System and method for switching modes and regulating pressure based on respiratory event and electronic equipment

Abstract

The invention relates to the technical field of medical equipment, in particular to a system and method for switching modes and regulating pressure based on respiratory events and electronic equipment. The system comprises a breathing machine monitoring module, a breathing event identification module, a breathing machine control module and a breathing machine alarm module. Wherein the breathing machine monitoring module collects multi-dimensional breathing parameters such as airway pressure and flow in real time; the respiratory event identification module accurately judges three types of events including obstructive sleep apnea, hypopnea and airflow limitation based on the parameters, and quantifies the airflow limitation degree; the breathing machine control module switches ventilation modes according to a preset progressive sequence, pressure parameters are dynamically adjusted, and pressure is reversely adjusted when breathing of the patient is recovered; the alarm module monitors the equipment state and the parameter safety range, and triggers sound-light alarm when the equipment state and the parameter safety range are abnormal. According to the invention, accurate identification of respiratory events, personalized mode adaptation and pressure regulation are realized, the curative effect and comfort are balanced, and treatment safety and long-term compliance are guaranteed.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a system, method, and electronic device based on respiratory event switching modes and pressure regulation. Background Technology

[0002] Sleep-disordered breathing and obstructive sleep apnea-hypopnea syndrome are chronic diseases characterized by repeated airway collapse and frequent respiratory events during sleep. Long-term illness can easily lead to multi-system complications, seriously threatening patients' health. Positive airway pressure (POP) therapy, as a first-line intervention for these diseases, aims to maintain unobstructed breathing through positive airway pressure. However, existing POP devices have significant shortcomings in adapting to individualized patient treatment needs: Firstly, the identification of respiratory events such as obstructive sleep apnea, hypopnea, and airflow limitation often relies on single flow or pressure parameters, lacking multi-dimensional quantitative analysis, resulting in insufficient accuracy in event identification and difficulty in accurately matching individual patient airway obstruction characteristics. Secondly, ventilation mode switching often uses fixed logic or relies on manual presets by medical staff, failing to dynamically adjust according to the patient's real-time physiological needs and treatment response. Furthermore, pressure parameter adjustments are often set with uniform gradients, without linkage to individual patient tolerance and disease relief effects, resulting in a lack of targeted treatment plans. This not only affects the intervention effect for some patients due to mismatched treatment parameters, but also often reduces long-term treatment compliance due to poor respiratory comfort, making it difficult to achieve the core need of providing precise and personalized treatment for patients. Summary of the Invention

[0003] The purpose of this invention is to provide a system, method, and electronic device based on respiratory event switching modes and pressure adjustment, in order to solve the problems of inaccurate respiratory event identification, difficulty in automatically adapting ventilation modes, lack of quantitative linkage in pressure adjustment, and neglect of respiratory comfort in the prior art, which cannot meet the needs of precise personalized treatment and comfortable use for patients.

[0004] The technical solution of this invention is: a system based on respiratory event switching modes and pressure regulation, comprising: The ventilator monitoring module is used to monitor the patient's respiratory parameters in real time, including airway pressure, tidal volume, inspiratory time, airway resistance, and flow rate. The respiratory event recognition module is used to identify the patient's respiratory events and calculate the degree of airflow limitation based on respiratory parameters. The respiratory events include obstructive sleep apnea, hypoventilation, and airflow limitation. The ventilator control module is used to trigger ventilation modes based on the patient's respiratory events, switch ventilation modes in a preset progressive order based on the degree of airflow limitation in the ventilation mode, and dynamically adjust pressure parameters. The ventilator alarm module is used to monitor the status of the ventilator equipment and the patient's respiratory parameters. When the equipment malfunctions or the respiratory parameters exceed the preset safety range, alarm details are generated and an audible and visual alarm is triggered.

[0005] Preferably, the step of identifying the patient's respiratory events based on respiratory parameters includes: When the flow rate amplitude is less than the first amplitude threshold and the duration is greater than or equal to the duration threshold and the mean airway resistance is greater than or equal to the resistance threshold, the patient is determined to be in an obstructive sleep apnea state. When the flow rate is less than the second amplitude threshold and the duration is greater than or equal to the duration threshold, the patient is determined to be in a state of hypoventilation. Calculate the average of the differences between the maximum and minimum flow rates in the previous n respiratory cycles, obtain the ratio of the difference between the maximum and minimum flow rates in the current respiratory cycle to the average of the differences, and record it as the flatness. When the flatness is less than or equal to the flatness threshold, the patient is determined to be in a state of airflow limitation.

[0006] Preferred methods for calculating the degree of airflow restriction include: When a patient is in a state of obstructive sleep apnea, the degree of airflow restriction is equal to the mean airway resistance. When a patient is in a state of hypoventilation, the global flow amplitude under the patient's normal breathing state is used as a benchmark, and a reference threshold is obtained by combining the global amplitude ratio k. The difference between the flow amplitude and the reference threshold in each time window during the occurrence of hypoventilation is calculated, the mean of all differences is calculated, and the mean is multiplied by the duration of hypoventilation to obtain the degree of airflow restriction of hypoventilation. When a patient is in a state of airflow limitation, the degree of airflow limitation is equal to the flatness.

