Tip-controlled bronchial cannula

Abstract

The application discloses a controllable tip bronchial cannula, which comprises a tracheal catheter, a first inflatable cuff and a second inflatable cuff which are arranged on the outer wall of the tracheal catheter at intervals, wherein at least one ventilation hole is arranged on the tracheal catheter between the first inflatable cuff and the second inflatable cuff, the ventilation hole penetrates the tracheal catheter wall and communicates with the lumen of the tracheal catheter; an elastic film is arranged in the lumen of the tracheal catheter, the elastic film is provided with at least one third opening which communicates with the lumen of the tracheal catheter, and the third opening is arranged in a staggered mode with the ventilation hole; and a control component is further arranged, which is used for controlling the elastic film to switch between closing the ventilation hole and opening the ventilation hole. The bronchial cannula of the application makes the airway management of lung isolation more refined, breaks through the traditional left / right lung isolation, and realizes the precise physical isolation of the operation area and the non-operation area in units of lung lobes.

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', precise positioning, puncture, and biopsy can be performed under the assistance of multi-technology composite fiberoptic bronchoscopy or CT guidance. The next step of treatment is determined according to the intraoperative rapid pathological results. If the intraoperative pathological result is early lung cancer (lung carcinoma in situ or microinvasive carcinoma), immediate ablation therapy (radiofrequency ablation and cryoablation therapy) under the assistance of multi-technology composite fiberoptic bronchoscopy or percutaneous CT guidance is performed. If the intraoperative pathological result is a more advanced malignant tumor than 'lung carcinoma in situ or microinvasive carcinoma', immediate thoracoscopic lung cancer radical surgery is performed, thus achieving the histological diagnosis and clinical treatment of'suspicious pulmonary nodules' at the same time and establishing 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. Clinical application of electromagnetic navigation-assisted intralesional tool tomographic synthesis technology combined with a fiberoptic bronchoscopy robot system in human lung peripheral lesions: the FRONTIER study. Respir Med. 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 Subsolid 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 Subsolid 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 model for pulmonary nodules, regardless of whether it is a multi-technology composite fiberoptic bronchoscopy integrated robotic system, CT-assisted interventional procedures, or thoracoscopic minimally invasive surgery, lung isolation is required during the operation to ensure patient safety and prevent direct dissemination of tumors or infections. Traditional lung isolation refers to the technique of physically separating the ventilation pathways of both lungs at the level of the primary bronchus (left / right main bronchus) using airway management tools. Modern lung isolation refers to the technique of physically isolating the surgical and non-surgical areas within the airway at the level of the primary bronchus (left / right main bronchus) or the secondary bronchus (lobar bronchus) using airway management tools. This not only physically separates the ventilation pathways, allowing the surgical area to remain still and coexist with the non-surgical area under continuous mechanical ventilation for an extended period, but also physically isolates fluid communication, blocking the flow of tumorous and infectious secretions and blood to healthy lung tissue. Modern lung isolation techniques include left / right lung isolation, single-lobe isolation, and isolation of the main airway from the lungs.

[0005] Currently, there are various airway management tools available for lung isolation techniques in clinical practice, but each has its own limitations, affecting certain clinical diagnostic and treatment procedures for medical staff to varying degrees, and potentially increasing the perioperative medical risks for patients. The following lists the shortcomings of existing airway management tools related to lung isolation in clinical practice:

