Wearable blood pressure monitoring equipment metering detection device

Abstract

The invention provides a wearable blood pressure monitoring equipment metering detection device, which comprises a blood flow simulator, a bionic simulation arm and a data analysis processing end, and is characterized in that the blood flow simulator comprises simulation blood, a buffer chamber and a vacuum pump, and the simulation blood is connected with the vacuum pump through a pipeline via the buffer chamber; the vacuum pump generates periodic pressure fluctuation in the buffer chamber by pumping simulated blood, the bionic simulated arm comprises a simulated blood vessel and bionic skin, the simulated blood vessel is located in the bionic skin and connected with the inlet and outlet end of the vacuum pump, and a high-precision pressure sensor is pre-embedded between the simulated blood vessel and the bionic skin. The data analysis processing end is electrically connected with the high-precision pressure sensor and used for conducting noise reduction and feature enhancement on original pressure data obtained by the sensor, key feature parameters of pulse waves are extracted by analyzing the waveform of the enhanced pressure data, and finally systolic pressure and diastolic pressure simulation values with metering traceability are output. The wearable blood pressure monitoring device does not need to be disassembled during measurement and detection.

Description

Technical Field

[0001] The present invention relates to the field of medical metrology technology, and in particular to a measurement and detection device for wearable blood pressure monitoring equipment. Background Art

[0002] Most of the mainstream wearable blood pressure monitoring devices (including wrist-type electronic blood pressure monitors) on the market currently use the oscillometric method to measure blood pressure. The existing measurement and detection method for wearable blood pressure monitoring devices requires removing the wristband or disassembling the instrument housing, inserting a tiny pipe into the pressure pipe of its host, connecting the blood pressure measurement standard device to the host of the wearable blood pressure monitoring device through a three-way pipe, and then using the blood pressure measurement standard device to input the standard pressure and dynamic simulated blood pressure value to the host of the wearable blood pressure monitoring device, and perform static pressure indication error and blood pressure indication repeatability detection. However, the inventors of this application have found through research that due to the structural integrated design of existing wearable blood pressure monitoring devices, their wristbands and pressure sensing modules usually adopt an integrated packaging process. Disassembling the wristband or disassembling the instrument housing during detection will inevitably bring the following problems:

[0003] First, because the shell fixing methods of devices of different brands vary significantly (such as plastic snap-on, screw reinforcement or ultrasonic welding), forced disassembly can easily cause problems such as shell breakage, internal air path damage or sensor displacement, which in turn poses a potential threat to the accuracy of the device's test results and the safety of subsequent clinical use.

[0004] Secondly, the wristband is the key interface between the wearable device and the human body, and its physical properties (such as fit and pressure transmission uniformity) directly affect the accuracy of blood pressure measurement. When the wristband is peeled off during the test and the main unit of the wearable blood pressure monitoring device is directly connected to the blood pressure measurement standard device, key variables in actual use scenarios such as the elastic deformation of the wristband and the mechanical stability of the adhesive buckle are ignored. As a result, the measurement results fail to cover the performance evaluation of the entire device system, which may lead to deviations in the qualified judgment and thus affect the reliability of clinical blood pressure monitoring data. Summary of the Invention

[0005] In response to the technical problem of existing wearable blood pressure monitoring devices requiring disassembly for measurement and testing, the present invention provides a measurement and testing device for wearable blood pressure monitoring devices. The device is a non-invasive design based on a bionic wrist structure. It not only effectively solves the inherent contradiction between mechanical adaptability and detection integrity of existing detection technologies, but also provides a new technical path for the accuracy and reliability measurement of wearable blood pressure monitoring devices by constructing a measurement and evaluation system close to the actual clinical use environment. It is expected to promote the optimization and innovation of measurement and testing standards in this field.

[0006] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0007] A wearable blood pressure monitoring device measurement and detection device includes a blood flow simulator, a bionic simulation arm and a data analysis and processing end. The blood flow simulator is used to accurately simulate the physiological blood flow state of the human body. The blood flow simulator includes simulated blood, a buffer chamber and a vacuum pump. The simulated blood is connected to the vacuum pump through a pipeline through the buffer chamber. The vacuum pump generates periodic pressure fluctuations in the buffer chamber by pumping the simulated blood; the bionic simulation arm includes simulated blood vessels and bionic skin. The simulated blood vessels are located inside the bionic skin. The simulated blood vessels are connected to the inlet and outlet ends of the vacuum pump to ensure that the pumped simulated blood forms a simulated blood flow in the simulated blood vessels. A high-precision pressure sensor is pre-buried between the simulated blood vessels and the bionic skin; the data analysis and processing end is electrically connected to the high-precision pressure sensor and is used to reduce noise and enhance features of the original pressure data obtained by the high-precision pressure sensor, extract key characteristic parameters of the pulse wave by analyzing the enhanced pressure data waveform, and finally output systolic and diastolic pressure simulation values ​​with metrological traceability.

