Continuous blood pressure collection apparatus and continuous blood pressure collection method

Abstract

Provided are a continuous blood pressure collection apparatus and a continuous blood pressure collection method. The apparatus comprises: an electrocardiogram electrode (20) and a MEMS pressure sensor array (10), the MEMS pressure sensor array (10) comprising a plurality of MEMS pressure sensors (11), the electrocardiogram electrode (20) being configured for measuring an electrocardiogram signal, and the MEMS pressure sensors (11) being configured for measuring pulse signals; a collector (30), connected to the electrocardiogram electrode (20) and the plurality of MEMS pressure sensors (11) and configured for synchronously and continuously collecting the electrocardiogram signal measured by the electrocardiogram electrode (20) and the pulse signals measured by the plurality of MEMS pressure sensors (11); and a processor (40), connected to the collector (30) and configured for acquiring the electrocardiogram signal collected by the collector (30) and the pulse signals of a plurality of channels of the plurality of MEMS pressure sensors (11), screening the pulse signals of the plurality of channels to obtain a pulse signal of one channel as a target pulse signal, and determining a blood pressure value on the basis of the target pulse signal and the electrocardiogram signal, thereby achieving accurate monitoring of blood pressure.

Description

Continuous blood pressure monitoring device and continuous blood pressure monitoring method Technical Field

[0001] This disclosure relates to the field of wearable medical device technology, and more particularly to a continuous blood pressure acquisition device and a continuous blood pressure acquisition method. Background Technology

[0002] The aging population and the increasing prevalence of diseases at younger ages have led to a continuous rise in the number of people suffering from and the prevalence of chronic diseases such as hypertension. The application of wearable medical devices for measuring blood pressure has enabled more refined, professional, and continuous management of chronic diseases like hypertension. Because blood pressure parameters are influenced by many factors such as physical condition, environmental conditions, and physiological rhythms, the results of single or intermittent measurements can vary significantly. Continuous measurement methods, which can measure blood pressure in every cardiac cycle, have greater significance in clinical practice and medical research.

[0003] Sensors used to monitor blood pressure are crucial for wearable medical devices; however, currently no sensor on the market has the accuracy and sensitivity required for medical-grade applications. Summary of the Invention

[0004] This disclosure provides a continuous blood pressure acquisition device and method to address the problems of low accuracy and sensitivity of existing blood pressure monitoring sensors.

[0005] To solve the above-mentioned technical problems, this disclosure is implemented as follows:

[0006] In a first aspect, embodiments of this disclosure provide a continuous blood pressure monitoring device, comprising:

[0007] An electrocardiogram (ECG) electrode and a MEMS pressure sensor array, wherein the MEMS pressure sensor array includes multiple MEMS pressure sensors; the ECG electrode is used to measure the ECG signal of the object being measured, and the MEMS pressure sensor is used to measure the pulse signal of the object being measured;

[0008] The data acquisition unit is connected to the ECG electrodes and the plurality of MEMS pressure sensors respectively, and is used to synchronously and continuously acquire the ECG signals measured by the ECG electrodes and the pulse signals measured by the plurality of MEMS pressure sensors.

[0009] The processor, connected to the acquisition unit, is used to acquire the electrocardiogram (ECG) signal and the pulse signals from multiple channels of the multiple MEMS pressure sensors acquired by the acquisition unit, filter the pulse signals from the multiple channels to obtain the pulse signal from one channel as the target pulse signal, and determine the blood pressure value of the measurement object based on the target pulse signal and the ECG signal.

[0010] Optionally, the MEMS pressure sensors located in different rows in the MEMS pressure sensor array are aligned or staggered, and the multiple MEMS pressure sensors are of the same model.

[0011] Optionally, the cross-sectional area of ​​each of the MEMS pressure sensors is 1-4 mm². 2 ;

[0012] And / or, the spacing between adjacent MEMS pressure sensors is 1-5 mm.

[0013] Optional, also includes:

[0014] A sensor circuit board, on which the plurality of MEMS pressure sensors are mounted.

[0015] Optional, also includes:

[0016] A barrier is installed on the sensor circuit board, and the MEMS pressure sensor is installed within the accommodating space defined by the barrier.

[0017] Optionally, the number of the enclosure is one, the enclosure defines an accommodating space, and all the MEMS pressure sensors are disposed within the accommodating space;

[0018] or

[0019] The number of enclosures is multiple, each enclosure defines a receiving space, and at least one MEMS pressure sensor is provided in each receiving space;

[0020] or

[0021] The number of enclosures is one, and the enclosures define multiple accommodating spaces, each of which is equipped with at least one of the MEMS pressure sensors.

[0022] Optional, also includes:

[0023] A flexible filler is provided to fill the enclosure and cover the MEMS pressure sensor. The flexible filler includes at least two flexible layers stacked on top of each other. The at least two flexible layers have different hardnesses, and the hardness of the at least two flexible layers gradually increases from the direction closer to the MEMS pressure sensor to the direction farther away from the MEMS pressure sensor.

[0024] Optionally, the height of the flexible filler is higher than that of the enclosure.

[0025] Optional, also includes:

[0026] A sensor mounting bracket, wherein the sensor circuit board is disposed on the first side of the sensor mounting bracket;

[0027] A flexible cover is disposed on the first side of the sensor mounting bracket. The flexible cover includes a cavity with one end open, and the sensor circuit board is housed in the cavity.

[0028] Optional, also includes:

[0029] The bottom shell has the sensor mounting bracket disposed inside it, and the flexible cover protrudes from the first side of the bottom shell.

[0030] Optionally, the flexible cover protrudes from the bottom shell by a height of 0.1-10 mm.

[0031] Optionally, the electrocardiogram electrodes include a first electrode and a second electrode;

[0032] The first electrode and the second electrode are disposed at different positions on the bottom shell, or the first electrode and the second electrode are connected to the collector in the bottom shell by wires.

[0033] Optionally, the collector includes:

[0034] Multiple analog-to-digital converters are used to perform analog-to-digital conversion on the acquired pulse signal and the electrocardiogram signal. Each MEMS pressure sensor corresponds to one analog-to-digital converter, and each electrocardiogram electrode corresponds to one analog-to-digital converter.

[0035] A synchronization controller is used to control the analog-to-digital converter to synchronously acquire the pulse signal and the electrocardiogram signal.

