An integrated airway management device

Abstract

This invention belongs to the field of medical device technology and provides an integrated airway management device, including an airway management main body and an independent heat dissipation system for the valve body. The airway management main body integrates an endotracheal intubation module, a multi-functional host module, and a software control system. The heat dissipation system is fitted onto the surface of the multi-channel switching valve body and includes a heat collection box, coaxial pipelines, an external heat exchange assembly, and a nitrogen circulation gas path, achieving independent heat dissipation at specific points on the valve body. The external heat exchange assembly also includes connecting pipe circuits and a replaceable water-cooled liquid jacket, forming a coupled heat dissipation structure with internal inert gas constant temperature insulation and external liquid cooling continuous heat dissipation. This invention also integrates automatic pressure compensation of the negative pressure suction synchronous cuff, adaptive regulation of secretions, and a dual-sensor redundant safety architecture; through the independent operation of the heat dissipation system and the external placement of the liquid phase heat exchange structure, it takes into account miniaturization, long-term stable operation, no internal condensation accumulation, and high clinical safety requirements.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an integrated airway management device. Background Technology

[0002] Integrated airway management devices are widely used in clinical anesthesia, intensive care and other scenarios to establish and maintain artificial airways for patients and ensure ventilation safety. These devices typically integrate multiple functions such as subglottic suction and cuff inflation monitoring and need to operate continuously 24 hours a day.

[0003] Existing integrated airway management devices are compact in size, with a multi-channel switching valve integrated inside the main unit. Frequent switching of the valve allows for alternating negative pressure suction and cuff inflation / deflation pathways, but generates significant heat during operation. However, this type of solution still has the following drawbacks in clinical use: Firstly, the internal installation space of the equipment is extremely small, making it impossible to install traditional built-in liquid cooling plates or condensation heat exchange components; and secondly, the strict clinical operating conditions require that liquid media and condensate water must not be present in the internal chambers of the machine. Long-term high temperature accumulation in the valve body causes the internal seals to age faster, resulting in negative pressure leakage, increased air bag replenishment loss, and high temperature radiation convection to the whole machine, causing monitoring accuracy drift and even component damage. Secondly, during subglottic negative pressure suction, the negative pressure airflow continuously draws gas from the inside of the double-sealed airbag through the gap in the pipeline. The rapid drop in airbag pressure causes the airway seal to fail, which poses a risk of gastric reflux and tube slippage. Existing equipment does not have an automatic compensation structure, and medical staff need to manually replenish gas and adjust the pressure repeatedly, which is cumbersome. In addition, traditional airbag pressure monitoring uses only a single sensor, which has the potential for single-point failure; and it cannot automatically identify the viscosity of secretions, and the negative pressure and flushing parameters rely entirely on manual adjustment, resulting in poor adaptability. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides an integrated airway management device that solves multiple technical problems, such as efficient heat dissipation of the valve body in a confined space, automatic compensation of cuff pressure during negative pressure suction, adaptive processing of secretions, and sensor redundancy for safety. This achieves a balance between long-term continuous and stable operation of miniaturized equipment and high clinical safety.

[0005] The integrated airway management device provided by this invention includes: The airway management system includes an endotracheal intubation module, a multi-functional main unit module, and a software control system. The endotracheal intubation module is equipped with a subglottic suction channel and an airbag inflation channel, and the distal end of the intubation tube is equipped with an inflatable double-layer sealed airbag. The multi-functional main unit module has a built-in micro negative pressure pump, an automatic inflation pump, a multi-channel switching valve body, and a dual pressure sensor assembly. The software control system is equipped with a microprocessor and control algorithms. An independent heat dissipation system for the valve body, fitted and installed on the surface of the multi-channel switching valve body, includes: The heat collection box is tightly fitted to the surface of the multi-channel switching valve body, and its outer side is provided with heat dissipation fins. The internal cavity is connected to the nitrogen pipeline. The coaxial pipeline consists of a nitrogen heat exchange inner tube, a vacuum insulation middle tube, and an insulation outer tube, from the inside out. The three tube cavities are isolated from each other and do not connect to each other. An external heat exchange assembly is located on the outside of the housing of the gas duct management body, for heat exchange between high-temperature nitrogen and the cooling medium; A nitrogen circulation path connects the heat collection box to the external heat exchange assembly, allowing nitrogen to circulate between the heat collection box and the external heat exchange assembly.

[0006] Furthermore, the dual-pressure sensor assembly includes a first pressure sensor and a second pressure sensor. The two pressure sensors are respectively connected to the inner cavity of the double-layered sealed airbag for synchronously acquiring airbag pressure data. The microprocessor is configured to automatically switch to the other pressure sensor to maintain monitoring and control when either pressure sensor reading shows an abnormal deviation, exceeds its range, or experiences a signal interruption. In practical applications, this design, through the synergistic effect of synchronous dual-sensor acquisition and automatic switching in case of abnormalities, achieves continuous and reliable airbag pressure monitoring, significantly improving clinical safety.