[0007] Preferably, the airway resistance is detected by FOT forced oscillation technology, and the average airway resistance is the average value of the airway resistance during the FOT start-up period.

[0008] Preferably, the ventilation modes include bilevel positive airway pressure with pressure support of 0 cmH2O, bilevel positive airway pressure with pressure support other than 0 cmH2O, and trilevel positive airway pressure.

[0009] Preferably, the pressure support for dual-level positive airway pressure (non-0 cmH2O) includes two waveforms: a sine wave mode and a square wave mode; the inspiratory pressure rise rate of the square wave mode is faster than that of the sine wave mode. The Tri-Level Positive Airway Pressure (TPAP) is based on Bi-Level Positive Airway Pressure (PBAP), with added pressure unloading at the end of expiration. Pressure unloading refers to the adjustment action of reducing airway pressure compared to the expiratory pressure corresponding to the Bi-Level Positive Airway Pressure (PBAP) mode.

[0010] Preferably, the switching of the ventilation mode follows a preset progressive order, and the switching triggering condition is related to the respiratory event and the relief effect of airflow limitation. The switching logic is as follows: The system initially defaults to a dual-level positive airway pressure (DLP) mode with a pressure support of 0 cmH2O. When a respiratory event is detected, it switches to a sine wave mode with a DLP mode that supports pressure support other than 0 cmH2O, and gradually increases the pressure support. During the gradual increase of pressure support, the airflow limitation of the respiratory event is compared with the corresponding airflow limitation threshold. If the airflow limitation of the respiratory event still does not meet the corresponding airflow limitation threshold after the pressure support is increased to the first pressure support limit, the system switches to a square wave mode. In square wave mode, the expiratory pressure is increased step by step. If the airflow limitation of the respiratory event still does not meet the corresponding airflow limitation threshold when the first expiratory pressure is increased to the upper limit, then switch to three-level positive airway pressure. If the patient resumes normal breathing during any breathing mode switch or pressure parameter adjustment, reduce pressure support or expiratory pressure.

[0011] On the other hand, this application also discloses a pressure regulation method based on respiratory event switching modes, including: Monitor the patient's respiratory parameters, including airway pressure, tidal volume, inspiratory time, airway resistance, and flow rate; The respiratory events of a patient are identified and the degree of airflow limitation is calculated based on respiratory parameters, including obstructive sleep apnea, hypoventilation, and airflow limitation. The ventilation mode of the ventilator is switched according to the patient's respiratory events, and the pressure parameters are dynamically adjusted based on the degree of airflow limitation after switching the ventilation mode. If the pressure parameter is equal to the pressure threshold of the corresponding pressure parameter of the current ventilation mode and the degree of airflow limitation is still greater than or equal to the airflow limitation threshold, the ventilation mode is switched again. The pressure parameters include expiratory pressure and pressure support. Monitor the status of the ventilator and the patient's respiratory parameters. When the equipment malfunctions or the respiratory parameters exceed the preset safety range, generate alarm details and trigger an audible and visual alarm.

[0012] On the other hand, this application further discloses an electronic device, including: One or more processors; Memory, used to store one or more programs; When the one or more programs are executed by the one or more processors, the one or more processors implement any of the described systems based on respiratory event switching modes and pressure regulation.

[0013] Compared with the prior art, the advantages of the present invention are: (1) Establish a control logic for respiratory event identification, progressive switching of ventilation modes, and quantitative adaptation of pressure parameters to overcome the core pain points of passive mode adaptation and disconnect between pressure adjustment and patient condition in existing equipment. By integrating multi-dimensional respiratory parameters such as airway resistance, the system can accurately identify and quantify the degree of limitation of three types of respiratory events. Then, it can automatically and progressively switch ventilation modes according to the event type and relief effect, and dynamically adjust pressure parameters in sync. When the patient's breathing recovers, the pressure is adjusted in reverse, which not only ensures effective airway support but also avoids discomfort caused by improper pressure, achieving a deep balance between therapeutic effect and comfort.

[0014] (2) Personalized intelligent adaptation is achieved by subdividing ventilation mode characteristics and quantitatively linking them with the degree of airflow limitation. Different modes such as gradual pressure increase, rapid pressure increase, and end-expiratory pressure unloading are matched for different disease severity. Combined with exclusive quantitative assessment of different respiratory events, the pressure adjustment can accurately match the patient's real-time physiological state and adapt to the individual differences and comorbidity scenarios of the patient.

