An intelligent shapeable supraglottic airway catheter ventilation device

Abstract

The application discloses a supraglottic airway catheter ventilation device with intelligent plasticity, which comprises a main body pipe, a sleeve, an inflation system, a visual system and a sealing sensing system; the main body pipe is provided with a distal port and a proximal port, and is used for self-adaptive plasticity according to the anatomic features of the upper respiratory tract of a patient; the sleeve is arranged on the distal port, is used for adapting to the structure of the throat anatomy of different patients and filling the anatomic dead space, and the surface of the sleeve is provided with a fit detection module; the inflation system is used for completing dynamic adjustment of inflation and deflation of the sleeve according to the signal of the sealing sensing system; the visual system is arranged in the interior of the main body pipe, and is used for providing airway visualization intubation, anatomic identification and risk monitoring of reflux, catheter displacement and the like for a user. The supraglottic airway catheter ventilation device with intelligent plasticity can improve the safety of clinical use.

Description

Technical Field

[0001] This invention relates to the field of medical airway device technology, and in particular to an intelligent and malleable supraglottic airway duct ventilation device. Background Technology

[0002] The supraglottic airway tube (laryngeal mask airway) is an important device for clinical anesthesia, emergency care, and perioperative airway management. It mainly relies on the cuff to form a sealed structure in the oropharynx and laryngopharynx to achieve mechanical ventilation.

[0003] Currently used supraglottic airway tubes cannot specifically fill anatomical dead spaces such as the pyriform recess and esophageal orifice, resulting in poor overall sealing and a tendency for air leakage. Cuff pressure can only be intermittently monitored manually or with a simple pressure gauge, lacking real-time dynamic monitoring. Factors such as changes in patient position during surgery, fluctuations in anesthesia depth leading to swallowing or coughing reflexes, and periodic ventilator-induced airflow impacts can all cause continuous fluctuations in cuff pressure, making it difficult to detect and address abnormal pressure promptly. Cuff pressure imbalance poses a double safety hazard: excessively high pressure continuously compresses the pharyngeal mucosa, causing ischemic damage and inducing postoperative sore throat, hoarseness, and dysphagia. Traditional tubes lack visual positioning and real-time monitoring capabilities, making it impossible to observe the alignment of the tube with the glottis and epiglottis in real time. Intraoperative tube displacement, airway secretions, and gastric reflux are also difficult to detect in a timely manner, further amplifying clinical risks. In summary, existing supraglottic airway tubes have significant shortcomings in terms of individualized fitting, pressure control, safety monitoring, and prevention of aspiration, resulting in insufficient safety in clinical use. Summary of the Invention

[0004] In order to overcome the shortcomings of the prior art, the purpose of this invention is to provide an intelligent and malleable supraglottic airway ventilation device that can improve the safety of clinical use.

[0005] The objective of this invention is achieved through the following technical solution:

[0006] A smart, shape-adjustable supraglottic airway ventilation device includes: a main tube, a cuff, an inflation system, and a visual system;

[0007] The main tube has a distal port and a proximal port, and the main tube is designed to adaptively shape according to the anatomical features of the patient's upper respiratory tract.

[0008] The cuff is located on the distal port. The cuff is used to adapt to the anatomical structure of different patients’ throats and fill the anatomical dead space. The surface of the cuff is provided with a fit detection module.

[0009] The inflation system is used to dynamically adjust the inflation and deflation of the bladder according to the signal from the fit detection module.

[0010] The visual system is located inside the main tube and is used to provide users with visual airway placement, anatomical identification, and risk monitoring such as reflux and tube displacement.

[0011] Furthermore, the sheath is made of silicone, TPE, or polyurethane.

[0012] Furthermore, the wall of the sheath has a material gradient structure.

[0013] Furthermore, a venting connector is provided on the near port, and the main tube also has a venting cavity, which is connected to the venting connector to enable mechanical ventilation.

[0014] Furthermore, the main tube also has an esophageal drainage cavity for draining gastric reflux.

[0015] Furthermore, the fit detection module is provided in multiple ways. The multiple fit detection modules and the processing module together constitute a seal sensing system. Each fit detection module is located on the surface of the sheath. Each fit detection module is located in the central area of ​​the back of the sheath, the area corresponding to the ventral esophageal opening, the area corresponding to the left ventral wing, the area corresponding to the right ventral wing, and the area corresponding to the tongue root. The processing module in the seal sensing system can drive the inflation system to dynamically adjust the inflation and deflation of the corresponding areas on the sheath in real time based on the feedback signals from the fit detection modules located in the central area of ​​the back of the sheath, the area corresponding to the ventral esophageal opening, the area corresponding to the left ventral wing, the area corresponding to the right ventral wing, and the area corresponding to the tongue root.

[0016] Furthermore, the inflation system includes an inflation / deflation extension tube and an inflation device. The inflation / deflation extension tube is located inside the main tube and is connected to the sheath. The inflation device is connected to the inflation / deflation extension tube and inflates or deflates the sheath through the inflation / deflation extension tube.

[0017] Furthermore, the inflation system also includes an inflation / deflation connector and an inflation indicator airbag. The inflation / deflation connector is located on the end of the inflation / deflation extension tube away from the airbag and is used to detachably connect to the inflation device. The inflation indicator airbag is located on the inflation / deflation extension tube and is used to indicate whether the inflation device is in an inflated state.

