Negative pressure device and method of controlling the same

Abstract

The application relates to a negative pressure device and a control method thereof. The negative pressure device comprises a flexible shell, a pump assembly, a sensor module and a controller module. The flexible shell is surrounded by a resonance cavity and is configured to be attached to a treatment area of a patient. The pump assembly is arranged in the resonance cavity and is configured to generate negative pressure in the resonance cavity. The sensor module is connected to the flexible shell and is configured to monitor physiological state information of the patient. The controller module is electrically connected to the sensor module and the pump assembly. When the negative pressure device is in a working state, the controller module controls the opening and closing of the pump assembly according to the physiological state information. The design of the negative pressure device can generate precise negative pressure traction force in a local area without relying on external devices such as masks, thereby effectively improving the wearing comfort while ensuring the airway traction effect, and significantly improving the intelligent level during the treatment process and the long-term compliance of the patient.

Description

Technical Field

[0001] This application relates to the field of medical devices, and more particularly to a negative pressure device and its control method. Background Technology

[0002] Obstructive sleep apnea (OSA) has become a global public health challenge. According to the latest epidemiological data, approximately one billion adults worldwide suffer from OSA to varying degrees. The nature of this disease is due to a decrease in the tension of the throat muscles (such as the muscles at the base of the tongue, soft palate, and lateral pharyngeal walls) during sleep, leading to anatomical narrowing or complete closure of the upper airway under the negative pressure of breathing. Summary of the Invention

[0003] This application provides a negative pressure device and its control method to address some or all of the shortcomings in the related technologies.

[0004] This application provides a negative pressure device, including a flexible housing, a pump assembly, a sensor module, and a controller module. The flexible housing encloses a resonant cavity and is configured to adhere to the treatment area of ​​a patient. The pump assembly is disposed in the resonant cavity and configured to generate negative pressure within the resonant cavity. The sensor module is connected to the flexible housing and configured to monitor the patient's physiological state information. The controller module is electrically connected to the sensor module and the pump assembly. The controller module is configured to control the opening and closing of the pump assembly based on the physiological state information when the negative pressure device is in operation.

[0005] Optionally, the flexible shell includes an adsorption port and an outer skirt. The adsorption port communicates with the resonant cavity, and the outer skirt surrounds the periphery of the adsorption port. The adsorption port is configured to adhere to the patient's treatment area, and the outer skirt is configured to deform to conform to the patient's skin.

[0006] Optionally, the negative pressure device further includes a support member disposed in the resonant cavity and forming a power unit compartment with the inner wall of the flexible shell. The pump assembly is disposed in the power unit compartment. The support member is configured to provide support for the side wall of the power unit compartment when the pump assembly is operating.

[0007] Optionally, the negative pressure device further includes an isolation bracket disposed in the power unit compartment, and the pump assembly is connected to the inner wall of the flexible housing via the isolation bracket. The isolation bracket is configured to reduce vibration transmitted from the pump assembly to the flexible housing when the pump assembly is operating.

[0008] Optionally, the isolation bracket includes at least two suspension columns, with each end of the suspension column abutting against the inner wall of the flexible housing and the pump assembly, respectively. The suspension columns are made of an elastic material.

[0009] Optionally, the negative pressure device further includes a spiral flow channel disposed in the power unit compartment and communicating with the pump assembly. The spiral flow channel is configured to guide the fluid discharged by the pump assembly to the outside of the power unit compartment when the pump assembly is operating.

[0010] Optionally, the sensor module includes a microsensor disposed on the side of the resonating cavity facing the treatment area and configured to detect characteristic vibration signals of the patient's airway tissue. And / or, the sensor module includes a vibration sensor configured to be attached to the patient's skin and detect bone conduction vibration signals. And / or, the sensor module includes a pressure sensor disposed in the resonating cavity and configured to detect adsorption pressure signals within the resonating cavity. And / or, the sensor module includes an audio frequency sensor configured to detect the patient's audio frequency signals.

[0011] This application also provides a control method for a negative pressure device, applied to the negative pressure device described above. The control method includes: controlling a pump assembly to start at an initial rotational speed and acquiring the patient's current initial state signal through a sensor module; controlling the sensor module to acquire the patient's real-time state signal and comparing the real-time state signal with the initial state signal; determining whether the patient's real-time state signal has undergone a step change compared to the initial state signal; if the determination result is yes, controlling the pump assembly to increase its rotational speed and traction the patient's subcutaneous soft tissue through a resonance cavity; if the determination result is no, controlling the sensor module to continue acquiring the patient's real-time state signal.

[0012] Optionally, the control pump assembly starts at a low speed and acquires the patient's current initial state signal through the sensor module, including: controlling the pump assembly to start at a low speed and acquiring the pressure signal within the resonance cavity through the sensor module. It is then determined whether the rate of increase of the pressure signal is lower than a preset threshold. If the determination result is yes, a leak alarm signal is issued. If the determination result is no, the patient's current initial state signal is acquired through the sensor module.

[0013] Optionally, after traction of the patient's subcutaneous soft tissue through the resonant cavity, the method further includes: determining whether the intervention duration of the negative pressure device exceeds a preset working time. If the determination result is yes, then controlling the pump assembly to reduce its rotation speed and releasing the negative pressure in the resonant cavity.

[0014] Optionally, after controlling the pump assembly to reduce its rotational speed and release the negative pressure in the resonance cavity, the method further includes: controlling the sensor module to continue acquiring the patient's real-time status signal within a preset rebound time. It is determined whether the real-time status signal still differs from the initial status signal. If the determination is yes, the pump assembly is controlled to increase its rotational speed after the preset rebound time, and the patient's subcutaneous soft tissue is re-tractioned through the resonance cavity. If the determination is no, the pump assembly is controlled to maintain its current rotational speed, and the sensor module is controlled to continue acquiring the patient's real-time status signal.

[0015] Optionally, if the determination result is yes, controlling the pump assembly to increase its rotation speed and traction the patient's subcutaneous soft tissue through the resonance cavity includes: The pump assembly speed is increased step by step according to a preset step value, and the real-time status signal of the patient is detected by the sensor module after each adjustment. Determine whether the patient's real-time status signal has recovered to the initial status signal range; If the determination result is yes, then control the pump assembly to maintain the current speed; If the determination result is negative, the speed of the pump assembly will continue to be adjusted according to the preset step value until the real-time status signal returns to the initial status signal range.