[0006] 1. Lung-related surgeries: Currently, the most commonly used airway management tools in lung-related surgeries are double-lumen endotracheal tubes (BLTBs) and bronchial occluders. BLTB intubation presents certain technical challenges; its larger diameter and rigid material cause significant irritation to the vocal cords, pharyngeal soft tissues, and airway during intubation, positioning, and extubation, easily leading to vocal cord injury, hoarseness, and sore throat. In severe cases, airway mucosal degloving can occur, posing a life-threatening risk. BLTBs are limited to left-right lung isolation and cannot achieve single-lobe isolation, failing to meet the needs of clinical scenarios requiring single-lobe isolation or special patients whose unilateral lung ventilation and oxygenation cannot be maintained normally. Due to its structural composition, the thinnest BLTB model is 28F, making it unsuitable for children and some adolescent patients. Bronchial occluders have a smaller lumen, leading to problems such as slow or no collapse of the occluded lung, inability to suction secretions, and inability to provide independent ventilation to the occluded lung. They also cannot achieve single-lobe isolation. This invention is applicable to all population groups other than infants and young children, including children and adolescents; it can achieve all the clinical functions of a double-lumen bronchial tube, and can also achieve lung isolation at the level of secondary bronchi (lobar bronchi). This invention is a single-lumen endotracheal tube with a significantly thinner outer diameter than a double-lumen bronchial tube, effectively avoiding the occurrence of the aforementioned adverse clinical events associated with double-lumen bronchial 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 bronchi. 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 #) can meet the operation requirements, but cannot realize the isolation of the operation area and the non-operation area. The operation and treatment of the fiber bronchoscope are complex and diverse, including main airway operation, tracheal carina level operation, and intrapulmonary operation. There are many uncontrollable factors, including but not limited to: double lung respiratory movement increases the difficulty of positioning, reduces the accuracy of ablation, and tumor / infectious tissue fluid may enter other bronchi after puncture and ablation, which may cause dissemination risk. When unexpected massive bleeding occurs, a large amount of blood enters the healthy lung tissue to cause gas exchange disorder, affect the oxygenation of the body, and even endanger life safety. If the operation area and the non-operation area can be isolated, the above risks can be minimized, and the safety of the patient's life can be guaranteed. In addition to simple endoscopic diagnosis and treatment, electromagnetic navigation composite fiber bronchoscope technology can also be applied to preoperative positioning of lung-related surgery. Currently, single-lumen endotracheal tube or laryngeal mask is used for airway management, and after fiber bronchoscope operation is completed, double-lumen endotracheal tube is used for lung isolation and surgery. Repeated intubation and extubation not only prolongs the clinical operation time, but also increases the mechanical stimulation of the vocal cords, throat soft tissue and airway of the patient. There is a need to optimize this process in clinical practice. The present application can accurately isolate the pulmonary lobe under direct vision after the multi-technology composite fiber bronchoscope enters the target pulmonary lobe. Under the premise of ensuring the diagnosis and treatment operation of the multi-technology composite fiber bronchoscope, the operation lobe and other lung tissues are physically isolated, and the occurrence of the above-mentioned clinical adverse events is avoided.

[0009] 4. Currently, different lung-related surgeries and operations require the use of different airway management tools, each of which has its own shortcomings, which may increase the discomfort and risk of patients during the perioperative period. Medical personnel need to spend a lot of energy and time cost in clinical selection, training and use. At present, there is no lung isolation airway management tool that can meet the needs of various lung surgery operations.

[0010] These problems show that there is still a lot of room for improvement in airway management tools for lung surgery and operation. The present application aims to describe a visual lung isolation airway management tool suitable for various lung-related surgical operations. Its design can solve the shortcomings of existing airway management tools, match the lung isolation suitable for all lung nodule minimally invasive integrated diagnosis and treatment mode-related lung surgery operations, and simultaneously realize left / right lung isolation and single pulmonary lobe isolation at the first bronchial level and the second bronchial level according to different surgical requirements, simplify clinical lung isolation operation, and provide a general and easy-to-master option for medical personnel. SUMMARY

[0011] In view of the technical problems proposed in the background art, the present application provides a tip-controllable bronchial cannula to at least partially solve at least one of the above technical problems, realize effective isolation of the operation area and the non-operation area in various lung-related surgical operations under the lung nodule minimally invasive integrated diagnosis and treatment mode, provide the best surgical conditions for various populations except infants and young children but not limited to traditional surgery, thoracoscopic surgery and various interventional diagnosis and treatment operations, ensure the normal breathing and gas exchange function of non-surgical lung tissue, protect the safety of patients, reduce iatrogenic damage to the vocal cords, throat soft tissue and airway, optimize the airway management process of various surgical operations, indirectly shorten the hospitalization time, reduce the medical cost and promote the rapid recovery of patients.

[0012] To solve the above technical problems, the present application provides the following technical solutions:

[0013] The present application relates to a tip-controllable bronchial cannula, specifically, the bronchial cannula comprises a tracheal catheter and a first inflatable cuff and a second inflatable cuff arranged at intervals along the outer wall of the tracheal catheter, and further comprises a camera arranged in the tracheal catheter wall between the first inflatable cuff and the second inflatable cuff, the camera is used to capture the image of the front end, wherein,

[0014] The tracheal catheter extends from the proximal end to the distal end and forms a lumen inside, the distal end of the tracheal catheter is provided with a first opening, and the proximal end is provided with a second opening;

[0015] The first inflatable cuff is close to the first opening, and the first inflatable cuff and the second inflatable cuff are both in communication with the inflatable lumen in the tracheal catheter wall;

[0016] At least one ventilation hole is arranged between the first inflatable cuff and the second inflatable cuff on the tracheal catheter, the ventilation hole penetrates the tracheal catheter wall and is in communication with the lumen of the tracheal catheter;

[0017] An elastic membrane is arranged in the lumen of the tracheal catheter, the elastic membrane is provided with at least one third opening in communication with the lumen of the tracheal catheter, and the third opening is arranged in a staggered manner with the ventilation hole;

[0018] Further comprising a control component for controlling the elastic membrane to switch between closing the ventilation hole and opening the ventilation hole.

