Spring impact abdominal pressure driven assisted sputum suction instrument coordinated with bistable airway quick opening valve

Abstract

This invention provides an auxiliary expectorant device that combines spring-loaded abdominal pressure actuation with a bistable airway quick-opening valve. The device includes an airway valve unit comprising a valve body, a valve plate assembly, and a magnetic coupling drive assembly. The valve body is a hollow tubular structure with a proximal interface matching the external interface of a standard tracheostomy cannula and a distal interface communicating with the expiratory outlet. The spring-loaded abdominal pressure device generates an impact time of 80–100 ms, highly matching the abdominal pressure establishment phase (70–110 ms) in patients with relaxed abdominal walls. The 12° distal head-side deflection trajectory guided by an arc-shaped guide rail is determined through biomechanical optimization, maximizing the effective component of the intra-abdominal pressure increment along the thoracic-abdominal hydraulic transmission axis, increasing the intra-thoracic pressure transmission increment by approximately 10–15% compared to pure vertical pressure application. An abdominal wall compliance adaptive calibration mechanism ensures that patients with relaxed abdominal walls receive a stable and effective intra-abdominal pressure increment each time.

Description

Technical Field

[0001] This invention relates to the field of respiratory rehabilitation medical device technology, and in particular to an auxiliary expectorant device that combines spring-driven abdominal pressure with a bistable airway quick-opening valve. It is especially suitable for ventilator-dependent patients with complete high cervical spinal cord injury (C1-C4) resulting in complete loss of cough muscle strength, as well as patients whose peak cough flow (CPF) is below the effective airway clearance threshold due to other reasons. Background Technology

[0002] Normal coughing relies on the coordinated work of the diaphragm (innervated by C3-C5), intercostal muscles (innervated by T1-T12), and abdominal muscles (innervated by T6-L1) to generate sufficient intrathoracic pressure in a short time, driving a high-speed airflow to expel airway secretions. In patients with complete high cervical spinal cord injury, all of the above muscle groups are paralyzed, and the peak cough flow rate is usually below 60 L / min, far below the 160 L / min threshold required for effective airway clearance. This makes them highly susceptible to recurrent pulmonary infections, which is a major cause of death in these patients.

[0003] Existing cough assist devices have the following main shortcomings: First, mechanical cough assist devices (MI-E) are bulky, expensive, and complex to operate, making them unsuitable for independent home use by patients; second, inflatable abdominal binders can only provide static continuous pressure, with inflation times much slower than the physiological cough dynamics requirements, resulting in a force transmission efficiency of less than 30% for relaxing the abdominal wall; third, existing airway control valves require 30–50 ms to open, and cannot guarantee safe airway opening in the event of a power outage; fourth, existing devices lack a timing coordination mechanism with the ventilator, posing safety risks of patient-ventilator asynchrony and excessive peak airway pressure. Summary of the Invention

[0004] The purpose of this invention is to provide an auxiliary cough device that combines spring-driven abdominal pressure with a bistable airway quick-opening valve. This device replaces the static compression of the inflatable cuff with the transient release of energy from a pre-stored disc spring; it shortens the airway opening time to 8–12 ms using a bistable disc spring valve and achieves a safe self-locking characteristic that opens upon power failure; the 12° end-head deflection trajectory guided by an arc-shaped guide rail is determined through biomechanical optimization to maximize the effective component of the intra-abdominal pressure increment along the thoracic-abdominal hydraulic transmission axis, increasing the intra-thoracic pressure transmission increment by approximately 10–15% compared to pure vertical pressure application; and it uses a T-type ventilator coordination interface to achieve timing synchronization and parasitic energy reuse with existing ventilators.

[0005] To solve the above-mentioned technical problems, one technical solution adopted in this application is: to provide an auxiliary expectorant device that combines spring-driven abdominal pressure with a bistable airway quick-opening valve, comprising: The airway valve body unit includes a valve body, a valve plate assembly, and a magnetic coupling drive assembly. The valve body is a hollow tubular structure with a proximal interface conforming to YY / T 0339 and ISO 5361 standards and matching the size of the standard endotracheal cannula's outer interface, and a distal interface communicating with the exhalation outlet. The valve plate assembly is placed in the inner cavity of the valve body and includes a composite plate composed of a pair of disc springs, a silicone sealing membrane, and a magnetic steel backing plate stacked sequentially. The pair of disc springs is snapped together and installed on a positioning seat that matches the inner diameter of the valve body, forming two self-locking states, a stable closed position and a stable fully open position, on both sides of the geometric critical point. The magnetic coupling drive assembly is fixed to the magnetically transparent section of the outer wall of the valve body. The abdominal impact unit includes a positioning plate, a rigid backplate, a disc spring assembly, a pre-inflated cylinder, an arc-shaped guide rail, an anatomical contouring impact head, a fast-release electromagnetic lock, and a travel-limiting buffer pad. The rigid backplate is fixed to the patient's back, providing reaction force support for the impact. One end of the pre-inflated cylinder is fixedly connected to the inner side of the rigid backplate, and the other end is connected to the disc spring assembly via a piston rod, applying a pre-tension force to the disc spring assembly. The rated pre-compression elastic potential energy of the disc spring assembly is 1.5–3.0 J, and the peak impact force after energy release is 80–150 N. The fast-release electromagnetic lock is located between the disc spring assembly and the anatomical contouring impact head, releasing within 5 ms after receiving a trigger signal. The elastic potential energy of the disc spring assembly drives the anatomical contouring impact head to move along the arc-shaped guide rail. The coordination and linkage unit includes a signal receiving module, a delay control module, and a drive output module, which are electrically connected to the magnetic coupling drive component of the airway valve body unit and the fast-release electromagnetic latch of the abdominal impact unit B. The delay control module takes the falling edge of the fast-release electromagnetic latch release signal as the starting point of T0 timing. After a delay of 75-90ms, the drive output module outputs a flip drive pulse to the magnetic coupling drive component. Combined with the 8-12ms flip time of the valve plate component, the airway valve body unit switches from the closed position to the fully open position within 85±20ms after T0 (i.e., within 65-105ms after T0). The abdominal cavity accumulated pressure drives the airflow to be exhaled explosively through the fully open airway, generating an auxiliary cough airflow with a peak flow rate of not less than 160L / min.

[0006] As a further preferred embodiment of this technical solution: the magnetic coupling drive assembly includes a pulse electromagnet and a permalloy magnetic shielding shell. The pulsed magnetic field generated by the pulse electromagnet penetrates the outer wall of the valve body and acts on the magnetic steel back plate, applying a transient thrust of no more than 0.5N to make the disc spring cross the geometric critical point and spontaneously flip to the fully open position. The flipping time is 8 to 12 ms.

[0007] As a further preferred embodiment of this technical solution: the track curve of the arc-shaped guide rail causes the impact head to move along the direction perpendicular to the abdominal wall in the initial segment of the stroke, and deflects 12° toward the patient's head at the end of the stroke, with an impact duration of 80-100ms; the stroke limiting buffer pad is fixed at the end of the arc-shaped guide rail, structurally limiting the maximum impact stroke to 25-35mm.

[0008] As a further preferred embodiment of this technical solution: the disc spring pair is made of Ti-6Al-4VELI medical-grade titanium alloy, and the pre-deformation of the disc spring is set at 5% beyond the geometric critical point, so that the system can stably lock itself in the closed position when there is no external force; the silicone sealing film is made of medical-grade silicone material with a thickness of 0.15-0.25mm, and forms an airtight connection with the inner wall of the valve body; the magnetically transparent section of the outer wall of the valve body is made of medical-grade PEEK material with a thickness not exceeding 2mm.