[0016] Optionally, after determining that if the determination result is yes, the pump assembly is controlled to maintain the current speed, the method further includes: Determine whether the patient's real-time status signal is maintained for more than a first preset duration within the initial status signal interval; If the determination result is yes, then control the pump assembly to reduce its speed to the initial speed.

[0017] Optionally, if the determination result is yes, after controlling the pump assembly to increase its rotation speed and traction the patient's subcutaneous soft tissue through the resonant cavity, the method further includes: Obtain the current rotational speed of the pump assembly; If the current speed of the pump assembly has reached the maximum speed, and after running for a second preset period of time, the real-time status signal is still different from the initial status signal, then an alarm signal is issued.

[0018] Optionally, after issuing the alarm signal, the method further includes: The patient's level of obstruction is determined based on the real-time status signal; In response to the blockage level, a corresponding protection action is performed; wherein the protection action includes at least one of the following actions: sending an emergency alarm message to the mobile terminal, emitting an alarm sound, and controlling the pump assembly to switch between increasing and decreasing the speed.

[0019] The technical solutions provided by the embodiments of this application may include the following beneficial effects: As can be seen from the above embodiments, the negative pressure device of this application, through the adsorption seal between the flexible shell and the skin, can generate precise negative pressure traction force locally without relying on external devices such as masks. Therefore, the negative pressure device of this application effectively improves wearing comfort while ensuring airway traction, and significantly enhances the level of intelligence in the treatment process and the patient's long-term compliance.

[0020] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and are not intended to limit this application. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the negative pressure device in one embodiment of this application.

[0023] Figure 2 This is a schematic diagram of the resonating cavity of the negative pressure device in one embodiment of this application.

[0024] Figure 3 This is a side view of the flexible housing of the negative pressure device in one embodiment of this application.

[0025] Figure 4 This is a schematic diagram of the power unit compartment of the negative pressure device in one embodiment of this application.

[0026] Figure 5 This is a flowchart illustrating the control method of a negative pressure device in one embodiment of this application.

[0027] Figure 6 This is a schematic diagram of a gas leak alarm in one embodiment of this application.

[0028] Figure 7 This is a schematic diagram of the process of the negative pressure device rebounding after timeout in one embodiment of this application.

[0029] Figure 8 This is a schematic diagram of the step adjustment process in one embodiment of this application.

[0030] Figure 9 This is a reference diagram showing the use of the negative pressure device in one embodiment of this application.

[0031] Figure 10This is a reference diagram showing the use of the negative pressure device in another embodiment of this application.

[0032] Explanation of reference numerals in the attached figures: 100. Negative pressure device; 1. Flexible shell; 11. Resonance cavity; 12. Adsorption port; 13. Outer skirt; 2. Pump assembly; 3. Support component; 31. Power unit compartment; 4. Isolation bracket; 41. Suspension column; 5. Spiral flow channel. Detailed Implementation

[0033] The technical solutions in the embodiments (or "implementations") of this application will be clearly and completely described herein with reference to the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements.

[0034] If the embodiments of this application contain terms relating to directional indications or positional relationships (such as up, down, left, right, front, back, inside, outside, top, bottom, center, vertical, horizontal, longitudinal, transverse, length, width, counterclockwise, clockwise, axial, radial, circumferential, etc.), such terms are only used to explain the relative positional relationships and movement of the components in a specific posture (as shown in the attached figures); if the specific posture changes, the directional indications or positional relationships will also change accordingly. Furthermore, the terms "first" and "second" used in the embodiments of this application are only for descriptive convenience and should not be construed as indicating or implying relative importance.

[0035] Obstructive sleep apnea (OSA) has become a global public health challenge. According to the latest epidemiological data, approximately one billion adults worldwide suffer from OSA to varying degrees. The nature of this disease is due to a decrease in the tone of the muscles in the throat (including but not limited to: the muscles at the base of the tongue, the muscles of the soft palate, and the muscles of the lateral pharyngeal wall) during sleep, leading to anatomical narrowing or complete closure of the upper airway under the negative pressure of breathing.

[0036] Currently, standard treatment options for OSA each have their own advantages and disadvantages. Among them, continuous positive airway pressure (CPAP) is widely recognized as the "gold standard" for the treatment of this disease. CPAP uses a mask to inject positive pressure air into the airway to solve the problem of breathing apnea in patients.

[0037] However, long-term adherence to CPAP is extremely poor, with approximately 30% to 50% of patients discontinuing treatment due to intolerance of the claustrophobia, nasal dryness, bloating, skin pressure sores, and constriction of the ventilator tubing caused by the mask. In view of this, this application provides a negative pressure device and its control method.

[0038] like Figure 1 and Figure 2 As shown, this application provides a negative pressure device 100, including a flexible housing 1, a pump assembly 2, a sensor module (not shown in the figure), and a controller module (not shown in the figure). The flexible housing 1 encloses a resonance cavity 11 and is configured to adhere to the treatment area of ​​the patient. The pump assembly 2 is disposed in the resonance cavity 11 and configured to generate negative pressure within the resonance cavity 11. The sensor module is connected to the flexible housing 1 and configured to monitor the patient's physiological state information. The controller module is electrically connected to the sensor module and the pump assembly 2. The controller module is configured to control the opening and closing of the pump assembly 2 based on the physiological state information when the negative pressure device 100 is in operation.

