Integrated valsalva challenge test system based on an ultrasound device

Abstract

The application provides an integrated Valsalva provocation test system based on an ultrasonic device, and relates to the technical fields of medical ultrasonic examination and Valsalva provocation test. The system is mainly composed of a pressure sensing assembly, a time synchronization module, a discrete event-continuous state coupling module and a real-time display module. The pressure sensing assembly is used for collecting pressure data of a patient during a Valsalva action; the time synchronization module is responsible for the time sequence unified calibration of multi-source data; the discrete event-continuous state coupling module can identify various discrete events in the Valsalva provocation process and complete the precise binding of events and unified time stamps; and the real-time display module can synchronously display pressure-related information on the interface of the ultrasonic device. The system can upload real-time pressure data to the ultrasonic device, realize coaxial mapping, synchronous acquisition and synchronous display of pressure data, ultrasonic images and spectral Doppler data, and effectively improve the consistency and accuracy of multi-source data registration of the Valsalva provocation test.

Description

Technical Field

[0001] This invention relates to the field of medical ultrasound examination and Valsalva provocation test technology, specifically to an integrated Valsalva provocation test system based on ultrasound equipment. Background Technology

[0002] Valsalva provocation test is an important and commonly used examination method in hypertrophic cardiomyopathy (HCM) and related cardiovascular diseases, especially for assessing occult left ventricular outflow tract obstruction (LVOTO).

[0003] Current clinical procedures typically involve the following approach: the patient lies on their left side for echocardiography; the patient inhales through a tube connected to a gimbal manometer, and the physician instructs the patient to maintain an inhalation pressure greater than 40 mmHg for at least 10 seconds; simultaneously, the sonographer observes the manometer and acquires Doppler spectrum or two-dimensional ultrasound images. This approach presents several problems: 1) The pressure display device and ultrasound equipment are independent, requiring the physician to frequently switch between the manometer and the ultrasound screen; furthermore, ultrasound image quality deteriorates during the Valsalva maneuver, significantly increasing the difficulty of the procedure and demanding greater concentration, while the physician must simultaneously instruct on pressure and acquire images, easily leading to distraction and affecting the acquisition of effective Doppler spectrum or ultrasound images; 2) Independently acquired pressure data cannot be precisely synchronized with ultrasound images and spectral data; 3) Traditional mechanical manometers cannot record and replay pressure waveforms; 4) Existing systems cannot automatically identify the target achievement time, maintenance period, and recovery period.

[0004] Therefore, there is an urgent need to propose a new system that can deeply integrate ultrasonic equipment with a pressure monitoring module used for Valsalva excitation tests, and can achieve unified time synchronization of pressure data, spectral Doppler data or ultrasonic image data, while also performing event status recognition, synchronous display and synchronous acquisition, in order to solve one or more of the technical problems mentioned above. Summary of the Invention

[0005] (a) Technical problems to be solved To address the shortcomings of existing technologies, this invention provides an integrated Valsalva excitation test system based on ultrasonic equipment. This system solves the problems in existing Valsalva excitation tests, such as the difficulty in achieving unified time synchronization of Valsalva blowing pressure data, ultrasonic image data, or spectral Doppler data; the difficulty in automatically identifying key excitation states; the difficulty in automatically marking effective excitation periods; and the difficulty in coupling the continuous pressure change process with the ultrasonic acquisition, display, storage, and playback process.

[0006] To achieve the above objectives, the present invention provides the following technical solution: (II) Technical Solution An integrated Valsalva provocation testing system based on ultrasound equipment, the system comprising: The pressure sensing component is configured to detect pressure data when the patient performs the Valsalva maneuver; The time synchronization module is configured to synchronize multi-source data in time; the multi-source data includes at least pressure data and ultrasound image data or spectral Doppler data; The real-time display module is configured to display pressure-related information on the display interface of the ultrasound device.

[0007] In one embodiment, the system further includes: The pressure signal state perception and compensation module is configured to identify the Valsalva maneuver stage based on the pressure data and related data during the patient's Valsalva maneuver, and to correct and compensate the original pressure signal based on the Valsalva maneuver stage.

[0008] In a preferred embodiment, when the pressure signal state sensing and compensation module corrects and compensates the original pressure signal, it includes: Acquire the raw pressure signal and bind a timestamp; Obtain the baseline pressure before the start of the Valsalva test, and perform zero-point correction on the original pressure signal by subtracting the baseline pressure from the original pressure signal; The pressure change rate is calculated based on the corrected pressure signal, and the Valsalva action phase is identified based on the pressure change rate. Segmented filtering is implemented based on the switching pressure signal processing parameters corresponding to the Valsalva action phase; Dynamic hysteresis compensation is performed on the filtered pressure signal; The effective Valsalva excitation range is determined based on the compensated pressure fluctuation amplitude and the mean square value of the pressure change rate; or the effective excitation score is calculated, and the effective Valsalva excitation range is determined when the effective excitation score is greater than a preset threshold. Bind pressure events corresponding to the effective Valsalva excitation range to ultrasound data or spectral Doppler data.

[0009] More preferably, the dynamic hysteresis compensation of the filtered pressure signal includes: performing dynamic hysteresis compensation on the filtered pressure signal according to the following formula: in, Indicates the first i Pressure signal after sampling time compensation Indicates the first i The pressure signal after sampling time is filtered. This represents the equivalent response time constant of the air blowing line and sensor interface. This indicates the rate of change of pressure.

[0010] In one embodiment, the system further includes: The discrete event-continuous state coupling module is configured to identify discrete events in the Valsalva excitation process based on multi-source data and bind the discrete events to a unified timestamp; The discrete events include at least one of the following: trigger start event, pressure target achievement event, effective stability maintenance event, pressure peak event, and pressure recovery end event; The continuous states include patient breathing pressure, pressure changes, pressure fluctuation amplitude, pressure maintenance time, spectral Doppler flow velocity curves or ultrasound image frame sequences, and electrocardiogram waveforms.

