Endotracheal intubation kit for protection against ventilator-associated pneumonia

By designing an endotracheal intubation assembly with dual airbags and a pH sensor, the invasion of secretions and pathogens is prevented, and retained products are monitored and cleared in a timely manner. This solves the problem of ventilator-associated pneumonia caused by endotracheal intubation, reduces nursing costs and workload, and improves patient prognosis.

CN119015556BActive Publication Date: 2026-04-03CAPITAL UNIVERSITY OF MEDICAL SCIENCES
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-08-21
Publication Date
2026-04-03

AI Technical Summary

Technical Problem

Existing endotracheal intubation methods are prone to causing ventilator-associated pneumonia during use. Current protective measures are ineffective, and nursing costs and workloads are high.

Method used

Design an endotracheal intubation assembly that includes dual airbags and a pH sensor. The dual airbags prevent secretions and pathogens from penetrating downwards, while the pH sensor monitors the pH value of subglottic retention, providing timely alarms and aspiration of the retention. Combined with a cannula, it prevents the endotracheal tube from contacting the oral cavity, reducing bacterial invasion.

Benefits of technology

It effectively reduced the incidence of ventilator-associated pneumonia, reduced nursing costs, reduced the workload of medical staff, and improved patient prognosis.

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Abstract

This invention discloses an endotracheal intubation assembly for ventilator-associated pneumonia (VAP) protection, comprising an endotracheal cannula and a cannula. The endotracheal cannula includes a cannula body, with first and second air bladders mounted on its lower part, suspended from the ground. The first air bladder is connected to a first inflation port via a first inflation connecting tube, and the second air bladder is connected to a second inflation port via a second inflation connecting tube. A first suction port is located on the cannula body above the first air bladder, and a second suction port is located on the cannula body above the second air bladder. A suction connecting tube fixed to the cannula body has one end connected to a suction port and the other end extending to the locations of the first and second suction ports. A pH sensor is located on the cannula body below the second air bladder. The cannula includes a T-shaped bite pad, consisting of a cylindrical bite pad handle and a sheet-like bite pad head, with a cylindrical isolation membrane extending from the bite pad handle. This invention has advantages such as preventing secretions and pathogens from invading downwards, thus reducing the incidence of VAP.
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Description

Technical Field

[0001] This invention relates to an endotracheal intubation assembly for the protection against ventilator-associated pneumonia, belonging to the field of endotracheal intubation devices for ventilators. Background Technology

[0002] Mechanical ventilation is an important means of treating critically ill patients. Endotracheal intubation (also known as endotracheal tube) is a common, rapid, and effective method for establishing an artificial airway. Currently available endotracheal tubes typically consist of a tube body, a connector at the top for mechanical connection to a ventilator, and a cuff near the bottom. The cuff is connected to an inflation connector with a one-way inflation valve via an inflation line. During use, the endotracheal tube is inserted into the patient's airway. Once it reaches the appropriate position, the syringe (with the needle removed) is connected to the inflation connector to inflate the cuff, securing the endotracheal tube in place. The ventilator is then connected to the connector to establish an artificial airway, and mechanical ventilation begins. However, in practice, it has been found that establishing an artificial airway can disrupt the normal defense functions of the human respiratory tract, especially in patients with endotracheal intubation via the orotracheal tube. The oral cavity is often open, reducing its self-cleaning ability and allowing a large number of bacteria to grow and multiply. Oropharyngeal secretions are difficult to clear and can descend with bacteria, remaining in the glottic space. Simultaneously, the influence of body position and the presence of a nasogastric tube increases the probability of reflux of gastric and esophageal contents. Gastric reflux leads to a lower pH level in the airway environment, making it more susceptible to bacterial or viral infections. Furthermore, coughing, changes in body position, and a decrease in cuff pressure on the endotracheal tube prevent a complete seal between the cuff and the airway wall. This allows trapped material containing a large number of microorganisms to easily enter the lower respiratory tract through the gap between the cuff and the airway, causing ventilator-associated pneumonia (VAP). This results in prolonged hospital stays and ICU stays for mechanically ventilated patients, increased mortality, and severely impacts patient prognosis. To address these issues, current measures include administering antibiotics, providing oral care, and managing body position after endotracheal intubation. However, these measures are not very effective in preventing infection, as bacteria in the oropharynx can still easily invade downwards and trapped material can seep into the lungs, resulting in a still high risk of ventilator-associated pneumonia. In addition, the workload of nurses is greatly increased, affecting compliance, and these measures need to be improved. Summary of the Invention

