Visual airway clearance device with function of intelligently regulating and controlling internal and external oscillation of airway

Abstract

The invention relates to a visual airway clearance device with an intelligent airway internal and external oscillation control function. The visual airway clearance device comprises an electrical impedance imaging device, a controller, an airway internal oscillation device and an airway external oscillation device. The electrical impedance imaging device is used for evaluating the lung ventilation function condition of a patient and transmitting measured lung ventilation function index parameters of the patient to the controller; the controller receives the pulmonary ventilation function index parameters of the electrical impedance imaging device, processes the pulmonary ventilation function index parameters and outputs a control signal; and after receiving the control signal, the air passage internal and external oscillation devices adjust the operation modes and parameters of the air passage internal and external oscillation devices in real time. The system has the advantages that a four-dimensional integrated structure of electrical impedance imaging visual evaluation, intelligent mode selection, double-oscillation cooperation and closed-loop feedback is created for the first time, the problem that the traditional technology cannot dynamically adapt to the heterogeneity of patients is solved, and personalized airway clearance modes and optimal adjustment parameters are provided for different patients; and the effect of removing airway deposited secretions is obvious.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, in particular to a visual airway clearing device with the function of intelligently regulating internal and external airway oscillations. Background Art

[0002] Mechanical airway clearance technology refers to a treatment method that mechanically clears accumulated airway secretions and maintains airway patency. Oscillation is a common technique that can loosen and liquefy mucus and metabolites on the respiratory surface. The changes in airway gas velocity caused by oscillation can generate a certain degree of shear force, which can help secretions break away from the tracheal wall. Oscillation can also promote the movement of airway cilia, promoting sputum expulsion.

[0003] Oscillation techniques are divided into airway oscillation (internal oscillation) and chest wall oscillation (external oscillation). Airway oscillation involves continuously inputting high-frequency oscillation waves into the large airways, which then spread to the small and medium airways. Chest wall oscillation primarily uses targeted percussion or a pulsed airflow generator to regulate the inflation and deflation of an inflatable vest, generating high-frequency oscillations of a certain frequency and amplitude that act on the chest wall. Under the action of intra-airway oscillation, the airways expand compared to pre-treatment, producing a lung expansion effect to prevent and treat atelectasis. It can also be combined with nebulized medications to act on the small airways, promoting the movement and clearance of secretions. However, poorly controlled intensity can easily lead to barotrauma or lung hyperinflation. Chest wall oscillation has the opposite effect. Under the oscillatory squeezing effect it produces, the airways contract and narrow to a certain extent. The direction of their ciliary beat is largely unaffected by external positive pressure, which is more conducive to sputum aggregation. However, due to the influence of tissue thickness, the oscillation intensity will be attenuated, affecting the airway clearance effect. Furthermore, if the oscillation intensity is too high, patients may easily become intolerant. Currently, the main challenges are the inability to accurately identify the most appropriate, personalized oscillation pattern and adjustment parameters (including frequency, intensity, and duration) for each patient, and the inability to visually and objectively evaluate airway clearance. Consequently, existing treatments fail to provide optimized oscillation patterns and adjustment parameters, achieve satisfactory airway clearance, or provide visual, intuitive evaluation of treatment efficacy.

[0004] To this end, we invented an airway clearing device that has the function of intelligently regulating internal and external airway oscillations, is visual, and can perform feedback adjustment, providing personalized airway clearing modes and optimized adjustment parameters for different patients. Summary of the Invention

[0005] The purpose of the present invention is to provide an airway clearing device that has the function of intelligently regulating internal and external airway oscillations, is visual and can perform feedback adjustment, and provides personalized airway clearing modes and optimized adjustment parameters for different patients.

[0006] The second object of the present invention is to provide a control method for a visual airway clearing device with the function of intelligently regulating internal and external airway oscillations.

[0007] To achieve the above object, the technical solution adopted by the present invention is:

[0008] A visual airway clearance device with intelligent control of airway internal and external oscillations. The airway clearance device includes an electrical impedance imaging device, a controller, an intra-airway oscillation device, and an extra-airway oscillation device. The electrical impedance imaging device assesses the patient's pulmonary ventilation function and transmits the measured patient's pulmonary ventilation function index parameters to the controller. The controller processes the pulmonary ventilation function index parameters received from the electrical impedance imaging device and outputs a control signal for activating the intra-airway oscillation device and / or the extra-airway oscillation device. After receiving the control signal from the controller, the intra-airway oscillation device and the extra-airway oscillation device adjust the operating mode and parameters of the intra-airway oscillation device and the extra-airway oscillation device in real time.

[0009] The intra-airway oscillation device and the extra-airway oscillation device operate independently or in coordination according to the operation mode in the working state;

[0010] During and after treatment with the intra-airway oscillation device and the extra-airway oscillation device, the electrical impedance imaging device performs continuous and real-time evaluation of the airway clearance treatment effect, and synchronously feeds back the pulmonary ventilation function index parameters to the controller, regenerating new control signals for the intra-airway oscillation device and the extra-airway oscillation device, thereby forming a closed-loop control of the operation of the intra-airway and extra-airway oscillation devices.

[0011] As a preferred technical solution, the electrical impedance imaging device includes an electrode strip, an electrical impedance imaging module, and a display; the input end of the electrical impedance imaging module is electrically connected to the electrode strip; the output end of the electrical impedance imaging module is electrically connected to the display; the electrical impedance imaging module is provided with an excitation current generator, a voltage measuring unit, a signal acquisition unit, a signal processing unit, and an image reconstruction unit; the output end of the excitation current generator is electrically connected to the electrode strip; the voltage measuring unit is used to measure the voltage of the electrode strip; the input end of the signal acquisition unit is electrically connected to the voltage measuring unit, and the output end is electrically connected to the signal processing unit; the output end of the signal processing unit is divided into two paths, one path is electrically connected to the image reconstruction unit, and the other path is connected to the controller.

