A medical ventilator system

Abstract

The application provides a medical breathing machine system for supporting ventilation in radiotherapy, wherein the breathing machine adopts a support ventilation PSV mode; in a preparation mode, breathing machine parameters are fine-tuned based on a monitored breathing curve and a physiological parameter curve of a target object; when a master control module determines that the breathing machine parameters remain unchanged within a preset period of time up to the present and that a first preset condition is met, a target breathing machine parameter is determined; in an imaging / treatment mode, the master control module judges whether a start imaging / radiation condition is met; if yes, a start imaging / radiation trigger signal is sent, and if not, a start imaging / radiation trigger signal is not sent, and a hold breath instruction is sent to the breathing machine; during the breath holding period, the master control module continues to judge whether imaging / radiation needs to be stopped; if yes, a stop imaging / radiation trigger signal is sent, and a hold breath instruction is sent to the breathing machine.

Description

Technical Field

[0001] This application relates to the field of medical ventilator systems, and more specifically, to medical ventilator systems for supporting ventilation. Background Technology

[0002] Deep Inspiration Breath Hold (DIBH) is a newly developed radiotherapy technique primarily used in the radiotherapy of breast cancer, lung cancer, and esophageal cancer. During deep inspiration, the expansion of the thoracic cavity and lungs causes the diaphragm to shift downwards, shifting the center of gravity of the heart to the lower right. This not only increases the distance between the target tumor and the heart, significantly reducing the radiation dose to the heart, but also reduces the irradiation area of ​​the lung tissue. Furthermore, by allowing the patient to hold their breath during deep inspiration, respiratory movements can be reduced or eliminated, thereby improving the precision of radiotherapy.

[0003] Currently, an Active Breathing Coordinator (ABC) device can be used, which includes a mouthpiece and an airflow valve. This airflow valve periodically closes at specific points during the patient's respiratory cycle to prevent airflow into or out of the patient, thus achieving breath-holding. The target tumor can then be irradiated while it is immobilized during breath-holding, after which the airflow valve can be opened and breathing can be resumed.

[0004] In active breathing control (ABC) technology, the patient is instructed to bite down on the breathing tube and actively inhale deeply. The machine then assists the patient in holding their breath, temporarily preventing them from inhaling or exhaling. During this process, the machine does not provide support ventilation but rather helps the patient maintain a breath-holding state to allow for more precise radiotherapy.

[0005] However, patients with lung-related diseases or those who are physically weak often find it difficult to achieve a stable breath-holding state on their own. Therefore, there is a need to design a medical ventilator system to support ventilation and assist patients in achieving a stable, reliable, and satisfactory breath-holding pattern. Summary of the Invention

[0006] To address the shortcomings of existing technologies, this application proposes a medical ventilator system for supporting ventilation in radiotherapy.

[0007] In existing technologies, ventilators mainly employ two support ventilation modes: pressure support ventilation (PSV) and volume support ventilation (VSV). In PSV, the ventilator is triggered with each respiratory effort. Volume support ventilation regulates the volume of gas exhaled per breath, i.e., tidal volume (TV). While it allows physicians to precisely control the patient's breathing, patients may experience discomfort or discomfort with this fixed ventilation mode. PSV, on the other hand, is a positive pressure mechanical ventilation mode. It is triggered with each breath during respiratory effort. At the onset of inspiration, the ventilator begins delivering air, rapidly raising the airway pressure to a preset value and maintaining it at that level. This ventilation mode is more comfortable for patients and helps them achieve a stable and reliable breath-hold during radiotherapy.

[0008] Therefore, the ventilator in this application is configured to use pressure support ventilation (PSV) mode and integrates deep inspiratory breath-hold (DIBH) control function to provide support ventilation for the target subject and assist the target subject in achieving stable deep inspiratory breath-hold.

[0009] Pressure support ventilation (PSV) is suitable for subjects with spontaneous breathing ability. In PSV mode, the ventilator provides preset pressure support to help the subject inspirate, thereby reducing respiratory burden and improving ventilation. PSV mode relies on the patient's inspiratory effort to trigger the ventilator. When the subject's inspiratory effort reaches the preset trigger sensitivity, the ventilator begins delivery. Once triggered, the ventilator provides preset pressure support to help the subject overcome airway resistance and the elastic resistance of lung tissue. When the ventilator begins delivery, it delivers air to the subject's lungs at the set pressure, and this support pressure continues until the end of inspiration. Typically, when the subject's expiratory effort reaches the preset trigger sensitivity, the ventilator recognizes the start of expiration and switches to the expiratory phase. At this time, the ventilator maintains a certain positive end-expiratory pressure (PEEP) to keep the airway open and reduce the risk of alveolar collapse.

[0010] When the ventilator detects that the target subject is making a deep inhalation effort and monitors that the target subject's breath-holding amplitude has reached the preset value, the ventilator activates the deep inhalation breath-holding (DIBH) control function, the ventilator stops delivering air, and the target subject enters a breath-holding state. When the preset breath-holding duration is reached, the ventilator automatically releases the breath-holding control, and the target subject resumes free breathing.

[0011] The ventilator system includes at least: a ventilator, a main control module, a respiratory sensor, a physiological parameter sensor, a terminal monitor, a user remote control, a deep learning model, and a respiratory guidance module.

[0012] The main control module connects to the ventilator, respiratory sensors, physiological parameter sensors, user remote control, terminal monitor, deep learning model, and respiratory guidance module. It receives parameter feedback or input from each module and, through internally preset control logic, outputs control commands to each module, thereby controlling the operation of the entire system. The main control module can be composed of a processor, which executes programs to implement its control functions.

[0013] The ventilator system includes multiple operating modes, including at least a preparation mode, an imaging mode, and a treatment mode. The mode switching unit in the main control module controls the ventilator system to switch operating modes. The different operating modes will be described in detail below.

[0014] (1) Preparation mode

[0015] The operating steps of the ventilator system in preparation mode are as follows:

[0016] Step S6: The ventilator supports ventilation and deep inhalation breath-hold control for the target subject based on the initial values ​​of the ventilator parameters sent by the main control module or the configuration of the ventilator parameters saved before the last pause of the ventilator. The medical staff sends ventilator parameter adjustment instructions to the main control module based on the real-time respiratory curve and physiological parameter curve of the target subject.

[0017] Step S7: When the main control module determines that the ventilator parameters remain unchanged within the current preset period and monitors that the respiratory curve within the current preset period meets the first preset condition, the ventilator parameters at this time are determined as the target ventilator parameters.

[0018] Step S8: The main control module determines the respiratory guidance curve based on the respiratory curve within the preset period up to the present, and sends a command to end the respiratory signal acquisition.

[0019] (2) Imaging mode

[0020] After completing the preparation mode, you can enable the imaging mode.

[0021] The operating steps of the ventilator system in imaging mode are as follows:

[0022] Step S9: The ventilator performs supportive ventilation and deep inspiratory breath-hold control for the patient based on the configuration of the target ventilator parameters. The main control module controls the respiratory guidance module to generate a respiratory guidance curve in real time and displays the real-time respiratory curve at the same time.

[0023] Step S10: When the main control module receives the signal that the target object has started holding its breath, it determines whether the conditions for starting imaging are met.

[0024] Step S11: If the conditions for starting imaging are met, send a trigger signal to start imaging and proceed to step S13.

[0025] Step S12: If the conditions for starting imaging are not met, the main control module will not send a trigger signal to start imaging, and will simultaneously send a pause breath-holding command to the ventilator, and return to step S9.

[0026] Step S13: During the breath-holding period, the main control module continues to determine whether imaging needs to be stopped;

[0027] Step S14: If it is determined that imaging needs to be stopped, a stop imaging trigger signal is sent to the imaging device, and a pause breath-holding command is sent to the ventilator at the same time, and the process returns to step S9;

[0028] Step S15: If it is determined that imaging does not need to be stopped, the ventilator will pause the breath-hold control after reaching the target breath-hold duration. When the imaging device starts imaging, the imaging device can determine the time to stop irradiation based on the breath-hold duration. That is, when the irradiation reaches the breath-hold duration, the imaging device will automatically stop imaging.

[0029] Repeat steps S9-S15 until the imaging device acquires a sufficient number of diagnostic images.

[0030] (3) Treatment Mode

[0031] Step S16: Same as step S9 in imaging mode;

[0032] Step S17: When the main control module receives the signal that the target object has started holding its breath, it determines whether the irradiation conditions are met.

[0033] Step S18: If the irradiation conditions are met, send a trigger signal to start irradiation and proceed to step S20;

[0034] Step S19: If the irradiation conditions are not met, the main control module will not send a trigger signal to start irradiation, and will simultaneously send a pause breath-hold command to the ventilator, returning to step S16;

[0035] Step S20: During the breath-holding period, the main control module continues to determine whether it is necessary to stop the irradiation urgently.