[0015] (3) Enhance treatment safety and long-term adherence, and expand clinical application value. Through real-time monitoring of device status and respiratory parameters and audible and visual alarms, combined with humidification adjustment and comfort mode design, adverse reactions are reduced; full-process automated control lowers the operation threshold, and the reverse pressure regulation mechanism improves nighttime use tolerance, helping patients to adhere to treatment in the long term and providing accurate and reliable technical support for family chronic disease management. Attached Figure Description

[0016] The present invention will be further described below with reference to the accompanying drawings and embodiments: Figure 1 This is a structural block diagram of a system based on respiratory event switching modes and pressure regulation according to the present invention; Figure 2 This is a schematic flowchart of a pressure regulation method based on respiratory event switching mode as described in this invention. Detailed Implementation

[0017] The present invention will be further described in detail below with reference to specific embodiments: This application is primarily applied to the scenario of long-term home-based nighttime treatment for patients with sleep-disordered breathing. In situations where the airway obstruction status changes dynamically during sleep and manual intervention is not possible, this application automatically identifies three types of respiratory events and quantifies the degree of restriction by real-time monitoring of multi-dimensional respiratory parameters. It then progressively switches ventilation modes and dynamically adjusts pressure parameters according to preset logic, while optimizing comfort with humidification adjustment and pressure unloading design. The core solution addresses the shortcomings of existing devices, such as difficulty in automatically adapting modes, lack of quantitative linkage in pressure adjustment, inaccurate event identification, and lack of reverse pressure regulation, which fail to meet the needs of precise and personalized treatment and comfortable use.

[0018] like Figure 1As shown, a system based on respiratory event switching modes and pressure regulation includes: The ventilator monitoring module is used to monitor the patient's respiratory parameters in real time, including airway pressure, tidal volume, inspiratory time, airway resistance, and flow rate.

[0019] Specifically, the ventilator monitoring module, as the core of the entire pressure regulation system, monitors various respiratory parameters that are crucial for assessing the patient's respiratory status, identifying respiratory events, and precisely adjusting the ventilation mode. Among these, airway pressure directly reflects airway support and is a core indicator for determining whether pressure parameters are appropriate; tidal volume reflects the amount of airflow per breath, helping to determine if ventilation is adequate; inspiratory time is used to analyze the rationality of the respiratory rhythm and reflects the patient's autonomous coordination of breathing; airway resistance quantifies the severity of airway obstruction and is a core dimension for assessing airflow limitation; and flow rate parameters visually present changes in airflow patency, providing direct data support for the rapid identification of respiratory events. The coordinated acquisition of these parameters ensures comprehensive and real-time perception of the patient's respiratory status.

[0020] The respiratory event recognition module is used to identify the patient's respiratory events and calculate the degree of airflow limitation based on respiratory parameters. Respiratory events include obstructive sleep apnea, hypoventilation, and airflow limitation.

[0021] Specifically, the respiratory event recognition module is the core analysis unit for achieving precision treatment. Its core function is to integrate and analyze the multi-dimensional respiratory parameters collected by the ventilator monitoring module. On the one hand, by distinguishing the characteristic patterns of different respiratory events, it accurately determines whether the patient is currently in a state of obstructive sleep apnea, hypoventilation, or airflow limitation. On the other hand, for different types of respiratory events, it uses an appropriate quantitative assessment method to calculate the degree of airflow limitation, providing a clear basis for the ventilator control module to ensure that ventilation mode switching and pressure adjustment can accurately match the patient's real-time respiratory status.

[0022] In one implementation, the respiratory event recognition module receives parameters such as airway pressure, tidal volume, inspiratory time, airway resistance, and flow rate in real time through a high-speed data interface. The data sampling interval is synchronized with the ventilator monitoring module to ensure the timeliness of the analysis.

[0023] The respiratory event recognition module performs feature matching for three types of respiratory events: obstructive sleep apnea is identified by the trend and duration of flow changes; hypoventilation is identified by the amplitude and duration of flow attenuation; and airflow limitation is identified by the fluctuation characteristics of the flow waveform during the inspiratory phase. At the same time, for each type of respiratory event after identification, the degree of airflow limitation is calculated using the corresponding quantitative model. The calculation results are output to the ventilator control module in real time. The entire recognition and calculation process is completed automatically without manual intervention, ensuring a rapid response to changes in the patient's respiratory status.

[0024] The ventilator control module is used to trigger ventilation modes based on the patient's respiratory events, switch ventilation modes in a preset progressive order based on the degree of airflow limitation in the ventilation mode, and dynamically adjust pressure parameters.

[0025] Specifically, the ventilator control module is the core control unit of the entire pressure regulation system, responsible for event response, mode switching, and pressure adaptation. Its core logic is to dynamically optimize the treatment plan based on the patient's real-time respiratory status: on the one hand, it receives data on the type of respiratory event and the degree of airflow limitation output by the respiratory event recognition module, using this as the trigger for switching ventilation modes; on the other hand, after switching to the target ventilation mode, it continuously tracks changes in the degree of airflow limitation and adjusts the two core pressure parameters, expiratory pressure and pressure support, accordingly to ensure that the pressure output is precisely matched with the patient's airway obstruction; where pressure support equals inspiratory pressure minus expiratory pressure.