[0008] Compared with existing technologies, the wearable blood pressure monitoring device measurement and detection device provided by the present invention is based on the core design concept of simulating the physiological characteristics and mechanical properties of the human wrist. By constructing a highly simulated bionic pressure conduction system, it breaks through the traditional detection method's reliance on physical disassembly or rigid connection of the device. It constructs a bionic wrist body containing a multi-layered flexible material composite structure, achieves accurate reproduction of the pressure conduction path in real human wear scenarios, and avoids the detection scene distortion problem caused by wristband disassembly or mechanical connection in traditional detection processes. Compared with existing detection methods, it has the following innovations:

[0009] (1) No need to physically disassemble the device under test, avoiding the risk of instrument damage caused by improper operation;

[0010] (2) The flexible simulation arm design is compatible with the differences in size and shape of various mainstream brands;

[0011] (3) A dynamic pressure transmission model is established to ensure the accuracy of the value transmission of parameters such as systolic pressure and diastolic pressure under complex working conditions, providing a standardized technical path for the value transmission of wearable blood pressure monitoring equipment, which has important practical significance for improving the medical equipment measurement system.

[0012] Furthermore, the simulated blood is composed of 36% to 40% by mass of glycerol, 58% to 62% by mass of water, and 1% to 3% by mass of a thickener, and the simulated blood density is 1.05 g / cm 3 ~1.06g / cm 3 , viscosity is 4.45mPa·s~4.55mPa·s, and surface tension is 54.5mN / m~55.5mN / m.

[0013] Furthermore, the thickener is carboxymethyl cellulose.

[0014] Furthermore, the simulated blood vessel is made of medical-grade polymer materials.

[0015] Furthermore, the bionic skin uses a human tissue-mimicking silicone material to simulate the subcutaneous fat and skin tissue layers. The material is composed of 25% by mass of hydrated silica, 25% of polydimethylsiloxane, 35% of oligosiloxane, 2% of a vulcanizing agent, 6.5% to 9% of a water-locking agent, 1% of an anti-adhesive agent, 1% of a chain extender, 0.5% to 1% of modified aramid fiber, and 2.5% to 3.5% of purified water.

[0016] Furthermore, the data analysis and processing end extracts key characteristic parameters of the pulse wave by analyzing the enhanced pressure data waveform, and ultimately outputs systolic and diastolic pressure simulation values ​​with metrological traceability, specifically including:

[0017] By analyzing the enhanced pressure data waveform, key characteristic parameters including the pulse wave's rise time, fall time, peak amplitude, and dicrotic wave notch are first extracted.

[0018] Then, the extracted key characteristic parameter data of the pulse wave is fitted through the PID algorithm, and the relevant pressure waveform is adjusted to form smoother and more distinct pressure peak platform data and trough platform data, namely systolic pressure and diastolic pressure;

[0019] Finally, by comparing the corrected pressure data with the initial pressure setting value, the pulse wave rise time and fall time, pressure data waveform and pressure peak and valley data are further reproduced and adjusted. The final fitted pressure peak and valley data are systolic and diastolic pressure simulation values ​​with metrological traceability. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a structural schematic diagram of the measuring and detecting device of the wearable blood pressure monitoring equipment provided by the present invention.

[0021] In the figure, 1. Blood flow simulator; 11. Simulated blood; 12. Buffer chamber; 13. Vacuum pump; 2. Bionic simulated arm; 21. Simulated blood vessels; 22. Bionic skin; 23. High-precision pressure sensor; 3. Data analysis and processing end. DETAILED DESCRIPTION

[0022] In order to make the technical means, creative features, objectives and effects achieved by the present invention easier to understand, the present invention is further described below with reference to specific illustrations.