[0012] As a preferred technical solution, the controller includes a lung function parameter evaluation module and an oscillation mode parameter selection unit; the lung function parameter module receives the lung ventilation function index parameters obtained by the electrical impedance imaging device for monitoring and evaluation and transmits them to the oscillation mode parameter selection unit, and the output end of the oscillation mode parameter selection unit intelligently selects and sends a control signal to the intra-airway oscillation device and / or the extra-airway oscillation device.

[0013] As a preferred technical solution, the pulmonary function parameters obtained by the electrical impedance imaging device include: [region of interest (ROI) divided by layer or quadrant, gravity dependent area ROI%,

[0014] Global Inhomogeneity Index (GI index), Center of Ventilation (CoV), End Expiratory Lung Impedance Difference (ΔEELI), Tidal Impedance Variation (TIV), Ventilation Perfusion Matching Index (LPB / HPB Index, LHI)]; the pulmonary function parameter evaluation module analyzes the above parameters, and when the pulmonary function parameter combination is: gravity dependent area ROI%↓+GI↑+CoV↓+ΔEELI↓+TIV↓+LHI↓; at least three of the main parameters are abnormal, it is judged as hypoventilation, and airway oscillation is started first; if hypoventilation is judged, an instruction is sent to the oscillation mode parameter selection unit; the oscillation mode parameter selection unit starts the airway oscillation device and matches the time, frequency and intensity of the airway oscillation;

[0015] When the lung function parameter combination is: normal ROI% of the gravity-dependent area + normal GI + normal CoV + stable ΔEELI + normal TIV + normal LHI; and any four or more of the above parameters are normal, ventilation is determined to be normal; if ventilation is determined to be normal, an instruction is sent to the oscillation mode parameter selection unit; the oscillation mode parameter selection unit starts the extra-airway oscillation device and matches the time, frequency and intensity of the intra-airway oscillation;

[0016] When the lung function parameter combination is: gravity-dependent area ROI%↑+GI↑+CoV↑+ΔEELI↑+TIV↑+LHI↑; at least three of the main parameters are abnormal, it is judged as overinflation; if it is judged as overventilation, an instruction is sent to the oscillation mode parameter selection unit; switch to the extra-airway oscillation device, and match the time, frequency and intensity of the extra-airway oscillation.

[0017] As a preferred technical solution, the oscillation mode parameter selection unit is used to output oscillation mode instructions and specific oscillation parameter instructions, wherein the oscillation mode includes two modes: intra-airway oscillation and extra-airway oscillation, and the oscillation parameters include frequency, time and intensity.

[0018] As a preferred technical solution, the oscillation mode parameter selection unit is based on TIV dynamic adjustment when selecting frequency; fosc=fbase+k*ΔTIV (fosc: oscillation frequency; fbase: base oscillation frequency; k: proportional coefficient; ΔTIV: tidal impedance change).

[0019] When selecting the intensity, the pressure amplitude is adjusted according to the weighted value of ROI and CoV, specifically: Pout = Pmax (ROI / 100) * (1-CoV / 100) (Pout: maximum output intensity; Pmax: maximum intensity).

[0020] As a preferred technical solution, the intra-airway oscillation device includes an intra-airway oscillation parameter identification unit; after the intra-airway oscillation parameter identification unit receives the control signal and performs identification, it outputs the time, frequency and intensity of the oscillation; the extra-airway oscillation device includes an extra-airway oscillation parameter identification unit; after the extra-airway oscillation parameter identification unit receives the control signal and performs identification, it outputs the time, frequency and intensity of the oscillation.

[0021] As a preferred technical solution, the extra-airway oscillation device further includes an oscillation host; the oscillation host is connected to a micro-treatment head; and the micro-treatment head is matched with a chest wall strap.

[0022] To achieve the above second purpose, the technical solution adopted by the present invention is:

[0023] A method for controlling visual airway clearance with intelligent control of internal and external airway oscillations comprises the following steps:

[0024] (a) Initialization scan: The patient's lungs are scanned in real time using an electrical impedance tomography device to obtain lung function parameters, including region of interest (ROI%), gravity-dependent region (ROI%), global inhomogeneity index (GI), ventilation center (CoV), end-expiratory lung impedance difference (ΔEELI), tidal impedance change (TIV), and ventilation-perfusion matching index (LHI).

[0025] (b) Parameter analysis: The controller analyzes the lung function parameters to determine whether the patient's current ventilation status is hypoventilation, normal ventilation, or hyperventilation;

[0026] (c) Mode selection and execution:

[0027] If ventilation is insufficient, the intra-airway oscillation device 5 is activated to dilate the small airways through high-frequency positive pressure pulses;

[0028] If ventilation is normal, the intra-airway oscillation device 5 and the extra-airway oscillation device 6 are executed alternately;

[0029] If ventilation is excessive, the extra-airway oscillation device 6 is activated to promote ciliary beating through targeted percussion;

[0030] (d) Closed-loop feedback regulation: During the oscillation execution process, the changes in ΔEELI and LHI are monitored in real time through the electrical impedance imaging device, and the oscillation parameters (including frequency, intensity, duration, and mode switching time) are dynamically adjusted to form a "monitoring-decision-execution-feedback" closed-loop control.

[0031] As a preferred technical solution, the closed-loop feedback regulation in step (d) includes:

[0032] (d1) Calculate the ΔEELI gain rate in real time. If the gain rate is ≥15%, maintain the current parameters; otherwise, switch to the oscillation mode.

[0033] (d2) Dynamically adjust the airway oscillation weight according to the ΔEELI gradient, and enhance the proportion of airway oscillation when the gradient is greater than 0.3.

[0034] The advantages of the present invention are:

[0035] 1. The present invention is a visual airway clearing device with the function of intelligently regulating internal and external airway oscillations. It pioneered the four-dimensional integrated architecture of "electrical impedance imaging visual evaluation - intelligent mode selection - dual oscillation coordination - closed-loop feedback", which solves the problem that traditional technology cannot dynamically adapt to patient heterogeneity, provides personalized airway clearing modes and optimized adjustment parameters for different patients, and is significantly effective in clearing airway secretions.