[0036] Step S21: If it is determined that irradiation needs to be stopped, a stop irradiation trigger signal is sent to the treatment device, and a pause breath-holding command is sent to the ventilator at the same time, and the process returns to step S16;

[0037] Step S22: If it is determined that irradiation does not need to be stopped, the ventilator will pause breath-hold control after reaching the target breath-hold duration. After the radiotherapy equipment starts irradiation, it can determine the time to stop irradiation based on the breath-hold duration; that is, when the irradiation reaches the breath-hold duration, the radiotherapy equipment will automatically stop irradiation.

[0038] Repeat steps S16-S22 until the current radiotherapy session is completed.

[0039] The beneficial effects of this application are as follows: 1. This application provides a medical ventilator system for supporting ventilation in radiotherapy, which provides supportive ventilation and deep inspiratory breath-hold control for the target subject. The ventilator adopts pressure support ventilation (PSV) mode, and the number of free breaths between deep inspiratory breath-holds can be autonomously adjusted by the target subject according to their own condition. The target subject can more comfortably reproduce the breath-holding mode, improving the user experience. Furthermore, based on a deep learning model and the fine-tuning of ventilator parameters by medical staff, suitable ventilator parameters are determined for the target subject, thereby assisting target subjects with lung-related diseases or physical weakness to achieve a stable, reliable, and satisfactory breath-holding mode.

[0040] 2. This application establishes a correlation between a tumor model, including the tumor location, and breath-holding pattern signals through imaging. Therefore, it enables respiratory gating of the radiotherapy equipment's irradiation based on real-time respiratory curves during radiotherapy. Furthermore, the ventilator system can determine whether its breath-holding state meets requirements based on the judgment criteria provided by the target respiratory pattern curve and the real-time monitored respiratory curve, thereby further determining whether to trigger imaging / irradiation. As a result, the radiation delivered by the radiotherapy equipment can be more accurately delivered to the target tumor rather than healthy surrounding tissue, ensuring the safety and effectiveness of the treatment.

[0041] Furthermore, considering that deep inhalation and breath-holding under a stable respiratory state is more conducive to reproducing a stable target breath-holding pattern, when determining whether the breath-holding state meets the requirements, the difference between the free breathing curve segment in the breath-holding cycle curve of the current respiratory curve and the free breathing pattern curve under a stable state in the respiratory guidance curve is also considered to ensure that a stable and reliable breath-holding state can be achieved subsequently, thereby reducing the possibility of terminating imaging / irradiation due to the breath-holding state not meeting the requirements after starting imaging / irradiation.

[0042] 3. Based on the respiratory curves collected in preparation mode, determine the respiratory guidance curve of the target object to ensure that the target object can see its own real-time respiratory curve and respiratory guidance curve, grasp the difference between its own respiratory state and the respiratory guidance curve in real time, and adjust its respiratory state in a timely manner to synchronize with the respiratory guidance curve as much as possible, thereby guiding the target object to better reproduce a stable respiratory state and breath-holding state. Attached Figure Description

[0043] Figure 1 This is a schematic diagram of a medical ventilator system used to support ventilation in radiotherapy, according to an embodiment of this disclosure.

[0044] Figure 2 This is a schematic diagram of the ventilator structure according to an embodiment of the present disclosure.

[0045] Figure 3 This is a flowchart of the operation steps of the ventilator system in the preparation mode according to an embodiment of the present disclosure.

[0046] Figure 4 This is a schematic diagram of the breath-holding period curve of an embodiment of this disclosure.

[0047] Figure 5 This is a flowchart of the operation steps of the ventilator system in imaging mode according to an embodiment of the present disclosure.

[0048] Figure 6 This is a flowchart of the operation steps of the ventilator system in treatment mode according to an embodiment of the present disclosure. Detailed Implementation

[0049] The present application will be further described below with reference to the accompanying drawings. The following embodiments are only used to more clearly illustrate the technical solutions of the present invention, and should not be construed as limiting the scope of protection of the present application.

[0050] Figure 1 The illustration schematically shows a medical ventilator system 100 for supporting ventilation in radiotherapy according to an embodiment of this application, which includes at least: a ventilator 12, a main control module 10, a respiratory sensor 14, a physiological parameter sensor 24, a terminal monitor 28, a user remote control 26, a deep learning model 22, and a respiratory guidance module 16.

[0051] The respiratory sensor 14 obtains the patient's respiratory rhythm signal through the rise and fall of the abdomen and / or chest, and is used to monitor the real-time respiratory curve of the target object; preferably, the respiratory sensor 14 can adopt pressure sensor technology or body surface marker-based technology.

[0052] The physiological parameter sensor 24 is used to provide feedback on the physiological state of the target object, and includes at least a heart rate sensor and a blood oxygen sensor. Optionally, the heart rate sensor may be an electrocardiogram (ECG) sensor and the blood oxygen sensor may be a pulse oximeter.

[0053] like Figure 2 As shown, the ventilator 12 includes a control unit 56, an air supply device 54, and a respiratory effort monitoring module 58. The ventilator 12 adopts pressure support ventilation (PSV) mode. Furthermore, the ventilator 12 is connected to a respiratory sensor 14 and receives real-time respiratory curve information sent by the respiratory sensor 14.

[0054] Preferably, the breathing effort monitoring module 58 can be a pressure sensor or a flow sensor, wherein the pressure sensor assesses the patient's breathing effort by monitoring changes in the airway pressure in the trachea, and the flow sensor is used to monitor the gas flow in the airway in the trachea.

[0055] The operating steps of the ventilator 12 in providing support ventilation and deep inhalation / breath-holding functions to the target subject are as follows:

[0056] Step S1: In the ventilation mode supported by the ventilator 12, the respiratory effort monitoring module 58 sends the detected respiratory effort signal of the target object to the control unit 56 in the ventilator 12 to determine whether the current inspiratory effort is a normal inspiratory effort or a deep inspiratory effort. If it is determined to be a normal inspiratory effort, proceed to step S2; if it is determined to be a deep inspiratory effort, proceed to step S3.

[0057] Step S2: Control unit 56 controls air supply device 54 to start delivering air at a set support pressure; when control unit 56 detects the expiratory effort of the target object, the expiratory phase begins, and control unit 56 controls air supply device 54 to maintain the set positive end-expiratory pressure (PEEP) to keep the airway open and reduce the risk of alveolar collapse.

[0058] Return to step S1;

[0059] Optionally, the current inhalation effort can be determined as a normal inhalation effort or a deep inhalation effort based on the rate of change of inhalation pressure / flow rate. If the rate of change of inhalation pressure / flow rate is lower than a set threshold, it is determined as a normal inhalation effort; if the rate of change of inhalation pressure / flow rate is higher than the set threshold, it is determined as a deep inhalation effort.

[0060] Step S3: If it is determined to be a deep inhalation effort, the control unit 56 controls the air supply device 54 to start delivering air at the set support pressure. The control unit 56 receives the respiratory curve sent by the respiratory sensor 14. When the respiratory curve information shows that the amplitude of this deep inhalation has reached the target breath-hold amplitude, the ventilator 12 switches to the deep inhalation and breath-hold DIBH control mode, and the control unit 56 controls the air supply device 54 to stop delivering air. At this time, the target subject enters the breath-hold state. When the breath-hold duration is reached, the control unit 56 controls the air supply device 54 to release the breath-hold control, the ventilator 12 switches to the support ventilation mode, and the target subject resumes free breathing. At this time, the subject first enters the exhalation phase, and the control unit 56 controls the air supply device 54 to maintain the set positive end-expiratory pressure (PEEP). Return to step S1.

[0061] The support ventilation mode is defined as follows: when the target subject's inspiratory effort is detected, the ventilator 12 starts to deliver air at a set support pressure, and when the target subject's expiratory effort is detected, the ventilator 12 maintains the set positive end-expiratory pressure (PEEP).

[0062] The deep inhalation and breath-holding (DIBH) control mode is defined as the ventilator 12 controlling the air supply device 54 to stop supplying air, at which point the target object enters a breath-holding state until the preset breath-holding duration is reached.

[0063] Therefore, the ventilator 12 can provide support ventilation for the target subject and assist the target subject in achieving stable deep inhalation and breath-holding.

[0064] The air supply device 54 in the ventilator 12 can be implemented according to known technologies, so its detailed structure will not be described in this embodiment.

[0065] In this embodiment, the ventilator adopts the pressure support ventilation (PSV) mode. The number of free breaths between deep inhalation and breath-holding can be autonomously adjusted by the target subject according to their own state. The target subject can more comfortably reproduce the breath-holding mode, thus improving the user experience.

[0066] like Figure 1 As shown, the main control module 10 is connected to the ventilator 12, respiratory sensor 14, physiological parameter sensor 24, user remote control 26, terminal monitor 28, deep learning model 22, and respiratory guidance module 16. It receives parameter feedback or input from each module and outputs control commands to each module through internally preset control logic, thereby controlling the operation of the entire system. The main control module 10 includes at least a mode switching unit 48, a storage unit 52, and a ventilator parameter setting unit 46. The main control module 10 can be composed of a processor, which executes programs to implement its control functions.