[0009] As a further preferred embodiment of this technical solution: the airway valve body unit also includes a normally open return spring, an electromagnetic latch, a supercapacitor backup normally open valve and a physical limit pin, forming a triple power failure protection mechanism. The normally open reset spring has a spring force of 0.08 to 0.12 N. During normal operation, it is overcome by the electromagnetic latch, and when the power is off, it drives the valve plate assembly to return to the fully open position. The supercapacitor backup normally open valve is powered by a supercapacitor with a rated capacity of 2 to 5F, and maintains the airway open for no less than 90 seconds after the main power is cut off. The physical limiting pin is used to manually insert into the pin hole reserved on the side wall of the valve body, mechanically preventing the valve plate assembly from entering the closed position.

[0010] As a further preferred embodiment of this technical solution: the airway valve body unit also includes a double-layer medical titanium mesh interceptor screen, which is located 4-6mm downstream of the valve plate assembly, with a mesh size not exceeding 0.3mm; the consumable housing of the airway valve body unit is embedded with an RFID chip, which is used to record the rated number of uses and cooperates with the coordination and linkage unit C to implement forced life management.

[0011] As a further preferred embodiment of this technical solution: the contact surface of the anatomical contouring impact head is a double-bladed arc structure, including a left-bladed contact surface, a right-bladed contact surface, and a central groove located between the two blades; The central groove has a depth of 6-10 mm and a width of 20-30 mm, which is adapted to the anatomical shape of the xiphoid process; The contact surface of the double-leaf arc structure is lined with a medical-grade silicone buffer layer with a Shore hardness of 20-30A. The buffer layer is embedded with an array of micro force sensing units for real-time monitoring of the uniformity of impact pressure distribution.

[0012] As a further preferred embodiment of this technical solution: the abdominal impact unit also includes an abdominal wall pre-detection mechanism; the abdominal wall pre-detection mechanism controls the anatomical contour impact head to contact the abdominal wall with a low force of no more than 8N, records the force-displacement curve and calculates the real-time stiffness of the abdominal wall through the force sensing unit, and when the patient has an indwelling catheter, it prioritizes the use of the intra-abdominal pressure baseline value obtained by the catheter bypass pressure sensor to jointly set the pretension of the disc spring group; when the patient does not have a catheter, it automatically switches to a degraded working mode that calculates the pretension separately based on the abdominal wall stiffness data, with a target effective intra-abdominal pressure increment of 30-80cmH2O, so that the effective intra-abdominal pressure increment transmitted by each impact for patients with different abdominal wall compliance is stably maintained within this target range.

[0013] As a further preferred embodiment of this technical solution, it also includes a T-type ventilator coordination interface, wherein the three interface ends of the T-type ventilator coordination interface are: the ventilator side end that connects to the ventilator air delivery circuit, the patient side end that connects to the tracheostomy tube, and the functional side end that connects to the airway valve body unit. The ventilator's side end cavity is equipped with a miniature axial flow impeller connected to a permanent magnet generator, which converts the kinetic energy of the ventilator's delivered air into electrical energy to drive the disc spring assembly to tension, with the additional airway pressure drop not exceeding 0.3 cmH2O; it is also equipped with two pressure sampling ports 20 mm apart along the airflow direction, which identify the ventilator's working phase through a differential pressure sensor and lock the trigger time of the cough assist sequence within the end-expiratory pause window.

[0014] As a further preferred embodiment of this technical solution: the airway valve body unit is a disposable sterile consumable, sterilized with ethylene oxide, and discarded entirely after a single use; The abdominal band liner and silicone cushioning layer in the abdominal impact unit that come into contact with the patient's body surface are detachable.

[0015] As a further preferred embodiment of this technical solution: the coordinated linkage unit also includes a real-time abdominal pressure monitoring module; the real-time abdominal pressure monitoring module collects the intra-abdominal pressure change curve in real time during the impact process through force sensing units deployed on the contact surface of the anatomical contour impact head, and uses the moment when the intra-abdominal pressure difference exceeds the preset pressure trigger threshold as the actual trigger point instead of the fixed delay, and sends a flipping drive pulse to the magnetic coupling drive component to achieve precise closed-loop synchronization between the airway opening moment and the actual peak moment of intra-abdominal pressure; the pressure trigger threshold is automatically set by the abdominal wall pre-detection data in the range of 10-50cmH2O according to the patient's abdominal wall compliance.

[0016] As a further preferred embodiment of this technical solution: the coordination and linkage unit has a built-in impact count counter to record the cumulative number of energy release impacts of the disc spring assembly; when the cumulative number of impacts exceeds a preset maintenance threshold, an audible and visual alarm is triggered to prompt for inspection, and the preset maintenance threshold is set to 10,000 times; the coordination and linkage unit also monitors the performance status of the disc spring assembly in real time based on the peak force data of each impact collected by the force sensing unit. If the peak force of three consecutive impacts is lower than 80% of the target value, a spring performance insufficiency alarm is triggered, prompting the spring to be repaired or replaced.

[0017] The embodiments of the present invention have the following advantages due to the adoption of the above technical solutions: 1. The bistable disc spring airway quick-opening valve shortens the valve opening time to 8-12ms, and with the triple physical power-off protection mechanism, it meets the core requirement of YY / T0708 that a single fault does not endanger the patient's life.

[0018] 2. The spring-loaded abdominal compression device generates an impact time of 80–100 ms, which closely matches the physiological cough abdominal muscle contraction time window. The 12° cephalic deflection trajectory guided by the arc-shaped guide rail is determined through biomechanical optimization: the initial vertical compression segment efficiently compresses the abdominal contents along the normal direction of the transverse abdominal fascia, maximizing the peak intra-abdominal pressure; the final 12° cephalic deflection directs the resultant impact force component toward the lower surface of the diaphragm, guiding the increase in intra-abdominal pressure toward the thoracic cavity, minimizing the deviation from the hydraulic transmission axis of the thoracic and abdominal cavities, and increasing the intra-thoracic pressure transmission increment by about 10–15% compared to the pure vertical compression scheme; the abdominal wall compliance adaptive calibration mechanism ensures that patients with relaxed abdominal walls receive a stable and effective increase in intra-abdominal pressure each time.

[0019] 3. The T-type ventilator coordination interface enables parasitic energy reuse (additional airway pressure drop not exceeding 0.3 cmH2O) and millisecond-level timing synchronization (phase synchronization accuracy at trigger time ±15ms, overall timing uncertainty of cough sequence approximately ±20ms), eliminating the risk of human-machine aggression from a mechanical structure perspective.

[0020] 4. The airway valve unit (A) is designed with disposable sterile consumables to completely eliminate the risk of cross-infection; the abdominal impact unit (B) is a permanently reusable main unit that supports patients' independent use at home.

[0021] The above overview is for illustrative purposes only and is not intended to be limiting in any way. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features of the invention will become readily apparent from the accompanying drawings and the following detailed description. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of this application 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 some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is a block diagram of the overall system of the cough aid device of the present invention; Figure 2 This is an exploded view of the mechanical structure of the airway valve body unit (A) of the present invention; Figure 3 (a) and (b) are schematic diagrams of the working principle of the bistable disc spring quick-opening valve (11) of the present invention in two stable states. Figure 4 This is a schematic diagram of the motion trajectory of the arc-shaped guide rail of the abdominal power unit of the present invention and the 12° deflection at the end. Figure 5 This is a cross-sectional view of the internal structure of the T-type ventilator coordination interface (12) of the present invention; Figure 6 This is a timing diagram of the cough auxiliary sequence of the present invention (three stages from T0 to T2).