[0018] Furthermore, the visual system includes a camera, a camera cable, and a display. The camera is located at the remote port and faces the sleeve. The camera lens surface is provided with an anti-fog coating and integrates an LED fill light. The display is electrically connected to the camera through the camera cable and is used to display the image data captured by the camera in real time.

[0019] Furthermore, the main tube is also equipped with a cleaning device for cleaning the lens surface of the camera.

[0020] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0021] 1. Based on the fact that the main tube has a distal end and a proximal end, the main tube is designed to adaptively shape according to the anatomical characteristics of the patient's upper respiratory tract. This invention utilizes an adaptively shapeable main tube, which can be bent and shaped according to the individual anatomical contour of the patient's upper respiratory tract before insertion. After insertion, the tube completely conforms to the natural shape of the airway, eliminating any gaps between the tube and the airway. On the one hand, this structurally limits the catheter from shifting or tilting during ventilation, stabilizing the overall placement of the device; on the other hand, it prevents the rigid tube from locally compressing the delicate pharyngeal mucosa, reducing mucosal damage and local pressure sores. The shaping and adapting structure achieves long-term stable catheter positioning, reducing ventilation safety risks from the perspective of catheter fixation, thereby improving the safety of clinical use.

[0022] 2. Based on the cuff being positioned on the distal port, the cuff is used to adapt to the anatomical structure of different patients' throats and fill anatomical dead spaces. The cuff surface is equipped with a fit detection module. The inflation system dynamically adjusts the inflation and deflation of the cuff based on signals from the fit detection module. This invention forms a basic sealing barrier by adapting the cuff to fill anatomical dead spaces. Simultaneously, the fit detection module on the cuff surface continuously collects mucosal contact pressure in various throat areas, transmitting real-time pressure signals to the inflation system to form a closed-loop control. The inflation system can automatically identify two dangerous conditions: insufficient overall air leakage pressure and excessive local pressure. It automatically performs small-amplitude inflation and deflation, dynamically maintaining the cuff mucosal pressure within a clinically safe range. This continuously isolates the esophageal opening and seals leak-prone areas such as the piriform recess, blocking reflux and leakage pathways, while preventing local high pressure damage to throat tissues. It simultaneously addresses the two major safety issues of seal failure and mucosal compression, further improving mucosal safety and airway sealing safety during ventilation.

[0023] 3. The visual system is located inside the main tube and is used to provide users with visual airway placement, anatomical identification, and risk monitoring such as reflux and tube displacement. This invention integrates the visual system inside the main tube, relying on real-time airway imaging to complete anatomical identification and precise alignment during placement, preventing risks such as tube misalignment and airway mechanical damage caused by blind placement. Throughout the ventilation process, it continuously and dynamically acquires images of the airway and device, automatically capturing potential safety hazards such as secretion accumulation, reflux, and tube displacement. Upon the occurrence of a safety hazard, it immediately outputs an early warning signal, reminding medical personnel to intervene promptly. This achieves visualized placement operation and real-time early warning of ventilation risks, preventing serious complications such as aspiration, airway damage, and ventilation interruption in advance. It provides comprehensive closed-loop management of the entire airway ventilation process, further improving the safety of clinical use. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the structure of an intelligent, malleable supraglottic airway duct ventilation device according to the present invention.

[0025] Figure 2 This is a cross-sectional schematic diagram of the present invention;

[0026] Figure 3 for Figure 2 Enlarged view of point A in the middle.

[0027] In the diagram: 1. Main tube; 11. Distal port; 12. Proximal port; 13. Ventilation chamber; 14. Esophageal drainage chamber; 2. Cuff; 3. Sealing sensing system; 31. Fit detection module; 32. Fit detection connector; 4. Inflation system; 41. Inflation / depression extension tube; 42. Inflation / depression connector; 43. Inflation indicator bladder; 51. Camera; 511. Camera wire; 512. Wire connector; 513. Camera flushing tube; 514. Flushing tube connector; 52. LED supplementary light; 6. Ventilation connector; 32. Fit detection connector; 7. Self-control handle. Detailed Implementation

[0028] The present invention will now be further described in conjunction with the accompanying drawings and 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.

[0029] It should be noted that when an element is described as being "fixed to" another element, it can be directly attached to the other element or there may be an intervening element. When an element is described as being "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementations.

[0030] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0031] See Figures 1-3 A preferred embodiment of the present invention provides an intelligent, shape-adaptable supraglottic airway ventilation device, comprising a main tube 1, a cuff 2, an inflation system 4, and a visualization system. These components work together to achieve visualized and precise airway placement, adaptive shaping and fitting, dynamic pressure regulation, and continuous risk monitoring, comprehensively improving the safety of clinical airway ventilation. The specific structure and operational details of each component are as follows:

[0032] The main tube 1 has a distal port 11 and a proximal port 12. The main tube 1 can be made entirely of medical-grade high-elasticity shape-memory molding material, thus possessing the characteristics of low-temperature shaping, room-temperature shaping, and high-temperature repositioning. It can adaptively shape according to the anatomical characteristics of different patients' upper respiratory tracts. In clinical use, medical staff can perform non-invasive bending and shaping of the main tube 1 based on individual anatomical differences such as the hard palate, soft palate, pharyngeal curvature, and airway length of the patient, conforming to the natural physiological curvature of the patient's upper respiratory tract. After shaping, the main tube 1 can stably maintain its appropriate shape. After being inserted into the patient's upper respiratory tract, it can closely conform to the anatomical contour of the airway, eliminating gaps between the tube and the soft tissue of the airway, ensuring a regular and unobstructed ventilation pathway, and preventing risks such as mucosal damage, local pressure sores, and airway deformation caused by the tube rigidly compressing the pharynx and delicate airway tissues.

