A physical intervention device based on mechanical stimulation of the nasal cavity and a control method thereof

Abstract

The application provides a physical intervention device based on nasal mechanical stimulation and a control method thereof. By setting a parameter control module, a stimulation source module, an output adjustment module and a nasal interface module, the physical intervention device can generate a control signal according to preset stimulation parameters, control the stimulation source module to generate periodic mechanical airflow or pressure pulses, and adjust the periodic mechanical airflow or pressure pulses by using the output adjustment module to form nasal mechanical stimulation matched with target requirements. Thus, controllable adjustment of the nasal mechanical stimulation parameters is realized, the stimulation form and action conditions are not limited by a fixed mode, and therefore the intervention mode can be adjusted for different physiological or pathological states, improving the adaptability, pertinence and controllability of the physical intervention. Meanwhile, the nasal mechanical stimulation is input to a subject by using the nasal interface module, which can reduce the dependence on and implementation restrictions of complex neural regulation equipment, thereby improving the intervention effect of the nasal mechanical stimulation.

Description

Technical Field

[0001] This invention relates to the field of biomedical engineering equipment technology, and in particular to a physical intervention device based on nasal cavity mechanical stimulation and its control method. Background Technology

[0002] Currently, various approaches have been developed in clinical practice and research to address local or systemic functional disorders and related lesions in organisms, including drug therapy, psychological or behavioral interventions, and neuromodulation. However, drug therapy may have issues such as adverse reactions, individual compliance differences, and drug resistance. While neuromodulation methods such as transcranial magnetic stimulation, transcranial electrical stimulation, and vagus nerve stimulation can directly or indirectly regulate central nervous system activity, they usually rely on specialized equipment and still face certain limitations in terms of cost, safety, indications, and operating conditions.

[0003] Based on this, non-invasive interventions using physical methods such as sound, light, electricity, magnetism, or mechanical stimulation, with their advantages of low side effects and relative ease of implementation, are gradually becoming a new approach for the intervention of neurological diseases. The nasal cavity, in particular, has abundant sensory nerve afferent pathways; therefore, applying periodic airflow or air pressure to the nasal cavity provides a new way to regulate related neural activity using peripheral sensory input.

[0004] Currently, nasal air pulse systems exist that can generate stimulation at specific frequencies, but they typically employ a single stimulation frequency. Meanwhile, existing ventilation, oxygen supply, anesthesia, and airway support devices can control the flow rate, pressure, concentration, or timing of gas action. However, most existing devices are designed for their specific purposes, with relatively fixed stimulation methods, operating parameters, and control mechanisms. The physiological effects produced under different parameter conditions and their relationship with the organism's state have not been fully utilized. Therefore, current technologies still have certain shortcomings in providing adaptive interventions for different physiological or pathological states and in improving the targeting and controllability of interventions. Summary of the Invention

[0005] In view of this, embodiments of the present invention provide a physical intervention device and its control method based on nasal cavity mechanical stimulation, in order to solve the problem that existing physical intervention methods have fixed stimulation parameters and are difficult to adaptively adjust for different physiological or pathological states.

[0006] To achieve the above objectives, the embodiments of the present invention provide the following technical solutions:

[0007] The first aspect of this invention discloses a physical intervention device based on nasal cavity mechanical stimulation, the physical intervention device comprising: a parameter control module, a stimulation source module, an output adjustment module, and a nasal cavity interface module;

[0008] The parameter control module is connected to the stimulation source module; the stimulation source module is connected to the output adjustment module; the output adjustment module is connected to the nasal cavity interface module.

[0009] The parameter control module is used to generate a control signal according to preset stimulation parameters and send the control signal to the stimulation source module;

[0010] The stimulation source module is used to generate periodic mechanical airflow or pressure pulses according to the control signal, and send the periodic mechanical airflow or pressure pulses to the output adjustment module;

[0011] The output adjustment module is used to adjust the periodic mechanical airflow or pressure pulse according to the preset stimulation parameters to obtain nasal mechanical stimulation and send it to the nasal interface module.

[0012] The nasal interface module is used to input the nasal mechanical stimulation into the nasal cavity of the subject.

[0013] Preferably, the stimulation source module includes a gas source and a flow regulation component;

[0014] The gas source is connected to the flow regulating component, and the flow regulating component is connected to the output regulating module;

[0015] The gas source is used to generate gas and deliver the gas to the flow regulating component;

[0016] The flow regulation component is used to adjust the on / off state and on / off time of the gas according to the control signal to obtain the periodic mechanical airflow or pressure pulse, and send the periodic mechanical airflow or pressure pulse to the output regulation module.

[0017] Preferably, the preset stimulation parameters include stimulation frequency and pulse width;

[0018] The parameter control module is used to determine the generation period of the periodic mechanical airflow or pressure pulse according to the stimulation frequency, determine the duration of a single periodic mechanical airflow or pressure pulse according to the pulse width, and generate the control signal according to the generation period and the duration.

[0019] The stimulation source module is used to generate the periodic mechanical airflow or pressure pulse according to the control signal, the generation cycle, and the duration.

[0020] Preferably, the nasal interface module includes a nasal interface and a connecting tube;

[0021] One end of the connecting pipe is connected to the output adjustment module, and the other end of the connecting pipe is connected to the nasal cavity interface;

[0022] The connecting pipe is used to receive the nasal mechanical stimulation sent by the output adjustment module and to deliver the nasal mechanical stimulation to the nasal interface.

[0023] The nasal interface is used to input the mechanical stimulation of the nasal cavity into the nasal cavity of the subject.

[0024] Preferably, the nasal interface includes at least one of a nasal cannula, a nasal ventilation cannula, a nasal catheter, a nasal plug, a nasal pillow, a nasal mask, or a face mask.

[0025] Preferably, the physical intervention device further includes a sensor feedback module;

[0026] The sensing feedback module is connected to the nasal cavity interface module and the parameter control module, respectively.

[0027] The sensing feedback module is used to collect the output status information of the nasal cavity mechanical stimulation and send the output status information to the parameter control module;

[0028] The parameter control module is used to adjust the preset stimulation parameters according to the output status information, update the control signal according to the adjusted preset stimulation parameters, and send the updated control signal to the stimulation source module.

[0029] Preferably, the sensing feedback module is further configured to collect feedback indicators of the subject, the feedback indicators including at least one of physiological signals and neural activity signals, and send the feedback indicators to the parameter control module;

[0030] The parameter control module is used to compare the feedback index with a preset target threshold, adjust the preset stimulation parameter according to the comparison result, update the control signal according to the adjusted preset stimulation parameter, and send the updated control signal to the stimulation source module.