[0024] Reference numerals: A, Airway valve body unit; B, Abdominal impact unit; C, Coordination and linkage unit; 10a-1, Rigid backplate; 10b, Disc spring assembly; 10c, Pre-charge cylinder; 10d, Arc-shaped guide rail; 10e, Anatomical contour impact head; 10e-1, Miniature force sensing unit; 10f, Quick-release electromagnetic latch; 10g, Stroke limit buffer pad; 11, Valve body; 11a, Valve plate assembly; 11a-1, Disc spring pair; 11a-2, Silicone sealing membrane; 11a-3, Magnetic steel backplate; 1 1b. Magnetic coupling drive assembly; 11b-1. Pulse electromagnet; 11b-2. Permalloy magnetic shielding shell; 11d. Normally open reset spring; 11e. Electromagnetic latch; 11f. Supercapacitor backup normally open valve; 11g. Physical limit pin; 11i. Double-layer medical titanium mesh interception screen; 12. T-type ventilator coordination interface; 12-1a. Miniature axial flow impeller; 12-1b. Permanent magnet generator; 12-2a. Upstream pressure sampling port; 12-2b. Downstream pressure sampling port; 12-3. Unidirectional isolation membrane. Detailed Implementation

[0025] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0026] like Figure 1-6As shown, the present invention provides an auxiliary expectorant device that combines spring-driven abdominal pressure actuation with a bistable airway quick-opening valve, comprising: Airway valve body unit A includes valve body 11, valve plate assembly 11a, and magnetic coupling drive assembly 11b. Valve body 11 is a hollow tubular structure with a proximal interface that conforms to YY / T 0339 and ISO 5361 standards and matches the size of the standard tracheal cannula's outer interface, and a distal interface that communicates with the exhalation outlet. Valve plate assembly 11a is placed in the inner cavity of valve body 11 and includes a composite plate composed of disc spring pair 11a-1, silicone sealing film 11a-2, and magnetic steel back plate 11a-3 stacked in sequence. Disc spring pair 11a-1 is snapped onto a positioning seat that matches the inner diameter of valve body 11 and forms two self-locking states, a stable closed position and a stable fully open position, on both sides of the geometric critical point. Magnetic coupling drive assembly 11b is fixed to the magnetically transparent section of the outer wall of valve body 11. The abdominal impact unit B includes a positioning plate 10a, a rigid back plate 10a-1, a disc spring assembly 10b, a pre-charge cylinder 10c, an arc-shaped guide rail 10d, an anatomical contour impact head 10e, a fast-release electromagnetic lock 10f, and a travel-limiting buffer pad 10g. The rigid back plate 10a-1 is fixed to the patient's back, providing reaction force support for the impact. One end of the pre-charge cylinder 10c is fixedly connected to the inner side of the rigid back plate 10a-1, and the other end is connected to the disc spring assembly 10b via a piston rod, applying pre-tension to the disc spring assembly 10b. The fast-release electromagnetic lock 10f is positioned between the disc spring assembly 10b and the anatomical contour impact head 10e, releasing within 5ms after receiving a trigger signal. The elastic potential energy of the disc spring assembly 10b drives the anatomical contour impact head 10e to move along the arc-shaped guide rail 10d. The coordination and linkage unit C is based on an ARM Cortex-M4 microcontroller (72MHz main frequency) and integrates a signal receiving module, a precision delay control module, and an H-bridge drive output module. The signal receiving module receives the release pulse (signal level 5V, pulse width ≥1ms) of the fast-release electromagnetic latch 10f through an optocoupler isolator, and starts a precision timer (timing resolution ≤1ms) with the falling edge of the pulse as T0. The delay control module delays for 75-90ms after T0 (default setting 82ms, which can be automatically adjusted within ±7ms based on the abdominal wall stiffness data obtained from the abdominal wall pre-detection) to generate a drive trigger signal. The drive output module outputs a rectangular pulse current with a peak current ≥500mA and a pulse width of 8-15ms. This drives the pulse electromagnet 11b-1 to generate a flipping magnetic field. Combined with the 8-12ms flipping time of the valve assembly 11a, the valve assembly 11a completes full-opening switching within 85±20ms after T0 (i.e., within 65-105ms after T0). The abdominal cavity pressure drives the airflow to be exhaled explosively through the fully open airway, generating an auxiliary cough airflow with a peak flow rate of not less than 160L / min. The system is equipped with an abnormal detection logic: if no valve flipping completion signal is detected within 20ms after the drive pulse output (feedback from the Hall sensor S_valve, which is fixed in the permanent host slot and has a rated sensing distance of 2±0.5mm from the magnetic steel backplate 11a-3), an audible and visual alarm is triggered, and the triple power-off protection mechanism is forcibly activated. At the same time, the fault event is recorded in the RFID chip for maintenance traceability. After the airway valve body unit A (disposable consumable) is installed in the airway, it achieves precise positioning by engaging the positioning boss on the mounting interface with the positioning groove on the permanent main unit. This ensures that after each consumable replacement, the axial deviation between the Hall sensor S_valve and the magnetic steel backplate 11a-3 does not exceed ±0.3mm and the radial deviation does not exceed ±0.5mm. Within this accuracy range, the amplitude change of the Hall sensor output signal does not exceed 5%, which does not affect the reliable identification of the flip-over completion signal. There is no need to recalibrate the sensor after each installation.

[0027] By adopting the above solution, the millisecond-level opening and closing characteristics of the bistable airway quick-opening valve and the transient energy release advantage of the spring-impact abdominal pressure unit can be leveraged to achieve precise timing coordination between peak abdominal pressure and airway opening through a coordinated linkage unit. This rapidly generates a high-speed airflow that conforms to physiological cough dynamics, effectively increasing the peak cough velocity to meet the airway secretion clearance requirements. Simultaneously, the overall structure boasts high integration, fast response, and excellent force transmission efficiency. It not only solves the pain points of traditional auxiliary expectoration devices, such as delayed opening and closing, inefficient pressure transmission, and poor timing coordination, but also adapts to standard clinical tubing and different patient usage scenarios, balancing safety, ease of operation, and clinical effectiveness. Specifically: The magnetic coupling drive assembly 11b includes a pulse electromagnet 11b-1 and a permalloy magnetic shielding shell 11b-2. The pulsed magnetic field generated by the pulse electromagnet 11b-1 penetrates the outer wall of the valve body 11 and acts on the magnetic steel back plate 11a-3, applying a transient thrust of no more than 0.5N to make the disc spring 11a-1 cross the geometric critical point and spontaneously flip to the fully open position. The flipping time is 8 to 12 ms.

[0028] By adopting the above scheme, the valve plate can be flipped in milliseconds using non-contact magnetic coupling drive. A tiny transient thrust of no more than 0.5N can drive the disc spring to cross the geometric critical point and automatically switch to the fully open position. This avoids the structural wear, jamming, and airway seal damage caused by direct mechanical drive. The extremely fast flipping speed of 8-12ms ensures precise synchronization between the airway opening action and the peak moment of abdominal pressure. At the same time, the permalloy magnetic shielding shell can effectively restrict magnetic field leakage and prevent electromagnetic interference to ventilators, monitors, and other peripheral medical equipment. The tiny thrust can also reduce the stress loss of the valve plate assembly, greatly improving the stability, safety, and service life of the device.

[0029] Specifically: the track curve of the arc-shaped guide rail 10d causes the impact head 10e to move along the direction perpendicular to the abdominal wall in the initial segment of the stroke, and deflects 12° toward the patient's head at the end of the stroke, with an impact duration of 80-100ms; the stroke limiting buffer pad 10g is fixed at the end of the arc-shaped guide rail 10d, which structurally limits the maximum impact stroke to 25-35mm.

[0030] By adopting the above scheme, a biomechanically optimized biphasic impact trajectory can be achieved: the initial vertical abdominal wall pressure segment (approximately the first 80% of the stroke) acts directly on the abdominal contents along the normal direction of the transverse abdominal fascia, maximizing the efficiency of intra-abdominal pressure accumulation with the shortest conduction path; the final 12° cephalic deflection (approximately the last 20% of the stroke, corresponding to 2.5–7 mm) directs the resultant impact force vector towards the lower surface of the diaphragm, maximizing the axial component of the intra-abdominal pressure increment along the thoracic and abdominal hydraulic transmission axis. Biomechanical analysis shows that this deflection angle maximizes the effective intrathoracic pressure driving component compared to the pure... The vertical pressure application scheme improves performance by approximately 10-15%; the impact duration of 80-100ms closely matches the abdominal pressure build-up phase (70-110ms) in patients with relaxed abdominal walls, ensuring that the abdominal pressure rise curve generated by the device precisely overlaps with the pressure window required for effective airway clearance; simultaneously, relying on a purely mechanical structure to achieve a 25-35mm hard limit on the stroke, eliminating the risk of exceeding the impact stroke limit without software intervention, and effectively reducing impact vibration and local pressure damage with the end buffer pad, balancing the effect of assisting coughing and the safety of patient use.

