A neonatal respiratory monitoring and resuscitation device and control method

Abstract

This application relates to a neonatal respiratory monitoring and resuscitation device and control method. The respiratory monitoring and resuscitation device includes a breathing mask assembly, a balloon assembly, a volume adjustment mechanism, an external drive mechanism, and a controller. The balloon is connected to the mask containing a pressure sensor via a one-way valve. The volume adjustment mechanism is located inside the balloon and controls the effective gas storage volume by adjusting the volume of the adjustment body, achieving precise in-situ adjustment of tidal volume. The external drive mechanism covers the outer periphery of the balloon, and the controller controls its compression frequency to synchronize with the neonatal breathing based on sensor signals. This respiratory monitoring and resuscitation device and control method effectively solve the problems of coarse tidal volume adjustment and mismatched ventilation rhythm that easily lead to human-ventilator asynchrony in the prior art, significantly improving the safety, adaptability, and effectiveness of neonatal resuscitation ventilation.

Description

Technical Field

[0001] This invention relates to respiratory monitoring systems, and more particularly to a neonatal respiratory monitoring and resuscitation device and control method. Background Technology

[0002] Newborns, due to their immature lung development, often face physiological characteristics such as insufficient spontaneous breathing, low lung compliance, and high airway resistance in the early stages of life. Therefore, simple respirators (such as resuscitation bags) are widely used in clinical practice for assisted ventilation. Especially in pre-hospital emergency care, delivery room resuscitation, and the NICU, these respiratory support devices play a crucial role in neonatal asphyxia resuscitation due to their advantages of simple structure, rapid operation, and no need for external power. With in-depth research into the mechanisms of neonatal ventilation injury, clinical medicine has placed higher safety requirements on the precise control of tidal volume, ventilation frequency, and the coordination of the infant's spontaneous breathing during assisted ventilation.

[0003] Existing neonatal resuscitation devices typically employ a manual resuscitation bag mode. Their main components include a face mask, an elastic bag, a one-way valve, and a deflation valve. During operation, the bag is manually squeezed or compressed using a simple mechanical device, forcing gas through the one-way valve into the face mask to supply air to the newborn. When the external force is released, the bag rebounds elastically and draws in fresh air, completing one ventilation cycle. The internal gas volume is usually determined by the bag's physical dimensions and structure, while the ventilation frequency and force depend primarily on manual operation by healthcare workers or a fixed rhythm setting of the mechanical device.

[0004] However, existing resuscitation devices still have significant limitations in terms of structure and control. Firstly, regarding tidal volume regulation, most existing balloons have a fixed volume, or can only achieve rough volume changes by replacing different balloon models. They lack a mechanism for directly, continuously, and precisely adjusting the effective gas storage volume within the balloon. This makes it difficult to accurately control the tidal volume delivered per breath when dealing with newborns of varying weights and lung compliance, easily leading to lung injury due to over-ventilation or hypoxia due to under-ventilation. Secondly, in terms of actuation and control, existing devices are mostly manually operated or use open-loop mechanical compression, failing to detect the newborn's weak spontaneous breathing signals. This results in a mismatch between the mechanical ventilation rhythm and the infant's own respiratory rate, increasing not only the infant's respiratory effort but also the risk of complications such as pneumothorax. Therefore, there is an urgent need to develop a respiratory monitoring resuscitation device and control method to address these problems. Summary of the Invention

[0005] The purpose of this invention is to provide a neonatal respiratory monitoring and resuscitation device and control method that can achieve precise internal volume adjustment, external automated drive, and synchronization with spontaneous breathing.

[0006] The technical solution adopted by the present invention to solve the above problems is: a neonatal respiratory monitoring and resuscitation device, comprising:

[0007] A breathing mask assembly, which contains a breathing chamber and a pressure sensor for monitoring pressure;

[0008] The balloon assembly includes a balloon body and a one-way valve. The distal end of the balloon body is provided with an air inlet, and the proximal end is connected to the breathing mask assembly through the one-way valve.

[0009] A volume adjustment mechanism is disposed inside the balloon body, including an adjustment body configured to controllably adjust the volume it occupies within the balloon body, thereby changing the effective gas storage volume within the balloon body.

[0010] An external drive mechanism, disposed outside the balloon body, includes an inflation and compression assembly covering the periphery of the balloon body, for applying compression force to the balloon body;

[0011] The controller is connected to the pressure sensor, the volume adjustment mechanism, and the external drive mechanism respectively; the controller is configured to control the operating frequency of the external drive mechanism according to the signal of the pressure sensor, so as to synchronize it with the breathing frequency of the newborn.

[0012] Preferably, the adjusting body has a spindle-shaped structure, and the long axis of the adjusting body is coaxial with the long axis of the balloon body; an annular laminar flow channel with a cross-sectional area that gradually changes from both ends to the middle is defined between the outer wall of the adjusting body and the inner wall of the balloon body, so as to guide the gas to flow in a laminar state along the direction from the one-way valve to the mask during ventilation.

[0013] Preferably, the regulating body includes a flexible outer membrane and a support frame disposed inside the flexible outer membrane, the support frame being configured to have a contracted state and an expanded state; in the expanded state, the support frame abuts against the inner wall of the flexible outer membrane to provide radial support, thereby limiting the deformation of the regulating body when the balloon body is compressed.

[0014] Preferably, the support frame includes:

[0015] A first guide sleeve and a second guide sleeve are coaxially spaced along the axial direction of the adjusting body. The first guide sleeve is fixed to the side of the adjusting body closer to the one-way valve, and the second guide sleeve is fixed to the side of the adjusting body away from the one-way valve.

[0016] The movable rod has its two ends slidably inserted into the first guide sleeve and the second guide sleeve, respectively.

[0017] A reset elastic element is sleeved on the moving rod or connected between the moving rod and the first guide sleeve, and is used to apply a reset force to the moving rod to keep the support frame in the contracted state;

[0018] A linkage assembly is disposed on the outside of the movable rod. The linkage assembly includes a plurality of linkages distributed circumferentially along the movable rod and corresponding arc-shaped pressure plates. One end of the linkage is rotatably connected to the movable rod, and the other end of the linkage is connected to the arc-shaped pressure plate. Each arc-shaped pressure plate is disposed on the inner wall of the flexible outer membrane and is evenly distributed along the circumference of the inner wall of the flexible outer membrane.

[0019] A driving mechanism is used to drive the moving rod to move axially, so as to drive the arc-shaped pressure plate to move through the connecting rod, thereby expanding the flexible outer film outward.

[0020] Preferably, the reset elastic element is a helical spring, which is sleeved on the outer periphery of the moving rod; one end of the helical spring abuts against the side end face of the second guide sleeve facing the first guide sleeve, and the other end of the helical spring abuts against the connection between the connecting rod and the moving rod; the helical spring is configured to push the moving rod back to its original position by its own elastic force when the drive mechanism is not activated, so as to maintain the support frame in the retracted state.

[0021] Preferably, one end face of the movable rod inserted into the first guide sleeve cooperates with the inner wall of the first guide sleeve and the inner bottom wall of the adjusting body to form a sealed pressure space; the driving mechanism includes a ventilation tube, one end of which is connected to the pressure space, and the other end of which extends out of the adjusting body and to the outside of the balloon body; wherein, the respiratory monitoring and resuscitation device is configured such that when gas is injected into the pressure space through the ventilation tube, the gas pressure pushes the movable rod to move towards the second guide sleeve, so that the supporting frame is in the expanded state.

[0022] Preferably, the regulating body is further provided with an inflation tube, which is directly connected to the internal cavity of the regulating body and is used to fill the flexible outer membrane with gas to cooperate with the support frame to limit the volume of the regulating body.

[0023] Preferably, the inflation and compression assembly includes a plurality of sub-cells arranged sequentially along the gas flow direction within the balloon body, adjacent sub-cells being interconnected, and an air inlet pipe being connected to the sub-cell closest to the air inlet; the sub-cells are configured to expand sequentially from the air inlet end toward the one-way valve when air is introduced through the air inlet pipe, so as to generate peristaltic pushing pressure on the balloon body.

[0024] Preferably, the external drive mechanism further includes a limiting housing, which is sleeved on the outside of the inflation and compression assembly; the sub-bladder is located between the outer surface of the balloon body and the inner wall of the limiting housing; the limiting housing is configured to abut against the outside of the sub-bladder when the sub-bladder inflates, so as to force the inflation deformation force of the sub-bladder to act inward on the balloon body.

[0025] Specifically, a control method for the above-mentioned respiratory monitoring and resuscitation device includes the following steps:

[0026] Receive target ventilation parameters, which are obtained from external input or calculated based on detection data;

[0027] According to the target ventilation parameters, the air source is controlled to inflate the flexible outer membrane of the regulating body through the inflation tube, and at the same time, it is inflated into the sealed pressure space through the ventilation tube to drive the moving rod to move, thereby expanding the support frame. The expanded support frame is used to resist external pressure and lock the effective air storage volume of the balloon body.

[0028] The pressure sensor signal is continuously monitored, and the newborn's inhalation action is identified based on signal changes;

[0029] When an inhalation action is detected, the external drive mechanism is controlled to operate, driving gas into the inflation and compression assembly, causing the inflation and compression assembly to expand sequentially from the distal end to the proximal end, thereby performing peristaltic compression on the balloon body, so that the gas inside the balloon body is output through the one-way valve.