[0011] In one embodiment, the time synchronization module matches the sampling points of multi-source data according to a unified timestamp to achieve time synchronization of multi-source data.

[0012] In one embodiment, the real-time display module displays pressure-related information on the display interface of the ultrasound device in the form of a semi-transparent floating window, a split-screen window, or an overlay curve. The pressure-related information includes at least one of real-time pressure value, pressure waveform, target pressure line, achievement prompt, stability prompt, and remaining maintenance time.

[0013] In one embodiment, the system further includes: an air blowing assembly configured for a patient to perform the Valsalva maneuver; the air blowing assembly includes, in sequence, an air blowing tube, an anti-backflow check valve, a connecting line, and a Luer lock connector, the Luer lock connector being connected to a pressure sensing assembly.

[0014] In one embodiment, the system further includes: a data acquisition and processing module configured to acquire and process pressure data from the pressure sensing component; In one embodiment, the system further includes an ultrasonic host communication module configured to establish data exchange between the pressure data processed by the data acquisition and processing module and the ultrasonic host.

[0015] Preferably, data exchange includes, but is not limited to, data transmission via at least one of USB, serial port, CAN, Ethernet, Wi-Fi, or Bluetooth.

[0016] In one embodiment, the system further includes a data storage and playback module, configured to synchronously save relevant data generated by the system and support on-demand data playback.

[0017] In one embodiment, the system further includes: An ultrasound data acquisition module is used to acquire spectral Doppler data and / or ultrasound image data.

[0018] In one embodiment, the system further includes a pressure quality control module configured to determine an invalid excitation state based on pressure correlation information and to display an operation prompt when an invalid excitation state is detected.

[0019] In one embodiment, the system further includes: The electromagnetic shielding structure is configured to completely enclose the pressure sensing component.

[0020] In one embodiment, the system further includes: A temperature drift compensation unit is embedded in or mounted on the analog signal conditioning circuit of the pressure sensing component to correct the temperature drift error of the sensor in real time.

[0021] (III) Beneficial Effects This invention provides an integrated Valsalva provocation testing system based on ultrasonic equipment. Compared with existing technologies, it has the following advantages: 1. The integrated Valsalva provocation test system based on ultrasonic equipment proposed in this application mainly includes: a pressure sensing component, a time synchronization module, and a real-time display module. This system can upload real-time pressure monitoring data to the ultrasonic equipment and map pressure data, spectral Doppler data, or ultrasonic image data to the same time axis, achieving synchronous acquisition and display of multi-source data, thereby improving the consistency and accuracy of multi-source data registration during the Valsalva provocation test.

[0022] 2. The integrated Valsalva excitation test system based on ultrasound equipment proposed in this application adopts a unified time axis synchronization mechanism in its time synchronization module. It uses a globally unified system clock as a reference to assign a unified timestamp to multi-source data and map the multi-source data to the same time axis. This approach does not simply display pressure, but unifies pressure data, ultrasound image frames or spectral Doppler data to the same time axis, so as to achieve replayable and traceable multi-source data registration.

[0023] 3. The integrated Valsalva excitation test system based on ultrasonic equipment proposed in this application adopts discrete event-continuous state coupling recognition. Instead of looking at just one pressure threshold, it judges the Valsalva excitation stage based on pressure value, pressure change rate, stability, maintenance time, and spectral flow rate change, so as to realize the automatic recognition of events such as excitation start, reaching the target, effective maintenance, release, and recovery.

[0024] 4. The integrated Valsalva excitation test system based on ultrasonic equipment proposed in this application includes a pressure signal state sensing and compensation module. By combining pressure value, pressure change rate, pressure stability, pressure maintenance time, and ultrasonic spectrum changes, the Valsalva process is divided into pressure initiation period, target achievement period, stable maintenance period, release period, and recovery period. Different compensation strategies are adopted for different stages to achieve pressure waveform correction, dynamic lag compensation, abnormal blowing identification, effective range correction, and ultrasonic data time registration. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the Valsalva excitation test operation in the prior art; Figure 2 This is a schematic diagram of the integrated Valsalva excitation test system based on ultrasonic equipment in an embodiment of the present invention; Figure 3 This is a schematic diagram of the air blowing assembly structure in an embodiment of the present invention; Figure 4 This is a structural diagram of the ultrasonic host communication module in an embodiment of the present invention; Figure 5 This is a schematic diagram of the real-time display module integrated on the ultrasonic instrument interface in an embodiment of the present invention; Figure 6 This is a time synchronization logic diagram in an embodiment of the present invention; Figure 7 This is a flowchart illustrating the discrete event-continuous state coupling in an embodiment of the present invention. Figure 8 This is a structural diagram of the data storage and playback module in an embodiment of the present invention; Figure 9 This is a flowchart illustrating the pressure signal state sensing and compensation process in an embodiment of the present invention. Detailed Implementation

[0026] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention are described clearly and completely. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0027] In recent years, with the advent and widespread application of drugs for the treatment of hypertrophic cardiomyopathy, the ultrasound diagnosis and evaluation of this disease have received considerable attention in clinical practice. The assessment of occult left ventricular outflow tract obstruction (LVOT) in hypertrophic cardiomyopathy currently relies primarily on the goal-directed Valsalva provocation test. For example... Figure 1 As shown, the examination method involves the patient lying on their left side for echocardiography, simultaneously using a gimbal-type blood pressure monitor and a modified hose device (usually placed next to the ultrasound equipment). The doctor instructs the patient to blow air into the hose, maintaining a pressure >40 mmHg for >10 seconds. Because the pressure display device and the ultrasound equipment are independent, the doctor needs to frequently switch their gaze between the pressure monitor and the ultrasound screen, leading to drawbacks such as doctor (or operator) distraction, poor patient cooperation (especially in the elderly or those with poor vision), and a lack of synchronization between pressure data and ultrasound images.