[0039] In this application, the pump assembly 2 is integrated inside the resonance cavity 11 of the flexible shell 1, making the negative pressure device 100 a wireless, wearable, integrated structure. This eliminates the need for larger external devices such as masks, significantly reducing the size and weight of the treatment equipment and improving patient comfort and ease of use. The flexible shell 1 can be directly attached to the patient's treatment area (including but not limited to the jaw, neck, and larynx), generating precise negative pressure traction locally through the resonance cavity 11, thereby stretching the subcutaneous soft tissue outward and expanding the upper airway cross-sectional area. Simultaneously, the sensor module can monitor the patient's physiological status information in real time, including but not limited to vibration signals of airway tissue, vibration signals of the skin surface, or pressure signals within the resonance cavity. The controller module then intelligently controls the opening and closing and rotation speed of the pump assembly 2 based on this information. Therefore, the negative pressure device 100 can promptly initiate intervention when it detects signs of airway collapse, and maintain low-speed standby or stop operation when the airway is clear, avoiding damage to skin tissue caused by continuous high negative pressure. It achieves intelligent control of intervention on demand, effectively reduces the incidence of skin ecchymosis, and improves patient compliance with long-term use.

[0040] In an optional embodiment, combined with Figure 2 and Figure 3 As shown, the flexible shell 1 includes an adsorption port 12 and an outer skirt 13. The adsorption port 12 is connected to the resonance cavity 11, and the outer skirt 13 surrounds the periphery of the adsorption port 12. The adsorption port 12 is configured to adsorb onto the patient's treatment area, and the outer skirt 13 is configured to deform to conform to the patient's skin.

[0041] Specifically, in this embodiment, the flexible shell 1 has an adsorption port 12 on the side facing the patient's skin. The adsorption port 12 serves as an opening connecting the resonance cavity 11 to the outside, providing a direct channel for negative pressure transmission to the skin surface. An outer skirt 13 surrounds the adsorption port 12, forming a flexible structure extending outwards. When the pump assembly 2 is activated and generates negative pressure within the resonance cavity 11, the negative pressure at the adsorption port 12 is transmitted to the skin surface, causing the flexible shell 1 to adhere to the treatment area. Simultaneously, the outer skirt 13 undergoes adaptive deformation under negative pressure, tightly conforming to the skin surface, thereby filling irregular depressions (such as Adam's apple undulations, neck folds, etc.) and forming a reliable seal. Through this design, the outer skirt 13 achieves a tight fit to complex skin structures through its own flexible deformation, constructing a good sealing barrier around the adsorption port 12, effectively reducing the risk of air leakage from the negative pressure device 100, ensuring the stability of the negative pressure within the resonance cavity 11, and thus guaranteeing the effectiveness and reliability of airway traction.

[0042] In optional embodiments, such as Figure 1 and Figure 2 As shown, the negative pressure device 100 also includes a support member 3, which is disposed in the resonance cavity 11 and forms a power unit compartment 31 with the inner wall of the flexible shell 1. The pump assembly 2 is disposed in the power unit compartment 31. The support member 3 is configured to provide support for the side wall of the power unit compartment 31 when the pump assembly 2 is working.

[0043] Specifically, in this embodiment, a support member 3 is provided inside the resonance cavity 11. The support member 3 separates a portion of the space in the resonance cavity 11, forming an independent power unit compartment 31 together with the inner wall of the flexible shell 1. The pump assembly 2 is installed inside this power unit compartment 31. When the pump assembly 2 is working, the vibration and negative pressure pulsation generated by its operation may be transmitted to the side wall of the flexible shell 1, causing deformation or vibration of the side wall, affecting the sealing effect and wearing stability. Therefore, the support member 3 provides rigid or semi-rigid support at the side wall of the power unit compartment 31 through its own structural strength, so that the space around the pump assembly 2 maintains a stable shape and will not collapse due to negative pressure or vibration. Through this design, the support member 3 divides a stronger structural area inside the flexible shell 1, effectively ensuring the stability of the internal space of the flexible shell 1 when the pump assembly 2 is working, avoiding the obstruction of the operation of the pump assembly 2 or the aggravation of vibration due to shell deformation, and also reducing the possibility of adsorption failure due to cavity deformation, further improving the reliability and operational stability of the negative pressure device 100.

[0044] In optional embodiments, such as Figure 4As shown, the negative pressure device 100 also includes an isolation bracket 4, which is disposed in the power unit compartment 31. The pump assembly 2 is connected to the inner wall of the flexible housing 1 through the isolation bracket 4. The isolation bracket 4 is configured to reduce the vibration transmitted from the pump assembly 2 to the flexible housing 1 when the pump assembly 2 is working.

[0045] Specifically, in practical applications, when the pump assembly 2 is working, its internal rotating structure generates mechanical vibrations. If these vibrations are directly transmitted to the flexible housing 1, they will be transmitted to the patient's neck skin, causing discomfort and even disrupting sleep. In this embodiment, the pump assembly 2 is not directly and rigidly connected to the inner wall of the flexible housing 1, but is flexibly connected through the isolation bracket 4. The isolation bracket 4, through its own elastic damping characteristics, can absorb and dissipate some of the vibration energy generated by the pump assembly 2, thereby reducing the vibration amplitude transmitted to the flexible housing 1. Thus, a structure that provides a buffer for the vibration transmission path is formed between the pump assembly 2 and the inner wall of the flexible housing 1. Through this design, the isolation bracket 4 achieves vibration decoupling between the pump assembly 2 and the flexible housing 1, effectively reducing the mechanical vibration transmitted to the skin surface during the operation of the pump assembly 2, reducing the patient's vibration illusion and discomfort when wearing it, and significantly improving the comfort and quietness of the negative pressure device 100 during long-term wear.

[0046] In an optional embodiment, the isolation bracket 4 includes at least two suspension columns 41, with both ends of the suspension columns 41 abutting against the inner wall of the flexible housing 1 and the pump assembly 2, respectively. The suspension columns 41 are made of an elastic material.

[0047] Specifically, in this embodiment, the isolation bracket 4 adopts a multi-point suspension method, supporting the pump assembly 2 within the power unit compartment 31 via suspension columns 41. Each suspension column 41 has its two ends abutting against the inner wall of the flexible housing 1 and the outer shell of the pump assembly 2, respectively. When the pump assembly 2 vibrates, the vibration energy is first transmitted to one end of the connected suspension column 41. Since the suspension column 41 is made of an elastic material (e.g., but not limited to: silicone, rubber, etc.), it can undergo elastic deformation, thereby converting mechanical energy into internal energy and dissipating it, resulting in a significant attenuation of the vibration energy transmitted to the inner wall of the flexible housing 1. Simultaneously, the multi-point distributed suspension columns 41 can support the pump assembly 2 from different directions, maintaining a stable spatial position within the power unit compartment 31 and preventing additional noise or impact caused by shaking. Through this design, the suspension columns 41 made of elastic material constitute a flexible suspension system for the pump assembly 2, effectively isolating the mechanical vibration generated by the pump assembly 2 while ensuring the installation stability of the pump assembly 2. Furthermore, the simple structure and easy assembly of the suspension column 41 facilitate efficient vibration reduction within a limited space, further enhancing the noise reduction performance and wearing comfort of the negative pressure device 100.