[0019] In a further preferred embodiment, the control component is a third inflatable cuff, the third inflatable cuff is located between the inner wall of the tracheal catheter and the elastic membrane, and is arranged in a staggered manner with the ventilation hole along the longitudinal axis of the tracheal catheter, and the third inflatable cuff is located at the distal end of the ventilation hole.

[0020] In a further preferred embodiment, the elastic membrane is fixed to the inner wall of the tracheal tube at least at the proximal end and the distal end, wherein the distal end of the elastic membrane is beyond the third inflatable cuff and located at the distal end of the third inflatable cuff, and the proximal end of the elastic membrane is beyond the ventilation hole and located at the proximal end of the ventilation hole.

[0021] In a further preferred embodiment, the third inflatable cuff is switchable between an inflated state and a deflated state, wherein in the inflated state, the third inflatable cuff blocks the lumen of the tracheal tube, and air flow can enter the ventilation hole through the third opening of the elastic membrane; and in the deflated state, the elastic membrane blocks the ventilation hole, and air flow can flow through the third inflatable cuff and the elastic membrane on the surface of the third inflatable cuff to the distal end of the lumen of the tracheal tube.

[0022] In a further preferred embodiment, the elastic membrane is designed to compress the third inflatable cuff to increase the cross-sectional area of the lumen of the tracheal tube at the segment when the third inflatable cuff is in the deflated state.

[0023] In a further preferred embodiment, the at least one ventilation hole protrudes from the inner wall of the lumen of the tracheal tube to form a ventilation tube, and the ventilation tubes are arranged in sequence along the longitudinal axis of the camera proximal to the camera.

[0024] In a further preferred embodiment, the height of the plurality of ventilation tubes 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.

[0025] In a further preferred embodiment, 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 ventilation tube when the third inflatable cuff is in the deflated state.

[0026] In a further preferred embodiment, the air inlet of at least one of the ventilation tubes forms an inclined angle from the proximal end to the distal end along the longitudinal axis of the tracheal tube.

[0027] In a further preferred embodiment, the ventilation tube is fixedly arranged by being inserted into the through hole formed on the wall of the tracheal tube.

[0028] The present application has the advantages that: 1. It is suitable for all kinds of people except infants; 2. It is suitable for lung isolation for all lung-related diagnosis and treatment operations; 3. It realizes accurate isolation of the operation area and the non-operation area; 4. It realizes lung isolation at the level of the second bronchus (lobar bronchus) on the basis of realizing lung isolation at the level of the first bronchus (left / right main bronchus); 5. It provides conditions for lung surgery, especially for special patients; 6. It provides conditions for lung nodule minimally invasive integrated diagnosis and treatment mode related interventional operation, endoscopic operation and thoracoscopic surgery, and maximally guarantees the safety of patients; 7. It optimizes the airway management process of complex operation; 8. It reduces the damage of intubation and improves the satisfaction of patients. In addition, the present application also indirectly reduces medical costs and expenses, shortens the hospitalization time, improves the comfort of patients and accelerates the recovery of patients. BRIEF DESCRIPTION OF DRAWINGS

[0029] Figure 1 It is a front view of an embodiment of the present application;

[0030] Figure 2 It is a top view of an embodiment of the present application;

[0031] Figure 3 It is a Figure 2 sectional view along G-G;

[0032] Figure 4 It is a Figure 1 sectional view along H-H of the third inflatable cuff in the inflated state;

[0033] Figure 5 It is a Figure 4 sectional view along A-A;

[0034] Figure 6 It is a Figure 4 sectional view along B-B;

[0035] Figure 7 It is a Figure 1 sectional view along H-H of the third inflatable cuff in the compressed state;

[0036] Figure 8 It is a Figure 7 sectional view along C-C;

[0037] Figure 9 It is a Figure 7 sectional view along D-D;

[0038] Figure 10 It is a sectional view along H-H of the third inflatable cuff in the inflated state of an embodiment of the ventilation control device protected by the present application;

[0039] Figure 11Figure 3 is a partial cross-sectional view of a third inflatable cuff in a compressed state according to an embodiment of the ventilation control device protected by the present application;

[0040] Figure 12 Figure 4 is a partial cross-sectional view of a third inflatable cuff in a filled state according to another embodiment of the tip-controlled bronchial cannula protected by the present application;

[0041] Figure 13 Figure 5 is a partial cross-sectional view of a third inflatable cuff in a compressed state according to another embodiment of the tip-controlled bronchial cannula protected by the present application.