[0067] The storage unit 52 in the main control module 10 acquires and stores the real-time respiratory curve information sent by the respiratory sensor 14 and the physiological parameter curve information sent by the physiological parameter sensor 24.

[0068] The terminal monitor 28 inputs relevant values ​​including safety conditions, a first preset range, a second preset range, a first threshold, a second threshold, a third threshold, and a preset period (details are explained below), and transmits them to the storage unit 52 in the main control module 10 for use by the main control module 10 during operation.

[0069] The ventilator system 100 includes multiple working modes, including at least a preparation mode, an imaging mode, and a treatment mode. The mode switching unit 48 in the main control module 10 controls the ventilator system 100 to switch working modes. The different working modes will be described in detail below.

[0070] Before the ventilator system 100 officially starts various working modes, there is also a preliminary data acquisition phase to determine the initial values ​​of the ventilator parameters. The preliminary data acquisition phase includes the following steps:

[0071] Step S4: The main control module 10 acquires the respiratory curve and physiological parameter curve of the target object under spontaneous breathing state, and determines the baseline of the target object's spontaneous breathing parameters and physiological parameters;

[0072] In this embodiment, the respiratory sensor 14 continuously collects respiratory curve signals from the target object during spontaneous breathing and sends them to the storage unit 52 in the main control module 10. The spontaneous breathing state refers to the breathing state of the target object without using any assisted ventilation or breath-hold control devices. The respiratory parameter determination unit 32 acquires the respiratory curve information from the storage unit 52 and determines the target object's spontaneous breathing parameters through data processing. These parameters include respiratory rate, respiratory amplitude, inspiratory-to-expiratory ratio, deep inspiratory breath-hold amplitude, and breath-hold duration. The data processing method can employ various known techniques, such as determining the average or median waveform from the respiratory curve data after outlier cleaning, thereby determining the spontaneous breathing parameters.

[0073] Furthermore, the main control module 10 also includes a baseline determination unit 34. Synchronously with the acquisition of the respiratory curves of the target object under spontaneous breathing conditions, the physiological parameter sensor 24 sends the continuously acquired physiological parameter curve signals of the target object to the storage unit 52 in the main control module 10. The physiological parameter curve signals include heart rate signals and blood oxygenation signals. The baseline determination unit 34 acquires the physiological parameter curve signals from the storage unit 52, determines the physiological parameter baseline, which includes the heart rate signal baseline and the blood oxygenation signal baseline, and sends them to the storage unit 52 as the baseline for subsequent comparison with the real-time acquired physiological parameter curves. The physiological parameter baseline signal can be a numerical and / or waveform signal.

[0074] Step S5: The main control module 10 transmits the autonomous breathing parameters, the acquired target object information, and the target breath-holding amplitude to the trained deep learning model 22, outputs the ventilator-related parameters, and determines the initial values ​​of the ventilator parameters in combination with the target breath-holding amplitude.

[0075] Specifically, the target object information and target breath-holding amplitude are input through the terminal monitor 28 and transmitted to the storage unit 52 in the main control module 10. The breathing parameter determination unit 32 retrieves the target object information and target breath-holding amplitude from the storage unit 52, sends the target object information, target breath-holding amplitude and the breathing parameters to the trained deep learning model 22, outputs the ventilator-related parameters, and transmits them to the ventilator parameter setting unit 46.

[0076] The ventilator-related parameters output by the deep learning model 22 include support pressure, trigger sensitivity, end-expiratory pressure (PEEP), pressure rise time, and breath-hold duration. Of course, the ventilator 12's settings should also include the target breath-hold amplitude. Therefore, the ventilator parameter setting unit 46 obtains the target breath-hold amplitude from the storage unit 52 and, together with the ventilator-related parameters output by the deep learning model 22, determines the initial values ​​of the ventilator parameters.

[0077] The target information includes basic information and health status information. The patient's basic information includes at least gender, age, weight, height, and occupation; the health status information includes at least tumor type, tumor severity, lung capacity, and cardiovascular function.

[0078] Of course, as is well known to those skilled in the art, the target breath-holding amplitude required during treatment can be determined through preliminary diagnostic imaging of the target object.

[0079] Optionally, the terminal monitor 28 can obtain target object information and target breath-holding amplitude information by manual input or by connecting to a database through a communication interface to access the data.

[0080] Further optionally, the deep learning model 22 is a pre-trained neural network model, preferably constructed using a convolutional neural network (CNN) algorithm.

[0081] Once the initial values ​​of the ventilator parameters are determined, the preparation mode can be activated.

[0082] (1) Preparation mode

[0083] When the preparation mode is enabled, the mode switching unit 48 in the main control module 10 controls the ventilator system 100 to switch to the preparation mode. In the preparation mode, the operating function units in the main control module 10 include a ventilator control unit 38, a breathing mode determination unit 36, a storage unit 52, and a ventilator parameter setting unit 46.

[0084] like Figure 3 As shown, the operating steps of the ventilator system 100 in the preparation mode are as follows:

[0085] Step S6: The ventilator 12 supports ventilation and deep inhalation breath-hold control for the target subject based on the initial values ​​of the ventilator parameters sent by the main control module 10 or the configuration of the ventilator parameters saved before the last pause of the ventilator 12. The medical staff sends ventilator parameter adjustment instructions to the main control module 10 based on the real-time respiratory curve and physiological parameter curve of the target subject.

[0086] Although deep learning models22 can process large amounts of data and learn patterns, each patient is unique and may exhibit individual differences. Therefore, the ventilator parameters output by the model need to be manually adjusted to better suit the patient's specific situation, thereby ensuring the safety and effectiveness of ventilator-assisted ventilation for the target population.

[0087] Step S6 specifically includes:

[0088] Step S6.1: The steps of ventilator 12 in supporting ventilation and deep inspiratory breath-hold control for the target subject are as described in steps S1-S3. When ventilator 12 supports ventilation and deep inspiratory breath-hold control for the target subject, respiratory sensor 14 and physiological parameter sensor 24 send the collected real-time respiratory curve and physiological parameter curve to the storage unit 52 of main control module 10. Terminal monitor 28 obtains and displays the real-time respiratory curve and physiological parameter curve of the target subject from storage unit 52. Terminal monitor 28 can also obtain and display the physiological parameter baseline signal in storage unit 52. Terminal monitor 28 can also obtain values ​​such as a first threshold and a first preset range from storage unit 52.

[0089] It is understood that the terminal monitor 28, the breathing sensor 14 and other external modules exchange data and communicate with each functional unit in the main control module 10 through the communication interface (not shown in the figure) in the main control module 10.

[0090] Specifically, the physiological parameter curves include heart rate signal curves and blood oxygen signal curves.

[0091] Step S6.2: Medical staff monitor the respiratory and physiological status of the target subject through the terminal monitor 28, and determine whether to adjust the ventilator parameters based on the difference between the respiratory curve and / or physiological parameter curve and the physiological parameter baseline signal. If so, the medical staff adjusts the ventilator parameters through the terminal monitor 28 with a preset step value and sends it to the ventilator parameter setting unit 46, which then sends it to the control unit 56 of the ventilator 12.

[0092] Of course, different preset step values ​​need to be set for different ventilator parameters. The preset step values ​​can be determined based on the experience of medical staff or based on a pre-trained model.

[0093] For example, when the terminal monitor 28 detects that the target object's heart rate signal is too high, that is, the difference between the heart rate signal baseline and the physiological parameter baseline is greater than a first threshold, it indicates that the support pressure setting is too low, and the medical staff can increase the support pressure by a preset step value; and / or, when it is detected that the fluctuation amplitude during multiple breath-holdings exceeds the first preset range, it indicates that the breath-holding time is too long, and the medical staff can reduce the breath-holding time by a preset step value.

[0094] Understandably, fluctuations in the breath-holding curve represent slight movements of the body surface caused by residual breathing during breath-holding, or the target subject's inability to maintain the current breath-holding state, which may lead to slight movement of the target tumor location.

[0095] The setting of the first threshold and the first preset range can be based on clinical guidelines, physicians' professional knowledge and clinical experience, or machine learning models, for example.

[0096] Further optionally, step S6 further includes the following: when any of the following safety emergencies occur, medical staff will assist the target subject in urgently removing the mask and then actuate to stop the ventilator 12. If the target subject is in a breath-holding state before the medical staff assists the target subject in urgently removing the mask, the medical staff will first send a stop breath-holding command to the main control module 10 through the terminal monitor 28, and the main control module 10 will control the ventilator 12 to stop the breath-holding.

[0097] Then, medical staff can inquire about the subject's subjective feelings. If the subject indicates that they are experiencing sudden physical discomfort, or fatigue or tension due to prolonged respiratory sampling, then there is no need to adjust the ventilator parameters temporarily. The process can continue after the subject has rested, relaxed, and adjusted their state. If the subject indicates that their current physical condition is normal, medical staff can determine whether to adjust the ventilator parameters by combining the respiratory curve and / or physiological parameter curves.

