Ventilation control device for an airway management tool

Abstract

The application discloses a ventilation control device for an airway management tool, comprising a tube segment, a ventilation hole and an opening and closing mechanism, wherein the opening and closing mechanism comprises an elastic film and a third inflatable cuff, which are used for controlling the switching of the ventilation hole between the open and closed states; the tube segment extends from a proximal end to a distal end and forms a lumen inside; at least one ventilation hole is arranged on the tube segment, the ventilation hole penetrates the tube wall of the tube segment and communicates with the lumen of the tube segment; the lumen of the tube segment is provided with an elastic film, the elastic film is provided with at least one third opening which communicates with the lumen of the tracheal tube and is arranged in a staggered manner with the ventilation hole; the third inflatable cuff is located between the inner wall of the tracheal tube and the elastic film and is arranged in a staggered manner with the ventilation hole along the longitudinal axis of the tracheal tube; the third inflatable cuff can be switched between the inflated state and the contracted state.

Description

TECHNICAL FIELD

[0001] The present application relates to a lung isolation airway management tool in general anesthesia, which is suitable for various types of lung-related surgeries in all types of people except infants, including but not limited to traditional open chest surgery, thoracoscopic surgery, mediastinoscopy, integrated diagnosis and treatment of pulmonary nodules under the assistance of multi-technology composite fiber bronchoscopy, CT-guided pulmonary nodule interventional surgery, etc. Airway management and lung isolation during the process, realizing primary bronchial isolation (left / right main bronchial lung isolation) and secondary bronchial isolation (surgical lung lobe isolation and surgical area and non-surgical area isolation). BACKGROUND

[0002] With the rapid development of medical biotechnology, the 5-year survival rate of early lung cancer can reach more than 97%, especially lung carcinoma in situ and lung microinvasive carcinoma. Early lung cancer is mainly discovered and diagnosed in the form of pulmonary nodule in clinical practice. Pulmonary nodule is the earliest clinical manifestation of lung cancer. See Yang Wenjie, Yan Fu-hua. Interpretation of the 2022 American National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Lung Cancer Screening (2nd Edition). Theory and Practice of Diagnosis. 2023; 1: 14-20. Therefore, pulmonary nodule has very important clinical value for early diagnosis and early treatment of lung cancer. Early intervention of "suspected pulmonary nodule" is an important key factor to reduce the incidence and mortality of lung cancer, improve the asymptomatic survival rate of lung cancer patients, and effectively reduce the personal and social economic burden.

[0003] With the improvement and popularization of health awareness, health check-ups are being accepted by more and more people. Lung cancer is also increasingly being diagnosed early in the form of pulmonary nodules. In recent years, the rapid development and iteration of endoscopic diagnosis and treatment technology, interventional therapy technology, and imaging technology have had a fundamental impact on the minimally invasive integrated model of lung nodule diagnosis and treatment. For'suspicious nodules', first, through multi-technology composite fiberoptic bronchoscopy or CT-guided auxiliary precise positioning, puncture, and biopsy, according to the intraoperative rapid pathological results, the next treatment plan is determined. If the intraoperative pathological result is early lung cancer (lung carcinoma in situ or microinvasive carcinoma), then multi-technology composite fiberoptic bronchoscopy or percutaneous CT-guided ablation therapy (radiofrequency ablation and cryoablation therapy) is performed immediately. If the intraoperative pathological result is a more advanced malignant tumor than 'lung carcinoma in situ or microinvasive carcinoma', then thoracoscopic lung cancer radical surgery is performed immediately, thus achieving the histological diagnosis and clinical treatment of'suspicious pulmonary nodules' at the same time, and building a new model of minimally invasive integrated diagnosis and treatment of pulmonary nodules. See: Reisenauer J, Duke JD, Kern R, et al. Combining Shape-Sensing Robotic Bronchoscopy With Mobile Three-Dimensional Imaging to Verify Tool-in-Lesion and Overcome Divergence: A Pilot Study. Mayo Clin Proc Innov Qual Outcomes. 2022 Apr 23;6(3):177-185. Currently, the electromagnetic navigation technology composite fiberoptic bronchoscopy integrated diagnosis and treatment robot system and the second-generation shape-sensing technology composite fiberoptic bronchoscopy integrated diagnosis and treatment robot system have been approved for marketing by the US FDA and the China National Medical Products Administration, opening up a new era for the minimally invasive integrated diagnosis and treatment of pulmonary nodules, making endoscopic diagnosis and treatment faster and more accurate, less invasive, histological diagnosis and clinical treatment at the same time, lower medical costs, faster patient recovery, and clear clinical effects. See, Saghaie T, Williamson JP, Phillips M, et al. Electromagnetic Navigation-Assisted Lesion-Within-Tool Tomosynthesis Technology Combined with Fiberoptic Bronchoscopy Robotic System in Human Pulmonary Peripheral Lesions: FRONTIER Study. Respir Med. 2024;29:969-975.Fernandez-Bussy S, Yu Lee-Mateus A, Reisenauer J, et al. Comparison of shape-sensing robotic-assisted bronchoscopy system and CT-guided transthoracic biopsy in the diagnosis and treatment of solid pulmonary nodules. Respiration. 2024; 103:280-288.

Saghaie T, Williamson JP, Phillips M, et al. First-in-human use of a new robotic electromagnetic navigation bronchoscopic platform with integrated Tool-in-Lesion Tomosynthesis (TiLT) technology for peripheral pulmonary lesions: The FRONTIER study. Respirology. 2024; 29:969-975.

Fernandez-Bussy S, Yu Lee-Mateus A, Reisenauer J, et al. Shape-Sensing Robotic-Assisted Bronchoscopy versus Computed Tomography-Guided Transthoracic Biopsy for the Evaluation of Solids Pulmonary Nodules. Respiration. 2024; 103:280-288.

Hsia DW, Musani AI. Bronchoscopic Therapies for Peripheral Lung Malignancies. Clin Chest Med. 2018; 39:245-259.

[0004] In the minimally invasive integrated diagnosis and treatment mode of pulmonary nodules, whether it is a multi-technology composite bronchoscopic diagnosis and treatment integrated robot system or a CT-assisted interventional diagnosis and treatment operation or a thoracoscopic minimally invasive surgical technique, in order to ensure the safety of patients during the operation and prevent direct dissemination of tumors or infections, lung isolation is required during the operation. The traditional lung isolation technique refers to the technique of physically separating the ventilation pathways of the two sides of the lung at the level of the primary bronchus (left / right main bronchus level) with the aid of airway management tools. The modern lung isolation technique refers to the technique of physically isolating the surgical operation area and the non-surgical operation area at the level of the primary bronchus (left / right main bronchus level) or the level of the secondary bronchus (lobar bronchus) with the aid of airway management tools. Not only is the ventilation pathway physically separated, allowing the respiratory movement of the surgical operation area to remain static and coexist with the continuous mechanical ventilation of the non-surgical operation area for a long time; but also is the body fluid transportation physically isolated, blocking the flow between the tumor and infectious secretions and blood and the healthy lung tissue. The modern lung isolation technique includes left / right lung isolation, single lobe isolation, and main airway and lung isolation, etc.