[0031] Specifically: the disc spring 11a-1 is made of Ti-6Al-4VELI medical-grade titanium alloy. The pre-deformation of the disc spring is set at 5% beyond the geometric critical point (corresponding to an absolute displacement of approximately 0.12–0.18 mm, verified by air pressure holding test at the factory: when a 0.3 N magnetic trigger force is applied to the magnetic steel back plate 11a-3, the valve plate should complete the flip within 8–12 ms; if the flip fails, the pre-deformation is deemed to be out of tolerance and needs to be readjusted), so that the system can stably lock itself in the closed position without external force; the silicone sealing film 11a-2 is made of medical-grade silicone material with a thickness of 0.15–0.25 mm, forming an airtight connection with the inner wall of the valve body 11; the magnetically transparent section of the outer wall of the valve body 11 is made of medical-grade PEEK material with a thickness not exceeding 2 mm. The disc spring for 11a-1 fatigue life design is based on the fatigue performance of Ti-6Al-4VELI titanium alloy under the condition that the peak stress does not exceed 75% of the material's yield strength (approximately 680MPa). According to ISO 26909 standard, the theoretical fatigue life is no less than 100,000 complete cycles. The airway valve body unit A is a disposable consumable, and the rated number of uses is recorded by the RFID chip. Each unit is limited to no more than 1,000 uses (corresponding to approximately 200 days of continuous use at 5 times / day on a single device), which is far below the fatigue limit, fundamentally eliminating the risk of fatigue fracture.

[0032] By adopting the above scheme, the excellent biocompatibility, fatigue resistance, and structural stability of Ti-6Al-4VELI medical titanium alloy can be relied upon to ensure the long-term reliable operation of the disc spring and meet medical safety standards. Setting the pre-deformation amount 5% outside the geometric critical point ensures that the system can stably lock in the closed position without external force, avoiding pressure leakage caused by accidental airway opening. The 0.15-0.25mm ultra-thin medical-grade silicone sealing membrane can form a tight airtight seal with the inner wall of the valve body, ensuring no air leakage during the pressure accumulation stage, and also has good flexibility, so it will not hinder the rapid rotation of the valve plate. The medical-grade PEEK magnetic transparent section with a thickness of no more than 2mm has both excellent magnetic penetration performance and structural strength. It does not affect the effective driving of the valve plate by the pulse magnetic field, and can meet the structural support and biosafety requirements of the airway valve body. Overall, it achieves multiple technical effects of reliable self-locking of the bistable valve plate, efficient sealing, and smooth magnetic drive transmission.

[0033] Specifically: the airway valve body unit A also includes a normally open return spring 11d, an electromagnetic latch 11e, a supercapacitor backup normally open valve 11f, and a physical limit pin 11g, which constitute a triple power failure protection mechanism. The normally open return spring 11d has a spring force of 0.08 to 0.12 N. During normal operation, it is overcome by the electromagnetic latch 11e. When the power is off, it drives the valve plate assembly 11a to return to the fully open position. The supercapacitor backup normally open valve 11f is powered by a supercapacitor with a rated capacity of 2 to 5F, and maintains the airway open for no less than 90 seconds after the main power is cut off; The physical limit pin 11g is used to manually insert into the pin hole reserved on the side wall of the valve body 11, mechanically preventing the valve plate assembly 11a from entering the closed position.

[0034] By adopting the above scheme, a triple power failure protection mechanism consisting of a normally open return spring, an electromagnetic latch, a supercapacitor backup normally open valve, and a physical limit pin can be constructed. This forms a full-dimensional safety redundancy of electrical reset, energy storage for opening, and mechanical locking, fully meeting the single-failure safety criteria for respiratory medical devices. The 0.08-0.12N normally open return spring can be reliably overcome during normal operation, and the valve plate is driven back to the fully open position without delay at the moment of power failure. The 2-5F high-capacity supercapacitor can maintain the airway open for no less than 90 seconds after the main power supply fails, reserving sufficient time for emergency response. The physical limit pin can be manually mechanically forced to fully open, fundamentally eliminating the risk of suffocation caused by airway closure in extreme scenarios such as power failure and equipment failure, and comprehensively ensuring the absolute safety of patients.

[0035] Specifically: the airway valve body unit A also includes a double-layer medical titanium mesh interceptor screen 11i, which is located 4-6mm downstream of the distal end of the valve plate assembly 11a, with a mesh size not exceeding 0.3mm; the consumable housing of the airway valve body unit A is embedded with an RFID chip, which is used to record the rated number of uses and cooperate with the coordination and linkage unit C to implement forced life management.

[0036] By adopting the above solution, a double-layer medical titanium mesh interceptor screen located 4-6mm downstream of the valve assembly can efficiently intercept tiny foreign objects such as phlegm plugs and detached tissue in the airway with a fine mesh size of no more than 0.3mm. This avoids foreign objects from getting stuck in the valve and affecting its opening and closing action, and also prevents the safety risks caused by accidental aspiration of foreign objects. Moreover, its close-range deployment does not increase airway ventilation resistance. At the same time, the RFID chip embedded in the consumable housing accurately records the number of uses, and in conjunction with the coordination and linkage unit, it achieves forced life management. This can effectively prevent problems such as structural fatigue and sealing failure of the airway valve unit due to overuse. From the perspective of consumable management, it ensures the reliability and safety of device operation and complies with the infection control and safe use specifications for respiratory medical devices.

[0037] Specifically: The contact surface of the anatomical contouring impact head 10e is a double-leaf arc-shaped structure, including a left-leaf contact surface, a right-leaf contact surface, and a central groove located between the two leaves; The central groove is 6–10 mm deep and 20–30 mm wide, which is adapted to the anatomical shape of the xiphoid process; The double-leaf arc-shaped contact surface is lined with a medical-grade silicone buffer layer with a Shore hardness of 20-30A. The buffer layer is embedded with an array of micro force sensing units 10e-1 for real-time monitoring of the uniformity of impact pressure distribution.

[0038] By adopting the above scheme, the contact surface of the impact head can perfectly conform to the shape of the human abdominal wall with a double-lobed arc structure. Combined with a central groove that is 6-10mm deep and 20-30mm wide, it can precisely avoid the xiphoid process, thus avoiding discomfort and tissue damage caused by bone compression, and allowing the impact pressure to be evenly applied to the effective area of ​​the abdomen. The medical-grade silicone buffer layer with a Shore hardness of 20-30A can flexibly buffer the impact force while ensuring efficient pressure transmission, protecting the abdominal organs. The embedded array of micro force sensing units can monitor and provide feedback on the uniformity of impact pressure distribution in real time, ensuring stable and controllable pressure output, further improving the effectiveness and safety of assisted coughing.

[0039] Specifically, the abdominal impact unit B also includes an abdominal wall pre-detection mechanism. The abdominal wall pre-detection mechanism controls the anatomical contour impact head 10e to contact the abdominal wall with a low force of no more than 8N. The force-displacement curve is recorded by the force sensing unit 10e-1 and the real-time stiffness of the abdominal wall is calculated. When the patient has an indwelling catheter, the pretension of the disc spring assembly 10b is set in conjunction with the baseline value of intra-abdominal pressure obtained by the catheter bypass pressure sensor. When the patient does not have a catheter, the system automatically switches to a degraded working mode. The pretension calibration table is indexed separately using the abdominal wall stiffness data. The target effective intra-abdominal pressure increment is set to 30-80 cmH2O, so that the effective intra-abdominal pressure increment transmitted by each impact for patients with different abdominal wall compliance is stably maintained within this target range.

