Tracheal intubation device for difficult intubation

CN122605058APending Publication Date: 2026-08-21XIANGSHAN COUNTY FIRST PEOPLES HOSPITAL MEDICAL HEALTH GRP (NINGBO FOURTH HOSPITAL NINGBO FOURTH HOSPITAL HOSPITAL MANAGEMENT RES INST)
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Patent Information

Application Number
CN202611116088.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-07-27
Publication Date
2026-08-21

AI Technical Summary

Benefits of technology

多个气囊沿气插管长度方向间隔布置,每一气囊均可与患者气管壁形成独立密封,从而在气道不同节段提供多重密封保障。同时又可减少充气量,降低对气管黏膜的压迫损伤。相邻气囊之间形成缓冲间隙,可容纳少量分泌物,避免其直接进入下呼吸道,进一步降低误吸风险。

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Abstract

The application discloses a trachea cannula device for difficult intubation, comprising a trachea cannula, a main capsule and a plurality of air bags, the main capsule is arranged along the length direction of the trachea cannula, the air bags are arranged around the trachea cannula, the air bags are arranged at intervals along the length direction of the trachea cannula, the inflation pipe and the deflation pipe are arranged on both sides of the air bags respectively, the main capsule forms a capsule skeleton after being inflated, the air bags are provided with the inflation pipe and the deflation pipe, the air bags form annular support for the inner wall of the trachea after being inflated, the air bags form a plurality of reinforcing points through the increase of the wall thickness, and flexible fitting areas are formed between the reinforcing points. Through the reinforcing points, the configuration of the outer side of the air bag is stabilized, the air bag can form uniform stress distribution when being inflated, the risk of sealing failure caused by the deformation of the air bag is reduced, and the air bag can automatically adjust the fitting degree according to the actual shape of the trachea during the inflation process.
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Description

Technical Field

[0001] This application relates to the field of medical assistive device technology, specifically to a tracheal intubation device for difficult intubation. Background Technology

[0002] Difficult intubation refers to a situation where a well-trained anesthesiologist encounters significant resistance or fails when attempting endotracheal intubation. The core coping strategy is to prioritize ensuring the patient's oxygenation, limit the number of attempts, and promptly activate backup plans. High-risk groups for difficult intubation include: (1) elderly patients, often accompanied by cervical degenerative lesions, which lead to limited neck movement and degeneration of the pharyngeal structure, resulting in increased intubation difficulties; (2) obese and overweight individuals, whose neck fat accumulation and tongue enlargement make airway exposure difficult; (3) employees who work at desks for long periods of time, whose improper sitting posture leads to the younger age of onset of cervical spondylosis; (4) patients with obstructive sleep apnea (OSA), whose airway anatomy is significantly abnormal; (5) an increase in severe, emergency, and trauma cases, often accompanied by airway edema, bleeding, or limited body position.

[0003] Difficult intubation is a common challenge in clinical anesthesia. When laying endotracheal tubes, sealing performance must be considered. For example, the irregularity of the trachea is higher in patients with fat accumulation in the neck, and the sealing performance needs to be further considered when laying the tubes. How to design a tightly fitting endotracheal tube device to solve the problem of difficult endotracheal tube laying in specific populations is a technical problem that urgently needs to be solved in this field. Summary of the Invention

[0004] The purpose of this application is to provide a endotracheal intubation device that fits snugly and is suitable for difficult intubation.

[0005] To achieve the above objectives, the technical solution adopted in this application is as follows: a endotracheal intubation device for difficult intubation, comprising an endotracheal tube, a main cuff, and multiple cuffs. The main cuff is arranged along the length of the endotracheal tube, the cuffs surround the endotracheal tube, and the multiple cuffs are arranged at intervals along the length of the endotracheal tube. After inflation, the main cuff forms a cuff skeleton. The cuffs are provided with an inflation tube and a deflation tube. After inflation, the cuffs form a ring support for the inner wall of the trachea. The cuffs form several reinforcing points by increasing the wall thickness, and a flexible fitting area is formed between the several reinforcing points. When inflated, after two adjacent reinforcing points reach the unfolded position, the flexible fitting area extends and adaptively fits the patient's trachea.