[0005] At present, there are various airway management tools related to lung isolation techniques in clinical practice, but each of them has some shortcomings, which affects the clinical diagnosis and treatment operations of medical personnel to varying degrees and may increase the medical risks of patients during the perioperative period. The following lists the shortcomings of the existing lung isolation-related airway management tools in clinical practice:

[0006] 1. Lung-related surgery: The most commonly used airway management tools for lung-related surgery currently mainly include double-lumen endobronchial tubes and bronchial occluders. Double-lumen endobronchial tube intubation has certain technical difficulty; its tube diameter is relatively thick, and the catheter texture is relatively hard, which causes greater irritation to the vocal cords, throat soft tissues and airway during intubation, positioning and extubation, and may cause vocal cord injury, hoarseness, throat pain, and even airway mucosal dislocation injury in severe cases. Double-lumen endobronchial tubes are limited to left / right lung isolation and cannot achieve single lobe isolation, which cannot meet the needs of clinical scenarios that require single lobe isolation and the needs of special patients whose unilateral lung ventilation and oxygenation cannot be maintained normally. Due to the influence of its structure, the thinnest model of double-lumen endobronchial tube is 28F, which cannot be applied to children and some adolescent patients. Bronchial occluder has a thin lumen, which has problems such as slow or unable to occlude the side lung, secretions cannot be suctioned out, and the occluded side lung cannot be ventilated alone in clinical practice, and also cannot achieve single lobe isolation. The present application can be applied to all types of people except infants, including children and adolescents; it can achieve all the clinical functions of double-lumen endobronchial tubes and also achieve lung isolation at the level of the secondary bronchus (lobar bronchus). The present application is a single-lumen endobronchial tube, which is significantly thinner than a double-lumen endobronchial tube, effectively avoiding the occurrence of the above-mentioned adverse events of double-lumen endobronchial tubes.

[0007] 2. CT-guided percutaneous lung nodule localization, puncture, biopsy and ablation therapy: The most commonly used airway tool for CT-guided interventional procedures is the single-lumen endotracheal tube. The single-lumen endotracheal tube is placed in the main airway, while CT-guided interventional procedures are more located in the periphery of a single lung lobe. The single-lumen endotracheal tube cannot achieve physical isolation of the surgical operation area and the non-surgical operation area of the single lung lobe or the single lung. The disadvantages of physical isolation are as follows: on the one hand, the lung nodule is small in size, and interventional procedures require precise positioning of the lesion. When using a single-lumen endotracheal tube for double-lung ventilation, it is difficult to avoid the movement of the target lung tissue, increasing the difficulty of positioning, reducing the accuracy of ablation, and even causing accidental damage to healthy tissue. If the respiration is suspended during the operation to achieve accurate positioning, it is not conducive to the oxygenation of the body and the protection of lung function. On the other hand, traumatic procedures such as puncture and ablation may cause tissue fluid and blood to enter other bronchial tubes. In the absence of effective isolation between the surgical operation area and the non-surgical operation area, adverse consequences such as the spread of tumor / infectious tissue fluid and the entry of blood secretions into healthy lung tissue affecting gas exchange may occur. Once unplanned bleeding occurs, it can cause some lung tissue or both lungs to be "flooded", seriously endangering the safety of the patient's life. The present application can accurately isolate a single lung lobe under direct vision, and other healthy lung tissue can be normally ventilated. The two states can coexist for a long time, meeting the needs of CT-guided interventional procedures, and maximizing patient safety.

[0008] 3. Multi-technology composite fiber bronchoscope diagnosis and treatment integrated robot system for lung nodule localization, puncture, biopsy and ablation therapy: The outer diameter of the fiber bronchoscope with composite single or multiple auxiliary technologies is usually thick (about 7 mm in diameter), which cannot pass through the lumen of the double-lumen endotracheal tube. The most commonly used in clinical practice is the thickest tube diameter (8.0 #While single-lumen endotracheal tubes or laryngeal masks can meet the operational requirements, they cannot achieve isolation between the surgical and non-surgical areas. Fiberoptic bronchoscopy involves complex and diverse procedures, including operations within the main airway, at the carina level, and within the lungs. Numerous uncontrollable factors exist, including but not limited to: increased difficulty in localization due to bilateral lung movement, reduced ablation accuracy; the potential for tumor / infectious tissue fluid to enter other bronchi after puncture and ablation, potentially leading to dissemination; and the risk of unplanned massive hemorrhage resulting in a large amount of blood entering healthy lung tissue, causing gas exchange disorders, affecting oxygenation, and even endangering life. Isolation between the surgical and non-surgical areas would minimize these risks and significantly improve patient safety. Besides simple endoscopic diagnosis and treatment, electromagnetic navigation combined with fiberoptic bronchoscopy can also be used for preoperative localization in lung-related surgeries. Currently, airway management requires a single-lumen endotracheal tube or laryngeal mask airway, followed by fiberoptic bronchoscopy, and then switching to a double-lumen endotracheal tube for lung isolation and surgery. This repeated intubation and extubation not only prolongs the clinical procedure time but also increases mechanical stimulation to the patient's vocal cords, pharyngeal soft tissues, and airway. There is a clinical need to optimize this process. This invention allows for precise lobar isolation under direct visualization after the multi-technology combined fiberoptic bronchoscopy enters the target lung lobe. While ensuring that the multi-technology combined fiberoptic bronchoscopy diagnosis and treatment is not affected, it achieves physical isolation of the operated lung lobe from other lung tissues, avoiding the aforementioned adverse clinical events.

[0009] 4. Currently, different lung-related surgeries and procedures require the use of different airway management tools, each of which has its own shortcomings and may increase the patient's perioperative discomfort and risks. Medical staff need to spend a lot of energy and time in selecting, training and using these tools in clinical practice. At present, there is no single lung isolation airway management tool that can meet the needs of various lung surgical procedures.

[0010] These issues indicate that there is still significant room for improvement in airway management tools used in lung surgery and procedures. This patent application aims to describe a visual lung isolation airway management tool applicable to various lung-related surgical procedures. Its design addresses the shortcomings of existing airway management tools, matching lung isolation for all lung surgical procedures related to the aforementioned minimally invasive integrated diagnosis and treatment model for pulmonary nodules. Depending on the surgical requirements, it can simultaneously achieve left / right lung isolation and single-lobe isolation at the primary and secondary bronchial levels, simplifying clinical lung isolation procedures and providing medical personnel with a universal and easy-to-use option. Summary of the Invention

[0011] In view of the technical problems mentioned in the background art, the present invention provides a ventilation control device for airway management tools, aiming to at least partially solve at least one of the above-mentioned technical problems, achieve effective isolation between the surgical operation area and the non-surgical operation area in various lung-related surgical procedures under the minimally invasive integrated diagnosis and treatment mode for pulmonary nodules, provide optimal surgical conditions for various populations except infants and young children, including but not limited to traditional surgery, thoracoscopic surgery and various interventional diagnosis and treatment procedures, ensure the normal breathing and gas exchange function of non-surgical lung tissue, protect the patient's life safety, reduce iatrogenic damage to the vocal cords, pharyngeal soft tissues and airway, optimize the airway management process of various surgical procedures, indirectly shorten hospital stay, reduce medical costs and promote rapid patient recovery.

[0012] To solve the above-mentioned technical problems, the present invention provides the following technical solution:

[0013] The present invention relates to a ventilation control device for an airway management tool, specifically including a tube section, a vent, and an opening and closing mechanism, wherein the opening and closing mechanism includes an elastic membrane and a third inflatable bladder, which is used to control the vent to switch between open and closed states.

[0014] The pipe segment extends from the proximal end to the distal end and forms a cavity inside. At least one vent hole is provided on the pipe segment, and the vent hole penetrates the pipe wall and communicates with the cavity of the pipe segment.

[0015] An elastic membrane is provided in the lumen of the tube segment, and the elastic membrane has at least one third opening that communicates with the lumen of the tracheal tube. The third opening is offset from the ventilation hole.

[0016] The third inflatable cuff is located between the inner wall of the endotracheal tube and the elastic membrane, and is offset from the ventilation port along the longitudinal axis of the endotracheal tube. The third inflatable cuff can switch between an inflated state and a deflated state. In the inflated state, the third inflatable cuff blocks the lumen of the tube segment, and airflow can enter the ventilation port through the third opening on the elastic membrane. In the deflated state, the elastic membrane blocks the ventilation port, and airflow can flow through the third inflatable cuff and its surface elastic membrane to the distal end of the tube segment lumen.