[0003] The purpose of this invention is to provide a tracheal intubation assembly for the prevention of ventilator-associated pneumonia, which has the advantages of preventing secretions and pathogens from invading downwards, reducing the incidence of ventilator-associated pneumonia, and reducing nursing costs.

[0004] To achieve the above objectives, the present invention adopts the following technical solution:

[0005] A tracheal intubation assembly for ventilator-associated pneumonia (VAP) protection includes an tracheal intubation tube, with a sheath covering the tube. The tracheal intubation tube includes a tube body, a connecting connector at the top opening, and a first and second airbag mounted on the lower part of the tube body, suspended from the ground. The second airbag is positioned above the first airbag, with the first airbag near the bottom opening of the tube body. The first airbag is connected to a first inflation port via a first inflation connecting tube, and the second airbag is connected to a second inflation port via a second inflation connecting tube. A first suction port is located on the tube body above the first airbag, and a second suction port is located on the tube body above the second airbag. The tube body is fixed with... The endotracheal tube has one end connected to the suction interface and the other end extending to the locations of the first and second suction holes. A pH sensor is located on the cannula body below the second airbag, and the pH sensor is connected to a processor with wireless communication capabilities via a wire. The cannula includes a T-shaped bite pad, which consists of a cylindrical bite pad handle and a sheet bite pad head. A cylindrical insulating film extends from the bottom of the bite pad handle. When the endotracheal tube is inserted from the top of the cannula but not protruding, the insulating film is wrinkled. When the endotracheal tube is forcefully protruded from the cannula, the insulating film flattens and tightly wraps around the outer wall of the cannula body, and the cannula is positioned above the second suction hole.

[0006] The advantages of this invention are:

[0007] This invention addresses several key issues. Firstly, the design of the first and second cuffs on the endotracheal tube creates a dual-cuff configuration, effectively preventing the downward invasion of secretions and pathogens. Secondly, a pH sensor enables real-time monitoring of the pH value of subglottic retention, triggering an alarm in case of abnormalities. The first and second suction ports facilitate the aspiration of retention material from the dual cuffs and between the cuffs and the airway wall, preventing blockage, accumulation, and downward lung infection. This allows healthcare professionals to monitor the patient's condition in real time and implement timely interventions, reducing the incidence of ventilator-associated pneumonia. Thirdly, the cannula effectively blocks the endotracheal tube during insertion, preventing direct contact between the tube and oropharyngeal pathogens during lower respiratory tract insertion and reducing the introduction of oral secretions and pathogens into the lower respiratory tract.

[0008] This invention is easy to use, reduces the workload of medical staff, lowers nursing costs, significantly reduces the incidence of ventilator-associated pneumonia, improves patient prognosis, and is suitable for widespread adoption. Attached Figure Description

[0009] Figure 1 This is a schematic diagram of the endotracheal intubation assembly of the present invention.

[0010] Figure 2 This is a schematic diagram of the endotracheal intubation system.