[0023] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0024] Please refer to Figure 1 As shown, the present invention provides a wearable blood pressure monitoring equipment measurement and detection device, including a blood flow simulator 1, a bionic simulation arm 2 and a data analysis and processing end 3, the blood flow simulator 1 uses a constant flow rate and periodic intermittent driving mechanism to achieve accurate simulation of the physiological blood flow state of the human body, the blood flow simulator 1 includes simulated blood 11, a buffer chamber 12 and a vacuum pump 13, the simulated blood 11 is connected to the vacuum pump 13 through a pipeline through the buffer chamber 12, the vacuum pump 13 generates periodic pressure fluctuations in the buffer chamber 12 by pumping the simulated blood 11, and then simulates the oscillation wave generated during the contraction / relaxation process of the heart to generate the required target value simulated blood pressure; the bionic simulation arm 2 includes a simulated blood vessel 21 and a bionic skin 22, the simulated blood vessel 21 is located inside the bionic skin 22, the simulated blood vessel 21 is connected to the inlet and outlet ends of the vacuum pump 13 (that is, a circular connection is formed between the simulated blood vessel 21 and the vacuum pump 13), to ensure that the pumped simulated blood 11 forms a simulated blood flow in the simulated blood vessel 21, the bionic skin 22 has good elastic deformation to adapt to wearable blood pressure monitoring devices of different shapes and sizes. High-precision pressure sensors 23 are pre-buried between the simulated blood vessels 21 and the bionic skin 22. These pressure sensors are distributed at key positions between the simulated blood vessels 21 and the bionic skin 22, and can capture the subtle oscillation waveforms generated by the simulated blood flow in real time; the data analysis and processing end 3 is electrically connected to the high-precision pressure sensor 23, and is used to reduce noise and enhance features of the original pressure data obtained by the high-precision pressure sensor 23. By analyzing the enhanced pressure data waveform, the key characteristic parameters of the pulse wave are extracted, and finally the systolic and diastolic pressure simulation values ​​with metrological traceability are output. The data analysis and processing end 3 uses the existing STM32 microcontroller combined with adjacent data averaging for signal processing. After each update of the target data, the device needs to stabilize the data for about 30 to 50 seconds (the peak and valley data finally stabilized after about 3 to 5 rounds of data acquisition-data processing-PID optimization rounds are used as the simulated systolic and diastolic pressure values ​​for metrological traceability).

[0025] Compared with existing technologies, the wearable blood pressure monitoring device measurement and detection device provided by the present invention is based on the core design concept of simulating the physiological characteristics and mechanical properties of the human wrist. By constructing a highly simulated bionic pressure conduction system, it breaks through the traditional detection method's reliance on physical disassembly or rigid connection of the device. It constructs a bionic wrist body containing a multi-layered flexible material composite structure, achieves accurate reproduction of the pressure conduction path in real human wear scenarios, and avoids the detection scene distortion problem caused by wristband disassembly or mechanical connection in traditional detection processes. Compared with existing detection methods, it has the following innovations:

[0026] (1) No need to physically disassemble the device under test, avoiding the risk of instrument damage caused by improper operation;

[0027] (2) The flexible simulation arm design is compatible with the differences in size and shape of various mainstream brands;

[0028] (3) A dynamic pressure transmission model is established to ensure the accuracy of the value transmission of parameters such as systolic pressure and diastolic pressure under complex working conditions, providing a standardized technical path for the value transmission of wearable blood pressure monitoring equipment, which has important practical significance for improving the medical equipment measurement system.

[0029] As a specific embodiment, the simulated blood 11 is composed of 36% to 40% by mass of glycerol, 58% to 62% by mass of water, and 1% to 3% by mass of a thickener. The simulated blood density is 1.05 g / cm 3 ~1.06g / cm 3 The viscosity is 4.45mPa·s~4.55mPa·s, and the surface tension is 54.5mN / m~55.5mN / m. The rheological properties analysis shows that its viscosity parameters and flow characteristics are highly consistent with human blood, effectively reducing the detection error caused by differences in fluid mechanics properties.

[0030] As a specific embodiment, the thickener is realized by selecting existing carboxymethyl cellulose, whose aqueous solution has good thickening, film-forming, bonding, moisture retention, colloid protection, emulsification and suspension effects.

[0031] As a specific embodiment, the simulated blood vessel 21 is made of existing medical-grade polymer materials, and its parameters such as tube diameter and elastic modulus are similar to those of real human blood vessels. When connected to the blood flow simulator 1, it can ensure that the flow characteristics of the simulated blood flow therein are highly similar to the blood flow characteristics in human blood vessels.

[0032] As a specific embodiment, the bionic skin 22 uses a human tissue-mimicking silicone phantom material to simulate the subcutaneous fat and skin tissue layer. The material (human tissue-mimicking silicone phantom material) is composed of 25% by mass of hydrated silica, 25% of polydimethylsiloxane, 35% of oligosiloxane, 2% of vulcanizing agent, 6.5% to 9% of water-locking agent, 1% of anti-adhesive agent, 1% of chain extender, 0.5% to 1% of modified aramid fiber and 2.5% to 3.5% of purified water. As a result, the human tissue-mimicking silicone phantom material has good longitudinal and transverse wave conduction capabilities and good repeatability, ensuring that the touch and pressure conduction are close to the human body, and the simulated intravascular pressure can be stably and clearly transmitted to the surface and detected by wearable blood pressure monitoring equipment.