[0028] Based on this, this application proposes an integrated Valsalva excitation test system based on ultrasonic equipment, which is based on a unified time axis and event state coupling to solve the above problems.

[0029] To better understand the above technical solutions, the following will provide a detailed explanation of the technical solutions in conjunction with the accompanying drawings and specific implementation methods.

[0030] Example 1: An integrated Valsalva provocation testing system based on ultrasonic equipment, which mainly includes: The pressure sensing component is configured to detect pressure data when the patient performs the Valsalva maneuver; The time synchronization module is configured to synchronize multi-source data in time; the multi-source data includes at least pressure data and ultrasound image data or spectral Doppler data acquired by an ultrasound device; The real-time display module is configured to display pressure-related information on the display interface of the ultrasound device.

[0031] The integrated Valsalva provocation test system based on ultrasound equipment proposed in this embodiment synchronously acquires, displays, and plays back multi-source data such as real-time pressure monitoring data, ultrasound image data, or spectral Doppler data. This achieves deep integration between the ultrasound equipment and the pressure monitoring module used for Valsalva provocation tests, reducing the difficulty of operation for doctors and improving their operating experience.

[0032] The following is in conjunction with the appendix Figure 2-9 The implementation process of a detailed embodiment of the present invention will be explained in detail, along with a detailed explanation of the specific implementation principles and functions of each module or component.

[0033] Example 2: An integrated Valsalva provocation test system based on ultrasonic equipment includes: an air blowing assembly, a pressure sensing assembly, a data acquisition and processing module, an ultrasonic host communication module, a real-time display module, a time synchronization module, a discrete event-continuous state coupling module, and a data storage and playback module.

[0034] The system includes a patient performing the Valsalva maneuver via an air-blowing component; a pressure sensing component that collects the patient's air-blowing pressure in real time; a data acquisition and processing module that collects and processes pressure-related data, ultrasound image data, or spectral Doppler data; a time synchronization module that synchronizes pressure data with multi-source data such as ultrasound images or spectral Doppler data; a real-time display module that overlays and displays the pressure waveform and values ​​on the ultrasound interface; a discrete event-continuous state coupling module that automatically identifies discrete events during the Valsalva maneuver based on pressure-related data, ultrasound image data, or spectral Doppler data, and binds these discrete events to a unified timestamp; and a data storage module that synchronously stores all data and supports playback. Specifically: The air blowing component is configured to generate pressure-related data during the Valsalva maneuver when the patient performs the Valsalva maneuver.

[0035] In one embodiment, such as Figure 3 As shown, the air blowing assembly includes: an air blowing pipe, an anti-backflow check valve, a connecting pipe, and a Luer lock connector. The air blowing pipe, anti-backflow check valve, connecting pipe, and Luer lock connector are connected sequentially. The output end of the Luer lock connector is used for quick connection to a pressure sensor. In actual manufacturing, the above components are designed with detachable connections, such as threaded interfaces or socket connections.

[0036] In a preferred embodiment, the inhalation tubing is made of medical-grade flexible material and is generally disposable to avoid cross-infection; the anti-backflow check valve is used to prevent the patient's exhaled air from flowing back; and the connecting tubing is a low-resistance connecting tubing to reduce the patient's additional respiratory load.

[0037] In a preferred embodiment, the above-described blowing assembly further includes a mouthpiece or mask-type blowing terminal, which is convenient for the patient to hold in their mouth and blow air or wear on their face for blowing air. The output end of the mouthpiece or mask-type blowing terminal is connected to the input end of the above-described blowing tube.

[0038] The pressure sensing component is configured to generate pressure data when the patient performs the Valsalva maneuver.

[0039] The specific process is as follows: the static pressure generated by the patient's breath enters the pressure sensing interface through the breath-blowing tubing and acts on a piezoresistive or capacitive MEMS pressure sensor. The sensor outputs an analog electrical signal related to the air pressure, which is then transmitted to the subsequent data acquisition and processing module.

[0040] The data acquisition and processing module is configured to acquire pressure-related data, ultrasound image data, or spectral Doppler data, process them, and output the processed data to the ultrasound host communication module.

[0041] The data acquisition and processing module includes a pressure data acquisition unit, a digital processing unit, and a data buffer unit. The pressure data acquisition unit receives analog or digital pressure signals output from the pressure sensing component, amplifies, filters, limits, and levels them using an instrumentation amplifier or analog front-end, and then inputs them to an ADC. The ADC converts the analog voltage into a digital quantity, and the microprocessor calculates the blowing pressure value based on a pre-calibrated pressure-voltage relationship. In some embodiments, when the pressure sensing component outputs an analog pressure signal, the pressure data acquisition unit further includes an analog-to-digital converter (ADC) to convert the analog pressure signal into a digital pressure signal.

[0042] The digital processing unit performs at least one of the following processing operations on the pressure data: filtering, zero-point correction, pressure conversion, pressure mean calculation, pressure fluctuation amplitude calculation, pressure stability calculation, and pressure maintenance time calculation. In an optional embodiment, the digital processing unit uses at least one of the following methods to process the pressure data: low-pass filtering, moving average filtering, median filtering, or adaptive filtering, to reduce the impact of breathing vibration, tubing vibration, or electrical noise on the pressure data.

[0043] The data caching unit is used to timestamp, cache, and package the processed stress data into data frames for subsequent display, event-state coupling, synchronous storage, or communication transmission.

[0044] The output of the data acquisition and processing module also includes a communication interface unit, which connects to the ultrasonic host communication module.

[0045] The ultrasound data acquisition module is used to acquire ultrasound image data or spectral Doppler data.