[0006] As a preferred embodiment, the diameter of the endotracheal tube is larger than the diameter of the inflation tube and the deflation tube; the reinforcing points are arranged at equal intervals along the circumference, and the number of the reinforcing points ranges from 6 to 30; the maximum outer diameter of the flexible fitting area when inflated is greater than the distance between two adjacent reinforcing points, so that the inflated flexible fitting area expands outward and extends toward the reinforcing points on both sides.

[0007] As a preferred embodiment, the flexible bonding area is arc-shaped after inflation, and the arc angle of the flexible bonding area after inflation is greater than or equal to 180°.

[0008] As a preferred embodiment, the flexible fitting area has a folded configuration. After inflation, the flexible fitting area is unfolded outward, and at least two of the folded areas extend towards the corresponding reinforcement points on both sides.

[0009] As a preferred embodiment, the endotracheal tube, the inflation tube, and the deflation tube are provided with a fixing bracket at their top, the fixing bracket being adapted to limit the initial position of the top of both the main capsule and the endotracheal tube.

[0010] As a preferred embodiment, the airbag is annular, and the main body of the airbag has multiple fixing points spaced apart along its inner circumference for fixing the airbag. A closed area is formed at the center of the inner side of the main body of the airbag, and the endotracheal tube is located within the closed area.

[0011] As a preferred embodiment, the inflation tube and the deflation tube are connected in an inner and outer sleeve configuration, with an inflation balloon and a deflation balloon respectively provided at their top ends; the inflation balloon and the deflation balloon are located on the same side of the air intubation tube, and a main balloon is provided on the other side of the air intubation tube, the main balloon being used to inflate and deflate the main balloon.

[0012] As a preferred embodiment, the inflation tube and the deflation tube are sleeved together to form a first tube body, and a second tube body is formed at the bottom of the main balloon. The second tube body is adapted to connect the main balloon body and the main balloon body, and the inner wall of the main balloon body simultaneously wraps the first tube body, the second tube body, and the endotracheal tube.

[0013] As a preferred embodiment, the endotracheal tube is provided with a handle and a visualization component at its top. The visualization component includes a rotating part at its bottom, which is connected to the handle so that the visualization component can be rotated for display.

[0014] As a preferred embodiment, the inner side of the handle integrates one or more of the following: an air pump, a control chip, a motor, and a pressure sensor.

[0015] Compared with the prior art, the beneficial effects of this application are as follows: Multiple cuffs are spaced apart along the length of the endotracheal tube, each forming an independent seal with the patient's tracheal wall, thus providing multiple layers of sealing protection at different segments of the airway. This also reduces the amount of air needed for inflation, minimizing pressure damage to the tracheal mucosa. A buffer gap is formed between adjacent cuffs, accommodating small amounts of secretions and preventing them from directly entering the lower respiratory tract, further reducing the risk of aspiration.

[0016] By incorporating reinforcement points, the outer shape of the airbag is stabilized, and a more uniform force distribution is achieved during inflation, reducing the risk of seal failure due to airbag deformation. Simultaneously, the combination of these reinforcement points and the flexible fitting area allows the airbag to automatically adjust its fit according to the actual shape of the airway during inflation. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the overall structure of one embodiment of this application.

[0018] Figure 2 yes Figure 1 A schematic diagram of the deployment of the middle air bladder and the main air bladder.

[0019] Figure 3 This is a schematic diagram of the airbag inflating.

[0020] Figure 4 yes Figure 3 Enlarged view of point A in the middle.

[0021] Figure 5 This is a schematic diagram of the airbag deploying.

[0022] Figure 6 yes Figure 5 Enlarged view of point B in the middle.

[0023] Figure 7 This is a schematic diagram of the inflation and deflation tubes corresponding to the airbag and main body.