[0048] In optional embodiments, such as Figure 4 As shown, the negative pressure device 100 also includes a spiral flow channel 5, which is disposed in the power unit compartment 31 and communicates with the pump assembly 2. The spiral flow channel 5 is configured to guide the fluid discharged by the pump assembly 2 to the outside of the power unit compartment 31 when the pump assembly 2 is working.

[0049] Specifically, in actual working scenarios, while pump assembly 2 draws air from the resonance chamber 11 to establish negative pressure, it also needs to guide its own high-pressure exhaust gas to the outside of the negative pressure device 100 to prevent gas from accumulating in the power unit chamber 31 and generating back pressure, which would affect the working efficiency of pump assembly 2. In this embodiment, the spiral flow channel 5 is connected to the exhaust port of pump assembly 2 and extends spirally along the inner wall or internal space of power unit chamber 31. When pump assembly 2 is working, the exhaust high-speed airflow enters the spiral flow channel 5, flows along the spiral path, and is finally discharged into the ambient air outside power unit chamber 31. Due to the design of the spiral flow channel 5, the airflow undergoes multiple turns and expansions as it flows through the spiral path, causing its flow velocity to gradually decrease and its energy to gradually dissipate. Through this design, the spiral flow channel 5 not only provides a smooth exhaust path for the gas discharged by pump assembly 2, avoiding back pressure accumulation, but also uses the spiral structure to extend the airflow path, playing a role in noise reduction and effectively reducing exhaust noise, further optimizing the patient's user experience.

[0050] In optional embodiments, the specific type and arrangement of the sensor modules can be flexibly configured according to actual monitoring needs to achieve multi-dimensional physiological state information collection. This application does not impose any limitations in this regard.

[0051] In one exemplary embodiment, the sensor module may include a microsensor disposed on the side of the resonance cavity 11 facing the treatment area and configured to detect characteristic vibration signals of the patient's airway tissue. Specifically, the microsensor (which may be a MEMS (Micro-Electro-Mechanical Systems) microphone or accelerometer) is positioned within the resonance cavity 11 directly opposite the airway and communicates with the cavity via an acoustically permeable and waterproof membrane. When the patient's airway tissue vibrates weakly at a characteristic frequency (e.g., irregular tremors around 380 Hz) before collapse, this vibration signal is transmitted through the skin and tissue to the resonance cavity 11 and captured by the microsensor. This design allows the microsensor to be positioned close to the airway tissue, thereby acquiring vibration signals at the closest possible location to the signal source, effectively improving the signal-to-noise ratio and sensitivity, and providing the controller module with accurate identification of pre-collapse precursors.

[0052] In another exemplary embodiment, the sensor module may further include a vibration sensor configured to adhere to the patient's skin and detect the patient's bone-conducted vibration signals. Specifically, the vibration sensor is embedded inside the edge of the flexible housing 1, directly pressed against the skin on the side of the neck. It acquires the patient's own physiological vibration signals through bone conduction, such as, but not limited to, vibrations of breath sounds, heartbeat sounds, or snoring transmitted to the skull and cervical bones. This bone-conducted vibration signal is not affected by airflow sounds from the oral cavity or nasal cavity, and has strong resistance to environmental noise. With this design, the vibration sensor can serve as a redundant verification of the acoustic signals within the resonance cavity 11. When both sensors detect consistent abnormal signals, the controller module can more reliably determine the occurrence of airway collapse, thereby effectively avoiding false triggering caused by environmental noise and body movement interference.

[0053] In another exemplary embodiment, the sensor module may further include a pressure sensor disposed in the resonance cavity 11 and configured to detect the adsorption pressure signal of the resonance cavity 11. Specifically, the pressure sensor is integrated at the air inlet to monitor the negative pressure value within the resonance cavity 11 in real time. Based on the feedback signal from the pressure sensor, the controller module can determine whether the sealing condition is good (e.g., but not limited to: whether the pressure rise rate is normal), whether the negative pressure has reached the target value, and when a pulse depressurization operation needs to be performed. Through this design, the pressure sensor provides core feedback parameters for the closed-loop control of the negative pressure device 100, enabling the system to accurately control the magnitude and duration of the negative pressure, avoiding intervention failure or skin damage caused by excessively high or low negative pressure.

[0054] In another exemplary embodiment, the sensor module may further include an audio frequency sensor configured to detect the patient's audio frequency signals. Specifically, the audio frequency sensor (e.g., but not limited to, a microphone) can monitor snoring signals emitted by the patient during sleep. By analyzing the frequency and intensity of the snoring, the patency of the airway can be indirectly assessed. When snoring exhibits specific frequency or intensity changes, it can serve as an auxiliary criterion for judging whether airway collapse is imminent. Through this design, the audio frequency sensor provides the negative pressure device 100 with an additional, non-contact monitoring method, further enriching the dimensions of physiological state information and improving the accuracy and reliability of recognizing signs of impending collapse.

[0055] like Figure 5 As shown, this application also provides a control method for a negative pressure device 100, applied to the negative pressure device 100 as described above. This method is used to control the intelligent intervention process of the negative pressure device 100 during a patient's sleep. The control method includes the following steps: Step S101: Control pump assembly 2 to start at initial speed and acquire the patient's current initial state signal through sensor module.