[0007] Furthermore, a flow sensor is installed within the subglottic suction channel; the microprocessor is configured to determine the viscosity of the secretions based on changes in suction airflow resistance detected by the flow sensor: when the secretions are determined to be thin, the micro-negative pressure pump is controlled to operate in a low-negative-pressure intermittent suction mode; when the secretions are determined to be viscous, the micro-negative pressure pump is controlled to operate in a high-negative-pressure continuous suction mode, and a pulse flushing program is simultaneously initiated. In practical applications, the flow sensor's real-time resistance detection and the microprocessor's graded control based on viscosity work synergistically to automatically adapt the negative pressure suction and flushing parameters according to the secretion state, eliminating the need for manual adjustments by medical personnel based on experience. This balances the effectiveness of secretion removal with airway mucosal protection, significantly improving the device's adaptability to different clinical scenarios and ease of operation.

[0008] Furthermore, the dual-layer sealing airbag has a dual-airbag structure, including a main airbag and a backup airbag; the backup airbag is fitted outside the main airbag; when the main airbag ruptures and fails, the system switches to the backup airbag to maintain the airway seal. In practical applications, this dual-airbag redundancy ensures that the actuator does not fail; together, they constitute a full-link safety guarantee from signal sensing to execution, effectively reducing the risk of airway seal failure due to the rupture of a single airbag.

[0009] Furthermore, the vacuum insulation middle layer tube is a high-vacuum sealed jacket; the insulation outer layer tube is a static sealed jacket. In practical applications, the active heat insulation of the high-vacuum jacket and the passive heat insulation of the static jacket work together to form a double thermal barrier, ensuring that very little heat leakage from the valve body into the main unit occurs during the outward transfer of heat along the inner tube. The operating temperatures of the pressure sensor, negative pressure pump, inflation pump, and control circuit board are kept stable, and the control accuracy of airbag pressure monitoring and automatic air replenishment compensation is not affected by high temperatures.

[0010] Furthermore, the external heat exchange assembly includes a sealed shell and a heat exchanger; the nitrogen heat exchange inner tube passes through the side wall of the sealed shell and communicates with the heat exchanger; the sealed shell is a sealed cavity structure, the heat exchanger is sealed inside the sealed shell, and the internal cavity of the sealed shell is sealed and filled with an inert cooling gas, namely argon. In practical applications, this technical solution utilizes the combined effect of the sealed shell's sealing isolation and the "argon inert cooling" to ensure that the heat exchange process is completed within a completely sealed cavity, and the heat exchange medium is an inert gas rather than a liquid; even if a slight leak occurs in the sealed shell, the leaked substance is argon rather than a corrosive liquid, and will not cause contamination or corrosion to the internal components of the device. This design achieves both directional heat transfer to the outside of the equipment and fundamentally eliminates the risk of coolant leakage into the device, perfectly meeting the clinical operating requirements where liquid media are strictly prohibited in the internal cavities of the device.

[0011] Furthermore, the external heat exchange assembly also includes a connecting pipe circuit and a replaceable water-cooled liquid jacket. Both ends of the connecting pipe circuit are connected to the sealed housing, and the middle portion extends outside the sealed housing. The replaceable water-cooled liquid jacket is detachably fitted onto the pipe wall of the connecting pipe circuit located outside the sealed housing. Room temperature cooling water flows through the water-cooled liquid jacket, forming a coupled heat dissipation structure with internal inert gas for constant temperature insulation and external liquid cooling for continuous heat removal. In practical applications, this design adds an external liquid cooling heat removal channel. The combined effect of internal argon gas for constant temperature insulation and external liquid cooling for continuous heat removal forms a gas-liquid coupled dual heat dissipation architecture. The internal argon gas evenly conducts the heat released by the heat exchanger to the connecting pipe circuit, while the external water-cooled liquid jacket continuously removes the heat through room temperature cooling water. Compared to relying solely on natural radiation heat dissipation from the shell wall, this structure significantly improves heat dissipation efficiency. At the same time, the detachable design of the water-cooled liquid jacket facilitates daily maintenance and replacement. The heat dissipation system can be inspected without disassembling the internal valve body and air duct pipeline, significantly reducing maintenance difficulty and downtime.