[0046] Generally speaking, the ultrasound data acquisition module is the signal acquisition hardware unit at the front end of the ultrasound host. It is a bridge connecting the probe and the back-end image processing or spectrum analysis, and there is no need to set up an additional ultrasound data acquisition module separately.

[0047] The ultrasonic host communication module is used to realize the data exchange between the pressure data and the ultrasonic host.

[0048] like Figure 4 As shown, the ultrasound host communication module receives input data from the data acquisition and processing module, identifies the data content through protocol conversion and encapsulation, and packages all the data into a standard data frame format that can be recognized by the internal bus of the ultrasound host. Then, it is transmitted to the real-time display module for display through the internal interface of the ultrasound host.

[0049] In one embodiment, the communication method of the ultrasound host communication module can be set to one or more of the following, including but not limited to USB, serial port, CAN, Ethernet, Wi-Fi, and Bluetooth, depending on actual needs. For compatibility, the corresponding protocol stack encapsulation can be selected according to different interfaces.

[0050] The real-time display module is configured to synchronously display pressure-related information on the display interface of the ultrasound equipment.

[0051] Pressure-related information includes, but is not limited to: real-time pressure values, pressure waveforms, target pressure lines, compliance status alerts, pressure stability alerts, etc. In some embodiments, such as Figure 5 As shown, the real-time display module reads the latest pressure value (real-time pressure value) and pressure waveform from the pressure data cache queue and displays them on the ultrasonic device interface in a semi-transparent floating window, curve overlay, or split-screen mode. At the same time, it displays the target pressure line, compliance status, pressure stability, and remaining maintenance time.

[0052] It should be noted that the real-time display module is only responsible for the human-computer interaction display; the raw pressure data and ultrasonic data are still stored synchronously with a unified timestamp to avoid display refresh delays affecting data synchronization accuracy. Users can freely adjust the window size, position, transparency, color, display mode, etc., according to their usage habits and preferences. Furthermore, when the pressure reaches a preset threshold, the system automatically issues an audible warning and prompt, and / or changes the interface color, and / or displays a compliance indicator.

[0053] The time synchronization module is configured to synchronize data from multiple sources based on a globally unified system clock.

[0054] The time synchronization module uses the ultrasound host system clock or the synchronized microcontroller clock as a unified time reference. Upon completion of pressure sampling, the pressure data is assigned a pressure sampling timestamp; ultrasound image frames, spectral Doppler sampling points, or ECG data are assigned corresponding acquisition timestamps by the ultrasound host. The system maps pressure data packets, ultrasound image frames, and spectral data points onto a unified time axis and establishes data correspondence using nearest neighbor matching, linear interpolation, or time window matching methods.

[0055] Generally, at least pressure data and ultrasound images need to be time-synchronized. Alternatively, pressure data, ultrasound image data or spectral Doppler data, ECG data (electrocardiogram data), or multiple data sources (generally including at least pressure data, ultrasound image data, or spectral Doppler data) can be time-synchronized. The principle of time synchronization for two types of data is the same as that for multiple types of data. The following uses the time synchronization of multiple types of data, such as pressure data, ultrasound image data, spectral Doppler data, and ECG data, as an example to explain the specific process of time synchronization in detail.

[0056] During data synchronization, a globally unified system clock is used as the sole reference time axis. The four data acquisition modules—pressure sensing, ultrasound imaging or Doppler acquisition, and ECG—share the same time base. The timestamps of each signal are anchored by four characteristic time sequence nodes: T0, T1, T2, and T3, to achieve high-precision alignment of multiple signals.

[0057] The system incorporates a global hardware system clock, generating a continuous and unified timeline. All data acquisition units (pressure acquisition card, ultrasonic main control unit, Doppler module, ECG acquisition chip) are synchronized using the same phase-locked loop clock. The local clock of each submodule is obtained by frequency division of the system clock, eliminating clock offset at the hardware level and ensuring a synchronization error of <10ms. In a preferred embodiment, the pressure sampling frequency is no less than 100Hz, the timestamp resolution is no less than 1ms, and pressure data and ultrasonic data are timestamped based on the unified system clock, enabling millisecond-level time registration accuracy between pressure events and ultrasonic data.

[0058] See Figure 6 In a preferred embodiment, the Valsalva excitation experiment is divided into several key nodes, and the data is synchronized in stages.

[0059] T0: Excitation start time (synchronization trigger point). The excitation start time is the end-to-end synchronization anchor point, with the time origins of all signals uniformly aligned. The system issues a synchronization trigger command at T0, simultaneously activating pressure, ultrasound or Doppler, and ECG acquisition. The MEMS pressure sensor and conditioning circuit begin continuous sampling, recording the first frame of pressure waveform with the timestamp T0; the ultrasound host activates B mode (black and white imaging mode) to acquire image frames, outputting the first ultrasound image, with the image frame timestamp bound to T0; Doppler radiofrequency sampling is simultaneously activated, starting to output blood flow spectrum waveforms with the start timestamp T0; the ECG acquisition module is simultaneously powered on and samples, marking the first ECG waveform with the reference time T0.

[0060] T1: Pressure Target Achieved. The pressure sensing component monitors the static pressure of the blown air in real time. When the pressure reaches the set threshold (40 mmHg), the hardware triggers the reporting of the T1 timestamp. The system synchronously sends this timestamp to the ultrasound, Doppler, and ECG acquisition units. The ultrasound host marks the ultrasound image frame number corresponding to time T1, the Doppler module marks the spectral waveform coordinates of the T1 position, and the ECG acquisition unit records the specific cardiac cycle point of the ECG waveform where T1 falls. Based on this, a one-to-one correspondence is achieved between the time position of the pressure target achievement event on the three waveforms.