[0017] In a further preferred embodiment, the elastic membrane is fixed to the pipe segment at least at its proximal and distal ends, wherein the distal end of the elastic membrane extends beyond the third inflatable bladder and is located at the distal end of the third inflatable bladder, and the proximal end of the elastic membrane extends beyond the vent and is located at the proximal end of the vent.

[0018] In a further preferred embodiment, the proximal and distal ends of the elastic film are fixed to the inner wall of the pipe section, or the proximal and distal ends of the elastic film are fixed to the end faces at both ends of the pipe section, or the proximal and distal ends of the elastic film are fixed to the outer wall of the pipe section.

[0019] In a further preferred embodiment, the elastic film and the pipe segment are bonded together with adhesive, and the bonding surface of the pipe segment at the bonding point is roughened; or the elastic film and the pipe segment are bonded together with heat fusion adhesive.

[0020] In a further preferred embodiment, the elastic film is designed to compress the third inflatable cuff to increase the cross-sectional area of ​​that section of the endotracheal tube when the third inflatable cuff is in a contracted state.

[0021] In a further preferred embodiment, the at least one ventilation hole protrudes from the inner wall of the endotracheal tube to form a ventilation tube, and the ventilation tube is fixedly installed by being inserted into a through hole formed on the wall of the endotracheal tube.

[0022] In a further preferred embodiment, along the longitudinal axis of the endotracheal tube from the proximal end to the distal end, the height of the plurality of ventilation tubes protruding from the inner wall of the lumen gradually increases, and the air inlet of at least one of the ventilation tubes forms an inclined angle along the longitudinal axis of the endotracheal tube from the proximal end to the distal end.

[0023] In a further preferred embodiment, when the third inflatable cuff is in a contracted state, its height protruding from the inner wall of the endotracheal tube is equal to or less than the height of the most distal ventilation tube.

[0024] In a further preferred embodiment, the vent is formed on a protrusion protruding from the inner wall of the pipe section.

[0025] In a further preferred embodiment, the protrusion forms a slope that rises from low to high along the longitudinal axis of the pipe segment from the proximal end to the distal end.

[0026] The beneficial effects of this invention are as follows: 1. Applicable to all population groups except infants and young children. 2. Applicable to lung isolation in all lung-related diagnostic and treatment procedures. 3. Refined airway management, achieving precise isolation between surgical and non-surgical areas. 4. Achieving lung isolation at the level of secondary bronchi (left / right main bronchus) in addition to primary bronchial isolation. 5. Providing conditions for lung surgery, especially for lung surgery on special patients. 6. Providing conditions for interventional, endoscopic, and thoracoscopic procedures related to the minimally invasive integrated diagnosis and treatment model for pulmonary nodules, maximizing patient safety. 7. Optimizing airway management procedures for complex surgical procedures. 8. Reducing intubation injury and improving patient satisfaction. Furthermore, this invention indirectly reduces medical costs and expenses, shortens hospital stays, improves patient comfort, and accelerates patient recovery. Attached Figure Description

[0027] Figure 1 This is a front view of an embodiment of the tip-controlled endotracheal cannula protected by the present invention;

[0028] Figure 2 This is a top view of an embodiment of the tip-controlled endotracheal cannula protected by this invention;

[0029] Figure 3 for Figure 2 Central section view along the GG line;

[0030] Figure 4 for Figure 1 A partial cross-sectional view along HH of the third inflatable bladder in its inflated state.

[0031] Figure 5 for Figure 4 Sectional view along the middle AA line;

[0032] Figure 6 for Figure 4 Sectional view along the middle BB line;

[0033] Figure 7 for Figure 1 Partial cross-sectional view along HH of the third inflatable bladder in its compressed state;

[0034] Figure 8 for Figure 7 CC section view;

[0035] Figure 9 for Figure 7 Sectional view along the middle DD line;

[0036] Figure 10 This is a partial cross-sectional view of the third inflatable bladder in the inflated state of an embodiment of the ventilation control device of the present invention.

[0037] Figure 11 This is a partial cross-sectional view of a third inflatable bladder in a compressed state according to an embodiment of the ventilation control device of the present invention.

[0038] Figure 12 A partial cross-sectional view of the third inflatable cuff in the inflated state of another embodiment of the tip-controlled endotracheal cannula protected by the present invention.

[0039] Figure 13 This is a partial cross-sectional view of the third inflatable cuff in the compressed state of another embodiment of the tip-controlled endotracheal cannula protected by the present invention.

[0040] In the diagram: 10-Bronchial cannula, 1-Tracheal tube, 11-Tube wall, 12-Lumen, 13-First opening, 14-Second opening, 15-Air vent, 151-Air tube, 152-Air inlet, 153-Through hole, 154-Protrusion, 16-Tube segment, 2-First inflatable cuff, 3-Second inflatable cuff, 4-Operating component, 41-Holding part, 42-Bending section, 5-Camera, 6-Opening and closing mechanism, 61-Elastic membrane, 611-Third opening, 62-Third inflatable cuff. Detailed Implementation

[0041] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0042] The features and exemplary embodiments of various aspects of the present invention will now be described in detail. To make the objectives, technical solutions, and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only configured to explain the present invention and are not configured to limit the present invention. For those skilled in the art, the present invention can be practiced without some of these specific details. The following description of the embodiments is merely intended to provide a better understanding of the present invention by illustrating examples of the invention.

[0043] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising..." does not exclude the presence of additional identical elements in the process, method, article, or apparatus that includes said element.

[0044] Early and appropriate intervention for pulmonary nodules is one of the effective means to reduce the incidence of lung cancer. The minimally invasive integrated diagnosis and treatment model for pulmonary nodules, as the optimal model for clinical intervention, is gradually becoming more widespread in clinical practice. Therefore, there is a clinical need for a safer, more comfortable, and more effective lung isolation airway management tool that is applicable to various related surgical procedures (including traditional open lung surgery, thoracoscopic lung surgery, CT-assisted percutaneous biopsy ablation, and multi-technique composite fiberoptic bronchoscopy) within the minimally invasive integrated diagnosis and treatment model for pulmonary nodules. Against this backdrop, this patent application aims to disclose a visual lung isolation airway management tool applicable to various lung-related surgical procedures for all population groups except infants and young children. Specifically, it is an endotracheal intubation device designed to address the shortcomings of existing products and provide medical personnel with a better option.

[0045] Example 1:

[0046] like Figures 1-9The diagram shows various views, partial views, and sectional views of a tip-controlled bronchial cannula protected by this invention patent. For ease of explanation and description, the end of the bronchial cannula that is operated by the physician is defined as the proximal or posterior end, or the operating end, while the end of the bronchial cannula that is inserted into the patient is defined as the distal or anterior end, or the tip. The terms proximal / posterior / operating end and distal / anterior / tip refer to relative positional relationships and are not limited to a specific fixed location.

[0047] The endotracheal cannula 10 protected by this invention patent includes at least an endotracheal tube 1 and a first inflatable cuff 2 and a second inflatable cuff 3 arranged at intervals along the longitudinal axis of the wall 11 of the endotracheal tube 1. A camera 5 is provided inside the wall 11 of the endotracheal tube 1 between the first inflatable cuff 2 and the second inflatable cuff 3. The camera 5 is used to capture images of its front end.

[0048] The endotracheal tube preferably has a certain degree of flexibility to facilitate bending. To better suit the internal tracheal and bronchial tissues of the human body, the endotracheal tube 1 is further preferably made of TPU or PVC material. Even more preferably, the outer surface of the wall 11 of the endotracheal tube 1 is coated with a hydrophilic coating to reduce friction between the endotracheal tube 1 and the tracheal wall tissue, thereby increasing the lubrication and passage of the endotracheal tube 1.