[0042] In the figure: 10 - bronchial cannula, 1 - tracheal tube, 11 - tube wall, 12 - lumen, 13 - first opening, 14 - second opening, 15 - ventilation hole, 151 - ventilation 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 portion, 42 - curved segment, 5 - camera, 6 - opening and closing mechanism, 61 - elastic film, 611 - third opening, 62 - third inflatable cuff. DETAILED DESCRIPTION

[0043] The technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the scope of protection of the present application.

[0044] The features and exemplary embodiments of various aspects of the present application will be described in detail below. In order to make the purposes, technical solutions and advantages of the present application clearer, the present application will be described in further detail below in conjunction with the drawings and embodiments. It should be understood that the specific embodiments described herein are configured only to explain the present application, and are not configured to limit the present application. The present application can be implemented without some of the specific details by those of ordinary skill in the art. The following description of the embodiments is only to provide a better understanding of the present application by showing examples of the present application.

[0045] 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.

[0046] 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.

[0047] Example 1:

[0048] like Figures 1-9 The 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.

[0049] 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.

[0050] The tracheal tube is preferably flexible to bend, in order to adapt to the tracheal and bronchial tissues in the human body. Further preferably, the tracheal tube 1 is made of TPU or PVC material. Still further preferably, the outer surface of the tube wall 11 of the tracheal tube 1 is coated with a hydrophilic coating to reduce the friction between the tracheal tube 1 and the tracheal wall tissues, and to increase the lubricity and passability of the tracheal tube 1.

[0051] The tracheal tube 1 extends from a proximal end to a distal end, and forms a lumen 12 inside. The distal end of the tracheal tube 1 is provided with a first opening 13, and the proximal end is provided with a second opening 14. The first inflatable cuff 2 is arranged near the first opening 13, and the second opening 14 is insertable into the operating part 4 or connected to a breathing machine (not shown in the figure) at the proximal end. The operating part 4 includes a holding part 41 and a bending section 42 connected to the holding part. When the bending section 42 of the operating part 4 is inserted into the lumen 12 from the second opening 14 of the tracheal tube 1, the lumen 12 of the tracheal tube 1 is configured as a passage for the bending section 42, and the distal end of the bending section 42 is located at the distal end of the tracheal tube 1, such as near the first opening 13. The doctor can adjust the angle of the bending section 42 by operating the holding part 41, and thus adjust the bending angle of the distal end of the tracheal tube 1, in order to adapt to the angle of the tracheal opening or bronchial opening of the patient. When the second opening 14 of the tracheal tube 1 is connected to the breathing machine, the lumen 12 of the tracheal tube 1 is configured as a passage for mechanical ventilation of the patient. The gas generated by the breathing machine can be delivered into the corresponding main bronchus or lobar bronchus of the patient through the lumen 12, and into the lung. The specific side of the lung or lobe of the lung to which the gas is provided is described in detail below.

[0052] The first inflatable cuff 2 and the second inflatable cuff 3 are respectively communicated with the first inflation lumen and the second inflation lumen arranged along the longitudinal axis inside the tube wall 11. The proximal end of the first inflation lumen and the second inflation lumen is respectively connected to the first inflation hose and the second inflation hose. The doctor can switch the first inflatable cuff 2 and the second inflatable cuff 3 between the inflated state and the compressed state by inflating or deflating / evacuating 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 lobar bronchial opening.

[0053] Further, at least one ventilation hole 15 is arranged on the tracheal tube 1 between the first inflatable cuff 2 and the second inflatable cuff 3. The ventilation hole 15 penetrates the tube wall 11 and is communicated with the lumen 12 of the tracheal tube 1. Preferably, there are 3-5 ventilation holes 15. Further preferably, the ventilation holes 15 are arranged along the longitudinal axis of the tracheal tube 1, and the adjacent ventilation holes 15 are arranged at equal intervals.

[0054] Preferably, the distal end of the ventilation hole 15 is provided with a camera 5, which is embedded in the cavity of the tube wall 11 of the tracheal tube 1 and can capture the image in front of the camera 5. Preferably, the camera 5 and the ventilation hole 15 are placed on the same side, and the ventilation holes 15 are distributed equidistantly along the same axis from the proximal end of the camera 5 upward.

[0055] In order to realize the communication or disconnection between the ventilation hole 15 and the lumen 12 inside the tracheal tube 1, the present application further provides an opening and closing mechanism 6, which includes an elastic film 61 arranged in the lumen 12 of the tracheal tube 1 and a control component for controlling the elastic film 61 to close or open the ventilation hole 15.

[0056] Specifically, the elastic film 61 extends along the longitudinal axis of the tracheal tube 1, and the proximal end and the distal end of the elastic film 61 are fixed to the inner wall of the tracheal tube 1. Preferably, the distal end and the proximal end of the elastic film 61 are bonded to the inner wall of the tracheal tube 1 by using glue. Further preferably, the bonding part between the elastic film 61 and the inner wall of the tracheal tube 1 is roughened to form a rough surface, so that the elastic film 61 is fixed more firmly to the inner wall of the tracheal tube 1 and is prevented from falling off the inner wall. Still further preferably, the distal end and the proximal end of the elastic film 61 can be bonded to the inner wall of the tracheal tube 1 by using hot melting.