[0036] Optionally, the processor includes:

[0037] The pulse signal filtering module is used to input the pulse signals from multiple channels of the multiple MEMS pressure sensors into the pulse waveform recognition algorithm model, and obtain a channel pulse signal filtered by the pulse waveform recognition algorithm model as the target pulse signal.

[0038] Optionally, the processor includes:

[0039] The feature extraction module is used to obtain, for each electrocardiogram peak value of the electrocardiogram signal, the first time corresponding to the electrocardiogram peak value, the first pulse peak value of the target pulse signal after the first time value, and the second time corresponding to the first pulse peak value;

[0040] A time difference calculation module is used to calculate the time difference between the first moment and the second moment; and to obtain a target time difference based on the time difference corresponding to at least one of the electrocardiogram peak values;

[0041] The blood pressure calculation module is used to input target input information, including the target time difference, into the blood pressure calculation model to obtain the blood pressure value output by the blood pressure calculation model.

[0042] Optionally, the target input information may further include: the body parameter information of the measurement object.

[0043] Optional, also includes:

[0044] The calibration module is used to calculate the time difference between calibration times in calibration mode, and obtain the calibration time difference.

[0045] The blood pressure calculation module is further configured to, in the calibration mode, input target input information including the target time difference, the body parameter information, the calibration time difference, and the calibration blood pressure value into the blood pressure calculation model to obtain the blood pressure value predicted by the blood pressure calculation model, compare the predicted blood pressure value with the calibration blood pressure value, and calibrate the blood pressure calculation model according to the comparison result. The calibration blood pressure value is input by the user or sent by other devices, and the calibration blood pressure value is measured at the calibration time.

[0046] Secondly, embodiments of this disclosure provide a continuous blood pressure monitoring method, including:

[0047] The system synchronously and continuously acquires electrocardiogram (ECG) signals measured by ECG electrodes and pulse signals measured by a MEMS pressure sensor array, wherein the MEMS pressure sensor array includes multiple MEMS pressure sensors.

[0048] The electrocardiogram (ECG) signal and pulse signals from multiple channels of the multiple MEMS pressure sensors are acquired. The pulse signals from the multiple channels are filtered to obtain the pulse signal from one channel as the target pulse signal. The blood pressure value of the measurement object is determined based on the target pulse signal and the ECG signal.

[0049] Optionally, the step of filtering the pulse signals from the multiple channels to obtain the pulse signal from one channel as the target pulse signal includes:

[0050] The pulse signals from multiple channels of the multiple MEMS pressure sensors are input into the pulse waveform recognition algorithm model to obtain a pulse signal from one channel selected by the pulse waveform recognition algorithm model as the target pulse signal.

[0051] Optionally, determining the blood pressure value of the measurement subject based on the target pulse signal and the electrocardiogram signal includes:

[0052] For each peak value of the electrocardiogram (ECG) signal, a first time point corresponding to the ECG peak value is obtained; the first pulse peak value of the target pulse signal after the first time point and a second time point corresponding to the first pulse peak value are obtained; the time difference between the first time point and the second time point is calculated; and a target time difference is obtained based on the time difference corresponding to at least one of the ECG peak values.

[0053] The target input information, including the target time difference, is input into the blood pressure calculation model to obtain the blood pressure value output by the blood pressure calculation model.

[0054] Optional, also includes:

[0055] In calibration mode, the time difference between calibration times is calculated to obtain the calibration time difference;

[0056] In the calibration mode, target input information including the target time difference, the body parameter information of the measurement object, the calibration time difference, and the calibration blood pressure value is input into the blood pressure calculation model to obtain the blood pressure value predicted by the blood pressure calculation model.

[0057] The predicted blood pressure value is compared with the calibrated blood pressure value, and the blood pressure calculation model is calibrated based on the comparison result;

[0058] The calibrated blood pressure value is input by the user or sent by other devices, and the calibrated blood pressure value is measured at the calibration time.

[0059] In this embodiment, a MEMS pressure sensor array is used to collect pulse signals, and an electrocardiogram (ECG) electrode is used to collect ECG signals. The MEMS pressure sensor array includes multiple MEMS pressure sensors arranged in an array. The ECG signals measured by the ECG electrode and the pulse signals measured by the multiple MEMS pressure sensors are collected synchronously and continuously. The pulse signals from multiple channels of the multiple MEMS pressure sensors are filtered to obtain the pulse signal from one channel. The blood pressure value of the measured object is determined based on the filtered pulse signal and the ECG signal. Since multiple MEMS pressure sensors arranged in an array are used to collect pulse signals, the problem of inaccurate pulse positioning by a single sensor can be solved. Even if the body shakes and some sensors cannot align with the pulse, the pulse signal measurement will not fail. In addition, combining the pulse signal and the ECG signal to determine the blood pressure value makes the blood pressure measurement more accurate. Attached Figure Description

[0060] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of this disclosure. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:

[0061] Figure 1 is a schematic diagram of one of the structures of the continuous blood pressure monitoring device according to an embodiment of the present disclosure;

[0062] Figure 2 is one of the schematic diagrams showing the arrangement of a MEMS pressure sensor array according to an embodiment of this disclosure;

[0063] Figure 3 is a second schematic diagram of the arrangement of the MEMS pressure sensor array according to an embodiment of this disclosure;

[0064] Figure 4 is a schematic diagram of the arrangement of the MEMS pressure sensor array according to an embodiment of this disclosure;

[0065] Figure 5 is a fourth schematic diagram of the arrangement of the MEMS pressure sensor array according to an embodiment of this disclosure;

[0066] Figure 6 is a schematic diagram of the sensor mounting bracket according to an embodiment of this disclosure;

[0067] Figure 7 is a schematic diagram of the structure of the flexible cover according to an embodiment of this disclosure;

[0068] Figure 8 is a schematic diagram of the sensor mounting bracket and flexible cover combined according to an embodiment of the present disclosure;

[0069] Figure 9 is a schematic diagram of the sensor circuit board according to an embodiment of this disclosure;

[0070] Figure 10 is one of the structural schematic diagrams of the enclosure according to an embodiment of this disclosure;

[0071] Figure 11 is a second schematic diagram of the structure of the enclosure according to an embodiment of this disclosure;