[0049] The endotracheal tube 1 extends from its proximal end to its distal end, forming a lumen 12 within it. The distal end of the endotracheal tube 1 has a first opening 13, and the proximal end has a second opening 14. A first inflatable cuff 2 is positioned near the first opening 13. An operating component 4 or a ventilator (not shown) can be inserted proximally into the second opening 14. The operating component 4 includes a grip 41 and a curved section 42 connected to the grip. When the curved section 42 of the operating component 4 is inserted into the lumen 12 through the second opening 14 of the endotracheal tube 1, the lumen 12 of the endotracheal tube 1 is configured as a channel for the curved section 42. The distal end of the curved section 42 is located at the distal end of the endotracheal tube 1, for example, near the first opening 13. The physician can adjust the angle of the curved section 42 by manipulating the grip 41, thereby adjusting the bending angle of the distal end of the endotracheal tube 1 to accommodate the angle of the patient's tracheal or bronchial opening. When the second opening 14 of the endotracheal tube 1 is connected to the ventilator, the lumen 12 of the endotracheal tube 1 is configured as a channel for mechanical ventilation of the patient. The gas generated by the ventilator can be delivered through the lumen 12 into the main bronchus or lobar bronchus of the corresponding side of the patient's body that is connected to the lumen 12. For details on which side of the lung or which lobe of the lung is provided with gas, please refer to the description below.

[0050] The first inflatable cuff 2 and the second inflatable cuff 3 are both connected to a first inflation lumen and a second inflation lumen arranged longitudinally within the tube wall 11, respectively. The proximal ends of the first inflation lumen and the second inflation lumen are connected to a first inflation hose and a second inflation hose, respectively. The doctor can switch the first inflatable cuff 2 and the second inflatable cuff 3 between an inflated state and a compressed state by inflating or deflating / aspirating the first inflation hose and the second inflation hose at the proximal end. Preferably, the first inflatable cuff 2 is a conical cuff, which is more suitable for the opening of the bronchus in the lung lobe.

[0051] Furthermore, at least one ventilation hole 15 is provided on the endotracheal tube 1 between the first inflatable cuff 2 and the second inflatable cuff 3. The ventilation hole 15 penetrates the tube wall 11 and communicates with the lumen 12 of the endotracheal tube 1. Preferably, there are 3-5 ventilation holes. More preferably, the ventilation holes 15 are arranged along the longitudinal axis of the endotracheal tube 1 and are equally spaced between adjacent ventilation holes 15.

[0052] Preferably, a camera 5 is disposed at the distal end of the ventilation port 15, and the camera 5 is embedded in the cavity of the tube wall 11 of the endotracheal tube 1, and the camera 5 can capture images of its front end. Preferably, the camera 5 and the ventilation port 15 are placed on the same side, and the ventilation ports 15 are equidistantly distributed upward along the same axis from the proximal end of the camera 5.

[0053] To enable the ventilation hole 15 to connect or disconnect from the lumen 12 inside the tracheal tube 1, this invention also provides an opening and closing mechanism 6. The opening and closing mechanism 6 includes an elastic membrane 61 disposed in the lumen 12 of the tracheal tube 1 and a control component for controlling the elastic membrane 61 to close or open the ventilation hole 15.

[0054] Specifically, the elastic membrane 61 extends along the longitudinal axis of the endotracheal tube 1, and both the proximal and distal ends of the elastic membrane 61 are fixed to the inner wall of the endotracheal tube 1. Preferably, at least the distal and proximal ends of the elastic membrane 61 are bonded to the inner wall of the endotracheal tube 1 using adhesive. More preferably, the bonding area between the elastic membrane 61 and the inner wall of the endotracheal tube 1 is roughened to form a rough surface, making the elastic membrane 61 more firmly fixed to the inner wall of the endotracheal tube 1 and preventing the elastic membrane 61 from falling off the inner wall. Even more preferably, the distal and proximal ends of the elastic membrane 61 can also be bonded to the inner wall of the endotracheal tube 1 using a heat-melting method.

[0055] The elastic membrane 61 has at least one third opening 611 communicating with the lumen 12 of the endotracheal tube 1, and the third opening 611 is offset from the vent 15. Preferably, along the longitudinal axis of the endotracheal tube 1, the third opening 611 is provided on one or both sides of the vent 15.

[0056] Furthermore, the control unit can control the elastic membrane 61 to switch between closing and opening the ventilation port 15, so as to control whether the gas delivered by the ventilator into the lumen 12 of the endotracheal tube 1 is delivered to the bronchus or lung lobe on the corresponding side of the patient through the ventilation port 15, forming a breathing channel for the patient. When the control unit controls the elastic membrane 61 to connect the ventilation port 15 with the lumen 12 of the endotracheal tube 1, gas can be delivered to the bronchus and lung on the side connected to the ventilation port 15 through the lumen 12, the third opening 611, and the ventilation port 15, forming a breathing channel for the patient; otherwise, gas is not delivered to the patient through the ventilation port 15.

[0057] Further preferably, the control component is a third inflatable cuff 62, which is located between the inner wall of the endotracheal tube 1 and the elastic membrane 61, and is offset from the ventilation hole 15 along the longitudinal axis of the endotracheal tube 1. Preferably, the third inflatable cuff 62 is located at the distal end of the ventilation hole 15 and is fixed to the inner wall of the lumen 12 of the endotracheal tube 1. The third inflatable cuff 62 communicates with the inflation lumen in the tube wall 11, and the inflation lumen is connected to the proximal inflation hose. By inflating or deflating / evacuating the inflation hose, the third inflatable cuff 62 is switched between an inflated state and a compressed state.

[0058] When the third inflatable cuff 62 is compressed, the elastic membrane 61 contracts due to its elasticity, thereby blocking the ventilation port 15. When the endotracheal tube 1 is mechanically ventilated, the pressure generated by the gas in the ventilation lumen 12 on the inner wall of the endotracheal tube can further aggravate the blockage of the ventilation port 15. At this time, the gas delivered by the ventilator into the lumen 12 of the endotracheal tube 1 is delivered from the proximal end of the endotracheal tube 1 and flows through the third inflatable cuff 62 and its surface elastic membrane 61 to the distal end of the endotracheal tube 1 to the first opening 13 at the distal end, and then to the bronchus and lungs connected to the first opening 13, so as to form a breathing channel for the patient. When the third inflatable cuff 62 is inflated, the distal ends of the third inflatable cuff 62 and the elastic membrane 61 are in close contact with the inner wall of the endotracheal tube 1, blocking the lumen 12 of the endotracheal tube 1 and preventing the ventilator from continuing to deliver gas to the distal end of the lumen 12. At the same time, the third inflatable cuff 62 pushes against the elastic membrane 61. The proximal end of the elastic membrane 61 is fixed to the inner wall of one side of the lumen 12. Due to the pushing of the distal end of the elastic membrane 61 by the inflated third inflatable cuff 62, the elastic membrane 61 also moves from the distal end to the proximal end towards the opposite end. The opposite wall of the tube pushes against the elastic membrane 61, causing the elastic membrane 61 to obliquely span the lumen 12. The elastic membrane 61 is released from the blockage of the ventilation port 15 and passes through the third opening 611 on the elastic membrane 61, thereby connecting the ventilation port 15 with the lumen 12 of the endotracheal tube 1. The gas input by the ventilator is delivered along the proximal end of the lumen 12 of the endotracheal tube 1, and then passes through the third opening 611 of the elastic membrane 61 that connects with the lumen 12 of the endotracheal tube 1 to enter the ventilation port 15. This allows the gas to be delivered to the bronchi and lungs connected to the ventilation port 15, thus forming a breathing channel for the patient.

[0059] Preferably, the elastic membrane 61 is designed to press the third inflatable cuff 62 against the tube wall when the third inflatable cuff 62 is in a compressed state, thereby increasing the cross-sectional area of ​​the lumen 12 of the endotracheal tube 1 in that section. More preferably, the elastic membrane 61 is a latex membrane.