[0056] After the patient puts on the negative pressure device 100 and starts the device, the controller module first controls the pump assembly 2 to start at a low speed, establishing an initial negative pressure in the resonance chamber 11, allowing the flexible shell 1 to adhere to the patient's neck skin and complete the seal. Subsequently, the sensor module begins to work, collecting the patient's current physiological state signal as an initial state signal. This initial state signal reflects the patient's baseline physiological parameters under airway patency, such as, but not limited to, the baseline pressure value in the resonance chamber 11, the baseline vibration spectrum of subcutaneous tissue, and the baseline snoring intensity. Through this design, the system can establish a unique "baseline" of the patient's current state before intervention, providing a reliable reference benchmark for subsequent real-time monitoring and anomaly detection, avoiding misjudgments due to individual differences, and improving monitoring accuracy.

[0057] Step S102: Control the sensor module to acquire the patient's real-time status signal and compare the real-time status signal with the initial status signal.

[0058] In low-speed standby mode, the sensor module continuously acquires the patient's real-time status signals and compares these signals with previously stored initial status signals. This comparison process may include, but is not limited to, analysis of changes in signal amplitude, frequency spectrum shifts, and energy changes in characteristic frequencies. Through this design, the system can continuously track the dynamic shift of the patient's physiological state relative to a baseline, thereby promptly detecting abnormal trends when the physical state of the airway changes, laying the foundation for rapid subsequent response.

[0059] Step S103: Determine whether the patient's real-time status signal has undergone a step change compared to the initial status signal.

[0060] The controller module analyzes the difference between the real-time state signal and the initial state signal to determine whether the difference constitutes a "step change," i.e., a significant and sustained change in signal characteristics within a short time window. Examples include, but are not limited to, a characteristic high-frequency vibration in the pressure waveform within the resonance chamber 11, or a surge in energy at a specific frequency detected by the vibration sensor. This step change typically corresponds to an early warning sign of airway collapse. Through this design, the system can utilize this step change characteristic to distinguish between normal physiological fluctuations (such as changes in respiratory rhythm) and early warning signs of airway collapse, thereby achieving precise identification of the intervention timing, avoiding unnecessary continuous adsorption, and reducing skin fatigue.

[0061] Step S104: If the determination result is yes, then control the pump assembly 2 to increase the rotation speed and pull the patient's subcutaneous soft tissue through the resonance cavity 11.

[0062] When the controller module determines that the real-time status signal has undergone a step change compared to the initial status signal, it confirms that the patient's airway is collapsing. At this time, the controller module immediately controls the pump assembly 2 to increase its speed via PWM (Pulse Width Modulation) commands, rapidly establishing a high negative pressure (e.g., -40 cmH2O) within the resonance chamber 11. Under the traction of the negative pressure, the patient's subcutaneous connective tissue is stretched outward, thereby moving soft tissues such as the base of the tongue forward, expanding the cross-sectional area of ​​the upper airway, and allowing the patient to resume unobstructed breathing. Through this design, the system achieves a rapid switch from "monitoring" to "intervention," initiating effective physical traction before or at the moment airway collapse occurs. Precise negative pressure intervention replaces continuous strong suction, minimizing the continuous stimulation of the skin by negative pressure while ensuring therapeutic efficacy.

[0063] Step S105: If the determination result is negative, the control sensor module continues to acquire the patient's real-time status signal.

[0064] When the real-time status signal does not change abruptly compared to the initial status signal, it indicates that the patient's airway is currently open and negative pressure intervention is unnecessary. At this time, the controller module controls the pump assembly 2 to maintain low-speed operation and controls the sensor module to continue acquiring the patient's real-time status signal for continuous monitoring. Through this design, the system maintains a low-power standby monitoring mode when no intervention is required, reducing energy consumption and noise while avoiding unnecessary interference to the patient, thereby improving the patient's overall sleep quality and wearing comfort.

[0065] In optional embodiments, such as Figure 6 As shown, step S101 further includes the following sub-steps: Step S101a: Control the pump assembly 2 to start at low speed and obtain the pressure signal in the resonance cavity 11 through the sensor module.

[0066] After the pump assembly 2 starts at low speed, the pressure sensor begins to monitor the pressure change in the resonance cavity 11 over time and obtains the pressure rise curve.

[0067] Step S101b: Determine whether the rise rate of the pressure signal is lower than a preset threshold.

[0068] The controller module calculates the rate of rise of the pressure signal and compares it with a preset rate threshold. If the seal between the flexible housing 1 and the skin is good, the negative pressure in the resonance chamber 11 should build up rapidly with the operation of the pump assembly 2, and the pressure rise rate should be high. Conversely, if there is a leak in the seal, the rate of negative pressure buildup will be significantly slower, and the pressure rise rate will be lower.

[0069] Step S101c: If the determination result is yes, then issue a gas leak alarm signal.

[0070] If the rate of increase of the pressure signal is lower than the preset threshold, it indicates that there is an air leak in the system, which may be due to improper wearing or uneven skin surface leading to a poor seal. At this time, the controller module issues an air leak alarm signal (e.g., but not limited to: sounding an audible alarm or sending a push notification to a mobile device) to remind the patient to readjust the wearing position. Through this design, the system completes a self-check of the seal before officially entering monitoring mode, ensuring the effectiveness of subsequent negative pressure establishment and intervention, and avoiding intervention failure due to air leaks.

[0071] Step S101d: If the determination result is negative, the patient's current initial state signal is obtained through the sensor module.

[0072] If the rate of increase of the pressure signal is not lower than a preset threshold, it indicates that a seal has been successfully established. At this point, the system officially enters monitoring mode, and the sensor module begins to collect the patient's current initial state signal as a benchmark for subsequent judgment. Through this design, the system establishes a baseline only after confirming a reliable seal, ensuring the accuracy and effectiveness of the initial state signal.

[0073] In optional embodiments, such as Figure 7 As shown, after step S104, the control method further includes the following steps: Step S106: Determine whether the intervention time of the negative pressure device 100 exceeds the preset working time.

[0074] After the pump assembly 2 increases its rotation speed and begins to traction the subcutaneous soft tissue, the controller module starts timing to monitor the duration of a single negative pressure intervention in real time. The preset working time is the maximum single adsorption time set according to the skin microcirculation safety threshold (e.g., but not limited to: 15 minutes, 20 minutes, etc.).

[0075] Step S107: If the determination result is yes, then control the pump assembly 2 to reduce the speed and release the negative pressure in the resonance chamber 11.