[0040] By adopting the above scheme, non-invasive abdominal wall probing can be achieved with a low force of no more than 8N by relying on the abdominal wall pre-detection mechanism. Combined with the force-displacement curve recorded by the force sensing unit, the real-time stiffness of the abdominal wall can be accurately calculated. In addition, the pretension of the disc spring group can be adaptively calibrated with the intra-abdominal pressure baseline value obtained by the catheter bypass pressure sensor. This allows patients of different weights and abdominal wall stiffness to obtain a stable and consistent effective increase in intra-abdominal pressure. This avoids insufficient pressure due to differences in abdominal wall compliance, which would lead to ineffective coughing, and also prevents excessive impact pressure from causing discomfort or tissue damage to abdominal organs. This significantly improves the device's adaptability to various patients, its coughing assistance effect, and its safety of use.

[0041] Specifically, it also includes a T-type ventilator coordination interface 12, which has three interface ends: the ventilator side end 12-A that connects to the ventilator's air delivery circuit, the patient side end 12-B that connects to the endotracheal cannula, and the functional side end 12-C that connects to the airway valve body unit A. The inner cavity of the ventilator side end 12-A is equipped with a miniature axial flow impeller 12-1a, which is connected to a permanent magnet generator 12-1b. This generator converts the kinetic energy of the ventilator's delivered air into electrical energy to drive the disc spring assembly 10b to tension, with the additional airway pressure drop not exceeding 0.3 cmH2O. It is also equipped with two pressure sampling ports 12-2a and 12-2b, which are 20 mm apart along the airflow direction. The differential pressure sensor identifies the working phase of the ventilator and locks the trigger time of the cough assist sequence within the end-expiratory pause window.

[0042] By adopting the above solution, seamless integration with existing clinical ventilator tubing can be achieved through the T-type three-port structure, allowing for rapid adaptation and use without equipment modification. A miniature axial flow impeller and permanent magnet generator convert the kinetic energy of the ventilator's delivered air into energy for the device's own use, enabling self-tightening of the disc spring assembly and achieving parasitic energy reuse, eliminating dependence on external power. Simultaneously, the additional airway pressure drop is controlled within 0.3 cmH2O, ensuring no interference with the ventilator's normal ventilation parameters and operating status. Dual pressure sampling ports with a 20mm spacing, combined with a differential pressure sensor, accurately identify the ventilator's operating phase, strictly locking cough assist triggering within the end-expiratory pause window, fundamentally avoiding patient-ventilator asynchrony and airway pressure exceeding limits, significantly improving the compatibility, stability, and safety of the device in working with the ventilator.

[0043]

Control Experiment 1: Effect of Different Impact Deflection Angles on Intrathoracic Pressure Transmission Efficiency

[0044]

Control Experiment 2: Comparison of Peak Cough Flow Rate between this Device and Traditional MI-E Device under Relaxed Abdominal Wall Model

[0045] Specifically: All components in Airway Valve Unit A that come into direct contact with airflow are made of materials that comply with the GB / T16886 series of biocompatibility standards; Airway Valve Unit A is a disposable sterile consumable that is sterilized with ethylene oxide at the factory and is discarded after a single use; The abdominal band liner and silicone buffer layer in Abdominal Impact Unit B that come into contact with the patient's body surface are removable and replaceable, and can withstand high-temperature and high-pressure steam sterilization at 134℃ for 18 minutes.

[0046] By adopting the above solution, the airway valve unit A can be designed as a disposable sterile consumable sterilized with ethylene oxide, which is discarded after a single use, thus eliminating the risk of cross-infection from the reuse of airway components and strictly complying with the clinical infection control standards for respiratory medical devices. At the same time, the abdominal band liner and silicone buffer layer in the abdominal impact unit B, which are in direct contact with the patient's body surface, are designed as detachable structures. This allows for easy disassembly and sterilization for reuse, effectively reducing long-term usage costs. Furthermore, the separate design of consumables and reusable components balances the sterile safety of airway use with the durability and practicality of the abdominal impact unit, making it suitable for long-term use in various scenarios such as hospital clinical settings and home rehabilitation.

[0047] Specifically: The coordinated linkage unit C also includes a real-time abdominal pressure monitoring module; the real-time abdominal pressure monitoring module collects the intra-abdominal pressure change curve in real time during the impact process through the force sensing unit 10e-1 deployed on the contact surface of the anatomical contour impact head 10e, and uses the moment when the intra-abdominal pressure difference exceeds the preset pressure trigger threshold as the actual trigger point instead of the fixed delay, and sends a flipping drive pulse to the magnetic coupling drive component 11b to achieve precise closed-loop synchronization between the airway opening moment and the actual peak moment of intra-abdominal pressure; the pressure trigger threshold is automatically set by the abdominal wall pre-detection data in the range of 10-50cmH2O according to the patient's abdominal wall compliance.

[0048] Specifically: The coordination and linkage unit C has a built-in impact count counter to record the cumulative number of energy release impacts of the disc spring assembly 10b; when the cumulative number of impacts exceeds a preset maintenance threshold, an audible and visual alarm is triggered to prompt for inspection, and the preset maintenance threshold is set to 10,000 times; the coordination and linkage unit C also monitors the performance status of the disc spring assembly 10b in real time based on the peak force data of each impact collected by the force sensing unit 10e-1. If the peak force of three consecutive impacts is lower than 80% of the target value (i.e., lower than 64N), a spring performance insufficiency alarm is triggered, prompting the spring to be repaired or replaced.

[0049] Comparative analysis of the technical effects with existing technologies: (i) Comparison with inflatable abdominal binders (inflatable bladder-type auxiliary cough device): Inflatable abdominal binders rely on the slow inflation of the bladder (inflation time 500ms to 2s) to apply continuous static pressure, and the force transmission efficiency is less than 30% (under the relaxed abdominal wall model); the disc spring impact abdominal pressure unit of this invention has an energy release time of about 80 to 100ms and generates a transient force rate (dF / dt) of about 800 to 1500 N / s. A simplified single-degree-of-freedom spring-damped mechanical model is established for the relaxed abdominal wall: the equivalent spring stiffness of the abdominal wall is k≈0.5~2.0N / mm, the equivalent damping ratio is ζ≈0.1~0.3, the equivalent mass of the abdominal contents is m≈3~5kg, and the natural frequency of the system is fn=√(k / m)≈1.6~4.1Hz; for spring impact excitation with a dominant frequency of about 5~10Hz, the excitation frequency f is higher than the natural frequency of the system fn, the frequency ratio is r=f / fn≈2~4, and the dynamic transmissibility TR=1 / √[(1-r²)²+(2ζr)] Substituting r=2~4 and ζ=0.1~0.3, we calculate TR≈1.1~2.8; that is, the peak intra-abdominal pressure after the spring impact force of the same amplitude is transmitted through the relaxed abdominal wall is 1.1~2.8 times that of the low-frequency static force transmission result of the inflatable balloon, and the equivalent force transmission efficiency is increased to about 55~75% (compared to the less than 30% static transmission efficiency of the inflatable balloon). This increases the peak airway clearance flow rate of patients with relaxed abdominal walls from about 80~100L / min in the existing technology to more than 160L / min. This principle analysis shows that for patients with relaxed abdominal walls, high-force transient impact has a significant dynamic synergistic advantage at the biomechanical level, which is an effect difference that cannot be achieved by inflatable balloon devices from a physical principle perspective.