[0030] The beneficial effects of the embodiments of the present invention are as follows:

[0031] 1. Because this device employs a volume adjustment mechanism inside the balloon body, which changes the effective gas storage volume inside the balloon by controlling the volume occupied by the adjustment body, and an external drive mechanism controlled by a controller outside the balloon body, combined with a pressure sensor inside the mask to monitor respiratory signals in real time, it effectively solves the technical problems of existing neonatal resuscitation balloons, such as coarse tidal volume adjustment, inability to meet individualized and precise air supply needs, difficulty in synchronizing ventilation frequency with the infant's spontaneous breathing rhythm, and the risk of patient-ventilator asynchrony and pneumothorax. It achieves continuous and precise in-situ adjustment of the output tidal volume without replacing the balloon, and intelligent synchronization of ventilation rhythm with the newborn's spontaneous breathing based on real-time respiratory monitoring, significantly improving the safety, adaptability, and effectiveness of neonatal resuscitation ventilation.

[0032] 2. By employing a spindle-shaped design for the regulating body, which is coaxially aligned with the balloon body, a ring-shaped laminar flow channel with a cross-sectional area that gradually changes from both ends to the middle is defined between the two. This effectively solves the technical problem in existing technologies where ordinary balloons easily form turbulent internal airflow during compression, leading to high airway resistance and easy damage to the fragile respiratory tract of newborns. As a result, it achieves the technical effect of using fluid dynamics principles to guide gas to a stable laminar flow state along the one-way valve to the mask, significantly reducing ventilation resistance and improving oxygen delivery efficiency.

[0033] 3. By employing a pneumatic-mechanical composite structure for the regulating body, and by setting a support frame consisting of guide sleeves, moving rods, and connecting rod assemblies inside the flexible outer membrane, and by using a venting tube to inflate the sealed pressure space to drive the moving rods to expand the frame and provide radial rigid support, along with a reset elastic element for automatic reset, and a dual-tube and path frame support mechanism that uses an independent inflation tube to fill the space inside the membrane, this system effectively solves the unexpected technical problem in existing dual-bag resuscitation systems where the internally simple flexible regulating body is prone to passive compression deformation when the external balloon is compressed and ventilated, leading to drift in the effective gas storage volume and errors in tidal volume control. This achieves the technical effect of using the mechanical rigidity of the frame to resist external high-pressure interference, ensuring that the regulating body maintains a constant volume and stable shape throughout the ventilation process, thereby guaranteeing the absolute accuracy of tidal volume output and the reliability of the system under high-pressure ventilation.

[0034] 4. Because the inflation compression assembly consists of several interconnected sub-cells arranged sequentially along the gas flow direction within the balloon body, and configured to expand sequentially from the air inlet towards the one-way valve to generate peristaltic pressure, and with the external limiting shell restricting the outward expansion of the sub-cells to force the deformation force to act entirely inward on the balloon body, the technical problem of gas residue dead zones, incomplete emptying, and lack of effective mechanisms to prevent airflow backflow in existing technologies is effectively solved. This achieves a toothpaste-like directional and orderly compression, which not only completely empties the gas inside the balloon, but also uses the physical compression sequence to assist the one-way valve in closing to prevent backflow, significantly improving the technical effect of gas delivery efficiency and unidirectional flow reliability. Attached Figure Description

[0035] Figure 1 This is a schematic cross-sectional view of a respiratory monitoring and resuscitation device shown in one embodiment of the present invention.

[0036] Figure 2 This is a schematic structural diagram of a respiratory monitoring and resuscitation device shown in one embodiment of the present invention.

[0037] Figure 3 This is a schematic cross-sectional view of the adjusting body shown in one embodiment of the present invention. Figure 1 .

[0038] Figure 4 This is a schematic cross-sectional view of the adjusting body shown in one embodiment of the present invention. Figure 2 .

[0039] Figure 5 This is a flowchart illustrating a control method for a respiratory monitoring and resuscitation device according to an embodiment of the present invention.

[0040] The components are as follows: 10. Respiratory mask assembly; 20. Bag assembly; 210. Bag body; 211. Air inlet; 220. One-way valve; 30. Volume adjustment mechanism; 310. Adjustment body; 311. Flexible outer membrane; 312. Support frame; 3121. First guide sleeve; 3122. Second guide sleeve; 3123. Moving rod; 3124. Connecting rod; 3125. Arc-shaped pressure plate; 3126. Ventilation tube; 3127. Inflation tube; 40. External drive mechanism; 410. Inflation and compression assembly; 411. Sub-bag; 412. Air inlet tube; 420. Limiting shell. Detailed Implementation

[0041] The specific embodiments of the present invention will be described in further detail below with reference to the accompanying drawings and examples. The following examples are for illustrative purposes only and are not intended to limit the scope of the invention.

[0042] In the description of this application, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are used only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as limiting the scope of protection of this application. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this application, unless otherwise stated, "a plurality of" means two or more.

[0043] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art will understand the specific meaning of the above terms in this application based on the specific circumstances.

[0044] Existing neonatal resuscitation devices typically employ a manual resuscitation bag mode. Their main components include a face mask, an elastic bag, a one-way valve 220, and an exhaust valve. During operation, the bag is manually squeezed or compressed using a simple mechanical device, forcing gas through the one-way valve 220 into the face mask to supply air to the newborn. When the external force is released, the bag rebounds elastically and inhales fresh air, completing one ventilation cycle. The internal gas volume is usually determined by the physical dimensions and structure of the bag itself, while the frequency and force of ventilation depend primarily on manual operation by medical personnel or a fixed rhythm setting of the mechanical device. However, most existing resuscitation devices have a fixed tidal volume or can only achieve a rough change in volume by changing different types of balloons. They lack a mechanism that can directly, continuously, and precisely adjust the effective gas storage volume inside the balloon. This makes it difficult to accurately control the tidal volume delivered in a single breath when dealing with newborns of different weights and lung compliance, which can easily lead to lung injury due to over-ventilation or hypoxia due to under-ventilation. Secondly, in terms of drive and control, existing devices are mostly manually operated or open-loop mechanical compression, which cannot detect the weak spontaneous breathing signals of newborns. This often results in a mismatch between the mechanical ventilation rhythm and the infant's own respiratory rate, which not only increases the infant's respiratory power consumption but also increases the risk of complications such as pneumothorax.

[0045] Therefore, a preferred embodiment of this application provides a respiratory monitoring and resuscitation device for newborns.

[0046] Figure 1 This is a schematic cross-sectional view of a respiratory monitoring and resuscitation device shown in one embodiment of the present invention; Figure 2 This is a schematic structural diagram of a respiratory monitoring and resuscitation device according to an embodiment of the present invention. Please refer to [link / reference]. Figures 1 to 2The respiratory monitoring and resuscitation device includes a breathing mask assembly 10, a balloon assembly 20, a volume adjustment mechanism 30, an external drive mechanism 40, and a controller (not shown in the figure). The breathing mask assembly 10 includes a breathing chamber and a pressure sensor for monitoring pressure. The balloon assembly 20 includes a balloon body 210 and a one-way valve 220. The balloon body 210 has an air inlet 211 at its distal end and is connected to the breathing mask assembly 10 through the one-way valve 220 at its proximal end. A volume adjustment mechanism 30 is disposed inside the balloon body 210 and includes an adjustment body 310 configured to controllably adjust its volume within the balloon body 210 to change the effective gas storage volume within the balloon body 210. An external drive mechanism 40 is disposed outside the balloon body 210 and includes an inflation and compression assembly 410 covering the outer periphery of the balloon body 210 for applying compression force to the balloon body 210. A controller is connected to the pressure sensor, the volume adjustment mechanism 30, and the external drive mechanism 40. The controller is configured to control the operating frequency of the external drive mechanism 40 according to the signal from the pressure sensor to synchronize it with the newborn's respiratory rate.

[0047] The breathing mask assembly 10 is designed to fit the facial contours of a newborn, fitting snugly over the infant's mouth and nose to create a relatively sealed ventilation space. An internal breathing chamber is provided within the breathing mask assembly 10, serving as a transit space for gas exchange. Crucially, the breathing mask assembly 10 integrates a highly sensitive pressure sensor. This pressure sensor (not shown in the figure), located within the breathing chamber or immediately adjacent to the interface of the breathing pathway, is used to collect real-time data on pressure changes within the mask, particularly capturing subtle negative pressure signals or airflow pressure fluctuations generated during spontaneous breathing in newborns.

[0048] The balloon assembly 20 is the core of the device for gas storage and pumping, and it includes a balloon body 210 and a one-way valve 220. The balloon body 210 is made of a medical flexible material with good elasticity and resilience (such as silicone or rubber), and an internal gas storage chamber is formed. The balloon body 210 has two ports: a distal air inlet 211 for connecting to an oxygen or air source to allow fresh gas to enter the balloon; and a proximal one-way valve 220. The one-way valve 220 is connected to the breathing mask assembly 10 via tubing, and its structure is configured to allow gas to flow from the balloon body 210 to the breathing mask and prevent exhaled gas from flowing back into the balloon, ensuring one-way ventilation.

[0049] To address the challenge of precisely adjusting tidal volume, this device incorporates a volume adjustment mechanism 30 within the balloon body 210. The core component of this device is the adjustment body 310. The adjustment body 310 is a physical structure located within the balloon body 210, configured to controllably change its size. Occupying a portion of the space within the balloon body 210, the effective gas storage volume is calculated by subtracting the volume occupied by the adjustment body 310 from the total volume of the balloon body 210. The adjustment body 310 is connected to corresponding control lines or conduits (depending on the specific drive method) and can expand or contract according to commands. For example, the adjustment body 310 can be an inner balloon placed inside the balloon, its size altered by inflating different amounts of gas; or it can be a mechanically expandable variable-volume structure. Increasing the volume of the adjustment body 310 reduces the effective gas storage volume within the balloon, thus decreasing the tidal volume output per compression; conversely, decreasing the volume reduces the volume of gas output per compression.