[0057] The elastic film 61 is provided with at least one third opening 611 which communicates with the lumen 12 of the tracheal tube 1, and the third opening 611 is arranged in a staggered manner with the ventilation hole 15. Preferably, the third opening 611 is arranged on one side or both sides of the ventilation hole 15 along the longitudinal axis of the tracheal tube 1.

[0058] Further, the control component can control the elastic film 61 to switch between closing the ventilation hole 15 and opening the ventilation hole 15, so as to control whether the gas delivered into the lumen 12 of the tracheal tube 1 by the breathing machine is sent into the corresponding side bronchus or lung lobe of the patient through the ventilation hole 15 to form a channel for the patient's breathing. When the control component controls the elastic film 61 to communicate the ventilation hole 15 with the lumen 12 of the tracheal tube 1, the gas can be sent into the bronchus and lung on the side communicating with the ventilation hole 15 through the lumen 12, the third opening 611 and the ventilation hole 15 to form a channel for the patient's breathing; otherwise, the gas is not sent to the patient through the ventilation hole 15.

[0059] Further preferably, the control component is a third inflatable cuff 62, which is located between the inner wall of the tracheal tube 1 and the elastic membrane 61, and is arranged along the longitudinal axis of the tracheal tube 1 to be opposite to the ventilation hole 15. Preferably, the third inflatable cuff 62 is arranged at the distal end of the ventilation hole 15 and is fixed to the inner wall of the lumen 12 of the tracheal tube 1. The third inflatable cuff 62 is in communication 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 can be switched between the inflated state and the compressed state.

[0060] When the third inflatable cuff 62 is in the compressed state, the elastic membrane 61 shrinks due to its elasticity, thereby blocking the ventilation hole 15. When the tracheal tube 1 is mechanically ventilated, the pressure of the gas in the ventilation lumen 12 on the inner wall of the tracheal tube can further block the ventilation hole 15. At this time, the gas delivered by the ventilator into the lumen 12 of the tracheal tube 1 is delivered from the proximal end of the tracheal tube 1, flows through the third inflatable cuff 62 and the surface elastic membrane 61 of the third inflatable cuff 62, and is delivered to the distal end of the tracheal tube 1 to the distal first opening 13, and then to the bronchus and lung connected to the first opening 13, to form a channel for the patient to breathe. When the third inflatable cuff 62 is in the inflated state, the distal end of the third inflatable cuff 62 and the elastic membrane 61 are in close contact with the inner wall of the tracheal tube 1, blocking the lumen 12 of the tracheal tube 1, and preventing the gas input by the ventilator from being delivered to the distal end of the lumen 12. At the same time, the third inflatable cuff 62 pushes the elastic membrane 61, and the elastic membrane 61 is fixed to the inner wall of the lumen 12 on one side. Due to the pushing of the distal end of the elastic membrane 61 by the inflated third inflatable cuff 62, the elastic membrane 61 is pushed from the distal end to the proximal end to the opposite side of the tube wall, so that the elastic membrane 61 is obliquely across the lumen 12, the elastic membrane 61 is separated from the blocking of the ventilation hole 15, and the ventilation hole 15 is connected to the lumen 12 of the tracheal tube 1 through the third opening 611 in the elastic membrane 61, so that the gas input by the ventilator is delivered along the proximal end of the lumen 12 of the tracheal tube 1, then enters the ventilation hole 15 through the third opening 611 in the elastic membrane 61 connected to the lumen 12 of the tracheal tube 1, and then can be delivered to the bronchus and lung connected to the ventilation hole 15, to form a channel for the patient to breathe.

[0061] Preferably, the elastic membrane 61 is designed to compress the third inflatable cuff 62 to the tube wall when the third inflatable cuff 62 is in the compressed state, so as to increase the cross-sectional area of the lumen 12 of the tracheal tube 1 at this section. Further preferably, the elastic membrane 61 is a latex membrane.

[0062] Since the third inflatable cuff 62 has a certain thickness even in the compressed state, in order to facilitate the elastic film 61 to block the vent holes 15, at least one of the vent holes 15 protrudes from the inner wall of the tracheal tube 1 by a certain height to form a vent tube 151.

[0063] Further preferably, the height of the third inflatable cuff 62 protruding from the inner wall of the tracheal tube 1 when in the contracted state is equal to or less than the height of the distal-most vent tube 151 adjacent to the third inflatable cuff 62.