[0036] 2. The electrical impedance imaging device uses an image reconstruction unit and display to perform lung function imaging, visualizing the patient's lung function. Airway pressure is correlated with lung ventilation, so lung visualization can be used to visualize the airway.

[0037] 3. The vibrations between the intra-airway oscillation device and the extra-airway oscillation device have a synergistic effect, achieving multimodal coordinated integration, including the oscillation mode, as well as the oscillation intensity, time, and frequency. In the existing technical solutions, the oscillation mode is single, either a single intra-airway oscillation mode or a single extra-airway oscillation mode, which cannot synergize and enhance the efficiency, and the efficiency of clearing viscous secretions is low (the effect decreases by 60% when the sputum viscosity is greater than 5Pa·s); secondly, the oscillation parameters of the dual oscillation are adjustable in real time, and multi-dimensional lung function parameters (ROI, GI index, CoV, etc.) are monitored in real time, and parameters such as oscillation frequency, intensity, and time are dynamically selected. Personalized airway clearance modes and optimized adjustment parameters are provided for different patients. In the existing technology, it relies on the operator's experience, which easily leads to fluctuations in efficacy (the sputum clearance amount varies by 2.3 times when different operators treat the same patient).

[0038] 4. The controller is equipped with a pulmonary function parameter evaluation module; the pulmonary function parameter evaluation module is used to evaluate the patient's pulmonary function parameters, so that these parameters evaluate the lung ventilation mechanism. When the intrapulmonary ventilation is insufficient, the intra-airway oscillation device is activated to expand the airway and loosen sputum. Subsequently, the extra-airway oscillation device is activated to promote ciliary swing and sputum aggregation; if the pulmonary function parameter evaluation module has indicated that the intrapulmonary ventilation is high or even excessive, the intra-airway oscillation is no longer suitable at this time, and the extra-airway oscillation device is activated. Intelligent adjustment of the oscillation mode is realized. The intra-airway and extra-airway oscillation modes each have their own advantages and disadvantages, and their advantages complement each other. The two modes can be selected alternately, or the intra-airway oscillation or extra-airway oscillation mode can be selected separately. Provide personalized airway clearance modes for different patients to achieve satisfactory airway clearance treatment effects.

[0039] During and after treatment with the intra- and extra-airway oscillation device, electrical impedance imaging provides continuous, real-time evaluation of airway clearance efficacy. Pulmonary function parameters are synchronously fed back to the controller, generating new control signals for the intra- and extra-airway oscillation devices. This creates a closed-loop control loop for the intra- and extra-airway oscillation devices. ΔEELI / LHI quantifies the efficacy in real time, enabling adaptive control driven by quantitative evaluation indicators. For example, ΔEELI reflects secretion clearance efficiency, allowing for dynamic adjustment of oscillation parameters to achieve adaptive treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 This is a structural block diagram of a visual airway clearing device of the present invention that has the function of intelligently regulating internal and external airway oscillations.

[0041] Figure 2 It is a structural block diagram of an electrical impedance tomography device.

[0042] Figure 3 It is a schematic diagram of the principle of the intra-airway oscillation device.

[0043] Figure 4 Schematic diagram of the extra-airway oscillation device.

[0044] Figure 5 This is a structural block diagram of a control method for visualized airway clearance of the present invention with the function of intelligently regulating internal and external airway oscillations.

[0045] Figure 6 This is a block diagram of the application principle of a visual airway clearance device of the present invention that has the function of intelligently regulating internal and external airway oscillations. DETAILED DESCRIPTION

[0046] The present invention will be further described below in conjunction with embodiments and with reference to the accompanying drawings.

[0047] The reference numerals and components in the drawings are as follows:

[0048] 1. Electrical impedance tomography device 11. Electrode belt

[0049] 12. Electrical impedance imaging module 121. Voltage measurement unit

[0050] 122. Signal acquisition unit 123. Signal processing unit

[0051] 13. Excitation current generator

[0052] 2. Image reconstruction unit 3. Display

[0053] 4. Controller 41. Pulmonary function parameter evaluation module

[0054] 42. Oscillation mode parameter selection unit 5. Intra-airway oscillation device

[0055] 51. Intra-airway oscillation parameter identification unit 6. Extra-airway oscillation grasping device

[0056] 61. Extra-airway oscillation parameter identification unit

[0057] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts shall fall within the scope of protection of the present invention.

[0058] To facilitate understanding of the embodiments of the present invention, specific embodiments will be further explained below with reference to the accompanying drawings. The embodiments do not limit the embodiments of the present invention.

[0059] In the description of the embodiments of the present invention, it should be noted that the terms "lower edge", "above", "one end", "the other end", "front and back", "left and right", "horizontal", "longitudinal" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention; in addition, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be internal communication between two elements. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0060] Please refer to Figure 1 , Figure 1 This is a structural diagram of a visual airway clearance device with intelligent control of airway internal and external oscillations.

[0061] Visual airway clearing device; the airway clearing device includes an electrical impedance imaging device 1, a controller, an intra-airway oscillation device 5, and an extra-airway oscillation device 6; the electrical impedance imaging device 1 evaluates the patient's pulmonary ventilation function status and transmits the measured patient's pulmonary ventilation function index parameters to the controller; the controller processes the pulmonary ventilation function index parameters received from the electrical impedance imaging device 1 and outputs two control signals for starting intra-airway oscillation and extra-airway oscillation; after receiving the control signal from the controller, the intra-airway oscillation and extra-airway oscillation adjust the operating mode and parameters of the intra-airway oscillation device 5 and the extra-airway oscillation device 6 in real time (including the frequency, intensity and duration of the independent operation of the intra-airway and extra-airway oscillation devices, as well as the alternating switching time of the two devices).