[0011] Figure 3 This is a schematic diagram of the sleeve structure. Detailed Implementation

[0012] like Figures 1 to 3 As shown, this invention proposes an endotracheal intubation assembly for ventilator-associated pneumonia (VAP) protection, including an endotracheal tube 10, with a sheath 20 covering the endotracheal tube 10. The endotracheal tube 10 includes a tube body 11, with a connector 12 for connection to a ventilator at its top opening. A first airbag 13 and a second airbag 14 are fitted onto the lower part of the tube body 11, off the ground. The second airbag 14 is positioned above the first airbag 13, with the first airbag 13 near the bottom opening of the tube body 11. The first airbag 13 is connected to a first inflation port 130 via a first inflation connecting tube 131, and the second airbag 14 is connected to a second inflation port 140 via a second inflation connecting tube 141. A first suction hole 15 is provided on the tube body 11 above the first airbag 13, and a second suction hole 16 is provided on the tube body 11 above the second airbag 14. The tube body 11 is fixed with... A suction connecting tube 181 is provided, one end of which is connected to the suction interface 18 and the other end extends to the location of the first suction hole 15 and the second suction hole 16; a pH sensor 17 is provided on the part of the cannula body 11 below the second airbag 14, and the pH sensor 17 is connected to the processor 170 with wireless communication function via a wire 171; the cannula 20 includes a T-shaped bite pad, which is composed of a cylindrical bite pad handle 21 and a sheet bite pad head 22, and a cylindrical isolation film 23 extends from the bottom opening of the bite pad handle 21; when the endotracheal tube 10 is inserted from the top of the cannula 20 but does not go out, the isolation film 23 is all or partly wrinkled, and when the endotracheal tube 10 is forced out of the cannula 20, the isolation film 23 is stretched flat and tightly wrapped on the outer wall of the cannula body 11 under the pulling action of the cannula body 11, and the entire cannula 20 is above the second suction hole 16.

[0013] In the actual design, the cannula body 11 is a flexible tube with a certain rigidity. Its bottom opening can be in the form of an oblique opening, etc., and its top opening is provided with a connecting connector 12 for mechanical connection with the ventilator. The connecting connector 12 is a standard connector.

[0014] In the actual design, the first airbag 13 and the second airbag 14 are in the shape of a ring and are connected and fixed to the outer wall of the cannula body 11. The first inflation port 130 and the second inflation port 140 are both equipped with one-way inflation valves.

[0015] A preferred design is that one end of the first inflation connecting tube 131 is connected to the first inflation port 130, and the other end of the first inflation connecting tube 131 enters the inner cavity of the cannula body 11 from the upper part, extends along the inner wall of the cannula body 11 to a position near the first airbag 13, and then exits the cannula body 11 to communicate with the inner cavity of the first airbag 13; one end of the second inflation connecting tube 141 is connected to the second inflation port 140, and the other end of the second inflation connecting tube 141 enters the inner cavity of the cannula body 11 from the upper part, extends along the inner wall of the cannula body 11 to a position near the second airbag 14, and then exits the cannula body 11 to communicate with the inner cavity of the second airbag 14. Of course, the arrangement of the first inflation connecting tube 131 and the second inflation connecting tube 141 on the cannula body 11 can also be designed in other forms, without limitation.

[0016] In the actual design, the cannula body 11 is provided with a plurality of first suction holes 15, preferably four first suction holes 15, and each first suction hole 15 is evenly distributed along the outer circumference of the cannula body 11; the cannula body 11 is provided with a plurality of second suction holes 16, preferably four second suction holes 16, and each second suction hole 16 is evenly distributed along the outer circumference of the cannula body 11.

[0017] Furthermore, the distance between the first suction hole 15 and the first airbag 13 can be set to 0.5cm, and the distance between the second suction hole 16 and the second airbag 14 can be 0.5cm, which is of course not limited.

[0018] A preferred design is that one end of the suction connecting tube 181 is connected to the suction port 18, and the other end of the suction connecting tube 181 passes through the upper part of the insertion tube body 11 into the inner cavity of the insertion tube body 11 and extends along the inner wall of the insertion tube body 11 to the location of the first suction hole 15 and the second suction hole 16.