[0033] The cuff 2 is located at the distal end 11 of the main tube 1. It is a flexible, irregularly shaped cuff adapted to the anatomical form of the human pharynx and can be made of materials such as ultra-thin, highly elastic silicone, giving it a soft texture, strong conformability, and self-adaptive deformation characteristics. It can adapt to the pharyngeal anatomy of different patients, including adults, children, obese individuals, and those with airway anatomical variations, filling the dead space of the pharynx and easily leaking gaps such as the esophageal orifice, piriform recess, and lateral walls of the pharynx. The cuff 2 can adopt a locally differentiated wall thickness design, with a thinner wall and stronger elastic deformation capacity corresponding to the key sealing areas of the esophageal orifice and piriform recess. During inflation, it can preferentially expand to fill gaps, quickly forming a sealed airway space, thereby effectively blocking airway leakage and backflow pathways. Meanwhile, the fit detection module 31 on the outer surface of the cuff 2 can employ a miniature thin-film pressure sensor. This sensor is non-protruding and provides no foreign body sensation. It can conform to the curved surface of the cuff 2 and comprehensively and continuously collect mucosal pressure signals from key contact areas of the throat. It accurately captures conditions such as excessive local pressure, insufficient overall sealing pressure, and uneven pressure distribution, providing precise data support for the subsequent intelligent adjustment of the inflation system 4. Alternatively, in addition to the miniature thin-film pressure sensor, the fit detection module 31 can also employ a flexible piezoresistive sensor sheet, a miniature capacitive thin-film pressure sensor, a fiber optic micro-pressure sensor probe, a piezoelectric flexible pressure sensor film, or a MEMS miniature pressure sensor chip with a flexible substrate.

[0034] The inflation system 4 can achieve closed-loop intelligent control through the fit detection module 31 on the surface of the cuff 2. After the tube is positioned, the initial inflation stage can be automatically inflated by preset pressure parameters. The cuff 2's differential deformation characteristics are used to quickly fill the pharyngeal gaps and build a stable initial airway seal structure. Simultaneously, an intelligent computing control unit is built into the inflation system 4. During the entire ventilation process, the fit detection module 31 continuously transmits the mucosal contact pressure signal collected in real time to the intelligent computing control unit. The control unit has a built-in safe pressure threshold range and can intelligently judge the current sealing status and pressure conditions: when excessive local mucosal pressure is detected, it automatically deflates slightly to avoid local high pressure compressing the pharyngeal mucosa, leading to congestion, edema, and damage; when insufficient overall sealing pressure is detected and there is a risk of air leakage, it automatically inflates slightly, dynamically stabilizing the contact pressure between the cuff 2 and the pharyngeal mucosa within the optimal clinical safety range, balancing airway sealing effectiveness and mucosal protection safety. The intelligent computing control unit can be a microcomputer, PLC, or microcontroller.

[0035] Before intubation, the visual system, once activated, can acquire high-definition images of the patient's airway in real time, clearly displaying the pharyngeal anatomy, glottic position, and airway mucosa condition. This assists medical staff in accurately identifying the airway anatomy and positioning the catheter, preventing problems such as catheter misalignment, insertion too deep or too shallow, or damage to airway tissue caused by blind placement, thus achieving visualized intubation. Throughout the ventilation process, the visual system continuously and dynamically monitors the airway environment and device operating status, automatically and accurately identifying various safety risks such as airway secretion accumulation, gastric reflux, catheter displacement, cuff displacement, and airway obstruction. Once an abnormality is detected, it immediately alerts and outputs warning signals through audible and visual alarms, guiding medical staff to quickly perform interventions such as suctioning, clearing refluxed material, and repositioning the catheter. This strengthens the ventilation safety line throughout the process and reduces the incidence of clinical ventilation complications.

[0036] Understandably, as a better implementation method, the main tube 1 is replaced with a segmented malleable structure. The main tube 1 is divided into three segments: a proximal connecting segment, a middle shaping segment, and a distal positioning segment. The segments are connected by flexible universal hinge rings, with the hinge rings having a built-in positioning and locking structure. The middle shaping segment is made of a high-elasticity shape memory alloy, while the proximal connecting segment and the distal positioning segment are made of rigid medical-grade plastic, balancing structural stability and shaping flexibility.