[0062] The oscillation device inside and outside the airway can be operated alternately, or the oscillation device inside the airway or the oscillation device outside the airway can be operated separately. Specifically, when the electrical impedance imaging device 1 detects insufficient ventilation in the lungs, the corresponding controller generates a control signal to start the oscillation device inside the airway 5; after the oscillation device inside the airway 5 receives the control signal, the oscillation device inside the airway 5 is started to expand the airway and loosen sputum. Subsequently, the oscillation device outside the airway 6 is started to promote ciliary vibration and sputum aggregation. When the electrical impedance imaging device 1 has indicated that the ventilation in the lungs is high or even excessive, the corresponding controller generates a control signal to start the oscillation device outside the airway 6; after the oscillation device outside the airway 6 receives the control signal, the oscillation device outside the airway 6 is started.

[0063] During and after the treatment with the internal and external airway oscillation device, the electrical impedance imaging device 1 performs continuous and real-time evaluation of the airway clearance treatment effect, and synchronously feeds back the pulmonary ventilation function index parameters to the controller, and then generates new control signals for the internal and external airway oscillation device, thereby forming a closed-loop control of the operation of the internal and external airway oscillation device.

[0064] The electrical impedance imaging device 1 includes an electrode belt 11, an electrical impedance imaging module 12, and a display 3; the input end of the electrical impedance imaging module 12 is electrically connected to the electrode belt 11; and the output end of the electrical impedance imaging module 12 is electrically connected to the display 3.

[0065] The electrical impedance imaging module 12 is provided with an excitation current generator, a voltage measuring unit 121, a signal acquisition unit 122, a signal processing unit 123, and an image reconstruction unit 2; the output end of the excitation current generator is electrically connected to the electrode belt 11; the voltage measuring unit 121 is used to measure the voltage of the electrode belt 11; the input end of the signal acquisition unit 122 is electrically connected to the voltage measuring unit 121, and the output end is electrically connected to the signal processing unit 123; the output end of the signal processing unit 123 is divided into two paths, one path is electrically connected to the image reconstruction unit 2, and the other path is connected to the controller.

[0066] The excitation current generator is used to generate a precise alternating current signal and inject it into the human body through the electrode belt 11. The frequency of the current is usually between 1 kHz and 1 MHz.

[0067] The electrical impedance imaging module 12 is provided with a voltage measuring unit 121; it can accurately measure the voltage of the electrode

[0068] The voltage on the strip 11. As an advantage, the voltage measuring unit 121 is configured with a low noise amplifier and a high-precision analog-to-digital converter; the voltage measuring unit 121 uses the low noise amplifier and the high-precision analog-to-digital converter (ADC) to ensure measurement accuracy.

[0069] The electrical impedance imaging module 12 is provided with a signal acquisition unit 122 and a signal processing unit 123; the signal acquisition unit 122 digitizes and stores the measured voltage signal; the signal processing unit 123 filters, amplifies and corrects the collected signal to improve the signal quality.

[0070] The electrical impedance imaging module 12 is provided with an image reconstruction unit 2, which is responsible for converting the collected voltage and current data into an electrical impedance distribution image.

[0071] The controller includes a lung function parameter evaluation module 41, an oscillation mode parameter selection unit 42, an intra-airway oscillation start unit, and an extra-airway oscillation start unit; the lung function parameter module receives the lung ventilation function index parameters obtained by the electrical impedance imaging device 1 for monitoring and evaluation and passes them to the oscillation mode parameter selection unit 42, and the output end of the oscillation mode parameter selection unit 42 intelligently selects and sends instructions to the intra-airway oscillation start unit and / or the extra-airway oscillation unit, and the intra-airway oscillation unit or the extra-airway oscillation unit receives the instructions and generates corresponding control signals for output.

[0072] Among them, the pulmonary ventilation function index parameters evaluated and monitored by the pulmonary function parameter evaluation module 41 can better characterize the ventilation status of each lung area, specifically:

[0073] Electrical impedance imaging parameters include the distribution of region of interest (ROI)% by layer or quadrant, gravity-dependent region (ROI)%, global inhomogeneity index (GI), ventilation center (CoV), end-expiratory lung impedance difference (ΔEELI), tidal impedance change (TIV), and ventilation-perfusion matching index (LHI).

[0074] The electrical impedance imaging device 1 outputs parameters: gravity-dependent area ROI%, GI, CoVΔEELI, TIV, LHI; the pulmonary function parameter evaluation module 41 analyzes the electrical impedance imaging parameters to determine the pulmonary ventilation status; specifically, as follows:

[0075]

[0076] When the lung function parameter combination is: gravity-dependent area ROI%↓+GI↑+CoV↓+ΔEELI↓+TIV↓+LHI↓; at least three of the main parameters are abnormal, it is judged as hypoventilation and intra-airway oscillation (high frequency and low amplitude) is activated first;

[0077] When the combination of lung function parameters is: normal ROI% of the dependent area + normal GI + normal CoV + stable ΔEELI + normal TIV + normal LHI; if any four or more of the above parameters are normal, ventilation is considered normal; switch to extra-airway oscillation (low frequency and high amplitude);

[0078] When the combination of lung function parameters is: gravity-dependent area ROI%↑+GI↑+CoV↑+ΔEELI↑+TIV↑+LHI↑; at least three of the main parameters are abnormal, it is judged as hyperinflation, and intra-airway oscillation is disabled, while extra-airway oscillation is maintained;

[0079] Control the frequency (5-30 Hz), intensity (5-50 cmH2O), and time (alternating cycle 1-5 minutes) of the airway internal / external oscillation device;

[0080] During and after treatment with the intra- and extra-airway oscillation devices, the electrical impedance imaging device continuously and in real time evaluates the effectiveness of airway clearance therapy, and synchronously transmits pulmonary ventilation function index parameters to the controller, which then generates new control signals for the intra- and extra-airway oscillation devices, thereby forming a closed-loop control of the operation of the intra- and extra-airway oscillation devices; the details are as follows:

[0081] When the GI index dropped to 0.45 and the gravity-dependent area ROI% recovered to 35%, the oscillation intensity was reduced.

[0082] Alternatively, if ΔEELI continues to increase, the duration of airway oscillations may need to be reduced to prevent barotrauma.

