CN111939413A

CN111939413A - Multifunctional airway management system

Info

Publication number: CN111939413A
Application number: CN202010851990.5A
Authority: CN
Inventors: 张晓民; 吴荣基; 金虎; 单荣
Original assignee: Daoqikang Medical Technology Suzhou Co Ltd
Current assignee: Daoqikang Medical Technology Suzhou Co Ltd
Priority date: 2020-08-21
Filing date: 2020-08-21
Publication date: 2020-11-17

Abstract

The invention provides a multifunctional airway management system, which comprises a tracheal intubation component, an interface panel, a control unit, a processing unit, a monitoring display unit and a supporting device, the interface panel, the control unit, the processing unit and the monitoring display unit are all arranged on the supporting device, the trachea cannula component is connected with the interface panel, the processing unit is respectively connected with the control unit and the monitoring display unit through signals, the invention realizes the three-in-one airway management equipment with functions of monitoring air leakage and secretion of the airway seal, an airway sight glass and an airway management function, can realize real-time monitoring and accurate control, and has the advantages of small infection probability and low manual participation.

Description

Multifunctional airway management system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a multifunctional airway management system, and particularly relates to an airway management system for realizing intubation airway monitoring control management and information processing through a patient intubation device.

Background

In ventilation therapy, an endotracheal tube is inserted into the patient's trachea, including a tracheostomy, typically through an opening made by mouth, nose or any other surgical procedure. One end of the endotracheal tube is connected to a ventilator that periodically forces air through the trachea and into the lungs. The distal end of the catheter is typically provided with an inflatable balloon which is inflated in a conventional manner after insertion of the catheter into the trachea. The inflated balloon is used to seal the endotracheal tube and the inner wall of the trachea.

The artificial airway is an effective means for ensuring the airway to be unobstructed, and plays an extremely important role in the rescue process. However, the establishment of the artificial airway can also damage and destroy the normal physiological and anatomical functions of the body to a certain extent, and the harm is brought to the patient. After the artificial airway, particularly tracheal intubation is established, the swallowing of a patient is limited, oral secretion and gastroesophageal reflux are blocked by the air sac and are retained above the air sac, and retentate on the air sac can be formed. Results from foreign studies have shown that the retentate on the air sac is an important source of the pathogen Ventilator Associated Pneumonia (VAP). Therefore, managing the balloon is one of the important means to reduce the occurrence of VAP.

The tracheal catheter is provided with the air bag, so that the device aims at closing an air passage, fixing the catheter, ensuring the supply of tidal volume, and preventing oropharyngeal secretions from entering the lung, thereby reducing the occurrence of complications such as lung infection and the like. The continuous or intermittent subglottal aspiration of an attractable tracheal catheter is a new reliable method for preventing Ventilator Associated Pneumonia (VAP) in clinic.

The monitoring of the trachea cannula in the prior ventilation process adopts the mode of manually checking the synchronization of a breathing machine, as shown in figure 4, the modes of tidal volume and air bag pressure cannot effectively stop air leakage in time, pollutants above the air bag are removed, the pressure is adjusted manually by injecting (or extracting) air by an injector, the air bag is sucked by manual negative pressure to an upper drainage tube of the air bag and physiological saline is injected into the upper drainage tube for flushing and the like, the work intensity is high, the operation accuracy is poor, the structure is simple, the real-time monitoring and control are not timely, the accuracy is low, and the management method is original and extensive.

Patent document CN209378241U discloses a multi-balloon endotracheal tube and a multi-balloon endotracheal tube assembly. Many gasbags trachea cannula includes trachea cannula, first gasbag subassembly, the second gasbag subassembly, carry out the first piece of aerifing and the second piece of aerifing to the second gasbag subassembly to first gasbag subassembly, the second gasbag subassembly, first piece and the second of aerifing is aerifyd and is all connected with trachea cannula, first gasbag subassembly and second gasbag subassembly cross arrangement, first piece and the first gasbag subassembly intercommunication of aerifing, the second of aerifing is aerifyd and is communicate with the second gasbag subassembly, but this design is big to the control degree of difficulty of gasbag pressure and gas leakage, be unfavorable for the intelligent management to trachea cannula.

Disclosure of Invention

In view of the shortcomings in the prior art, it is an object of the present invention to provide a multifunctional airway management system.

The invention provides a multifunctional airway management system, which comprises a tracheal intubation component, an interface panel, a control unit, a processing unit, a monitoring display unit and a supporting device, wherein the tracheal intubation component is connected with the interface panel;

the interface panel, the control unit, the processing unit and the monitoring display unit are all arranged on the supporting device;

the trachea cannula assembly is connected with the interface panel;

and the processing unit is respectively in signal connection with the control unit and the monitoring display unit.