[0060] Since the third inflatable cuff 62 has a certain thickness even when compressed, in order to facilitate the sealing of the vent hole 15 by the elastic membrane 61, at least one of the above-mentioned vent holes 15 protrudes from the inner wall of the tracheal tube 1 at a certain height to form a vent tube 151.

[0061] More preferably, when the third inflatable cuff 62 is in a contracted state, the height of its protrusion from the inner wall of the endotracheal tube 1 is equal to or less than the height of the distal airway 151 adjacent to the third inflatable cuff 62.

[0062] Further preferably, since the third inflatable cuff 62 still has a certain height when it is in the contracted state, in order to facilitate the sealing of each air tube 151 by the elastic membrane 61, the height of the multiple air tubes 151 protruding from the inner wall of the lumen gradually increases from the proximal end to the distal end along the longitudinal axis of the tracheal tube 1, forming a certain sequential height difference. The height of the air tube 151 closest to the third inflatable cuff 62 is greater than or equal to the thickness of the third inflatable cuff in the contracted state.

[0063] More preferably, the air inlet 152 of at least one ventilator 151 is inclined from the proximal end to the distal end along the longitudinal axis of the tracheal tube 1. In this way, even if multiple ventilators 151 gradually increase in height from the proximal end to the distal end, the elastic membrane 61 forms an inclined surface as a whole when sealing the air inlets 152 of multiple ventilators 151, so that the elastic membrane 61 can more effectively seal the air inlets 152 of each ventilator 151. The pressure on the inner wall generated by mechanical ventilation in the tracheal tube 1 further presses the elastic membrane 61 against the ventilator, avoiding the problem of air leakage due to incomplete sealing.

[0064] The ventilation tube 151 is fixed by being inserted through a through hole 153 formed in the tube wall 11. Specifically, multiple through holes 153 are first formed at corresponding positions in the tube wall 11. The through holes 153 can be formed by perforation or pre-reserved during the molding of the endotracheal tube. Preferably, the multiple through holes 153 are of the same size. Then, the ventilation tube 151 is inserted into the through hole 153. Preferably, one end of the ventilation tube 151 inserted into the through hole 153 is flush with the outer wall of the endotracheal tube 1, and the ventilation tube 151 protrudes from the inner wall of the lumen 12 of the endotracheal tube 1. More preferably, the ventilation tube 151 is fixed in the through hole 153 by adhesive. Along the longitudinal axis of the endotracheal tube 1 from the proximal end to the distal end, the height of the multiple ventilation tubes 151 protruding from the inner wall of the lumen gradually increases, forming a certain sequential height difference. The height of the ventilation tube 151 closest to the third inflatable cuff 62 is greater than or equal to the thickness of the third inflatable cuff in the contracted state.

[0065] Example 2:

[0066] like Figures 10-11 As shown, this invention patent also relates to a ventilation control device for airway management tools, which includes a tube section 16, a ventilation port 15, and an opening and closing mechanism 6, which is equivalent to the previous embodiment one (as shown in the image). Figures 1-9 The portion between the first inflatable cuff 2 and the second inflatable cuff 3 of the bronchial cannula (as shown) is a ventilation control device that is an independent component. It can be assembled into the bronchial cannula described in Embodiment 1 or into other airway management tools to control ventilation. This application of the present invention does not limit the scope of the device.

[0067] The tube segment 16 forms a cavity 12 inside, and at least one vent hole 15 is provided on the tube wall 11 of the tube segment 16. The vent hole 15 penetrates the tube wall 11 of the tube segment 16 and communicates with the cavity 12. Preferably, there are 3-5 vent holes 15. More preferably, the vent holes 15 are arranged along the longitudinal axis of the tube segment 16 and the adjacent vent holes 15 are equally spaced. Even more preferably, the vent holes 15 are distributed equidistantly along the same axis at the proximal end of the camera, which facilitates the intraoperative adjustment of the specific position and direction of the vent holes.

[0068] In order to enable the vent 15 to be connected or disconnected from the cavity 12 inside the pipe section 16, the present invention also provides an opening and closing mechanism 6, which includes an elastic membrane 61 disposed in the cavity 12 inside the pipe section 16 and a control component for controlling the elastic membrane 61 to close or open the vent 15.

[0069] Specifically, the elastic film 61 extends along the longitudinal axis of the pipe segment 16, and both the proximal and distal ends of the elastic film 61 are fixed to the inner wall of the pipe segment 16. Preferably, at least the distal and proximal ends of the elastic film 61 are bonded to the inner wall of the pipe segment 16 using adhesive. Preferably, the distal and proximal ends of the elastic film 61 can also be bonded to the inner wall of the pipe segment 16 by heat fusion.

[0070] Because the internal space of the cavity 12 of pipe segment 16 is narrow, it is not conducive to the bonding and fixing of the elastic film 61. Furthermore, the inner wall of pipe segment 16 is relatively smooth, which may lead to weak adhesion of the elastic film 61. In a preferred embodiment, the proximal and distal ends of the elastic film 61 extend from the cavity 12 of pipe segment 16 to both ends of pipe segment 16 and are fixed to the end faces of both ends of pipe segment 16. More preferably, the elastic film 61 extends further from both ends of pipe segment 16 to the outer wall of pipe segment 16, and the proximal and distal ends of the elastic film are bonded to the outer wall of pipe segment 16 using adhesive. Even more preferably, the proximal and distal ends of the elastic film are bonded to the outer wall of pipe segment 16 using a heat-melting method.

[0071] More preferably, the pipe wall 11 at the distal and proximal ends of the pipe segment 16 has a stepped structure, so that the proximal and distal ends of the pipe segment 16 can be inserted and fixed to the conduit connected to it. In this embodiment, the elastic film 61 can be further pressed against the end face of the pipe segment 16 or the outer or inner wall of the pipe segment 16 when the pipe segment 16 is inserted and fixed to the distal and proximal conduits.

[0072] Preferably, the adhesive bonding area between the elastic film 61 and the pipe segment 16 is roughened to ensure that the elastic film 61 is firmly fixed to the pipe segment 16 and to prevent the elastic film 61 from falling off the pipe segment 16.

[0073] The elastic membrane 61 has at least one third opening 611 communicating with the lumen 12 of the pipe segment 16, and the third opening 611 is offset from the vent hole 15. Preferably, along the longitudinal axis of the pipe segment 16, the third opening 611 is provided on one or both sides of the vent hole 15.

[0074] Furthermore, the control unit can control the elastic membrane 61 to switch between closing and opening the ventilation port 15, so as to control whether the gas delivered in the lumen 12 of the ventilator into the patient's corresponding bronchus or lung lobe through the ventilation port 15, thus forming a breathing channel for the patient. When the control unit controls the elastic membrane 61 to connect the ventilation port 15 with the lumen 12 of the lumen 16, gas can be delivered through the lumen 12, the third opening 611, and the ventilation port 15 to the bronchus or lung lobe on the side connected to the ventilation port 15, thus forming a breathing channel for the patient; otherwise, oxygen will not be delivered to the patient through the ventilation port 15.

[0075] Further preferably, the control component is a third inflatable bladder 62, which is located between the inner wall of the pipe segment 16 and the elastic membrane 61, and is offset from the vent hole 15 along the longitudinal axis of the pipe segment 16. Preferably, the third inflatable bladder 62 is located at the distal end of the vent hole 15 and is fixed to the inner wall of the cavity 12 of the pipe segment 16. The third inflatable bladder 62 communicates with the inflation cavity in the pipe wall 11 of the pipe segment 16. By inflating or deflating / evacuating the inflation cavity, the third inflatable bladder 62 can be switched between an inflated state and a compressed state. The inflation cavity can be connected to the inflation cavity in the proximal pipe wall and the inflation hose.