[0012] Furthermore, the nitrogen circulation path is filled with high-purity nitrogen as the working fluid, and the nitrogen circulation path is a closed-loop path. This design ensures the high purity, low reactivity, and long-term stability of the working fluid. High-purity nitrogen, as an inert gas, is unlikely to chemically react with pipeline materials during long-term high-temperature circulation, and will not produce corrosive byproducts, ensuring a long lifespan and low maintenance requirements for the gas path system. The closed-loop design allows nitrogen to circulate and be reused between the heat collector and the external heat exchange assembly, eliminating the need for continuous replenishment of the working fluid, further reducing operating costs and maintenance frequency, and providing a reliable guarantee for the continuous 24-hour operation of the device.

[0013] As can be seen from the above technical solution, the beneficial effects of the integrated airway management device provided by the present invention are as follows: 1. The present invention comprises an airway management body consisting of an endotracheal intubation module, a multi-functional host module and a software control system. The endotracheal intubation module is equipped with an independent subglottic suction channel and an airbag inflation channel as well as a double-layer sealed airbag, so that the suction and inflation functions are physically independent and do not interfere with each other. The multi-functional main unit module integrates a miniature negative pressure pump, an automatic air pump, a multi-channel switching valve, and a dual pressure sensor assembly, achieving a high degree of integration of multiple functions and effectively reducing size. The multi-channel switching valve orderly switches between different gas paths, avoiding the risk of cross-contamination. The software control system is equipped with a microprocessor and control algorithms, enabling the device to have intelligent automatic control capabilities, providing the computational and execution basis for pressure compensation, adaptive suction, and redundant switching. The above components work together to achieve functional integration, structural miniaturization, and intelligent control, laying a dual hardware and software foundation for long-term stable operation and safe clinical use.

[0014] 2. This invention features an independent heat dissipation system that is fitted to the surface of the multi-channel switching valve body. By tightly fitting the heat collection box to the valve body surface and increasing the heat conduction area through heat dissipation fins, the continuous heat generated by the high-frequency switching of the valve body can be quickly collected, achieving point-to-point heat dissipation. On this basis, through a three-layer isolation structure consisting of inner tube heat transfer, middle layer vacuum insulation, and outer layer static insulation, high-temperature nitrogen gas is transported outward only along the inner tube, and very little heat from the valve body diffuses into the main unit. This avoids monitoring accuracy drift and component aging and damage caused by temperature rise in pressure sensors and control circuit boards.

[0015] 3. In this invention, the external heat exchange assembly is located on the outside of the shell, making the liquid-cooled heat exchange structure completely external. Only nitrogen gas flows inside the device without the intervention of liquid media, which eliminates the risk of internal condensation and liquid accumulation corroding precision gas circuits and sensing elements from the source. The nitrogen gas circulation circuit realizes the closed-loop directional transfer of heat from the valve body to the external heat exchange assembly. The entire heat dissipation system operates independently and has a simplified structure. It does not require built-in purge air ducts, regenerators or phase change cooling media. The pipeline flow resistance is small and the number of parts is small. It is suitable for small-scale equipment assembly and has high reliability for long-term continuous operation.

[0016] In summary, this invention works synergistically from three levels: heat dissipation path, thermal insulation barrier, and heat exchange terminal, to achieve efficient, safe, and long-term heat dissipation of the heating valve body in a confined space, providing a physical basis for the long-term operation of the equipment. Attached Figure Description

[0017] To more clearly illustrate the specific embodiments of the present invention, the accompanying drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. In all the drawings, the elements or parts are not necessarily drawn to scale.

[0018] Figure 1 A front view of an integrated airway management device provided in an embodiment of the present invention; Figure 2 for Figure 1 The enlarged structural diagram at point A is shown below; Figure 3 This is a schematic diagram of the coaxial pipeline structure in this invention; Figure label: 1. Endotracheal intubation module, 11. Double-layer sealed airbag, 11. Main airbag, 11. Backup airbag, 11.2. Subglottic suction channel, 12. Airbag inflation channel, 13. Multifunctional main unit module, 2. Miniature negative pressure pump, 21. Automatic inflation pump, 22. Multi-channel switching valve body, 23. Dual pressure sensor assembly, 24. Software control system, 3. Heat collection box, 4. Heat dissipation fins, 41. Coaxial pipeline, 5. Nitrogen heat exchange inner tube, 51. Vacuum insulation middle tube, 52. Insulation outer tube, 53. External heat exchange assembly, 6. Sealed shell, 61. Heat exchanger, 62. Connecting pipe circuit, 63. Replaceable water cooling liquid jacket, 64. Nitrogen circulation gas path, 7. Detailed Implementation

[0019] The embodiments of the technical solution of the present invention will now be described in detail with reference to the accompanying drawings. These embodiments are merely illustrative of the technical solution of the present invention and are therefore intended to limit the scope of protection of the present invention.