[0072] Figure 12 is a third schematic diagram of the structure of the enclosure according to an embodiment of this disclosure;

[0073] Figure 13 is a fourth schematic diagram of the structure of the enclosure according to an embodiment of this disclosure;

[0074] Figure 14 is a fifth schematic diagram of the structure of the enclosure according to an embodiment of this disclosure;

[0075] Figure 15 is a schematic diagram of the structure of the flexible filler according to an embodiment of the present disclosure;

[0076] Figure 16 is a second schematic diagram of the structure of the flexible filler according to an embodiment of this disclosure;

[0077] Figure 17 is a schematic diagram of the bottom shell structure according to an embodiment of this disclosure;

[0078] Figure 18 is a schematic diagram of one of the wearing methods of the continuous blood pressure monitoring device according to an embodiment of the present disclosure;

[0079] Figure 19 is a second schematic diagram of the wearing method of the continuous blood pressure monitoring device according to an embodiment of the present disclosure;

[0080] Figure 20 is a third schematic diagram of the wearing method of the continuous blood pressure monitoring device according to an embodiment of the present disclosure;

[0081] Figure 21 is a fourth schematic diagram of the wearing method of the continuous blood pressure monitoring device according to an embodiment of the present disclosure;

[0082] Figure 22 is a schematic diagram of the structure of a MEMS pressure sensor according to an embodiment of this disclosure;

[0083] Figure 23 is one of the schematic diagrams of the continuous blood pressure collection method according to an embodiment of the present disclosure;

[0084] Figure 24 is a second schematic diagram of the continuous blood pressure collection method according to an embodiment of the present disclosure;

[0085] Figure 25 is a flowchart illustrating the continuous blood pressure collection method according to an embodiment of the present disclosure;

[0086] Figure 26 is a schematic diagram of the blood pressure calculation method under the correction mode of this disclosure embodiment. Detailed Implementation

[0087] The technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this disclosure. Based on the embodiments of this disclosure, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this disclosure.

[0088] Among the relevant methods, one approach uses a single MEMS (Micro-Electro-Mechanical System) sensor to measure blood pressure. Sensors fabricated using MEMS technology have high sensitivity and can detect even weak pulse beats. However, using a single sensor makes it difficult to align it with the artery, leading to measurement failure. There are two main reasons for this: First, the small cross-sectional area of ​​a single sensor, with the pressure point at the center of the cross-section, further reduces the pressure area, making it very difficult to align with the pulse in the artery. Second, the radial artery has a relatively small diameter. Based on ultrasound imaging results, the diameter of the radial artery in adults can be divided into three grades, as shown in Table 1.

[0089] Table 1

[0090] Even if the sensor is aligned with the pulse when worn for the first time, body movement will likely cause mismatch, resulting in measurement failure.

[0091] To address the issues of low accuracy and sensitivity in existing blood pressure monitoring sensors, please refer to Figure 1. This disclosure provides a continuous blood pressure acquisition device, comprising:

[0092] The device includes an electrocardiogram (ECG) electrode 20 and a MEMS pressure sensor array 10, wherein the MEMS pressure sensor array 10 includes a plurality of MEMS pressure sensors 11; the ECG electrode 20 is used to measure the ECG signal of the subject being measured, and the MEMS pressure sensors 11 are used to measure the pulse signal of the subject being measured.

[0093] The data acquisition unit 30 is connected to the electrocardiogram electrode 20 and the plurality of MEMS pressure sensors 11 respectively, and is used to synchronously and continuously acquire the electrocardiogram signal measured by the electrocardiogram electrode 20 and the pulse signal measured by the plurality of MEMS pressure sensors 11.

[0094] The processor 40, connected to the acquisition unit 30, is used to acquire the electrocardiogram signal and the pulse signals of multiple channels of the multiple MEMS pressure sensors 11 acquired by the acquisition unit 30, filter the pulse signals of the multiple channels to obtain the pulse signal of one channel as the target pulse signal, and determine the blood pressure value of the measurement object based on the target pulse signal and the electrocardiogram signal.

[0095] In this embodiment, a MEMS pressure sensor array is used to collect pulse signals, and an electrocardiogram (ECG) electrode is used to collect ECG signals. The MEMS pressure sensor array includes multiple MEMS pressure sensors arranged in an array. The ECG signals measured by the ECG electrode and the pulse signals measured by the multiple MEMS pressure sensors are collected synchronously and continuously. The pulse signals from multiple channels of the multiple MEMS pressure sensors are filtered to obtain the pulse signal from one channel. The blood pressure value of the measured object is determined based on the filtered pulse signal and the ECG signal. Since multiple MEMS pressure sensors arranged in an array are used to collect pulse signals, the problem of inaccurate pulse positioning by a single sensor can be solved. Even if the body shakes and some sensors cannot align with the pulse, the pulse signal measurement will not fail. In addition, combining the pulse signal and the ECG signal to determine the blood pressure value makes the blood pressure measurement more accurate.

[0096] In some embodiments, optionally, the continuous blood pressure acquisition device is a wearable device, such as a watch, which can conveniently and continuously acquire the electrocardiogram and pulse signals of the subject, thereby better monitoring the subject's blood pressure value.

[0097] In some embodiments, optionally, the plurality of MEMS pressure sensors are of the same model, which can save costs on the one hand and simplify the subsequent screening of pulse signals on the other.

[0098] In some embodiments, optionally, the multiple MEMS pressure sensors are arranged in a two-dimensional array. A two-dimensional array refers to an array composed of rows and columns, for example, including M rows and N columns, where M and N are both positive integers greater than or equal to 1. By using multiple MEMS pressure sensors arranged in an array to collect pulse signals, the problem of inaccurate pulse localization by a single sensor can be solved. Even if body movement causes some sensors to misalign with the pulse, the pulse signal measurement will not fail. In some embodiments, optionally, the MEMS pressure sensors located in different rows of the MEMS pressure sensor array can be aligned, as shown in Figure 1. This method saves space occupied by the MEMS pressure sensor array, allowing the continuous blood pressure acquisition device to be smaller and more suitable for wearable scenarios.