[0076] When the third inflatable cuff 62 is compressed, the elastic membrane 61 contracts due to its elasticity, thereby blocking the ventilation port 15. When the endotracheal tube 1 is mechanically ventilated, the pressure generated by the gas in the ventilation lumen 12 on the inner wall of the endotracheal tube can further aggravate the blockage of the ventilation port 15. At this time, the gas delivered into the lumen 12 of the tube segment 16 flows through the third inflatable cuff 62 and its surface elastic membrane 61 to the bronchus or lung lobe connected to the distal end of the lumen 12 of the tube segment 16, so as to form a breathing channel for the patient. When the third inflatable bladder 62 is inflated, it is in close contact with the inner wall of the pipe section 16, sealing the lumen 12 of the pipe section 16 and preventing the input gas from continuing to be delivered to the distal end of the lumen 12. At the same time, the third inflatable bladder 62 pushes against the elastic membrane 61. The proximal end of the elastic membrane 61 is fixed to the inner wall of one side of the lumen 12. Due to the pushing of the distal end of the elastic membrane 61 by the inflated third inflatable bladder 62, the elastic membrane 61 also moves from the distal end to the proximal end towards the opposite side of the pipe wall. Pushing the ventilator causes the elastic membrane 61 to be obliquely spanned in the lumen 12, releasing the ventilator 61 from the blockage of the ventilation port 15. The ventilation port 15 is then connected to the lumen 12 of the tube segment 16 through the third opening 611 on the elastic membrane 61. The incoming gas is transported along the proximal end of the lumen 12 of the tube segment 16, and then passes through the third opening 611 of the elastic membrane 61 that connects to the lumen 12 of the tube segment 16 and enters the ventilation port 15. This allows the gas to be delivered to the bronchus or lung lobe connected to the ventilation port 15, thus forming a breathing channel for the patient.

[0077] As an optional embodiment, when the first inflatable cuff 2 is in a contracted state and the second inflatable cuff 3 is in an inflated state, regardless of whether the third inflatable cuff 62 is in a contracted or inflated state, the airflow passes through the first opening 13 or the ventilation hole 15, through the gap between the bronchial wall and the tracheal tube, and reaches the contralateral lung or other lobes of the bronchus, thereby forming bilateral lung ventilation.

[0078] Preferably, the elastic membrane 61 is designed to press the third inflatable cuff 62 against the tube wall when the third inflatable cuff 62 is in a compressed state, thereby increasing the cross-sectional area of ​​the lumen 12 of the endotracheal tube 1 in that section. More preferably, the elastic membrane 61 is a latex membrane.

[0079] Since the third inflatable cuff 62 has a certain thickness even when compressed, in order to facilitate the sealing of the vent hole 15 by the elastic membrane 61, at least one of the above-mentioned vent holes 15 protrudes from the inner wall of the tracheal tube 1 at a certain height to form a vent tube 151.

[0080] More preferably, when the third inflatable cuff 62 is in a contracted state, the height of its protrusion from the inner wall of the endotracheal tube 1 is equal to or less than the height of the distal airway 151 adjacent to the third inflatable cuff 62.

[0081] Further preferably, since the third inflatable cuff 62 still has a certain height when it is in the contracted state, in order to facilitate the elastic membrane 61 to seal each ventilator 151, the height of the multiple ventilators 151 protruding from the inner wall of the lumen gradually increases from the proximal end to the distal end along the longitudinal axis of the tube segment 16, forming a certain sequential height difference, and the height of the ventilator closest to the third inflatable cuff is greater than or equal to the thickness of the third inflatable cuff in the contracted state.

[0082] More preferably, the air inlet 152 of at least one ventilator 151 is inclined from the proximal end to the distal end along the longitudinal axis of the pipe segment 16. In this way, even if multiple ventilators 151 gradually increase in height from the proximal end to the distal end, the elastic membrane 61 forms an inclined surface as a whole when sealing the air inlets 152 of multiple ventilators 151, so that the elastic membrane 61 can seal the air inlets 152 of each ventilator 151. The pressure on the inner wall generated by mechanical ventilation in the tracheal tube 1 further presses the elastic membrane 61 against the ventilator, avoiding the problem of air leakage due to incomplete sealing.

[0083] The ventilation tube 151 is fixed by being inserted into a through hole 153 formed in the wall 11 of the tube segment 16. Specifically, firstly, multiple through holes 153 are formed at corresponding positions in the wall 11 of the tube segment 16. The through holes 153 can be formed by perforation or pre-reserved during the molding of the endotracheal tube. Preferably, the through holes 153 are of the same size. Then, the ventilation tube 151 is inserted into the through hole 153. Preferably, one end of the ventilation tube 151 inserted into the through hole 153 is flush with the outer wall of the tube segment 16, and the ventilation tube 151 in the lumen 12 of the tube segment 16 protrudes from the inner wall. More preferably, the ventilation tube 151 is fixed in the through hole 153 by adhesive. Along the longitudinal axis of the endotracheal tube 1 from the proximal end to the distal end, the height of the multiple ventilation tubes 151 protruding from the inner wall of the lumen gradually increases, forming a certain sequential height difference, and the height of the ventilation tube 151 closest to the third inflatable cuff 62 is greater than or equal to the thickness of the third inflatable cuff 62 in the contracted state.

[0084] Example 3

[0085] like Figures 12-13As shown, this third embodiment further improves the structure of the ventilation holes 15 based on the first and second embodiments described above. Multiple ventilation holes 15 are formed on protrusions 154 that face the inner wall of the endotracheal tube 1 / segment 16 and protrude a certain height from the inner wall. Preferably, the height of the protrusions 154 is equal to or greater than the height of the third inflatable cuff 62 when it is in the contracted state. More preferably, the protrusions 154 form a slope from low to high along the longitudinal axis of the endotracheal tube 1 / segment 16 from the proximal end to the distal end. This way, when the elastic membrane 61 seals the multiple ventilation holes 15, it forms an inclined surface from the proximal end to the distal end, allowing the elastic membrane 61 to effectively seal each ventilation hole 15 and avoid leakage due to incomplete sealing. Furthermore, the pressure on the inner wall generated by mechanical ventilation within the endotracheal tube 1 further presses the elastic membrane 61 against the ventilation tube.

[0086] More preferably, a through groove is first formed at the corresponding position of the ventilation hole of the endotracheal tube 1 / segment 16. Preferably, the through groove is rectangular, the protrusion 154 is formed separately, and its shape and size match the through groove. Multiple ventilation holes 15 are formed on the protrusion 154. Then, the protrusion 154 is fixed in the through groove. The outer surface of the protrusion 154 is flush with the outer wall of the endotracheal tube 1 / segment 16. Preferably, the protrusion 154 is fixed by adhesive.

[0087] The tip-controlled endotracheal cannula and ventilation control device for airway management tools described in the above embodiments of this invention patent can achieve at least the following objectives:

[0088] 1. Achieve lung isolation to meet the needs of traditional lung-related surgeries.

[0089] In airway management during lung-related surgeries, it is necessary to ensure both patient safety during artificial ventilation and normal oxygenation (i.e., normal artificial ventilation at non-surgical sites), while simultaneously creating space and conditions for the surgeon's operations. This requires the lung tissue at the surgical site to collapse and remain quiescent, allowing the two different ventilation states at the surgical and non-surgical sites to coexist for an extended period. At the same time, the flow of body fluids between the surgical and non-surgical sites should be physically blocked. Traditional airway management tools can physically separate the ventilation pathways of the two lungs at the level of the tracheal carina or the left / right main bronchi, achieving lung isolation. Double-lumen endotracheal tubes and bronchial occluders come in various models and types, requiring selection based on the clinical scenario. Intubation presents certain technical challenges and is prone to difficulties and misalignment.