Preferably, the interface panel comprises at least five panel connectors, each of the five panel connectors being connected to the proximal ends of at least five tubes in the endotracheal tube assembly, the five tubes comprising a first fluid line, a second fluid line, a third fluid line, a fourth fluid line, and a fifth fluid line; wherein, the tracheal cannula groupThe piece still includes trachea cannula, trachea cannula's distal end is provided with the gasbag, and first fluid pipeline is trachea cannula internal pressure pipeline, and the second fluid pipeline is gasbag internal pressure inflation pipeline, and the third fluid pipeline is the outside CO of trachea cannula₂Concentration, temperature and humidity and sight glass pipeline, fourth fluid line are trachea cannula outside liquid flushing line, and the fifth fluid line is trachea cannula outside washing liquid suction line.

Preferably, the device further comprises a pneumatic module, the control unit comprises a plurality of operating modules, the plurality of operating modules comprises an irrigation module, a suction module, a balloon inflation and deflation module and a leak detection module;

the pneumatic module is capable of selecting a valve arrangement for fluid ventilation and pressure regulation between the operational module and the interface panel;

the processing unit is configured to instruct the control unit to send a signal to the operation module to perform operations including a flushing procedure, a suction procedure, a balloon inflation procedure, a leak detection procedure, and an exhaust procedure, respectively, and to send a signal to a valve of the pneumatic module to select any one of the five fluid lines to perform the flushing procedure, the suction procedure, the balloon inflation procedure, the leak detection procedure, or the exhaust procedure;

the monitoring display unit can display pressure and CO in a graphic mode₂Concentration, temperature and humidity, and can display the state, action state and alarm state between the tracheal cannula and the tracheal wall through endoscope images.

Preferably, the tracheal secretions are collected during the aspiration procedure by a tracheal discharge collection vessel, the interface panel comprising a vacuum pump connector connected to a proximal drain line of the tracheal discharge collection vessel, wherein the control unit is configurable to direct tracheal secretions collected during the aspiration procedure to the tracheal discharge collection vessel.

Preferably, the pumping procedure can employ one periodic procedure or a manually controlled operation procedure, wherein the one periodic procedure includes a pumping operation and a pressure release operation.

Preferably, the irrigation procedure can be a partially staggered process with controlled gaps between sequential irrigation stages, enabling irrigation while aspiration is simultaneously occurring.

Preferably, the control unit can be configured to deliver fluid into the fourth fluid line at a first volumetric flow rate and simultaneously withdraw irrigation fluid from the fifth fluid line at a second volumetric flow rate, wherein there is a proportional relationship between the first volumetric flow rate and the second volumetric flow rate.

Preferably, the control unit can be configured to automatically increase the pressure in the second fluid line and monitor whether the second fluid line is leaking before the flushing procedure is performed.

Preferably, the control unit comprises an adjustable pressure regulator connectable to a vacuum source and configured to adjust the vacuum level of the aspiration during the aspiration procedure to ensure that the vacuum level is within a predetermined range.

Preferably, the processing unit is configured for identifying an occlusion in the second fluid line, and the control unit is configured to perform an exhaust operation through the second fluid line in response to the identification of the occlusion.

Preferably, the bladder inflation and deflation module is configured to measure bladder pressure within the second fluid line to identify bladder pressure changes and enable control of the pressure in a closed loop control in response to the identified changes.

Preferably, the processing unit is configured to compare the identified balloon pressure change to a characteristic breathing pattern of a subject intubated with an trachea and obtain comparison information, wherein the balloon inflation and deflation module is configured to control the balloon pressure in response to the comparison information.

Preferably, the processing unit is configured to identify a cough event based on the endotracheal tube pressure.

Preferably, the interface panel comprises at least five connectors, wherein one of the connectors is adapted to establish fluid communication with a suction line for sucking secretions from above the balloon, wherein the balloon inflation and deflation module is configured to measure balloon pressure within the second fluid line and to identify balloon pressure variations, wherein the control unit is configured to perform a suction procedure through the suction line in synchronism with the pressure variations.

Preferably, the monitoring display unit can display the acquired signals on a display screen in a graphic image mode, the displayed content comprises an operation state and an alarm state, the pressure change state, the humidity change state, the air leakage state, the operation state, the alarm state and the control navigation in the air passage can be visually seen through the display screen, and the alarm state comprises air bag rupture and over-high and over-low air bag pressure.

Preferably, the processing unit can convert the acquired signals into displayable graphics signals and can judge whether air leaks or not through calculation so as to obtain graphics information and air leakage information;

the processing unit transmits the graphic information and the air leakage information to the monitoring display unit, calculates and monitors according to parameters set by a user to form control signals, and transmits the control signals to the control unit and the pneumatic module to form actions.

Preferably, the collected signals are sent to a remote terminal to realize remote system monitoring.