[0031] Preferably, the physical intervention device further includes a safety protection module;

[0032] The safety protection module is connected to the sensing feedback module and the parameter control module respectively;

[0033] The safety protection module is used to receive the output status information sent by the sensing feedback module, and generate a safety control signal if the output status information meets the preset safety conditions.

[0034] The parameter control module is used to update the control signal according to the safety control signal.

[0035] Preferably, the physical intervention device further includes a user interface module and a data storage module;

[0036] The user interface module is connected to the parameter control module; the data storage module is connected to both the parameter control module and the user interface module.

[0037] The user interface module is used to receive program selection instructions and stimulation parameter setting information input by the user, and send the program selection instructions and stimulation parameter setting information to the parameter control module;

[0038] The parameter control module is used to determine the execution mode of the preset stimulation parameters according to the program selection instruction, and to determine the preset stimulation parameters according to the stimulation parameter setting information, and to generate the control signal based on the execution mode and the preset stimulation parameters;

[0039] The data storage module is used to store the execution method of the preset stimulus parameters, the preset stimulus parameters, and usage history information.

[0040] A second aspect of this invention discloses a control method for a physical intervention device based on nasal cavity mechanical stimulation, the control method comprising:

[0041] Obtain preset stimulation parameters and generate control signals based on the preset stimulation parameters;

[0042] The control signal generates periodic mechanical airflow or pressure pulses.

[0043] The periodic mechanical airflow or pressure pulse is adjusted according to the preset stimulation parameters to obtain nasal mechanical stimulation;

[0044] The mechanical stimulation of the nasal cavity is delivered to the nasal cavity interface.

[0045] Based on the above embodiments of the present invention, a physical intervention device and its control method based on nasal cavity mechanical stimulation are provided. By setting a parameter control module, a stimulation source module, an output adjustment module, and a nasal cavity interface module, the physical intervention device can generate control signals according to preset stimulation parameters and control the stimulation source module to generate periodic mechanical airflow or pressure pulses. Simultaneously, the output adjustment module adjusts the periodic mechanical airflow or pressure pulses to form nasal cavity mechanical stimulation that matches the target needs. This achieves controllable adjustment of nasal cavity mechanical stimulation parameters, freeing the stimulation form and action conditions from fixed patterns. Therefore, the intervention method can be adjusted for different physiological or pathological states, improving the adaptability, specificity, and controllability of physical intervention. Furthermore, using the nasal cavity interface module to input nasal cavity mechanical stimulation into the subject reduces reliance on complex neuromodulation devices and implementation limitations, thereby improving the intervention effect of nasal cavity mechanical stimulation. Attached Figure Description

[0046] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0047] Figure 1 A structural block diagram of a physical intervention device based on nasal cavity mechanical stimulation provided in an embodiment of the present invention;

[0048] Figure 2 Another structural block diagram of a physical intervention device based on nasal cavity mechanical stimulation provided in an embodiment of the present invention;

[0049] Figure 3 A schematic diagram of a nasal cavity interface device for humans or large animals provided in an embodiment of the present invention;

[0050] Figure 4 A schematic diagram of mechanical stimulation of the nasal cavity in rodents provided in an embodiment of the present invention;

[0051] Figure 5 This is a flowchart of a long-term intervention for low-frequency nasal stimulation provided in an embodiment of the present invention.

[0052] Figure 6 Example diagrams of the detection values ​​of the elevated cross maze open arm index, open field test index, and high-frequency gamma activity of the nasal periosteum provided in the embodiments of the present invention;

[0053] Figure 7 A flowchart illustrating a control method for a physical intervention device based on nasal cavity mechanical stimulation, provided as an embodiment of the present invention;

[0054] Figure 8 Another flowchart of a control method for a physical intervention device based on nasal cavity mechanical stimulation provided in an embodiment of the present invention. Detailed Implementation

[0055] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0056] In this application, the terms "comprising," "including," or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0057] As can be seen from the background technology, existing nasal air pulse systems typically use a single stimulation frequency. The stimulation patterns, operating parameters, and control methods of existing ventilation, oxygen supply, anesthesia, and airway support equipment are also relatively fixed, making it difficult to adaptively adjust nasal mechanical stimulation for different physiological or pathological states.

[0058] Therefore, this invention provides a physical intervention device and its control method based on nasal cavity mechanical stimulation. By setting a parameter control module, a stimulation source module, an output adjustment module, and a nasal cavity interface module, the physical intervention device can generate control signals according to preset stimulation parameters and control the stimulation source module to generate periodic mechanical airflow or pressure pulses. Simultaneously, the output adjustment module adjusts the periodic mechanical airflow or pressure pulses to form nasal cavity mechanical stimulation that matches the target needs. This achieves controllable adjustment of nasal cavity mechanical stimulation parameters, freeing the stimulation form and action conditions from being limited to fixed patterns. This allows for adjustments to the intervention method according to different physiological or pathological states, improving the adaptability, specificity, and controllability of physical intervention. Furthermore, the use of the nasal cavity interface module to input nasal cavity mechanical stimulation into the subject eliminates the need for complex neuromodulation equipment, reducing implementation limitations. Through this method, the shortcomings of existing neuromodulation methods in terms of cost, safety, and operational conditions can be overcome, and the application effect of nasal cavity mechanical stimulation intervention can be improved.

[0059] See Figure 1 The diagram illustrates a structural block diagram of a physical intervention device based on nasal cavity mechanical stimulation according to an embodiment of the present invention. The physical intervention device includes: a parameter control module 100, a stimulation source module 200, an output adjustment module 300, and a nasal cavity interface module 400.

[0060] Specifically, the parameter control module 100 is connected to the stimulation source module 200; the stimulation source module 200 is connected to the output adjustment module 300; and the output adjustment module 300 is connected to the nasal interface module 400.

[0061] The parameter control module 100 is used to generate control signals according to preset stimulation parameters and send the control signals to the stimulation source module 200.

[0062] It is understood that the parameter control module 100 can be implemented by a microcontroller, a programmable logic controller, an embedded controller, a computer, a mobile terminal application, or host computer software.

[0063] The stimulation source module 200 is used to generate periodic mechanical airflow or pressure pulses according to the control signal and send the periodic mechanical airflow or pressure pulses to the output regulation module 300.