[0090] The endotracheal tube designed in this invention has only one ventilation lumen, resulting in a relatively small overall tube diameter and reducing the likelihood of intubation difficulties. The tube can be used alone or in conjunction with a laryngeal mask airway. Its function is suitable for routine lung isolation and does not differentiate between left and right tubes. Visualization technology simplifies and facilitates the intubation and tube alignment procedures. During routine lung isolation (physical isolation of the affected and healthy lungs), the left and right lungs can be isolated at the level of the tracheal carina. During surgery, the healthy lung is mechanically ventilated to ensure gas exchange, while the affected lung can remain static for an extended period without respiration, eliminating the impact of respiratory movement on the operation of the lesion site and providing optimal surgical conditions. Furthermore, ventilation of the left and right lungs can be freely switched as needed.

[0091] 2. To achieve lobar isolation and provide conditions for lung surgery for special patients.

[0092] Traditional lung isolation techniques can only achieve one-lung ventilation. However, during one-lung ventilation, approximately 50% of the contralateral lung tissue remains unventilated. Due to lung hypoxia and repeated collapse and re-expansion, the unventilated lung is prone to lung injury. For patients with pre-existing lung function impairment, traditional lung isolation techniques may be unable to tolerate one-lung ventilation, leading to hypoxemia and hypoxia. With the increasing prevalence of health checkups, the number of lung nodule-related surgeries has increased dramatically. Lung nodule-related surgeries often target only a single lobe. If single-lobe isolation could be achieved—that is, physical isolation of the diseased lobe from the healthy lobe—it would significantly increase the ventilated lung area, reduce the unventilated lung area, reduce lung injury, protect lung function, ensure oxygenation, and increase lung isolation tolerance in special populations. However, existing airway management tools, due to limitations in length, diameter, and maneuverability, cannot achieve single-lobe isolation or ventilation.

[0093] This invention features a slender catheter with good mobility. The catheter tip can be freely manipulated using the catheter operation component 4, allowing for single-lobe isolation at the bronchial level. The distal end of the catheter has a cone-shaped inflatable cuff design, which is better suited for the bronchial opening. Real-time visualization via a camera at the distal end ensures proper alignment of the catheter with the bronchial opening throughout the procedure. When performing single-lobe isolation (i.e., physical isolation between the surgical and non-surgical areas), the affected lobe can be isolated at the bronchial opening level, allowing only the affected lobe to collapse and remain static during surgery, while other healthy / non-surgical lobes can undergo normal artificial ventilation and gas exchange. This reduces the non-ventilated lung area, maximizing oxygenation, minimizing lung injury, and protecting lung function. Currently, there are increasingly more elderly patients, patients with chronic lung diseases and poor lung function, and patients who have previously undergone contralateral lung surgery and whose contralateral lung gas exchange area is impaired. These patients are unable to tolerate one-lung ventilation and may experience hypoxia and various serious complications caused by hypoxia during one-lung ventilation, which may even endanger their lives. The single-lobe isolation technique increases the ventilation area of ​​the lungs during surgery and reduces the area of ​​the non-ventilated lung lobes, creating surgical conditions and providing safety guarantees for lung surgery in special patients.

[0094] 3. To provide conditions for percutaneous CT-guided interventional diagnostic and therapeutic procedures and improve the safety of airway management.

[0095] Percutaneous CT-guided interventional procedures use real-time CT images to locate lesions in the lungs, followed by percutaneous biopsy and ablation. During these procedures, the target lung nodule moves due to respiratory motion, increasing the difficulty of localization, reducing the accuracy of ablation, and even causing collateral damage to surrounding healthy tissues. Currently, single-lumen endotracheal tubes are commonly used in clinical practice for bilateral lung ventilation, which cannot keep the target lung nodule stationary for extended periods. If breathing is paused during the procedure for accurate localization, it is detrimental to oxygenation and lung function protection. Furthermore, when using a single-lumen endotracheal tube, the two lungs communicate through the main airway and bronchi, making it difficult to prevent tumor / infectious tissue fluid or blood from entering healthy lung tissue.

[0096] This invention utilizes a tubular operating component 4 to freely control the direction of the catheter tip, allowing for single-lobe isolation at the bronchial level. The distal end of the catheter features a cone-shaped inflatable cuff, better suited for the bronchial opening. Real-time visualization via a camera at the distal end ensures proper alignment of the catheter with the bronchial opening throughout the procedure, achieving physical isolation between the surgical and non-surgical areas at the secondary bronchial level. The target lobe is isolated via the bronchial duct and remains stationary during the intervention, improving the accuracy of pulmonary nodule ablation and reducing collateral thermal or cold damage to surrounding normal tissues caused by respiratory movements. Isolation of the target lobe also prevents communication between its blood and secretions and healthy lobes. In the event of unplanned massive bleeding during treatment, the bleeding can be confined to a single lobe, ensuring the patient's safety.

[0097] 4. To provide operating conditions for the multi-technology composite fiber optic bronchoscopy integrated diagnostic and therapeutic robotic system and improve the safety of airway management.

[0098] The multi-technology composite fiber optic bronchoscopy integrated robotic system examines and treats "suspicious pulmonary nodules" through the body's natural cavities, offering advantages such as minimal invasiveness, rapid recovery, and high patient comfort. However, this new technology also presents new challenges for intraoperative airway management. Firstly, both the multi-technology composite fiber optic bronchoscopy and airway management tools operate through the trachea. The multi-technology composite fiber optic bronchoscopy, due to its complex structure and large outer diameter (up to 7mm), requires 1-2mm of space during clinical operation, making it difficult to coexist with traditional airway management tools within the airway. Secondly, the operation and treatment of multi-technology composite fiber optic bronchoscopy are complex and varied, with numerous uncontrollable factors. When using a single-lumen endotracheal tube or laryngeal mask airway for bipulmonary ventilation, respiratory movements increase the difficulty of localization and reduce ablation accuracy. Tumor / infectious tissue fluid may enter the main bronchus and be released after puncture and ablation. In the event of unplanned massive bleeding during the procedure, a large amount of blood may enter healthy lung tissue in a short period, causing gas exchange disorders, affecting oxygenation, and threatening life.

[0099] Because this invention uses a single-lumen tube, the catheter diameter can be designed to be relatively small, meeting the surgical operation requirements of a multi-technology composite fiberoptic bronchoscopy integrated diagnostic and therapeutic robotic system while maximizing patient safety. For the multi-technology composite fiberoptic bronchoscopy, the catheter can be inserted into the airway parallel to the tube body outside the body for diagnostic and therapeutic operations, overcoming the limitation that the multi-technology composite fiberoptic bronchoscopy cannot enter the airway through the lumen of existing clinical lung isolation airway management tools.

[0100] For multi-technique fiberoptic bronchoscopy procedures related to the lungs, this invention designs a catheter to be inserted into the main bronchus of the non-operating lung, isolating the left / right lung at the level of the carina. For patients with poor lung function who cannot tolerate unilateral ventilation, before the multi-technique fiberoptic bronchoscopy reaches the target site for diagnosis and treatment, this designed catheter can be inserted into the opening of the affected lung lobe to isolate a single lung lobe before performing the fiberoptic bronchoscopy-related diagnostic and treatment procedures. This provides an excellent diagnostic and treatment environment while achieving physical isolation between the surgical and non-surgical areas.

[0101] For multi-technique composite bronchoscopic procedures related to the mediastinum, this invention designs a system where, after the catheter is inserted into the main airway, the first inflatable cuff contracts while the second inflatable cuff inflates above the carina, physically isolating both lungs from the main airway. This ensures that bronchoscopic procedures for mediastinal lesions can be performed without affecting normal ventilation of both lungs. In the event of unplanned bleeding during mediastinal lesion treatment, the inflated second inflatable cuff moves upward to the bleeding point to compress and stop the bleeding, while the first inflatable cuff inflates to isolate the main airway from both lungs or one lung, thereby maximizing patient safety.

[0102] 5. Reduces iatrogenic damage to the vocal cords, pharyngeal soft tissues, and airway, improving patient comfort.

