Intelligent blood pressure correction module capable of being in butt joint with sphygmomanometer and implementation method thereof

Abstract

The invention relates to an intelligent blood pressure correction module capable of being in butt joint with a sphygmomanometer and an implementation method of the intelligent blood pressure correction module, belongs to the technical field of medical equipment, and aims to solve the problems that a measurement result of an existing electronic sphygmomanometer is easily interfered and a postmortem analysis and calibration mechanism is lacked. The module is connected in series between a sphygmomanometer and a cuff, collects a gas path pressure signal in real time through a pressure sensor, records a complete pressure waveform through a data collection, storage and analysis unit, performs automatic analysis and manual correction based on an oscillography principle, and finally outputs a corrected blood pressure value. According to the invention, traceability and accurate correction of the blood pressure measurement process are realized, and the reliability and clinical application value of the measurement result are improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical equipment, in particular to a correction device and method for blood pressure measurement, and more particularly to an intelligent module capable of being docked with an existing electronic sphygmomanometer to record, analyze and correct blood pressure measurement data and an implementation method thereof. BACKGROUND

[0002] Non-invasive blood pressure measurement is one of the most basic and most frequent vital sign monitoring methods in clinical medicine and daily health monitoring. At present, the electronic non-invasive sphygmomanometers based on the principle of oscillometric method are widely used in the market. Such sphygmomanometers will be calibrated under static pressure when leaving the factory, but in actual use, the measurement accuracy thereof is easily affected by various factors.

[0003] In the prior art, the measurement accuracy of the electronic non-invasive sphygmomanometer highly depends on the standardized measurement process and stable measurement environment. In the measurement process, any slight disturbance, such as movement of the measured person's arm, body sway, muscle tremor caused by emotional tension, or improper wearing position of the cuff, unsuitable tightness, and too thick clothes, etc., can cause distortion of the pressure waveform in the cuff, and thus cause significant errors in the systolic pressure, diastolic pressure and pulse rate results obtained by automatic measurement, or even lead to measurement failure.

[0004] However, the existing electronic non-invasive sphygmomanometer usually only displays a final numerical result after the measurement is completed, and lacks a complete record of the measurement process data and a mechanism for post-analysis verification. When a doctor or user gets a suspicious blood pressure value, the original data of the measurement process cannot be traced back to determine the validity of the result. Clinicians often have to rely on personal experience to determine whether the data is reliable, which brings uncertainty to subjective judgment, especially in scenarios where the treatment plan needs to be accurately adjusted, and false blood pressure data can cause greater clinical risks.

[0005] In particular, in the application of 24-hour ambulatory blood pressure monitoring (ABPM), most patients perform timed automatic measurement in uncontrolled home or daily environment, and interference factors are more common, resulting in a large amount of invalid or large-error data being collected. When interpreting the ambulatory blood pressure report, doctors face a list of numerical values and it is difficult to effectively identify which data are "bad points" caused by interference, so that diagnosis may be made based on false data, affecting the treatment effect.

[0006] Therefore, there is an urgent need in the art for a tool and method capable of recording, playing back, analyzing and calibrating the measurement process of the existing sphygmomanometer to make up for the shortcomings of the prior art and improve the clinical reliability of the blood pressure measurement results. SUMMARY

[0007] The main purpose of the present application is to solve the technical problem that the existing electronic non-invasive blood pressure meter has uncertain measurement results, large errors and lacks post-analysis calibration mechanism due to interference factors in the measurement process.

[0008] To achieve the above-mentioned purpose, the present application provides an intelligent blood pressure correction module which can be docked with a blood pressure meter. The module can be connected in series to the air path of the existing electronic non-invasive blood pressure meter, and the complete pressure waveform data in the measurement process can be recorded synchronously without changing the original working mode of the blood pressure meter. After the measurement is completed, the module or its analysis software can play back and analyze the measurement process data in a graphical manner, and provide automatic analysis and manual calibration functions based on the principle of oscillography, thereby helping the user (such as a clinician) to identify the effectiveness and accurately calibrate the measurement results.