[0064] The output adjustment module 300 is used to adjust the periodic mechanical airflow or pressure pulse according to the preset stimulation parameters to obtain nasal mechanical stimulation and send it to the nasal interface module 400.

[0065] The nasal interface module 400 is used to input mechanical stimulation into the nasal cavity of the subject.

[0066] In the specific implementation process, combined with Figure 2 As shown, the physical intervention device also includes a power module. The power module is used to supply power to each module in the physical intervention device.

[0067] It should be noted that test subjects include, but are not limited to, laboratory animals (such as rodents), non-human primates, or human subjects. Nasal mechanical stimulation can be applied to the nasal cavity, nasal inlet, nasal mucosa, olfactory epithelium, or adjacent structures, modulating nasal sensory afferent activity according to preset stimulation parameters. For different species or individuals, the fitting method can be determined by considering nasal cavity size, natural breathing patency, nasal inlet sealing, and tolerance.

[0068] Understandably, the preset stimulation parameters can be determined by the frequency generator in the parameter control module 100 based on the subject type, baseline nasal breathing state, and experimental objective. When the preset stimulation parameters include stimulation frequency and pulse width, the parameter control module 100 is used to determine the generation period of the periodic mechanical airflow or pressure pulse based on the stimulation frequency, determine the duration of a single periodic mechanical airflow or pressure pulse based on the pulse width, and generate a control signal based on the generation period and duration. The stimulation source module 200 is used to generate periodic mechanical airflow or pressure pulses according to the generation period and duration based on the control signal.

[0069] It should be noted that, in addition to stimulation frequency and pulse width, the preset stimulation parameters may also include one or more of the following: flow rate, pressure, single-pulse gas volume, duty cycle, waveform, duration of a single stimulation, number of stimulations per day, treatment course, and safety threshold. The parameter control module 100 can determine the preset stimulation parameters according to the subject type, baseline nasal breathing status, and intervention purpose, and generate control signals based on the preset stimulation parameters.

[0070] Understandably, stimulation frequency can be used as an independent and calibrable control variable. For mice, stimulation frequency can be relatively categorized as low, medium, and high based on the resting nasal respiratory rate; for example, approximately half the resting nasal respiratory rate can be used as a low-frequency condition, close to the resting nasal respiratory rate as a medium-frequency condition, and approximately twice the resting nasal respiratory rate as a high-frequency condition. For other animals or humans, the individual's baseline nasal respiratory rate or the species' physiological respiratory rate can be obtained first, and then relative frequency conversion and calibration can be performed.

[0071] In the validated mouse examples, frequencies below 3.5 Hz can be used as low-frequency conditions, such as 2 Hz; frequencies between 3.5 Hz and 4.5 Hz can be used as mid-frequency conditions, such as 4 Hz; and frequencies above 4.5 Hz can be used as high-frequency conditions, such as 7 Hz. These frequencies are used to illustrate different stimulus frequencies and do not directly equate mouse frequencies with effective frequencies in other species or humans.

[0072] In some embodiments, the stimulation source module 200 includes a gas source and a flow regulation component.

[0073] Specifically, the gas source is connected to the flow regulation component, and the flow regulation component is connected to the output regulation module 300.

[0074] The gas source generates gas and delivers it to the flow regulation component. The flow regulation component adjusts the on / off state and on / off time of the gas according to the control signal to obtain periodic mechanical airflow or pressure pulses, and sends the periodic mechanical airflow or pressure pulses to the output regulation module 300.

[0075] Understandably, the gas source can be at least one of an air pump, compressed gas source, micro fan, piezoelectric micro pump, diaphragm pump, positive pressure source, negative pressure source, or mass flow controller; the flow regulation component can be a solenoid valve or an equivalent component with gas on / off regulation function. The parameter control module 100 controls the on / off state and on / off time of the flow regulation component to make the gas source output form a periodic mechanical airflow or pressure pulse.

[0076] In one alternative implementation, such as Figure 2 As shown, a drive circuit can also be provided between the parameter control module 100 and the stimulation source module 200. The drive circuit is used to convert the control signal into an electrical signal that can drive the flow regulation component (such as a valve or pump) or the light source for research. The drive circuit in the mechanical airflow embodiment may include a relay, a power switch, a drive chip, and a solenoid valve control circuit; the non-human animal-assisted photostimulation embodiment may include a laser driver, a light-emitting diode driver, or a light pulse control circuit.

[0077] Combination Figure 2As shown, the output adjustment module 300 can adjust the periodic mechanical airflow or pressure pulse according to preset stimulation parameters. The adjustment parameters may include at least one of the following: flow rate, air source pressure, actual pressure at the nasal interface, single-pulse gas volume, flow rate adjustment component on-time, flow rate adjustment component off-time, duty cycle, waveform, and stimulation duration. The air source pressure and the actual pressure at the nasal interface can be recorded separately, and the actual pressure at the nasal interface can be measured and calibrated using a pressure sensor. For non-human animal photostimulation embodiments, the output adjustment module can adjust the light wavelength, light power, pulse width, frequency, and stimulation duration. Candidate devices intended for use in large animals or humans should also include filtration, temperature, humidity, and comfort controls.

[0078] Understandably, the waveform of a periodic mechanical airflow or pressure pulse can be a positive pressure pulse, a negative pressure pulse, an alternating positive and negative pressure pulse, or a micro-airflow oscillation. Odor components can also be mixed into the gas according to usage requirements. When using different waveforms, the output frequency, actual pressure at the nasal interface, flow rate, pulse width, and safety threshold can all be measured and calibrated.

[0079] In one embodiment of mechanical airflow in mice, the gas source pressure can be set to 6 psi, the stimulation frequency can be set to 2 Hz, 4 Hz, or 7 Hz, the single-pulse gas volume can be set to 0.4 mL, and the average gas flow rate can be set in the range of 50 mL / min to 170 mL / min. The parameter control module 100 adjusts the number of times the flow regulation component is turned on per unit time and the duration of each turn to form the corresponding stimulation frequency and pulse width.

[0080] In some embodiments, the nasal interface module 400 includes a nasal interface and a connecting tube.

[0081] Specifically, one end of the connecting tube is connected to the output adjustment module 300, and the other end is connected to the nasal cavity interface. The nasal cavity interface and connecting tube can be equipped with a fixed, sealed, and anti-detachment structure, and can be designed for easy cleaning or one-time replacement to maintain stable stimulation input direction and avoid excessive obstruction of natural breathing.