[0024] In the diagram: 1. Intubation tube; 2. Handle; 3. Rotating component; 4. Visualization component; 5. Main balloon; 6. Inflatable balloon; 7. Deflatable balloon; 8. Airbag; 9. Main balloon body; 10. Flexible fitting area; 11. Reinforcement point. Detailed Implementation

[0025] The present application will be further described below with reference to specific embodiments. It should be noted that, without conflict, the various embodiments or technical features described below can be arbitrarily combined to form new embodiments.

[0026] In the description of this application, it should be noted that the terms "center", "lateral", "longitudinal", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", etc., which indicate the orientation and positional relationship based on the orientation or positional relationship shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and should not be construed as limiting the specific protection scope of this application.

[0027] It should be noted that the terms "first," "second," etc., in the specification and claims of this application are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence.

[0028] The terms “comprising” and “having”, and any variations thereof, in the specification and claims of this application are intended to cover non-exclusive inclusion, for example, a process, method, system, product, or device that includes a series of steps or units is not necessarily limited to those steps or units that are explicitly listed, but may include other steps or units that are not explicitly listed or that are inherent to such process, method, product, or device.

[0029] Example: Reference Figures 1 to 7 This embodiment proposes a tracheal intubation device for difficult intubation, including a tracheal tube 1, a main cuff 9 and a cuff 8. The main cuff 9 is arranged along the length of the tracheal tube 1. After the main cuff 9 is inflated, it forms a cuff skeleton, so that the tracheal tube 1 maintains a stable posture and a closed state in the patient's airway.

[0030] like Figure 1 , Figure 2 The cuff 8 surrounds the endotracheal tube 1. The cuff 8 is equipped with an inflation tube and a deflation tube. After inflation, the cuff 8 forms a ring-shaped support against the inner wall of the trachea. The cuff 8, once inflated, forms a seal against the patient's tracheal wall. The commonly applied pressure for adults is approximately 25-30 cmH2O. The main cuff 9 also applies this pressure range to ensure relatively controllable overall pressure. The main cuff 9 ensures a seal between the inside of the cuff 8 and the endotracheal tube 1, while the cuff 8 primarily ensures a seal between itself and the patient's tracheal wall. Together, they effectively prevent gas leakage and reduce the risk of aspiration.

[0031] In this embodiment, multiple air bags 8 are preferably provided, spaced apart along the length of the endotracheal tube 1. Each air bag 8 can form an independent seal with the patient's tracheal wall, thus providing multiple sealing protections at different segments of the airway. This also reduces the amount of air needed, minimizing pressure damage to the tracheal mucosa. A buffer gap is formed between adjacent air bags 8, which can accommodate small amounts of secretions, preventing them from directly entering the lower respiratory tract and further reducing the risk of aspiration.

[0032] Furthermore, the airbag 8 has several reinforcing points 11 formed by increasing its wall thickness. These reinforcing points 11 form a flexible fitting area 10. During inflation, after two adjacent reinforcing points 11 reach their deployed positions, the flexible fitting area 10 extends and adaptively fits the patient's trachea. Adjacent flexible fitting areas 10, after deployment, abut against each other and flexibly deform to fill the gaps. This structural design allows the airbag 8 to better adapt to the anatomical differences in the trachea of ​​different patients during inflation, ensuring a good seal while avoiding local high-pressure damage to the tracheal mucosa due to overinflation. The reinforcing points 11 stabilize the outer shape of the airbag 8 and allow for a more uniform force distribution during inflation, reducing the risk of seal failure due to airbag 8 deformation. Simultaneously, the cooperation between the reinforcing points 11 and the flexible fitting area 10 allows the airbag 8 to automatically adjust its fit according to the actual shape of the trachea during inflation.

[0033] The reinforcement point 11 is spaced a short distance from the tracheal wall after the airbag 8 deploys. Subsequently, through the elastic deformation of the flexible fitting area 10, it further conforms to the uneven areas of the tracheal wall, forming a continuous and uniform sealing contact surface. This design balances sealing reliability and tissue protection, and can significantly reduce the incidence of airbag 8-related complications in clinical applications.