[0050] To achieve automated ventilation, an external drive mechanism 40 is provided on the outside of the balloon body 210. The device includes an inflation compression assembly 410, which covers the outer periphery of the balloon body 210. The inflation compression assembly 410 can be a flexible material balloon sleeve or a mechanical compression arm, simulating the squeezing action of a human hand. When the inflation compression assembly 410 receives a drive signal, it applies an inward compressive force to the balloon body 210, forcing the balloon body 210 to be compressed, thereby pumping the internal gas into the breathing mask through the one-way valve 220.

[0051] The controller is the control center of the entire system, and it establishes electrical or signal connections with the pressure sensor, the volume adjustment mechanism 30, and the external drive mechanism 40. The controller integrates signal processing algorithms and control logic to receive feedback from the sensors and issue control commands.

[0052] The operation of this device mainly includes the tidal volume setting stage and the synchronous ventilation operation stage:

[0053] Before or during resuscitation, the target tidal volume is determined based on parameters such as the newborn's weight, gestational age, and lung compliance. The controller calculates the required effective gas storage volume within the balloon body 210 based on the target tidal volume. Subsequently, the controller sends a command to the volume adjustment mechanism 30, driving the adjuster 310 located inside the balloon to change its volume. For example, if a reduction in tidal volume is needed, the controller drives the adjuster 310 to expand, occupying more space within the balloon; if an increase in tidal volume is needed, the controller drives the adjuster 310 to contract. In this way, continuous and precise physical limitation of the single ventilation volume is achieved without replacing the balloon body 210.

[0054] Once the device is operational, the pressure sensor continuously monitors the pressure changes within the breathing mask assembly 10.

[0055] When a newborn inhales spontaneously, a slight negative pressure or pressure drop is generated inside the breathing mask. The pressure sensor captures this signal and transmits it to the controller. The controller identifies and processes the signal, and once it confirms a valid inhalation, it immediately controls the external drive mechanism 40 to start.

[0056] The inflation and compression assembly 410 of the external drive mechanism 40 moves rapidly, applying compression force to the balloon body 210. Since the effective volume inside the balloon has been limited by the adjuster 310, the balloon body 210, after being compressed, pushes a fixed amount of gas into the mask through the one-way valve 220, assisting the child in completing inhalation.

[0057] After ventilation is completed, the controller controls the external drive mechanism 40 to release the pressure. The balloon body 210 recovers its elasticity and draws in fresh air through the inlet 211, preparing for the next ventilation. Simultaneously, the infant exhales, and the exhaled air is discharged through the exhaust channel on the mask (usually integrated into the one-way valve 220 or the mask). Throughout the process, the controller's operating frequency strictly follows the respiratory signal fed back by the pressure sensor, achieving synchronous resonance between mechanical ventilation and the newborn's spontaneous breathing.

[0058] This device is primarily suitable for use in hospital neonatal intensive care units (NICUs), delivery resuscitation areas, and pre-hospital ambulances. It is applicable to newborns of different gestational ages (including premature infants) and weights requiring respiratory support. Due to its automated control function, the device can be set by medical staff and operate automatically, or it can be used in a manual intervention mode in emergencies, reducing reliance on the operator's manual compression skills.

[0059] In other embodiments, the inflation compression assembly 410 can be replaced by a motor-driven mechanical gripper or pressure plate, as long as it can cover the balloon and apply inward periodic compression force. Furthermore, while a pressure sensor is preferred in this embodiment, in other embodiments, a flow sensor can be connected in series at the mask to detect breathing movements by monitoring changes in airflow velocity, thus achieving the same synchronous triggering function.

[0060] In this embodiment, by employing a variable-volume adjuster 310 inside the balloon body 210 to precisely limit the effective gas storage volume, and by setting an automated compression component controlled by respiratory signals outside the balloon, the technical problems of difficult and inaccurate tidal volume adjustment of neonatal resuscitation balloons, which easily leads to lung injury or insufficient ventilation, and the inability of mechanical ventilation frequency to synchronize with the infant's spontaneous breathing, which easily leads to human-ventilator asynchrony and complications, are effectively solved. This allows for continuous and precise in-situ adjustment of tidal volume without changing the equipment, as well as intelligent human-ventilator synchronized respiratory support based on real-time biofeedback, significantly improving the safety, accuracy, and effectiveness of neonatal resuscitation treatment.

[0061] Figure 3 This is a schematic cross-sectional view of the adjusting body 310 shown in one embodiment of the present invention. Figure 1 ; Figure 4 This is a schematic cross-sectional view of the adjusting body 310 shown in one embodiment of the present invention. Figure 2 .

[0062] The airways of newborns are extremely fragile. The airflow during compression of a conventional balloon is turbulent and chaotic. Therefore, to ensure precise control of the preset tidal volume under high-pressure ventilation and to prevent the regulator 310 from being compressed due to compression of the balloon body 210, please refer to [the relevant documentation / reference]. Figure 1 , Figure 3 and Figure 4 In some embodiments, a uniform annular airflow channel needs to be formed to make the output airflow laminar. The regulating body 310 has a spindle-shaped structure, and the long axis of the regulating body 310 is coaxial with the long axis of the balloon body 210; the outer wall of the regulating body 310 and the inner wall of the balloon body 210 define an annular laminar flow channel with a cross-sectional area that gradually changes from both ends to the middle, so as to guide the gas to flow in a laminar state along the direction from the one-way valve 220 to the mask during ventilation.

[0063] In this embodiment, to optimize gas flow characteristics, the regulating body 310 in the volume regulating mechanism 30 adopts a specific streamlined design. Specifically, the regulating body 310 is constructed as a spindle-shaped structure (or olive-shaped) that contracts at both ends and bulges in the middle. The regulating body 310 is installed in the internal cavity of the balloon body 210, and in terms of spatial layout, the central long axis of the regulating body 310 is coaxial with the central long axis of the balloon body 210, that is, their central axes coincide.

[0064] Based on the aforementioned coaxial nested structure, the outer wall of the regulating body 310 and the inner wall of the balloon body 210 are not tightly fitted, but rather a certain gap is maintained. This gap forms a continuous annular channel surrounding the regulating body 310 in space. Since the balloon body 210 is typically ellipsoidal, and in conjunction with the internal spindle-shaped regulating body 310, the cross-sectional area of ​​this annular channel is not constant along the axial direction, but exhibits a geometric feature that smoothly transitions and gradually changes from both ends to the middle. The outer surface of the regulating body 310 is made of a smooth medical-grade material to minimize frictional resistance when gas flows over the surface. This structural design aims to create a flow-guiding structure that conforms to the principles of fluid mechanics, ensuring a smooth and unobstructed flow path for gas inside the balloon.

[0065] In actual ventilation operations, when the external drive mechanism 40 compresses the balloon body 210, or when the balloon body 210 rebounds to inhale, the gas needs to flow rapidly inside the balloon.

[0066] In traditional balloons, gas often impacts irregular inner walls or central obstructions, generating eddies and turbulence, leading to unstable output airflow. In this embodiment, however, when gas enters through inlet 211 or flows towards one-way valve 220, gas molecules first contact the streamlined end of spindle-shaped regulator 310. The surface of regulator 310 acts like a guide vane, smoothly separating the airflow and guiding the gas into the aforementioned annular laminar flow channel.

[0067] As the gas flows through the annular channel, the change in the channel's cross-sectional area is smooth and gradual, avoiding pressure spikes or airflow separation caused by abrupt changes in cross-section. The gas flows orderly along the channel between the smooth outer wall of the regulator 310 and the inner wall of the balloon, being rectified into a laminar flow with parallel streamlines. When the gas finally converges towards the one-way valve 220 and the mask, a stable, vortex-free laminar air column has been formed. This orderly flow significantly reduces collisions between gas molecules and friction between the gas and the tube wall, thereby minimizing internal air resistance and ensuring that the mechanical pressure applied to the balloon is efficiently converted into ventilation pressure delivered to the newborn.

[0068] In other embodiments, while a spindle shape is preferred, the regulating body 310 can also be designed as a teardrop shape or a streamlined elliptical body, as long as its surface curvature can guide the airflow smoothly and form an annular channel with the inner wall of the balloon. The outer surface of the regulating body 310 may also be provided with fine flow-guiding grooves to further assist in airflow orientation; or it may be coated with a hydrophobic drag-reducing coating to further reduce gas flow resistance.

[0069] In this embodiment, by employing a spindle-shaped structure with the adjustment body 310 coaxially aligned with the balloon body 210, a smoothly varying annular laminar flow channel with a gradually changing cross-sectional area is defined between the outer wall of the adjustment body 310 and the inner wall of the balloon. This effectively solves the technical problem in the prior art where ordinary balloons easily generate turbulent internal airflow during compression ventilation, leading to increased airway resistance and unstable output airflow. Furthermore, it achieves the technical effect of using the fluid dynamics rectification principle to guide gas to form a stable laminar flow output, significantly reducing the impact and resistance on the fragile respiratory tract of newborns, and greatly improving oxygen delivery efficiency and ventilation safety.