[0082] Understandably, the connecting tubing is used to receive nasal mechanical stimulation sent by the output adjustment module 300 and to deliver the nasal mechanical stimulation to the nasal interface. The nasal interface is used to input the nasal mechanical stimulation into the subject's nasal cavity.

[0083] It should be noted that the nasal interface includes at least one of the following: nasal cannula, nasal ventilation cannula, nasal duct, nasal plug, nasal pillow, nasal mask, or face mask.

[0084] For small rodents or other small animals, nasal interfaces can be implanted nasal cannulas, fixed nasal cannulas, bilateral nasal ventilation cannulas, or unilateral nasal ventilation cannulas. For large rodents, rabbits, dogs, pigs, or non-human primates, suitable cannulas, nasal plugs, or nasal masks can be designed according to the size of the nasal cavity. For large animals or humans, nasal interfaces can be non-invasive nasal cannulas, nasal plugs, nasal pillows, nasal masks, face masks, or flexible interfaces that fit snugly against the nasal inlet. Nasal interfaces should ensure stable stimulation input direction, avoid excessive obstruction of natural breathing, and be easy to fix and clean.

[0085] In some embodiments, combined with Figure 2 As shown, the physical intervention device also includes a sensor feedback module.

[0086] Specifically, the sensor feedback module is connected to the nasal cavity interface module 400 and the parameter control module 100, respectively.

[0087] The sensor feedback module is used to collect the output status information of nasal cavity mechanical stimulation and send the output status information to the parameter control module 100. The output status information may include at least one of pressure, flow rate, stimulation frequency, nasal breathing, air leakage status, and interface blockage status. The output status information can be used for data recording, preset stimulation parameter calibration, and closed-loop control.

[0088] The parameter control module 100 is used to adjust the preset stimulation parameters according to the output status information, update the control signal according to the adjusted preset stimulation parameters, and send the updated control signal to the stimulation source module 200.

[0089] In practical applications, the sensor feedback module is also used to collect feedback indicators from the test subjects. These indicators include at least one of physiological signals and neural activity signals, and are sent to the parameter control module 100. The parameter control module 100 compares the feedback indicators with a preset target threshold, adjusts the preset stimulation parameters based on the comparison results, updates the control signal based on the adjusted preset stimulation parameters, and sends the updated control signal to the stimulation source module 200.

[0090] Understandably, physiological signals can include at least one of nasal respiratory rate, blood oxygenation, heart rate, heart rate variability, skin conductance, and motor status; neural activity signals can include at least one of electroencephalogram (EEG) signals, local field potential signals, and neural calcium activity signals. Feedback indicators can be used for parameter selection, effect evaluation, or closed-loop feedback.

[0091] In animal experiments, feedback indicators may also include behavioral indicators. For example, behavioral indicators may include at least one of the following: dwell time in the open arm of the elevated cruciate maze, dwell time in the central area of ​​the open field experiment, movement speed, and total distance traveled. Neural activity signals can be used to interpret and evaluate the technical effects corresponding to different preset stimulus parameters, but the acquisition of neural activity signals does not constitute an invasive test that must be performed when the physical intervention device is in operation.

[0092] In some specific embodiments, the local field potential power in the 65Hz to 95Hz frequency band can be used as high-frequency gamma activity and as one of the feedback indicators. The parameter control module 100 compares the feedback indicator with a preset target threshold and adjusts one or more of the stimulation frequency, flow rate, pressure, pulse width, duty cycle, or stimulation duration based on the comparison result to update the control signal.

[0093] The physical intervention device can employ open-loop or closed-loop control. In open-loop control, the parameter control module 100 continuously outputs control signals according to preset stimulation parameters and their execution methods, without automatically changing the output based on real-time feedback. For example, mice can be stimulated at 2Hz for 2 hours daily for 14 consecutive days, or at 4Hz or 7Hz as different frequency conditions. In addition to frequency, the open-loop program can also preset flow rate, pressure, waveform, pulse width, duty cycle, and duration.

[0094] During closed-loop control, the sensor feedback module can first collect nasal breathing, pressure, flow rate, and optional physiological or neural activity signals within a preset time window in a quiet state to determine the baseline value and perform signal quality checks. Subsequently, the parameter control module 100 starts outputting according to the preset stimulation parameters and calculates the change of the feedback index relative to the baseline value within the sliding time window.

[0095] It should be further noted that when the feedback indicator does not reach the target range corresponding to the preset target threshold, the parameter control module 100 can adjust one or more of the following parameters according to a preset step size: stimulation frequency, flow rate, pressure, pulse width, duty cycle, or stimulation duration. When the feedback indicator reaches the target range, the current preset stimulation parameters can be maintained. When the feedback indicator cannot be reliably obtained, the system can revert to the pre-calibrated open-loop program or stop outputting. To reduce repeated switching when the feedback indicator is near the preset target threshold, a continuous judgment time and hysteresis interval can also be set.

[0096] Understandably, in combination Figure 2The closed-loop software flow, as shown, includes: device self-test; reading object and interface information; acquiring baseline; verifying signal quality; selecting open-loop or closed-loop mode; generating parameter control signals; driving the stimulus source; recording output status and feedback indicators; comparing target threshold and safety threshold; adjusting one or more parameters in limited steps; and ending when the target, maximum duration, or safety protection condition is reached. If reliable feedback cannot be obtained, the system reverts to the validated open-loop procedure or stops outputting.

[0097] In some embodiments, combined with Figure 2 As shown, the physical intervention device also includes a safety protection module.

[0098] Specifically, the safety protection module is connected to both the sensing feedback module and the parameter control module 100. The safety protection module receives output status information sent by the sensing feedback module, and generates a safety control signal if the output status information meets preset safety conditions. The parameter control module 100 updates the control signal based on the safety control signal.

[0099] Understandably, the safety protection module can set safety limits for at least one of the following: maximum output pressure, maximum output flow rate, maximum single stimulation duration, maximum daily stimulation duration, and maximum number of consecutive stimulation days. Preset safety conditions can correspond to at least one of the following: abnormal pressure, abnormal flow rate, interface blockage, interface detachment, air leakage, abnormal breathing or physiological state of the test subject.

[0100] When the output status information meets the preset safety conditions, the safety protection module generates a safety control signal. The parameter control module 100 updates the control signal according to the safety control signal to reduce, limit, or stop the output. For example, the safety protection module can perform alarm, stop output, reduce output intensity, or emergency stop protection.