[0037] It is understood that, as a further implementation, the cuff 2 can be replaced with a multi-cavity independent partitioned cuff 2. The cuff 2 is internally divided into four independent sealed air cavities: the esophageal sealing area, the piriform recess sealing area, the pharyngeal lateral wall sealing area, and the glottic periglottic sealing area. Each air cavity corresponds to an independent micro inflation / deflation branch and an independent fit detection module 31. The inflation system 4 is equipped with a multi-channel independent control unit and a dedicated self-control handle 7. The self-control handle 7 can be connected to the fit detection module 31 and the inflation system 4 via electrical or wireless signal connection. The self-control handle 7 can monitor the fit detection module 31 in each sealing area of ​​the cuff 2 in real time. Based on the signal changes in the fit detection module 31 in each sealing area, the self-control handle 7 can manually or automatically control the inflation system 4 to inflate or deflate the corresponding sealing area, thereby achieving dynamic pressure control. As an alternative, in addition to adding a dedicated self-control handle 7, a remote mobile APP can be used to monitor the signal of the fit detection module 31 in each sealing area of ​​the signal connector in real time through the fit detection module 31 in each sealing area, and can manually or automatically adjust the inflation system 4 to inflate and deflate the corresponding sealing areas to achieve dynamic pressure control.

[0038] The working principle of this invention is as follows: During operation, the entire device is inserted into the patient's upper respiratory tract through the self-adaptive and shape-adaptable main tube 1. It autonomously shapes and adapts to the patient's pharyngeal anatomy, ensuring proper positioning and preventing displacement during use. The cuff 2, located at the distal end 11 of the main tube 1, is stably positioned above the glottis in the pharyngeal region, adapting to different patients' pharyngeal anatomy and filling anatomical dead spaces. This ensures stable placement and provides the foundation for airway sealing and ventilation. Before insertion, the operator uses real-time airway images from a visual system inside the main tube 1 to identify the airway anatomy and locate the catheter, precisely positioning the distal end of the main tube 1 in the target area above the glottis. This visualized and precise placement prevents alignment errors caused by blind placement. After placement, the inflation system 4 is activated, and gas flows through the inflation tube. The cuff 2 is inserted into the airway, and the pressure of the cuff 2 preferentially expands the thin, soft walls of the cuff in key, easily leaking areas such as the esophageal orifice and piriform recess, intelligently filling the easily leaking gaps in the pharyngeal anatomy and quickly forming a stable initial airway seal structure to block airway leakage pathways. During ventilation, the fit detection module 31 deployed on the surface of the cuff 2 continuously collects mucosal contact pressure signals from key areas of the pharynx and feeds them back to the inflation system 4 in real time. The inflation system 4 performs intelligent judgment and calculation based on the feedback pressure signals. When it detects insufficient overall seal or excessive local pressure, it automatically triggers small-amplitude precise inflation and deflation adjustments to dynamically maintain the mucosal contact pressure of the cuff 2 within the safe and optimal range. Throughout the ventilation operation, the visual system continuously collects images of the airway environment and device position, and automatically identifies safety risks such as airway secretion accumulation, gastric contents reflux, and catheter displacement. After identifying abnormal risks, it promptly outputs warning signals to guide medical staff to intervene and handle the situation quickly.

[0039] Clearly, based on the distal port 11 and proximal port 12 of the main tube 1, the main tube 1 is designed to adaptively shape according to the anatomical characteristics of the patient's upper respiratory tract. This invention, through its adaptively shapeable main tube 1, allows for bending and shaping according to the individual anatomical contour of the patient's upper respiratory tract before insertion. After insertion, the tube completely conforms to the natural shape of the airway, eliminating any gaps between the tube and the airway. On one hand, this structurally limits the catheter's deviation and tilting during ventilation, stabilizing the overall placement of the device. On the other hand, it prevents the rigid tube from locally compressing the delicate pharyngeal mucosa, reducing mucosal damage and local pressure sores. The shaping and adapting structure achieves long-term stable catheter positioning, reducing ventilation safety risks from the perspective of catheter fixation, thereby improving the safety of clinical use.

[0040] The cuff 2, positioned on the distal port 11, is designed to adapt to the anatomical structure of different patients' throats and fill anatomical dead spaces. A fit detection module 31 is provided on the surface of the cuff 2. The inflation system 4 dynamically adjusts the inflation and deflation of the cuff 2 based on signals from the fit detection module 31. This invention forms a basic sealing barrier by adapting the cuff 2 to fill anatomical dead spaces. Simultaneously, the fit detection module 31 on the cuff 2 continuously collects mucosal contact pressure in various throat regions, transmitting real-time pressure signals to the inflation system 4 to form a closed-loop control. The inflation system 4 can automatically identify two dangerous conditions: insufficient overall air leakage pressure and excessive local pressure. It automatically performs small-amplitude inflation and deflation, dynamically maintaining the mucosal pressure of the cuff 2 within a clinically safe range. This continuously seals leak-prone areas such as the esophageal opening and piriform recess, blocking reflux and leakage pathways, while preventing local high pressure damage to throat tissues. It simultaneously addresses the two major safety issues of seal failure and mucosal compression, further improving mucosal safety and airway sealing safety during ventilation.

[0041] The visual system is located inside the main tube 1 and is used to provide users with visual airway placement, anatomical identification, and risk monitoring such as reflux and tube displacement. This invention integrates the visual system inside the main tube 1, relying on real-time airway imaging to complete anatomical identification and precise alignment during placement, preventing blind placement that could lead to tube misalignment or airway mechanical damage. Throughout the ventilation process, it continuously and dynamically acquires images of the airway and device, automatically capturing potential safety hazards such as secretion accumulation, reflux, and tube displacement. Upon the occurrence of a safety hazard, it immediately outputs an early warning signal, reminding medical personnel to intervene promptly. This achieves visualized placement procedures and real-time early warning of ventilation risks, preventing serious complications such as aspiration, airway damage, and ventilation interruption. It provides comprehensive closed-loop management of the entire airway ventilation process, further improving clinical safety.