[0083] Alternatively, treatment parameters can be adjusted through real-time feedback of ΔEELI and LHI.

[0084] Alternatively, the oscillation mode parameter selection unit dynamically adjusts the frequency based on TIV; fosc=fbase+k*ΔTIV (fosc: oscillation frequency; fbase: base oscillation frequency; k: proportional coefficient, ΔTIV: tidal impedance change).

[0085] When selecting the intensity, the pressure amplitude is adjusted according to the weighted value of ROI and CoV, specifically: Pout = Pmax (ROI / 100) * (1-CoV / 100) (Pout: maximum output intensity; Pmax: maximum intensity).

[0086] (1) Electrical impedance imaging parameters (including ROI% distribution, gravity-dependent ROI%, GI index, CoV, ΔEELI, TIV, and LHI)

[0087] ①ROI and gravity-dependent area ROI%

[0088] The electrical impedance tomography image of pulmonary ventilation is divided into regions according to the "hierarchical distribution from ventral to dorsal" or "four-quadrant distribution with the center of the image as the origin". The electrical impedance imaging pulmonary ventilation image is artificially divided into four parallel regions or quadrants, namely the customized region of interest ROI, that is, the pulmonary ventilation image can be divided into ROI1, ROI2, ROI3 and ROI4. The area covered by each ROI is displayed by the corresponding regional impedance waveform. The regional impedance waveform shows the sum of the impedance changes within a specific ROI, and the impedance changes in different regions of the lungs can be compared to present the regional ventilation distribution of the lungs. For the selected ROI, ROI% = selected regional impedance change / global impedance change × 100% (i.e. ROI% = regional ventilation volume / total ventilation volume

[0089] × 100%), so in the customized region of interest, ROI1%+ROI2%+ROI3%+ROI4%=100%.

[0090] In clinical practice, ROIs 1 and 2 are generally considered to be independent regions, while ROIs 3 and 4 are considered to be dependent regions (i.e., dependent region ROI% = ROI3% + ROI4%). Changes in patient position can alter ventilation in the dependent regions of the lung, affecting both overall and local ventilation distribution.

[0091] ②GI index

[0092] The GI index (GI) is the dispersion of tidal impedance changes at each pixel, calculated using electrical impedance tomography (EIT). It reflects the spatial heterogeneity of regional lung ventilation. The GI index is highly correlated with the degree of local alveolar patency. A smaller GI index indicates more uniform overall lung ventilation.

[0093] ③CoV

[0094] CoV refers to the ventilation center calculated based on the weighted average of the change in tidal resistance at each pixel point in spatial position. It aims to quantify the change in ventilation distribution in the vertical direction of the ventral and dorsal regions. A value less than 50% means that ventilation is preferentially distributed to the ventral region, and an increase in the ratio indicates an increase in the proportion of ventilation preferentially distributed to the dorsal region.

[0095] ④ΔEELI

[0096] ΔEELI is the difference in end-expiratory impedance between two points in the respiratory cycle, primarily reflecting changes in end-expiratory lung volume. Because the change in end-expiratory lung volume increases linearly with ΔEELI, ΔEELI can be used to measure the change in end-expiratory lung volume between two points in time. To illustrate regional ventilation changes, the ΔEELI value of each pixel is represented by different color scales. When ΔEELI is greater than 0, it is indicated in blue; when ΔEELI is less than 0, it is indicated in orange; and areas where ΔEELI = 0 are indicated in black. The brighter the color, the greater the absolute value of the relative rate of change in ΔEELI.

[0097] ⑤TIV

[0098] TIV is the difference between impedance measured at the end of inspiration and impedance measured at the end of expiration and is related to tidal volume. At the end of inspiration, when lung gas content is highest, the electrical impedance reaches its maximum. Conversely, at the end of expiration, the impedance reaches its minimum. The difference between these two values ​​is the TIV. Global TIV is the sum of the impedance changes across all quadrant pixels in the entire lung region, while regional TIV represents the impedance change within a specific ROI.

[0099] ⑥LHI

[0100] LHI stands for the ventilation-perfusion matching index (LPB / HPB Index). In the LHI calculation, L represents the low-speed passband (LPB), which is the portion of the raw voltage signal that passes through a low-pass filter; H represents the high-speed passband (HPB), which is the portion of the raw voltage signal that passes through a bandpass filter. When the cutoff frequency is set between three times the respiratory rate and the heart rate, the LPB represents the ventilation signal, and the HPB represents the perfusion signal. The LHI performs a correlation calculation on the LPB and HPB signals to determine the degree of correlation between the ventilation and perfusion signals. The LHI reflects the similarity of ventilation and perfusion distribution, specifically the degree of spatial alignment and intensity between pulmonary ventilation and pulmonary perfusion, also known as ventilation / perfusion (V / Q) matching. For lung lesions primarily located in gravity-dependent areas, abnormalities in both ventilation and perfusion distribution may occur. The LHI can be used to assess whether treatment improves both ventilation and perfusion. An increased LHI indicates better ventilation / perfusion (V / Q) matching.

[0101] The intra-airway oscillation device 5 includes an intra-airway oscillation parameter identification unit 51. After receiving the control signal, the intra-airway oscillation parameter identification unit 51 identifies the oscillation time, frequency, and intensity and outputs the oscillation time, frequency, and intensity to the intra-airway oscillation device 5. Specifically, in a preferred embodiment, when the intra-airway oscillation device 5 is in continuous high-frequency oscillation (CHFO) mode, the high-frequency oscillation frequency is within 180-300 bpm; the low-frequency oscillation frequency is within 100-180 bpm; the high-frequency intensity is such that the peak airway pressure is within 8-38 cmH2O; and the low-frequency intensity is such that the peak airway pressure is within 8-30 cmH2O. The intra-airway oscillation device 5 can be connected to an external mask or mouthpiece.

[0102] The extra-airway oscillation device 6 includes an extra-airway oscillation parameter identification unit 61; after receiving the control signal, the extra-airway oscillation parameter identification unit 61 identifies the oscillation time, frequency and intensity and outputs the oscillation time, frequency and intensity to the extra-airway oscillation device 6.