[0070] To impart sufficient radial rigidity to the regulating body 310 and achieve controllable volume change, the regulating body 310 is constructed as a composite structure comprising a flexible outer membrane 311 and an internal mechanical support frame 312. (See also...) Figure 1 The support frame 312 includes a first guide sleeve 3121, a second guide sleeve 3122, a moving rod 3123, a reset elastic element, a connecting rod assembly, and a drive mechanism. The first guide sleeve 3121 and the second guide sleeve 3122 are coaxially spaced along the axial direction of the adjusting body 310. The first guide sleeve 3121 is fixed to the side of the adjusting body 310 near the one-way valve 220, and the second guide sleeve 3122 is fixed to the side of the adjusting body 310 away from the one-way valve 220. The two ends of the moving rod 3123 are slidably inserted into the first guide sleeve 3121 and the second guide sleeve 3122, respectively. The reset elastic element is sleeved on the moving rod 3123 or connected between the moving rod 3123 and the first guide sleeve 3121, and is used to apply force to the moving rod 3123 to maintain the support frame 312 in the correct position. The resetting force in the contracted state; the linkage assembly is disposed on the outside of the moving rod 3123, the linkage assembly includes several connecting rods 3124 distributed circumferentially along the moving rod 3123 and corresponding arc-shaped pressure plates 3125, one end of the connecting rod 3124 is rotatably connected to the moving rod 3123, and the other end of the connecting rod 3124 is connected to the arc-shaped pressure plate 3125, each of the arc-shaped pressure plates 3125 is disposed on the inner wall of the flexible outer membrane 311 and is evenly distributed along the circumference of the inner wall of the flexible outer membrane 311; the driving mechanism is used to drive the moving rod 3123 to move axially, so as to drive the arc-shaped pressure plates 3125 to move through the connecting rods 3124, so as to expand the flexible outer membrane 311 outward.

[0071] The core guiding structure of the supporting frame 312 consists of a first guide sleeve 3121 and a second guide sleeve 3122. These two guide sleeves are coaxially spaced along the central axis of the adjusting body 310, ensuring the straightness of the moving parts. Spatially, the first guide sleeve 3121 is fixedly installed inside the adjusting body 310 on the side near the one-way valve 220 (i.e., near the gas outlet), while the second guide sleeve 3122 is fixedly installed inside the adjusting body 310 on the side away from the one-way valve 220 (i.e., near the air inlet or tail end). The guide sleeves are typically made of a lightweight yet strong rigid material, and their inner surface is smoothed to reduce friction.

[0072] A movable rod 3123 is provided between the two guide sleeves. The two ends of the movable rod 3123 are slidably inserted into the inner holes of the first guide sleeve 3121 and the second guide sleeve 3122, respectively, so that it can perform stable reciprocating linear motion in the axial direction of the adjusting body 310. The movable rod 3123, as the active component of the frame, bears and transmits the driving force.

[0073] To ensure that the support frame 312 can automatically return to and maintain its minimum volume state when not driven, a reset elastic element (not shown in the figure) is provided in the device. This reset elastic element can be a helical spring, sleeved on the outer periphery of the moving rod 3123; or connected between the moving rod 3123 and the first guide sleeve 3121. The reset elastic element is configured to always apply an axial reset force (e.g., elastic force) to the moving rod 3123, the direction of which causes the support frame 312 to tend to remain in the contracted state, preventing accidental expansion without external intervention.

[0074] Linkage assemblies are evenly distributed along the outer circumference of the moving rod 3123. Each linkage assembly includes several connecting rods 3124 and corresponding arc-shaped pressure plates 3125.

[0075] One end of each connecting rod 3124 is rotatably connected to the moving rod 3123 via a pin or hinge, forming a movable hinge point.

[0076] The other end of the connecting rod 3124 is connected to an arc-shaped pressure plate 3125. Each arc-shaped pressure plate 3125 is fitted onto the inner wall of the flexible outer membrane 311 of the adjusting body 310 and is evenly distributed along the periphery of the inner wall of the flexible outer membrane 311. The curvature design of the arc-shaped pressure plate 3125 matches the target shape of the flexible outer membrane 311 when it is expanded, so as to increase the contact area and prevent stress concentration from puncturing the membrane.

[0077] A drive mechanism (such as a pneumatic push rod or linear actuator interface) is associated with the moving rod 3123 to overcome the resistance of the reset elastic element and drive the moving rod 3123 to move axially.

[0078] The working process of the support frame 312 consists of two states: controlled expansion and automatic contraction.

[0079] When it is necessary to increase the volume of the adjusting body 310 to reduce the effective gas storage volume of the balloon, the drive mechanism is activated. The driving force pushes the moving rod 3123 to slide axially within the first guide sleeve 3121 and the second guide sleeve 3122. As the moving rod 3123 displaces, the several connecting rods 3124 hinged to the moving rod 3123 undergo angular deflection under force (similar to the action of opening an umbrella). The ends of the connecting rods 3124 push the arc-shaped pressure plate 3125 outward, thereby uniformly expanding the flexible outer membrane 311 outward. When the moving rod 3123 moves to the designated position, the flexible outer membrane 311 is expanded to the target diameter, and the adjusting body 310 reaches the preset volume. At this time, the rigid connecting rods 3124 and the arc-shaped pressure plate 3125 constitute a robust internal skeleton, capable of resisting external pressure from the inside.

[0080] When it is necessary to reduce the volume of the adjusting body 310 or to reset it, the driving mechanism removes the driving force. At this time, the reset elastic element releases the stored elastic energy and applies a reverse reset force to the moving rod 3123. The moving rod 3123 slides in the opposite direction under the action of the elastic force, causing the connecting rod 3124 to fall back and retract. The connecting rod 3124 pulls the arc-shaped pressure plate 3125 closer to the central axis, and the flexible outer membrane 311 retracts accordingly. Finally, under the action of the reset elastic element, the support frame 312 returns to and locks in the initial contracted state.

[0081] This structure is suitable for neonatal resuscitation scenarios where high precision in volume control is required, especially when the external balloon needs to withstand high-frequency and high-force compression. It requires that the interior of the adjuster 310 has a small space to install the aforementioned mechanical structure, and that each moving part has fatigue-resistant properties to withstand long-term, repeated expansion and contraction operations.

[0082] In other embodiments, the reset elastic element may be a compression spring or a tension spring built into the guide sleeve, in addition to a sleeved helical spring. The linkage assembly may be a single link 3124 directly supported, or it may be a scissor-type multi-link 3124 structure to obtain a larger radial spread ratio within a limited axial travel. The surface of the arc-shaped pressure plate 3125 may be covered with a soft rubber layer to further protect the flexible outer membrane 311.

[0083] In this embodiment, a mechanical support frame 312 consisting of a guide sleeve, a moving rod 3123, a reset elastic element, and a connecting rod assembly is set inside the adjusting body 310. The moving rod 3123 is driven axially by a drive mechanism to drive the connecting rod 3124 and the arc-shaped pressure plate 3125 to expand the flexible outer membrane 311. Therefore, the technical problem of the existing simple flexible airbag adjusting body 310 being prone to passive compression deformation under external high pressure, resulting in inaccurate tidal volume adjustment, is effectively solved. This achieves the technical effect of using an internal rigid frame to resist external pressure interference and ensure that the volume and shape of the adjusting body 310 remain constant during ventilation.

[0084] Furthermore, to ensure that the internal support frame 312 can automatically and reliably return to and remain in its minimum volume contracted state when not in operation, the reset elastic element in the device is specifically designed as a helical spring, which is sleeved on the outer periphery of the moving rod 3123; one end of the helical spring abuts against the side end face of the second guide sleeve 3122 facing the first guide sleeve 3121, and the other end of the helical spring abuts against the connection between the connecting rod 3124 and the moving rod 3123; the helical spring is configured to use its own elastic force to push the moving rod 3123 back to its retracted state when the drive mechanism is not activated.

[0085] The helical spring is made of metal or high-strength elastic material, and its inner diameter is slightly larger than the outer diameter of the moving rod 3123, so that it can be coaxially sleeved on the outer peripheral surface of the moving rod 3123 and can freely extend and retract on the moving rod 3123 without interference.

[0086] In terms of specific installation position, the helical spring is located within the travel space of the moving rod 3123. One end (fixed end) of the helical spring abuts against one side of the second guide sleeve 3122, specifically against the end face of the second guide sleeve 3122 facing the first guide sleeve 3121. This end face serves as the fixed reaction force fulcrum when the spring is compressed. The other end (movable end) of the helical spring abuts against the connection between the connecting rod assembly and the moving rod 3123. This connection can be a hinge seat, boss, or specially designed retaining ring on the moving rod 3123. With this structural layout, the helical spring is pre-tensioned or naturally positioned within the axial space between the connection point of the second guide sleeve 3122 and the connecting rod 3124, forming a compact coaxial reset assembly together with the moving rod 3123.

[0087] When the drive mechanism actuates (e.g., through inflation), pushing the moving rod 3123 axially toward the second guide sleeve 3122, the connecting rod 3124 on the moving rod 3123 moves accordingly, compressing the helical spring. As the displacement of the moving rod 3123 increases, the support frame 312 gradually expands, while the helical spring is continuously compressed, accumulating reverse elastic potential energy within it. At this time, the external driving force overcomes the spring's elastic force, maintaining the expanded state of the frame.

[0088] When the drive mechanism stops operating (e.g., stops inflating and deflates), the driving force applied externally to the moving rod 3123 disappears. At this moment, the elastic potential energy stored in the helical spring is released instantaneously, generating an axial reset thrust. This thrust acts on the connection between the connecting rod 3124 and the moving rod 3123, pushing the moving rod 3123 to slide in the opposite axial direction (i.e., away from the second guide sleeve 3122). As the moving rod 3123 resets, the connecting rod assembly is pulled back, causing the arc-shaped pressure plate 3125 to retract inward. Finally, under the continuous action of the spring force, the moving rod 3123 returns to its initial position, and the support frame 312 is forcibly restored and locked in the retracted state, awaiting the next drive.

[0089] This reset structure is suitable for scenarios where the internal space of the adjustment body 310 is limited and high-reliability reset is required. The helical spring is sleeved on the moving rod 3123, making full use of the axial space without adding extra radial volume, making it suitable for installation inside the elongated adjustment body 310. The spring material must possess excellent fatigue resistance to withstand the frequent expansion and contraction cycles during resuscitation; simultaneously, considering the operating environment of medical devices, the spring surface is typically treated with rust prevention or biocompatibility.