[0099] In some embodiments, optionally, the MEMS pressure sensors in different rows of the MEMS pressure sensor array are staggered, thereby effectively increasing the measurement area of ​​the MEMS pressure sensor array and significantly improving the detection rate of pulse signals compared to a single sensor. Referring to Figures 2, 3, 4, and 5, the pressure sensor array can be a 2x2 array, a 1x3 array, a 3x2 array, a 4x3 array, etc., in which the MEMS pressure sensors in different rows are staggered. The staggered position can be such that the MEMS pressure sensors are located exactly between two MEMS pressure sensors in adjacent rows, thereby allowing the MEMS pressure sensor array to cover a larger area.

[0100] In some embodiments, optionally, the cross-sectional area of ​​each MEMS pressure sensor is 1-4 mm². 2 ; and / or, the spacing between adjacent MEMS pressure sensors is 1-5 mm. Referring to the embodiments shown in Figures 2-5, in these embodiments, each MEMS pressure sensor has a size of 2 mm * 2 mm and a cross-sectional area of ​​4 mm². 2 The spacing between two adjacent MEMS pressure sensors in the same row is 2 mm, and the spacing between two adjacent MEMS pressure sensors in the same column is 1.4 mm. In some embodiments, optionally, each MEMS pressure sensor may also have a size of 1 mm * 1 mm and a cross-sectional area of ​​1 mm². 2Of course, the size of the MEMS pressure sensor can also be adjusted appropriately according to needs to meet specific measurement requirements. The MEMS pressure sensor in the embodiments of this disclosure has a small cross-sectional area, which allows it to be arranged into a force sensor array to measure the pressure distribution at different locations.

[0101] In the embodiments shown in Figures 1-5 above, the cross-section of the MEMS pressure sensor is rectangular. In other embodiments of this disclosure, it can also be other shapes, such as circular or elliptical, and this disclosure does not impose any limitations. When the cross-section of the MEMS pressure sensor is circular, the diameter of the circle can optionally be 1-5 mm.

[0102] In some embodiments, optionally, referring to Figure 9, the blood pressure acquisition device further includes:

[0103] A sensor circuit board 120 is provided, on which a plurality of MEMS pressure sensors 11 are disposed. In this embodiment of the present disclosure, the sensor circuit board 120 can be used to carry the MEMS pressure sensors 11 and can transmit the signals collected by the MEMS pressure sensors 11 to a data acquisition unit.

[0104] In some embodiments, optionally, the sensor circuit board 120 may include terminals connected to the MEMS pressure sensor 11 and the data acquisition unit, for transmitting the pulse signal measured by the MEMS pressure sensor 11 to the data acquisition unit.

[0105] In some embodiments, the data collector may optionally be located on the sensor circuit board 120.

[0106] In some embodiments, optionally, the sensor circuit board 120 may be a printed circuit board (PCB) or a flexible printed circuit (FPC), etc.

[0107] In some embodiments, optionally, referring to Figures 10, 11, 12, 13, and 14, the blood pressure acquisition device further includes:

[0108] A barrier 70 is disposed on the sensor circuit board 120, and the MEMS pressure sensor 11 is disposed within the accommodating space defined by the barrier 70.

[0109] In this embodiment of the disclosure, the enclosure 70 is formed as a cover with openings at both ends, and the enclosure 70 is placed over the MEMS pressure sensor 11.

[0110] In this embodiment, the enclosure 70 serves to protect the MEMS pressure sensor 11. In this embodiment, the height of the enclosure 70 is higher than the height of the MEMS pressure sensor 11.

[0111] Referring to Figure 10, in some embodiments, the number of enclosures 70 is one, and the enclosure defines a receiving space in which all the MEMS pressure sensors 11 are disposed. In this manner, the manufacturing cost of the enclosure is lower, as only one enclosure needs to be manufactured.

[0112] Please refer to Figures 11 and 12. In some embodiments, the number of enclosures 70 may also be multiple, and at least one MEMS pressure sensor 11 is provided in the accommodating space defined by each enclosure 70.

[0113] In the embodiment shown in Figure 11, the number of enclosures 70 is the same as the number of MEMS pressure sensors 11, each enclosure 70 defines a receiving space, and one MEMS pressure sensor 11 is disposed in one receiving space.

[0114] In the embodiment shown in Figure 12, the number of enclosures 70 is less than the number of MEMS pressure sensors 11, and two MEMS pressure sensors 11 are provided in the accommodating space defined by each enclosure 70.

[0115] By setting up the enclosure 70, the MEMS pressure sensor 11 can be protected on the one hand, and the mutual interference between the MEMS pressure sensors 11 can be avoided on the other hand.

[0116] As can be seen from the above embodiments, the multiple fences 70 can be independent of each other. Of course, in some embodiments, the multiple fences 70 can also be connected together to form a whole, which can also be referred to as a single fence.

[0117] Please refer to Figures 13 and 14. In some embodiments, the number of enclosures 70 is one, and the enclosures 70 define multiple accommodating spaces, each of which is provided with at least one of the MEMS pressure sensors.

[0118] In the embodiment shown in Figure 13, there is one enclosure 70, which defines four accommodating spaces, and each accommodating space is provided with one MEMS pressure sensor.

[0119] In the embodiment shown in Figure 14, there is one enclosure 70, which defines three accommodating spaces. One MEMS pressure sensor is disposed in one accommodating space. Two MEMS pressure sensors are disposed in one accommodating space.

[0120] In this method, the fence is formed in one piece, resulting in a more stable structure.

[0121] Of course, it should be noted that the methods of setting up fences are not limited to the examples mentioned above, and will not be listed one by one here.

[0122] In this embodiment of the disclosure, the material of the enclosure 70 can be metal or rigid plastic material, etc.

[0123] In some embodiments, optionally, referring to Figures 15 and 16, the continuous blood pressure acquisition device of this disclosure embodiment further includes:

[0124] Flexible filler 80 is filled within the enclosure 70 and covers the MEMS pressure sensor 11.

[0125] The flexible filler 80 serves two purposes: firstly, to protect the MEMS pressure sensor 11, and secondly, to act as a medium for force transmission.

[0126] Optionally, the flexible filler 80 can be formed from materials such as soft rubber.

[0127] In some embodiments, optionally, the flexible filler comprises at least two flexible layers stacked on top of each other. The at least two flexible layers have different hardnesses, with the hardness gradually increasing from the direction closest to the MEMS pressure sensor to the direction furthest away from the MEMS pressure sensor. That is, the flexible layer closer to the MEMS pressure sensor has lower hardness to prevent damage to the MEMS pressure sensor, while the flexible layer furthest away from the MEMS pressure sensor can be set to a higher hardness to provide better force conduction.