[0020] The basic implementation examples are as follows: Figures 1 to 3 As shown: Example 1: like Figures 1-3 As shown, this embodiment provides an integrated airway management device, including an airway management body and an independent heat dissipation system for the valve body.

[0021] The airway management system consists of an endotracheal intubation module 1, a multi-functional main unit module 2, and a software control system 3.

[0022] The endotracheal intubation module 1 is equipped with an independent airbag inflation channel 13 and a subglottic suction channel 12. The proximal end of the intubation tube is connected to the endotracheal intubation module 1, and the distal end of the intubation tube is equipped with an inflatable double-layer sealed airbag 11. The input end of the airbag inflation channel 13 is connected to the automatic inflation pump 22 in the multi-functional host module 2, which is used to inflate the double-layer sealed airbag 11 to maintain airway sealing. The output end of the subglottic suction channel 12 is connected to the miniature negative pressure pump 21 in the multi-functional host module 2, which is used to aspirate subglottic secretions.

[0023] The multi-functional host module 2 has a built-in micro negative pressure pump 21, an automatic inflation pump 22, a multi-channel switching valve body 23, and a dual pressure sensor assembly 24. The multi-channel switching valve body 23 is responsible for switching between various air paths such as negative pressure suction, airbag replenishment, and pipeline flushing, and is the most important heat-generating component during device operation. The dual pressure sensor assembly 24 includes a first pressure sensor and a second pressure sensor. The two pressure sensors are connected to the inner cavity of the double-layer sealed airbag 11 through independent air path pipes to synchronously collect airbag pressure data.

[0024] The software control system 3 is equipped with a microprocessor and supporting control algorithms. It collects data from the dual pressure sensors 24 and the flow sensor in real time, and controls the micro negative pressure pump 21, the automatic air pump 22 and the actions of each valve in a unified manner.

[0025] The valve body independent heat dissipation system is attached to the surface of the multi-channel switching valve body 23, including the heat collection box 4, coaxial pipeline 5, external heat exchange assembly 6 and nitrogen circulation gas path 7.

[0026] Solar collector box structure like Figure 1 As shown, the heat collection box 4 is tightly attached to the surface of the multi-channel switching valve body 23; the outer side of the heat collection box 4 is provided with non-equidistant and irregularly arranged heat dissipation fins 41, which are used to increase the metal thermal contact area and quickly collect the continuous heat generated by the high-frequency switching of the valve body. The internal cavity of the heat collection box 4 is connected to the nitrogen heat exchange inner tube 51, and the nitrogen fully absorbs heat inside the box and carries away the volume heat of the valve body at a fixed point.

[0027] A thermally conductive interface material, such as thermally conductive silicone grease, is provided between the heat collector housing 4 and the multi-channel switching valve body 23 to reduce contact thermal resistance and improve thermal conductivity. The heat collector housing 4 is preferably made of a metal material with high thermal conductivity, such as aluminum alloy.

[0028] Coaxial piping structure like Figure 3 As shown, the coaxial pipeline 5 is a three-layer cavity structure arranged coaxially and nested. From the inside to the outside, it consists of a nitrogen heat exchange inner tube 51, a vacuum insulation middle tube 52, and an insulation outer tube 53. The three cavities are isolated from each other and do not communicate with each other.

[0029] The nitrogen heat exchange inner tube 51 is a nitrogen heat exchange channel and is interconnected with the internal cavity of the heat collection box 4. High-purity nitrogen flows in a closed loop inside the nitrogen heat exchange inner tube 51, carrying the heat of the valve body to the outside. The nitrogen heat exchange inner tube 51 is preferably made of a corrosion-resistant and thermally conductive metal material, such as stainless steel or copper alloy.

[0030] Vacuum-insulated middle layer tube 52 is a high-vacuum sealed interlayer, with a preferred vacuum level of 10. -3 ~10 -4 Pa; The vacuum jacket utilizes the principle of vacuum insulation to effectively block the radiation and convection heat transfer from the high temperature of the valve body to the inside of the air passage management host, thus preventing the internal temperature of the host from rising and affecting the normal operation of the negative pressure pump, air pump, pressure sensor and control circuit board.

[0031] The outer insulation tube 53 is a static sealed interlayer that does not allow airflow or contain phase change media. It is used to help block the residual radiant heat of the vacuum interlayer, reduce the temperature of the outer wall of the pipe, and prevent the overall internal temperature of the machine from rising.

[0032] The walls of each layer of the three-layer pipeline are kept coaxially positioned by a support structure. The support structure is preferably made of ceramic material with low thermal conductivity to reduce interlayer heat conduction.