[0090] In other embodiments, variable pitch springs can be used to obtain nonlinear restoring force characteristics, or conical helical springs can be used to further save axial space during compression. Furthermore, in addition to directly abutting the connection point of the connecting rod 3124, one end of the helical spring can also serve as an abutment point by setting an independent limiting circlip or washer on the moving rod 3123, as long as it can achieve the function of compressing the spring as the moving rod 3123 moves.

[0091] In this embodiment, by employing a technique that constructs the reset elastic element as a helical spring coaxially sleeved around the outer periphery of the moving rod 3123, and utilizes the connection point between the end face of the second guide sleeve 3122 and the connecting rod 3124 as the abutment fulcrum at both ends of the spring to construct an automatic reset circuit, the technical problems of incomplete reset, slow response speed, and inability to automatically retract to a safe volume in the prior art due to the internal support structure of the adjusting body 310 relying solely on the elastic force of the flexible membrane itself are effectively solved. This achieves the technical effect of using mechanical energy storage elements to ensure that the support frame 312 can quickly, forcibly, and reliably automatically reset to the contracted state after the driving force is removed, significantly improving the stability and safety of the device operation.

[0092] Furthermore, to achieve remote, non-contact actuation of the internal support frame 312 of the regulating body 310, a pneumatic drive structure is employed. Please refer to [link / reference]. Figure 3 and Figure 4 The moving rod 3123 is inserted into the first guide sleeve 3121. One end face of the rod is engaged with the inner wall of the first guide sleeve 3121 and the inner bottom wall of the adjusting body 310 to form a sealed pressure space. The driving mechanism includes a ventilation tube 3126. One end of the ventilation tube 3126 is connected to the pressure space, and the other end of the ventilation tube 3126 extends out of the adjusting body 310 and extends to the outside of the balloon body 210. The respiratory monitoring and resuscitation device is configured such that when gas is injected into the pressure space through the ventilation tube 3126, the air pressure pushes the moving rod 3123 to move towards the second guide sleeve 3122, so that the supporting frame 312 is in the expanded state.

[0093] Construction of the sealed pressure space. The first guide sleeve 3121 not only serves as a linear motion guide for the moving rod 3123, but is also constructed as a pneumatically driven cylinder. Specifically, the end of the moving rod 3123 inserted into the first guide sleeve 3121 is designed as a force-bearing piston end. This piston end face, the inner wall of the first guide sleeve 3121, and the inner bottom wall of the adjusting body 310 (i.e., the bottom closed surface where the first guide sleeve 3121 is fixed) together form a closed cavity, namely the sealed pressure space. To ensure airtightness, a sealing component, such as a rubber O-ring or lip seal, is typically provided between the outer periphery of the force-bearing end of the moving rod 3123 and the inner wall of the first guide sleeve 3121 to prevent high-pressure gas from leaking into other internal spaces of the adjusting body 310.

[0094] The drive mechanism includes a dedicated vent tube 3126. One end of the vent tube 3126 is in fluid communication with the aforementioned sealed pressure space, typically connected via a vent hole on the side wall or bottom of the first guide sleeve 3121. The tube body of the vent tube 3126 passes through the internal chamber of the regulator 310 and extends through the flexible outer membrane 311 or base of the regulator 310 to the outside of the balloon body 210. At the point where the vent tube 3126 exits the regulator 310, a strict sealing structure (such as sealant or a sealing joint) is provided to ensure complete isolation of the airways between the internal chamber of the regulator 310 (the flexible space for inflation and volume change) and the sealed pressure space (the pneumatic space for driving the frame), preventing interference between them. The external port of the vent tube 3126 is designed as a standard airway interface for connecting to an external control air source.

[0095] The working principle of this pneumatic drive mechanism is similar to that of a single-acting cylinder, and the specific operation process is as follows:

[0096] When it is necessary to expand the support frame 312 to fix the shape of the adjusting body 310, the external control system injects compressed gas (such as air or oxygen) into the sealed pressure space through the vent pipe 3126. As the gas enters, the air pressure in the sealed pressure space rises rapidly. The high-pressure gas acts on the end face of the insertion end of the moving rod 3123, generating an axial thrust. When this air pressure thrust overcomes the system resistance (such as the elasticity and friction of the reset element), it pushes the moving rod 3123 to slide axially towards the second guide sleeve 3122 within the first guide sleeve 3121. The displacement of the moving rod 3123 causes the connecting rod assembly to move, thereby expanding the support frame 312.

[0097] After the support frame 312 reaches the predetermined expanded state, the external air source maintains a constant air pressure in the vent pipe 3126, keeping the moving rod 3123 in the extended position, thereby locking the rigid support state of the frame.

[0098] When the frame needs to be retracted, the vent pipe 3126 is depressurized, the gas in the sealed pressure space is discharged, the thrust disappears, and the moving rod 3123 retracts under the action of the restoring force, and the space volume is reduced.

[0099] In other embodiments, under specific high-pressure requirements, the vent pipe 3126 may also be vented with an incompressible liquid (such as saline) for hydraulic actuation to obtain a smoother thrust.

[0100] In this embodiment, by employing a sealed pressure space formed by the cooperation of the first guide sleeve 3121 and the moving rod 3123, and by introducing an air source through a dedicated vent pipe 3126 to directly drive the axial movement of the moving rod 3123, the technical problems of difficulty in arranging electric drive components and the existence of electrical safety hazards in the narrow and enclosed adjustment body 310, as well as the complexity of traditional mechanical transmission structures and the difficulty in achieving remote and precise control, are effectively solved. Thus, the technical effect of using pure pneumatic principles to powerfully, reliably, and precisely expand and control the internal frame in an environment without electricity or sparks is achieved, while maintaining the compactness of the adjustment body 310 structure and the inherent safety of the system.

[0101] Furthermore, to achieve finer control over the volume and shape of the regulating body 310, please refer to [link / reference needed]. Figures 1 to 2 In addition to the power interface for driving the frame movement, the adjustment body 310 is also equipped with an independent inflation pipe 3127 system. That is, the adjustment body 310 is provided with an inflation pipe 3127, which is directly connected to the internal cavity of the adjustment body 310 and is used to fill the flexible outer membrane 311 with gas to cooperate with the support frame 312 to limit the volume of the adjustment body 310.

[0102] The inflation tube 3127 is a conduit with a certain degree of flexibility and pressure resistance. One end of it passes directly through the base or sealed interface of the regulator 310 and is in fluid communication with the internal chamber of the regulator 310 (i.e., the cavity between the flexible outer membrane 311 and the internal support assembly). The other end extends to the outside of the regulator 310 and the balloon body 210 and is provided with a standard interface for connecting an external control air source.

[0103] It should be noted that the internal air passage of the inflation pipe 3127 is completely physically isolated from the sealed pressure space of the drive support frame 312. The former is responsible for filling the large chamber of the flexible outer membrane 311 with gas, while the latter is responsible for injecting the power medium into the small chamber of the drive rod. Structurally, the two are not interconnected and have their own independent air intake channels and pressure control valves.

[0104] The operation of this dual-pipeline system embodies the dual synergistic logic of skeleton shaping and air pressure filling, specifically encompassing two levels: independence and correlation.

[0105] As mentioned earlier, the main function of inflating the vent pipe 3126 of the pressure space is to push the moving rod 3123, thus expanding the internal rigid frame. This step determines the theoretical maximum boundary and compressive rigidity of the adjusting body 310.

[0106] Inflating the air tube 3127 directly changes the total amount of gas inside the flexible outer membrane 311. This step determines the surface tension and saturation of the regulating body 310.

[0107] In practice, the two must work closely together to achieve the best results:

[0108] First, the support frame 312 is fully expanded by the air tube 3126. At this point, although the frame has a rigid structure, if it is not inflated, the flexible outer membrane 311 covering the frame may collapse or wrinkle at the gaps in the frame, and will not be full enough.

[0109] Subsequently (or simultaneously), an appropriate amount of gas is injected into the internal cavity of the regulating body 310 through the inflation tube 3127. The gas fills all the gaps between the skeleton and the outer membrane, causing the flexible outer membrane 311 to bulge outward under the action of air pressure until it is tightly attached to the stretched rigid support skeleton 312.

[0110] At this point, the regulating body 310 possesses both the rigid support provided by the skeleton (preventing compression by external high pressure) and the smooth shape (facilitating laminar flow) and uniform surface resulting from gas filling. The air pressure inside the inflation tube 3127 is typically set slightly higher than the working pressure of the external balloon, but not exceeding the skeleton's tolerance limit, thus achieving a perfect combination of internal rigidity and external flexibility.

[0111] The gas source requires a dual-channel gas source controller, which can independently adjust the pressure and flow rate of the two gas streams. During operation, attention must be paid to the balance of the two gas pressures. Generally, the frame drive pressure needs to be sufficient to overcome the force of the reset spring, while the membrane filling pressure needs to be sufficient to maintain the outer membrane fullness but should not be too high to avoid damaging the frame connection points.

[0112] In other embodiments, a miniature pressure sensor can be installed on the inflation tube 3127 to monitor the intramembrane pressure in real time. When external balloon compression causes pressure fluctuations in the regulator 310, millisecond-level pressure compensation can be performed through the inflation tube 3127, further improving the stability of volume locking.