[0128] In some embodiments, the flexible filler may optionally be higher than the enclosure, thereby allowing for better force transmission.

[0129] In some embodiments, optionally, referring to Figures 6, 7, and 8, the continuous blood pressure acquisition device further includes:

[0130] A sensor mounting bracket 50 is provided, and the sensor circuit board 120 is disposed on the first side of the sensor mounting bracket 50.

[0131] A flexible cover 60 is disposed on the first side of the sensor mounting bracket 50. The flexible cover 60 includes a cavity with one end open, and the sensor circuit board 120 is accommodated in the cavity.

[0132] That is, the flexible cover 60 is mounted on the sensor circuit board 120, and the plurality of MEMS pressure sensors 11 are all covered by the flexible cover 60 and housed in the cavity of the flexible cover 60.

[0133] Figure 6 is a schematic diagram of the sensor circuit board and sensor mounting bracket according to an embodiment of this disclosure. The MEMS pressure sensor 11 is not shown in Figure 6. The sensor circuit board 120 can be a printed circuit board (PCB) or a flexible printed circuit board (FPC), etc. The sensor circuit board 120 may include terminals 121, which are connected to the MEMS pressure sensor 11 and the data acquisition unit, for transmitting the pulse signal detected by the MEMS pressure sensor 11 to the data acquisition unit. Optionally, in this embodiment, the data acquisition unit and / or processor may be mounted on the sensor mounting bracket.

[0134] Figure 7 is a schematic diagram of the flexible cover 60 according to an embodiment of the present disclosure. The flexible cover 60 is formed of a flexible material, such as silicone. The flexible cover 60 can be formed into a cap shape. The open end of the flexible cover 60 is attached to the first side of the sensor mounting bracket 50. Please refer to Figure 8. Figure 8 is a schematic diagram of the structure of the flexible cover 60 and the sensor mounting bracket installed together. After the flexible cover 60 and the sensor mounting bracket 50 are installed and combined, the sensor circuit board 120 with the MEMS pressure sensor 11 is accommodated in the flexible cover 60. The flexible cover 60 can protect the MEMS pressure sensor 11 on the one hand, and on the other hand, when measuring the pulse signal, the outer wall of the protruding chamber bottom of the flexible cover 60 is attached to the skin of the measurement object. This method is more in line with the requirements of human-machine wearing and can collect more stable pulse signals.

[0135] In this embodiment of the present disclosure, as shown in FIG7, the flexible cover 60 further includes an annular edge 61 disposed at the opening end, and the annular edge 61 is provided with a plurality of mounting holes. Correspondingly, the sensor mounting bracket 50 is also provided with a plurality of mounting holes. The flexible cover 60 and the sensor mounting bracket 50 are fixedly connected through the mounting holes on the flexible cover 60 and the mounting holes on the sensor mounting bracket 50.

[0136] In some embodiments, optionally, the depth of the bottom outer wall of the cavity of the flexible cover 60 relative to the opening end of the flexible cover 60 is 0.1-10mm, which is more in line with the needs of human wear.

[0137] In some embodiments, optionally, the length L2 of the chamber of the flexible cover 60 is 15-25mm and the width L1 is 10-15mm. This size allows the continuous blood pressure monitoring device to be smaller and easier to wear.

[0138] Please refer to Figure 17. In some embodiments, optionally, the continuous blood pressure acquisition device further includes:

[0139] The bottom shell 90, the sensor mounting bracket 50 is disposed inside the bottom shell 90, and the flexible cover 60 protrudes from the bottom shell 90.

[0140] In the embodiment shown in Figure 17, the bottom shell 90 is bent, which makes the bottom shell 90 fit the measuring object more closely and conforms to ergonomics.

[0141] In this embodiment of the present disclosure, the flexible cover 60 protrudes from the bottom shell by 0.1-10mm. This protrusion height is more in line with the needs of human wearers, so that when the measurement object wears it, the flexible cover 60 fits tightly against the skin of the measurement object.

[0142] In this embodiment of the disclosure, the bottom shell 90 can be made of hard materials such as plastic, which serves to protect and support the structure.

[0143] Please refer to Figure 17. In some embodiments, optionally, the continuous blood pressure acquisition device further includes a display screen 100, which is disposed on the bottom shell 90. The display screen 100 is connected to the processor 40 and is used to display the blood pressure value calculated by the processor 40 for easy viewing by the user.

[0144] In this embodiment of the disclosure, optionally, the electrocardiogram electrode 20 includes a first electrode and a second electrode. In some embodiments, the number of the first electrode is two, and the number of the second electrode is one.

[0145] In some embodiments, optionally, the first electrode and the second electrode are disposed at different positions on the bottom shell 90. For example, as shown in Figure 17, the first electrode 21 is disposed on one side of the bottom shell 90, that is, the side that is in close contact with the skin, and the second electrode 22 is disposed on the opposite side of the bottom shell 90. Referring to Figure 21, when measuring blood pressure, one side of the bottom shell 90 is in close contact with the object being measured, the flexible cover 60 and the first electrode 21 are attached to the skin of the object being measured, and the object being measured also needs to press its finger on the second electrode 22 to measure the pulse signal and electrocardiogram signal.

[0146] In some embodiments, optionally, the first electrode 21 and the second electrode 22 are connected to the collector in the bottom shell 90 via wires. Referring to Figures 18, 19, and 20, when measuring blood pressure, the first electrode 21 and the second electrode 22 are applied to different locations on the human body, and the first electrode 21 and the second electrode 22 are connected to the collector in the bottom shell 90 via wires.

[0147] In some embodiments, optionally, the continuous blood pressure monitoring device further includes a watch strap, with the base shell 90 disposed on the watch strap. Please refer to Figure 18, which is one schematic diagram of how the continuous blood pressure monitoring device according to an embodiment of the present disclosure is worn. This continuous blood pressure monitoring device includes a watch strap, with the base shell 90 disposed on the watch strap. By wearing the watch strap on the wrist, the radial artery pulse signal and electrocardiogram (ECG) signal can be monitored. Please refer to Figure 19, which is another schematic diagram of how the continuous blood pressure monitoring device according to an embodiment of the present disclosure is worn. This continuous blood pressure monitoring device includes a watch strap, with the base shell 90 disposed on the watch strap. By wearing the watch strap on the arm, the brachial artery pulse signal and ECG signal can be monitored.