[0103] The extra-airway oscillation device 6 also includes an oscillation main unit; a micro-treatment head is connected to the oscillation main unit; and the micro-treatment head is matched with a chest wall strap. The extra-airway oscillation device 6 mainly uses mechanical physical percussion, inflated expectoration vests, and other methods to compress the lungs and remove airway secretions.

[0104] It should be noted that:

[0105] The electrical impedance imaging device 1 injects a weak safe current into the human body surface and measures the surface voltage through the electrode belt 11, and uses the corresponding imaging algorithm to obtain the distribution of electrical impedance changes inside the human body to reflect the related physiological and pathological information. It has bedside, non-invasive, non-radiation, real-time continuous dynamic monitoring of global and local lung area ventilation conditions.

[0106] The imaging principle of the electrical impedance imaging device 1 is that there are large impedance differences between different tissues of the human body.

[0107] The impedance of the same tissue is different under different physiological states. When a biological tissue becomes diseased, its impedance value also changes accordingly.

[0108] Please refer to Figure 2 , Figure 2 The electrical impedance tomography device 1 generates a lung function image in the following steps:

[0109] S1: applying an excitation current to the electrode belt 11 through an excitation current generator, and measuring the body surface voltage of the electrode belt 11 through a voltage measuring unit 121;

[0110] S2: Collect voltage signal data and characteristics through the signal acquisition unit 122 and the signal processing unit 123, reconstruct the electrical impedance change, determine the sensitive area, and obtain the human body impedance distribution;

[0111] S3: The image reconstruction unit 2 uses an image reconstruction algorithm to calculate an electrical impedance image based on the electrical impedance or the electrical impedance change;

[0112] S4: Combine physiologically relevant measurements with imaging algorithms to obtain lung function imaging.

[0113] The electrical impedance imaging device 1 in this embodiment can realize lung function imaging and visualize the patient's lung ventilation function status through the image reconstruction unit and the display 3.

[0114] The controller is provided with a pulmonary function parameter evaluation module 41; the pulmonary function parameter evaluation module 41 is used to evaluate the patient's pulmonary ventilation function parameters, thereby evaluating the pulmonary ventilation mechanism through these parameters. When the ventilation in the lungs is insufficient, the intra-airway oscillation device 5 is activated to expand the airway and loosen sputum. Subsequently, the extra-airway oscillation device 6 is activated to promote ciliary swing and sputum aggregation; if the pulmonary function parameter evaluation module 41 has indicated that the ventilation in the lungs is high or even excessive, the intra-airway oscillation is no longer suitable at this time, and the extra-airway oscillation device 6 is activated. Intelligent adjustment of the oscillation mode is realized. The intra-airway and extra-airway oscillation modes each have their own advantages and disadvantages, and their advantages complement each other. The two modes can be selected alternately, or the intra-airway oscillation or extra-airway oscillation mode can be selected separately. Personalized airway clearance modes are provided for different patients to achieve satisfactory airway clearance treatment effects.

[0115] In addition, the pulmonary function parameter evaluation module 41 provides a basis for intelligently selecting adjustment parameters (including frequency, intensity and time) based on the monitored pulmonary ventilation function index parameters (ROI, gravity-dependent area ROI%, GI index, CoV, ΔEELI, TIV, LHI) to achieve satisfactory airway clearance treatment effects.

[0116] Please refer to Figure 3 , Figure 3 This is a schematic diagram of an intra-airway oscillation device. An intra-airway oscillation device 5 is provided to oscillate the airway with continuous positive pressure pulses. This high-frequency oscillation is maintained during inspiration and expiration, causing the tracheal wall to expand outward from its initial state. This expansion creates a pressure differential in the small airways obstructed by secretions (sputum). This pressure differential generates an accelerated expiratory flow, which can be used to help secretions move to the larger airways. Nebulization therapy can be combined with treatment to enhance mucus clearance.

[0117] Please refer to Figure 4 , Figure 4 The schematic diagram of the extra-tracheal oscillation device is provided. The extra-tracheal oscillation device 6 is provided to squeeze the tracheal wall inward from its original state, mainly through directional percussion to generate a certain frequency and amplitude.

[0118] The device generates high-frequency oscillations of varying degrees and acts on the chest wall. Chest wall oscillations can loosen and liquefy mucus and metabolites on the surface of the respiratory tract. The changes in gas flow rate in the airway caused by the oscillations can generate a certain intensity of shear force, prompting secretions to detach from the tracheal wall. In addition, the oscillations can also promote the swinging of airway cilia and promote the discharge of sputum. At the same time, along with the oscillation of the chest wall, the airway will also shrink and narrow to a certain extent. The direction of its cilia swing will basically not be affected by external positive pressure, which is conducive to the accumulation of sputum. Secondly, the external oscillation device adopts a directional percussion method to optimize the mechanical excitation of the chest wall and reduce energy attenuation.

[0119] The vibrations between the intra-airway oscillation device 5 and the extra-airway oscillation device 6 have a synergistic effect, achieving multimodal coordinated integration, including the oscillation mode, as well as the intensity, time and frequency of the oscillation. In the existing technical solutions, the oscillation mode is single, either a single intra-airway oscillation mode or a single extra-airway oscillation mode, which cannot be synergistically enhanced, and the efficiency of clearing viscous secretions is low (the effect decreases by 60% when the sputum viscosity is greater than 5Pa·s); secondly, the oscillation parameters of the dual oscillation are adjustable in real time, and the oscillation frequency, intensity, time and other parameters are intelligently and dynamically selected according to the multi-dimensional lung function parameters (ROI, GI index, CoV, etc.) monitored in real time. Provide personalized airway clearance mode and optimized adjustment parameters for different patients. In the existing technology: relying on the operator's experience, it is easy to cause fluctuations in efficacy (the sputum clearance amount varies by 2.3 times when different operators treat the same patient).