[0050] (II) Comparison with mechanically assisted cough devices (MI-E, such as positive and negative pressure airway mechanically assisted cough devices): MI-E generates airflow by applying positive pressure (blowing) to the airway and then quickly switching to negative pressure (vacuuming), which is effective for patients with complete airway paralysis. However, it relies on large power supplies and professional operators, the device is large, and patients cannot use it independently at home. In addition, MI-E uses a standard pneumatic valve, and the airway valve opening time is about 30-50ms. The bistable magnetic coupling quick-opening valve of this invention has an opening time of only 8-12ms. According to the fluid dynamics airway resistance model analysis: at the peak of the abdominal pressure (T0+85ms), the switching time of the airway from "completely closed (infinite resistance)" to "completely open (minimum resistance)" is shortened from 30-50ms to 8-12ms, which means that the effective airflow window (the time period when the airway is completely open and the abdominal pressure is higher than the end-expiratory pressure) is extended by about 20-40ms, and the corresponding peak flow rate is increased by about 15-25%. Furthermore, this invention features a miniaturized spring energy storage design, allowing patients to use it independently at home, overcoming the MI-E's dependence on institutional professionals and large power supplies.

[0051] Safety usage restrictions and contraindications: The maximum impact peak force shall not exceed 150 N, the maximum increment of intra-abdominal pressure shall not exceed 80 cmH2O, and the maximum single impact stroke shall not exceed 35 mm (guaranteed by the 10 g mechanical limit of the stroke limit buffer). The following clinical contraindications exist for this device, and a clear assessment by the attending physician is required before use: ① Severe osteoporosis (bone density T value < -2.5), abdominal impact may cause rib or xiphoid fractures; ② Within 3 months after abdominal surgery, risk of anastomotic rupture; ③ Hepatosplenomegaly (organ edge exceeding the costal arch), risk of parenchymal organ rupture; ④ Pregnancy (absolute contraindication); ⑤ Abdominal aortic aneurysm or other major abdominal vascular diseases; ⑥ Abdominal surface infection or skin damage (area where the impact head contacts); ⑦ Severe coagulation dysfunction. For patients with relative contraindications, the pre-tensioning amount can be adjusted down to 50% of the standard value (corresponding to an impact peak force of 40 - 75 N), and it should be used cautiously after assessment by the physician.

[0052] According to the above scheme, the present invention also provides an embodiment of specific application: Embodiment 1: Installation of the airway valve body unit and the bistable working principle Please refer to Figure 2 、 Figure 3 , the installation steps of the airway valve body unit A are as follows: Align the proximal interface of the valve body 11 with the outer end of the tracheal cannula, and push it axially until the positioning boss engages with the groove is felt, and then rotate it 15° to the locked position: The rotation action synchronously compresses the air path sealing ring through the eccentric wedge boss (to achieve air path sealing) and aligns the magnetic coupling on the outer wall of the magnetic transparent section with the central axis of the host magnetic coupling drive component 11b (to achieve magnetic coupling positioning), and these two operations are联动完成 by a single rotation action; After installation, the coordinated linkage unit C automatically performs air path sealing self-check (qualified if there is no leakage under a positive pressure of 0.5 cmH2O for 30 seconds) and magnetic trigger function self-check (completed within 3 seconds after power-on). The distal interface is connected to the functional side 12-C of the T-shaped ventilator coordination interface 12. The bistable working principle of the valve piece assembly 11a is as Figure 3As shown: In the first steady state of the closed position, the arc-shaped opening of the disc spring pair 11a-1 bends towards the patient side, and the silicone sealing membrane 11a-2 is sealed against the inner wall of the valve body 11, blocking the airway. The abdominal pressure generated by the abdominal impact accumulates during this stage. When the coordination unit C issues a flip command, the pulse electromagnet 11b-1 outputs a pulsed magnetic field of about 3ms, which penetrates the PEEK magnetic transparent section and acts on the magnetic steel back plate 11a-3, applying a thrust of no more than 0.5N, causing the disc spring pair 11a-1 to cross the geometric critical point and spontaneously flip to the second steady state of the fully open position. The flip time is 8-12ms (at time T1, i.e., within 65-105ms after T0). The accumulated intra-abdominal pressure drives the airflow to be exhaled explosively through the fully open airway, generating an auxiliary cough airflow. After the assisted cough airflow is generated, the valve enters the reset and closing phase (at time T2, defined as 250-400ms after T0, i.e., approximately 100-150ms after the peak airflow ends): the coordination unit C outputs a reset command, driving the electromagnetic latch 11e to re-energize and engage (locking response time ≤ 5ms). Simultaneously, the pulse electromagnet 11b-1 outputs a reverse drive pulse, causing the disc spring 11a-1 to reverse over the geometric critical point. The closing and flipping time is also 8-12ms. After closing, the electromagnetic latch 11e remains energized, locking the valve plate in the first stable state of the closed position. The normally open reset spring 11d (elastic force 0.08-0.12N) stores passive reset force in this state as a safety backup in case of power failure. If a power failure occurs, the triple protection mechanism responds sequentially. The normally open reset spring 11d immediately drives the valve plate to move towards the fully open position, ensuring that the airway always remains fully open and will not enter the closed position due to power failure, causing airway obstruction.