[0026] Meanwhile, the module has a built-in pressure threshold determination mechanism. When the pressure parameter of the current ventilation mode has risen to the pressure threshold corresponding to that mode, but the airflow restriction degree still does not meet the airflow restriction threshold condition, the module will automatically start the progressive switching of the next level of ventilation mode to avoid the problem that a single mode or fixed pressure cannot relieve airway obstruction.

[0027] In one implementation, the ventilator control module employs a high-speed closed-loop feedback control architecture. It establishes real-time data interaction with the respiratory event recognition module and the ventilator monitoring module via a serial communication interface, with data transmission latency controlled within 20ms to ensure the immediacy of control actions. The module initially defaults to basic ventilation mode, with a preset initial expiratory pressure of 4 cmH2O and initial pressure support of 0 cmH2O. It also stores pressure thresholds corresponding to each ventilation mode, including the upper limit of pressure support, the upper limit of expiratory pressure, and the airflow limitation threshold. When a respiratory event signal is received from the respiratory event recognition module, the module immediately switches to the first-level ventilation mode and initiates a dynamic pressure parameter adjustment process. It assesses the adjustment needs based on the latest airflow limitation data. If the airflow limitation is not alleviated, the pressure support is increased incrementally, simultaneously comparing the current pressure support with the first pressure support threshold. If the airflow limitation still does not meet the airflow limitation threshold after the pressure support reaches the threshold, the module automatically switches to the second-level ventilation mode. In the second-stage ventilation mode, the focus of control is switched to expiratory pressure, and the expiratory pressure is gradually increased in a gradient while continuously monitoring the relief effect of airflow limitation. When the expiratory pressure rises to the first expiratory pressure threshold corresponding to this mode and the airflow limitation has not improved, the system is further switched to the third-stage ventilation mode.

[0028] The ventilator alarm module is used to monitor the status of the ventilator equipment and the patient's respiratory parameters. When the equipment malfunctions or the respiratory parameters exceed the preset safety range, alarm details are generated and an audible and visual alarm is triggered.

[0029] Specifically, the ventilator alarm module is the core of the entire pressure regulation system's safety assurance, undertaking the dual functions of monitoring equipment operation status and protecting patient treatment safety. Its core logic is to simultaneously monitor two key dimensions: first, the ventilator's core equipment status, covering the operation of critical components and systems affecting normal treatment; second, the patient's real-time respiratory parameters, namely airway pressure, tidal volume, and other parameters directly related to treatment effectiveness and patient vital signs. When any abnormality is detected in either dimension, including ventilator malfunction leading to inoperability, or patient respiratory parameters exceeding the preset safety range, the module simultaneously performs two key actions: first, it generates precise alarm details, clearly identifying the type of abnormality, the abnormal data value, and the time of occurrence, providing a clear basis for subsequent investigation and handling; second, it immediately triggers an audible and visual alarm, providing a direct sensory warning to promptly alert patients or medical staff to the abnormal situation, preventing treatment interruptions, poor efficacy, or even safety risks due to equipment malfunction or abnormal respiratory status, comprehensively ensuring the safety and reliability of the treatment process.

[0030] In summary, the system proposed in this application, which is based on switching modes and adjusting pressure according to respiratory events, accurately identifies three types of respiratory events—obstructive sleep apnea, hypoventilation, and airflow limitation—by real-time monitoring of multi-dimensional respiratory parameters such as airway pressure and tidal volume, and quantifies the degree of airflow limitation. It dynamically adjusts pressure parameters, monitors the device status and the safe range of respiratory parameters, and triggers audible and visual alarms. This system fundamentally solves the problems of inaccurate event identification and passive mode adaptation in existing devices, enabling precise and personalized positive pressure ventilation therapy.

[0031] Based on the aforementioned system for switching modes and adjusting pressure according to respiratory events, the following further elaborates on the complete technical details and implementation scheme of this system: Identifying a patient's respiratory events based on respiratory parameters, including: When the flow rate amplitude is less than the first amplitude threshold and the duration is greater than or equal to the duration threshold and the mean airway resistance is greater than or equal to the resistance threshold, the patient is determined to be in an obstructive sleep apnea state. When the flow rate is less than the second amplitude threshold and the duration is greater than or equal to the duration threshold, the patient is determined to be in a state of hypoventilation. Calculate the average of the differences between the maximum and minimum flow rates in the previous n respiratory cycles, obtain the ratio of the difference between the maximum and minimum flow rates in the current respiratory cycle to the average of the differences, and record it as the flatness. When the flatness is less than or equal to the flatness threshold, the patient is determined to be in a state of airflow limitation.