[0033] Double airbag nested structure like Figure 2 As shown, the double-layer sealed airbag 11 has a double-airbag structure with an inner and outer nested arrangement. Specifically, the double-layer sealed airbag 11 includes an inner main airbag 111 and an outer spare airbag 112. The spare airbag 112 is fitted outside the main airbag 111. The two are coaxially arranged and overlapped on the outer side of the distal end of the intubation tube. The main airbag 111 and the spare airbag 112 are respectively connected to the multi-functional host module 2 through independent airbag inflation channels 13, and independent inflation and deflation control is achieved by the multi-channel switching valve body 23.

[0034] Under normal use, the main airbag 111 inflates and fits tightly against the patient's tracheal wall, establishing and maintaining an airway seal. The backup airbag 112 is normally in a deflated or slightly inflated state, fitting snugly against the outer surface of the main airbag 111 and not contributing to the airway seal. When the main airbag 111 fails due to aging from prolonged use, puncture by a sharp object, or other reasons, the microprocessor detects that the airbag pressure cannot be maintained through the dual pressure sensor assembly 24. It then issues a control command, opening the inflation channel of the backup airbag 112 via the multi-channel switching valve 23 and activating the automatic inflation pump 22 to inflate the backup airbag 112. Once inflated, the backup airbag 112 replaces the main airbag 111, fitting tightly against the tracheal wall and maintaining an airway seal. Simultaneously, the system issues an audible and visual alarm to alert medical staff that the inner airbag has failed and the backup airbag 112 has been activated.

[0035] In the aforementioned nested double-layered sealed airbag 11, the main airbag 111 and the backup airbag 112 are sequentially nested radially, sharing the same axial installation position. This does not increase the axial length of the distal end of the insertion tube, avoiding the insertion difficulties that might arise from the increased axial dimensions of parallel-arranged dual airbags. Furthermore, since the backup airbag 112 completely encloses the main airbag 111, when the main airbag 111 ruptures, the backup airbag 112 can directly inflate in its original position, maintaining a seal without adjusting the insertion tube position, thus achieving true "non-destructive switching."

[0036] The main airbag 111 and the backup airbag 112 are each connected to an independent inflation line. Each inflation line extends from the inside or outside of the tube wall of the endotracheal tube module 1 to the multi-functional main unit module 2 and is controlled by the multi-channel switching valve body 23. Both inflation lines are equipped with a one-way valve to prevent gas backflow.

[0037] Nitrogen circulation gas path and external heat exchange assembly like Figure 1 As shown, the nitrogen circulation path 7 connects the heat collector box 4 and the external heat exchange assembly 6, supplying nitrogen gas to circulate between the heat collector box 4 and the external heat exchange assembly 6. The nitrogen circulation path 7 is a closed-loop path, filled with high-purity nitrogen gas as the circulating working fluid, preferably with a nitrogen purity of not less than 99.99%.

[0038] The complete circulation flow of nitrogen is as follows: the heat of the multi-channel switching valve body 23 is conducted to the heat collection box 4. The nitrogen in the heat collection box 4 absorbs the heat of the valve body to form high-temperature nitrogen. Driven by the circulation power, it passes through the nitrogen heat exchange inner tube 51 and exits the gas management equipment shell, flows into the external heat exchange assembly 6 to complete the cooling, and the low-temperature nitrogen flows back into the heat collection box 4 to absorb heat in a cycle.

[0039] The nitrogen circulation circuit 7 is equipped with a circulation power source, preferably a micro air pump, to drive the nitrogen to circulate in the closed-loop pipeline. The start-up, shutdown and speed of the circulation power source are automatically adjusted by the software control system 3 according to the temperature of the heat collection box 4: when the temperature of the heat collection box 4 exceeds the first temperature threshold (e.g., 50°C), circulation is started, and when it is below the second temperature threshold (e.g., 40°C), it stops or slows down.

[0040] The external heat exchange assembly 6 is located on the outside of the housing of the air duct management body. For example... Figure 1 As shown, the external heat exchange assembly 6 includes a sealed shell 61 and a heat exchanger 62. The nitrogen heat exchange inner tube 51 passes through the sealed shell 61 and communicates with the heat exchanger 62. The sealed shell 61 is a sealed cavity structure. The heat exchanger 62 is sealed inside the sealed shell 61. The internal cavity of the sealed shell 61 is sealed and filled with an inert cooling gas, which is argon. The purity of the argon is preferably not less than 99.99%.

[0041] After high-temperature nitrogen enters the external heat exchange assembly 6, it flows through the heat exchanger 62 and exchanges heat with the argon gas filled in the sealed shell 61; after absorbing heat, the argon gas radiates heat to the external environment through the shell wall of the sealed shell 61.