Compared with the prior art, the invention has the following beneficial effects:

1. the invention adopts the trachea cannula assembly and each functional unit, has the functions of monitoring air leakage and secretion of the air passage, an air passage sight glass and an air passage management function, is a three-in-one air passage management device, can realize the functions of air leakage monitoring of the air bag and the air passage, air bag pressure monitoring, gas category monitoring, image monitoring, air leakage judgment, air bag sealing sleeve pressurization and closed loop management, cleaning management between the air passage and the cannula and monitoring data recording, transmitting and counting, so as to realize the optimal airway monitoring, carry out the omnibearing control management, reduce the infection probability, reduce the airway injury, accelerate the ventilation treatment process, have low manual participation degree, reduce the working intensity of the working personnel, and the control is accurate, the real-time monitoring can be realized, and the defects of untimely control, low accuracy and original and extensive management method in the prior art are overcome.

2. According to the invention, the air leakage is judged by monitoring the state of the air passage, the manual process is embedded into the control system, the air passage is managed by adopting a mode of combining manual control and automatic control, the occurrence rate of air leakage and air passage infection is favorably reduced, a data storage and transmission function is provided, and then remote monitoring and statistical analysis are realized.

3. According to the invention, the peristaltic pump connected with the drainage tube on the air bag is responsible for sucking out sputum, the peristaltic pump connected with the normal saline supply tube is responsible for adding normal saline, so that the cleaning of the sputum accumulated on the air flue air bag and the dilution of the sputum are realized, the automatic sucking out of the sputum and the automatic cleaning of the upper part of the air flue air bag are realized through the matching of the two peristaltic pumps, manual operation is not needed, the labor intensity of operators is greatly reduced when the artificial air flue is used, and the setting is scientific and reasonable.

4. The peristaltic pump is adopted to control the addition amount of the physiological saline, so that the accurate control of the addition amount of the physiological saline is realized, and the smoothness of sputum aspiration operation and the comfort of patients are further ensured.

5. The product can be used in combination with a breathing machine to realize automatic supply of gas.

6. The temperature acquisition chip for testing the temperature in the equipment is also arranged, when the temperature acquisition chip detects that the temperature of the equipment is overhigh, the CPU controls the cooling fan to work, the cooling operation of the equipment is realized, the arrangement effectively ensures that the equipment is always at the normal working temperature, the stability of the working performance of the equipment and the longer service life of the equipment are further ensured, and the arrangement is scientific and reasonable.

7. The fault alarm device is arranged in the invention, so that the automatic alarm function can be realized, the user can find the equipment abnormity and maintain the equipment in time conveniently, the convenience and the safety of the equipment use are further ensured, and the use requirement is met.

8. The host is also additionally provided with a communication chip and a program downloading interface, and the communication chip is arranged to facilitate a user to keep communication with the equipment as required and control the operation of the equipment or lead out the operation data of the equipment; the program downloading interface is arranged to facilitate the user to write programs into the CPU or debug the programs in the CPU according to the requirement. The arrangement further improves the convenience of the equipment, increases the application range of the equipment and improves the practicability of the device.

9. The arrangement of the carbon dioxide concentration detection module realizes the intelligent detection of whether the air bag leaks air, improves the intelligent degree of the performance of the equipment, ensures the use safety of the equipment and meets the use requirements of the equipment.

Drawings

Other features, objects and advantages of the invention will become more apparent upon reading of the detailed description of non-limiting embodiments with reference to the following drawings:

FIG. 1 is a schematic structural diagram of an embodiment of the present invention;

FIG. 2 is a schematic cross-sectional view of an endotracheal tube assembly, wherein the outer large circle in the left side view of FIG. 2 is a schematic cross-sectional view of the endotracheal tube, the small circle is a schematic cross-sectional view of the main conduit for communicating with the human body, and the conduits between the large and small circles are schematic fluid conduits;

FIG. 3 is a schematic flow chart of the treatment process of the present invention;

FIG. 4 is a flow chart illustrating a conventional airway management process according to the present invention;

FIG. 5 is a schematic view of a conventional standard trachea;

FIG. 6 is a schematic view of the endotracheal tube assembly in connection with the control unit;

fig. 7 is a schematic diagram of the circuit connections of the components of the present invention.

The figures show that:

first fluid line 1 CO₂Temperature and humidity detection and sight glass port 9

Second fluid line 2 saline bag interface 10

Suction canister connection 11 of the third fluid line 3

Fourth fluid line 4 display 12

Fifth fluid line 5 host 13

Trachea cannula 6 physiological saline bag 14

Suction pot 15 of pressure detection port 7 in trachea cannula

Air bag pressure detection and inflation port 8 trolley 16

Detailed Description

The present invention will be described in detail with reference to specific examples. The following examples will assist those skilled in the art in further understanding the invention, but are not intended to limit the invention in any way. It should be noted that it would be obvious to those skilled in the art that various changes and modifications can be made without departing from the spirit of the invention. All falling within the scope of the present invention.