[0009] To achieve the above-mentioned purpose, the present application provides the following technical solutions:

[0010] An intelligent blood pressure correction module which can be docked with a blood pressure meter, comprising:

[0011] An air tube interface for being connected in series in a detachable manner in the air path between the blood pressure meter and the cuff;

[0012] A pressure sensor in communication with the air tube interface for collecting pressure signals in the air path in real time;

[0013] A data acquisition unit electrically connected with the pressure sensor for converting the pressure signals into digitized pressure waveform data;

[0014] A data storage unit for storing the pressure waveform data in a complete blood pressure measurement process converted by the data acquisition unit; and

[0015] A data analysis unit for calling the pressure waveform data stored in the data storage unit for analysis after the blood pressure measurement is completed, so as to obtain or correct the blood pressure measurement value.

[0016] Another technical solution of the present application is as follows:

[0017] An intelligent blood pressure correction method, comprising the following steps:

[0018] Providing an intelligent blood pressure correction module as described above, and connecting it in series in the air path between the blood pressure meter and the cuff;

[0019] When the blood pressure meter performs blood pressure measurement, the module is used to collect and record the pressure waveform data in the whole measurement process in real time;

[0020] After the blood pressure measurement, the recorded pressure waveform data is analyzed to determine or correct the systolic, diastolic and pulse rate values of the blood pressure measurement.

[0021] The present application has the following advantages:

[0022] (1) The present application can capture and record the raw pressure waveform data of the whole process of each blood pressure measurement, while the existing sphygmomanometer only provides the final result. This provides a complete data basis for post-analysis, so that each measurement result becomes traceable and verifiable.

[0023] (2) Through post-analysis of the raw waveform, more accurate blood pressure values than the automatic measurement results of traditional sphygmomanometers can be obtained by identifying and excluding waveform distortions caused by accidental interference (such as arm movement) or by manually correcting key feature points.

[0024] (3) The present application provides a graphical analysis tool for clinicians to visually review measurement quality, identify invalid measurements, and confirm suspicious readings, effectively reducing the risk of clinical misjudgment caused by blood pressure measurement errors, especially for the interpretation of 24-hour ambulatory blood pressure monitoring data.

[0025] (4) The present application as an independent external module can be compatible with various existing electronic sphygmomanometers in hospitals or user homes, without the need to replace expensive original equipment, achieving functional upgrade with good economic efficiency and application universality.

[0026] Other advantages, objects and features of the present application will be set forth in part in the following specification, and in part will become apparent to those skilled in the art upon examination of the following specification, or can be learned from practice of the present application. The objects and other advantages of the present application can be realized and attained by the methods and instrumentalities particularly pointed out in the following specification. BRIEF DESCRIPTION OF DRAWINGS

[0027] In order to make the objects, technical solutions and advantages of the present application clearer, the preferred detailed description of the present application will be made below in combination with the drawings, in which:

[0028] Figure 1 Connection diagram of the intelligent blood pressure correction module in the embodiment of the present application and the existing sphygmomanometer and cuff;

[0029] Figure 2 Functional unit layout diagram of the intelligent blood pressure correction module in the embodiment of the present application;

[0030] Figure 3 User interface diagram of the external analysis software in the embodiment of the present application;

[0031] Figure 4 This is a flowchart of the intelligent blood pressure correction method in an embodiment of the present invention.

[0032] Reference numerals: Intelligent blood pressure correction module 100, first tracheal interface 110a, second tracheal interface 110b, tracheal interface 110, pressure sensor 120, data acquisition unit 130, data storage unit 140, data analysis unit 150, data transmission unit 160, electronic blood pressure monitor 200, cuff 300. Detailed Implementation

[0033] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in the following embodiments are only schematic representations of the basic concept of the present invention. Unless otherwise specified, the following embodiments and features can be combined with each other.