[0019] Furthermore, the suction connecting tube 181 extends along the inner wall of the cannula body 11 and then divides into two branches. One branch extends to near each of the first suction holes 15 and then divides into multiple first branch tubes, each of which extends to be opposite to a corresponding first suction hole 15. The other branch extends to near each of the second suction holes 16 and then divides into multiple second branch tubes, each of which extends to be opposite to a corresponding second suction hole 16. Of course, the arrangement and branching structure of the suction connecting tube 181 on the cannula body 11 can also be designed in other forms, without limitation.

[0020] In this invention, the dental pad of the cannula 20 has a structure that is basically the same as that of an existing ordinary dental pad. The dental pad handle 21 constituting the dental pad is generally cylindrical, and the top of the dental pad handle 21 extends outward to form a dental pad head 22. That is, the dental pad has a hole for the insertion cannula body 11 to pass through, and this hole is connected to the hole of the isolation film 23 extending downward from the dental pad handle 21, and together they are used for the insertion of the insertion cannula body 11. In other words, the cannula 20 has a hole for the insertion of the insertion cannula body 11, and the diameter of the hole is adapted to the outer diameter of the insertion cannula body 11, that is, the hole formed by the cannula 20 should be slightly smaller than the outer diameter of the insertion cannula body 11.

[0021] In this invention, the thickness of the insulating film 23 of the sleeve 20 is no greater than 0.1 cm.

[0022] Furthermore, the isolation film 23 of the cannula 20 is extremely thin. When the cannula 20 is not fitted onto the endotracheal tube 10, the isolation film 23 is usually wrinkled. However, as the endotracheal tube 10 is inserted into the cannula 20 through the top opening, the isolation film 23 gradually stretches and flattens under the pulling action of the tube body 11, tightly wrapping around the outer wall of the tube body 11. The function of the isolation film 23 is to ensure that the endotracheal tube 10 remains within the cannula 20, or the isolation film 23, during its passage through the patient's mouth, and only extends out of the isolation film 23 after reaching the desired position, thus only contacting the lower respiratory tract and preventing oral secretions and pathogens from being carried into the lower respiratory tract.

[0023] like Figure 3 The head 22 of the dental pad has symmetrical perforations 220, which are used for inserting medical 3M tape, etc.

[0024] Typically, the endotracheal tube 10 and cannula 20 are designed to be transparent, and they are made of existing antibacterial materials to reduce the chance of bacterial growth. The antibacterial materials can be, for example, existing silver-based inorganic antibacterial materials, and are not limited to any particular type.

[0025] In the actual design, the pH sensor 17 is located on the inner wall of the cannula body 11, the wire 171 is laid along the inner wall of the cannula body 11, and the processor 170 may or may not be located on the cannula body 11; the processor 170 is used to communicate wirelessly with the receiver to send the monitoring information to the remote terminal via the receiver.

[0026] In practical implementation, after the endotracheal intubation assembly of this invention reaches the designated position, the pH sensor 17 is used to monitor the pH value of the subglottic retention at regular intervals. The processor 170 processes the detection results fed back by the pH sensor 17 (such as summing and averaging the detection results obtained at multiple time points before and after). When the body position and indwelling gastric tube affect the reflux of gastric and esophageal contents, causing the airway environment pH value to drop to a predetermined value, it indicates that bacterial or viral infection is likely to occur. Therefore, the receiver sends alarm and other monitoring information to the remote terminal to remind medical staff to take relevant measures, such as suctioning the retention in the subglottic area through the first suction port 15 and the second suction port 16. At the same time, the detection and processing results are stored in the database for research on ventilator-associated pneumonia.

[0027] Here, the pH sensor 17 and the processor 170 are well-known devices in the art, and the remote terminal is, for example, a desktop computer, a handheld mobile computer (PDA), etc.