The invention provides a multifunctional airway management system which comprises an endotracheal tube assembly, an interface panel, a control unit, a processing unit, a monitoring display unit and a supporting device, wherein the interface panel, the control unit, the processing unit and the monitoring display unit are all arranged on the supporting device, the endotracheal tube assembly is connected with the interface panel, and the processing unit is in signal connection with the control unit and the monitoring display unit respectively.

Further, in a preferred embodiment, as shown in fig. 1, the monitoring and displaying unit includes a display 12, the supporting device is a trolley 16, and casters are disposed at the bottom of the trolley 16 and can move at any time according to actual conditions to meet actual requirements of use.

Specifically, the interface panel comprises at least five panel joints, in a preferred example, as shown in fig. 1, the interface panel comprises a host 13, the host 13 comprises a control unit and a processing unit, the panel joints comprise a pressure detection port 7 in the endotracheal tube, a balloon pressure detection and inflation port 8, and CO₂A temperature and humidity detection and sight glass port 9, a normal saline bag interface 10 and a suction tank interface 11, wherein the normal saline bag interface 10 is connected with a normal saline bag 14, the suction tank interface 11 is connected with a suction tank 15, five panel joints are respectively connected with the near ends of at least five pipelines in the trachea cannula assembly, and the five pipelines comprise a first fluidThe trachea cannula pressure detection device comprises a pipeline 1, a second fluid pipeline 2, a third fluid pipeline 3, a fourth fluid pipeline 4 and a fifth fluid pipeline 5, wherein the proximal ends of the first fluid pipeline 1, the second fluid pipeline 2, the third fluid pipeline 3, the fourth fluid pipeline 4 and the fifth fluid pipeline 5 are respectively connected with a trachea cannula pressure detection port 7, a balloon pressure detection and inflation port 8, and CO₂The temperature and humidity detection and endoscope opening 9, the physiological saline bag interface 10 and the suction tank interface 11 are connected.

Further, as shown in fig. 1 and 6, the endotracheal tube assembly further includes an endotracheal tube 6, a balloon 17 is disposed at a distal end of the endotracheal tube 6, the first fluid line 1 is a pressure line inside the endotracheal tube 6, the first fluid line 1 is communicated with the endotracheal tube 6, the second fluid line 2 is a pressure inflation line inside the balloon, the second fluid line 2 is communicated with the balloon 17, and the third fluid line 3 is CO outside the endotracheal tube 6₂Concentration, temperature and humidity and sight glass pipeline, third fluid pipeline 3 is connected with the cavity between trachea cannula 6 and the human trachea inner wall, fourth fluid pipeline 4 is the outside liquid flushing line of trachea cannula 6, fourth fluid pipeline 4 is connected with the cavity between trachea cannula 6 and the human trachea inner wall, fifth fluid pipeline 5 is the outside washing liquid suction pipeline of trachea cannula 6, fifth fluid pipeline 5 is connected with the cavity between trachea cannula 6 and the human trachea inner wall.

The invention can be communicated with the main pipeline in the tracheal intubation component through the respirator, thereby realizing the airway ventilation path.

In particular, the invention also comprises a pneumatic module, the control unit comprising a power supply, a backup battery, an electronic board and a plurality of operating modules including a flushing module, a suction module, a balloon inflation and deflation module and a leak detection module, wherein the balloon inflation and deflation module evacuates air in the sensor conduit, sucks gas above the balloon 17, and the gas passes through the CO₂The sensor and the temperature and humidity sensor are used for adjusting the pressure of the air bag catheter through the motor so as to realize air bag pressure adjustment; the flushing module comprises a peristaltic pump, the peristaltic pump conveys saline water to flush the tracheal cannula 6 and the tracheal lumen, and the suction module sucks liquid through the vacuum pump and the suction catheter; wherein each of the control unitsThe module is provided with a pump valve for gas or liquid to achieve the desired function. The standby battery in the control unit adopts an Uninterruptible Power Supply (UPS), the Power stability is high, and uninterrupted Power can be provided when necessary.

Further, the processing unit comprises a central processing unit, a pressure sensor and a CO₂The sensor, the temperature and humidity sensor, the sight glass CCD sensor, the communication module and other circuits and embedded software comprise gas leakage analysis software which can pass through CO in the tube₂Concentration and humidity signals to determine whether air is leaking, CO₂The concentration is higher than that of CO in air₂When the concentration and the humidity have a correlation with the pressure change of the air passage, judging that air leakage occurs, and when the air leakage occurs, sending a pressure regulating instruction to regulate the pressure of the air bag through an air bag inflating and exhausting module; and after the air is not leaked for a certain period of time, the processing unit sends a pressure reduction regulating instruction to obtain sealing pressure and sets the pressure of the regulating air bag as the sealing pressure.