[0076] When the duration of a single intervention reaches the preset working time, it indicates that the local skin tissue has been under continuous pressure for an extended period. Maintaining high negative pressure may inhibit capillary blood perfusion, leading to bruising or pressure sores. At this point, the controller module controls the pump assembly 2 to reduce its speed and releases the negative pressure within the resonance chamber 11 via a pressure relief valve or by stopping the pump, allowing the skin tissue to "rest" and restore microcirculation. Through this design, the system introduces a "pulse rebound" pressure relief mechanism, actively interrupting prolonged continuous negative pressure, effectively protecting local tissue blood perfusion, significantly reducing the incidence of negative pressure-induced skin bruising, and making long-term nighttime wear possible.

[0077] In an optional embodiment, after step S107, the control method further includes the following steps: Step S108: Control the sensor module to continue acquiring the patient's real-time status signal within the preset rebound time.

[0078] After depressurization, the system does not immediately return to a high negative pressure state, but first enters a preset rebound observation period (e.g., but not limited to: 5 minutes or 10 minutes). During this period, the sensor module continues to work, collecting physiological state signals of the patient under this low negative pressure or normal pressure state.

[0079] Step S109: Determine whether the real-time state signal still has a difference compared to the initial state signal.

[0080] The controller module will compare the real-time status signal collected during the rebound observation period with the initial status signal again to determine whether the difference between the two still exists.

[0081] Step S110: If the determination result is yes, then after the preset rebound time, control the pump assembly 2 to increase the rotation speed, and re-traction the patient's subcutaneous soft tissue through the resonance cavity 11.

[0082] If, after the rebound observation period, the real-time status signal still shows a significant difference compared to the initial status signal, it indicates that the patient's airway collapse risk has not been eliminated and external negative pressure traction support is still required. At this time, the controller module again controls the pump assembly 2 to increase its speed, re-establish high negative pressure, and traction the subcutaneous soft tissue, entering the next intervention cycle. Through this design, the system can autonomously determine whether to restart the intervention based on the patient's real-time physiological state after pulse depressurization, realizing intelligent closed-loop control of "monitoring-intervention-depressurization-re-monitoring-re-intervention." This ensures the continuity of intervention while minimizing unnecessary negative pressure adsorption, further improving the safety and comfort of treatment.

[0083] Step S111: If the determination result is negative, control the pump assembly 2 to maintain the current speed and control the sensor module to continue to acquire the patient's real-time status signal.

[0084] If, after the rebound observation period, the real-time status signal no longer shows a significant difference compared to the initial status signal, it indicates that the patient's airway remains open in the current state, and no immediate further intervention is required. At this time, the system control pump component 2 maintains low-speed standby operation and continues to monitor in real time via the sensor module, responding only when the next signs of collapse appear. Through this design, the system can automatically exit the high negative pressure intervention mode when the airway is restored to open, avoiding overtreatment, saving energy, and providing the patient with a more natural and comfortable sleep experience.

[0085] In optional embodiments, such as Figure 8 As shown, step S104 further includes: Step S104a: The rotation speed of pump assembly 2 is increased step by step according to the preset step value, and the real-time status signal of the patient is detected by the sensor module after each adjustment.

[0086] To avoid excessive treatment or excessive vibration of the negative pressure device 100 due to excessive one-time movement of the pump assembly 2, which would reduce the patient's experience, the controller module in this application adopts a step-by-step adjustment strategy. Each time, the speed of the pump assembly 2 is gradually adjusted according to a preset step value (e.g., 2% to 5% of the maximum speed), and the real-time status signal of the patient is re-detected after each adjustment.

[0087] Step S104b: Determine whether the patient's real-time status signal has recovered to the initial status signal range.

[0088] After each step adjustment, the controller module will reassess whether the patient's real-time status signal has returned to the initial status signal range.

[0089] Step S104c: If the determination result is yes, then control the pump assembly 2 to maintain the current speed.

[0090] When the patient's real-time status signal has returned to the initial status signal range, the speed adjustment is stopped and the current speed is maintained.

[0091] Step S104d: If the determination result is negative, continue to adjust the speed of pump assembly 2 according to the preset step value until the real-time status signal returns to the initial status signal range.

[0092] If the patient's real-time status signal does not return to the initial status signal range after one step adjustment, the next step adjustment is performed until the real-time status signal is restored. This step adjustment strategy effectively avoids problems such as excessive negative pressure and significant vibration caused by excessive adjustment in a single step, making the treatment intervention process more stable and comfortable, and effectively improving patient comfort and user experience.

[0093] In an optional embodiment, after step S104c, the method further includes: Step S104e: Determine whether the patient's real-time status signal has been maintained for more than a first preset duration within the initial status signal interval.

[0094] Step S104f: If the determination result is yes, then control the pump assembly 2 to reduce the speed to the initial speed.

[0095] After the speed is adjusted to a suitable speed, the controller module checks whether the patient's real-time status signal remains within the initial status signal range for more than a first preset duration. This first preset duration can be determined according to the effective treatment time in the actual working scenario, such as 5 minutes or 10 minutes. Therefore, the negative pressure device 100 can ensure effective therapeutic intervention under appropriate suction force.

[0096] In optional embodiments, such as Figure 5 As shown, after step S104, the following steps are also included: Step S112: Obtain the current speed of pump assembly 2.

[0097] The controller module obtains the current speed of pump assembly 2.

[0098] Step S113: If the current speed of pump assembly 2 has reached the maximum speed, and after running for a second preset time, the real-time status signal is still different from the initial status signal, then an alarm signal is issued.

[0099] If pump assembly 2 has been running at maximum speed for a second preset duration (e.g., but not limited to: 1 minute, 2 minutes, or 3 minutes), but the patient's real-time status signal still differs from the dehumidification status signal, indicating that the patient's breathing obstruction problem has not been resolved, it means that the current negative pressure device 100 is no longer able to meet the patient's intervention needs. In this case, the controller module will issue an alarm signal. Through this design, the system can promptly identify situations where the negative pressure device 100 cannot handle the situation, and then issue an alarm signal to remind the patient or other accompanying personnel to take timely measures to prevent the patient from developing more serious problems due to persistent breathing difficulties.