[0042] Preferably, the cuff 2 is made of silicone, TPE, or polyurethane. Specifically, silicone, TPE, and polyurethane are all medical-grade flexible polymer materials. When the cuff 2 is made of any of these materials, it is thin, soft, and has excellent elastic deformation capabilities. When the cuff 2 adheres to the pharyngeal mucosa, there are no hard protrusions or localized hard spots. It can fully extend along the irregular anatomical curves of the pharynx, adapting to the concave and convex gaps of the esophagus, piriform recess, etc., improving the airway sealing fit, stably filling anatomical dead spaces, and effectively blocking air leakage and the reflux of gastric contents. Alternatively, in addition to silicone, TPE, and polyurethane, the cuff 2 can also be made of medical latex, thermoplastic polyurethane elastomer (TPU), composite polymer film materials, or medical soft PVC toughened modified materials.

[0043] Preferably, the cuff 2 has a material gradient structure. Specifically, when the inflation system 4 detects insufficient sealing of the cuff 2, it will inflate for a short period of approximately 200-500 milliseconds. Simultaneously, utilizing the material gradient characteristics of the cuff 2, gas preferentially flows to and expands the thin, soft areas with low stiffness, effectively eliminating local leakage gaps. In particular, when any fit detection module 31 detects that the pressure exceeds a safety threshold (e.g., >60 cmH2O), the inflation system 4 will immediately deflate and issue an alarm signal. The material gradient structure of the cuff wall allows for a continuous and gradual transition in material hardness, elasticity, and thickness along different areas of the cuff 2. The cuff wall areas corresponding to the esophageal orifice and piriform recess have higher elasticity and thinner wall thickness, allowing for preferential expansion and deformation after inflation, quickly filling leaky gaps in the pharynx and rapidly constructing a sealed airway. The cuff wall areas corresponding to the pharyngeal lateral walls and paraglottic support areas have higher hardness and greater structural strength, providing stable support and preventing localized over-expansion that could cause mucosal high-pressure damage. The gradient structure eliminates abrupt changes in hardness, ensuring uniform stress on the cuff wall during inflation and eliminating the risk of stress concentration and breakage. This guarantees effective sealing at critical locations while evenly distributing contact pressure between the cuff 2 and the pharyngeal mucosa. Combined with the surface fit detection module 31, the data collected by the module more closely reflects the actual mucosal stress state, improving the accuracy of dynamic pressure adjustment in the inflation system 4 and balancing airway sealing with pharyngeal mucosal protection. Alternatively, in addition to the gradient material structure, the cuff 2 wall can also employ a zoned, independently thick, integrally molded structure; a multi-layered composite structure of soft and hard materials; a locally embedded elastic reinforcing rib structure; or an integrally molded multi-stage wall thickness segmented structure.

[0044] Preferably, the near port 12 is provided with a venting connector 6, and the main tube 1 also has a venting cavity 13, which is connected to the venting connector 6 to enable mechanical ventilation. Specifically, the ventilation connector 6 is centrally located near the port 12 of the main tube 1. The ventilation chamber 13 extends through the main tube 1 and is directly connected to the ventilation connector 6, ensuring a continuous and smooth structural pathway. The ventilator tubing can be quickly connected to the ventilation connector 6, and the high-pressure ventilation airflow can reach the patient's airway above the glottis without obstruction along the ventilation chamber 13, stably delivering the gas required for mechanical ventilation. The independently connected ventilation chamber 13 is separated from the visible and inflation tubing, ensuring that various tubing do not interfere with each other and do not encroach on the cross-sectional area of ​​the ventilation channel, effectively reducing ventilation airflow resistance and ensuring precise control of ventilation flow and tidal volume. The ventilation connector 6 is centrally exposed on the proximal end of the body, making it convenient to install and remove the ventilator tubing without having to penetrate deep into the patient's throat area, reducing the risk of catheter displacement and airway irritation, and adapting to various clinical ventilation scenarios such as intraoperative anesthesia ventilation and continuous mechanical ventilation for critically ill patients. As an alternative implementation, in addition to using the integrated ventilation connector 6 near the port 12 to cooperate with the through ventilation cavity 13 to achieve mechanical ventilation, a side-mounted bypass ventilation connector 6 structure, a pluggable split ventilation connector 6 structure, a multi-channel integrated composite ventilation connector 6 structure, and a ventilation connector 6 structure with a one-way anti-backflow valve can also be used.