In particular, the CCD is a short term of a charge coupled device (charged coupled device) which can convert light into electric charges and store and transfer the electric charges, and can also take out the stored electric charges to change the voltage, so that the CCD is an ideal CCD camera element, and thus the sight glass CCD sensor has the characteristics of small volume, light weight, no influence of a magnetic field, and vibration and impact resistance. The scope CCD sensor can be entered into the human body through the third fluid line 3.

Further, the present invention provides a method for detecting rupture of a balloon, wherein the method for detecting rupture of the balloon in an endotracheal tube assembly introduced into the trachea of a subject by a processing unit is to monitor the pressure of the balloon and determine rupture when the pressure cannot rise due to pressurization.

Specifically, when a washing instruction of the display unit is obtained at regular time or in real time, the processing unit sends a washing instruction to the control unit, and executes a washing task and a suction task; meanwhile, the processing unit sends the collected signals to the monitoring display unit continuously to display related information.

Specifically, the monitoring display unit respectively receives the sensor signals sent by the processing unit andvideo signal, display CO₂The operator can set a periodic cleaning function, the upper and lower limits of the pressure of the air bag, a test sealing pressure period and manual operation actions to send to the control unit through a monitoring management interface on the monitoring display unit; endotracheal tube assembly types may also be provided, for example, with only a balloon; as another example, with a balloon and irrigation tubing; also for example, with air bags, sensors, irrigation lines, etc. The monitoring display unit can also convert the corresponding information into a specific format for storage, so that a specific interface can be selected to transmit the acquired signal to a remote terminal, and the monitoring of a remote system is realized. The management unit in the monitoring display unit stores log information including operation information, alarm information, sensor information and the like.

In particular, the pneumatic module is able to select a valve arrangement for fluid ventilation and pressure regulation between the operating module and the interface panel, as shown in fig. 7; the processing unit is configured to instruct the control unit to send a signal to the operation module to perform operations including a flushing procedure, a suction procedure, a balloon inflation procedure, a leak detection procedure, and an exhaust procedure, respectively, and to send a signal to a valve of the pneumatic module to select any one of the five fluid lines to perform the flushing procedure, the suction procedure, the balloon inflation procedure, the leak detection procedure, or the exhaust procedure; the monitoring display unit can display pressure and CO in a graphic mode₂Concentration, temperature and humidity, and can display the state, action state and alarm state between the tracheal cannula 6 and the tracheal wall through endoscope images. Air leakage is calculated and judged according to the information of the sensor, pressure is controlled, the air passage is controlled to be cleaned, an alarm is generated, the operation state is displayed, and data is analyzed, processed and transmitted.

The invention provides air bag pressure control for all air bag-equipped tracheal cannulas, and provides a method for sucking or discharging subglottic secretion from the upper part of an air bag to all cuff-equipped tracheal cannulas. As shown in FIG. 5, the present invention provides a user preset range of fixed balloon pressures when connected to a standard balloon endotracheal tube; when the tracheal cannula with the air bag and the flushing pipe is connected through the suction inlet, the fixed air bag pressure within the preset range of a user is provided, and subglottic pollutants are sucked from the upper part of the air bag in time or as required; when connected to a multi-line endotracheal tube, the present invention continuously measures and controls the cuff pressure, and timely or on-demand suction, or simultaneous irrigation and suction of subglottal contaminants, based on the carbon dioxide and humidity readings around the endotracheal tube cuff or the cuff pressure within a user's preset range.

In particular, the present invention further comprises a drainage collection container, the interface panel comprising a vacuum pump connector connected with a proximal drainage line of the drainage collection container, wherein the control unit is configurable to direct tracheal secretions and lung secretions collected during the aspiration procedure to the drainage collection container.

In particular, the pumping procedure can employ one periodic procedure or a manually controlled operating procedure, wherein the one periodic procedure includes a pumping operation and a pressure release operation.

In particular, the irrigation procedure can be partially an interlaced process with controlled gaps between sequential irrigation phases, enabling irrigation while aspiration, improving irrigation efficiency and patient comfort.

In particular, the control unit can be configured to deliver fluid into the fourth fluid line 4 at a first volumetric flow rate and simultaneously withdraw rinse liquid from the fifth fluid line 5 at a second volumetric flow rate, wherein there is a proportional relationship between the first and second volumetric flow rates, the proportional relationship between the first and second volumetric flow rates being adjusted to bring the input rinse fluid into equilibrium with the withdrawn rinse liquid.