[0148] In some embodiments, optionally, the continuous blood pressure monitoring device further includes a patch, with the base shell 90 disposed on the patch. Please refer to Figure 20, which is a third schematic diagram of the wearing method of the continuous blood pressure monitoring device according to an embodiment of this disclosure. The continuous blood pressure monitoring device includes a patch, with the base shell 90 disposed on the patch. By attaching the patch to the neck, the pulse signal of the carotid artery and the electrocardiogram signal can be monitored.

[0149] The structure of the MEMS pressure sensor according to an embodiment of this disclosure will be illustrated below.

[0150] In some embodiments, referring to FIG22, the MEMS pressure sensor in this disclosure includes:

[0151] Substrate 110, wherein a first groove 110a is formed on the first side surface of the substrate;

[0152] A cantilever beam 111 is disposed on the first side of the substrate 110 and overlaps the first groove 110a. A second groove 111a is formed on the side of the cantilever beam 111 facing away from the substrate 110.

[0153] A force transmission structure 112 is disposed within the second groove 111a;

[0154] A varistor 113 is disposed on the cantilever beam 111.

[0155] The sensor circuit board 120 is disposed on the side of the force transmission structure 112 away from the substrate 110 and is connected to the varistor 113.

[0156] When the MEMS pressure sensor of this embodiment is in use, the pulse wave signal acts on the force transmission structure 112, the force transmission structure 112 squeezes the cantilever beam 111, causing the cantilever beam 111 to deform, thereby causing the resistance value of the pressure-sensitive resistor 113 on the cantilever beam 111 to change. The external pressure can be detected by the change in resistance value.

[0157] Of course, the structure of the MEMS pressure sensor in the embodiments of this disclosure is not limited thereto.

[0158] In some embodiments, optionally, referring to FIG23, the collector 30 includes:

[0159] Multiple analog-to-digital converters (ADCs) are used to perform analog-to-digital conversion on the acquired pulse signal and the electrocardiogram signal. Each MEMS pressure sensor corresponds to one ADC, and each electrocardiogram electrode corresponds to one ADC.

[0160] A synchronization controller is used to control the analog-to-digital converter to synchronously acquire the pulse signal and the electrocardiogram signal.

[0161] In this embodiment of the disclosure, optionally, the collector 30 may further include a data acquisition buffer for caching the pulse signal and electrocardiogram signal after analog-to-digital conversion.

[0162] In some embodiments, optionally, the processor 40 includes:

[0163] The pulse signal filtering module is used to input the pulse signals from multiple channels of the multiple MEMS pressure sensors 11 into the pulse waveform recognition algorithm model, and obtain a pulse signal from one channel selected by the pulse waveform recognition algorithm model as the target pulse signal.

[0164] In this embodiment of the disclosure, the pulse waveform recognition algorithm model can be trained based on multiple historically measured real pulse signals. This is equivalent to an expert model that can identify the optimal pulse signal.

[0165] Of course, in other embodiments of this disclosure, the processor 40 may also filter the target pulse signal in other ways, such as by pulse amplitude.

[0166] Please refer to Figure 23. The top four waveforms in Figure 23 are pulse signals, and the bottom waveform is an electrocardiogram signal. Select one pulse signal from the four pulse signals, for example, the pulse signal of the nth channel (second row) as the target pulse signal.

[0167] In some embodiments, optionally, the processor 40 includes:

[0168] The feature extraction module is used to obtain, for each electrocardiogram peak value of the electrocardiogram signal, the first time corresponding to the electrocardiogram peak value, the first pulse peak value of the target pulse signal after the first time value, and the second time corresponding to the first pulse peak value;

[0169] A time difference calculation module is used to calculate the time difference between the first moment and the second moment; and to obtain a target time difference based on the time difference corresponding to at least one of the electrocardiogram peak values;

[0170] The blood pressure calculation module is used to input target input information, including the target time difference, into the blood pressure calculation model to obtain the blood pressure value output by the blood pressure calculation model.

[0171] In this embodiment of the disclosure, optionally, the target input information further includes: the body parameter information of the measurement object, such as height, weight, age, gender, etc.

[0172] Please refer to Figure 24. Select the pulse signal in the second row as the target pulse signal. For each peak value of the ECG signal (see the black dot on the ECG signal in Figure 23), obtain the first time T1 corresponding to the peak value. Obtain the first peak value of the target pulse signal after the first time T1 (see the black dot on the pulse signal in the second channel in Figure 23) and the second time T2 corresponding to the first peak value. Calculate the time difference T between the first time T1 and the second time T2. Obtain the target time difference based on the time difference T corresponding to at least one of the ECG peak values.

[0173] Optionally, the target time difference can be obtained by averaging the time differences T corresponding to multiple ECG peak values ​​over a period of time.

[0174] In this embodiment of the disclosure, the blood pressure calculation model can be trained based on multiple target time differences measured in history and the actual blood pressure values ​​corresponding to the multiple target time differences.

[0175] In this embodiment of the disclosure, optionally, as shown in FIG26, the continuous blood pressure acquisition device may further include:

[0176] The calibration module is used to calculate the time difference between calibration times in calibration mode, and obtain the calibration time difference.

[0177] The blood pressure calculation module is further configured to, in the calibration mode, input target input information including the target time difference, the body parameter information, the calibration time difference, and the calibration blood pressure value into the blood pressure calculation model to obtain the blood pressure value predicted by the blood pressure calculation model, compare the predicted blood pressure value with the calibration blood pressure value, and calibrate the blood pressure calculation model according to the comparison result. The calibration blood pressure value is input by the user or sent by other devices, and the calibration blood pressure value is measured at the calibration time.

[0178] The continuous blood pressure monitoring device can be calibrated using the calibration mode. Typically, the continuous blood pressure monitoring device can be calibrated when the subject wears it for the first time.

[0179] In other words, in calibration mode, the target input information input to the blood pressure calculation model includes at least the target time difference, the calibration time difference, and the calibration blood pressure value, and may also include the body parameter information. In normal measurement mode, the target input information input to the blood pressure calculation model includes at least the target time difference, and may also include the body parameter information.