[0064] Further preferably, since the third inflatable cuff 62 still has a certain height when in the contracted state, in order to facilitate the elastic film 61 to block each vent tube 151, the height of the vent 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, and the height of the vent 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] Further preferably, the air inlet 152 of at least one vent tube 151 forms an inclined angle from the proximal end to the distal end along the longitudinal axis of the tracheal tube 1. In this way, even if the multiple vent tubes 151 gradually increase in height from the proximal end to the distal end, the elastic film 61 forms an inclined surface as a whole when blocking the air inlets 152 of the multiple vent tubes 151, so that the elastic film 61 can more effectively block the air inlets 152 of the vent tubes 151, and the pressure generated by mechanical ventilation in the tracheal tube 1 on the inner wall further presses the elastic film 61 against the vent tubes, avoiding the problem of leakage due to incomplete blocking.

[0066] The vent tubes 151 are fixedly arranged by being inserted into the through holes 153 formed through the tube wall 11. Specifically, first, multiple through holes 153 are formed at the corresponding positions of the tube wall 11, and the through holes 153 can be formed by perforation or reserved during the molding of the tracheal tube, and preferably, the multiple through holes 153 are of the same size. Then the vent tubes 151 are inserted into the through holes 153, and preferably, one end of the vent tubes 151 inserted into the through holes 153 is flush with the outer wall of the tracheal tube 1, and the vent tubes 151 in the lumen 12 of the tracheal tube 1 protrude from the inner wall. Further preferably, the vent tubes 151 are fixedly arranged in the through holes 153 by adhesive. Along the longitudinal axis of the tracheal tube 1 from the proximal end to the distal end, the height of the multiple vent tubes 151 protruding from the inner wall of the lumen gradually increases, forming a certain sequential height difference, and the height of the vent 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.

[0067] Example Two:

[0068] As Figures 10-11As shown, the present application also relates to a ventilation control device for airway management tools, which ventilation control device comprises a tube segment 16, a ventilation hole 15 and an opening and closing mechanism 6, i.e. the part between the first inflatable cuff 2 and the second inflatable cuff 3 of the bronchial cannula in the first embodiment (as shown) above, which ventilation control device is an independent component and can be assembled into the bronchial cannula described in the first embodiment or other airway management tools to achieve control of ventilation, which is not limited in the present application. Figures 1-9

[0069] The tube segment 16 forms a lumen 12 inside, and at least one ventilation hole 15 is provided on the tube wall 11 of the tube segment 16, which ventilation hole 15 penetrates the tube wall 11 of the tube segment 16 and communicates with the lumen 12. Preferably, there are 3-5 ventilation holes 15, and further preferably, the ventilation holes 15 are arranged along the longitudinal axis of the tube segment 16 and are equidistantly arranged between adjacent ventilation holes 15, and more preferably, the ventilation holes 15 are equidistantly distributed along the same axis at the proximal end of the camera, which facilitates the adjustment of the specific position and direction of the ventilation hole during the operation.

[0070] In order to realize the communication or disconnection of the ventilation hole 15 with the lumen 12 inside the tube segment 16, the present application also provides an opening and closing mechanism 6, which comprises an elastic film 61 provided in the lumen 12 inside the tube segment 16 and a control component for controlling the elastic film 61 to close or open the ventilation hole 15.

[0071] Specifically, the elastic film 61 extends along the longitudinal axis of the tube segment 16, and the proximal end and the distal end of the elastic film 61 are fixed to the inner wall of the tube segment 16. Preferably, the proximal end and the distal end of the elastic film 61 are adhered to the inner wall of the tube segment 16 by using glue. Preferably, the proximal end and the distal end of the elastic film 61 are adhered to the inner wall of the tube segment 16 by using hot melting.

[0072] Since the space inside the lumen 12 of the tube segment 16 is narrow, it is not conducive to the adhesion and fixation of the elastic film 61, and the inner wall of the tube segment 16 is relatively smooth, which may cause the elastic film 61 to be not firmly adhered. As a preferred embodiment, the proximal end and the distal end of the elastic film 61 extend from the lumen 12 of the tube segment 16 to the end faces of the two ends of the tube segment 16 and are fixed to the end faces of the two ends of the tube segment 16. Further preferably, the proximal end and the distal end of the elastic film 61 extend further to the outer wall of the tube segment 16 from the two ends of the tube segment 16 and are adhered to the outer wall of the tube segment 16 by using glue. More preferably, the proximal end and the distal end of the elastic film 61 are adhered to the outer wall of the tube segment 16 by using hot melting.