In particular, the control unit can be configured to automatically increase the pressure in the second fluid line 2 and monitor whether the second fluid line is leaking before the flushing procedure is performed. The control unit is configured to perform a leak detection procedure through the first fluid line 1 in case the first fluid line 1 is not blocked, to perform the leak detection procedure through the second fluid line 2 if the second fluid line 2 is not blocked, and to skip the leak detection procedure if both the first fluid line 1 and the second fluid line 2 are blocked.

Further, the control unit is configured to perform the pumping procedure and the venting simultaneously through two different fluid lines.

The control unit is configured to perform a pumping procedure via the respective fluid line after identifying a blockage in the fluid line, wherein a vacuum level of the pumping procedure is at least temporarily changed in order to exclude the line, the vacuum level being gradually updated, wherein after each update the flow rate is measured to identify occlusions. In a preferred embodiment, the pressure characteristic of the vacuum level is always maintained above-120 mmHg.

In particular, the control unit comprises an adjustable pressure regulator connectable to a vacuum source and configured to adjust the vacuum level of the aspiration during the aspiration procedure to ensure that the vacuum level is within a predetermined range.

In particular, the processing unit is configured for identifying an occlusion in the second fluid line 2, and the control unit is configured to perform an exhaust operation through the second fluid line 2 in response to the identification of the occlusion.

In a preferred embodiment, the invention comprises a leak detection procedure through a first line and then a leak detection procedure through a second line, wherein the control unit is configured to stop the leak detection procedure of the first line, the second line and to switch to a balloon sealing phase when a leak above a predetermined level is detected, the balloon sealing phase comprising a blockage detection procedure through the first line and the second line, wherein the control unit is configured to perform a flushing procedure and a venting procedure in the fluid line when a blockage is detected.

Further, the balloon sealing phase comprises a leak detection procedure, wherein the control unit is configured to increase the pressure in the balloon inflation line when a leak above a predetermined level is detected, and otherwise decrease the pressure in the balloon inflation line, in a preferred example the rate indicative of the pressure increase is higher than the rate indicative of the decompression.

In particular, the bladder inflation and deflation module is configured to measure the bladder pressure within the second fluid line 2 to identify bladder pressure changes and enable control of the pressure in a closed loop control in response to the identified changes.

In particular, the processing unit is configured to compare the identified balloon pressure variation with a characteristic breathing pattern of the subject intubated with the trachea 6 and obtain comparison information, wherein the balloon inflation and deflation module is configured to control the balloon pressure in response to the comparison information.

Specifically, in one preferred embodiment, the airbag inflation and deflation module is configured to gradually decrease the pressure when the measured pressure over a predetermined period of time is above a predetermined pressure threshold.

In particular, the processing unit is configured to identify a cough event based on the pressure within the endotracheal tube 6, and in a preferred embodiment, the processing unit is configured to monitor the cough event over a period of time and issue a statistical analysis report related to the monitored cough event.

In particular, the processing unit is configured to search for statistically significant frequencies of pressure peaks and determine whether there is a balloon puncture when a statistically significant frequency is found.

In particular, the interface panel comprises at least five connectors, wherein one of the connectors is adapted to establish fluid communication with a suction line for sucking secretions from above the balloon 17, wherein the balloon inflation and deflation module is configured to measure the balloon pressure within the second fluid line 2 and to identify balloon 17 pressure variations, wherein the control unit is configured to perform a suction procedure in synchronization with the pressure variations through the suction line.

In particular, the processing unit is configured to determine the presence of a rupture of the airbag when the airbag pressure is below a predetermined threshold or if a sudden drop in the airbag pressure is identified. The control unit is configured to stop maintaining the generally constant bladder pressure for a predetermined time interval, and to temporarily stop the closed-loop control when the bladder pressure changes beyond a predetermined threshold. The control unit is configured to maintain a generally constant bladder pressure.

In particular, the processing unit is configured to analyze changes in balloon pressure within the balloon inflation line over a predetermined time interval and to identify, based on the analysis, any one of the following events: an occlusion in the balloon inflation line, a perforation in the balloon wall, a rupture in the balloon wall, and a cough in the patient.

In particular, the processing unit is configured to analyze a change in bladder pressure within the bladder inflation line within a predetermined time interval and to obtain any of the following quantities based on the analysis calculations: tracheal pressure, respiratory rate, pulse wave rate, degree of occlusion of the main lumen of the endotracheal intubation assembly, and resistance to flow of the main lumen.

Specifically, the monitoring display unit can display the acquired signals on a display screen in a graphical image mode, the displayed content comprises an operation state and an alarm state, the pressure change state in the air passage, the humidity change state, the air leakage state, the operation state, the alarm state and the control navigation can be visually seen through the display screen, the alarm state comprises air bag rupture and air bag pressure overhigh and overlow, and in a preferred example, the processing unit is configured to determine the air bag rupture and send out an alarm signal when the air bag rupture is determined.