[0061] T2: Peak pressure moment. When the pressure value reaches its peak, the system clock captures the T2 time stamp and synchronously marks four signals: pressure waveform (T2 is the starting point of the steady-state pressure); ultrasound image corresponding to T2 (spectral Doppler, T2 corresponds to the corresponding spectral position); ECG (T2 aligns with the corresponding ECG curve position).

[0062] T3: End of recovery. The blowing action ends, the pressure drops back to the baseline, the pressure sensor reports the T3 termination time mark, the system uniformly marks the end position of the four signals, all acquisition modules synchronously stop or finish sampling at T3, and define the data boundary of the entire cycle of a single detection.

[0063] When binding the acquired signals with timestamps, for pressure waveforms, the ADC continuously samples at >100Hz, with each sampling point carrying a system clock timestamp, and is mapped point by point to a unified time axis; for ultrasound images, each frame of B-ultrasound image is packaged with a system timestamp of the frame exposure time, and the frame sequence is arranged along the time axis; for spectral Doppler, each sampling point of the continuous time-domain spectral data is embedded with a timestamp and aligned with the pressure curve along the time axis; for ECG signals, the high-frequency ECG sampling data is bound to the system time point by point and automatically associated with the global time sequence.

[0064] Furthermore, to avoid crystal oscillator drift in each data acquisition unit (pressure, 2D ultrasound / Doppler spectrum, and ECG three-channel acquisition unit), achieve error control, and improve time synchronization accuracy, the four acquisition circuits use a shared system clock frequency division to avoid crystal oscillator drift in each module. Simultaneously, event-triggered synchronization is utilized, i.e., hardware interrupts are used to trigger time stamps at key nodes T0, T1, T2, and T3, avoiding software scheduling delays. Ultimately, the overall channel synchronization error is less than 10ms, and multiple waveforms are precisely aligned laterally on the same time axis, allowing for horizontal comparison of pressure values, ultrasound anatomical morphology, blood flow velocity, and electrocardiographic activity at the same moment.

[0065] It should be noted that the time synchronization module uses a unified system clock as the main time reference T0, and synchronously triggers the acquisition of four characteristic events T0, T1, T2 and T3 across all channels to mark and anchor the corresponding positions of each signal. Each sampled data carries a local time stamp and is mapped to the global time axis, ultimately achieving high-precision time synchronization of three physiological signals: pressure, two-dimensional ultrasound image or Doppler spectrum and ECG.

[0066] The discrete event-continuous state coupling module is configured to identify discrete events in the Valsalva excitation process based on multi-source data (pressure-related data and ultrasound image data or Doppler spectral data) and bind the discrete events to a uniform timestamp.

[0067] In one embodiment, the Valsalva excitation process is divided into a preparation phase, a pressure initiation phase, a pressure reaching phase, a peak pressure phase, and a recovery phase, and the corresponding time nodes for each phase are recorded. Correspondingly, discrete events include, but are not limited to, one or more of the following: excitation start event, pressure reaching phase event, effective stability maintenance event, pressure peak event, and pressure recovery end event.

[0068] In one embodiment, the continuous state includes patient breathing pressure P(t), pressure change dP / dt, pressure fluctuation amplitude, pressure maintenance time, spectral Doppler flow velocity curve or ultrasound image frame sequence, electrocardiogram (ECG) waveform, etc.

[0069] The identification of key continuous states in the excitation test includes: achievement identification, stability maintenance identification, pressure drop identification, excitation end identification, automatic spectrum freezing, and automatic key frame marking.

[0070] like Figure 7As shown, when the pressure continuously exceeds 40 mmHg and persists for a set time, the system automatically determines that it has entered the effective excitation phase, and automatically marks the corresponding time point of the ultrasound image. Specifically, the discrete event-continuous state coupling module automatically generates event tags based on the continuous pressure state and changes in the ultrasound spectrum. The system continuously calculates parameters such as the blowing pressure P(t), the pressure change rate dP / dt, the pressure fluctuation amplitude, and the pressure maintenance time. When P(t) exceeds the pressure threshold and dP / dt is greater than the set value, it is marked as "excitation start event"; when P(t) reaches the target pressure range and persists for the set time, it is marked as "pressure target achieved event"; when the pressure fluctuates less than the set threshold within the target range and continuously meets the time requirement, it is marked as "effective stable maintenance event"; when the pressure drops rapidly, it is marked as "pressure release event"; when the pressure and / or blood flow spectrum recover to near the baseline, it is marked as "recovery end event".

[0071] When the discrete event-continuous state coupling module identifies a valid stable discrete event, it automatically triggers the ultrasound equipment to perform at least one of the following operations: keyframe saving, spectrum freezing, peak flow velocity marking, valid segment extraction, and report generation. This enables the discrete event to be bound to a unified timestamp, thereby achieving the coupling between the discrete event and the continuous state.

[0072] The data storage and playback module is configured to synchronously save relevant data generated by the system and support on-demand data playback.

[0073] See Figure 8 The data storage and playback module includes: Valsalva pressure waveform data, Valsalva pressure numerical data, two-dimensional ultrasound image data, spectral Doppler data, ECG data (electrocardiogram data), and time-stamped data, etc.

[0074] During playback, the pressure waveform and ultrasonic image are displayed synchronously. The system can also automatically generate pressure-flow rate correlation curves and export excitation test reports as needed by the operator.

[0075] In one embodiment, during data storage, each event tag includes: event type, event timestamp, corresponding pressure value, nearest neighbor ultrasound image frame number, corresponding spectral time point, and event confidence level. The time synchronization module searches for the nearest ultrasound image frame or spectral data point on a unified timeline based on the event timestamp and binds the event tag to that image frame or spectral segment, thereby enabling keyframe saving, spectrum freezing, effective segment extraction, and synchronized playback.