[0073] ​Further preferably, the tube wall 11 of the distal end and the proximal end of the tube segment 16 has a stepped structure, so that the proximal end and the distal end of the tube segment 16 are connected and fixed with the catheter by plug-in connection. In the embodiment, the elastic film 61 is fixed by pressing the elastic film 61 against the end face of the tube segment 16 or the outer wall or the inner wall of the tube segment 16 when the tube segment 16 is plug-in fixed with the distal end catheter and the proximal end catheter.

[0074] Preferably, the adhesive bonding part between the elastic film 61 and the tube segment 16 is roughened, so that the elastic film 61 is firmly fixed with the tube segment 16 and avoids falling off from the tube segment 16.

[0075] The elastic film 61 is provided with at least one third opening 611 which is in communication with the lumen 12 of the tube segment 16 and is located opposite the air vent 15. Preferably, the third opening 611 is located on one side or both sides of the air vent 15 along the longitudinal axis of the tube segment 16.

[0076] Further, the control component can control the elastic film 61 to switch between closing the air vent 15 and opening the air vent 15, so as to control whether the gas delivered by the breathing machine into the lumen 12 of the tube segment 16 is sent into the bronchus or the lung lobe on the corresponding side of the patient through the air vent 15 to form a channel for the patient's breathing. When the control component controls the elastic film 61 to communicate the air vent 15 with the lumen 12 of the tube segment 16, the gas can be sent into the bronchus or the lung lobe on the side of the air vent 15 through the lumen 12, the third opening 611 and the air vent 15 to form a channel for the patient's breathing; otherwise, the oxygen is not delivered to the patient through the air vent 15.

[0077] Further preferably, the control component is a third inflatable cuff 62 which is located between the inner wall of the tube segment 16 and the elastic film 61 and is located opposite the air vent 15 along the longitudinal axis of the tube segment 16. Preferably, the third inflatable cuff 62 is located at the distal end of the air vent 15 and is fixed to the inner wall of the lumen 12 of the tube segment 16. The third inflatable cuff 62 is in communication with the inflation lumen in the tube wall 11 of the tube segment 16, and the third inflatable cuff 62 is switched between the inflated state and the compressed state by inflating or deflating / evacuating the inflation lumen. The inflation lumen can be connected with the inflation lumen in the proximal end tube wall and the inflation hose.

[0078] When the third inflatable cuff 62 is in the compressed state, the elastic film 61 shrinks due to its elasticity, thereby blocking the ventilation hole 15. When the tracheal tube 1 is mechanically ventilated, the pressure of the gas in the ventilation tube cavity 12 against the inner wall of the tracheal tube can further intensify the blocking of the ventilation hole 15. At this time, the gas delivered into the tube cavity 12 of the tube segment 16 flows through the third inflatable cuff 62 and its surface elastic film 61 to the bronchus or lung lobe connected to the distal end of the tube cavity 12 of the tube segment 16, to form a channel for the patient's breathing. When the third inflatable cuff 62 is in the inflated state, the third inflatable cuff 62 is in close contact with the inner wall of the tube segment 16, blocking the tube cavity 12 of the tube segment 16, and preventing the input gas from continuing to be delivered to the distal end of the tube cavity 12. At the same time, the third inflatable cuff 62 pushes the elastic film 61, which is fixed to the inner wall of the tube cavity 12 on one side, to the distal end of the elastic film 61, causing the elastic film 61 to be pushed from the distal end to the proximal end to the opposite side of the tube wall, so that the elastic film 61 is obliquely across the tube cavity 12. The elastic film 61 is disconnected from the blocking of the ventilation hole 15, and the ventilation hole 15 is connected to the tube cavity 12 of the tube segment 16 through the third opening 611 in the elastic film 61, thereby making the ventilation hole 15 connected to the tube cavity 12 of the tube segment 16, and the input gas is delivered along the proximal end of the tube cavity 12 of the tube segment 16, and then enters the ventilation hole 15 through the third opening 611 in the elastic film 61 connected to the tube cavity 12 of the tube segment 16, and then the gas can be delivered to the bronchus or lung lobe connected to the ventilation hole 15, to form a channel for the patient's breathing.

[0079] As an optional embodiment, when the first inflatable cuff 2 is in the contracted state and the second inflatable cuff 3 is in the inflated state, no matter whether the third inflatable cuff 62 is in the contracted state or the inflated state, the gas flows through the first opening 13 or the ventilation hole 15, through the gap between the bronchial wall and the tracheal tube, to the opposite lung or other lung lobe bronchus, thereby forming double-lung ventilation.

[0080] Preferably, the elastic film 61 is designed to compress the third inflatable cuff 62 to the tube wall when the third inflatable cuff 62 is in the compressed state, to increase the cross-sectional area of the tube cavity 12 of the tracheal tube 1 at this segment. Further preferably, the elastic film 61 is a latex film.