[0113] In this embodiment, by adding an independent inflation pipe 3127 to the regulating body 310 and directly connecting it to the internal chamber, it forms two independent air paths with the ventilation pipe 3126 of the driving frame. The inflation pipe 3127 is used to fill the flexible outer membrane 311 with gas to cooperate with the supporting frame 312 to limit the volume of the regulating body 310. Therefore, it effectively solves the contradictory technical problems in the prior art that relying solely on the frame support may lead to the collapse and wrinkling of the membrane surface, thus affecting the laminar flow characteristics, and relying solely on airbag filling lacks rigid pressure resistance. This achieves the synergistic effect of the rigid frame defining the boundary and the gas filling shaping the form, ensuring the absolute constancy of the volume of the regulating body 310 under high-pressure ventilation, and ensuring that the surface of the regulating body 310 is smooth and full to form a perfect annular laminar flow channel. This significantly improves the technical effect of tidal volume control accuracy and gas delivery efficiency.

[0114] To ensure complete evacuation of the gas from the balloon body 210 and prevent backflow, the inflation compression assembly 410 in the external drive mechanism 40 is specially constructed as a segmented structure. (See also...) Figure 1 In some embodiments, the inflation and compression assembly 410 includes a plurality of sub-bladders 411 arranged sequentially along the gas flow direction within the balloon body 210. Adjacent sub-bladders 411 are interconnected, and an air inlet pipe 412 is connected to the sub-bladder 411 located closest to the air inlet 211. The sub-bladders 411 are configured to expand sequentially from the air inlet end toward the one-way valve 220 when air is introduced through the air inlet pipe 412, so as to generate peristaltic pushing pressure on the balloon body 210.

[0115] The inflation compression assembly 410 is not a single large-cavity airbag, but is composed of several independent, annular or semi-annular sub-bags 411.

[0116] These daughter capsules 411 are arranged sequentially along the axial direction of the balloon body 210 (i.e., the direction of gas flow from the inlet 211 to the one-way valve 220). The daughter capsules 411 tightly cover the outer periphery of the balloon body 210 and correspond to the inlet section (distal), middle section and outlet section (proximal) of the balloon body 210, respectively.

[0117] Adjacent sub-cells 411 are not isolated in terms of airflow path; instead, they are interconnected through internal flow channels or throttling orifices, forming a series airflow system. The key structural design lies in the air intake method: the air intake pipe 412 of the external driving air source is directly connected only to the rearmost sub-cell 411, specifically the sub-cell 411 located on the side of the air intake port 211 of the balloon body 210 (the side furthest from the mask). The remaining sub-cells 411 are not directly connected to the air intake pipe 412; instead, they rely on the gas within the preceding sub-cell 411 flowing in through the connecting port to achieve inflation. This structure establishes a unidirectional flow path for the gas within the compression assembly.

[0118] This multi-segment structure utilizes the physical delay characteristics of pneumatic transmission to generate a directional creeping compression effect, the specific process of which is as follows:

[0119] When the controller issues a ventilation command, compressed gas first enters the first sub-bladder 411 at the bottom (near the balloon inlet 211) through the inlet pipe 412. Due to the design of the inlet and the connection port, this sub-bladder 411 builds up pressure first and expands rapidly.

[0120] After the first sub-sac 411 inflates, it compresses the bottom of the balloon body 210, forcing the gas at the bottom upwards. Subsequently, the gas flows through the connecting port into the next adjacent sub-sac 411, causing the second sub-sac 411 to inflate and compress the middle section of the balloon body 210. This process propagates forward in a wave-like manner.

[0121] Finally, gas fills the topmost daughter capsule 411 (near the one-way valve 220), causing it to expand and compress the top of the balloon body 210.

[0122] The entire inflation process is sequentially timed down to the millisecond level, ensuring that the squeezing action on the balloon body 210 does not occur simultaneously, but rather proceeds sequentially from the inlet end to the outlet end. This action is similar to the peristaltic motion of squeezing toothpaste, forcing the gas inside the balloon body 210 to flow only in one direction (towards the mask) until it is completely expelled.

[0123] This structure is suitable for resuscitation scenarios with high requirements for ventilation efficiency and backflow prevention. Furthermore, the communication apertures between each daughter balloon 411 need to be precisely calculated to ensure a significant expansion time difference (phase difference) is generated at a given inlet pressure. This design is particularly suitable for the automated control mode of balloon resuscitators, minimizing residual gas in the dead space.

[0124] Furthermore, to more precisely control the peristaltic speed, a one-way valve 220 (not shown in the figure) or a throttle valve (not shown in the figure) can be installed on the connecting channel between adjacent cysts 411 to enhance the sequential expansion effect. Also, although this embodiment preferably uses a series connection structure (simple structure), in an alternative, each cyst 411 can also have an independent air inlet pipe 412, which is opened sequentially by a controller via a multi-way solenoid valve according to a preset timing sequence, thereby achieving more flexible electronically controlled peristaltic compression.

[0125] In this embodiment, by designing the inflation compression assembly 410 as a series of interconnected sub-bladders 411 distributed sequentially along the gas flow direction, and connecting the air inlet pipe 412 to the sub-bladder 411 closest to the air inlet 211, the technical means of achieving sequential expansion from the air inlet end to the one-way valve 220 by utilizing the airflow conduction sequence, the technical problems of gas residue dead zones easily formed at both ends of the balloon in the existing integral airbag compression and gas backflow or incomplete emptying due to the non-directional compression are effectively solved. Thus, a directional peristaltic pushing force is generated on the balloon body 210, which can completely empty the gas in the balloon, and the one-way valve 220 is closed with the assistance of physical compression wave, which significantly improves the ventilation efficiency and unidirectional flow safety.

[0126] Furthermore, in order to optimize the mechanical transmission efficiency of the inflation compression assembly 410 and protect the internal flexible components, the external drive mechanism 40 is provided with a rigid limiting shell 420 on the outermost layer. The limiting shell 420 is sleeved on the outside of the inflation compression assembly 410. The daughter bladder 411 is located between the outer surface of the balloon body 210 and the inner wall of the limiting shell 420. The limiting shell 420 is configured to abut against the outside of the daughter bladder 411 when the daughter bladder 411 inflates, so as to force the expansion deformation force of the daughter bladder 411 to act inward on the balloon body 210.

[0127] The limiting housing 420 is typically constructed as a hollow cylindrical or cage-like structure, the shape of which is adapted to the overall contour of the internal balloon body 210 and the inflation compression assembly 410 (e.g., cylindrical or elliptical cylindrical). The limiting housing 420 is made of a rigid material with high structural strength and rigidity, such as medical-grade rigid plastics (polycarbonate, ABS, etc.) or lightweight metal alloys, to ensure that it does not deform during operation.

[0128] The limiting shell 420 is fitted over the entire inflation and compression assembly 410 (i.e., the several daughter capsules 411). This creates a sandwich-like hierarchical structure in the radial cross-section of the device: the innermost layer is the balloon body 210, the middle layer is the daughter capsules 411 of the inflation and compression assembly 410, and the outermost layer is the limiting shell 420. The daughter capsules 411 are precisely positioned within the annular gap defined between the outer surface of the balloon body 210 and the inner wall of the limiting shell 420.

[0129] The two ends of the limiting housing 420 are usually fixedly connected to the base or top cover of the device to form a static external frame, providing physical protection and reaction force support for the entire drive system.

[0130] The core function of the limiting housing 420 in the system is to provide radial constraint and reaction force support. Its working process is as follows:

[0131] When the bladder 411 is not inflated, it is in a flat or relaxed state, housed in the gap between the balloon body 210 and the limiting shell 420. At this time, the limiting shell 420 primarily protects the internal air bladder from puncture or accidental contact by sharp objects. When control gas is introduced into the bladder 411 to cause it to inflate, the bladder 411 attempts to expand in all directions (360 degrees). The outer wall of the bladder 411 first contacts and abuts against the inner wall of the limiting shell 420. Because the limiting shell 420 is rigid and fixed in position, it restricts the outward displacement of the bladder 411. At this time, the inner wall of the limiting shell 420 exerts a reaction force on the bladder 411. This physical constraint forces the expansion kinetic energy of the bladder 411 to be released only in the direction of least resistance, preventing it from being released outward. Therefore, all the expansion deformation potential energy of the bladder 411 is forcibly directed inward, converted into radial pressure pointing towards the center, and concentrated on the outer wall of the balloon body 210.

[0132] This structure is suitable for portable medical devices that require compact size and high energy efficiency. The wall thickness and material of the limiting housing 420 must be calculated to withstand the maximum internal pressure of the daughter capsule 411 when fully inflated without bursting or yielding. The inner diameter design of the limiting housing 420 is crucial; it must ensure that the capsule body 210 can be compressed to the predetermined deflation state after the daughter capsule 411 is inflated. Excessive clearance will result in insufficient compression, while insufficient clearance will make assembly difficult.

[0133] In other embodiments, the limiting housing 420 is not limited to a fully enclosed tubular structure; it can also be a perforated mesh or frame structure, as long as it provides sufficient rigid support area to prevent the sub-bladder 411 from bulging out. This reduces the weight of the device and facilitates observation of the internal balloon's working status. In some alternatives, the limiting housing 420 can also be designed as a diameter-adjustable clamp-type structure. By adjusting the housing diameter, the pre-tightening force of the sub-bladder 411 on the balloon can be changed, thereby fine-tuning the compression depth.

[0134] In this embodiment, by employing a rigid limiting shell 420 fitted outside the inflation compression assembly 410 and confining the sub-bladder 411 within the gap between the balloon body 210 and the limiting shell 420, and utilizing the rigid inner wall of the limiting shell 420 to abut against the expanding sub-bladder 411 to provide reaction force support, the technical problem in the prior art where flexible airbags tend to expand disorderly in all directions during inflation, resulting in a large amount of expansion power being wasted on outward expansion, causing insufficient or unstable actual compression force acting on the balloon body 210, and thus affecting the tidal volume delivery efficiency, is effectively solved. This achieves forced physical constraint on the inflation direction of the airbag, converting 100% of the deformation energy of the airbag into effective inward compression force, significantly improving the system's energy utilization efficiency and the accuracy of balloon compression control.