[0042] Furthermore, the external heat exchange assembly 6 also includes a connecting pipe circuit 63 and a replaceable water-cooled liquid jacket 64; both ends of the connecting pipe circuit 63 are connected to the internal cavity of the sealed housing 61, and the middle part extends to the outside of the sealed housing 61; the replaceable water-cooled liquid jacket 64 is detachably fitted onto the pipe wall of the connecting pipe circuit 63 located outside the sealed housing 61, and room temperature cooling water (preferably 15~30℃) is circulated inside the water-cooled liquid jacket 64. The connecting pipe circuit 63 leads the argon gas inside the sealed housing 61 to the outside of the housing, and the room temperature cooling water inside the replaceable water-cooled liquid jacket 64 removes the heat, forming a coupled heat dissipation structure in which the internal inert gas is kept at a constant temperature and the external liquid cooling continuously dissipates heat; the detachable design of the replaceable water-cooled liquid jacket 64 facilitates daily maintenance and replacement, and the heat dissipation system can be repaired without disassembling the internal valve body and gas pipeline.

[0043] During use, all the waste heat generated by the valve body is carried to the external heat exchange assembly 6 through nitrogen circulation and released outside the equipment; the condensation and water temperature rise generated by heat exchange are all isolated outside the equipment, and do not pollute or corrode the internal components of the gas passage device. The external heat exchange assembly 6 is connected to the housing of the air duct management body by a detachable structure, which facilitates maintenance of the heat dissipation circuit without disassembling the internal valve body and air duct pipeline.

[0044] Automatic airbag pressure compensation control like Figure 2 As shown, the process of the microprocessor executing automatic airbag pressure compensation control is as follows: (1) When the command to start the subglottic suction is issued, the microprocessor simultaneously turns on the micro negative pressure pump 21, and the subglottic suction channel 12 is opened through the multi-channel switching valve body 23; at the same time, the dual pressure sensor assembly 24 collects the real-time pressure of the double-layer sealed airbag 11 at a frequency of not less than 10 times per second (preferably 20 to 50 times per second).

[0045] (2) The system presets the standard airbag pressure stabilization range as 25~30cmH2O, and the pressure drop trigger threshold is instantaneous pressure drop ≥3cmH2O; the control system compares the values ​​of the two pressure sensors in real time to determine the gas loss caused by negative pressure suction.

[0046] (3) If the pressure drop reaches the trigger threshold, the system immediately activates the one-way gas replenishment solenoid valve and starts the micro automatic air pump 22 to perform gas replenishment; the gas replenishment method is performed in stages according to the pressure drop amplitude: for slight pressure drop (such as instantaneous pressure drop ≥3cmH2O but <6cmH2O), pulse intermittent small flow gas replenishment is used; for large pressure drop (such as instantaneous pressure drop ≥6cmH2O), short-term continuous low flow gas replenishment is used. The gas replenishment pipeline has a built-in flow limiting damper to avoid instantaneous high pressure damage to the airway mucosa.

[0047] (4) After the values ​​of the dual pressure sensors all rise back to the standard pressure stabilization range (25~30cmH2O), the control system cuts off the solenoid valve and stops the automatic inflation pump 22 to maintain the static pressure of the airbag; when the negative pressure continues to draw in and the gas continues to flow out, the closed-loop compensation of "monitoring-gas replenishment-pressure stabilization" is executed in a cycle.

[0048] (5) Safety linkage logic: When the reading deviation of the dual sensors exceeds the standard or the signal is interrupted, the fault channel data is automatically removed and the pressure compensation is continuously completed by the normal sensor; if the pressure cannot be restored after a long time, it is determined that the airbag is leaking and the host will sound and light alarm; if the airbag pressure exceeds the upper limit threshold (such as 35cmH2O), it will automatically release the pressure slightly to prevent airway mucosal ischemia damage.

[0049] The subglottic negative pressure suction circuit and the airbag replenishment circuit are physically independent and work together only through the linkage of the control system. The negative pressure will not flow back to the air pump and cause damage to the equipment.

[0050] Adaptive processing of secretions The subglottic suction channel 12 has a built-in flow sensor, and the microprocessor automatically identifies the viscosity of the secretions by the change in the airflow resistance during suction. When the suction airflow resistance is detected to be lower than the first preset threshold, it is determined to be thin secretions, and the system automatically switches to the low negative pressure intermittent suction mode to reduce excessive stimulation of the airway. When the suction airflow resistance is detected to be at or above the first preset threshold, it is determined to be viscous secretions. The system automatically switches to the large negative pressure continuous suction mode and simultaneously starts the pulse flushing program to thoroughly unclog the tubes and remove secretions. The pulse flushing procedure is as follows: flushing fluid (such as physiological saline) is pulsedly injected into the subglottic suction channel 12 at a preset frequency and pressure. The flushing fluid mixes with the secretions and is then suctioned out together under negative pressure. The frequency and pressure of the pulse flushing are dynamically adjusted by the microprocessor based on feedback from the flow sensor.