[0032] Specifically, the respiratory event recognition logic employs a multi-parameter collaborative verification and differentiated threshold matching design. By combining flow characteristics and duration in multiple dimensions, it accurately distinguishes three types of respiratory events, avoiding misjudgment by a single parameter or interference from random fluctuations: For obstructive sleep apnea, a flow amplitude less than the first amplitude threshold is a direct indication of near-complete airway obstruction, and a duration threshold can exclude instantaneous airflow fluctuations; both conditions are met simultaneously to ensure the rigor of the judgment. For hypoventilation, the second amplitude threshold is higher than the first amplitude threshold, and similarly, the duration threshold is used to exclude random cases, achieving accurate differentiation from obstructive sleep apnea. For airflow-restricted states, it focuses on the flow fluctuation characteristics of n inspiratory phases. By calculating the ratio of the extreme difference in flow during each inspiratory phase to the average extreme difference within the cycle, it quantifies the flatness of the flow waveform, capturing early restricted states where the airway partially collapses but has not yet reached the apnea or hypoventilation standard, achieving full-scenario coverage and accurate recognition of respiratory events.

[0033] The methods for calculating the degree of airflow restriction include: When a patient is in a state of obstructive sleep apnea, the degree of airflow restriction is equal to the mean airway resistance; When a patient is in a state of hypoventilation, the global flow amplitude under the patient's normal breathing state is used as a benchmark, and a reference threshold is obtained by combining the global amplitude ratio k. The difference between the flow amplitude and the reference threshold in each time window during the occurrence of hypoventilation is calculated, the mean of all differences is calculated, and the mean is multiplied by the duration of hypoventilation to obtain the degree of airflow restriction of hypoventilation. When a patient is in a state of airflow limitation, the degree of airflow limitation is equal to the degree of flatness.

[0034] Airway resistance is detected using FOT forced oscillation technology, and the average airway resistance is the average value of airway resistance during the FOT initiation period.

[0035] Specifically, the calculation method for the degree of airflow limitation adopts a quantitative design specific to the type of respiratory event. It matches a highly adaptable calculation logic to the core characteristic differences of the three types of respiratory events, ensuring that the quantitative results accurately reflect the actual airway obstruction.

[0036] For obstructive sleep apnea, the core characteristic is near-complete airway obstruction. Airway resistance is directly related to the severity of obstruction; therefore, using average airway resistance as a quantitative indicator of airflow limitation is both intuitive and accurate in reflecting the core pathological state of airway obstruction. Airway resistance is obtained through Forced Oscillation Therapy (FOT), a non-invasive, real-time airway resistance detection method. Its core principle involves a ventilator-embedded fan outputting a sinusoidal oscillation wave with specific parameters to the airway, accurately capturing airway mechanics. The oscillation wave is set to a standard waveform with a frequency of 2Hz and an amplitude of 0.5cmH2O. This parameter combination effectively penetrates the airway and reflects the true resistance without interfering with the patient's breathing. When the patient meets the preliminary criteria for obstructive sleep apnea, FOT technology automatically activates. Under the influence of the oscillation wave, a pressure sensor collects the real-time airway pressure change ΔP, and a flow sensor collects the corresponding airflow change ΔF. Then, based on the core airway resistance calculation formula R=ΔP / ΔF, the airway resistance value corresponding to a single oscillation is calculated cycle by cycle.

[0037] The FOT initiation period refers to the complete time from the initial identification of the obstructive sleep apnea event and the initiation of FOT technology to the patient's return to normal breathing and the cessation of FOT technology. This period is precisely synchronized with the duration of the apnea. The mean airway resistance is calculated by arithmetically averaging all airway resistance values ​​obtained cycle by cycle within this initiation period. Using the average value calculation method effectively eliminates accidental interference that may exist in a single oscillation, such as instantaneous airflow fluctuations, ensuring the stability and accuracy of the quantitative results. This accurately reflects the true severity of airway collapse in obstructive sleep apnea, providing a reliable quantitative basis for subsequent ventilation mode switching and pressure adjustment.

[0038] For hypoventilation, the essence is that the airflow partially decreases and persists. The calculation first uses the global flow amplitude of the patient's normal breathing as a benchmark, multiplies it by the global amplitude ratio k to determine the reference threshold that fits the patient, and then captures the dynamic changes of flow amplitude by dividing the time window. The mean of the difference reflects the average level of flow decrease, and multiplies it by the duration of hypoventilation to obtain the degree of airflow restriction in hypoventilation. This value comprehensively considers the degree of flow decrease and the continuous impact, and fully quantifies the severity of hypoventilation.

[0039] For airflow-restricted conditions, the core characteristic is a smooth flow waveform during the inhalation phase. Therefore, by continuing the inhalation cycle analysis dimension of the identification phase, the smoothness of flow fluctuations can be directly quantified by the ratio of the extreme difference of flow in each cycle to the average extreme difference within the cycle. The smaller the ratio, the more constrained the airflow is. This calculation method is highly consistent with the characteristics of airflow restriction and can accurately capture the degree of restriction of early airway partial collapse.