[0100] In an optional embodiment, after step S113, the method further includes: Step S114: Determine the patient's level of obstruction based on the real-time status signal.

[0101] The controller module classifies the patient's airway obstruction status into different levels (e.g., but not limited to: mild obstruction, moderate obstruction, severe obstruction, etc.) based on the degree of deviation between the real-time status signal and the initial status signal.

[0102] Step S115: In response to the blockage level, execute the corresponding protection action; wherein the protection action includes at least one of the following actions: sending an emergency alarm message to the mobile terminal, emitting an alarm sound, and controlling the pump assembly to switch between increasing and decreasing the speed.

[0103] For different levels of obstruction, the controller module executes corresponding protection measures. For example, if the patient's current state signal cannot be restored to its initial state, but the sensor module detects that the patient's airway vibration frequency, respiratory rate, and other physiological characteristics are still close to normal, it is determined to be a minor obstruction. In this case, the pump assembly 2 can be repeatedly controlled by increasing, decreasing, increasing, and decreasing the pump speed to improve the intervention effect. If the sensor module detects a significant difference between the patient's current state signal and normal, it is determined to be a moderate obstruction. An alarm message can be sent to the mobile device for backup to alert the patient and their family. If the sensor module detects that the patient's breathing has stopped or the airway is completely blocked, it is determined to be a severe obstruction. In this case, an alarm sound can be emitted directly through a speaker or buzzer to wake the patient or their companion. Through this design, the negative pressure device 100 can proactively intervene and respond in stages when effective intervention is not possible, providing multi-layered safety protection for the patient and effectively preventing more serious consequences caused by airway obstruction, further improving the reliability and safety of the device.

[0104] In practical application scenarios, such as Figure 9 As shown, the negative pressure device 100 of this application is used in the following way: Before going to bed, Mr. A placed the negative pressure device 100 on his neck below his chin. After double-clicking the pressure sensing area on the back of the device or activating it via the mobile terminal, the pump assembly 2 slightly started, beginning to operate at an initial speed and establishing preliminary negative pressure within the resonance chamber 11. During this process, the outer skirt 13, under the action of negative pressure, tightly adhered to Mr. A's neck skin, adaptively filling the recessed area on the side of the Adam's apple, completing a reliable seal. Simultaneously, the pressure sensor in the sensor module monitored the rate of pressure rise within the resonance chamber 11 in real time, and the system determined that the seal was established normally. Subsequently, the mobile app displayed "Seal established successfully, initial pressure -10cmH2O," and the system entered silent monitoring mode.

[0105] After Mr. A falls asleep, the negative pressure device 100 enters a low-speed standby state. The miniature sensor in the resonance chamber 11 continuously collects signals such as airflow and tissue vibration, and monitors the spectrum in real time through the FFT (Fast Fourier Transform) algorithm. At this time, Mr. A is in a side-lying position, his airway remains open, the system maintains low-energy operation, and the operating noise is lower than the ambient noise, so it does not affect Mr. A's sleep.

[0106] At 2:00 AM, Mr. A turned to a supine position. Gravity caused his tongue to fall back, and his airway began to exhibit weak, irregular vibrations with a characteristic frequency of 380Hz. The miniature sensor within the resonance chamber 11 instantly captured this precursor signal of collapse and compared it with the initial state signal. The controller module recognized the step change in the signal and immediately increased the rotation speed of the pump assembly 2 within 1.5 seconds via a PWM command, causing the negative pressure within the resonance chamber 11 to rapidly rise to the therapeutic value of -40cmH2O.

[0107] Under the traction of high negative pressure, Mr. A's subcutaneous connective tissue in his neck was stretched outward by approximately 4.5 mm, significantly increasing the cross-sectional area of ​​the upper airway and restoring smooth breathing. After 20 minutes of continuous intervention, the controller module determined that the single intervention duration had reached the preset working time and then actively executed a "pulse rebound" depressurization operation, controlling the pump assembly 2 to reduce its speed and lowering the negative pressure in the resonance chamber 11 to -20 cmH2O to restore skin microcirculation. During this period, the sensor module continued to collect Mr. A's physiological state signals. Five minutes later, the system determined that the risk of Mr. A's airway collapse had not been eliminated and again controlled the pump assembly 2 to increase its speed to restore the treatment pressure. This cycle was repeated until dawn.

[0108] At 7:00 AM, Mr. A woke up, removed the negative pressure device 100, and checked the overnight report via his mobile app. The report showed that his AHI (Apnea-Hypopnea Index) had decreased from 35 breaths / hour at baseline to 5 breaths / hour, his average blood oxygen saturation remained above 94%, and there were no obvious redness or bruising on his neck.

[0109] It should be noted that, in Figure 9 In the illustrated embodiment, a suitable amount of biocompatible adhesive can be applied to the side of the negative pressure device 100 facing the patient's skin to facilitate adhesion of the negative pressure device 100 to the patient's skin; alternatively, a similar adhesive material can be used to adhere the negative pressure device 100 to the patient's skin surface, thereby improving the stability and accuracy of the negative pressure device 100 during use. This application does not impose any limitations on this.

[0110] In such Figure 10 In the illustrated embodiment, this application can also use a strap wrapped around the patient's neck to secure the negative pressure device 100 to the patient's throat. The strap can be, but is not limited to, Velcro, snap fasteners, or stretchable elastic materials, etc., and this application does not impose any limitations on this.

[0111] Therefore, it can be seen that the negative pressure device 100 has a variety of fitting methods in this application, and different usage plans can be selected according to the preferences and specific physical conditions of different patients, thereby significantly expanding the applicable scenarios of the negative pressure device 100 and improving the user experience of patients.

[0112] It should be noted that the technical solutions or features described in the above embodiments can be combined or supplemented with each other without conflict. The scope of protection of this application is not limited to the precise structures described in the above embodiments and shown in the accompanying drawings; all modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A negative pressure device, characterized in that, include: A flexible shell is provided to form a resonant cavity and is configured to adhere to the patient's treatment area. A pump assembly is disposed in the resonant cavity and configured to generate negative pressure within the resonant cavity; A sensor module, connected to the flexible housing, is configured to monitor the patient's physiological state information; as well as The controller module is electrically connected to the sensor module and the pump assembly; The controller module is configured to control the opening and closing of the pump assembly based on the physiological state information when the negative pressure device is in operation.