[0034] The accompanying drawings are for illustrative purposes only and are schematic diagrams, not actual pictures. They should not be construed as limiting the invention. To better illustrate the embodiments of the invention, some parts in the drawings may be omitted, enlarged, or reduced, and do not represent the actual product dimensions. It is understandable to those skilled in the art that some well-known structures and their descriptions may be omitted in the drawings.

[0035] In the accompanying drawings of the embodiments of the present invention, the same or similar reference numerals correspond to the same or similar components. In the description of the present invention, it should be understood that if terms such as "upper," "lower," "left," "right," "front," and "rear" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, they 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, or be constructed and operated in a specific orientation. Therefore, the terms used to describe positional relationships in the drawings are only for illustrative purposes and should not be construed as limiting the present invention. For those skilled in the art, the specific meaning of the above terms can be understood according to the specific circumstances.

[0036] Example 1: Intelligent Blood Pressure Correction Module

[0037] Please see Figure 1 and Figure 2 This embodiment provides an intelligent blood pressure correction module 100 that can be connected to a blood pressure monitor.

[0038] like Figure 1As shown, the intelligent blood pressure correction module 100 is designed as a small and portable device, with a housing size less than 70mm x 30mm x 55mm, for easy carrying and installation. Its core function is to be used as a "middleware" or "plug-in" for existing blood pressure meter systems. The intelligent blood pressure correction module 100 has two air tube interfaces, a first air tube interface 110a and a second air tube interface 110b. In use, the air tube of an existing electronic blood pressure meter 200 is pulled out of the cuff 300 and inserted into the first air tube interface 110a of the intelligent blood pressure correction module 100; and a short connecting tube is used to connect the second air tube interface 110b of the intelligent blood pressure correction module 100 with the cuff 300. In this way, the intelligent blood pressure correction module 100 is seamlessly connected in series into the air path between the electronic blood pressure meter 200 and the cuff 300, forming a connection path of "blood pressure meter-correction module-cuff".

[0039] As shown, the intelligent blood pressure correction module 100 is designed as a small and portable device, with a housing size less than 70mm x 30mm x 55mm, for easy carrying and installation. Its core function is to be used as a "middleware" or "plug-in" for existing blood pressure meter systems. The intelligent blood pressure correction module 100 has two air tube interfaces, a first air tube interface 110a and a second air tube interface 110b. In use, the air tube of an existing electronic blood pressure meter 200 is pulled out of the cuff 300 and inserted into the first air tube interface 110a of the intelligent blood pressure correction module 100; and a short connecting tube is used to connect the second air tube interface 110b of the intelligent blood pressure correction module 100 with the cuff 300. In this way, the intelligent blood pressure correction module 100 is seamlessly connected in series into the air path between the electronic blood pressure meter 200 and the cuff 300, forming a connection path of "blood pressure meter-correction module-cuff". Figure 2 As shown, the intelligent blood pressure correction module 100 is designed as a small and portable device, with a housing size less than 70mm x 30mm x 55mm, for easy carrying and installation. Its core function is to be used as a "middleware" or "plug-in" for existing blood pressure meter systems. The intelligent blood pressure correction module 100 has two air tube interfaces, a first air tube interface 110a and a second air tube interface 110b. In use, the air tube of an existing electronic blood pressure meter 200 is pulled out of the cuff 300 and inserted into the first air tube interface 110a of the intelligent blood pressure correction module 100; and a short connecting tube is used to connect the second air tube interface 110b of the intelligent blood pressure correction module 100 with the cuff 300. In this way, the intelligent blood pressure correction module 100 is seamlessly connected in series into the air path between the electronic blood pressure meter 200 and the cuff 300, forming a connection path of "blood pressure meter-correction module-cuff".

[0040] Air tube interface 110: corresponding to 110a and 110b, physically used for air path docking, ensuring air tightness. Figure 1

[0041] Pressure sensor 120: in communication with the internal air path, typically using a high-precision, high-sensitivity micro-electro-mechanical system (MEMS) pressure sensor, with a pressure recording range of 0mmHg to 280mmHg and a measurement accuracy of ±1.5% FS (full scale). It is responsible for real-time sensing of pressure changes in the air path caused by blood pressure meter inflation and deflation and arterial pulsation, and converting these physical pressure changes into continuous analog voltage or current signals.