[0033] As a specific embodiment, the data analysis and processing end extracts key characteristic parameters of the pulse wave by analyzing the enhanced pressure data waveform, and ultimately outputs systolic and diastolic pressure simulation values ​​with metrological traceability, specifically including:

[0034] By analyzing the enhanced pressure data waveform, key characteristic parameters including the pulse wave's rise time, fall time, peak amplitude, and dicrotic wave notch are first extracted. These characteristic parameters have a specific correlation with systolic and diastolic blood pressure.

[0035] Then, the extracted key characteristic parameter data of the pulse wave is fitted through the PID algorithm, and the relevant pressure waveform is adjusted to form smoother and more distinct pressure peak platform data and trough platform data, namely systolic pressure and diastolic pressure;

[0036] Finally, by comparing the corrected pressure data with the initial pressure setting value, the pulse wave rise time and fall time, pressure data waveform and pressure peak and valley data are further reproduced and adjusted. The final fitted pressure peak and valley data are systolic and diastolic pressure simulation values ​​with metrological traceability.

[0037] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not limiting. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present invention may be modified or replaced by equivalents without departing from the purpose and scope of the technical solutions of the present invention, which should all be included in the scope of the claims of the present invention.

Claims

1. A wearable blood pressure monitoring device measuring and detecting device, characterized in that: It includes a blood flow simulator, a bionic simulation arm and a data analysis and processing end. The blood flow simulator is used to achieve accurate simulation of the physiological blood flow state of the human body. The blood flow simulator includes simulated blood, a buffer chamber and a vacuum pump. The simulated blood is connected to the vacuum pump through a pipeline through the buffer chamber. The vacuum pump generates periodic pressure fluctuations in the buffer chamber by pumping the simulated blood; the bionic simulation arm includes simulated blood vessels and bionic skin. The simulated blood vessels are located inside the bionic skin. The simulated blood vessels are connected to the inlet and outlet ends of the vacuum pump to ensure that the pumped simulated blood forms a simulated blood flow in the simulated blood vessels. A high-precision pressure sensor is pre-buried between the simulated blood vessels and the bionic skin; the data analysis and processing end is electrically connected to the high-precision pressure sensor, and is used to reduce noise and enhance features of the original pressure data obtained by the high-precision pressure sensor, extract key characteristic parameters of the pulse wave by analyzing the enhanced pressure data waveform, and finally output systolic and diastolic pressure simulation values ​​with metrological traceability.

2. The wearable blood pressure monitoring device according to claim 1, wherein: The simulated blood is composed of 36% to 40% by mass of glycerol, 58% to 62% by mass of water, and 1% to 3% by mass of a thickener. The simulated blood density is 1.05 g / cm 3 ~1.06g / cm 3 , viscosity is 4.45mPa·s~4.55mPa·s, and surface tension is 54.5mN / m~55.5mN / m.

3. The wearable blood pressure monitoring device according to claim 2, wherein: The thickener is carboxymethyl cellulose.

4. The wearable blood pressure monitoring device according to claim 1, wherein: The simulated blood vessel is made of medical-grade polymer materials.

5. The wearable blood pressure monitoring device according to claim 1, wherein: The bionic skin uses a human tissue-mimicking silicone biomimetic material to simulate subcutaneous fat and skin tissue layers. The material is prepared by mixing 25% by mass of hydrated silicon dioxide, 25% of polydimethylsiloxane, 35% of oligosiloxane, 2% of a vulcanizing agent, 6.5% to 9% of a water-locking agent, 1% of an anti-adhesive agent, 1% of a chain extender, 0.5% to 1% of modified aramid fiber, and 2.5% to 3.5% of purified water.

6. The wearable blood pressure monitoring device according to claim 1, wherein: The data analysis and processing end analyzes the enhanced pressure data waveform, extracts key characteristic parameters of the pulse wave, and ultimately outputs systolic and diastolic pressure simulation values ​​with metrological traceability, specifically including: By analyzing the enhanced pressure data waveform, key characteristic parameters including the pulse wave's rise time, fall time, peak amplitude, and dicrotic wave notch are first extracted. Then, the extracted key characteristic parameter data of the pulse wave is fitted through the PID algorithm, and the relevant pressure waveform is adjusted to form smoother and more distinct pressure peak platform data and trough platform data, namely systolic pressure and diastolic pressure; Finally, by comparing the corrected pressure data with the initial pressure setting value, the pulse wave rise time and fall time, pressure data waveform and pressure peak and valley data are further reproduced and adjusted. The final fitted pressure peak and valley data are systolic and diastolic pressure simulation values ​​with metrological traceability.

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