[0120] During and after treatment with the intra- and extra-airway oscillation devices, the electrical impedance imaging device 1 provides continuous, real-time evaluation of the airway clearance treatment effect. It also transmits synchronous feedback of pulmonary ventilation function parameters to the controller, which then generates new control signals for the intra- and extra-airway oscillation devices, thus forming a closed-loop control loop for the operation of the intra- and extra-airway oscillation devices. ΔEELI / LHI quantifies the therapeutic effect in real time, enabling adaptive control driven by quantitative evaluation indicators. For example, ΔEELI reflects secretion clearance efficiency, and the oscillation parameters are dynamically adjusted to achieve adaptive treatment.

[0121] Please refer to Figure 5 , Figure 5 This is a structural block diagram of a control method for visual airway clearance with intelligent control of airway internal and external oscillations of the present invention. A control method for visual airway clearance with intelligent control of airway internal and external oscillations includes the following steps:

[0122] (a) Initialization scan: The patient's lungs are scanned in real time using an electrical impedance tomography device to obtain lung function parameters, including (ROI, % dependent area ROI, GI index, CoV, ΔEELI, TIV, LHI);

[0123] (b) Parameter analysis: The controller analyzes the lung function parameters to determine whether the patient's current ventilation status is hypoventilation, normal ventilation, or hyperventilation;

[0124] (c) Mode selection and execution:

[0125] If ventilation is insufficient, the intra-airway oscillation device 5 is activated to dilate the small airways through high-frequency positive pressure pulses;

[0126] If ventilation is normal, the intra-airway oscillation device 5 and the extra-airway oscillation device 6 are executed alternately;

[0127] If ventilation is excessive, the extra-airway oscillation device 6 is activated to promote ciliary beating through targeted percussion;

[0128] (d) Closed-loop feedback regulation: During the oscillation execution process, the electrical impedance imaging device monitors the changes in ROI, gravity-dependent area ROI%, GI index, CoV, ΔEELI, TIV, and LHI in real time, and dynamically adjusts the oscillation parameters (including frequency, intensity, duration, and mode switching time), forming a "monitoring-decision-execution-feedback" closed-loop control.

[0129] As a preferred technical solution, the closed-loop feedback regulation in step (d) includes:

[0130] (d1) Calculate the ΔEELI gain rate in real time. If the gain rate is ≥15%, maintain the current parameters; otherwise, switch to the oscillation mode.

[0131] (d2) Dynamically adjust the airway oscillation weight according to the ΔEELI gradient, and enhance the proportion of airway oscillation when the gradient is greater than 0.3.

[0132] Please refer to Figure 6 , Figure 6 This is a block diagram of the application principle of a visual airway clearance device with intelligent control of airway internal and external oscillations of the present invention. The application principle of a visual airway clearance device with intelligent control of airway internal and external oscillations of the present invention is:

[0133] Electrical impedance imaging visual assessment: chest impedance data is acquired through 16 electrode strips to generate ventilation / perfusion dynamic images, including: ROI% stratified analysis; ΔEELI dynamic imaging; LHI perfusion matching;

[0134] Intelligent mode selection: Based on fuzzy logic algorithm and combined with clinical rule base, the optimal mode is selected;

[0135] Double oscillation coordination: internal oscillation high-frequency pulses, 20-30Hz high-frequency pulses superimposed on the respiratory cycle; external oscillation directional percussion, 10-15Hz chest wall vibration synchronized with the respiratory phase; coordinated timing control;

[0136] Closed-loop feedback regulation: Real-time parameter monitoring: Dynamic frequency adjustment, updating EIT parameters every 5 seconds, and adjusting oscillation intensity through the controller.

[0137] The present invention is a visualized airway clearing device with the function of intelligently regulating internal and external airway oscillations. It pioneered the four-dimensional integrated architecture of "electrical impedance imaging visualization evaluation-intelligent mode selection-dual oscillation coordination-closed-loop feedback", which solves the problem that traditional technology cannot dynamically adapt to patient heterogeneity, provides personalized airway clearing modes and optimized adjustment parameters for different patients, and has a significant effect in clearing airway congestion and secretions.

[0138] The above is only a preferred embodiment of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the principles of the present invention. These improvements and supplements should also be regarded as the scope of protection of the present invention.

Claims

1. A visual airway clearance device with intelligent control of airway internal and external oscillations, characterized in that: The airway clearance device includes an electrical impedance imaging device, a controller, an intra-airway oscillation device, and an extra-airway oscillation device; the electrical impedance imaging device assesses the patient's pulmonary ventilation function and transmits the measured pulmonary ventilation function index parameters of the patient to the controller; the controller processes the pulmonary ventilation function index parameters received from the electrical impedance imaging device and outputs a control signal for activating the intra-airway oscillation device and / or the extra-airway oscillation device; the intra-airway oscillation device and the extra-airway oscillation device adjust their operating modes and parameters in real time after receiving the control signal from the controller; The intra-airway oscillation device and the extra-airway oscillation device operate independently or in coordination according to the operation mode in the working state; During and after treatment with the intra-airway oscillation device and the extra-airway oscillation device, the electrical impedance imaging device continuously and in real time evaluates the status of the lung ventilation function, and synchronously feeds back the lung ventilation function index parameters to the controller, thereby generating new control signals for the intra-airway oscillation device and the extra-airway oscillation device, thereby forming a closed-loop control of the operation of the intra-airway and extra-airway oscillation devices.

2. The visual airway clearance device for intelligently controlling the internal and external airway oscillation function according to claim 1, characterized in that: The electrical impedance imaging device includes an electrode strip, an electrical impedance imaging module, and a display; the input end of the electrical impedance imaging module is electrically connected to the electrode strip; the output end of the electrical impedance imaging module is electrically connected to the display; the electrical impedance imaging module is provided with an excitation current generator, a voltage measuring unit, a signal acquisition unit, a signal processing unit, and an image reconstruction unit; the output end of the excitation current generator is electrically connected to the electrode strip; the voltage measuring unit is used to measure the voltage of the electrode strip; the input end of the signal acquisition unit is electrically connected to the voltage measuring unit, and the output end is electrically connected to the signal processing unit; the output end of the signal processing unit is divided into two paths, one path is electrically connected to the image reconstruction unit, and the other path is connected to the controller.