[0040] In one implementation, the first amplitude threshold is set to 10% of the normal amplitude, and the duration threshold is set to 10 seconds; when the patient's flow amplitude is detected to drop to 10% or less of the normal amplitude and the duration is greater than or equal to 10 seconds, the patient is determined to be in an obstructive sleep apnea state.

[0041] The second amplitude threshold is set to 50% of the normal amplitude; when the patient's flow amplitude is detected to drop to 50% or below the normal amplitude, but is higher than 10% of the normal amplitude, and the duration is greater than or equal to 10 seconds, the patient is determined to be in a state of hypoventilation.

[0042] Qualitatively, a specific flow waveform indicates airway collapse to some extent, signifying airflow limitation. Quantitatively, the average difference between the maximum and minimum flow rates during the inspiratory phase over n respiratory cycles is calculated. This average difference is then divided by the average difference for each cycle to obtain a ratio q. The ratio q represents the flatness of the flow waveform during each inspiratory phase; a smaller q indicates a flatter waveform and more severe airflow limitation. If the flatness q during the current inspiratory phase is less than or equal to a flatness threshold, the patient is considered to be in a state of airflow limitation.

[0043] After identifying a respiratory event, this application proposes a method for sequentially switching between multiple ventilation modes; wherein the ventilation modes include bilevel positive airway pressure with pressure support of 0 cmH2O, bilevel positive airway pressure with pressure support of non-0 cmH2O, and trilevel positive airway pressure.

[0044] The pressure support for dual-level positive airway pressure (PEAP) with non-0 cmH2O also includes two waveforms: a sine wave mode and a square wave mode; among them, the inspiratory pressure rises faster in the square wave mode than in the sine wave mode. Triple-level positive airway pressure (TPAP) is based on bilevel positive airway pressure (PBAP) but adds pressure unloading at the end of expiration. Pressure unloading refers to the regulatory action of reducing airway pressure compared to the expiratory pressure corresponding to the bilevel positive airway pressure mode.

[0045] The switching of ventilation modes follows a preset progressive order, and the switching trigger conditions are related to respiratory events and the relief effect of airflow limitation. The switching logic is as follows: The system initially defaults to a dual-level positive airway pressure (DLP) mode with a pressure support of 0 cmH2O. When a respiratory event is detected, it switches to a sine wave mode with a DLP mode that supports pressure support other than 0 cmH2O, and gradually increases the pressure support. During the gradual increase of pressure support, the airflow limitation of the respiratory event is compared with the corresponding airflow limitation threshold. If the airflow limitation of the respiratory event still does not meet the corresponding airflow limitation threshold after the pressure support is increased to the first pressure support limit, the system switches to a square wave mode. In square wave mode, the expiratory pressure is increased step by step. If the airflow limitation of the respiratory event still does not meet the corresponding airflow limitation threshold when the first expiratory pressure is increased to the upper limit, then switch to three-level positive airway pressure. If the patient resumes normal breathing during any breathing mode switch or pressure parameter adjustment, reduce pressure support or expiratory pressure.

[0046] Specifically, the ventilation modes and subdivided waveforms proposed in this application each have their own suitable scenarios, forming a gradient switching system. The initial default pressure support of 0 cmH2O in the Bilevel Positive Airway Pressure (PBAP) mode is the basic mode, with inspiratory and expiratory pressures output according to preset fixed values. This mode is suitable for scenarios without respiratory events or with mild respiratory limitation, ensuring basic ventilation while minimizing respiratory burden. The PBAP mode with pressure support other than 0 cmH2O is a mode for further intervention in patient breathing. In the sine wave mode, the inspiratory pressure rises linearly and smoothly, with a gentle pressure increase, suitable for moderate airflow limitation and also for... For scenarios requiring high breathing comfort, the square wave mode offers a faster inspiratory pressure rise, quickly reaching the target inspiratory pressure and effectively increasing tidal volume, making it suitable for moderate to severe respiratory limitation requiring enhanced ventilatory support. The Tri-Level Positive Airway Pressure (TPAP) mode is a further optimized mode, adding an end-expiratory pressure unloading design to the inspiratory and expiratory pressures of the Bi-Level Positive Airway Pressure (PBAP) mode. Compared to the expiratory pressure of the Bi-Level mode, the end-expiratory pressure is appropriately reduced, preserving sufficient airway support to alleviate severe obstruction while reducing the pressure burden during exhalation, thus solving the problem of expiratory discomfort under high-pressure support.

[0047] The switching process is initially triggered by determining the presence of three types of respiratory events, with the relief of airflow limitation as the core criterion. The mode is switched in a fixed order to ensure the targeted nature and safety of the intervention.