[0028] The process of using this invention is as follows:

[0029] First, insert the endotracheal tube 10 from the top of the cannula 20 but not through it (the isolation membrane 23 is wholly or partially pleated). Hold the laryngoscope in one hand and gently place the lens into the patient's mouth. Adjust the angle and depth so that the epiglottis (the structure above the glottis) can be seen in the magnified field of view of the lens. When the epiglottis is clearly visible, gently lift the epiglottis with the laryngoscope to expose the glottis. The glottis presents two crescent-shaped openings, which are the entrances to the airway. Quickly and accurately insert the endotracheal tube 10 with the cannula 20 through the glottis into the airway. Pay close attention to the field of view of the laryngoscope. With the other hand, apply downward force to make the endotracheal tube 10 pass through the cannula 20. At this time, the isolation membrane 23 gradually stretches and flattens under the pulling action of the tube body 11 and tightly wraps around the outer wall of the tube body 11. Once the endotracheal tube 10 is positioned correctly, medical 3M adhesive tape is inserted through the perforation 220 of the bite block head 22 to secure the cannula 20 and the endotracheal tube 10 tightly together. At this point, the entire cannula 20 should be positioned above the second suction port 16. Then, the syringe (with the needle removed) is connected to the first inflation port 130 to inflate the first cuff 13, and the syringe (with the needle removed) is connected to the second inflation port 140 to inflate the second cuff 14, thus securing the endotracheal tube 10 with the cannula 20 in the airway. Finally, adhesive tape or elastic band is inserted through the perforation 220 of the bite block head 22 to secure the endotracheal tube 10 with the cannula 20 to the patient's face or neck. At this time, the first air sac 13 and the second air sac 14 are closely attached to the airway and are separated by a distance, forming an effective barrier to physically block pathogens and secretions, preventing subglottic reflux material such as gastric and esophageal reflux from invading the lungs.

[0030] The ventilator (or other respiratory support equipment) is then connected to connector 12, establishing an artificial airway and initiating mechanical ventilation. During ventilation, pH sensor 17 periodically monitors the pH value of subglottic effluent and feeds the results back to processor 170 for processing. When processor 170 determines that the pH value is too low to a predetermined level, indicating a high risk of bacterial or viral infection, it sends an alarm to a remote terminal via receiver, alerting medical staff to take appropriate action. Medical staff then connect a syringe (with the needle removed) to suction port 18, allowing the effluent to be continuously suctioned out through first suction port 15 and second suction port 16.

[0031] The syringe described above is manually operated. In practice, an electric air pump can also be used to inflate the first air bag 13 and the second air bag 14. The suction port 18 can also be connected to an existing negative pressure suction device to clear the retained material and reduce the incidence of ventilator-associated pneumonia.

[0032] The advantages of this invention are:

[0033] This invention addresses several key issues. Firstly, the design of the first and second cuffs on the endotracheal tube creates a dual-cuff configuration, effectively preventing the downward invasion of secretions and pathogens. Secondly, a pH sensor enables real-time monitoring of the pH value of subglottic retention, triggering an alarm in case of abnormalities. The first and second suction ports facilitate the aspiration of retention material from the dual cuffs and between the cuffs and the airway wall, preventing blockage, accumulation, and downward lung infection. This allows healthcare professionals to monitor the patient's condition in real time and implement timely interventions, reducing the incidence of ventilator-associated pneumonia. Thirdly, the cannula effectively blocks the endotracheal tube during insertion, preventing direct contact between the tube and oropharyngeal pathogens during lower respiratory tract insertion and reducing the introduction of oral secretions and pathogens into the lower respiratory tract.

[0034] The above description describes the preferred embodiments of the present invention and the technical principles applied thereto. For those skilled in the art, any obvious changes such as equivalent transformations or simple substitutions based on the technical solutions of the present invention, without departing from the spirit and scope of the present invention, shall fall within the protection scope of the present invention.