[0135] It is worth noting that the supporting frame 312, the spindle-shaped adjusting body 310 and the spindle-shaped annular flow channel formed by the inner wall of the balloon body 210, and the multi-segment peristaltic inflation and compression assembly 410 in this embodiment are not isolated technical improvements. The three have a close synergistic coupling relationship in terms of physical structure and functional implementation, and together they constitute a high-precision, low-damage neonatal ventilation system with excellent hydrodynamic characteristics.

[0136] First, there is a synergy between the support frame 312 and the spindle-shaped annular flow channel in terms of shape fixation and flow stabilization. The spindle-shaped regulating body 310 is designed to guide laminar flow and reduce air resistance by forming an annular flow channel with a gradually changing cross-section. However, if the regulating body 310 is merely a simple flexible airbag, the flexible surface is prone to vibration or distortion under high-speed gas flow or external compression, leading to dynamic changes in the cross-sectional shape of the flow channel, which in turn disrupts the laminar boundary layer and generates turbulence. In this device, the internally expanded support frame 312 provides a rigid geometric framework for the regulating body 310, ensuring that the regulating body 310 strictly maintains the preset spindle shape under any operating condition. This internally rigid and externally flexible structure provides an absolutely stable inner wall boundary for the annular flow channel, allowing the fluid dynamics design to function undisturbed and ensuring that the airflow remains stable.

[0137] Secondly, there is a synergistic pumping effect between the annular flow channel and the multi-stage peristaltic inflation and compression assembly 410. The peristaltic compression wave generated by the multi-stage capsules 411 achieves the highest fluid transport efficiency within the narrow and regular annular flow channel. Because the annular flow channel restricts the gas flow cross-section, a significant pressure gradient propulsion wave (pumping effect) can be formed within the flow channel as the outer capsules 411 expand sequentially. Compared to compression within an empty balloon, peristaltic compression within the annular flow channel can produce higher flow rates and more thorough emptying with a smaller compression amplitude. This efficient pumping mechanism is particularly suitable for neonatal resuscitation scenarios with poor lung compliance that require rapid and effortless ventilation.

[0138] Finally, and most importantly, the support frame 312 and the multi-stage peristaltic extrusion assembly exhibit interference resistance and precise synergy, jointly overcoming the inherent defects of dual flexible system coupling. To achieve complete evacuation, multi-stage peristaltic extrusion often requires generating high local extrusion pressure. In traditional dual-bladder systems, external high-pressure extrusion directly causes the internal regulating bladder to be compressed (volume reduction), resulting in uncontrollable drift of the preset tidal volume (i.e., an increase in actual output). In this device, the introduction of the mechanical support frame 312 provides radial rigid support, forming a hard core capable of resisting strong external peristaltic extrusion. This allows the external drive mechanism 40 to confidently perform high-intensity peristaltic evacuation without worrying about disrupting the volume setting of the internal regulating body 310.

[0139] In summary, this complete structural improvement fundamentally overcomes the unexpected technical challenge of volumetric accuracy drift in existing dual-flexible capsule coupling systems, achieving the technical effect of maintaining a constant physical volume and outputting stable laminar airflow even under dynamic high-pressure creeping compression. This systematic improvement based on deep coupling of multiple components is something that those skilled in the art cannot foresee or derive through simple component stacking.

[0140] Figure 5 This is a flowchart illustrating a control method for a respiratory monitoring and resuscitation device according to an embodiment of the present invention.

[0141] To enable the aforementioned respiratory monitoring and resuscitation device to achieve high-precision tidal volume locking and intelligent respiratory synchronization, a control method for this device is proposed. Please refer to [link to relevant documentation]. Figure 5 The control method includes the following steps:

[0142] Step S100: Receive target ventilation parameters, which are obtained from external input or calculated based on detection data;

[0143] Step S200: According to the target ventilation parameters, control the air source to inflate the flexible outer membrane 311 of the regulating body 310 through the inflation tube 3127, and simultaneously inflate the sealed pressure space through the ventilation tube 3126 to drive the moving rod 3123 to move, thereby expanding the support frame 312. The expanded support frame 312 is used to resist external pressure and lock the effective air storage volume of the balloon body 210.

[0144] Step S300: Continuously monitor the signal of the pressure sensor and identify the newborn's inhalation action based on the signal changes;

[0145] Step S400: When an inhalation action is detected, the external drive mechanism 40 is controlled to operate, driving gas into the inflation and compression assembly 410, causing the inflation and compression assembly 410 to expand sequentially from the distal end to the proximal end, thereby performing peristaltic compression on the balloon body 210, so that the gas in the balloon body 210 is output through the one-way valve 220.

[0146] Specifically:

[0147] Step S100 involves receiving the target ventilation volume parameter. This step aims to determine the required single ventilation volume for the newborn. The target ventilation volume parameter can be obtained by the operator inputting the newborn's basic physical parameters (at least including weight, length, and gestational age) through an external input terminal. The system has a built-in empirical mapping model (e.g., "tidal volume = 6-8 mL / kg × weight"), and the controller automatically calculates the recommended target ventilation volume based on the input parameters. In another mode, if the system is connected to other monitoring equipment, the target ventilation volume can also be automatically calculated and adjusted directly based on detection data (such as historical trends in blood oxygen saturation).

[0148] Step S200 involves locking the effective gas storage volume of the balloon body 210 based on the target ventilation volume parameters. This step is crucial for achieving precise volume control, and its execution process demonstrates the unique advantages of combined pneumatic and mechanical regulation. The controller calculates the required volume of the regulating body 310 based on the target ventilation volume and executes the following dual-channel control: First, the controller controls the gas source to inject compressed gas into the sealed pressure space through the ventilation tube 3126. The high-pressure gas pushes the moving rod 3123 to overcome the resistance of the reset elastic element and move axially, causing the connecting rod assembly to open. Based on the stroke corresponding to the target volume, the controller controls the gas pressure value within the ventilation tube 3126, causing the support frame 312 to open to a determined mechanical diameter, thereby constructing a rigid volume boundary to resist subsequent external pressure. Simultaneously (or immediately following), the controller controls the gas source to inject an appropriate amount of gas into the internal cavity of the flexible outer membrane 311 of the regulating body 310 through the inflation tube 3127. This portion of gas is used to fill the gap between the supporting frame 312 and the flexible outer membrane 311, allowing the flexible outer membrane 311 to fully adhere to the expanded frame under gas pressure, forming a smooth spindle-shaped outer surface. Through the above dual operation, the regulating body 310 forms a constant-volume entity inside the balloon that has both a rigid core and a smooth outer surface, precisely locking the remaining effective gas storage volume of the balloon body 210.

[0149] Step S300: Continuously monitor the signal from the pressure sensor and identify the newborn's inhalation action based on signal changes. This step is the core of achieving human-machine synchronization. To accurately capture the newborn's weak spontaneous inhalation signal from complex mask pressure fluctuations, this embodiment introduces a complete signal processing flow including signal preprocessing, interference removal, feature extraction, and multi-level logical filtering. Specifically, it includes the following sub-steps:

[0150] Step S301: Pressure sequence generation. The pressure sensor continuously collects the air pressure value inside the mask at a fixed sampling frequency fs (preferably 50Hz or higher), generating a time-varying air pressure sequence P={p1,p2,...,pn}. This sequence reflects the dynamic pressure changes inside the mask caused by balloon inflation, spontaneous infant breathing, and background noise.

[0151] Step S302: Locking and Removing the Balloon Interference Window. The peristaltic squeezing in step S400 causes a rapid increase in mask pressure within a short period (forming a high-amplitude positive pressure pulse). The amplitude of this positive pressure pulse is much larger than the weak negative pressure signal generated by the infant's spontaneous inhalation, and its downward trend during the pressure drop phase is easily misinterpreted by the algorithm as an inhalation action. Therefore, the system must identify and lock this balloon interference window, removing all pressure fluctuation data within this window and monitoring the inhalation signal only during non-interference periods. The controller uses a pressure gradient abrupt change detection method to lock this process: performing first-order difference calculations on the pressure sequence to generate a gradient sequence. Set a positive gradient threshold. (e.g., 100 Pa / sampling period). When multiple consecutive gradient values ​​are detected. When the total pressure increase during this segment exceeds a set threshold (e.g., 200 Pa), it is determined to be a balloon compression inflation action. The system records the start time of this pressure increase segment. and end time Furthermore, a certain safety margin (e.g., 50ms) is extended before and after this, defining a balloon interference window. All data within this window is marked as invalid and does not participate in subsequent inhalation recognition.

[0152] Step S303: Candidate Inspiratory Feature Extraction (Sliding Window Method). During the effective time period outside the aforementioned interference window, the controller performs sliding window processing on the pressure sequence (window size...). (3 to 5 sampling points are recommended). Within each sliding window, determine whether the air pressure shows a continuous downward trend. If so, mark it as a downward segment. Within each downward segment, search for local minimum points of air pressure. These minimum points represent the troughs of pressure changes and are potential peaks of neonatal inspiratory negative pressure, which are marked as candidate inspiratory events.

[0153] Step S304: First-level screening – Amplitude logic judgment. To filter out weak noise caused by sensor jitter or airflow disturbance, the system performs amplitude verification on each candidate inhalation event. The logic is: backtrack to the minimum point. Find the local maximum value within a certain time window (e.g., 0.5 seconds). Calculate the pressure drop. .Will With the preset effective inhalation amplitude threshold Compare them. The standard setting is typically 50 to 100 Pa (based on clinical experience). If If the fluctuation amplitude is insufficient to constitute a valid physiological inhalation, the candidate point is eliminated.