[0098] The aforementioned security emergencies include:

[0099] 1) When the respiratory mode determination unit 36 ​​in the main control module 10 detects that the difference between the physiological parameter curve and the corresponding physiological parameter baseline signal does not meet the safety conditions, it sends an alarm to the terminal monitor 28.

[0100] 2) The target object actuates the pause ventilator button on the user remote control 26, sending an alarm to the terminal monitor 28;

[0101] 3) The target object actuates the pause breath-hold button on the user remote control 26. After receiving the pause breath-hold command transmitted by the user remote control 26, the main control module 10 controls the ventilator 12 to pause breath-holding.

[0102] Specifically, since the physiological parameter curve signal includes heart rate and blood oxygenation signals, the safety condition is defined as the difference between the heart rate signal curve and the heart rate signal baseline, and the difference between the blood oxygenation signal and the blood oxygenation signal baseline, both being within the normal physiological fluctuation range. This normal physiological fluctuation range can typically be determined based on clinical guidelines, physician expertise and clinical experience, or machine learning models.

[0103] The ventilator control unit 38 sends a breath-holding pause command to the control unit 56 of the ventilator 12. The breathing mode determination unit 36 ​​obtains real-time breathing curve information, physiological parameter curve information, and physiological parameter baseline signals from the storage unit 52 to determine the target ventilator parameters and breathing guidance curve. The breathing mode determination unit 36 ​​can also retrieve the values ​​of the safety conditions, the first preset range, the second preset range, the first threshold, the second threshold, the third threshold, and the preset period from the storage unit 52.

[0104] Further, optionally, the emergency response method for the aforementioned safety emergency includes the following steps:

[0105] 1) When the breathing mode determination unit 36 ​​in the main control module 10 detects that the difference between the physiological parameter curve and the corresponding baseline physiological parameter signal does not meet the safety conditions, it sends an alarm to the terminal monitor 28. The alarm can be in the form of light and / or sound. If the patient is in a breath-holding state, the medical staff first activates the pause breath-holding button on the terminal monitor 28 and transmits it to the ventilator control unit 38. The ventilator control unit 38 sends the pause breath-holding command to the control unit 56 of the ventilator 12. The ventilator pauses the breath-holding control and switches to the ventilation support mode. In order to facilitate asking the target subject the reason for pausing breath-holding so as to determine whether to adjust the ventilator parameters later, the medical staff assists the target subject to urgently remove the mask and then activates the pause ventilator button. If the patient is in the ventilation support mode, the medical staff directly assists the target subject to urgently remove the mask and then pauses the ventilator 12. The target subject resumes spontaneous breathing.

[0106] 2) The system also includes a user remote control 26, which includes a pause ventilator button. The target object sends an alarm to the terminal monitor 28 by activating the pause ventilator button on the user remote control 26. Medical staff will assist the target object in urgently removing the mask and restoring spontaneous breathing. The medical staff will then operate the pause ventilator 12.

[0107] The user remote control 26 is connected to the terminal monitor 28. Considering that when the target needs to stop the ventilator 12, medical staff need to help remove the mask first, the user remote control 26 is also connected to the terminal monitor 28 for communication. When the target actuates the ventilator stop button, the ventilator stop command is sent to the terminal monitor 28.

[0108] 3) The user remote control 26 also includes a pause breath-hold button. The target object activates the pause breath-hold button on the user remote control 26 and transmits the command to the ventilator control unit 38. The ventilator control unit 38 sends the pause breath-hold command to the ventilator control unit 56. The ventilator 12 pauses the breath-hold control and switches to the ventilation support mode. The target object resumes free breathing. The user remote control 26 also simultaneously sends the pause breath-hold command to the terminal monitor 28. In order to facilitate asking the target object why the breath-hold was paused, medical staff will assist the target object to urgently remove the mask and resume spontaneous breathing. The medical staff will then operate to pause the ventilator 12.

[0109] Furthermore, in order to ensure that the respiratory curve signals collected in the storage unit 52 of the main control module 10 only include the respiratory curve signals when the target object is ventilated by the ventilator 12, so as to facilitate the subsequent analysis of the collected respiratory curve information when ventilating by the ventilator 12, the main control module 10 should be turned off when the medical staff stops the ventilator 12.

[0110] Understandably, when the ventilator control unit 38 sends the command to pause breath-holding to the ventilator control unit 56, the control unit 56 will control the air supply device 54 to release the breath-holding control, the ventilator 12 will switch to the support ventilation mode, and the target subject will resume free breathing. At this time, the expiratory phase will begin first, and the control unit 56 will control the air supply device 54 to maintain the set positive end-expiratory pressure (PEEP), and then continue to execute the support ventilation mode of the ventilator 12.

[0111] For example, the actuation pause ventilator 12 can be operated directly by medical staff using the pause button on the ventilator 12.

[0112] Since the target subject is prone to fatigue or tension during prolonged repeated breath-holding, which affects the breath-holding state, it is further optional that, in the preparation mode, the real-time respiratory curve of the target subject using ventilator 12 can be collected multiple times. The ventilator parameters after the last adjustment are saved in the ventilator parameter setting unit 46. When the preparation mode is restarted next time, ventilator 12 performs support ventilation and deep inspiratory breath-holding control on the target subject based on the configuration of the ventilator parameters saved in the ventilator parameter setting unit 46, that is, returns to step S6.

[0113] Of course, when the target object pauses the ventilator 12 due to the aforementioned safety emergency, the ventilator 12 will also ventilate the target object based on the configuration of the ventilator parameters stored in the ventilator parameter setting unit 46 when restarting the preparation mode, that is, return to step S6.

[0114] Therefore, the system provides feedback on the physiological state and subjective feelings of the target subject, and corresponding safety measures are designed. When the target subject's physiological parameters become abnormal or they experience discomfort, their safety can be ensured by pausing breath-holding or stopping ventilator ventilation.

[0115] Step S7: When the main control module 10 determines that the ventilator parameters remain unchanged within the current preset period and monitors that the respiratory curve within the current preset period meets the first preset condition, the ventilator parameters at this time are determined as the target ventilator parameters.

[0116] The target breath-hold amplitude in the ventilator parameters remains constant throughout.

[0117] Each time the ventilator parameter setting unit 46 updates its parameters, it sends a parameter update signal to the breathing mode determination unit 36 ​​and sends the current ventilator parameters to the breathing mode determination unit 36.

[0118] It is worth mentioning that the breathing mode determination unit 36 ​​includes a memory (not shown in the figure) for storing the breathing curve information retrieved from the storage unit 52, as well as the parameter update signal and ventilator parameters sent by the ventilator parameter setting unit 46, so as to ensure that the information is not lost after the main control module is powered off and restarted, and to ensure that the judgment on whether the breathing curve meets the first preset condition can be performed subsequently.

[0119] It is understood that, since the target object typically uses the ventilator system 100 in multiple sessions, the preset period is defined as the sum of the time periods during which the target object uses the ventilator system 100 to collect respiratory signals.

[0120] Specifically, when the breathing mode determination unit 36 ​​determines that the ventilator parameters in the ventilator parameter setting unit 46 remain unchanged within the current preset period, and monitors that the breathing curve within the current preset period meets the first preset condition, it sends an instruction to the ventilator parameter setting unit 46 to save the current ventilator parameters as the target ventilator parameters for later imaging / treatment.

[0121] Specifically, when analyzing the monitored respiratory curves over the current preset period, the respiratory curves are first divided into several breath-holding cycle curves. Each breath-holding cycle curve is defined as a segment of the deep inhalation breath-holding curve and the preceding N (N is at least 2) free breathing cycles. In other words, as... Figure 4 As shown, the breath-holding cycle curve includes a deep inhalation breath-holding curve segment and a free breathing curve segment. As is well known to those skilled in the art, the breath-holding cycle curve can be divided into several breath-holding cycle curves by detecting the peak and trough values ​​in the breathing curve.

[0122] Optionally, the first preset condition is: within the preset period up to the present, the total number of breath-holding cycle curves is greater than the second threshold, and the proportion of reproducible breath-holding cycle curves in all breath-holding cycle curves is not less than the third threshold, for example, the value of the third threshold can be set between 80% and 90%.

[0123] The reproducible breath-hold cycle curve is defined as follows: breath-hold amplitude is the target breath-hold amplitude, breath-hold duration is the target breath-hold duration in the ventilator parameters, and the breath-hold curve fluctuates within a first preset range. Furthermore, the differences between the free breathing curve segments in each breath-hold cycle curve are within a second preset range. The breath-hold curve is defined as the breathing curve under breath-hold conditions.

[0124] Specifically, the differences between the free breathing curve segments in each breath-holding cycle curve can be determined by statistical analysis methods such as comparison of breathing parameters, comparison of linear similarity, and comparison of frequency domain analysis.

[0125] Optionally, the setting of the second preset range can be based on clinical guidelines, physiological parameters, and machine learning models, for example.