[0101] For human-operated devices, at least one of the following can also be provided: a user stop button, overcurrent protection, a filter and disinfection structure, temperature and humidity limits, and a disposable nasal interface.

[0102] In some embodiments, combined with Figure 2 As shown, the physical intervention device also includes a user interface module and a data storage module.

[0103] Specifically, the user interface module is connected to the parameter control module 100; the data storage module is connected to both the parameter control module 100 and the user interface module.

[0104] Understandably, the user interface module receives user input of program selection instructions and stimulus parameter setting information, and sends these instructions and information to the parameter control module 100. The parameter control module 100 determines the execution method of the preset stimulus parameters based on the program selection instructions, determines the preset stimulus parameters based on the stimulus parameter setting information, and generates control signals based on the execution method and preset stimulus parameters. The data storage module stores the execution method of the preset stimulus parameters, the preset stimulus parameters, and usage history information.

[0105] It should be noted that the execution method of the preset stimulation parameters may include at least one of the following: fixed parameter program, phased program, frequency conversion scanning, pulse train, respiratory synchronization program, respiratory reversal program, and closed-loop program that automatically adjusts the preset stimulation parameters based on feedback indicators.

[0106] Specifically, the user interface module can be used to select a fixed-parameter program, a phased program, a comparison program, a non-human animal model program, or a personalized closed-loop program, and input stimulation parameter settings (such as setting frequency, flow rate, pressure, waveform, pulse width, duty cycle, stimulation duration, and treatment course). The data storage module can save the execution method of preset stimulation parameters, preset stimulation parameters, feedback indicators, alarm information, and usage history information to support experimental reproduction, effect tracking, and equipment quality control.

[0107] It should be noted that baseline and safety assessments can be performed before the physical intervention device is used. Animal experiments can collect data on elevated cruciate maze, open field test, movement speed, total distance traveled, nasal respiratory rate, and local field potential signals in brain regions; large animal or human devices can collect nasal respiratory rate, pressure, flow rate, heart rate, heart rate variability, skin conductance, or electroencephalography (EEG) signals for device calibration, safety monitoring, or feedback input.

[0108] For large animals or humans, the physical intervention device can first acquire a baseline of quiet nasal breathing, then generate candidate stimulation frequencies below, near, or above that baseline, and calibrate them within safe ranges for pressure, flow rate, temperature, humidity, and comfort. The output regulation module 300 may also include a filter, humidifier, or temperature control component to filter, humidify, or regulate the temperature of the gas entering the nasal cavity. Specific safety limits and candidate stimulation frequencies can be determined based on the safety, tolerability, and efficacy verification results of the respective subjects.

[0109] Physical intervention devices can be used for research or physical intervention of neurological conditions such as stress, anxiety, depression, pain, sleep, and cognitive impairment. For different physiological or pathological states, different parameter combinations can be formed by changing preset stimulus parameters, and the changing trends of different parameter combinations can be evaluated by combining feedback indicators.

[0110] For ease of understanding, see Figure 3 The diagram shows a schematic of a nasal interface device for humans or large animals.

[0111] Figure 3 Display control host, stimulation source module, safety protection module, sensor feedback module and optional non-invasive nasal interface. Figure 3 Solid lines represent airflow pathways, while dashed lines represent signal or feedback pathways. The stimulation source module outputs regulated airflow or pressure pulses, which are then introduced into the subject's nasal cavity via a nasal cannula, nasal plug, nasal pillow, or nasal mask. The sensor feedback module collects pressure, flow rate, temperature, humidity, and alarm information, and feeds it back to the control host and safety protection module.

[0112] The proposed device can be implemented in large animals or individual humans, preferably using a non-invasive nasal cannula, nasal plug, nasal pillow, or nasal mask. The control unit can be configured with frequency, flow rate, pressure, duty cycle, time period, and data display and storage functions. The stimulation source module may include a gas source, micro-pump, flow controller, pressure regulator, humidifier, filter, and temperature regulator. The safety protection module sets pressure / flow rate limits, temperature and humidity limits, alarms for interface detachment or blockage, and user emergency stop. Specific limits should be determined through safety and tolerance testing on the appropriate subjects.

[0113] A 2Hz frequency in mice cannot be directly equated to an effective human frequency. For candidate or large animal devices, a quiet nasal breathing baseline can be acquired first, and then candidate input frequencies below, near, or above that baseline can be generated and calibrated within safe limits for pressure, flow rate, and comfort. This section pertains to device translation concepts; the animal experiments described herein do not constitute direct evidence of the effectiveness or safety of the human anxiety intervention.

[0114] Combination Figure 4 The diagram illustrates mechanical stimulation of the nasal cavity in small rodents. This implementation includes an air pump, solenoid valves, relays, tubing, and bilateral nasal cannulas. The air pump provides the air supply; the relays receive pulse signals from the parameter control module; the solenoid valves open and close according to target parameters; and the tubing connects the solenoid valves to the nasal cannulas. The stimulation frequency, single-pulse gas volume, and average gas flow rate can be controlled by adjusting the trigger frequency, valve opening duration, and air supply output. The air supply pressure and the actual pressure at the nasal interface should be recorded separately; the actual interface pressure is preferably calibrated using a pressure sensor.

[0115] The working process of the mechanical airflow embodiment for mice is as follows: First, connect the bilateral nasal cannulas to the connecting tubing, start the air source and check the sealing of the connecting tubing. Then, the parameter control module 100 outputs a control signal of 2Hz, 4Hz, or 7Hz, which drives the solenoid valve to open and close via a relay. The solenoid valve generates a periodic mechanical airflow or pressure pulse with a corresponding stimulation frequency, single-pulse gas volume, and average airflow rate based on the number of openings and the duration of opening. This pulse is then introduced into the animal's nasal cavity through the connecting tubing and the bilateral nasal cannulas.

[0116] Understandable, Figure 4 The solid arrows in the diagram indicate the direction of airflow, while the dashed lines represent electrical or control signals. Figure 4 Typical parameters for a mouse mechanical airflow example are given: gas source pressure 6 psi, stimulation frequency 2 Hz, 4 Hz, or 7 Hz, single-pulse gas volume 0.4 mL, and average gas flow rate 50 to 170 mL / min. When monitoring nasal respiration rate in small rodents, the monitoring cannula can be positioned approximately 1 mm anterior to the fissure between the frontal and nasal bones and approximately 1 mm lateral to the midline, and fixed with dental cement and adhesive. This position for the nasal respiration monitoring cannula does not constitute the sole limitation on the location of the nasal interface.

