid sac is used to contact with human skin; An ultrasonic array transducer is disposed outside the liquid capsule and is used to transmit or receive ultrasonic waves within a preset range, thereby obtaining the user's three-dimensional spatial pulsation information; a pressurizing portion, disposed on the outer side of the ultrasonic array transducer, for applying a preset pressure to the ultrasonic array transducer, so that the inner side of the liquid sac is in close contact with the skin surface; a wearing portion, disposed on the outer side of the pressurizing portion and used for being worn on human tissue; The control unit is arranged on the wearable part and connected to the ultrasonic array transducer, and is used to receive the three-dimensional spatial pulsation information sent by the ultrasonic array transducer, and calculate the blood pressure based on a preset algorithm, thereby outputting the blood pressure monitoring result.

2. The three-dimensional pulse wave non-invasive blood pressure monitoring device according to claim 1, characterized in that: The liquid sac is made of a thin film with high acoustic impedance and is arc-shaped or ring-shaped as a whole. The liquid sac is filled with a liquid medium having acoustic properties similar to those of human tissue.

3. The three-dimensional pulse wave non-invasive blood pressure monitoring device according to claim 2, characterized in that: The ultrasonic area array transducer includes a plurality of ultrasonic transducer units, and the plurality of ultrasonic transducer units are arranged in an area array along the outer side of the liquid sac to form an arc or a ring.

4. The three-dimensional pulse wave non-invasive blood pressure monitoring device according to claim 3, wherein: The ultrasonic transducer unit is a rigid two-dimensional ultrasonic phased array transducer or a flexible curved surface transducer.

5. The three-dimensional pulse wave non-invasive blood pressure monitoring device according to claim 1, characterized in that The pressurizing portion includes: An airbag is arranged on the outside of the ultrasonic array transducer and has an inflation port and a deflation port; an air pump connected to the inflation port of the airbag, for inflating the airbag to expand the airbag, thereby applying a preset pressure to the ultrasonic array transducer; Wherein, a solenoid valve is provided at the air release port, and the solenoid valve is connected to the control unit so that the opening of the solenoid valve is controlled by the control unit, thereby automatically adjusting the expansion degree of the airbag.

6. The three-dimensional pulse wave non-invasive blood pressure monitoring device according to claim 1, characterized in that: The control unit also has a sound velocity correction unit, which compares the propagation speed of ultrasound in a standard medium with the propagation speed of ultrasound in human tissue to calculate a sound velocity correction factor, and performs data correction on the three-dimensional spatial pulsation information based on the sound velocity correction factor.

7. The three-dimensional pulse wave non-invasive blood pressure monitoring device according to claim 1, characterized in that The control unit calculates the blood pressure monitoring result through the following steps: receiving three-dimensional spatial pulsation information sent by the ultrasonic array transducer; Digitally processing the three-dimensional spatial pulsation information to form digital data; Preprocessing the digitized data to form preprocessed data; Performing three-dimensional reconstruction on the pre-processed data using a three-dimensional ultrasound imaging algorithm to generate pulsation waveform data of the arterial blood vessel in three-dimensional space; Based on the pulse waveform data and in combination with the user's multiple physiological parameters, a model calculation is performed using a preset algorithm model to output a blood pressure monitoring result corresponding to the user; Among them, the multiple physiological parameters include at least: pulse wave conduction velocity, pulse wave morphological characteristics and vascular elastic modulus; the blood pressure monitoring results include at least: systolic pressure, diastolic pressure and mean arterial pressure; the algorithm model includes at least a machine learning model or a neural network model.

8. The three-dimensional pulse wave non-invasive blood pressure monitoring device according to claim 1, characterized in that Also includes: an alarm, disposed on the wearable portion and connected to the control portion, for issuing an alarm based on a preset abnormal blood pressure threshold; A display is connected to the controller and is used to display the blood pressure monitoring results.

9. A three-dimensional pulse wave non-invasive blood pressure monitoring method, characterized in that The steps include: Wearing the three-dimensional pulse wave non-invasive blood pressure monitoring device according to any one of claims 1 to 8 on human tissue; Controlling the pressurizing part to continuously apply pressure to the ultrasonic array transducer until a preset pressure value is reached, thereby making the inner side of the liquid sac fit tightly against the skin surface; Controlling the ultrasonic array transducer to emit ultrasonic pulses within a preset range so that the ultrasonic pulses pass through the fluid pocket and reach the skin surface and arterial walls; and receiving reflected echo signals through the ultrasonic array transducer to obtain three-dimensional spatial pulsation information of the user based on the echo signals at multiple angles. The controller receives the three-dimensional spatial pulse information sent by the ultrasonic array transducer, calculates the blood pressure using a preset algorithm, and outputs the blood pressure monitoring result; The blood pressure monitoring result is displayed on a display.

10. The three-dimensional pulse wave non-invasive blood pressure monitoring method according to claim 9, characterized in that Also includes: The blood pressure monitoring results are synchronized and stored with the smart terminal APP or cloud platform so that users can view historical monitoring data at any time.

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