[0126] Typically, after each deep inhalation and breath-holding pause, the subject's breathing tends to be relatively rapid for a short period, indicating brief instability. This is followed by a gradual return to stable breathing. When breathing is stable, the frequency, depth, and rhythm are consistent, which helps in better control of breathing. Furthermore, a stable breathing state helps the subject remain relaxed and comfortable during breath-holding, reducing unstable breathing caused by tension or anxiety. Therefore, performing deep inhalation and breath-holding while in a stable breathing state is more conducive to reproducing a stable breath-holding state. In other words, if the subject is in an unstable breathing state during free breathing, the likelihood of them reproducing a stable breath-holding state is considered low. This is especially true for subjects with poor cardiopulmonary function or physical weakness, as only a stable breathing state can guarantee their good breath-holding ability.

[0127] Therefore, when determining whether the ventilator parameters are set appropriately, in addition to checking whether the breath-holding state meets the requirements, it is also necessary to determine whether the patient was in a stable breathing state beforehand. When the breathing curve meets the first preset condition, it indicates that the ventilator parameters are set appropriately. When the ventilator operates based on these parameters, the target subject can better reproduce a stable breath-holding state under stable free breathing conditions during subsequent imaging / treatment, thereby reducing the possibility of terminating imaging / irradiation due to an unsuitable breath-holding state after it has been initiated.

[0128] Therefore, in this step, when determining whether the respiratory curve within the current preset period meets the first preset condition, the breath-holding cycle curve, including the deep inhalation breath-holding curve segment and the free breathing curve segment, is used as the analysis object.

[0129] Additionally, it is understood that, in order to ensure that the target object performs a sufficient number of breath-holding cycles within the current preset period, and to ensure the effectiveness of the collected breathing curve data in determining whether the breathing curve meets the first preset condition, the first preset condition requires that the total number of breath-holding cycle curves within the current preset period be greater than a second threshold. The second threshold can be set, for example, based on the duration of the preset period and the ratio of breath-holding duration to free breathing duration.

[0130] Step S8: The main control module 10 determines the respiratory guidance curve based on the respiratory curve within the preset period up to the present, and sends a command to end the respiratory signal acquisition;

[0131] Specifically, the breathing pattern determination unit 36 ​​determines a breathing guidance curve based on the reproducible breath-holding cycle curves within the preset period up to the present. That is, it determines a typical breathing pattern from the reproducible breath-holding cycle curves using an inductive analysis method, and modifies the deep inspiratory breath-holding curve of the typical breathing pattern based on the target breath-holding amplitude and breath-holding duration in the target ventilator parameters, thereby forming the breathing guidance curve. Thus, the breathing guidance curve represents the target breathing pattern, including a stable free breathing pattern curve and a deep inspiratory breath-holding pattern curve, where the stable state means that the respiratory rate and amplitude are basically consistent. The inductive analysis method can, for example, calculate the average or median waveform of the free breathing curve segment among all the reproducible breath-holding cycle curves as the typical breathing pattern.

[0132] The breathing pattern determination unit 36 ​​sends a command to the terminal monitor 28 to end the breathing signal acquisition, informing medical staff that signal acquisition can be terminated. Simultaneously, the breathing pattern determination unit 36 ​​sends the breathing guidance curve to the storage unit 52 and the breathing guidance module 16.

[0133] Furthermore, the breathing pattern determination unit 36 ​​can determine a third preset range based on the maximum difference between the free breathing curve segment in the reproducible breath-holding cycle curve up to the current preset period and the free breathing pattern curve in the breathing guidance curve in step S7, and send it to the storage unit 52 for use as a basis for judging whether the real-time breathing curve meets the requirements for starting imaging / irradiation in subsequent imaging / treatment processes.

[0134] Optionally, the ventilator parameter setting unit 46 updates the ventilator-related parameters other than the target breath-holding amplitude from the determined target ventilator parameters to the deep learning model 22, so that the model can learn more individual differences and change patterns, improve its adaptability and generalization ability, and thus improve the prediction accuracy of the model.

[0135] This embodiment uses a deep learning model and medical staff to fine-tune the ventilator parameters to determine the appropriate ventilator parameters for the target subject. In other words, when the ventilator is configured based on these ventilator parameters to support ventilation and deep inspiratory breath-hold control, it can ensure that the target subject can better reproduce a stable breath-hold state under a stable free breathing state during subsequent imaging / treatment.

[0136] Furthermore, by determining the respiratory guidance curve of the target subject based on the respiratory curve collected in the preparation mode, the target subject can be guided to adjust its breathing state in a timely manner to synchronize with the respiratory guidance curve as much as possible, thereby better reproducing a stable breathing state and breath-holding state.

[0137] (2) Imaging mode

[0138] After completing the preparation mode, you can enable the imaging mode.

[0139] When the imaging mode is enabled, the mode switching unit 48 in the main control module 10 controls the ventilator system 100 to switch to the imaging mode. In the imaging mode, the operating function units of the main control module 10 include a respiratory gating unit 42, a respiratory guidance curve generation unit 44, a storage unit 52, and a ventilator parameter setting unit 46.

[0140] It is known that the storage unit 52 has already stored the safety conditions and the values ​​of the first preset range. Furthermore, in the preparation mode, the storage unit 52 stores the physiological parameter baseline signal, the respiratory guidance curve information, and the values ​​of the third preset range. The respiratory guidance module 16 has received and stored the respiratory guidance curve information. The ventilator 12 will ventilate the target subject based on the target ventilator parameters determined in the preparation mode.

[0141] The ventilator system 100 can send gating commands to the relevant medical device 18 to start or stop imaging. The relevant medical device 18 includes an imaging device.

[0142] like Figure 5 As shown, the operating steps of the ventilator system 100 in imaging mode are as follows:

[0143] Step S9: The ventilator 12 performs supportive ventilation and deep inspiratory breath-hold control for the patient based on the configuration of the target ventilator parameters. The main control module 10 controls the respiratory guidance module 16 to generate a respiratory guidance curve in real time and simultaneously displays the real-time respiratory curve.

[0144] Specifically, once the target is ready, the ventilator system 100 is turned on, and the ventilator parameter setting module 46 sends the target ventilator parameters determined in the preparation mode to the control unit 56 of the ventilator 12. The ventilator 12 provides support ventilation for the target. The support ventilation and deep inhalation breath-hold control methods of the ventilator 12 are as shown in steps S1-S3.

[0145] Generally, when the target subject performs deep inhalation and breath-holding while in a stable breathing state, it is more helpful for them to reproduce a stable breath-holding state. Therefore, breathing guidance curves can be used to guide the breathing of the target subject during free breathing and deep inhalation and breath-holding.

[0146] The breathing guidance module 16 includes a display unit that displays a breathing guidance curve to guide the target subject in stabilizing breathing before breath-holding and inducing deep inhalation and breath-holding, enabling the target subject to better reproduce a stable target breath-holding pattern. The breathing guidance curve includes a free breathing pattern curve under stable conditions and a deep inhalation and breath-holding pattern curve.

[0147] The main control module 10 controls the terminal monitor 28 to generate and display the real-time breathing guidance curve, specifically including:

[0148] Step S9.1: The breathing guidance curve generation unit 44 retrieves the monitored real-time breathing curve from the storage unit 52, the value of the third preset range, and receives the normal inspiratory effort signal and deep inspiratory effort signal sent by the control unit 56 of the ventilator 12. If the target object is detected to have started stable free breathing, that is, the difference between the free breathing curve of several cycles monitored in real time and the free breathing mode curve in the stable state in the breathing guidance curve does not exceed the third preset range, then when a normal inspiratory effort signal is received thereafter, a trigger signal is sent to the breathing guidance module 16, and the breathing guidance module 16 retrieves the free breathing mode curve of the breathing guidance curve and displays it on the display.

[0149] Step S9.2: If the breathing guidance curve generation unit 44 receives the deep inhalation effort signal, it sends a trigger signal to the breathing guidance module 16. The breathing guidance module 16 retrieves the deep inhalation breath-holding mode curve of the breathing guidance curve and displays it on the display.

[0150] In steps S9.1-S9.2 above, the breathing guidance curve generation unit 44 also sends the real-time breathing curve to the breathing guidance module 16 for synchronous display on the monitor.

[0151] The display is used to show the target object's own real-time breathing curve and breathing guidance curve. It is set in front of the target object to ensure that the target object can see its own real-time breathing curve and breathing guidance curve, grasp the difference between its breathing state and the breathing guidance curve in real time, and adjust its breathing state in a timely manner to synchronize with the breathing guidance curve as much as possible, thereby helping the target object to better reproduce the target breathing pattern.

[0152] Optionally, the breathing guidance module 16 further includes a photoacoustic guidance unit, which is used to generate and play a photoacoustic instruction file according to the rhythm of the breathing guidance curve, and send "inhale" and / or "hold your breath" and / or "exhale" instructions through photoacoustic to guide the target object to perform the corresponding breathing action.

[0153] Step S10: When the main control module 10 receives the signal that the target object has started holding its breath, it determines whether the conditions for starting imaging are met.

[0154] Step S11: If the conditions for starting imaging are met, send a trigger signal to start imaging and proceed to step S13.