[0180] In this embodiment of the present disclosure, optionally, the continuous blood pressure acquisition device may further include a communication module for connecting to the processor 40 and for transmitting the blood pressure value calculated by the processor 40 to an external user device, such as a user's mobile phone. The communication module may employ wireless communication technologies such as Bluetooth for communication.

[0181] Optionally, in this embodiment of the disclosure, the continuous blood pressure monitoring device may also display the calculated blood pressure value through the display screen of the continuous blood pressure monitoring device.

[0182] Please refer to Figure 25. This embodiment of the present disclosure also provides a continuous blood pressure collection method, including:

[0183] Step S11: Synchronously and continuously acquire the electrocardiogram signal measured by the electrocardiogram electrodes and the pulse signal measured by the MEMS pressure sensor array, wherein the MEMS pressure sensor array includes multiple MEMS pressure sensors;

[0184] Step S12: Acquire the collected electrocardiogram signal and pulse signals from multiple channels of the multiple MEMS pressure sensors, filter the pulse signals from the multiple channels to obtain the pulse signal from one channel as the target pulse signal, and determine the blood pressure value of the measurement object based on the target pulse signal and the electrocardiogram signal.

[0185] In this embodiment, a MEMS pressure sensor array is used to collect pulse signals, and an electrocardiogram (ECG) electrode is used to collect ECG signals. The MEMS pressure sensor array includes multiple MEMS pressure sensors arranged in an array. The ECG signals measured by the ECG electrode and the pulse signals measured by the multiple MEMS pressure sensors are collected synchronously and continuously. The pulse signals from multiple channels of the multiple MEMS pressure sensors are filtered to obtain the pulse signal from one channel. The blood pressure value of the measured object is determined based on the filtered pulse signal and the ECG signal. Since multiple MEMS pressure sensors arranged in an array are used to collect pulse signals, the problem of inaccurate pulse positioning by a single sensor can be solved. Even if the body shakes and some sensors cannot align with the pulse, the pulse signal measurement will not fail. In addition, combining the pulse signal and the ECG signal to determine the blood pressure value makes the blood pressure measurement more accurate.

[0186] In some embodiments, optionally, the step of filtering the pulse signals from the plurality of channels to obtain the pulse signal of one channel as the target pulse signal includes:

[0187] The pulse signals from multiple channels of the multiple MEMS pressure sensors are input into the pulse waveform recognition algorithm model to obtain a pulse signal from one channel selected by the pulse waveform recognition algorithm model as the target pulse signal.

[0188] In some embodiments, optionally, determining the blood pressure value of the measurement subject based on the target pulse signal and the electrocardiogram signal includes:

[0189] For each peak value of the electrocardiogram (ECG) signal, a first time point corresponding to the ECG peak value is obtained; the first pulse peak value of the target pulse signal after the first time point and a second time point corresponding to the first pulse peak value are obtained; the time difference between the first time point and the second time point is calculated; and a target time difference is obtained based on the time difference corresponding to at least one of the ECG peak values.

[0190] The target input information, including the target time difference, is input into the blood pressure calculation model to obtain the blood pressure value output by the blood pressure calculation model.

[0191] In some embodiments, optionally, it also includes:

[0192] In calibration mode, the time difference between calibration times is calculated to obtain the calibration time difference;

[0193] In the calibration mode, target input information including the target time difference, the body parameter information of the measurement object, the calibration time difference, and the calibration blood pressure value is input into the blood pressure calculation model to obtain the blood pressure value predicted by the blood pressure calculation model.

[0194] The predicted blood pressure value is compared with the calibrated blood pressure value, and the blood pressure calculation model is calibrated based on the comparison result;

[0195] The calibrated blood pressure value is input by the user or sent by other devices, and is measured at the calibration time. The other devices may be, for example, cuff blood pressure measuring devices. These other devices can transmit the standard blood pressure value to the continuous blood pressure acquisition device via wireless communication technologies such as Bluetooth.

[0196] The embodiments of this disclosure have been described above with reference to the accompanying drawings. However, this disclosure is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of this disclosure without departing from the spirit and scope of the claims, and all of these forms are within the protection scope of this disclosure.

Claims

1. A continuous blood pressure monitoring device, characterized in that, include: ECG electrodes and a MEMS pressure sensor array, wherein the MEMS pressure sensor array includes multiple MEMS pressure sensors; The electrocardiogram electrode is used to measure the electrocardiogram signal of the subject being measured, and the MEMS pressure sensor is used to measure the pulse signal of the subject being measured. The data acquisition unit is connected to the ECG electrodes and the plurality of MEMS pressure sensors respectively, and is used to synchronously and continuously acquire the ECG signals measured by the ECG electrodes and the pulse signals measured by the plurality of MEMS pressure sensors. The processor, connected to the acquisition unit, is used to acquire the electrocardiogram (ECG) signal and the pulse signals from multiple channels of the multiple MEMS pressure sensors acquired by the acquisition unit, filter the pulse signals from the multiple channels to obtain the pulse signal from one channel as the target pulse signal, and determine the blood pressure value of the measurement object based on the target pulse signal and the ECG signal.

2. The continuous blood pressure monitoring device as described in claim 1, characterized in that, The MEMS pressure sensors in different rows of the MEMS pressure sensor array are aligned or staggered, and the multiple MEMS pressure sensors are of the same model.

3. The continuous blood pressure acquisition device as described in claim 1, characterized in that: Each of the aforementioned MEMS pressure sensors has a cross-sectional area of ​​1-4 mm². 2 ; And / or, the spacing between adjacent MEMS pressure sensors is 1-5 mm.

4. The continuous blood pressure monitoring device as described in claim 1, characterized in that, Also includes: A sensor circuit board, on which the plurality of MEMS pressure sensors are mounted.

5. The continuous blood pressure acquisition device as described in claim 4, characterized in that, Also includes: A barrier is installed on the sensor circuit board, and the MEMS pressure sensor is installed within the accommodating space defined by the barrier.