[0045] Preferably, the main tube 1 also has an esophageal drainage cavity 14, which is used to drain gastric reflux. Specifically, this setup eliminates the need for medical staff to insert additional independent suction tubes or gastric drainage tubes. The dedicated drainage cavity allows for routine suctioning and cleaning of gastric reflux, airway sputum, and secretions, avoiding repeated insertion and removal of multiple instruments that could cause friction damage to the pharyngeal mucosa and airway irritation. The independent drainage cavity has a straight and unobstructed path, without bends or dead ends, reaching areas prone to fluid accumulation above the glottis and around the esophageal inlet. This allows for rapid and smooth drainage of reflux and secretions, reducing the serious clinical risks of secretion accumulation, airway obstruction caused by gastric contents reflux, and aspiration pneumonia. Meanwhile, the drainage cavity can be used in conjunction with the risk monitoring and early warning function of the visual system. When the potential for reflux or secretion accumulation is detected, negative pressure drainage can be activated in real time to achieve early detection and treatment of potential risks. This improves the clinical safety and stability of supraglottic airway ventilation throughout the process and is suitable for various clinical scenarios such as long-term mechanical ventilation, ventilation during general anesthesia surgery, and airway management for critically ill patients.

[0046] Preferably, multiple fit detection modules 31 are provided, and the multiple fit detection modules 31 and the processing module together constitute the sealing sensing system 3. Each fit detection module 31 is disposed on the surface of the cuff 2, and each fit detection module 31 is located in the central area of ​​the dorsal pouch, the corresponding area of ​​the ventral esophageal opening, the corresponding area of ​​the ventral left wing, the corresponding area of ​​the ventral right wing, and the corresponding area of ​​the tongue root of the cuff 2. The processing module in the sealing sensing system 3 can drive the inflation system 4 to dynamically adjust the inflation and deflation of the corresponding areas on the cuff 2 in real time based on the feedback signals of the fit detection modules 31 located in the central area of ​​the dorsal pouch, the corresponding area of ​​the ventral esophageal opening, the corresponding area of ​​the ventral left wing, the corresponding area of ​​the ventral right wing, and the corresponding area of ​​the tongue root. Specifically, the processing module built into the sealing sensing system 3 can analyze the feedback signals of the fit detection modules 31 in each area in real time, and then drive the inflation system 4 to dynamically adjust the inflation and deflation of each area of ​​the cuff 2, so that the surface of the cuff 2 better fits the patient's mucosa. The sealing sensing system 3 can be equipped with a dedicated control panel, allowing the user to manually control the inflation system 4 and set a specific threshold to control its operation (i.e., setting a critical value; if the built-in processing module detects that the fit detection module 31 signal in a certain area is below or above the set critical value, it drives the inflation system 4 to inflate or deflate the corresponding area; the processing module can drive the inflation system 4 by sending commands). The fit detection module 31 can be a flexible piezoresistive pressure sensing membrane, a flexible capacitive pressure sensing membrane, or a flexible piezoelectric pressure sensing film, etc. As a further embodiment, a dedicated connecting wire can be provided inside the main tube 1, and the connecting wire is equipped with a fit detection connector 3232.

[0047] Preferably, the inflation system 4 includes an inflation / deflation extension tube 41 and an inflation device. The inflation / deflation extension tube 41 is located inside the main tube 1 and connects to the sleeve 2. The inflation device is connected to the inflation / deflation extension tube 41, and the inflation device inflates or deflates the sleeve 2 through the deflation extension tube 41. This arrangement integrates the inflation / deflation extension tube 41 within the main tube 1, resulting in a neat overall pipeline without any external suspended lines. This effectively prevents the problems of bending, compression, tangling, and detachment associated with traditional external inflation tubes, ensuring a smooth and stable inflation / deflation path throughout the process. The built-in pipeline layout can adaptively shape itself synchronously with the main tube 1, preventing pipeline blockage and airflow obstruction due to tube bending or positional changes. This ensures that the air pressure signal output by the inflation device is transmitted to the inside of the sleeve 2 without delay or loss. Combined with the real-time pressure feedback from the fit detection module 31, this enables high-precision and rapid-response dynamic inflation / deflation adjustment. Meanwhile, the built-in tubing structure is smooth and simple, reducing the risk of abrasion and irritation to the airway mucosa during insertion, minimizing operational interference caused by exposed tubing, improving the convenience of insertion and the safety of clinical use, and ensuring that the sealing pressure of the cuff 2 is continuous, precise and controllable throughout the ventilation process. The inflation / deflation extension tube 41 can be made of medical flexible TPU ventilation tubing, medical silicone pressure-resistant tubing, thin-walled high-elasticity PEEK microcatheter, or bend-resistant braided reinforced medical tubing; the inflation device can be a miniature intelligent electric inflation pump, a micro-precision electrically controlled inflation / deflation integrated machine, a portable negative and positive pressure combined inflation device, or a miniature servo inflation component with pressure closed-loop feedback. It is understood that, as alternative implementation methods, in addition to adopting the structure of the main tube 1 with built-in inflation / deflation extension tube 41 and external inflation device, the following can also be adopted: integrated inflation / deflation structure with embedded micro-tube channel in the tube wall, dual-pipeline independent air intake and exhaust separation inflation / deflation structure, integrated inflation / deflation pipeline structure with one-way pressure regulating valve, and detachable external inflation / deflation conduit assembly structure.