[0155] Specifically, the respiratory gating unit 42 in the main control module 10 retrieves the respiratory guidance curve information, physiological parameter baseline signal, the safety conditions, the values ​​of the first preset range and the third preset range, as well as the real-time monitored respiratory curve and physiological parameter curve from the storage unit 52, and receives the start-of-breath signal fed by the control unit 56 of the ventilator 12. When the start-of-breath signal is received, it determines whether the start-of-imaging condition is met. If the start-of-imaging condition is met, it sends a start-of-imaging trigger signal to the imaging device to start imaging. The imaging device acquires diagnostic images at preset time intervals and proceeds to step S13.

[0156] The conditions for starting imaging are: the difference between the free breathing curve segment in the breath-holding cycle curve of the current breathing curve and the free breathing mode curve in the steady state in the breathing guidance curve is within the third preset range, and the difference between the monitored physiological parameter curve and the physiological parameter baseline signal meets the safety conditions.

[0157] It should be noted that, based on the description of the operation steps of the ventilator 12 in steps S1-S3, the control unit 56 will only activate the deep inhalation and breath-hold control when the deep inhalation amplitude in the respiratory curve information is detected to reach the target breath-hold amplitude. In other words, when the respiratory gating unit 42 receives the start breath-hold signal, it can determine that the deep inhalation amplitude has reached the target breath-hold amplitude.

[0158] Step S12: If the conditions for starting imaging are not met, the main control module 10 will not send a trigger signal to start imaging, and will simultaneously send a pause breath-holding command to the ventilator 12, and return to step S9;

[0159] If the respiratory gating unit 42 determines that the conditions for starting imaging are not met, it will not send a trigger signal to start imaging, and will simultaneously send a pause breath-hold command to the control unit 56 of the ventilator 12. The ventilator 12 will then switch to ventilation mode, and the target subject will resume free breathing. Then, the process returns to step S9.

[0160] Generally, when breathing is stable, the respiratory rate, depth, and rhythm are relatively consistent, which helps in better controlling breathing. Furthermore, a stable breathing state helps the target subject remain relaxed and comfortable during breath-holding, reducing unstable breathing caused by tension or anxiety. Therefore, deep inhalation and breath-holding under stable breathing conditions are more conducive to reproducing a stable target breath-holding pattern. Conversely, if the target subject is in an unstable breathing state during free breathing, it suggests a lower likelihood of reproducing a stable and reliable breath-holding state. This is especially true for targets with poor cardiopulmonary function or physical weakness; only under stable breathing conditions can their good breath-holding ability be guaranteed, thus reducing the possibility of imaging being terminated due to an unsuitable breath-holding state after imaging begins. Therefore, when determining the imaging start conditions, it is necessary to determine whether the difference between the free breathing curve segment of the current breathing curve's breath-holding cycle curve and the free breathing pattern curve under stable conditions in the breathing guidance curve meets the requirements.

[0161] Step S13: During the breath-holding period, the main control module 10 continues to determine whether imaging needs to be stopped;

[0162] Step S14: If it is determined that imaging needs to be stopped, a stop imaging trigger signal is sent to the imaging device, and a pause breath-holding command is sent to the ventilator 12 at the same time, and the process returns to step S9;

[0163] During breath-holding, the respiratory gating unit 42 continues to monitor the real-time breath-holding curve and physiological parameter curve signals. If the fluctuation range of the real-time breath-holding curve exceeds the first preset range, and / or, the difference between the physiological parameter curve and the physiological parameter baseline signal does not meet the safety conditions, and / or, a pause breath-holding command is received from the user remote control 26, the respiratory gating unit 42 sends a stop imaging trigger signal to the imaging device and simultaneously sends a pause breath-holding command to the control unit 56 of the ventilator 12. The ventilator 12 switches to the ventilation support mode, the target object resumes free breathing, and then returns to step S9.

[0164] It should be noted that in the imaging mode, the breathing gating unit 42 receives the pause breath-holding command sent by the user remote controller 26 and transmits it to the ventilator 12, rather than the ventilator control unit 38. This is because in the imaging mode, the operating function units in the main control module 10 only include the breathing gating unit 42, the breathing guidance curve generation unit 44, the storage unit 52, and the ventilator parameter setting unit 46, and do not include the ventilator control unit 38.

[0165] In addition, in imaging mode, the ventilator parameter setting unit 46 will turn off receiving ventilator parameter adjustment commands sent by the terminal monitor 28, and ventilator parameters will not be allowed to be adjusted.

[0166] Step S15: If it is determined that imaging does not need to be stopped, the ventilator 12 will pause the breath-hold control after reaching the target breath-hold duration. When the imaging device starts imaging, the imaging device can determine the time to stop irradiation based on the breath-hold duration. That is, when the irradiation reaches the breath-hold duration, the imaging device will automatically stop imaging.

[0167] Repeat steps S9-S15 until the imaging device acquires a sufficient number of diagnostic images.

[0168] It should be noted that the respiratory gating unit 42 can determine the start of the breath-hold phase based on the start breath-hold signal fed by the control unit 56 of the ventilator 12, and determine the end of the breath-hold based on the breath-hold pause signal or the breath-hold duration in the target ventilator parameters, thereby determining whether the current stage is the support ventilation mode stage or the breath-hold phase. The breath-hold duration can be retrieved by the respiratory gating unit 42 from the ventilator parameter setting unit 46.

[0169] Optionally, in any of steps S9-S15 above, when the respiratory gating unit 42 determines that it is currently in the support ventilation mode, if it receives a pause ventilator button sent by the target subject via the user remote control 26, or if the difference between the physiological parameter curve and the physiological parameter baseline signal does not meet the safety conditions, it sends an alarm to the terminal monitor 28. Medical personnel will then assist the target subject in urgently removing the mask to restore spontaneous breathing, and the medical personnel will operate the pause ventilator 12. After rest and relaxation, the system will determine whether to continue imaging, i.e., return to step S9, or terminate the current imaging operation, based on the target subject's condition.

[0170] Imaging equipment may include MRI imaging equipment, CT imaging equipment, PET imaging equipment, ultrasound imaging equipment, or other medical imaging equipment used to acquire medical images of a patient. Imaging equipment may be configured to acquire one or more images of the patient's anatomical structures targeting a tumor.

[0171] Imaging can determine the location, morphology, and other information of the target tumor when the target object reproduces the deep inhalation and breath-holding pattern in the target breathing pattern. In other words, a correlation is established between the tumor model, including the tumor location, and the breath-holding pattern signal. Therefore, a treatment plan can be determined based on imaging, and the location of the target tumor can be accurately determined based on the real-time breathing curve during radiotherapy, thereby guiding the radiotherapy equipment to perform irradiation.

[0172] (3) Treatment Mode

[0173] After the imaging mode is completed, a radiotherapy plan can be determined based on the imaging, and then the treatment mode can be started.

[0174] Once the treatment mode is enabled, the mode switching unit 48 in the main control module 10 controls the ventilator system 100 to switch to the treatment mode. In the treatment mode, the operating function units of the main control module 10 include a respiratory gating unit 42, a respiratory guidance curve generation unit 44, a storage unit 52, and a ventilator parameter setting unit 46.

[0175] It is known that the storage unit 52 has already stored the safety conditions and the values ​​of the first preset range. Furthermore, in the preparation mode, the storage unit 52 stores the physiological parameter baseline signal, the respiratory guidance curve information, and the values ​​of the third preset range. The respiratory guidance module 16 has received and stored the respiratory guidance curve information. The ventilator 12 ventilates the target subject based on the target ventilator parameters determined in the preparation mode.

[0176] The ventilator system 100 can send gating commands to related medical devices 18 to turn on or off irradiation. The related medical devices 18 include treatment devices.

[0177] like Figure 6 As shown, the operating steps of the ventilator system 100 in treatment mode are as follows:

[0178] Step S16: Same as step S9 in imaging mode;

[0179] Step S17: When the main control module 10 receives the signal that the target object has started holding its breath, it determines whether the irradiation conditions are met.

[0180] Step S18: If the irradiation conditions are met, send a trigger signal to start irradiation and proceed to step S20;

[0181] Specifically, the respiratory gating unit 42 in the main control module 10 retrieves the respiratory guidance curve information, physiological parameter baseline signal, the values ​​of the safety conditions, the first preset range and the third preset range, as well as the real-time monitored respiratory curve and physiological parameter curve from the storage unit 52, and receives the start-of-breath-hold signal fed by the control unit 56 of the ventilator 12. When the start-of-breath-hold signal is received, it determines whether the irradiation conditions are met. If the irradiation conditions are met, it sends a trigger signal to start irradiation to the radiotherapy equipment to start radiation and proceeds to step S20.

[0182] The irradiation conditions are as follows: the difference between the free breathing curve segment in the breath-holding cycle curve of the current breathing curve and the free breathing mode curve in the steady state in the breathing guidance curve is within the third preset range, and the difference between the monitored physiological parameter curve and the physiological parameter baseline signal meets the safety conditions.