[0034] The tracheal wall is not typically a perfectly regular cylinder, but rather exhibits irregular structures such as physiological bends, indentations, and mucosal folds. The synergistic design of the reinforcing point 11 and the flexible fitting area 10 allows the airbag 8 to actively adapt to these minute morphological differences after inflation. For example, when the airbag 8 encounters a slight bend in the tracheal wall, because the outer diameter of the reinforcing point 11 is slightly smaller than the outer diameter of the tracheal wall when deployed, the entire endotracheal cannula can be inserted into the appropriate position first. After inflation, the reinforcing point 11 does not directly act on the bend in the tracheal wall, but rather fills the gap between the bend and the airbag through the elastic deformation of the flexible fitting area 10, thereby achieving an effective seal without increasing local pressure. At the same time, the elastic deformation capability of the flexible fitting area 10 allows it to adapt to minor depressions or protrusions in the tracheal wall, ensuring the continuity of the seal.

[0035] The aforementioned components, such as the air bladder 8, main bladder body 9, inflation tube, and deflation tube, can be made of medical-grade silicone, rubber, or other materials with good ductility. These materials have good biocompatibility and elasticity, meeting the needs of short-term endotracheal intubation. Furthermore, these types of endotracheal tubes are generally designed for single use to avoid the risk of cross-infection. In terms of manufacturing process, the reinforcing point 11 and the flexible fitting area 10 can be integrally molded, with mature production technology, controllable costs, and ease of large-scale production.

[0036] The diameter of the endotracheal tube 1 is larger than the diameter of the inflation tube and the deflation tube; the reinforcing points 11 are set at equal intervals along the circumference, and the number of reinforcing points 11 ranges from 6 to 30. The maximum outer diameter of the flexible fitting area 10 when inflated is larger than the distance between two adjacent reinforcing points 11, so that the flexible fitting area 10 expands outward after inflation and extends towards the reinforcing points 11 on both sides.

[0037] The reinforcing point 11 has less contact with the tracheal wall. Its main function is to form a stable fulcrum and serve as a pre-set skeleton for the deployment configuration of the outer wall of the airbag 8. The flexible fitting area 10 undertakes the main sealing function. When the number of reinforcing points 11 is small (less than 6), the span of the flexible fitting area 10 between adjacent reinforcing points 11 is too large. After inflation, it is easy to cause local collapse or over-expansion, resulting in uneven sealing. When the number of reinforcing points 11 is too large (more than 30), the overall rigidity of the airbag 8 is enhanced, the flexible fitting area 10 is too small, and the space for deformation of the flexible fitting area 10 is limited. It is difficult to fully adapt to the shape changes of the tracheal wall, which reduces the compliance and comfort of the seal. At the same time, it further increases the manufacturing cost and process complexity of the airbag 8.

[0038] Therefore, the design with 6 to 30 reinforcement points achieves a good balance between sealing performance, manufacturing cost, and clinical suitability.

[0039] A preferred flexible fitting area 10 is arc-shaped after inflation (the arc shape corresponds to the curvature of the tracheal wall and is elastically deformed to adapt to the specific shape of the tracheal wall), and the corresponding curvature angle of the flexible fitting area 10 after inflation is greater than or equal to 180°.

[0040] The aforementioned arc shape describes its shape from a cross-sectional perspective. The three-dimensional shape is a columnar structure formed by a superior arc seal and subsequent stretching. This structure ensures that the distance between two adjacent reinforcing points 11 is less than the maximum outer diameter of the flexible fitting area 10 when expanded. This design guarantees that the flexible fitting area 10 can fully expand outwards during inflation. Since the contact between the reinforcing points 11 and the trachea is biased towards point / line contact, the flexible fitting area 10, after expansion, needs to fill the gaps between the reinforcing points 11 as much as possible to form a continuous sealing surface. This structure allows the airbag 8 to achieve efficient sealing even with low inflation, reducing pressure on the tracheal mucosa.

[0041] Another preferred flexible fitting area 10 has a folded configuration. After inflation, the flexible fitting area 10 unfolds outwards, and at least two of the folded areas extend towards the corresponding reinforcement points 11. When folded, the flexible fitting area 10 contracts and is stored between adjacent reinforcement points 11. The folded flexible fitting area 10 is in a folded and contracted state when not inflated, effectively reducing the initial volume of the airbag 8, facilitating the insertion of the intubation tube 1 and the storage of unused parts. Furthermore, the folded shape facilitates the design of the airbag 8 structure, and the specific design of the airbag 8 molding process can be further simplified, making the airbag 8 production easier.