In particular, the processing unit is configured to transmit to the monitoring display unit a history of at least one parameter selected from the group consisting of balloon pressure, balloon leakage, fluid line of the first and/or second occluded endotracheal intubation subject, lung compliance and/or resistance.

In particular, the suction pressure through the suction line is adapted accordingly to the balloon pressure.

In particular, the processing unit is configured to identify an exhalation cycle, wherein the control unit is configured to synchronize with the exhalation cycle through the inhalation conduit.

Specifically, the endotracheal tube assembly also has a suction line embedded in the wall, which is an extension of the suction lumen, and has an opening below the cuff at or near the distal end of the endotracheal tube assembly.

In particular, the external irrigation fluid intake line is a separate retractable tube that is introducible into the main lumen of the endotracheal tube assembly and has a distal opening below the balloon at or above the distal end of the endotracheal tube assembly.

In particular, the invention includes a user interface, wherein the control unit is configured to receive a signal from the user interface and to change or bypass at least one operation in response to the signal.

In particular, the operation includes a weaning phase in which at least two of the irrigation procedure, the aspiration procedure, the leak detection procedure and the ventilation procedure are disabled.

Specifically, the irrigation solution includes at least one substance selected from the group consisting of a preservative substance, a biomarker substance, a local analgesic substance, and a secretion diluting substance.

Specifically, the processing unit can convert the acquired signals into displayable graph signals and can judge whether air leakage exists or not through calculation so as to obtain graph information and air leakage information;

When the invention is used, the trachea cannula assembly is inserted into a patient body according to the clinical treatment requirement, the airway air bag catheter port is connected to the artificial airway air bag port, the equipment is started, the operation parameters (the artificial airway air bag pressure, the normal working temperature of the equipment and the like) of the equipment are set through the operation panel in the monitoring display unit, the processor in the processing unit monitors the air bag pressure in real time, and when the processor detects that the air bag pressure is lower than or higher than the normal range, the processor controls the electromagnetic valve and the air pump to work, so that the air supply or air discharge operation of the air bag 17 is realized. The operation of sucking sputum through the drainage tube on the air bag 17 can be carried out in three modes, the manual mode is controlled through a button on an operation panel, the automatic control is carried out by setting suction time in advance, as shown in figure 3, during suction, the peristaltic pump connected with the drainage tube on the air bag 17 is responsible for sucking out sputum, the peristaltic pump connected with a saline supply tube is responsible for adding saline, the cleaning of sputum accumulated on the air flue air bag and the dilution of the sputum are realized, the peristaltic pumps are matched, the automatic suction of the sputum and the automatic cleaning of the upper part of the air flue air bag are realized, wherein, the addition amount of the saline is controlled by the peristaltic pump, the accurate control of the addition amount of the saline is realized, and the smoothness of sputum sucking operation and the comfort of a patient are further ensured. The product can be used in combination with a respirator to realize automatic supply of gas.

The operation panel comprises a keyboard and a display screen which are arranged on the main machine box body and are connected with the CPU. The setting of keyboard is convenient for the user to carry out manual operation to equipment, and the user of then being convenient for of display screen observes the equipment behavior, and the display screen still can set up to the touch-sensitive screen simultaneously, practices thrift operating panel's area, improves the convenience of equipment operation. The CPU is also connected with the soft start module. The soft start module effectively reduces the starting voltage and current, reduces the impact force on the equipment when starting, reduces the damage to the equipment and prolongs the service life of the equipment.

In the description of the present application, it is to be understood that the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience in describing the present application and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present application.

Those skilled in the art will appreciate that, in addition to implementing the systems, apparatus, and various modules thereof provided by the present invention in purely computer readable program code, the same procedures can be implemented entirely by logically programming method steps such that the systems, apparatus, and various modules thereof are provided in the form of logic gates, switches, application specific integrated circuits, programmable logic controllers, embedded microcontrollers and the like. Therefore, the system, the device and the modules thereof provided by the present invention can be considered as a hardware component, and the modules included in the system, the device and the modules thereof for implementing various programs can also be considered as structures in the hardware component; modules for performing various functions may also be considered to be both software programs for performing the methods and structures within hardware components.

The foregoing description of specific embodiments of the present invention has been presented. It is to be understood that the present invention is not limited to the specific embodiments described above, and that various changes or modifications may be made by one skilled in the art within the scope of the appended claims without departing from the spirit of the invention. The embodiments and features of the embodiments of the present application may be combined with each other arbitrarily without conflict.