[0103] The incidence and severity of postoperative hoarseness and sore throat are directly related to the diameter of the endotracheal tube. Currently, commonly used lung isolation airway management tools all have problems to varying degrees, such as large tube diameter and rigid tube material. Direct contact and static compression of the vocal cords, pharyngeal soft tissues and airway may cause damage, and friction damage may also occur during intubation, extubation and dynamic positioning and use during surgery.

[0104] This invention features a catheter with a smaller diameter and a softer material, which can effectively reduce or avoid static compression and dynamic damage to the vocal cords, pharyngeal soft tissues, and airway during the procedure. This reduces postoperative hoarseness and sore throat, eliminates tracheal mucosal degloving injuries, and improves patient comfort and satisfaction.

[0105] 6. Optimize airway management procedures for complex surgical procedures.

[0106] The clinical demand for combining multi-technique fiberoptic bronchoscopy with intraoperative lung-related surgeries is gradually increasing, for purposes such as preoperative lesion localization and preoperative biopsy to clarify histological diagnosis. However, the outer diameter of the multi-technique fiberoptic bronchoscopy is relatively large, making it impossible to pass through the lumen or outside of a double-lumen endotracheal tube. Currently, in clinical practice, when performing combined procedures, it is necessary to first use a larger-diameter single-lumen endotracheal tube (ID 8.0mm) or laryngeal mask airway for airway management and fiberoptic bronchoscopy, and then switch to a double-lumen endotracheal tube for lung isolation and surgery. This repeated intubation and extubation not only prolongs the clinical operation time but also increases mechanical stimulation to the patient's vocal cords, pharyngeal soft tissues, and airway.

[0107] This invention is designed to meet the needs of lung isolation procedures related to the integrated diagnosis and treatment of pulmonary nodules. When using a multi-technology composite fiberoptic bronchoscope for diagnosis and treatment, this invention is designed to enter the airway in parallel with the fiberoptic bronchoscope. The bronchoscope is placed in the healthy side's main airway for lung isolation and concurrent mechanical ventilation, while the multi-technology composite fiberoptic bronchoscope is placed in the affected lung for relevant diagnostic and treatment procedures. The bronchoscope can be withdrawn immediately after the diagnostic procedure, allowing for immediate surgical treatment without the need for tube replacement. Clinical procedures are more time-saving and labor-saving, management is more flexible, and the damage caused by repeated intubation and extubation is reduced.

[0108] 7. A single airway management tool can meet the needs of various surgeries and procedures, facilitating medical staff and reducing medical costs.

[0109] Currently, different lung-related surgeries and procedures require the use of different airway management tools. Medical staff need to spend a lot of energy and time in selecting, training, and using these tools in clinical practice. Traditional lung isolation ventilation techniques can no longer meet the needs of updated and iterated minimally invasive surgical procedures, and may even increase patients' perioperative discomfort and risks.

[0110] This invention is designed to meet the lung isolation requirements of surgical procedures related to the integrated diagnosis and treatment of pulmonary nodules, achieving isolation between the surgical and non-surgical areas. It not only satisfies and improves the airway management needs of traditional lung-related surgeries but also significantly increases the safety of airway management in novel diagnostic and therapeutic procedures such as interventional surgery and endoscopic treatments. While protecting patients' lives, it also makes clinical practice more convenient for medical personnel and indirectly reduces medical costs.

[0111] It should be clarified that the present invention is not limited to the above embodiments. Where the above embodiments do not conflict, new embodiments can be formed by combining them, all of which fall within the scope of protection of the present invention. The present invention is not limited to the specific structures and processes described above and shown in the figures. For the sake of brevity, detailed descriptions of known methods are omitted here. In the above embodiments, several specific steps are described and shown as examples. However, the method process of the present invention is not limited to the specific steps described and shown. Those skilled in the art can make various changes, modifications, and additions, or change the order of steps, after understanding the spirit of the present invention.

[0112] It should also be noted that the exemplary embodiments mentioned in this invention describe methods or systems based on a series of steps or apparatus. However, this invention is not limited to the order of the steps described above; that is, the steps can be performed in the order mentioned in the embodiments, or in a different order, or several steps can be performed simultaneously.

[0113] The above description is merely a specific embodiment of the present invention. Those skilled in the art will clearly understand that, for the sake of convenience and brevity, the specific working processes of the systems, modules, and units described above can be referred to the corresponding processes in the foregoing method embodiments, and will not be repeated here. It should be understood that the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various equivalent modifications or substitutions within the technical scope disclosed in the present invention, and these modifications or substitutions should all be covered within the protection scope of the present invention.

Claims

1. A ventilation control device for an airway management tool, characterized in that, The tube section, the vent hole and the opening and closing mechanism, wherein the opening and closing mechanism comprises an elastic film and a third inflatable cuff for controlling the switching of the vent hole between the open and closed states; The tube section extends from a proximal end to a distal end and forms a lumen inside, and at least one vent hole is arranged on the tube section, which penetrates the tube wall of the tube section and communicates with the lumen of the tube section; An elastic film is arranged in the lumen of the tube section, and the elastic film is provided with at least one third opening communicating with the lumen of the tracheal tube, and the third opening is arranged in a staggered manner with the vent hole; The third inflatable cuff is arranged between the inner wall of the tracheal tube and the elastic film in a staggered manner along the longitudinal axis of the tracheal tube; the third inflatable cuff can switch between the inflated state and the contracted state, and in the inflated state, the third inflatable cuff blocks the lumen of the tube section, and the airflow can enter the vent hole through the third opening of the elastic film; in the contracted state, the elastic film blocks the vent hole, and the airflow can flow through the third inflatable cuff and the surface elastic film thereof to the distal end of the lumen of the tube section.

2. The ventilation control device of claim 1, wherein, The proximal end and the distal end of the elastic film are fixed on the tube section, wherein the distal end of the elastic film is beyond the third inflatable cuff and located at the distal end of the third inflatable cuff, and the proximal end of the elastic film is beyond the vent hole and located at the proximal end of the vent hole.

3. The ventilation control device of claim 2, wherein, The proximal end and the distal end of the elastic film are fixed on the inner wall of the tube section, or the proximal end and the distal end of the elastic film are fixed on the end face of the tube section at both ends, or the proximal end and the distal end of the elastic film are fixed on the outer wall of the tube section.

4. The ventilation control device of claim 3, wherein, The elastic film is fixed by adhesive bonding with the tube section, and the bonding surface of the tube section at the bonding position is roughened; or the elastic film is fixed by hot melt bonding with the tube section.

5. The ventilation control device of claim 4, wherein, The elastic film is designed to compress the third inflatable cuff to increase the cross-sectional area of the lumen of the tracheal tube at the position of the third inflatable cuff when the third inflatable cuff is in the contracted state.

6. The ventilation control device according to any one of claims 1 to 5, characterized in that The at least one vent hole protrudes from the inner wall of the lumen of the tracheal tube to form a vent pipe, and the vent pipe is fixed by being inserted into the through hole formed on the wall of the tracheal tube.

7. The ventilation control device of claim 6, wherein, Along the longitudinal axis of the tracheal tube, from the proximal end to the distal end, the height of the plurality of vent pipes protruding from the inner wall of the lumen gradually increases, and the air inlet of at least one of the vent pipes forms an inclined angle from the proximal end to the distal end along the longitudinal axis of the tracheal tube.

8. The ventilation control device of claim 7, wherein, When the third inflatable cuff is in the contracted state, the height of the third inflatable cuff protruding from the inner wall of the tracheal tube is equal to or less than the height of the most distal vent pipe.

9. The ventilation control device according to any one of claims 1-5, characterized in that, The vent hole is formed on a protruding block protruding from the inner wall of the tube section.

10. The ventilation control device of claim 9, wherein, The protruding block forms a slope from low to high along the longitudinal axis of the tube section from the proximal end to the distal end.

Images