[0042] Due to the multi-structure design of the main bladder 9, air bladder 8, and endotracheal cannula 1, this difficult-to-intubate endotracheal intubation device has a fixing bracket at the top of the endotracheal cannula 1, inflation tube, and deflation tube. The fixing bracket is suitable for restricting the initial position of the top of the main bladder 9, endotracheal cannula 1, and inflation / deflation tubes. The main function of the fixing bracket is to facilitate the integration and storage of the endotracheal cannula, inflation / deflation tube, etc. In addition, it also facilitates the connection of the endotracheal cannula to the handle, visualization component, etc.

[0043] The air bladder 8 is annular, and the main bladder body 9 has multiple fixing points spaced along its inner circumference for securing the air bladder 8. A closed area is formed at the center of the inner side of the main bladder body 9, and the endotracheal tube 1 is located within this closed area. After insertion, the endotracheal tube 1 generally needs to be sealed. A seal is formed between the main bladder body 9 and the endotracheal tube 1, and a seal is also formed between the main bladder body 9 and the deployed air bladder 8 when the main bladder body 9 is deployed. This double sealing structure effectively prevents gas leakage and improves the airtightness and stability after intubation.

[0044] The aforementioned inflation and deflation tubes are designed with an inner and outer sleeve connection (mainly in the lower area). Inflation balloon 6 and deflation balloon 7 are respectively installed at the top of the inflation and deflation tubes. Inflation balloon 6 and deflation balloon 7 are located on the same side of the endotracheal tube 1, while a main balloon 5 is located on the other side of the endotracheal tube 1. The main balloon 5 is used to inflate and deflate the main balloon body 9. The structures of inflation balloon 6, deflation balloon 7, and main balloon 5 are similar or identical; essentially, they are valve structures used to control gas flow. Inflation balloon 6 and deflation balloon 7 can employ a one-way valve design, responsible for establishing a tight seal with the endotracheal tube wall. Since the endotracheal tube wall is not a perfectly smooth plane / arc surface, the balloon 8 needs to have better flexibility and adaptability than the main balloon 5. Correspondingly, it requires higher precision during inflation and deflation. Therefore, the one-way valve design effectively controls the unidirectional flow of gas, preventing backflow and ensuring that the balloon 8 maintains a stable pressure after inflation. Inflation of the main bladder 9 is achieved through the main balloon 5. The main balloon 5 can employ a two-way valve design for rapid inflation and deflation to adjust the fit between the main bladder 9 and the tracheal wall. Sufficient fit between the main bladder 9 and the airbag 8 is sufficient. Even if the gas pressure inside the main bladder 9 is slightly lower than that of the airbag 8, effective sealing can be achieved through the flexible deformation of the airbag 8. Therefore, the required inflation / deflation precision of the main bladder 9 is lower than that of the airbag 8, and the rapid inflation and deflation of the main balloon 5 is sufficient to meet the usage requirements.

[0045] The aforementioned inflation and deflation tubes are joined together to form a first tube body, and a second tube body is formed at the bottom of the main balloon 5. The second tube body is adapted to connect the main balloon body 9 and the main balloon 5. The inner wall of the main balloon body 9 simultaneously wraps the first tube body, the second tube body, and the endotracheal cannula 1. The aforementioned fixing bracket can be used to fix the relative positions of the first tube body, the second tube body, and the endotracheal cannula 1, avoiding sealing failure or operational inconvenience due to tube displacement during intubation or use.

[0046] The endotracheal tube 1 has a handle 2 and a visualization component 4 at its top. The visualization component 4 includes a rotating part 3 at the bottom, which is connected to the handle 2 so that the visualization component 4 can be rotated for display. The combination of the endotracheal tube 1 and the visualization component allows the operator to observe the internal condition of the trachea from different angles, improving the accuracy of intubation. The handle 2 can selectively integrate one or more of the following components: an air pump, a control chip, a motor, and a pressure sensor, thereby enriching the functionality of the endotracheal tube 1.