[0053] Example 2: Spring tensioning and impact execution process of the abdominal impact unit Please see Figure 4The working process of the abdominal impact unit B is as follows: During the energy storage stage, the miniature axial flow impeller 12-1a (blade diameter 12mm) of the T-type ventilator coordination interface 12 rotates every time the ventilator delivers air, driving the permanent magnet generator 12-1b to generate electricity. The generated electrical energy is stored in two independent sets of supercapacitors: the energy storage drive group (capacity 5-15F) is dedicated to driving the pre-charge cylinder 10c to compress the disc spring group 10b, and the safety backup group (capacity 2-5F) is dedicated to maintaining the airway safely open after power failure. The two sets of supercapacitors are independent of each other in terms of charging path, discharging path and protection circuit, ensuring that the energy storage function and the safety backup function do not interfere with each other. The elastic potential energy required for a single tensioning of the disc spring assembly 10b is 1.5–3.0 J. Under standard ventilator flow rate (approximately 30 L / min), the net power generation of the miniature axial flow impeller is approximately 50–150 mW, corresponding to an energy storage time of approximately 10–60 seconds (i.e., approximately 2–14 respiratory cycles at a respiratory rate of 14 breaths / min). The shortest interval between two assisted coughs is approximately 1–2 minutes, which is consistent with the interval (≥2 minutes) recommended by the clinical assisted cough operation guidelines. During the pre-triggered calibration phase, the coordinated linkage unit C controls the impact head 10e to pre-contact the abdominal wall with a low force not exceeding 8N. The force-displacement curve is recorded by the force sensing unit 10e-1, and the real-time stiffness of the abdominal wall is calculated. According to the built-in abdominal wall stiffness calibration table, the corresponding pre-tensioning amount is indexed: when the abdominal wall stiffness is about 0.5N / mm (extremely relaxed abdominal wall), the pre-tensioning compression amount is about 18-22mm (elastic potential energy 2.5-3.0J); when the abdominal wall stiffness is about 1.0N / mm (typical C1-C4 complete damage), the pre-tensioning compression amount is about 14-17mm (elastic potential energy 1.8-2.2J); and when the abdominal wall stiffness is about 2... When the pressure is 0 N / mm (incomplete injury, with partial retention of abdominal wall tension), the pre-tensioning compression is approximately 10–13 mm (elastic potential energy 1.5–1.8 J). The calibration table mapping relationship is based on the target intra-abdominal pressure increment ΔP target = 50 cmH2O (median value of 30–80 cmH2O), the equivalent abdominal cross-sectional area is approximately 200 cm², and the abdominal wall conduction efficiency is approximately 60%, which calculates the required peak force to be approximately 170 N. Then, the compression is established by back-calculating the linear segment stiffness of the disc spring assembly (approximately 12–18 N / mm), so that the intra-abdominal pressure increment generated by each impact in patients with relaxed abdominal walls is stabilized at 30–80 cmH2O.During the impact execution phase, the fast-release electromagnetic latch 10f is released, and the disc spring assembly 10b explosively extends, releasing 1.5–3.0 J of elastic potential energy, generating a peak impact force of 80–150 N. This drives the impact head 10e to move along the arc-shaped guide rail 10d. In the initial segment (approximately the first 80% of the stroke), it presses perpendicularly into the abdominal wall to efficiently accumulate intra-abdominal pressure. In the final segment (approximately the last 20% of the stroke, corresponding to 2.5–7 mm), it deflects 12° toward the patient's head, causing the resultant force vector of the impact to point towards the lower surface of the diaphragm. This maximizes the axial component of the increase in intra-abdominal pressure along the thoracic and abdominal hydraulic transmission axis. Biomechanical analysis shows that this deflection angle increases the effective intra-thoracic pressure transmission increment by approximately 10–15% compared to pure vertical pressure application. The impact duration is 80–100 ms. The physiological basis for the 75-90ms delay in triggering valve opening is as follows: the peak intra-abdominal pressure generated by the spring impact occurs approximately 80-95ms after the latch release (based on an equivalent 1-DOF spring-damped system model of the relaxed abdominal wall, with an equivalent spring stiffness k≈0.5-2.0 N / mm, damping ratio ζ≈0.1-0.3, excitation frequency f approximately 5-10 Hz, and dynamic transfer rate TR approximately 1.1-2.8). Combined with a valve flipping time of 8-12ms, setting the delay to 75-90ms ensures that, under ≥95% of clinical use conditions, the airway fully opens during the peak intra-abdominal pressure period (65-105ms window after T0), with a synchronization error not exceeding ±20ms. Compared to the traditional 30-50ms opening time of pneumatic valves, the 8-12ms flipping time of the bistable magnetic coupling quick-opening valve extends the effective airflow window within the peak intra-abdominal pressure period by approximately 20-40ms, increasing the peak airway clearance velocity by approximately 15-25%. After the assisted cough airflow is generated, the valve reset phase begins (at time T2, defined as 250–400 ms after T0, i.e., approximately 100–150 ms after the peak airflow ends): The coordination unit C outputs a reset command, driving the electromagnetic latch 11e to re-energize and engage (locking time ≤ 5 ms), overcoming the spring force of the normally open reset spring 11d (0.08–0.12 N). The valve assembly 11a closes and flips for 8–12 ms. After closing, the electromagnetic latch 11e remains energized, locking the valve in the closed position, preparing for the accumulation of abdominal pressure in the next cough-assisted sequence. The entire cough-assisted sequence timing is as follows. Figure 6As shown: T0 is the latch release time (starting point), T1 is the valve fully open time (65-105ms after T0), and T2 is the valve reset and closing time (250-400ms after T0). Fatigue reliability design of disc spring assembly 10b in abdominal impact unit B: As a permanently reused main component, disc spring assembly 10b has a rated working stress much higher than that of the airway valve disc spring pair 11a-1. Each energy release impact generates a peak force of 80-150N, corresponding to a maximum cross-sectional stress of approximately 55-65% of the yield strength of Ti-6Al-4V ELI (approximately 880MPa); according to ISO 26909 standard and Ti-6Al-4V... The ELI fatigue SN curve indicates a theoretical fatigue life of no less than 200,000 complete cycles at this stress level, far exceeding the cumulative number of cycles in conservative usage scenarios (5 times per day, approximately 5,475 cycles over 3 years). The failure mode of disc spring assembly 10b is progressive elasticity decay (rather than brittle fracture). The abdominal wall pre-detection mechanism can detect the decreasing trend of impact force through the force-displacement curve. If the peak force is lower than the target lower limit (80N) for 3 consecutive times, the system triggers a "insufficient spring performance" alarm. The coordinated linkage unit C has a built-in impact counter, which triggers a maintenance prompt when the cumulative impact reaches 10,000 cycles, recommending inspection or replacement of disc spring assembly 10b. This device has the following contraindications and should be evaluated by a physician before use: severe osteoporosis (abdominal impact may cause rib or sternal fractures), within 3 months after abdominal surgery (risk of anastomotic rupture), hepatosplenomegaly (risk of rupture of solid organs), pregnancy (absolute contraindication), abdominal aortic aneurysm and other abdominal vascular diseases.

[0054] Example 3: Energy recovery and phase synchronization of the T-type ventilator coordination interface Please see Figure 5 The T-type ventilator coordination interface 12 is inserted between the ventilator's Y-type tubing and the endotracheal cannula. During ventilator delivery (approximately 30 L / min), the airflow drives the micro axial impeller 12-1a to rotate, adding a pressure drop to the airway of no more than 0.3 cmH2O. Through dual-point differential pressure detection at a 20 mm distance between the upstream pressure sampling port 12-2a and the downstream pressure sampling port 12-2b, the inspiratory phase, expiratory phase, and end-expiratory apnea (EEP) are identified in real time, locking the cough assist sequence triggering time within the EEP window. The end-expiratory apnea phase detection accuracy is ±15 ms, and the overall timing uncertainty of the cough sequence (including a 5 ms latch response, a 10 ms delay control error, and a 10 ms valve flip) is approximately ±20 ms. Triggering is forcibly prohibited when the airflow velocity exceeds 0.3 L / s to prevent accidental activation during the inspiratory or expiratory peak, which could cause patient-ventilator asynchrony.

[0055] The above description has been given for purposes of illustration and description. Furthermore, this description is not intended to limit the embodiments of this disclosure to the forms disclosed herein. Although numerous exemplary aspects and embodiments have been discussed above, those skilled in the art will recognize certain variations, modifications, alterations, additions, and sub-combinations thereof.

Claims

1. An auxiliary expectorant device that combines spring-driven abdominal pressure with a bistable airway quick-opening valve, characterized in that, include: The airway valve body unit (A) includes a valve body (11), a valve plate assembly (11a), and a magnetic coupling drive assembly (11b). The valve body (11) is a hollow tubular structure with a proximal interface that conforms to YY / T 0339 and ISO 5361 standards and matches the size of the standard tracheal tube external interface, and a distal interface that communicates with the exhalation outlet. The valve plate assembly (11a) is placed in the inner cavity of the valve body (11) and includes a composite plate composed of a disc spring pair (11a-1), a silicone sealing film (11a-2), and a magnetic steel back plate (11a-3) stacked in sequence. The disc spring pair (11a-1) is snapped onto a positioning seat that matches the inner diameter of the valve body (11) and forms two self-locking states, a stable closed position and a stable fully open position, on both sides of the geometric critical point. The magnetic coupling drive assembly (11b) is fixed to the magnetically transparent section of the outer wall of the valve body (11). The abdominal impact unit (B) includes a positioning plate (10a), a rigid backplate (10a-1), a disc spring assembly (10b), a pre-inflated cylinder (10c), an arc-shaped guide rail (10d), an anatomically contoured impact head (10e), a fast-release electromagnetic lock (10f), and a travel-limiting buffer pad (10g). The rigid backplate (10a-1) is fixed to the patient's back, providing reaction force support for the impact. One end of the pre-inflated cylinder (10c) is fixedly connected to the inner side of the rigid backplate (10a-1), and the other end is connected to the disc spring assembly (10b) via a piston rod. 0b) Apply pre-tension force. The rated pre-compression elastic potential energy of the disc spring assembly (10b) is 1.5 to 3.0 J. After energy release, the peak impact force is 80 to 150 N. After conduction through the abdominal wall and abdominal contents, it can make the transient increase of intra-abdominal pressure in the relaxed abdominal wall reach 30 to 80 cmH2O. The fast-release electromagnetic lock (10f) is set between the disc spring assembly (10b) and the anatomical contouring impact head (10e). After receiving the trigger signal, it is released within 5 ms. The elastic potential energy of the disc spring assembly (10b) drives the anatomical contouring impact head (10e) to move along the arc-shaped guide rail (10d). The coordination and linkage unit (C) includes a signal receiving module, a delay control module, and a drive output module, which are electrically connected to the magnetic coupling drive component (11b) of the airway valve body unit (A) and the fast-release electromagnetic latch (10f) of the abdominal impact unit (B). The delay control module takes the falling edge of the release signal of the fast-release electromagnetic latch (10f) as the starting point of T0 timing. After a delay of 75 to 90 ms, the drive output module outputs a flipping drive pulse to the magnetic coupling drive component (11b). Combined with the 8 to 12 ms flipping time of the valve plate component (11a), the valve plate component (11a) switches from the closed position to the fully open position within 85 ± 20 ms after T0. The abdominal cavity accumulated pressure drives the airflow to be exhaled explosively through the fully open airway, generating an auxiliary cough airflow with a peak flow rate of not less than 160 L / min.