[0051] Redundancy security The dual pressure sensor assembly 24 includes a first pressure sensor and a second pressure sensor. The two pressure sensors are connected to the inner cavity of the double-layer sealed airbag 11 through independent air passages to synchronously collect airbag pressure data. When the microprocessor detects an abnormal deviation in the reading of the first pressure sensor (such as a deviation from the reading of the second pressure sensor exceeding a preset deviation threshold), over-range operation, or signal interruption, the system automatically removes the data from the first pressure sensor and switches to the second pressure sensor to continue monitoring and control, ensuring uninterrupted airway management.

[0052] Since the main airbag 111 and the backup airbag 112 are connected to the multi-functional host module 2 through independent airbag inflation channels and are independently controlled by the multi-channel switching valve body 23, when the main airbag 111 ruptures and fails, it switches to the backup airbag 112 to inflate and expand, maintaining the airway seal.

[0053] Dual pressure sensor redundancy and dual airbag redundancy are functionally independent and complementary; dual sensor redundancy ensures that the pressure monitoring signal is not interrupted, and dual airbag redundancy ensures that the actuator does not fail; together they constitute a full-link safety guarantee from signal perception to execution action.

[0054] Multiple implementation methods of external heat exchange assemblies The external heat exchange assembly 6 can be implemented in various ways to meet different clinical environments and heat dissipation requirements: As an optional implementation, the external heat exchange assembly 6 only includes a sealed shell 61 and a heat exchanger 62. After the high-temperature nitrogen gas flows through the heat exchanger 62, the heat is naturally radiated and dissipated through the shell wall of the sealed shell 61. This method has the simplest structure and is suitable for use scenarios with low ambient temperature and small heat dissipation.

[0055] As another optional implementation, the external heat exchange assembly 6 further includes a connecting pipe circuit 63 and a replaceable water-cooled liquid jacket 64 on the basis of the sealed shell 61 and the heat exchanger 62, forming a coupled heat dissipation structure with internal argon gas constant temperature insulation and external liquid cooling continuous heat dissipation. This method has higher heat dissipation efficiency and is suitable for application scenarios where the device operates under high load for a long time and the valve body generates a large amount of heat.

[0056] The replaceable water coolant jacket 64 is detachably connected to the connecting pipe circuit 63, for example, by means of clamps, threads, or quick couplings. When the water coolant jacket 64 needs to be cleaned or replaced, it is not necessary to disassemble the sealing shell 61 and the internal heat exchanger 62. The water coolant jacket 64 can be removed from the connecting pipe circuit 63 simply by disconnecting the detachable connection, which is simple and quick.

[0057] Overall working process of the device The overall operation of the integrated airway management device of the present invention is as follows: (1) The airway management device operates continuously for 24 hours. The multi-channel switching valve body 23 frequently switches the negative pressure suction and the air bag replenishment passage continuously heats up, and the heat is conducted to the surface-adhered heat collection box 4. (2) The nitrogen gas inside the heat collection box 4 absorbs the heat of the valve body to form high-temperature nitrogen gas, which enters the nitrogen heat exchange inner tube 51 of the coaxial pipeline 5 under the drive of the circulating power. (3) The vacuum insulation middle tube 52 and the heat insulation outer tube 53 provide double insulation. High-temperature nitrogen gas is only transported outward along the nitrogen heat exchange inner tube 51, and very little heat is diffused into the main unit of the gas channel device, protecting the pressure sensor and pressure compensation control system. (4) High-temperature nitrogen gas passes through the equipment shell and enters the external heat exchange assembly 6. The high-temperature nitrogen gas flows through the heat exchanger 62 and exchanges heat with the argon gas filled in the sealed shell 61. After the argon gas absorbs heat, part of the heat is radiated and dissipated to the external environment through the shell wall of the sealed shell 61, and the other part of the heat is carried away by the room temperature cooling water in the replaceable water-cooled liquid jacket 64 through the connecting pipe circuit 63, thus completing the cooling. (5) Low-temperature nitrogen gas flows back to the heat collection box 4 inside the device, absorbs the heat of the valve body again, and continuously circulates to dissipate heat. (6) All heat from the valve body is discharged outside the equipment. The air passage device has no liquid or internal heat exchange structure inside the whole machine, eliminating the risk of condensation and liquid accumulation. (7) Synchronous operation of airway management function: When the subglottic negative pressure suction is started, the control system synchronously performs automatic compensation of airbag pressure, which offsets the airbag gas loss caused by negative pressure in real time and maintains stable airbag sealing pressure throughout the process; at the same time, the suction mode is automatically switched according to the viscosity of secretions; dual pressure sensors provide redundant monitoring throughout the process to ensure the system is safe and reliable.