6. The continuous blood pressure acquisition device as described in claim 5, characterized in that, The number of the enclosure is one, and the enclosure defines an accommodating space, in which all the MEMS pressure sensors are disposed; or The number of enclosures is multiple, each enclosure defines a receiving space, and at least one MEMS pressure sensor is provided in each receiving space; or The number of enclosures is one, and the enclosures define multiple accommodating spaces, each of which is equipped with at least one of the MEMS pressure sensors.

7. The continuous blood pressure acquisition device as described in claim 5, characterized in that, Also includes: A flexible filler is provided to fill the enclosure and cover the MEMS pressure sensor. The flexible filler includes at least two flexible layers stacked on top of each other. The at least two flexible layers have different hardnesses, and the hardness of the at least two flexible layers gradually increases from the direction closer to the MEMS pressure sensor to the direction farther away from the MEMS pressure sensor.

8. The continuous blood pressure acquisition device as described in claim 7, characterized in that, The height of the flexible filler is higher than that of the enclosure.

9. The continuous blood pressure acquisition device according to any one of claims 4-7, characterized in that, Also includes: A sensor mounting bracket, wherein the sensor circuit board is disposed on the first side of the sensor mounting bracket; A flexible cover is disposed on the first side of the sensor mounting bracket. The flexible cover includes a cavity with one end open, and the sensor circuit board is housed in the cavity.

10. The continuous blood pressure acquisition device as described in claim 9, characterized in that, Also includes: The bottom shell has the sensor mounting bracket disposed inside it, and the flexible cover protrudes from the first side of the bottom shell.

11. The continuous blood pressure monitoring device as described in claim 10, characterized in that, The flexible cover protrudes from the bottom shell by 0.1-10 mm.

12. The continuous blood pressure monitoring device as described in claim 10, characterized in that, The electrocardiogram electrodes include a first electrode and a second electrode; The first electrode and the second electrode are disposed at different positions on the bottom shell, or the first electrode and the second electrode are connected to the collector in the bottom shell by wires.

13. The continuous blood pressure monitoring device as described in claim 1, characterized in that, The data collector includes: Multiple analog-to-digital converters are used to perform analog-to-digital conversion on the acquired pulse signal and the electrocardiogram signal. Each MEMS pressure sensor corresponds to one analog-to-digital converter, and each electrocardiogram electrode corresponds to one analog-to-digital converter. A synchronization controller is used to control the analog-to-digital converter to synchronously acquire the pulse signal and the electrocardiogram signal.

14. The continuous blood pressure acquisition device as described in claim 1, characterized in that, The processor includes: The pulse signal filtering module is used to input the pulse signals from multiple channels of the multiple MEMS pressure sensors into the pulse waveform recognition algorithm model, and obtain a channel pulse signal filtered by the pulse waveform recognition algorithm model as the target pulse signal.

15. The continuous blood pressure acquisition device as described in claim 1, characterized in that, The processor includes: The feature extraction module is used to obtain, for each electrocardiogram peak value of the electrocardiogram signal, the first time corresponding to the electrocardiogram peak value, the first pulse peak value of the target pulse signal after the first time value, and the second time corresponding to the first pulse peak value; A time difference calculation module is used to calculate the time difference between the first moment and the second moment; and to obtain a target time difference based on the time difference corresponding to at least one of the electrocardiogram peak values; The blood pressure calculation module is used to input target input information, including the target time difference, into the blood pressure calculation model to obtain the blood pressure value output by the blood pressure calculation model.

16. The continuous blood pressure acquisition device as described in claim 15, characterized in that, The target input information also includes: the body parameter information of the measurement object.

17. The continuous blood pressure acquisition device as described in claim 16, characterized in that, Also includes: The calibration module is used to calculate the time difference between calibration times in calibration mode, and obtain the calibration time difference. The blood pressure calculation module is further configured to, in the calibration mode, input target input information including the target time difference, the body parameter information, the calibration time difference, and the calibration blood pressure value into the blood pressure calculation model to obtain the blood pressure value predicted by the blood pressure calculation model, compare the predicted blood pressure value with the calibration blood pressure value, and calibrate the blood pressure calculation model according to the comparison result. The calibration blood pressure value is input by the user or sent by other devices, and the calibration blood pressure value is measured at the calibration time.

18. A method for continuous blood pressure collection, characterized in that, include: The system synchronously and continuously acquires electrocardiogram (ECG) signals measured by ECG electrodes and pulse signals measured by a MEMS pressure sensor array, wherein the MEMS pressure sensor array includes multiple MEMS pressure sensors. The electrocardiogram (ECG) signal and pulse signals from multiple channels of the multiple MEMS pressure sensors are acquired. The pulse signals from the multiple channels are filtered to obtain the pulse signal from one channel as the target pulse signal. The blood pressure value of the measurement object is determined based on the target pulse signal and the ECG signal.

19. The continuous blood pressure collection method as described in claim 18, characterized in that, The step of filtering the pulse signals from the multiple channels to obtain the pulse signal from one channel as the target pulse signal includes: The pulse signals from multiple channels of the multiple MEMS pressure sensors are input into the pulse waveform recognition algorithm model to obtain a pulse signal from one channel selected by the pulse waveform recognition algorithm model as the target pulse signal.

20. The continuous blood pressure collection method as described in claim 18, characterized in that, Determining the blood pressure value of the measurement subject based on the target pulse signal and the electrocardiogram signal includes: For each peak value of the electrocardiogram (ECG) signal, a first time point corresponding to the ECG peak value is obtained; the first pulse peak value of the target pulse signal after the first time point and a second time point corresponding to the first pulse peak value are obtained; the time difference between the first time point and the second time point is calculated; and a target time difference is obtained based on the time difference corresponding to at least one of the ECG peak values. The target input information, including the target time difference, is input into the blood pressure calculation model to obtain the blood pressure value output by the blood pressure calculation model.

21. The continuous blood pressure collection method as described in claim 20, characterized in that, Also includes: In calibration mode, the time difference between calibration times is calculated to obtain the calibration time difference; In the calibration mode, target input information including the target time difference, the body parameter information of the measurement object, the calibration time difference, and the calibration blood pressure value is input into the blood pressure calculation model to obtain the blood pressure value predicted by the blood pressure calculation model. The predicted blood pressure value is compared with the calibrated blood pressure value, and the blood pressure calculation model is calibrated based on the comparison result; The calibrated blood pressure value is input by the user or sent by other devices, and the calibrated blood pressure value is measured at the calibration time.

Images