2. The negative pressure device according to claim 1, characterized in that, The flexible shell includes an adsorption port and an outer skirt. The adsorption port is connected to the resonant cavity, and the outer skirt surrounds the periphery of the adsorption port. The adsorption port is configured to adsorb onto the patient's treatment area, and the outer skirt is configured to deform to conform to the patient's skin.

3. The negative pressure device according to claim 1, characterized in that, The negative pressure device further includes a support member disposed in the resonance cavity and forming a power unit compartment with the inner wall of the flexible shell; the pump assembly is disposed in the power unit compartment; wherein, the support member is configured to provide support for the side wall of the power unit compartment when the pump assembly is working.

4. The negative pressure device according to claim 3, characterized in that, The negative pressure device further includes an isolation bracket, which is disposed in the power unit compartment, and the pump assembly is connected to the inner wall of the flexible housing through the isolation bracket; wherein, the isolation bracket is configured to reduce the vibration transmitted from the pump assembly to the flexible housing when the pump assembly is working.

5. The negative pressure device according to claim 4, characterized in that, The isolation bracket includes at least two suspension columns, the two ends of which abut against the inner wall of the flexible housing and the pump assembly, respectively; wherein the suspension columns are made of elastic material.

6. The negative pressure device according to claim 3, characterized in that, The negative pressure device further includes a spiral flow channel, which is disposed in the power unit compartment and communicates with the pump assembly; wherein, the spiral flow channel is configured to guide the fluid discharged by the pump assembly to the outside of the power unit compartment when the pump assembly is working.

7. The negative pressure device according to claim 1, characterized in that, The sensor module includes a microsensor disposed on the side of the resonant cavity facing the treatment area and configured to detect characteristic vibration signals of the patient's airway tissue. And / or, the sensor module includes a vibration sensor configured to be attached to the patient's skin and detect bone conduction vibration signals from the patient; And / or, the sensor module includes a pressure sensor disposed in the resonant cavity and configured to detect the adsorption pressure signal of the resonant cavity; And / or, the sensor module includes an audio sensor configured to detect the patient's audio signals.

8. A control method for a negative pressure device, characterized in that, The control method is applied to the negative pressure device as described in any one of claims 1 to 7, and includes: The control pump assembly starts at the initial speed and acquires the patient's current initial state signal through the sensor module; The sensor module is controlled to acquire the patient's real-time status signal and compare the real-time status signal with the initial status signal. Determine whether the patient's real-time status signal has undergone a step change compared to the initial status signal; If the determination result is yes, then control the pump assembly to increase the rotation speed and pull the patient's subcutaneous soft tissue through the resonance cavity; If the determination result is negative, the sensor module is controlled to continue acquiring the patient's real-time status signals.

9. The control method for the negative pressure device according to claim 8, characterized in that, The control pump assembly starts at a low speed and acquires the patient's current initial state signal through the sensor module, including: The control pump assembly starts at low speed and acquires the pressure signal inside the resonance cavity through the sensor module; Determine whether the rate of increase of the pressure signal is lower than a preset threshold; If the determination result is yes, a gas leak alarm signal will be issued; If the determination result is negative, the patient's current initial state signal is obtained through the sensor module.

10. The control method for the negative pressure device according to claim 8, characterized in that, After the patient's subcutaneous soft tissue is pulled through the resonant cavity, the procedure further includes: Determine whether the intervention time of the negative pressure device exceeds the preset working time; If the determination result is yes, then control the pump assembly to reduce the speed and release the negative pressure in the resonance chamber.

11. The control method for the negative pressure device according to claim 10, characterized in that, After controlling the pump assembly to reduce its rotational speed and releasing the negative pressure in the resonant cavity, the method further includes: The sensor module is controlled to continue acquiring the patient's real-time status signal within a preset rebound time. Determine whether the real-time state signal still differs from the initial state signal; If the determination result is yes, then after the preset rebound time, the pump assembly is controlled to increase the rotation speed, and the patient's subcutaneous soft tissue is re-tractioned through the resonance cavity; If the determination result is negative, the pump assembly is controlled to maintain the current speed, and the sensor module is controlled to continue to acquire the patient's real-time status signal.

12. The control method for the negative pressure device according to claim 8, characterized in that, If the determination result is yes, then control the pump assembly to increase its rotation speed and pull the patient's subcutaneous soft tissue through the resonance cavity, including: The pump assembly speed is increased step by step according to a preset step value, and the real-time status signal of the patient is detected by the sensor module after each adjustment. Determine whether the patient's real-time status signal has recovered to the initial status signal range; If the determination result is yes, then control the pump assembly to maintain the current speed; If the determination result is negative, the speed of the pump assembly will continue to be adjusted according to the preset step value until the real-time status signal returns to the initial status signal range.

13. The control method for the negative pressure device according to claim 12, characterized in that, After determining that if the result is yes, the pump assembly is controlled to maintain the current speed, the method further includes: Determine whether the patient's real-time status signal is maintained for more than a first preset duration within the initial status signal interval; If the determination result is yes, then control the pump assembly to reduce its speed to the initial speed.

14. The control method for the negative pressure device according to claim 8, characterized in that, If the determination result is yes, then after controlling the pump assembly to increase its rotation speed and pulling the patient's subcutaneous soft tissue through the resonance cavity, the method further includes: Obtain the current rotational speed of the pump assembly; If the current speed of the pump assembly has reached the maximum speed, and after running for a second preset period of time, the real-time status signal is still different from the initial status signal, then an alarm signal is issued.

15. The control method for the negative pressure device according to claim 14, characterized in that, After issuing the alarm signal, the following is also included: The patient's level of obstruction is determined based on the real-time status signal; In response to the blockage level, a corresponding protection action is performed; wherein the protection action includes at least one of the following actions: sending an emergency alarm message to the mobile terminal, emitting an alarm sound, and controlling the pump assembly to switch between increasing and decreasing the speed.

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