[0058] In summary, this integrated airway management device is not only rationally designed, but also effectively ensures long-term operation through its independent internal and external dual heat dissipation system. Therefore, this device is suitable for industry promotion.

[0059] Numerous specific details are set forth in this specification. However, it will be understood that embodiments of the invention may be practiced without these specific details. In some instances, well-known methods, structures, and techniques have not been shown in detail so as not to obscure the understanding of this specification.

[0060] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be covered within the scope of the claims and specification of the present invention.

Claims

1. An integrated airway management device, characterized in that, include: The airway management system includes an endotracheal intubation module, a multi-functional main unit module, and a software control system. The endotracheal intubation module is equipped with a subglottic suction channel and an airbag inflation channel, and the distal end of the intubation tube is equipped with an inflatable double-layer sealed airbag. The multi-functional main unit module has a built-in micro negative pressure pump, an automatic inflation pump, a multi-channel switching valve body, and a dual pressure sensor assembly. The software control system is equipped with a microprocessor and control algorithms. An independent heat dissipation system for the valve body, fitted and installed on the surface of the multi-channel switching valve body, includes: The heat collection box is tightly fitted to the surface of the multi-channel switching valve body, and its outer side is provided with heat dissipation fins. The internal cavity is connected to the nitrogen pipeline. The coaxial pipeline consists of a nitrogen heat exchange inner tube, a vacuum insulation middle tube, and an insulation outer tube, from the inside out. The three tube cavities are isolated from each other and do not connect to each other. An external heat exchange assembly is located on the outside of the housing of the gas duct management body, for heat exchange between high-temperature nitrogen and the cooling medium; A nitrogen circulation path connects the heat collection box to the external heat exchange assembly, allowing nitrogen to circulate between the heat collection box and the external heat exchange assembly.

2. The integrated airway management device according to claim 1, characterized in that, The dual pressure sensor assembly includes a first pressure sensor and a second pressure sensor. The two pressure sensors are respectively connected to the inner cavity of the double-layer sealed airbag for synchronously collecting airbag pressure data. The microprocessor is configured to automatically switch to the other pressure sensor to maintain monitoring and control when the reading of either pressure sensor shows an abnormal deviation, exceeds the range, or the signal is interrupted.

3. The integrated airway management device according to claim 1, characterized in that, A flow sensor is installed in the subglottic suction channel; the microprocessor is configured to determine the viscosity of the secretion based on the change in suction airflow resistance detected by the flow sensor: when the secretion is determined to be thin, the micro negative pressure pump is controlled to operate in a small negative pressure intermittent suction mode; when the secretion is determined to be viscous, the micro negative pressure pump is controlled to operate in a large negative pressure continuous suction mode, and a pulse flushing program is started simultaneously.

4. The integrated airway management device according to claim 1, characterized in that, The double-layer sealing airbag has a dual-airbag structure, including a main airbag and a backup airbag; the backup airbag is sleeved on the outside of the main airbag; when the main airbag ruptures and fails, the system switches to the backup airbag to maintain the airway seal.

5. The integrated airway management device according to claim 1, characterized in that, The vacuum insulation middle layer tube is a high-vacuum sealed interlayer; the heat-insulating outer layer tube is a static sealed interlayer.

6. The integrated airway management device according to claim 1, characterized in that, The external heat exchange assembly includes a sealed shell and a heat exchanger; the nitrogen heat exchange inner tube passes through the side wall of the sealed shell and communicates with the heat exchanger; the sealed shell is a sealed cavity structure, the heat exchanger is sealed inside the sealed shell, and the internal cavity of the sealed shell is sealed and filled with an inert cooling gas, which is argon.

7. The integrated airway management device according to claim 6, characterized in that, The external heat exchange assembly also includes a connecting pipe circuit and a replaceable water-cooled liquid jacket. Both ends of the connecting pipe circuit are connected to the sealed shell, and the middle part extends to the outside of the sealed shell. The replaceable water-cooled liquid jacket is detachably fitted onto the pipe wall of the connecting pipe circuit located outside the sealed shell. Room temperature cooling water is circulated inside the water-cooled liquid jacket to form a coupled heat dissipation structure in which the internal inert gas is kept at a constant temperature and the external liquid cooling continuously dissipates heat.

8. The integrated airway management device according to claim 1, characterized in that, The nitrogen circulation path is filled with high-purity nitrogen as the circulating working fluid, and the nitrogen circulation path is a closed-loop path.

Images