[0117] It should be noted that the long-term low-frequency experiment used a 2Hz mechanical airflow for 2 hours daily for 14 consecutive days; 4Hz and 7Hz were used as comparison conditions for medium and high frequencies, respectively. The above frequency settings are only examples of parameters for mouse experiments.

[0118] See Figure 5 The flowchart of long-term intervention for low-frequency nasal stimulation is shown below. The following explanation, based on mouse experiments, illustrates the selection of preset stimulation parameters and their technical effects.

[0119] In a long-term low-frequency nasal mechanical stimulation experiment, C57BL / 6J mice can be used to establish an anxiety-like state by randomly spaced plantar electric shocks at 0.1 mA for 5 seconds each time, with stimulation intervals of 5 to 99 seconds, 100 times a day for 5 consecutive days.

[0120] After completing the baseline elevated cross maze, open field test, and local field potential recording of the nasal cortex, the experimental group received 2Hz nasal mechanical stimulation for 2 hours daily for 14 consecutive days; the control group received no mechanical airflow under the same connection and duration.

[0121] In the above experiment, male mice aged 8 to 16 weeks could be used. The experimental group sample size could be 7 mice, and the control group sample size could be 6 mice. Animal species, age, sex, and sample size are used to describe specific experimental conditions and are not intended to limit other species or individuals.

[0122] The elevated cruciate maze open arm index, open field test index, and high-frequency gamma activity in the nasal periosteum can be measured on days 1, 7, and 14. Figure 6 The contents shown (unless otherwise specified) Figure 6 The error bar represents the mean ± standard error (sem); ns indicates that the difference is not statistically significant. , , , These represent P<0.05, P<0.01, P<0.001, and P<0.0001, respectively.

[0123] Figure 6 The main results of 2Hz mechanical nasal airflow for 2 hours daily for 14 consecutive days are shown. A, B, and C represent the normalized changes in high-frequency gamma activity in the elevated cruciate maze open arm, the central area of ​​the open field test, and the perinatal cortex at baseline (BL), day 1 (D1), day 7 (D7), and day 14 (D14), respectively; LF represents the 2Hz mechanical stimulation group (n=7), and Ctrl represents the control group without mechanical airflow output at the same time course (n=6); data are presented as mean ± sem. This figure does not include data from day 21.

[0124] Depend on Figure 6 It can be determined that under the experimental conditions, the open arm index of the elevated cross maze improved on the 7th day, and the improvement increased further on the 14th day; the index of the central area of ​​the open field experiment improved on the 14th day, and the high-frequency gamma activity of the perinatal cortex increased.

[0125] Figure 6 The corresponding statistical results are as follows: On the 7th day, the open arm index of the elevated cross maze t(11) = 3.044, P = 0.004; on the 14th day, the open arm index of the elevated cross maze t(11) = 5.945, P < 0.0001; on the 14th day, the open field experiment index t(11) = 2.833, P = 0.0069; and on the 14th day, the high-frequency γ activity of the nasal periosteum t(11) = 3.490, P = 0.005.

[0126] Further testing on day 21, one week after stimulation was stopped, revealed a significant decrease in behavioral indicators and high-frequency gamma activity in the perinatal cortex compared to day 14. This result is used to supplement the understanding of the trend following prolonged low-frequency stimulation; the improvement effect during the 14-day stimulation period was primarily validated by the results from days 1, 7, and 14.

[0127] In the above experiments, 2 Hz, 2 hours daily, and 14 consecutive days constituted a validated long-term stimulation protocol. Other single-stimulation durations, daily stimulation frequencies, or consecutive stimulation days can be considered as candidate protocols for calibration and further determined based on subject type, actual pressure and flow at the nasal interface, and safety monitoring results. Wide ranges such as 5 minutes to 4 hours or 1 day to several weeks should not be directly presented as validated effective ranges. Devices intended for use in large animals or humans should first undergo interface, safety threshold, and parameter tolerance validation.

[0128] In another set of non-human animal mechanism studies used to illustrate frequency dependence, the relationship between nasal sensory afferent activity and stimulation frequency can be verified through independent light stimulation methods.

[0129] It is understood that light stimulation is an independent, non-human animal mechanism study method used to activate olfactory sensory neurons (OSNs) expressing channelrhodopsin-2 (ChR2) according to target parameters and to verify frequency-dependent behavioral and neural effects. This method is not a necessary structure for human mechanical airflow devices.

[0130] This mechanism study can use olfactory sensory neurons expressing the light-sensitive channel protein ChR2 (channelrhodopsin-2) as stimulation targets. An optical fiber (such as a blue laser, jumper wire, or fiber implanted near the nasal cavity or olfactory epithelium) is fixed in the nasal cavity or adjacent area of ​​the olfactory epithelium, and 473nm blue light is output via the optical fiber using a blue laser or light-emitting diode. The light pulse width can be set to 80ms, the power to 4mW, and the stimulation frequency to 2Hz, 4Hz, or 7Hz. This light stimulation method is used for mechanism verification and is not a necessary component of a physical intervention device to generate periodic mechanical airflow or pressure pulses.

[0131] The photostimulation implementation includes: establishing a non-human animal model expressing ChR2; fixing an optical fiber to the nasal cavity or adjacent area of ​​the olfactory epithelium; generating a light pulse signal with preset stimulation parameters by a controller; outputting the light source according to the signal; and simultaneously recording behavioral and neural indicators. This implementation demonstrates that frequency modulation of OSN activity can produce outputs in different directions, but the technical implementation of the mechanical airflow device still revolves around measurable and calibrable nasal airflow or pressure pulses.

[0132] In the aforementioned non-human animal mechanism study, under the corresponding experimental conditions, 2Hz stimulation was accompanied by increased high-frequency gamma activity in the perinasal cortex and reduced anxiety-like behavior; 7Hz stimulation was accompanied by decreased high-frequency gamma activity in the perinasal cortex and enhanced anxiety-like behavior; and 4Hz stimulation did not detect significant behavioral changes compared to the control. These experimental results are intended to illustrate that different stimulation frequencies can correspond to different neural activity and behavioral changes, and 4Hz is not defined as a neutral frequency applicable to all species or individuals.