[0048] In one implementation, the ventilator initially operates in a dual-level positive airway pressure (PBAP) mode with a default pressure support of 0 cmH2O and a preset initial expiratory pressure of 4 cmH2O. When any respiratory event, such as obstructive sleep apnea, hypoventilation, or airflow limitation, is detected, the system immediately switches to a sine wave mode and increases pressure support in increments of 1 cmH2O, up to a maximum of 3 cmH2O. During each pressure adjustment, the degree of airflow limitation is compared with the corresponding airflow limitation threshold in real time. If the limitation is not relieved after the pressure support reaches the upper limit, indicating that the calculated degree of airflow limitation for the corresponding event does not match its airflow limitation threshold, it means that gentle pressure increase is no longer sufficient, and the system switches to a square wave mode with faster pressure increase.

[0049] After entering square wave mode, the focus of control shifts to expiratory pressure. The expiratory pressure is gradually increased in increments of 1 cmH2O until it reaches 8 cmH2O, which is the first upper limit of expiratory pressure. This further alleviates obstruction by enhancing basic airway support. If the restriction does not improve at this upper limit, it indicates that expiratory comfort needs to be optimized while strengthening support. Then, switch to three-level positive airway pressure mode.

[0050] In the three-level positive airway pressure mode, the expiratory pressure can be increased in increments of 1 cmH2O, up to a maximum of 12 cmH2O, while maintaining the end-expiratory pressure unloading function. This ensures that while high-pressure support relieves severe obstruction, the patient does not experience significant respiratory burden during exhalation, thus avoiding respiratory resistance caused by excessive pressure.

[0051] It should be noted that pressure support equals inspiratory pressure minus expiratory pressure. When adjusting pressure support, the expiratory pressure remains constant while the inspiratory pressure is changed; when adjusting expiratory pressure, the pressure support remains constant while the inspiratory pressure is adjusted.

[0052] The entire switching and parameter adjustment process is not a one-way upgrade, but forms a closed loop from intervention, feedback to adjustment. After switching to any mode or during pressure parameter adjustment, the device continuously monitors the patient's respiratory parameters. If the airflow returns to normal and the degree of airflow restriction meets the corresponding threshold conditions for multiple consecutive respiratory cycles, it indicates that the current intervention intensity is excessive. The pressure support or expiratory pressure will be lowered in the gradient. If breathing is still normal after the pressure returns to the initial value of the corresponding mode, the device will switch back to the previous ventilation mode until it returns to the initial default mode. This avoids discomfort caused by excessive pressure and can dynamically adapt to the fluctuations in the patient's respiratory status.

[0053] This application also provides a pressure regulation method based on respiratory event switching modes, such as... Figure 2 As shown, it includes: Monitor the patient's respiratory parameters, including airway pressure, tidal volume, inspiratory time, airway resistance, and flow rate; The respiratory events of a patient are identified and the degree of airflow limitation is calculated based on respiratory parameters, including obstructive sleep apnea, hypoventilation, and airflow limitation. The ventilation mode is triggered based on the patient's respiratory events. The ventilation mode is switched in a preset progressive order based on the degree of airflow limitation in the ventilation mode, and the pressure parameters are dynamically adjusted. Monitor the status of the ventilator and the patient's respiratory parameters. When the equipment malfunctions or the respiratory parameters exceed the preset safety range, generate alarm details and trigger an audible and visual alarm.

[0054] An electronic device, comprising: One or more processors; Memory, used to store one or more programs; When the one or more programs are executed by one or more processors, the one or more processors implement a system based on respiratory event switching modes and pressure regulation.

[0055] The above embodiments are merely illustrative of the technical concept and features of the present invention, intended to enable those skilled in the art to understand the content of the present invention and implement it accordingly, and should not be construed as limiting the scope of protection of the present invention. It will be apparent to those skilled in the art that the present invention is not limited to the details of the above exemplary embodiments, and that the present invention can be implemented in other specific forms without departing from the spirit or essential characteristics of the present invention. Therefore, the embodiments should be considered exemplary and non-limiting in all respects. The scope of the present invention is defined by the appended claims rather than the foregoing description, and thus all changes falling within the meaning and scope of the equivalents of the claims are intended to be included within the present invention.

Claims

1. A system for switching modes and regulating pressure based on respiratory events, characterized in that, include: The ventilator monitoring module is used to monitor the patient's respiratory parameters in real time, including airway pressure, tidal volume, inspiratory time, airway resistance, and flow rate. The respiratory event recognition module is used to identify the patient's respiratory events and calculate the degree of airflow limitation based on respiratory parameters. The respiratory events include obstructive sleep apnea, hypoventilation, and airflow limitation. The ventilator control module is used to trigger ventilation modes based on the patient's respiratory events, switch ventilation modes in a preset progressive order based on the degree of airflow limitation in the ventilation mode, and dynamically adjust pressure parameters. The ventilator alarm module is used to monitor the status of the ventilator equipment and the patient's respiratory parameters. When the equipment malfunctions or the respiratory parameters exceed the preset safety range, alarm details are generated and an audible and visual alarm is triggered.