[0183] It should be noted that, based on the description of the operation steps of the ventilator 12 in steps S1-S3, the control unit 56 will only activate the deep inhalation and breath-hold control when the deep inhalation amplitude in the respiratory curve information is detected to reach the target breath-hold amplitude. In other words, when the respiratory gating unit 42 receives the start breath-hold signal, it can determine that the deep inhalation and breath-hold amplitude has reached the target breath-hold amplitude.

[0184] Step S19: If the irradiation conditions are not met, the main control module 10 will not send a trigger signal to start irradiation, and will simultaneously send a pause breath-holding command to the ventilator 12, returning to step S16.

[0185] If the respiratory gating unit 42 determines that the irradiation conditions are not met, it will not send a trigger signal to start irradiation, and will simultaneously send a pause breath-hold command to the control unit 56 of the ventilator 12. The ventilator 12 will then switch to the ventilation support mode, and the target subject will resume free breathing. Then, the process returns to step S16.

[0186] Generally, when breathing is stable, the respiratory rate, depth, and rhythm are relatively consistent, which helps in better controlling breathing. Furthermore, a stable breathing state helps the target subject remain relaxed and comfortable during breath-holding, reducing unstable breathing caused by tension or anxiety. Therefore, deep inhalation and breath-holding under stable breathing conditions are more conducive to reproducing a stable target breath-holding pattern. Conversely, if the target subject is in an unstable breathing state during free breathing, it suggests a lower likelihood of reproducing a stable and reliable breath-holding state. This is especially true for targets with poor cardiopulmonary function or physical weakness; only under stable breathing conditions can their good breath-holding ability be guaranteed, thus reducing the possibility of irradiation being discontinued due to an unsatisfactory breath-holding state after irradiation begins. Therefore, when determining irradiation conditions, it is necessary to determine whether the difference between the free breathing curve segment of the current respiratory curve's breath-holding cycle curve and the free breathing pattern curve under stable conditions in the respiratory guidance curve meets the requirements.

[0187] In step S20, during the breath-holding period, the main control module 10 continues to determine whether it is necessary to stop the irradiation urgently;

[0188] Step S21: If it is determined that irradiation needs to be stopped, a stop irradiation trigger signal is sent to the treatment device, and a pause breath-hold command is sent to the ventilator 12 at the same time, and the process returns to step S16;

[0189] During breath-holding, the respiratory gating unit 42 continues to monitor the real-time breath-holding curve and physiological parameter curve signals. If the fluctuation range of the real-time breath-holding curve exceeds the first preset range, and / or, the difference between the physiological parameter curve and the physiological parameter baseline signal does not meet the safety conditions, and / or, a pause breath-holding command is received from the user remote controller 26, then the respiratory gating unit 42 sends a stop irradiation trigger signal to the treatment device and simultaneously sends a pause breath-holding command to the control unit 56 of the ventilator 12. The ventilator 12 switches to the ventilation support mode, the target object resumes free breathing, and then returns to step S16.

[0190] It should be noted that in the treatment mode, the breathing gating unit 42 receives the pause breath-holding command sent by the user remote controller 26 and transmits it to the ventilator 12, rather than the ventilator control unit 38. This is because in the treatment mode, the operating function units in the main control module 10 only include the breathing gating unit 42, the breathing guidance curve generation unit 44, the storage unit 52, and the ventilator parameter setting unit 46, and do not include the ventilator control unit 38.

[0191] In addition, in imaging mode, the ventilator parameter setting unit 46 will turn off receiving ventilator parameter adjustment commands sent by the terminal monitor 28, and ventilator parameters will not be allowed to be adjusted.

[0192] Step S22: If it is determined that irradiation does not need to be stopped, the ventilator 12 will pause breath-hold control after reaching the target breath-hold duration. When the radiotherapy equipment starts irradiation, it can determine the time to stop irradiation based on the breath-hold duration; that is, when the irradiation reaches the breath-hold duration, the radiotherapy equipment will automatically stop irradiation.

[0193] Repeat steps S16-S22 until the current radiotherapy session is completed.

[0194] It should be noted that the respiratory gating unit 42 can determine the start of the breath-hold phase based on the start breath-hold signal fed by the control unit 56 of the ventilator 12, and determine the end of the breath-hold based on the breath-hold pause signal or the breath-hold duration in the target ventilator parameters, thereby determining whether the current stage is the support ventilation mode stage or the breath-hold phase. The breath-hold duration can be retrieved by the respiratory gating unit 42 from the ventilator parameter setting unit 46.

[0195] Optionally, in any of steps S16-S22 above, when the respiratory gating unit 42 determines that it is currently in the support ventilation mode, if it receives a pause ventilator button sent by the target subject via the user remote control 26, or if the difference between the physiological parameter curve and the physiological parameter baseline signal does not meet the safety conditions, it sends an alarm to the terminal monitor 28. Medical personnel will then assist the target subject in urgently removing the mask to restore spontaneous breathing, and the medical personnel will operate the pause ventilator 12. After rest and relaxation, the treatment will be determined based on the target subject's condition: either continue treatment (i.e., return to step S16) or terminate the current radiotherapy.

[0196] In this embodiment, the ventilator employs pressure support ventilation (PSV) mode. The number of free breaths between deep inspiration and breath-holding can be autonomously adjusted by the target patient according to their own condition, allowing them to more comfortably reproduce the breath-holding pattern and improving the user experience. Furthermore, when the target patient reproduces the deep inspiration and breath-holding pattern during radiotherapy, the target tumor can be kept in a fixed position. Therefore, the radiation delivered by the radiotherapy equipment can be more precisely delivered to the target tumor rather than healthy surrounding tissue, ensuring the safety and effectiveness of the treatment.

[0197] Optionally, the operating mode of the medical ventilator system 100 may also include a practice mode, which can simulate the treatment mode. Its operation steps can refer to the operation steps of the treatment mode. For example, in the operation steps of the treatment mode, the respiratory gating unit 42 can send trigger signals to the radiotherapy device to start irradiation and stop irradiation as trigger signals to send voice prompts of "start irradiation" and "stop irradiation".

[0198] Breathing exercises can help the target subject better adapt to the breathing pattern, thereby ensuring that the target subject can achieve a stable breathing state during radiotherapy and more smoothly reproduce the target breathing pattern.

[0199] In summary, this embodiment provides a medical ventilator system 100 for supporting ventilation during radiotherapy. It provides supportive ventilation and deep inspiratory breath-hold control for the target patient. The ventilator employs a pressure support ventilation (PSV) mode, and the number of free breaths between deep inspiratory breath-holds can be autonomously adjusted by the target patient according to their own condition. This allows the target patient to more comfortably reproduce the breath-holding pattern, improving the user experience. Furthermore, based on a deep learning model and fine-tuning of ventilator parameters by medical personnel, suitable ventilator parameters are determined for the target patient, thereby assisting target patients with lung-related diseases or physical weakness to achieve a stable, reliable, and satisfactory breath-holding pattern.

[0200] In this embodiment, a correlation was established between a tumor model, including the tumor location, and a breath-holding pattern signal through imaging. Therefore, respiratory gating of the radiotherapy equipment's irradiation can be performed based on real-time respiratory curves during radiotherapy. Furthermore, the ventilator system can determine whether the breath-holding state meets the requirements based on the judgment criteria provided by the target respiratory pattern curve, thereby further determining whether to trigger imaging / irradiation. As a result, the radiation delivered by the radiotherapy equipment can be more accurately delivered to the target tumor rather than healthy surrounding tissue, ensuring the safety and effectiveness of the treatment.

[0201] Furthermore, considering that deep inhalation and breath-holding under a stable respiratory state is more conducive to reproducing a stable target breath-holding pattern, when determining whether the breath-holding state meets the requirements, the difference between the free breathing curve segment in the breath-holding cycle curve of the current respiratory curve and the free breathing pattern curve under a stable state in the respiratory guidance curve is also considered to ensure that a stable and reliable breath-holding state can be achieved subsequently, thereby reducing the possibility of terminating imaging / irradiation due to the breath-holding state not meeting the requirements after starting imaging / irradiation.

[0202] Based on the respiratory curves collected in preparation mode, the respiratory guidance curve of the target object is determined, ensuring that the target object can see its own real-time respiratory curve and respiratory guidance curve, and can grasp the difference between its own respiratory state and the respiratory guidance curve in real time, and adjust its respiratory state in a timely manner to synchronize with the respiratory guidance curve as much as possible, thereby guiding the target object to better reproduce a stable respiratory state and breath-holding state.

[0203] The applicant of this invention has provided a detailed description of the embodiments of the invention in conjunction with the accompanying drawings. However, those skilled in the art should understand that the above embodiments are merely preferred embodiments of the invention. The detailed description is only intended to help readers better understand the spirit of the invention and is not intended to limit the scope of protection of the invention. On the contrary, any improvements or modifications made based on the inventive spirit of the invention should fall within the scope of protection of the invention.