[0133] In this embodiment of the invention, by setting a parameter control module, a stimulation source module, an output adjustment module, and a nasal interface module, the nasal stimulation parameters (frequency, intensity, duty cycle, duration, etc.) are set as independently controllable core quantities. The control module generates periodic signals to drive an air pump or solenoid valve to generate mechanical airflow or pressure pulses, achieving independent setting, calibration, and stable reproduction of parameters without relying on active breathing. Simultaneously, using the output adjustment module and sensor feedback module, closed-loop adjustment can be performed based on specific brain region neural activity and behavioral indicators, enabling directionally controllable interventions in different frequency ranges targeting disease-related states. Furthermore, the non-invasive design of the nasal interface reduces reliance on complex neuromodulation devices, improving the adaptability of the intervention and the objectivity of effect evaluation in basic research.

[0134] A physical intervention device based on nasal cavity mechanical stimulation provided in the above embodiments of the present invention is described in [reference needed]. Figure 7 The diagram illustrates a flowchart of a control method for a physical intervention device based on nasal cavity mechanical stimulation, provided by an embodiment of the present invention. The control method includes:

[0135] Step S701: Obtain preset stimulation parameters and generate control signals based on the preset stimulation parameters.

[0136] Combination Figure 8 As shown, in step S701, the subject and nasal cavity interface are first determined.

[0137] The validated embodiments used male mice aged 8 to 16 weeks and a fixed nasal interface; other species or human candidates should be adapted based on nasal cavity size, natural breathing patency, interface sealing and tolerability, and the age, sex, frequency and interface size of the mouse embodiments should not be directly extrapolated.

[0138] Baseline and safety assessments are then conducted: Animal experiments can record elevated cruciate maze, open field test, movement speed, total distance traveled, nasal respiratory rate, and local brain activity; human devices can collect information such as nasal respiratory rate, pressure, flow rate, heart rate, heart rate variability, skin conductance, or electroencephalography (EEG) for device calibration and safety monitoring, rather than directly outputting disease diagnoses. Based on this, preset stimulation parameters are determined, which may include frequency, flow rate, pressure, waveform, pulse width, duty cycle, and stimulation duration. Figure 8 The preset stimulus parameter combinations A, B, and C shown correspond to increases, no significant changes, and decreases in the target indicator relative to baseline or control, respectively. The preset stimulus parameters and evaluation indicators are not limited to... Figure 8 Examples are listed in the document.

[0139] Taking frequency as an example, the mouse validation examples used 2Hz, 4Hz and 7Hz respectively: 2Hz was used for low-frequency mechanical stimulation experiments, 4Hz did not show significant behavioral changes relative to the control under the experimental conditions, and 7Hz was used for high-frequency comparison or non-human animal model studies.

[0140] For candidate devices of other species or humans, candidate parameters should be determined based on baseline status and safety assessment. The specific effective range and safety boundaries need to be determined after species or individual calibration. This paper does not take unverified percentage ranges as experimental conclusions.

[0141] Next, the stimulation parameters are set. The preset stimulation parameters include stimulation frequency, flow rate, air source pressure, actual pressure at the nasal cavity interface, single pulse gas volume, valve opening time, duty cycle, waveform, single stimulation duration, number of stimulations per day, treatment course, and safety threshold.

[0142] Step S702: Generate periodic mechanical airflow or pressure pulses according to the control signal.

[0143] It should be noted that the verified implementation of the product involves mechanical airflow or pressure pulses, which can be generated by an air pump, compressed gas source, micro fan, piezoelectric micro pump, diaphragm pump, or mass flow controller in conjunction with a solenoid valve. Alternating positive / negative pressure or micro-airflow oscillation can be used as a mechanical equivalent, but it should meet the requirements that the output frequency, interface pressure, flow rate, pulse width, and safety threshold are measurable and calibrable.

[0144] Step S703: Adjust the periodic mechanical airflow or pressure pulse according to the preset stimulation parameters to obtain nasal mechanical stimulation.

[0145] Understandably, after generating a pulsed airflow, it is adjusted according to preset stimulation parameters, including frequency, flow rate, pressure, pulse width, and duty cycle, to ensure the output meets the set target value. During adjustment, an open-loop mode can be used to output according to the preset frequency and duration, or a closed-loop mode can be used to dynamically adjust the frequency, flow rate, pressure, pulse width, or duration based on calibrated feedback indicators (such as pressure, flow rate, and respiratory signals). When pressure, flow rate, interface status, or respiratory signal exceeds a safety threshold, the system prioritizes reducing or stopping the output. In mouse experiments, 2Hz, 4Hz, and 7Hz can be used as exemplary conditions for different frequency parameters. After the above adjustments, nasal mechanical stimulation that meets the preset requirements is obtained.

[0146] Step S704: Deliver nasal mechanical stimulation to the nasal cavity interface.

[0147] In the specific implementation step S704, the adjusted nasal mechanical stimulation is output to the subject through the nasal interface.

[0148] The nasal interface is selected based on the type of subject: for small rodents or other small animals, an implantable nasal cannula, bilateral nasal ventilation cannula, unilateral nasal ventilation cannula, or a fixed nasal interface can be used; for humans or large animals, nasal cannulas, nasal plugs, nasal pillows, nasal masks, face masks, or flexible interfaces that fit snugly into the nasal inlet can be used. The nasal interface should be connected to the stimulation source module via tubing, optical fiber, or wire, and should have a structure that is fixed, sealed, prevents dislodgement, and is easy to clean or replace once.

[0149] In practical applications, after stimulus output, evaluation indicators are recorded: animal behavioral indicators may include EPM open arm dwell time, OFT central zone dwell time, movement speed, and total movement distance; neural indicators may include electrophysiological signals and neural calcium activity signals. Candidate devices may record nasal respiratory rate, heart rate, HRV, skin conductance, EEG, or subject self-report status, but these indicators are primarily used in this application for parameter calibration, safety monitoring, or feedback input. Based on the evaluation results, device parameters can be adjusted or the procedure can be terminated. This adjustment process can return to step S701 or step S703 for parameter reset or closed-loop correction.

[0150] It should be noted that the above parameter values, animal species, experimental conditions, and statistical results are used to illustrate the specific implementation of the physical intervention device and control method, as well as the basis for parameter selection. For other animals or humans, corresponding calibrations can be made based on individual baseline nasal breathing status, safety assessment results, and feedback indicators, rather than directly extrapolating the stimulation frequency, interface size, or effectiveness conclusions in the mouse embodiment.