[0154] Step S305: Secondary screening - time interval logic judgment. To eliminate possible high-frequency false signals (such as rapid pressure fluctuations caused by crying or swallowing), the system introduces a physiological refractory period limit. Calculate the time interval ΔT between the current candidate point and the previous confirmed inhalation point. Set the "minimum physiological inhalation cycle" Tmin (based on the upper limit of the neonatal respiratory rate of 60 - 80 breaths per minute, this threshold can be set to about 0.3 seconds). If ΔT < Tmin, it means that the two signals are too close and do not conform to physiological laws. At this time, the system executes a competition logic: retain the point with a larger ΔP (descending amplitude) and eliminate the false signal with a smaller amplitude.

[0155] Step S306: Inhalation confirmation and synchronous triggering. The local minimum points retained after the double screening of steps S304 and S305 above are confirmed as valid neonatal inhalation actions. Once the inhalation action is confirmed (or in algorithm optimization, when a large descending trend is detected and the minimum value has not been reached), the controller immediately generates a synchronous trigger signal and jumps to execute step S400 to start the external drive mechanism 40 for assisted ventilation. In addition, the controller can also calculate the real-time respiratory rate based on the time intervals of multiple consecutive inhalation events for adjusting subsequent ventilation protection strategies.

[0156] Step S400 is to control the operation of the external drive mechanism 40 to implement peristaltic squeezing when an inhalation action is recognized. Once step S300 confirms the inhalation action, the controller immediately responds and starts ventilation support, but its execution method is not a simple overall compression, but a peristaltic process with a specific time sequence: the controller controls the external gas source to drive the gas into the inflation squeezing component 410. The gas first enters the sub-sac 411 closest to the balloon air inlet 211 (distal end), causing it to expand first, closing the bottom of the balloon and pushing the gas upward; subsequently, the gas enters the middle and proximal sub-sacs 411 in sequence through the communication structure (or the controller sequentially opens the valves of each independent sub-sac 411). This sequential expansion from the distal end to the proximal end (in the direction of the one-way valve 220) forms a directional squeezing wave outside the balloon. This squeezing wave, like squeezing toothpaste, strongly and thoroughly pushes the gas in the balloon body 210 towards the air outlet. During this process, due to the strong radial rigidity provided by the support skeleton 312撑开 in step S200, even if a high-intensity peristaltic squeezing force is applied by the external sub-sac 411, the internal adjustment body 310 will not be passively compressed, thus ensuring that the amount of gas extruded is strictly equal to the preset tidal volume. After the gas delivery is completed, the controller controls the sub-sac 411 to release pressure and waits for the next inhalation trigger.

[0157] The control method proposed in this embodiment employs a dual-channel inflation strategy to drive the rigid frame to expand and fill the flexible outer membrane 311 to lock the volume. It also combines a respiratory recognition logic based on interference window elimination and dual screening algorithms to trigger the directional peristaltic compression of the outer sac 411. Therefore, it effectively solves the technical problems in the prior art, such as volume drift under high pressure caused by relying solely on the flexible adjustment body 310, difficulty in accurately recognizing respiratory signals under mechanical interference, and dead zones and backflow in traditional compression methods. Thus, it achieves a zero-dead-zone, high-efficiency assisted ventilation effect that is synchronized with the weak breathing of newborns at the millisecond level while ensuring absolute accuracy of tidal volume.

[0158] The above description is merely illustrative of the invention. Those skilled in the art can make various modifications or additions to the described specific embodiments or use similar methods to replace them, as long as they do not depart from the content of this specification or exceed the scope defined by the claims, all of which should fall within the protection scope of this invention.

Claims

1. A neonatal respiratory monitoring and resuscitation device, characterized in that, include: A breathing mask assembly, which contains a breathing chamber and a pressure sensor for monitoring pressure; The balloon assembly includes a balloon body and a one-way valve. The distal end of the balloon body is provided with an air inlet, and the proximal end is connected to the breathing mask assembly through the one-way valve. A volume adjustment mechanism, disposed inside the balloon body, includes an adjustment body configured to controllably adjust its volume within the balloon body to change the effective gas storage volume within the balloon body. The adjustment body includes a flexible outer membrane and a support frame disposed within the flexible outer membrane. The support frame is configured to have a contracted state and an expanded state. In the expanded state, the support frame abuts against the inner wall of the flexible outer membrane to provide radial support, thereby limiting the deformation of the adjustment body when the balloon body is compressed. The support frame includes: A first guide sleeve and a second guide sleeve are coaxially spaced along the axial direction of the adjusting body. The first guide sleeve is fixed to the side of the adjusting body closer to the one-way valve, and the second guide sleeve is fixed to the side of the adjusting body away from the one-way valve. The movable rod has its two ends slidably inserted into the first guide sleeve and the second guide sleeve, respectively. A reset elastic element is sleeved on the moving rod or connected between the moving rod and the first guide sleeve, and is used to apply a reset force to the moving rod to keep the support frame in the contracted state; A linkage assembly is disposed on the outside of the movable rod. The linkage assembly includes a plurality of linkages distributed circumferentially along the movable rod and corresponding arc-shaped pressure plates. One end of the linkage is rotatably connected to the movable rod, and the other end of the linkage is connected to the arc-shaped pressure plate. Each arc-shaped pressure plate is disposed on the inner wall of the flexible outer membrane and is evenly distributed along the circumference of the inner wall of the flexible outer membrane. A driving mechanism is used to drive the moving rod to move axially, so as to drive the arc-shaped pressure plate to move through the connecting rod, thereby expanding the flexible outer film outward. An external drive mechanism, disposed outside the balloon body, includes an inflation and compression assembly covering the periphery of the balloon body, for applying compression force to the balloon body; The controller is connected to the pressure sensor, the volume adjustment mechanism, and the external drive mechanism respectively; the controller is configured to control the operating frequency of the external drive mechanism according to the signal of the pressure sensor, so as to synchronize it with the breathing frequency of the newborn.

2. The respiratory monitoring and resuscitation device according to claim 1, characterized in that, The regulating body has a spindle-shaped structure, and the long axis of the regulating body is coaxial with the long axis of the balloon body; the outer wall of the regulating body and the inner wall of the balloon body define an annular laminar flow channel with a cross-sectional area that gradually changes from both ends to the middle, so as to guide the gas to flow in a laminar state along the direction from the one-way valve to the mask during ventilation.

3. The respiratory monitoring and resuscitation device according to claim 1, characterized in that, The reset elastic element is a helical spring, which is sleeved on the outer periphery of the moving rod; one end of the helical spring abuts against the side end face of the second guide sleeve facing the first guide sleeve, and the other end of the helical spring abuts against the connection between the connecting rod and the moving rod; the helical spring is configured to push the moving rod back to its original position by its own elastic force when the drive mechanism is not activated, so as to maintain the support frame in the retracted state.

4. In the respiratory monitoring and resuscitation device according to claim 1, one end face of the movable rod inserted into the first guide sleeve cooperates with the inner wall of the first guide sleeve and the inner bottom wall of the adjusting body to form a sealed pressure space; the driving mechanism includes a ventilation tube, one end of which communicates with the pressure space, and the other end of which extends out of the adjusting body and to the outside of the balloon body; wherein, The respiratory monitoring and resuscitation device is configured such that when gas is introduced into the pressure space through the ventilation tube, the gas pressure pushes the moving rod to move toward the second guide sleeve, so that the support frame is in the expanded state.

5. The respiratory monitoring and resuscitation device according to claim 4, wherein the regulating body is further provided with an inflation tube, the inflation tube being directly connected to the internal chamber of the regulating body, for filling the flexible outer membrane with gas to cooperate with the support frame to limit the volume of the regulating body.

6. The respiratory monitoring and resuscitation device according to claim 5, characterized in that, The inflation and compression assembly includes a plurality of sub-cells arranged sequentially along the gas flow direction within the balloon body. Adjacent sub-cells are interconnected, and an air inlet pipe is connected to the sub-cell closest to the air inlet. The sub-cells are configured to expand sequentially from the air inlet end toward the one-way valve when air is introduced through the air inlet pipe, thereby generating a peristaltic pushing force on the balloon body.

7. The respiratory monitoring and resuscitation device according to claim 6, characterized in that, The external drive mechanism further includes a limiting housing, which is sleeved on the outside of the inflation and compression assembly; the sub-bladder is located between the outer surface of the balloon body and the inner wall of the limiting housing; the limiting housing is configured to abut against the outside of the sub-bladder when the sub-bladder inflates, so as to force the inflation deformation force of the sub-bladder to act inward on the balloon body.

8. The respiratory monitoring and resuscitation device according to any one of claims 4 to 7, characterized in that, The controller includes the following control steps: Receive target ventilation parameters, which are obtained from external input or calculated based on detection data; According to the target ventilation parameters, the air source is controlled to inflate the flexible outer membrane of the regulator through the inflation tube, and at the same time, it is inflated into the sealed pressure space through the ventilation tube to drive the moving rod to move, thereby expanding the support frame. The expanded support frame is used to resist external pressure and lock the effective air storage volume of the balloon body. The pressure sensor signal is continuously monitored, and the newborn's inhalation action is identified based on signal changes; When an inhalation action is detected, the external drive mechanism is controlled to operate, driving gas into the inflation and compression assembly, causing the inflation and compression assembly to expand sequentially from the distal end to the proximal end, thereby performing peristaltic compression on the balloon body, so that the gas inside the balloon body is output through the one-way valve.

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