[0048] Preferably, the inflation system 4 further includes an inflation / deflation connector 42 and an inflation indicator balloon 43. The inflation / deflation connector 42 is located on the end of the inflation / deflation extension tube 41 away from the cuff 2. The inflation / deflation connector 42 is used for detachable connection with the inflation device. The inflation indicator balloon 43 is located on the inflation / deflation extension tube 41 and is used to indicate whether the inflation device is in an inflated state. This configuration, with the detachable inflation / deflation connector 42 at the end, enables quick docking and disassembly of the inflation device and the internal inflation / deflation extension tube 41. This allows the inflation device to be repeatedly matched with different catheters, is easy to assemble and disassemble, and has strong adaptability. At the same time, it can be quickly connected for pressure adjustment after catheter placement and can be quickly disconnected after pressure adjustment, avoiding the inflation device occupying operating space and interfering with clinical ventilation operations. The added inflation indicator airbag 43 can visually reflect the inflation status and pressure changes inside the pipeline through its own expansion and contraction. Medical staff can visually determine whether the pipeline is in inflation, pressure holding, or deflation without relying on electronic control equipment. It can also assist in verifying the working status of the fit detection module 31 and the inflation device, and promptly detect faults such as pipeline blockage, leakage, and abnormal inflation / deflation response. The inflation indicator airbag 43 can be made of highly elastic transparent medical silicone, thin-walled TPU visual inflation airbag, or pressure-resistant high-resilience polyurethane indicator airbag. The inflation / deflation connector 42 can be made of medical Luer quick connector, self-locking anti-detachment connector, sealed screw-on connector, or anti-misinsertion one-way inflation connector. It is understood that, as alternative implementations, in addition to the above-mentioned combination structure of inflation / deflation connector 42 and external inflation indicator airbag 43, an embedded air pressure viewing window indicator structure, a self-locking quick-connect connector structure with open / closed status indication, an intelligent inflation / deflation connector 42 structure with integrated air pressure value display, and an electronic inflation status monitoring component structure with sound and light prompts can also be used.

[0049] Preferably, the visual system includes a camera 51, a camera cable 511, and a display. The camera 51 is located at the distal port 11, and its orientation is towards the cuff 2. The lens surface of the camera 51 is coated with an anti-fog coating and integrates an LED fill light 52. The display is electrically connected to the camera 51 via the camera cable 511, and the display is used to display the image data captured by the camera 51 in real time. This configuration, integrating the camera 51 into the distal port 11 of the main tube 1 and oriented towards the cuff 2, can accurately cover the sealed area of ​​the cuff 2, the pharyngeal anatomical area, and the periglottic field of view. It can completely capture key operational conditions such as tube placement alignment, cuff 2 fit status, changes in the airway environment, and regurgitation displacement, achieving visualized positioning and full-process risk monitoring during tube placement. The camera 51 features an anti-fog coating to prevent fogging and obstruction of the view caused by moisture, mist, and secretion vapor adhering to the airway, ensuring clear and stable images throughout the procedure. The integrated LED supplemental light 52 provides uniform illumination to the dark and enclosed airway, resolving issues of insufficient light leading to dim images and loss of detail, ensuring clear visibility of anatomical structures, secretions, and potential reflux hazards. Real-time image transmission to a monitor via the camera cable 511 enhances the accuracy of catheter placement and allows for real-time monitoring of safety risks such as catheter displacement, abnormal cuff sealing, gastric reflux, and airway secretion accumulation, facilitating timely intervention by medical staff and further improving the precision and clinical safety of supraglottic airway ventilation. The camera cable 511 can be fitted with a dedicated connector 512 for easy disassembly and replacement. The anti-fog coating of the camera 51 can be a nano-hydrophobic anti-fog coating, a medical hydrophilic anti-fog coating, or a wear-resistant, stain-resistant, and light-transmitting anti-fog coating; the LED fill light 52 can be a miniature patch-type cold light LED, a low-power shadowless fill light LED, or a high-brightness uniform diffused light LED; the camera 51 can be a miniature high-definition medical endoscope 51, a wide-angle miniature camera probe, a low-light low-light camera 51, or a high-stability MEMS miniature camera module; the camera wire 511 can be an ultra-fine flexible shielded camera wire bundle 511, a bend-resistant medical-grade fine and soft data cable, or an integrated embedded waterproof camera wire cable 511; the display can be a portable high-definition touch screen, a miniature wall-mounted medical monitor, a handheld portable visual display, or an embedded high-definition image display terminal.

[0050] It is understood that, as a preferred implementation, the camera 51 in the visual system can be a camera 51 with the function of automatically capturing multiple sets of images. The visual system has a corresponding processor that compares the multiple sets of images automatically captured by the camera 51 to determine whether the positions of the sleeve 2 and the main tube 1 have shifted. At the same time, the visual system also includes a corresponding alarm module. When the processor determines that the positions of the sleeve 2 and the main tube 1 have shifted, it will control the corresponding alarm module to generate an alarm signal to remind the operator. The processor can be a microcomputer, etc.; the alarm module can be a buzzer, alarm light, etc.