[0151] In this embodiment of the invention, the nasal stimulation parameters (frequency, intensity, duty cycle, and duration) are set as independent and controllable core quantities. A periodic signal is generated by the parameter control module, driving an air pump or solenoid valve to produce mechanical airflow / pressure pulses. This achieves independent parameter setting, calibration, and stable reproduction without relying on active respiratory rhythm. Simultaneously, this invention overcomes the limitations of open-loop unidirectional output by using specific brain region neural activity and behavioral indicators as the basis for closed-loop feedback. The parameters are directionally adjusted according to the baseline nasal breathing state, allowing for targeted interventions at different frequency ranges for disease-related states. Furthermore, compared to invasive central nervous system modulation tools, this invention applies non-invasive physical input through the nasal interface. Combined with output adjustment and sensor feedback structures, it significantly improves the objectivity of model building and effect evaluation in basic research and the efficiency of parameter screening while ensuring safety and reproducibility.

[0152] The various embodiments in this specification are described in a progressive manner. Similar or identical parts between embodiments can be referred to mutually. Each embodiment focuses on describing the differences from other embodiments. In particular, for system or system embodiments, since they are basically similar to method embodiments, the description is relatively simple, and relevant parts can be referred to the descriptions in the method embodiments. The systems and system embodiments described above are merely illustrative. The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the modules can be selected to achieve the purpose of this embodiment according to actual needs. Those skilled in the art can understand and implement this without creative effort.

[0153] Those skilled in the art will further recognize that the units and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, computer software, or a combination of both. To clearly illustrate the interchangeability of hardware and software, the components and steps of the various examples have been generally described in terms of functionality in the foregoing description. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementations should not be considered beyond the scope of this invention.

[0154] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A physical intervention device based on nasal cavity mechanical stimulation, characterized in that, The physical intervention device includes: a parameter control module, a stimulation source module, an output adjustment module, and a nasal interface module; The parameter control module is connected to the stimulation source module; the stimulation source module is connected to the output adjustment module; the output adjustment module is connected to the nasal cavity interface module. The parameter control module is used to generate a control signal according to preset stimulation parameters and send the control signal to the stimulation source module; The stimulation source module is used to generate periodic mechanical airflow or pressure pulses according to the control signal, and send the periodic mechanical airflow or pressure pulses to the output adjustment module; The output adjustment module is used to adjust the periodic mechanical airflow or pressure pulse according to the preset stimulation parameters to obtain nasal mechanical stimulation and send it to the nasal interface module. The nasal interface module is used to input the nasal mechanical stimulation into the nasal cavity of the subject.

2. The physical intervention device according to claim 1, characterized in that, The stimulation source module includes a gas source and a flow regulation component; The gas source is connected to the flow regulating component, and the flow regulating component is connected to the output regulating module; The gas source is used to generate gas and deliver the gas to the flow regulating component; The flow regulation component is used to adjust the on / off state and on / off time of the gas according to the control signal to obtain the periodic mechanical airflow or pressure pulse, and send the periodic mechanical airflow or pressure pulse to the output regulation module.

3. The physical intervention device according to claim 1, characterized in that, The preset stimulation parameters include stimulation frequency and pulse width; The parameter control module is used to determine the generation period of the periodic mechanical airflow or pressure pulse according to the stimulation frequency, determine the duration of a single periodic mechanical airflow or pressure pulse according to the pulse width, and generate the control signal according to the generation period and the duration. The stimulation source module is used to generate the periodic mechanical airflow or pressure pulse according to the control signal, the generation cycle, and the duration.

4. The physical intervention device according to claim 1, characterized in that, The nasal interface module includes a nasal interface and connecting tubing; One end of the connecting pipe is connected to the output adjustment module, and the other end of the connecting pipe is connected to the nasal cavity interface; The connecting pipe is used to receive the nasal mechanical stimulation sent by the output adjustment module and to deliver the nasal mechanical stimulation to the nasal interface. The nasal interface is used to input the mechanical stimulation of the nasal cavity into the nasal cavity of the subject.

5. The physical intervention device according to claim 4, characterized in that, The nasal interface includes at least one of a nasal cannula, a nasal ventilation cannula, a nasal catheter, a nasal plug, a nasal pillow, a nasal mask, or a face mask.

6. The physical intervention device according to claim 1, characterized in that, The physical intervention device also includes a sensor feedback module; The sensing feedback module is connected to the nasal cavity interface module and the parameter control module, respectively. The sensing feedback module is used to collect the output status information of the nasal cavity mechanical stimulation and send the output status information to the parameter control module; The parameter control module is used to adjust the preset stimulation parameters according to the output status information, update the control signal according to the adjusted preset stimulation parameters, and send the updated control signal to the stimulation source module.

7. The physical intervention device according to claim 6, characterized in that, The sensor feedback module is also used to collect feedback indicators of the test subject, the feedback indicators including at least one of physiological signals and neural activity signals, and send the feedback indicators to the parameter control module; The parameter control module is used to compare the feedback index with a preset target threshold, adjust the preset stimulation parameter according to the comparison result, update the control signal according to the adjusted preset stimulation parameter, and send the updated control signal to the stimulation source module.

8. The physical intervention device according to claim 6, characterized in that, The physical intervention device also includes a safety protection module; The safety protection module is connected to the sensing feedback module and the parameter control module respectively; The safety protection module is used to receive the output status information sent by the sensing feedback module, and generate a safety control signal if the output status information meets the preset safety conditions. The parameter control module is used to update the control signal according to the safety control signal.

9. The physical intervention device according to claim 1, characterized in that, The physical intervention device also includes a user interface module and a data storage module; The user interface module is connected to the parameter control module; the data storage module is connected to both the parameter control module and the user interface module. The user interface module is used to receive program selection instructions and stimulation parameter setting information input by the user, and send the program selection instructions and stimulation parameter setting information to the parameter control module; The parameter control module is used to determine the execution mode of the preset stimulation parameters according to the program selection instruction, and to determine the preset stimulation parameters according to the stimulation parameter setting information, and to generate the control signal based on the execution mode and the preset stimulation parameters; The data storage module is used to store the execution method of the preset stimulus parameters, the preset stimulus parameters, and usage history information.

10. A control method for a physical intervention device based on nasal cavity mechanical stimulation, characterized in that, The control method includes: Obtain preset stimulation parameters and generate control signals based on the preset stimulation parameters; The control signal generates periodic mechanical airflow or pressure pulses. The periodic mechanical airflow or pressure pulse is adjusted according to the preset stimulation parameters to obtain nasal mechanical stimulation; The mechanical stimulation of the nasal cavity is delivered to the nasal cavity interface.

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