Claims

1. A endotracheal intubation assembly for ventilator-associated pneumonia protection, characterized in that, The device includes an endotracheal tube, which is covered by a sheath. The endotracheal tube comprises a tube body, with a connecting connector at its top. A first airbag and a second airbag are fitted onto the lower part of the tube body, which is off the ground. The second airbag is positioned above the first airbag, and the first airbag is close to the bottom of the tube body. The first airbag is connected to a first inflation port via a first inflation connecting tube, and the second airbag is connected to a second inflation port via a second inflation connecting tube. A first suction hole is located on the tube body above the first airbag, and a second suction hole is located on the tube body above the second airbag. A suction connecting tube is fixed to the tube body, with one end connected to a suction port and the other end extending to the locations of the first and second suction holes. The portion of the tube body below the second airbag... A pH sensor is provided, which is connected to a processor with wireless communication function via a wire; the cannula includes a T-shaped dental pad, which is composed of a cylindrical dental pad handle and a sheet dental pad head, with a cylindrical isolation film extending from the bottom of the dental pad handle; when the endotracheal tube is inserted from the top of the cannula but not out, the isolation film is wrinkled, and when the endotracheal tube is forced out of the cannula, the isolation film stretches flat and tightly wraps around the outer wall of the tube body, and the cannula is above the second suction port; the thickness of the isolation film of the cannula is no more than 0.1 cm; the function of the isolation film is to ensure that the endotracheal tube is inside the isolation film during the process of passing through the patient's mouth, and only extends out of the isolation film after reaching the position, so as to only contact the lower respiratory tract and prevent oral secretions and pathogens from being brought into the lower respiratory tract.

2. The endotracheal intubation assembly for ventilator-associated pneumonia protection as described in claim 1, characterized in that, The first airbag and the second airbag are ring-shaped and are connected and fixed to the outer wall of the cannula body. The first inflation port and the second inflation port are both equipped with one-way inflation valves.

3. The endotracheal intubation assembly for ventilator-associated pneumonia protection as described in claim 2, characterized in that, One end of the first inflation connector is connected to the first inflation port, and the other end of the first inflation connector enters the inner cavity of the cannula body from the upper part of the cannula body, extends along the inner wall to a position close to the first airbag, and then exits the cannula body to communicate with the inner cavity of the first airbag; one end of the second inflation connector is connected to the second inflation port, and the other end of the second inflation connector enters the inner cavity of the cannula body from the upper part of the cannula body, extends along the inner wall to a position close to the second airbag, and then exits the cannula body to communicate with the inner cavity of the second airbag.

4. The endotracheal intubation assembly for ventilator-associated pneumonia protection as described in claim 1, characterized in that, The cannula body is provided with a plurality of first suction holes, each of the first suction holes being evenly distributed along the outer circumference of the cannula body; the cannula body is provided with a plurality of second suction holes, each of the second suction holes being evenly distributed along the outer circumference of the cannula body.

5. The endotracheal intubation assembly for ventilator-associated pneumonia protection as described in claim 4, characterized in that, One end of the suction connecting tube is connected to the suction interface, and the other end of the suction connecting tube passes through the upper part of the insertion tube body into the inner cavity of the insertion tube body and extends along the inner wall to the location of the first suction hole and the second suction hole.

6. The endotracheal intubation assembly for ventilator-associated pneumonia protection as described in claim 5, characterized in that, The suction connecting tube extends along the inner wall of the insertion tube body and then divides into two branches. One branch extends to near each of the first suction holes and then divides into multiple first branch tubes, each of which extends to be opposite to a corresponding first suction hole. The other branch extends to near each of the second suction holes and then divides into multiple second branch tubes, each of which extends to be opposite to a corresponding second suction hole.

7. The endotracheal intubation assembly for ventilator-associated pneumonia protection as described in claim 1, characterized in that, The cannula has a hole through which the cannula body passes, and the diameter of the hole is adapted to the outer diameter of the cannula body.

8. The endotracheal intubation assembly for ventilator-associated pneumonia protection as described in claim 1, characterized in that, The dental pad has a perforation on its head.

9. The endotracheal intubation assembly for ventilator-associated pneumonia protection as described in claim 1, characterized in that, The pH sensor is located on the inner wall of the cannula body, the wire is laid along the inner wall of the cannula body, and the processor may or may not be located on the cannula body; the processor is used to wirelessly communicate with the receiver to send the monitoring information to a remote terminal via the receiver.

Citation Information

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