[0042] Data acquisition unit 130: the unit is electrically connected with the pressure sensor 120. Its core is a high-performance analog-to-digital converter (ADC). In order to accurately capture the subtle changes of the pressure pulse wave, the ADC preferably has a high sampling accuracy of 16 bits to 24 bits, and an adjustable sampling rate of 80sps to 640sps (sampling points per second), with a resolution that matches the ±1.5% FS accuracy requirement of the pressure sensor 120. High precision and high sampling rate ensure that the converted digital signal can restore the true pressure waveform to the greatest extent.

[0043] ​Data storage unit 140: This unit is used to store the digitized pressure waveform data outputted by data acquisition unit 130. To ensure data is not lost after power-off, this unit preferably employs non-volatile memory such as Flash memory or Ferroelectric Random Access Memory (FRAM). Its storage capacity is sufficient to record data of multiple complete blood pressure measurement processes, for example, more than 200 measurement waveforms in a 24-hour ambulatory monitoring scenario.

[0044] Data analysis unit 150: This is the "brain" of the module, usually implemented by a low-power microcontroller (MCU) or processor, for example, a chip based on the ARM Cortex-M core series. Its power consumption can be controlled below 500 mW to ensure long-term working endurance. After the blood pressure measurement is completed, it is responsible for reading the complete pressure waveform data from data storage unit 140 and executing analysis algorithms to obtain or correct blood pressure values.

[0045] Power supply unit: Provides power for the entire module, which can be powered by a built-in rechargeable lithium battery and charged through a USB interface.

[0046] The smart blood pressure correction module 100 of the present embodiment further includes a data transmission unit 160. This unit is connected with the data analysis unit 150 and is responsible for communication with external devices. The transmission method can be wired (such as a wired serial port) or wireless, for example, integrated Wi-Fi module or Bluetooth module. Through this unit, the stored raw waveform data or analyzed results can be sent to a smartphone, tablet computer or hospital workstation for subsequent viewing and management by the user.

[0047] The function of data analysis unit 150 can be extended and work together with the user interface (UI) of external devices. Please refer to Figure 3 , which is a user interface diagram of an analysis software running on a mobile phone or computer. After the data transmission unit 160 sends the pressure waveform data of a certain measurement to the software, the software interface will present the complete pressure-time waveform graph in a graphical way.

[0048] The data analysis unit 150 (or external software) first automatically analyzes the waveform based on the oscillometric method. Specifically, the oscillometric method determines blood pressure by detecting the tiny pressure oscillations superimposed on the static pressure of the cuff caused by the heartbeat during the slow decrease of the cuff pressure. The data analysis unit 150 first filters the acquired raw pressure waveform data to separate the oscillation wave envelope representing the arterial pulsation. Then, it finds the cuff pressure corresponding to the maximum amplitude of the oscillation wave; this pressure is the mean arterial pressure (MAP).

[0049] Systolic blood pressure (SBP) and diastolic blood pressure (DBP) are estimated using mean arterial pressure and specific coefficients. A commonly used empirical formula is:

[0050] P SBP =P MAP +k1·A MAP

[0051] P DBP =P MAP +k2·A MAP

[0052] Where: P SBP P is the calculated systolic pressure. DBP P is the calculated diastolic pressure. MAP The measured mean arterial pressure is the cuff pressure corresponding to the peak value of the oscillating wave envelope; A MAP is the amplitude of the oscillation wave corresponding to the mean arterial pressure; k1 and k2 are empirical coefficients, the values ​​of which are related to individual physiological characteristics and algorithm models.