[0076] In one embodiment, the system further includes: The pressure quality control module is configured to identify at least one invalid excitation state among pressure value, pressure change rate, pressure fluctuation amplitude, and pressure maintenance time, namely, insufficient exhalation, air leakage, pressure overshoot, excessive pressure fluctuation, premature release, cough interference, or swallowing interference. When the pressure quality control module identifies an invalid excitation state, the system outputs a pressure adjustment prompt, maintenance time prompt, retry prompt, or invalid reason prompt on the ultrasound device display interface and / or patient prompt interface.

[0077] It should be noted that the pressure quality control and invalid excitation prompts enable the system to identify insufficient exhalation, air leakage, pressure overshoot, excessive pressure fluctuations, premature release, coughing or swallowing interference, and prompt the doctor or patient to repeat the procedure. Compared to simple "synchronous display", this is more clinically valuable.

[0078] Example 3: Based on either embodiment 1 or 2 above, and its preferred embodiment, this embodiment further includes the following components to prevent electromagnetic interference: Electromagnetic shielding structure. This electromagnetic shielding structure is a metal shielding layer that completely covers all sensing components of the pressure sensing assembly, including the MEMS sensor, analog signal conditioning circuit, and analog-to-digital conversion unit. There are no electrical signal connections, making it a passive protection structure that isolates the ultrasonic main unit, power supply, and surrounding circuits from EMI interference.

[0079] It should be noted that the MEMS pressure sensor uses an isolated independent power supply, electrically isolated from the ultrasonic host power supply, cutting off power crosstalk and ground loop interference, and preventing power supply noise from coupling into the analog signal. The entire sensing component is wrapped with a metal shielding layer to shield the high-frequency ultrasonic circuit of the ultrasonic probe and the radio frequency or power frequency electromagnetic interference of the whole machine's switching power supply, preventing interference from tampering with the weak analog voltage and causing measurement errors. In addition, the sensor is physically isolated from the ultrasonic probe to isolate the mechanical vibration during ultrasonic operation, preventing the vibration from causing deformation of the sensor diaphragm and generating false pressure signals, further meeting the high accuracy requirement of ±2mmHg.

[0080] Example 4: Based on any one of the embodiments 1-3 and their preferred embodiments, this embodiment, in order to correct the temperature drift error of the MEMS pressure sensor in real time, further includes the following pressure sensing component: Temperature drift compensation unit. The temperature drift compensation unit is embedded in or mounted on the analog signal conditioning circuit. It corrects the sensor's temperature drift error in real time through temperature acquisition and compensation algorithms or hardware compensation circuits. Compensation algorithms include, but are not limited to, piecewise linear interpolation temperature drift compensation algorithms and first-order polynomial fitting temperature drift compensation algorithms. Hardware compensation circuits include, but are not limited to, voltage divider thermistor compensation circuits, constant current source isothermal compensation circuits, and differential pair transistor temperature cancellation compensation circuits.

[0081] The temperature drift compensation unit synchronously collects ambient or chip temperature data and dynamically corrects the conditioning circuit reference and sensor offset voltage in real time to offset the measurement error caused by temperature changes and ensure that the accuracy is better than ±2mmHg across the entire temperature range.

[0082] Example 5: This embodiment, based on any one of embodiments 1-4 and their preferred embodiments, further includes: Pressure signal status sensing and compensation module.

[0083] The pressure signal state perception and compensation module is used to identify the Valsalva maneuver stage based on the pressure-related data (data associated with the pressure signal) during the patient's Valsalva maneuver, and to correct and compensate the original pressure signal based on the Valsalva maneuver stage.

[0084] The pressure signal state perception and compensation module identifies the Valsalva maneuver stage based on pressure-related data such as pressure value, pressure change rate, pressure fluctuation amplitude, and pressure maintenance time during the patient's Valsalva maneuver. It then switches pressure signal processing parameters according to the identified Valsalva maneuver stage to perform zero-point correction, dynamic hysteresis compensation, and stability correction on the original pressure signal, thereby obtaining a compensated pressure signal.

[0085] In practical implementation, the main program of the pressure signal state perception and compensation module calls the pressure signal state perception and compensation algorithm through an interface. (See [link to relevant documentation]). Figure 9 The algorithm mainly includes the following steps when executed: S1. Obtain the raw pressure signal and bind a timestamp.

[0086] The pressure sensing component acquires the raw pressure signal when the patient performs the Valsalva maneuver, and the data acquisition and processing module assigns a sampling timestamp to each sampling point to form the raw pressure sequence. The timestamp is used for synchronization matching of subsequent stress events with ultrasound image frames and spectral Doppler data points.

[0087] S2. Obtain the baseline pressure before the start of the Valsalva test, and subtract the baseline pressure from the original pressure signal to perform zero-point correction on the original pressure signal.

[0088] Before the Valsalva test began, in a no-blow state, the system collected a baseline pressure data point and calculated the mean baseline pressure. The baseline pressure is then subtracted from the original pressure signal to obtain the zero-point corrected pressure signal. This reduces the impact of pressure sensor zero-point offset, pipeline residual pressure, or changes in ambient static pressure on the judgment results.

[0089] in, This represents the mean baseline pressure under conditions of no air blowing. Indicates the first i Each sampling time The original pressure value, This represents the pressure value after zero-point correction. n This indicates the total number of sampling points used to calculate the baseline.

[0090] S3. Calculate the pressure change rate based on the corrected pressure signal, and identify the Valsalva action phase based on the pressure change rate.

[0091] The system calculates the pressure change rate based on the zero-point corrected pressure signal. The Valsalva action phase is identified by combining pressure value, pressure fluctuation amplitude, and pressure duration.

[0092] in, Indicates the first i The sampling time corresponding to frame sampling Indicates the previous frame (the first frame) The sampling time corresponding to the frame. This represents the actual pressure after zero-point correction in the previous frame.