2. The auxiliary expectorant device according to claim 1, characterized in that: The magnetic coupling drive assembly (11b) includes a pulse electromagnet (11b-1) and a permalloy magnetic shielding shell (11b-2). The pulse magnetic field generated by the pulse electromagnet (11b-1) penetrates the outer wall of the valve body (11) and acts on the magnetic steel back plate (11a-3). A transient thrust of no more than 0.5N is applied to make the disc spring pair (11a-1) cross the geometric critical point and spontaneously flip to the fully open position. The flipping time is 8 to 12 ms.

3. The auxiliary expectorant device according to claim 1, characterized in that: The trajectory curve of the arc-shaped guide rail (10d) causes the impact head (10e) to move along the direction perpendicular to the abdominal wall in the initial segment of the stroke, and deflects 12° toward the patient's head at the end of the stroke, with an impact duration of 80-100ms; the stroke limiting buffer pad (10g) is fixed at the end of the arc-shaped guide rail (10d), which structurally limits the maximum impact stroke to 25-35mm.

4. The auxiliary expectorant device according to claim 1, characterized in that: The disc spring pair (11a-1) is made of Ti-6Al-4VELI medical titanium alloy. The pre-deformation of the disc spring is set at 5% beyond the geometric critical point, so that the system can be stably locked in the closed position when there is no external force. The silicone sealing film (11a-2) is made of medical grade silicone material with a thickness of 0.15 to 0.25 mm, and forms an airtight connection with the inner wall of the valve body (11). The magnetic transparent section of the outer wall of the valve body (11) is made of medical grade PEEK material with a thickness of no more than 2 mm.

5. The auxiliary expectorant device according to claim 1, characterized in that: The airway valve body unit (A) also includes a normally open return spring (11d), an electromagnetic latch (11e), a supercapacitor backup normally open valve (11f), and a physical limit pin (11g), forming a triple power failure protection mechanism. The normally open return spring (11d) has a spring force of 0.08 to 0.12 N. During normal operation, it is overcome by the electromagnetic latch (11e). When the power is off, it drives the valve plate assembly (11a) to return to the fully open position. The supercapacitor backup normally open valve (11f) is powered by a supercapacitor with a rated capacity of 2 to 5F, and maintains the airway open for no less than 90 seconds after the main power is cut off. The physical limiting pin (11g) is used to manually insert into the pin hole reserved on the side wall of the valve body (11) to mechanically prevent the valve plate assembly (11a) from entering the closed position.

6. The auxiliary expectorant device according to claim 1, characterized in that: The airway valve body unit (A) also includes a double-layer medical titanium mesh interceptor screen (11i), which is located 4-6mm downstream of the distal end of the valve plate assembly (11a), with a mesh size not exceeding 0.3mm; the consumable housing of the airway valve body unit (A) is embedded with an RFID chip, which is used to record the rated number of uses and cooperate with the coordination and linkage unit (C) to implement forced life management.

7. The auxiliary expectorant device according to claim 1, characterized in that: The contact surface of the anatomical contouring impact head (10e) is a double-leaf arc-shaped structure, including a left leaf contact surface, a right leaf contact surface, and a central groove located between the two leaves; The central groove has a depth of 6-10 mm and a width of 20-30 mm, which is adapted to the anatomical shape of the xiphoid process; The contact surface of the double-leaf arc structure is lined with a medical-grade silicone buffer layer with a Shore hardness of 20-30A. The buffer layer is embedded with an array of micro force sensing units (10e-1) for real-time monitoring of the uniformity of impact pressure distribution.

8. The auxiliary expectorant device according to claim 1, characterized in that: The abdominal impact unit (B) also includes an abdominal wall pre-detection mechanism. The abdominal wall pre-detection mechanism controls the anatomical contour impact head (10e) to contact the abdominal wall with a low force of no more than 8N. The force-displacement curve is recorded by the force sensing unit (10e-1) and the real-time stiffness of the abdominal wall is calculated. When the patient has an indwelling catheter, the pretension of the disc spring assembly (10b) is set in combination with the baseline value of intra-abdominal pressure obtained by the catheter bypass pressure sensor. When the patient does not have a catheter, the system automatically switches to a degraded working mode and calculates the pretension separately using the abdominal wall stiffness data measured by the force sensing unit. The pretension is indexed according to the corresponding value in the abdominal wall stiffness calibration table. The target effective intra-abdominal pressure increment is set to 30-80 cmH2O, so that the effective intra-abdominal pressure increment transmitted by each impact for patients with different abdominal wall compliance is stably maintained within the target range.

9. The auxiliary expectorant device according to claim 1, characterized in that: It also includes a T-type ventilator coordination interface (12), the three interface ends of which are: the ventilator side end (12-A) that connects to the ventilator air delivery line, the patient side end (12-B) that connects to the tracheostomy tube, and the functional side end (12-C) that connects to the airway valve body unit (A). The ventilator side end (12-A) inner cavity is equipped with a miniature axial flow impeller (12-1a), which is connected to a permanent magnet generator (12-1b) to convert the kinetic energy of the ventilator's delivered air into electrical energy to drive the disc spring assembly (10b) to tension, with the additional airway pressure drop not exceeding 0.3cmH2O; it is also equipped with two pressure sampling ports (12-2a, 12-2b) 20mm apart along the airflow direction, which identify the ventilator's working phase through a differential pressure sensor and lock the trigger time of the cough assist sequence within the end-expiratory pause window.

10. The auxiliary expectorant device according to claim 1, characterized in that: The airway valve body unit (A) is a disposable sterile consumable, sterilized with ethylene oxide, and is discarded entirely after a single use. The abdominal band liner and silicone buffer layer in the abdominal impact unit (B) that come into contact with the patient's body surface are detachable.

11. The auxiliary expectorant device according to claim 1, characterized in that: The coordinated linkage unit (C) also includes a real-time intra-abdominal pressure monitoring module. The real-time intra-abdominal pressure monitoring module collects the intra-abdominal pressure change curve in real time during the impact by force sensing unit (10e-1) arranged on the contact surface of the anatomical contour impact head (10e). The actual trigger point is replaced by the moment when the intra-abdominal pressure difference exceeds the preset pressure trigger threshold. The module sends a flipping drive pulse to the magnetic coupling drive component (11b) to achieve precise closed-loop synchronization between the airway opening moment and the actual peak moment of intra-abdominal pressure. The pressure trigger threshold is automatically set by the abdominal wall pre-detection data in the range of 10-50 cmH2O according to the patient's abdominal wall compliance.

12. The auxiliary expectorant device according to claim 1, characterized in that: The coordination unit (C) has a built-in impact count counter to record the cumulative number of energy release impacts of the disc spring assembly (10b). When the cumulative number of impacts exceeds a preset maintenance threshold, an audible and visual alarm is triggered to prompt for inspection. The preset maintenance threshold is set to 10,000 times. The coordination unit (C) also monitors the performance status of the disc spring assembly (10b) in real time based on the peak force data of each impact collected by the force sensing unit (10e-1). If the peak force of three consecutive impacts is lower than 80% of the target value, a spring performance insufficiency alarm is triggered, prompting the spring to be repaired or replaced.

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