[0053] After the analysis is completed, the results will be as follows: Figure 3 As shown in the diagram, the calculated systolic blood pressure point (SYS), diastolic blood pressure point (DIA), and mean blood pressure point (MAP) are marked on the graph. If a doctor observes the waveform and finds obvious motion interference waves, or believes that the automatically calibrated points are offset due to atypical waveforms, they can manually drag the markers for SYS, DIA, or MAP to the correct positions using a mouse or touchscreen. This manual adjustment command is received by the system, and the data analysis unit 150 then recalculates based on the new adjusted positions to obtain a more reliable blood pressure measurement value that has been manually calibrated. This process perfectly illustrates the interactive calibration function.

[0054] Example 2: Intelligent blood pressure correction module with local display and control

[0055] This embodiment provides another module form. Unlike the first embodiment which mainly relies on external devices for data display and interaction, the module of this embodiment itself integrates a small-sized display screen (such as an OLED screen) and several physical buttons.

[0056] In this configuration, after completing a data collection, the module not only stores the data, but also directly displays the automatic analysis results (systolic pressure, diastolic pressure, pulse rate) of this measurement on the local display screen. The user can review the historical records through the buttons.

[0057] Furthermore, the data analysis unit 150 can draw a simplified pressure waveform graph on the local screen. The user can move the cursor on the simplified waveform graph to select different feature points and make fine adjustments through button combinations. Although the interactive experience is not as intuitive as the graphical interface of a large screen, it enables the module to perform basic and immediate result review and correction without external device connection, enhancing the independent working ability of the device. The data can still be exported for more detailed analysis when needed through the data transmission unit 160.

[0058] Embodiment Three: Intelligent Blood Pressure Correction Method

[0059] Please refer to Figure 4 This embodiment provides an intelligent blood pressure correction method based on the above-mentioned intelligent blood pressure correction module 100.

[0060] S401: Connection and Preparation.

[0061] As described in the first embodiment, the intelligent blood pressure correction module 100 is correctly connected in series between the user's electronic blood pressure meter 200 and the cuff 300. Turn on the power of the intelligent blood pressure correction module 100. The module enters the standby monitoring state.

[0062] S402: Automatic Collection and Recording.

[0063] The user starts the electronic blood pressure meter 200 for blood pressure measurement in the usual way. When the blood pressure meter starts to inflate the cuff, the pressure sensor 120 in the intelligent blood pressure correction module 100 detects the continuous rise of the airway pressure, and the data analysis unit 150 takes this as the trigger signal for "measurement start", immediately activates the data collection unit 130 and the data storage unit 140, starts to record the pressure waveform data from inflation, deflation to the end of measurement, and stores it in the non-volatile memory in real time. When the measurement is complete and the pressure is completely released, the module automatically stops recording and marks this data as a complete measurement event, which can be accompanied by timestamp information.

[0064] S403: Post-analysis and Correction.

[0065] This is the core step of the method, which can be performed immediately after the measurement is finished, or after all the data is exported after the 24-hour monitoring is completed.

[0066] Automatic analysis: First, the data analysis unit 150 will execute a preset automatic analysis algorithm based on the principle of oscillography. As described in Embodiment I, the algorithm determines the mean pressure by finding the peak value of the oscillation envelope, and determines the systolic and diastolic pressures according to the empirical formula or feature point recognition method, and calculates the pulse rate according to the period of the pulse wave.

[0067] Graphical presentation and manual correction: As described in Embodiments I and Figure 3 , the raw waveform data and the results of automatic analysis can be transmitted to an external device and presented to the doctor or user in a graphical manner. The user can review the results of automatic analysis. If abnormalities are found, the user can receive manual calibration or adjustment instructions on the graphical pressure waveform. For example, the user moves the marker of the systolic pressure point to a new position to the left or right, and the system captures this operation. Subsequently, the system recalculates and updates the blood pressure value according to the new position of the manual adjustment.

[0068] S404: Data transmission and output.