[0093] The Valsalva action phase combines pressure value, pressure change rate, pressure fluctuation amplitude, and duration for joint judgment. In one embodiment, the Valsalva action phase includes: Preparation period: The pressure is near the baseline, and the absolute value of the pressure change rate is less than a certain threshold; Pressure build-up period: The pressure is higher than the pressure build-up threshold, and the rate of change of pressure is greater than the rate of change of pressure threshold. Achievement period: The pressure first enters the target pressure range, for example, reaching above 40 mmHg, and continues to reach the preset confirmation time; Stable maintenance period: The pressure remains within the target pressure range, the pressure fluctuation amplitude within the sliding time window is less than the fluctuation threshold, and the root mean square of the pressure change rate is less than the stability threshold. Release period: The rate of pressure change is less than the negative release threshold, or the pressure drops rapidly from the target pressure range; Recovery period: The pressure drops back to the baseline allowable range, and the absolute value of the pressure change rate remains within the recovery threshold for a preset time.

[0094] The thresholds required for each stage can be determined and set based on real data corresponding to existing Valsalva action stages.

[0095] S4. Implement segmented filtering based on the switching pressure signal processing parameters corresponding to the Valsalva action phase.

[0096] The system switches pressure signal processing parameters based on the identified Valsalva maneuver phase. Specifically, during the pressure build-up and release phases, a first filter parameter B1 is used to preserve the characteristics of rapid pressure changes; during the stable maintenance phase, a second filter parameter B2 is used to suppress blowing jitter and pipeline vibration noise. The filter bandwidth corresponding to the first filter parameter B1 is greater than the filter bandwidth corresponding to the second filter parameter B2.

[0097] S5. Perform dynamic hysteresis compensation on the filtered pressure signal.

[0098] Considering the potential pressure transmission lag introduced by the air blowing line, filter membrane, buffer chamber, check valve, and pressure sensing interface, the system dynamically compensates for the filtered pressure signal based on the pressure change rate to obtain a compensated pressure signal. .in, The equivalent response time constant can be obtained through factory calibration or updated based on the pressure initiation and release phases in this test.

[0099] in, Indicates the first i Pressure signal after sampling time compensation Indicates the first i The pressure signal after sampling time is filtered. This represents the equivalent response time constant of the piping and sensing interfaces.

[0100] S6. Determine the effective Valsalva excitation range based on the compensated pressure fluctuation amplitude and the mean square value of the pressure change rate, or calculate the effective excitation score. When the effective excitation score is greater than the preset threshold, it is determined that the effective Valsalva excitation range has been entered.

[0101] During the target achievement period and the stable maintenance period, the system calculates the pressure fluctuation amplitude within a sliding time window. and the mean square value of pressure change rate The effective Valsalva excitation range was determined by combining the degree of pressure attainment and the duration of maintenance.

[0102] In one embodiment, the effective Valsalva excitation range is determined using a two-stage approach: a basic condition determination and a stability determination.

[0103] First, the basic conditions must be met: And the duration of continuous maintenance: Preferably, target pressure It can be set to 40 mmHg, minimum maintenance time. Set to 10 seconds.

[0104] Based on this, the following conditions must be met within the sliding time window: in, This indicates the maximum value of the compensated pressure within the current sliding time window. This represents the minimum compensated pressure within the current sliding time window; Indicates the first in the window k The instantaneous pressure change rate corresponding to each sampling point m This indicates the total number of sampling points contained within the sliding time window.

[0105] The time period during which the above conditions are continuously met is defined as the effective Valsalva excitation interval. Preferably, the pressure fluctuation threshold can be used. Set the pressure change rate root mean square threshold to 3~5 mmHg. Set to 1~2 mmHg / s. In actual operation, these parameters can be adjusted according to the calibration results.

[0106] If the pressure does not reach the target value, the duration is insufficient, the pressure fluctuation is too large, or the root mean square of the pressure change rate exceeds the threshold, the excitation range is judged to be invalid or of substandard quality.

[0107] In one embodiment, the system can calculate an effective excitation score based on the degree of pressure compliance, pressure stability, maintenance time, and stability of pressure changes. Q .when Q When the value exceeds a preset threshold, the corresponding time period is defined as the effective Valsalva excitation interval; when... Q If the preset threshold is not reached, the system will output warnings such as insufficient airflow, excessive pressure fluctuations, premature release, air leakage, coughing, or swallowing interference. When setting the preset threshold, several groups of valid and invalid Valsalva test samples are manually labeled, and the determination is based on the consistency between the scoring results and the manual judgment; alternatively, it can be preset according to clinical operating procedures and equipment calibration results, and the operator is allowed to adjust it according to different examination protocols.

[0108] in, A Indicates the degree to which the pressure is met. SIndicates pressure stability. T Indicates the duration of pressure. L Indicates the stability of pressure changes. Indicates the weight of the degree to which the pressure target is met; Indicates the pressure stability weight; Indicates the duration weight; This indicates the weighting of the stability of pressure changes.

[0109] Sum of weights Considering that whether the pressure is met and the duration of maintenance are the main conditions for the validity of the Valsalva test, in a preferred embodiment, the following is set: Among these, the degree of pressure achievement and the duration of pressure maintenance are given relatively high weights, followed by pressure stability, with pressure change stability serving as a secondary evaluation indicator. Of course, the weighting of each indicator can be adjusted based on clinical expert annotations, equipment calibration data, or statistical analysis results.

[0110] S7. Bind the pressure events corresponding to the effective Valsalva excitation range with ultrasound data or spectral Doppler data.

[0111] The system sends the start time stamp, end time stamp, pressure threshold time stamp, and pressure release time stamp of the effective Valsalva excitation interval to the time synchronization module. The time synchronization module then locates the ultrasound image frame or spectral Doppler data point closest to the pressure event on a unified timeline and performs time binding.