Claims

1. A multifunctional airway management system is characterized by comprising a tracheal intubation component, an interface panel, a control unit, a processing unit, a monitoring display unit and a supporting device;

the trachea cannula assembly is connected with the interface panel;

2. A multifunctional airway management system according to claim 1 characterized in that the interface panel comprises at least five panel joints, five of said panel joints being connected to the proximal ends of at least five tubes in an endotracheal tube assembly, respectively, said five tubes comprising a first fluid line (1), a second fluid line (2), a third fluid line (3), a fourth fluid line (4), a fifth fluid line (5); wherein, trachea cannula subassembly still includes trachea cannula (6), the distal end of trachea cannula (6) is provided with gasbag (17), and first fluid pipeline (1) is trachea cannula (6) internal pressure pipeline, and second fluid pipeline (2) is gasbag internal pressure inflation pipeline, and third fluid pipeline (3) are trachea cannula (6) outside CO₂Concentration, temperature and humidity as well as sight glass pipelines, a fourth fluid pipeline (4) is a liquid flushing pipeline outside a tracheal cannula (6), and a fifth fluid pipeline (5) is a tracheaThe outside of the cannula (6) is provided with a flushing liquid suction pipeline.

3. The multifunctional airway management system according to claim 2, further comprising a pneumatic module, wherein the control unit comprises a plurality of operational modules, including an irrigation module, a suction module, a balloon inflation and deflation module, and a leak detection module;

the monitoring display unit can display pressure and CO in a graphic mode₂Concentration, temperature and humidity, and can display the state, action state and alarm state between the tracheal cannula (6) and the tracheal wall through endoscope images.

4. The multifunctional airway management system according to claim 3, further comprising a drain collection container, wherein the interface panel comprises a vacuum pump connector connected to a proximal drain line of the drain collection container, wherein the control unit is configurable to direct tracheal secretions collected during the suction procedure to the drain collection container.

5. A multifunctional airway management system according to claim 3 or claim 4 wherein the suction procedure can employ one periodic procedure or a manually controlled procedure, wherein the one periodic procedure includes a suction operation and a pressure release operation.

6. A multifunctional airway management system according to claim 3 or claim 4 wherein the irrigation procedure can be partly an interleaved process with controlled gaps between sequential irrigation phases enabling simultaneous irrigation and aspiration.

7. Multifunctional airway management system according to claim 3, characterized in that the control unit can be configured to deliver fluid into the fourth fluid line (4) at a first volumetric flow rate and simultaneously withdraw flushing fluid from the fifth fluid line (5) at a second volumetric flow rate, wherein there is a proportional relationship between the first and second volumetric flow rates.

8. A multifunctional airway management system according to claim 3 characterized in that the control unit can be configured to automatically increase the pressure in the second fluid line (2) and monitor if there is an air leak in the second fluid line before the flushing procedure is performed.

9. A multifunctional airway management system according to claim 3 or claim 4 wherein the control unit includes an adjustable pressure regulator connectable to a vacuum source and configured to adjust the vacuum level of a puff during the puff to ensure that the vacuum level is within a predetermined range.

10. A multifunctional airway management system according to claim 3, characterized in that the processing unit is configured for identifying an occlusion in the second fluid line (2), and the control unit is configured to perform an exhaust operation through the second fluid line (2) in response to the identification of the occlusion.

11. A multifunctional airway management system according to claim 3 characterized in that the balloon inflation and deflation module is configured to measure balloon pressure within the second fluid line (2) to identify balloon pressure changes and to enable control of the pressure in response to the identified changes in closed loop control.

12. The multifunctional airway management system according to claim 11, wherein the processing unit is configured to compare the identified balloon pressure change to a characteristic breathing pattern of a subject intubated with an endotracheal tube (6) and obtain comparison information, wherein the balloon inflation and deflation module is configured to control the balloon pressure in response to the comparison information.

13. The multifunctional airway management system according to claim 11, characterized in that the processing unit is configured to identify a cough event based on pressure inside the endotracheal tube (6).

14. A multifunctional airway management system according to claim 3 characterized in that the interface panel comprises at least five connectors, wherein one of the connectors is adapted to establish fluid communication with a suction line for sucking secretions from above the balloon (17), wherein the balloon inflation and deflation module is configured to measure balloon pressure within the second fluid line (2) and to identify balloon (17) pressure variations, wherein the control unit is configured to perform a suction procedure in synchronization with the pressure variations through the suction line.

15. The multifunctional airway management system according to claim 3, wherein the monitoring display unit can display the acquired signals on a display screen in a graphical image mode, the displayed content comprises an operation state and an alarm state, the pressure change state, the humidity change state, the air leakage state, the operation state, the alarm state and the control navigation in the airway can be visually seen through the display screen, and the alarm state comprises airbag rupture and airbag pressure overhigh and overlow.

16. The multifunctional airway management system according to claim 3, wherein the processing unit is capable of converting the collected signals into displayable graphical signals and capable of calculating to determine whether air is leaked so as to obtain graphical information and air leakage information;

17. The multifunctional airway management system according to claim 15, wherein the collected signals are transmitted to a remote terminal for remote system monitoring.