3. The visual airway clearance device for intelligently controlling the internal and external airway oscillation function according to claim 1, characterized in that: The controller includes a lung function parameter evaluation module and an oscillation mode parameter selection unit; the lung function parameter module receives the lung ventilation function index parameters obtained by the electrical impedance imaging device for monitoring and evaluation, and transmits them to the oscillation mode parameter selection unit. The output end of the oscillation mode parameter selection unit intelligently selects and sends a control signal to the intra-airway oscillation device and / or the extra-airway oscillation device.

4. The visual airway clearance device for intelligently controlling the internal and external airway oscillation function according to claim 1, characterized in that: The pulmonary function parameters acquired by the electrical impedance imaging device include: region of interest (ROI) distribution, gravity-dependent ROI ratio, global inhomogeneity index (GI index), ventilation center (CoV), end-expiratory lung impedance difference (ΔEELI), tidal impedance change (TIV) and ventilation-perfusion matching index (LHI); the pulmonary function parameter evaluation module analyzes the above parameters; When the lung function parameter combination is: gravity-dependent area ROI%↓+GI↑+CoV↓+ΔEELI↓+TIV↓+LHI↓; at least three of the main parameters are abnormal, it is judged as hypoventilation, and the airway oscillation is activated first; if hypoventilation is determined, an instruction is sent to the oscillation mode parameter selection unit; the oscillation mode parameter selection unit activates the airway oscillation device and matches the time, frequency and intensity of the airway oscillation; When the lung function parameter combination is: normal ROI% of the gravity-dependent area + normal GI + normal CoV + stable ΔEELI + normal TIV + normal LHI; and any four or more of the above parameters are normal, ventilation is judged to be normal; an instruction is sent to the oscillation mode parameter selection unit; the oscillation mode parameter selection unit starts the extra-airway oscillation device and matches the time, frequency and intensity of the intra-airway oscillation; When the lung function parameter combination is: gravity-dependent area ROI%↑+GI↑+CoV↑+ΔEELI↑+TIV↑+LH↑; at least three of the main parameters are abnormal, it is judged as overinflation; if it is judged as overventilation, an instruction is sent to the oscillation mode parameter selection unit; switch to the extra-airway oscillation device, and match the time, frequency and intensity of the extra-airway oscillation.

5. The visual airway clearance device for intelligently controlling the internal and external airway oscillation function according to claim 1, characterized in that: The oscillation mode parameter selection unit is used to output an oscillation mode instruction and a specific oscillation parameter instruction, wherein the oscillation mode includes two modes: intra-airway oscillation and extra-airway oscillation, and the oscillation parameters include frequency, time and intensity.

6. The visual airway clearance device for intelligently controlling the internal and external airway oscillation function according to claim 1, characterized in that: The oscillation mode parameter selection unit is dynamically adjusted based on TIV when selecting frequency; fosc=fbase+k*ΔTIV (fosc: oscillation frequency; fbase: base oscillation frequency; k: proportional coefficient, ΔTIV: tidal impedance change). When selecting the intensity, the pressure amplitude is adjusted according to the weighted value of ROI and CoV, specifically: Pout = Pmax (ROI / 100) * (1-CoV / 100) (Pout: maximum output intensity; Pmax: maximum intensity).

7. The visual airway clearance device for intelligently controlling the internal and external airway oscillation function according to claim 1, characterized in that: The intra-airway oscillation device includes an intra-airway oscillation parameter identification unit; after receiving the control signal, the intra-airway oscillation parameter identification unit identifies and outputs the oscillation time, frequency and intensity; the extra-airway oscillation device includes an extra-airway oscillation parameter identification unit; After receiving the control signal, the extra-airway oscillation parameter identification unit identifies the signal and outputs the time, frequency and intensity of the oscillation.

8. The visual airway clearance device for intelligently controlling the internal and external airway oscillation function according to claim 1, characterized in that: The extra-airway oscillation device further comprises an oscillation host; the oscillation host is connected to a micro-treatment head; the micro-treatment head is matched with a chest wall strap.

9. A visual airway clearance control method with intelligent control of airway internal and external oscillations, characterized in that: The following steps are involved: (a) Initialization scan: The patient's lungs are scanned in real time using an electrical impedance tomography device to obtain lung function parameters, including the distribution of region of interest (ROI) percentage by layer or quadrant, the gravity-dependent region (ROI), the global inhomogeneity index (GI), the ventilation center (CoV), the end-expiratory lung impedance difference (ΔEELI), the tidal impedance change (TIV), and the ventilation-perfusion matching index (LHI). (b) Parameter analysis: The controller analyzes the lung function parameters to determine whether the patient's current ventilation status is hypoventilation, normal ventilation, or hyperventilation; (c) Mode selection and execution: If ventilation is insufficient, the intra-airway oscillation device is activated to dilate the small airways through high-frequency positive pressure pulses; If ventilation is normal, alternate between the intra-airway oscillation device and the extra-airway oscillation device; If ventilation is excessive, the extra-airway oscillation device is activated to promote ciliary beating through targeted tapping; (d) Closed-loop feedback regulation: During the oscillation process, the changes in ΔEELI and LHI are monitored in real time using an electrical impedance imaging (EI) device, and the oscillation parameters (including frequency, intensity, duration, and mode switching time) are dynamically adjusted, forming a "monitoring-decision-execution-feedback" closed-loop control.

10. The control method of the visual airway clearance device for intelligently regulating the internal and external oscillation functions of the airway according to claim 9, characterized in that: The closed-loop feedback regulation in step (d) includes: (d1) Calculate the ΔEELI gain rate in real time. If the gain rate is ≥15%, maintain the current parameters; otherwise, switch to the oscillation mode. (d2) Dynamically adjust the airway oscillation weight according to the ΔEELI gradient, and enhance the proportion of airway oscillation when the gradient is greater than 0.3.

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