[0112] | in, This represents an ultrasound image frame that matches the timestamp of the pressure event. The standard operator is represented by the subscript that limits the traversed object. ; It can represent the first j Two-dimensional ultrasound image, or the first frame j One spectral Doppler raw data sampling point, | | This represents the absolute value operation, indicating the time difference between the pressure event and the ultrasound frame. This represents the timestamp of a Valsalva stress event. Representing ultrasound data The corresponding global unified timestamp means that all ultrasonic and pressure signals share the same clock reference time axis.

[0113] It should be noted that, through the pressure signal state perception compensation method described above, the system can adopt different pressure processing strategies in different Valsalva action stages, reduce the impact of zero drift, pipeline lag, air blowing jitter and abnormal pressure segments on pressure event identification, improve the reliability of effective excitation interval judgment and time registration between pressure data and ultrasonic image data and spectral Doppler data.

[0114] The following describes the usage of the integrated Valsalva provocation test system based on ultrasonic equipment proposed in the above embodiments and preferred embodiments of this application: 1) The patient connects to the inhalation unit; 2) Initialize the system and calibrate the zero pressure point; 3) The ultrasound machine begins acquiring two-dimensional images and spectral Doppler data; 4) The patient performs the blowing action; 5) Pressure sensors collect pressure data in real time; 6) Pressure data is displayed in real time on the ultrasound interface; 7) The system automatically identifies whether the pressure has reached the preset threshold; 8) The system automatically records the time point after the threshold is reached; 9) Synchronously acquire pressure, ultrasound images, and spectral data; 10) The data will be automatically saved and a report will be generated after the process is completed.

[0115] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0116] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. An integrated Valsalva provocation testing system based on ultrasonic equipment, characterized in that, The system includes: The pressure sensing component is configured to detect pressure data when the patient performs the Valsalva maneuver; The time synchronization module is configured to synchronize multi-source data in time; the multi-source data includes at least pressure data and ultrasound image data or spectral Doppler data; The real-time display module is configured to display pressure-related information on the display interface of the ultrasound device.

2. The system as described in claim 1, characterized in that, The system also includes: The pressure signal state perception and compensation module is configured to identify the Valsalva maneuver stage based on the pressure data and related data during the patient's Valsalva maneuver, and to correct and compensate the original pressure signal based on the Valsalva maneuver stage.

3. The system as described in claim 2, characterized in that, When the pressure signal state sensing and compensation module corrects and compensates the original pressure signal, it includes: Acquire the raw pressure signal and bind a timestamp; Obtain the baseline pressure before the start of the Valsalva test, and perform zero-point correction on the original pressure signal by subtracting the baseline pressure from the original pressure signal; The pressure change rate is calculated based on the corrected pressure signal, and the Valsalva action phase is identified based on the pressure change rate. Segmented filtering is implemented based on the switching pressure signal processing parameters corresponding to the Valsalva action phase; Dynamic hysteresis compensation is performed on the filtered pressure signal; The effective Valsalva excitation range is determined based on the compensated pressure fluctuation amplitude and the mean square value of the pressure change rate; or the effective excitation score is calculated, and the effective Valsalva excitation range is determined when the effective excitation score is greater than a preset threshold. Bind pressure events corresponding to the effective Valsalva excitation range to ultrasound data or spectral Doppler data.

4. The system as described in claim 3, characterized in that, The dynamic hysteresis compensation of the filtered pressure signal includes: performing dynamic hysteresis compensation on the filtered pressure signal according to the following formula: in, Indicates the first i Pressure signal after sampling time compensation Indicates the first i The pressure signal after sampling time is filtered. This represents the equivalent response time constant of the air blowing line and sensor interface. This indicates the rate of change of pressure.

5. The system as described in claim 1, characterized in that, The system also includes: The discrete event-continuous state coupling module is configured to identify discrete events in the Valsalva excitation process based on multi-source data and bind the discrete events to a unified timestamp; The discrete events include at least one of the following: trigger start event, pressure target achievement event, effective stability maintenance event, pressure peak event, and pressure recovery end event; The continuous states include patient breathing pressure, pressure changes, pressure fluctuation amplitude, pressure maintenance time, spectral Doppler flow velocity curves or ultrasound image frame sequences, and electrocardiogram waveforms.

6. The system as described in claim 1, characterized in that, The time synchronization module matches the sampling points of multi-source data according to a unified timestamp to achieve time synchronization of multi-source data.

7. The system as described in claim 1, characterized in that, The real-time display module displays pressure-related information on the display interface of the ultrasound device in the form of a semi-transparent floating window, a split-screen window, or an overlay curve. The pressure-related information includes at least one of the following: real-time pressure value, pressure waveform, target pressure line, achievement prompt, stability prompt, and remaining maintenance time.

8. The system as described in claim 1, characterized in that, The system also includes: An air blowing assembly is configured for a patient to perform the Valsalva maneuver; the air blowing assembly includes, in sequence, an air blowing tube, a backflow prevention check valve, a connecting line, and a Luer lock connector, the Luer lock connector being connected to a pressure sensing assembly. The data acquisition and processing module is configured to acquire and process pressure data from the pressure sensing component. The ultrasonic host communication module is configured to establish data exchange between the pressure data processed by the data acquisition and processing module and the ultrasonic host. The data storage and playback module is configured to synchronously save relevant data generated by the system and support on-demand data playback.

9. The system according to any one of claims 1-8, characterized in that, The system also includes: The electromagnetic shielding structure is configured to completely enclose the pressure sensing component.

10. The system according to any one of claims 1-8, characterized in that, The system also includes: A temperature drift compensation unit is embedded in or mounted on the analog signal conditioning circuit of the pressure sensing component to correct the temperature drift error of the sensor in real time.

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