2. The system for switching modes and adjusting pressure based on respiratory events according to claim 1, characterized in that, The method of identifying a patient's respiratory events based on respiratory parameters includes: When the flow rate amplitude is less than the first amplitude threshold and the duration is greater than or equal to the duration threshold and the mean airway resistance is greater than or equal to the resistance threshold, the patient is determined to be in an obstructive sleep apnea state. When the flow rate is less than the second amplitude threshold and the duration is greater than or equal to the duration threshold, the patient is determined to be in a state of hypoventilation. Calculate the average of the differences between the maximum and minimum flow rates in the previous n respiratory cycles, obtain the ratio of the difference between the maximum and minimum flow rates in the current respiratory cycle to the average of the differences, and record it as the flatness. When the flatness is less than or equal to the flatness threshold, the patient is determined to be in a state of airflow limitation.

3. The system for switching modes and adjusting pressure based on respiratory events according to claim 2, characterized in that, Methods for calculating the degree of airflow restriction include: When a patient is in a state of obstructive sleep apnea, the degree of airflow restriction is equal to the mean airway resistance. When a patient is in a state of hypoventilation, the global flow amplitude under the patient's normal breathing state is used as a benchmark, and a reference threshold is obtained by combining the global amplitude ratio k. The difference between the flow amplitude and the reference threshold in each time window during the occurrence of hypoventilation is calculated, the mean of all differences is calculated, and the mean is multiplied by the duration of hypoventilation to obtain the degree of airflow restriction of hypoventilation. When a patient is in a state of airflow limitation, the degree of airflow limitation is equal to the flatness.

4. The system for switching modes and adjusting pressure based on respiratory events according to claim 3, characterized in that, Airway resistance is detected using FOT forced oscillation technology, and the average airway resistance is the average value of airway resistance during the FOT start-up period.

5. The system for switching modes and adjusting pressure based on respiratory events according to claim 1, characterized in that, The ventilation modes include bilevel positive airway pressure with pressure support of 0 cmH2O, bilevel positive airway pressure with pressure support other than 0 cmH2O, and trilevel positive airway pressure.

6. A system for switching modes and adjusting pressure based on respiratory events according to claim 5, characterized in that, The pressure support for dual-level positive airway pressure (non-0 cmH2O) includes two waveforms: a sine wave mode and a square wave mode; the inspiratory pressure rises faster in the square wave mode than in the sine wave mode. The Tri-Level Positive Airway Pressure (TPAP) is based on Bi-Level Positive Airway Pressure (PBAP), with added pressure unloading at the end of expiration. Pressure unloading refers to the adjustment action of reducing airway pressure compared to the expiratory pressure corresponding to the Bi-Level Positive Airway Pressure (PBAP) mode.

7. The system for switching modes and adjusting pressure based on respiratory events according to claim 1, characterized in that, The switching of the ventilation mode follows a preset progressive order, and the switching trigger condition is related to the respiratory event and the relief effect of airflow limitation. The switching logic is as follows: The system initially defaults to a dual-level positive airway pressure (DLP) mode with a pressure support of 0 cmH2O. When a respiratory event is detected, it switches to a sine wave mode with a DLP mode that supports pressure support other than 0 cmH2O, and gradually increases the pressure support. During the gradual increase of pressure support, the airflow limitation of the respiratory event is compared with the corresponding airflow limitation threshold. If the airflow limitation of the respiratory event still does not meet the corresponding airflow limitation threshold after the pressure support is increased to the first pressure support limit, the system switches to a square wave mode. In square wave mode, the expiratory pressure is increased step by step. If the airflow limitation of the respiratory event still does not meet the corresponding airflow limitation threshold when the first expiratory pressure is increased to the upper limit, then switch to three-level positive airway pressure. If the patient resumes normal breathing during any breathing mode switch or pressure parameter adjustment, reduce pressure support or expiratory pressure.

8. A pressure regulation method based on respiratory event switching modes, characterized in that, include: Monitor the patient's respiratory parameters, including airway pressure, tidal volume, inspiratory time, airway resistance, and flow rate; The respiratory events of a patient are identified and the degree of airflow limitation is calculated based on respiratory parameters, including obstructive sleep apnea, hypoventilation, and airflow limitation. The ventilation mode is triggered based on the patient's respiratory events. The ventilation mode is switched in a preset progressive order based on the degree of airflow limitation in the ventilation mode, and the pressure parameters are dynamically adjusted. Monitor the status of the ventilator and the patient's respiratory parameters. When the equipment malfunctions or the respiratory parameters exceed the preset safety range, generate alarm details and trigger an audible and visual alarm.

9. An electronic device, characterized in that: The electronic device includes: One or more processors; Memory, used to store one or more programs; When the one or more programs are executed by the one or more processors, the one or more processors implement a system based on respiratory event switching modes and pressure regulation as described in any one of claims 1-7.

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