[0069] After the analysis and correction are completed, the final blood pressure value (whether it is automatically analyzed or manually corrected) and the original pressure waveform data can be sent to an external device through the data transmission unit 160. For example, all valid readings and correction instructions of the 24-hour ambulatory blood pressure monitoring can be integrated to generate a detailed PDF report, or directly imported into the hospital's electronic medical record (EMR) system, providing reliable data support for clinical diagnosis.

[0070] In summary, the present application solves the long-standing problem of invisible process and unreliable results in non-invasive blood pressure measurement through a clever and compatible intelligent module, and greatly improves the accuracy of blood pressure measurement and the clinical application value by introducing the mechanism of post-analysis and human-computer interaction correction.

[0071] Finally, it should be pointed out that the above embodiments are only used to illustrate the technical solutions of the present application and are not limiting. Although the present application 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 application can be modified or replaced by equivalents without departing from the spirit and scope of the present application, and all should be included in the scope of the claims of the present application.

Claims

1. An intelligent blood pressure correction module that can be interfaced with a sphygmomanometer, characterized by: The application comprises: a tracheal interface for detachably connecting in series between the air path of a sphygmomanometer and a cuff; a pressure sensor in communication with the tracheal interface for collecting pressure signals in the air path in real time; a data acquisition unit electrically connected with the pressure sensor for converting the pressure signals into digitized pressure waveform data; a data storage unit for storing the pressure waveform data converted by the data acquisition unit during a complete blood pressure measurement process; and a data analysis unit for analyzing the pressure waveform data stored in the data storage unit after the blood pressure measurement to obtain or correct the blood pressure measurement value.

2. The smart blood pressure correction module that is dockable with a sphygmomanometer of claim 1, wherein: The application further comprises: a data transmission unit for sending the pressure waveform data stored in the data storage unit or the blood pressure measurement value analyzed by the data analysis unit to an external analysis device through wired or wireless means.

3. The smart blood pressure correction module that is dockable with a sphygmomanometer of claim 2, wherein: The wireless means includes Wi-Fi or Bluetooth.

4. The smart blood pressure correction module that is dockable with a sphygmomanometer of claim 1, wherein: The data analysis unit is further used for: presenting the pressure waveform data in a graphical manner; recomputing the blood pressure measurement value in response to a user's manual adjustment instruction on the presented graphical pressure waveform data.

5. The smart blood pressure correction module that is dockable with a sphygmomanometer of claim 4, wherein: The manual adjustment instruction includes adjustment of the position of the maximum pressure pulse wave or the position of the waveform mutation point corresponding to the systolic pressure and diastolic pressure.

6. The smart blood pressure correction module that is dockable with a sphygmomanometer of claim 1, wherein: The data acquisition unit includes an analog-to-digital converter (ADC) with a sampling accuracy of 16 bits to 24 bits.

7. An intelligent blood pressure correction method, characterized in that: The application comprises the following steps: providing a smart blood pressure correction module as claimed in any one of claims 1 to 6 that can be docked with a sphygmomanometer and connecting it in series between the air path of the sphygmomanometer and a cuff; collecting and recording pressure waveform data during the entire measurement process using the module when the sphygmomanometer performs blood pressure measurement; after the blood pressure measurement, analyzing the recorded pressure waveform data to determine or correct the systolic pressure, diastolic pressure and pulse rate value of the blood pressure measurement.

8. The intelligent blood pressure correction method of claim 7, wherein: The analysis of the recorded pressure waveform data specifically includes: automatically analyzing the pressure waveform data based on the oscillography principle to calculate the systolic pressure, diastolic pressure and pulse rate value.

9. The intelligent blood pressure correction method of claim 7 or 8, wherein: The post-analysis further includes: presenting the pressure waveform data in a graphical manner; receiving a user's manual calibration or adjustment instruction on the graphical pressure waveform; recomputing the systolic pressure, diastolic pressure and pulse rate value according to the manual calibration or adjustment instruction.

10. The intelligent blood pressure correction method of claim 7, wherein: The smart blood pressure correction method further comprises: sending the recorded pressure waveform data or the corrected blood pressure measurement value to an external device through a data transmission unit.

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