Claims

1. A medical ventilator system (100) for supporting ventilation, characterized in that, At least including: Ventilator (12), main control module (10), respiratory sensor (14), physiological parameter sensor (24), terminal monitor (28); The main control module (10) is connected to the ventilator (12), the respiratory sensor (14), the physiological parameter sensor (24), and the terminal monitor (28); The ventilator (12) uses pressure support ventilation (PSV) mode; The operating steps of the ventilator system (100) in the preparation mode are as follows: Step S6: The ventilator (12) supports ventilation and deep inhalation breath-hold control for the target object based on the initial value of the ventilator parameters sent by the main control module (10) or the configuration of the ventilator parameters saved before the last pause of the ventilator (12). The medical staff sends the ventilator parameter adjustment command to the main control module (10) based on the respiratory curve information and physiological parameter curve of the target object monitored by the terminal monitor (28). The respiratory sensor (14) and the physiological parameter sensor (24) send the collected respiratory curve information and physiological parameter curve to the main control module (10), and the terminal monitor (28) obtains and displays the respiratory curve information, physiological parameter curve and physiological parameter baseline signal of the target object from the main control module (10). Step S7: When the main control module (10) determines that the ventilator parameters remain unchanged within the current preset period and monitors that the respiratory curve information within the current preset period meets the first preset condition, the ventilator parameters at this time are determined as the target ventilator parameters. The first preset condition is: within the preset period up to the present, the total number of breath-holding cycle curves is greater than the second threshold, and the proportion of reproducible breath-holding cycle curves in all the breath-holding cycle curves is not less than the third threshold. The breath-holding cycle curve is defined as taking each deep inhalation breath-holding curve segment and the N preceding free breathing cycles as a breath-holding cycle curve, where N is at least 2. That is, the breath-holding cycle curve includes the deep inhalation breath-holding curve segment and the free breathing curve segment. Wherein, the reproducible breath-holding cycle curve is defined as the breath-holding amplitude being the target breath-holding amplitude, and the breath-holding duration being the breath-holding duration in the target ventilator parameters, and the breath-holding curve fluctuating within a first preset range, and the difference between the free breathing curve segments in each of the breath-holding cycle curves is within a second preset range of several of the breath-holding cycle curves. The preset period is defined as the sum of the time periods during which the target object uses the ventilator system 100 to collect respiratory signals; Step S8: The main control module (10) determines the breathing guidance curve based on the reproducible breath-holding cycle curve within the preset period up to the present, and sends an instruction to the terminal monitor (28) to end the respiratory signal acquisition; it determines the breathing mode from the reproducible breath-holding cycle curve, and corrects the deep inspiratory breath-holding curve in the breathing mode based on the target breath-holding amplitude and breath-holding duration in the target ventilator parameters, thereby forming a breathing guidance curve, which includes a free breathing mode curve in a stable state and a deep inspiratory breath-holding mode curve; Furthermore, the ventilator system (100) also includes a respiratory guidance module (16). In the imaging mode or treatment mode of the ventilator system 100, the respiratory guidance curve is displayed in the respiratory guidance module (16) for guiding the breathing of the target object. In the imaging mode or the treatment mode, the ventilator system (100) performs support ventilation and deep inspiratory breath-hold control on the target subject based on the target ventilator parameters.

2. A medical ventilator system (100) for supporting ventilation according to claim 1, characterized in that, The ventilator (12) includes a control unit (56), an air supply device (54), and a breathing effort monitoring module (58). The ventilator (12) is connected to the breathing sensor (14) and receives the breathing curve information sent by the breathing sensor (14).

3. A medical ventilator system (100) for supporting ventilation according to claim 2, characterized in that, The operation steps of the ventilator (12) supporting ventilation and deep inhalation breath-hold control for the target object based on the initial values ​​of the ventilator parameters sent by the main control module (10) are as follows: Step S1: In the ventilation support mode of the ventilator (12), the breathing effort monitoring module 58 sends the detected breathing effort signal of the target object to the control unit (56) in the ventilator (12). The control unit (56) determines whether the current inspiratory effort is a normal inspiratory effort or a deep inspiratory effort. If it is determined to be a normal inspiratory effort, proceed to step S2; if it is determined to be a deep inspiratory effort, proceed to step S3. Step S2: The control unit (56) controls the air supply device (54) to start delivering air at a set support pressure; when the control unit (56) detects the expiratory effort of the target object, it enters the expiratory phase, and the control unit (56) controls the air supply device (54) to maintain the set positive end-expiratory pressure (PEEP) and continues to return to step S1; Step S3: If it is determined that it is a deep inhalation effort, the control unit (56) controls the air supply device (54) to start delivering air at the set support pressure. The control unit (56) receives the breathing curve information sent by the breathing sensor (14). When it is detected that the deep inhalation amplitude in the breathing curve information reaches the target breath-hold amplitude, the ventilator (12) switches to deep inhalation breath-hold control mode. The control unit (56) controls the air supply device (54) to stop delivering air. At this time, the target object enters the breath-hold state. When the breath-hold duration is reached, the control unit (56) controls the air supply device (54) to release the breath-hold control. The ventilator (12) switches to support ventilation mode. The target object resumes free breathing. At this time, it first enters the exhalation stage. The control unit (56) controls the air supply device (54) to maintain the set positive end-expiratory pressure (PEEP) and continues to return to step S1.

4. A medical ventilator system (100) for supporting ventilation according to claim 3, characterized in that, Step S6 specifically includes: Step S6.1: The ventilator (12) supports ventilation and deep inhalation breath-hold control for the target object, as shown in steps S1-S3; the terminal monitor (28) obtains and displays the respiratory curve information, physiological parameter curve and physiological parameter baseline signal of the target object from the main control module (10); Step S6.2: Medical staff monitor the breathing and physiological status of the target object through the terminal monitor (28), and determine whether to adjust the ventilator parameters based on the breathing curve information and / or the difference between the physiological parameter curve and the physiological parameter baseline signal. If yes, the medical staff adjusts the ventilator parameters through the terminal monitor (28) with a preset step value, and sends the adjustment to the control unit (56) of the ventilator (12) through the main control module (10).

5. A medical ventilator system (100) for supporting ventilation according to claim 4, characterized in that, Different preset step values ​​are set for different ventilator parameters. The preset step values ​​are determined based on the experience of medical staff or on a pre-trained model.

6. A medical ventilator system (100) for supporting ventilation according to claim 4, characterized in that, The ventilator system (100) also includes a user remote control (26). In step S6, when any of the following safety emergencies occur, medical staff will assist the target object to remove the mask urgently and then actuate to stop the ventilator (12). If the target object is in a breath-holding state before the medical staff assists the target object to remove the mask urgently, the medical staff will first send a pause breath-holding command to the main control module (10) through the terminal monitor (28), and the main control module (10) will control the ventilator (12) to pause breath-holding. Medical staff can determine whether to adjust the ventilator parameters based on the target subject's subjective feelings, the respiratory curve information, and / or the physiological parameter curves. The aforementioned security emergencies include: 1) When the main control module (10) detects that the difference between the physiological parameter curve and the physiological parameter baseline signal does not meet the safety conditions, it sends an alarm to the terminal monitor (28); 2) The target object actuates the pause ventilator button on the user remote control (26) and sends an alarm to the terminal monitor (28); 3) The target object actuates the pause breath-hold button on the user remote control (26). After receiving the pause breath-hold command transmitted by the user remote control (26), the main control module (10) controls the ventilator (12) to pause breath-holding.

7. A medical ventilator system (100) for supporting ventilation according to claim 6, characterized in that, in, The physiological parameter curves include heart rate signals and blood oxygen signals. The safety condition is defined as the difference between the heart rate signal curve and the heart rate signal baseline, and the difference between the blood oxygen signal curve and the blood oxygen signal baseline, both of which are within the normal physiological fluctuation range.

8. A medical ventilator system (100) for supporting ventilation according to claim 1, characterized in that, The ventilator system also includes a deep learning model (22), and the main control module (10) is communicatively connected to the deep learning model (22); Before the ventilator system (100) starts the preparation mode, a preliminary data acquisition phase is included to determine the initial values ​​of the ventilator parameters. The preliminary data acquisition phase includes the following steps: Step S4: The main control module (10) acquires the spontaneous breathing curve information and physiological parameter information of the target object under spontaneous breathing state, and determines the spontaneous breathing parameters of the target object and the baseline signal of the physiological parameters; Step S5: The main control module (10) transmits the autonomous breathing parameters, the acquired target object information, and the target breath-holding amplitude to the trained deep learning model (22), outputs the ventilator-related parameters, and determines the initial values ​​of the ventilator parameters in combination with the target breath-holding amplitude.

9. A medical ventilator system (100) for supporting ventilation according to claim 8, characterized in that, The parameters related to the ventilator output by the deep learning model (22) include support pressure, trigger sensitivity, end-expiratory pressure peep, pressure rise time, and breath-hold duration.

10. A medical ventilator system (100) for supporting ventilation according to claim 9, characterized in that, The main control module (10) updates the ventilator-related parameters, excluding the target breath-holding amplitude, in the target ventilator parameters to the deep learning model (22).

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