[0051] Preferably, the main tube 1 is further provided with a cleaning device for cleaning the lens surface of the camera 51. Specifically, the cleaning device includes a camera flushing tube 513 and a flushing tube connector 514. This configuration, by providing a dedicated camera flushing tube 513 and flushing tube connector 514 to the main tube 1, allows for targeted cleaning of the lens surface of the camera 51. This effectively removes contaminants such as airway secretions, sputum, reflux deposits, and residual moisture adhering to the lens surface, preventing contaminants from obstructing the lens's field of view and causing problems such as blurred images and loss of detail. Compared to passive anti-fog coating-based methods, the active cleaning structure enables dynamic lens cleaning during prolonged ventilation, solving the problems of visual monitoring failure and inaccurate risk identification caused by lens contamination after long-term intubation. It continuously ensures clear imaging and a complete field of view for the camera 51, making intubation alignment, cuff 2 status monitoring, and reflux and displacement risk identification accurate and reliable throughout the process. This maintains the continuous monitoring capability of the visual system and further enhances the stability and safety of the device during long-term clinical ventilation. The camera rinsing tube 513 can be a micro-tube (the liquid inside the tube can be physiological saline). It is understood that, as an alternative implementation, in addition to the structure of actively cleaning the camera 51 lens using the aforementioned dedicated cleaning device, a lens micro-pulse water spray self-cleaning structure, an airflow blowing lens cleaning structure, a vibration self-cleaning lens anti-fouling structure, and a detachable wipe-type lens cleaning auxiliary structure can also be used.

[0052] In the description of this specification, references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of those different embodiments or examples.

[0053] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "a plurality of" means two or more, unless otherwise explicitly specified.

[0054] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any person skilled in the art can easily conceive of various variations or substitutions within the technical scope disclosed in this application, and these should all be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A smart, shape-adjustable supraglottic airway duct ventilation device, characterized in that, include: A main tube (1) having a distal port (11) and a proximal port (12), the main tube (1) being adapted to be shaped according to the anatomical features of the patient's upper respiratory tract; The cuff (2) is located on the distal port (11). The cuff (2) is used to adapt to the anatomical structure of different patients' throats and fill the anatomical dead space. The surface of the cuff (2) is provided with a fit detection module (31). An inflation system (4) is used to dynamically adjust the inflation and deflation of the bladder (2) according to the signal from the fit detection module (31); A visual system is located inside the main tube (1) and is used to provide users with visual airway placement, anatomical identification, and risk monitoring such as reflux and tube displacement.

2. The intelligent, malleable supraglottic airway duct ventilation device according to claim 1, characterized in that, The sheath (2) is made of silicone, TPE or polyurethane.

3. The intelligent, malleable supraglottic airway duct ventilation device according to claim 2, characterized in that, The wall of the sheath (2) has a material gradient structure.

4. The intelligent, malleable supraglottic airway duct ventilation device according to claim 1, characterized in that, The near port (12) is provided with a ventilation connector (6), and the main tube (1) also has a ventilation cavity (13). The ventilation cavity (13) is connected to the ventilation connector (6) to enable mechanical ventilation.

5. The intelligent, malleable supraglottic airway duct ventilation device according to claim 1, characterized in that, The main tube (1) also has an esophageal drainage cavity (14) for draining gastric reflux.

6. The intelligent, malleable supraglottic airway duct ventilation device according to claim 1, characterized in that, The fit detection module (31) is provided in multiple ways. The multiple fit detection modules (31) and the processing module together constitute a sealing sensing system. Each fit detection module (31) is located on the surface of the sheath (2). Each fit detection module (31) is located in the middle area of ​​the back pouch, the area corresponding to the ventral esophageal opening, the area corresponding to the left ventral wing, the area corresponding to the right ventral wing, and the area corresponding to the tongue root of the sheath (2). The processing module in the sealing sensing system can drive the inflation system to dynamically adjust the inflation and deflation of the corresponding areas on the sheath (2) in real time according to the feedback signals of the fit detection modules (31) located in the middle area of ​​the back pouch, the area corresponding to the ventral esophageal opening, the area corresponding to the left ventral wing, the area corresponding to the right ventral wing, and the area corresponding to the tongue root.

7. The intelligent, malleable supraglottic airway duct ventilation device according to claim 1, characterized in that, The inflation system (4) includes an inflation / deflation extension tube (41) and an inflation device. The inflation / deflation extension tube (41) is located inside the main tube (1). The inflation / deflation extension tube (41) is connected to the bladder (2). The inflation device is connected to the inflation / deflation extension tube (41). The inflation device inflates or deflates the bladder (2) through the inflation / deflation extension tube (41).

8. The intelligent, malleable supraglottic airway duct ventilation device according to claim 7, characterized in that, The inflation system (4) further includes an inflation / deflation connector (42) and an inflation indicator airbag (43). The inflation / deflation connector (42) is located on the end of the inflation / deflation extension tube (41) away from the sleeve (2). The inflation / deflation connector (42) is used to detachably connect to the inflation device. The inflation indicator airbag (43) is located on the inflation / deflation extension tube (41) and is used to indicate whether the inflation device is in an inflated state.

9. The intelligent, malleable supraglottic airway duct ventilation device according to claim 1, characterized in that, The visual system includes a camera (51), a camera cable (511), and a display. The camera (51) is located at the remote port (11) and faces the sheath (2). The lens surface of the camera (51) is provided with an anti-fog coating and integrates an LED fill light (52). The display is electrically connected to the camera (51) through the camera cable (511) and is used to display the image data collected by the camera (51) in real time.

10. The intelligent, malleable supraglottic airway duct ventilation device according to claim 9, characterized in that, The main tube (1) is also provided with a cleaning device, which is used to clean the lens surface of the camera (51).

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