[0047] The basic principles, main features, and advantages of this application have been described above. Those skilled in the art should understand that this application is not limited to the above embodiments. The embodiments and descriptions in the specification are merely the principles of this application. Various changes and modifications can be made to this application without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claims. The scope of protection claimed by this application is defined by the appended claims and their equivalents.

Claims

1. A endotracheal intubation device for difficult intubation, characterized in that, It includes an endotracheal tube, a main bladder body, and multiple air bladders. The main bladder body is arranged along the length of the endotracheal tube, and the air bladders surround the endotracheal tube. The multiple air bladders are arranged at intervals along the length of the endotracheal tube. After the main bladder body is inflated, it forms a bladder body skeleton. The air bladders are provided with inflation tubes and deflation tubes. After the air bladders are inflated, they form a ring support for the inner wall of the trachea. The airbag forms several reinforcing points by increasing the wall thickness, and a flexible fitting area is formed between the reinforcing points. When inflated, after two adjacent reinforcing points reach the unfolded position, the flexible fitting area extends and adaptively fits the patient's trachea.

2. The endotracheal intubation device for difficult intubation as described in claim 1, characterized in that, The diameter of the endotracheal tube is larger than the diameter of the inflation tube and the deflation tube; the reinforcing points are arranged at equal intervals along the circumference, and the number of the reinforcing points ranges from 6 to 30; the maximum outer diameter of the flexible fitting area when inflated is larger than the distance between two adjacent reinforcing points, so that the inflated flexible fitting area expands outward and extends toward the reinforcing points on both sides.

3. The endotracheal intubation device for difficult intubation as described in claim 2, characterized in that, The flexible bonding area becomes arc-shaped after inflation, and the corresponding arc angle of the flexible bonding area after inflation is greater than or equal to 180°.

4. The endotracheal intubation device for difficult intubation as described in claim 2, characterized in that, The flexible bonding area has a folded configuration. After inflation, the flexible bonding area is unfolded outward, and at least two of the folded areas extend towards the corresponding reinforcement points on both sides.

5. The endotracheal intubation device for difficult intubation as described in claim 2, characterized in that, The endotracheal tube, the inflation tube, and the deflation tube are provided with a fixing frame at their top, which is adapted to limit the initial position of the top of the main capsule and the endotracheal tube.

6. The endotracheal intubation device for difficult intubation as described in claim 5, characterized in that, The airbag is circular, and the main body of the airbag has multiple fixing points spaced at intervals along its inner circumference for fixing the airbag. A closed area is formed at the center of the inner side of the main body of the airbag, and the endotracheal tube is located within the closed area.

7. The endotracheal intubation device for difficult intubation as described in claim 6, characterized in that, The inflation tube and the deflation tube are connected in an inner and outer sleeve configuration. The top ends of the inflation tube and the deflation tube are respectively provided with an inflation balloon and a deflation balloon. The inflation balloon and the deflation balloon are located on the same side of the air intubation tube, and a main balloon is provided on the other side of the air intubation tube. The main balloon is used to inflate and deflate the main balloon.

8. The endotracheal intubation device for difficult intubation as described in claim 7, characterized in that, The inflation tube and the deflation tube are sleeved together to form a first tube body, and a second tube body is formed at the bottom of the main balloon. The second tube body is adapted to connect the main balloon body and the main balloon. The inner wall of the main balloon body simultaneously wraps the first tube body, the second tube body, and the endotracheal tube.

9. The endotracheal intubation device for difficult intubation as described in claim 1, characterized in that, The endotracheal tube is provided with a handle and a visualization component at the top. The visualization component includes a rotating part at the bottom, which is connected to the handle so that the visualization component can be rotated for display.

10. The endotracheal intubation device for difficult intubation as described in claim 9, characterized in that, The inner side of the handle integrates one or more of the following: an air pump, a control chip, a motor, and a pressure sensor.