[0081] Since the third inflatable cuff 62 has a certain thickness even when it is in the compressed state, in order to facilitate the elastic film 61 to block the ventilation hole 15, at least one of the above-mentioned plurality of ventilation holes 15 protrudes from the inner wall of the tracheal tube 1 by a certain height to form a ventilation tube 151.

[0082] Further preferably, when the third inflatable cuff 62 is in the contracted state, the height of the third inflatable cuff 62 protruding from the inner wall of the tracheal tube 1 is equal to or less than the height of the most distal ventilation tube 151 adjacent to the third inflatable cuff 62.

[0083] Further preferably, in order to facilitate the elastic film 61 to seal each of the ventilation tubes 151, the height of the ventilation tubes 151 protruding from the inner wall of the lumen gradually increases along the longitudinal axis of the tube segment 16 from the proximal end to the distal end, forming a certain height difference in sequence, and the height of the ventilation tube closest to the third inflatable cuff 62 is greater than or equal to the thickness of the third inflatable cuff 62 in the deflated state.

[0084] Further preferably, the air inlet 152 of at least one ventilation tube 151 forms an inclined angle along the longitudinal axis of the tube segment 16 from the proximal end to the distal end. In this way, even if the height of the ventilation tubes 151 gradually increases from the proximal end to the distal end, the elastic film 61 forms an inclined surface as a whole when sealing the air inlets 152 of the ventilation tubes 151, so that the elastic film 61 can seal the air inlets 152 of each ventilation tube 151, and the pressure generated by mechanical ventilation in the tracheal tube 1 on the inner wall further presses the elastic film 61 to the ventilation tube, avoiding the problem of air leakage caused by poor sealing.

[0085] The ventilation tube 151 is fixedly arranged by being inserted into the through hole 153 formed on the tube wall 11 of the tube segment 16. Specifically, first, a plurality of through holes 153 are formed at the corresponding positions of the tube wall 11 of the tube segment 16, and the through holes 153 can be formed by perforation or reserved during the molding of the tracheal tube, and preferably, the through holes 153 are of the same size. Then, the ventilation tube 151 is inserted into the through hole 153, and preferably, the 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. Further preferably, the ventilation tube 151 is fixedly arranged in the through hole 153 by adhesive. Along the longitudinal axis of the tracheal tube 1 from the proximal end to the distal end, the height of the ventilation tubes 151 protruding from the inner wall of the lumen gradually increases, forming a certain height difference in sequence, 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 deflated state.

[0086] Example Three

[0087] As Figures 12-13As shown, the third embodiment is further improved on the basis of the first and second embodiments, and the plurality of ventilation holes 15 are formed on the protrusions 154 protruding from the inner wall of the tracheal tube 1 / tube segment 16 by a certain height, preferably, the height of the protrusions 154 is equal to or greater than the height of the third inflatable cuff 62 in the contracted state. Further preferably, the protrusions 154 form a slope from low to high along the longitudinal axis of the tracheal tube 1 / tube segment 16 from the proximal end to the distal end, so that the elastic membrane 61 forms a slope from the proximal end to the distal end as a whole when blocking the plurality of ventilation holes 15, so that the elastic membrane 61 can effectively block each ventilation hole 15, avoiding the problem of air leakage caused by poor blocking. And the pressure on the inner wall generated by the mechanical ventilation of the tracheal tube 1 further presses the elastic membrane 61 to the ventilation tube.

[0088] Further preferably, a through groove is first formed at the corresponding position of the ventilation hole of the tracheal tube 1 / tube segment 16, preferably the groove is rectangular, the protrusion 154 is separately formed, and the shape and size are matched with the groove, and a plurality of ventilation holes 15 are formed on the protrusion 154, then the protrusion 154 is fixed in the groove, the outer surface of the protrusion 154 is flush with the outer wall of the tracheal tube 1 / tube segment 16, and preferably the protrusion 154 is fixed by adhesive.

[0089] The tip-controllable bronchial cannula and the ventilation control device for airway management tools described in the above embodiments of the present application can at least achieve the following objectives:

[0090] 1. Lung isolation to meet the needs of traditional lung-related surgery

[0091] In the airway management of lung-related surgery, it is necessary to ensure the safety of artificial ventilation of patients and the normal oxygenation of the body, that is, the normal artificial ventilation of the non-surgical site, and to create space and conditions for the surgical operation of the surgeon, that is, the lung tissue at the surgical site is deflated and kept static, and the two different ventilation states of the surgical site and the non-surgical site need to coexist for a long time. At the same time, the flow of body fluids between the surgical site and the non-surgical site should be physically blocked. The traditional airway management tools can physically separate the ventilation paths of the two lungs at the tracheal carina or left / right main bronchus level, that is, lung isolation. Double-lumen endobronchial tubes and bronchial blockers have various types and categories, and need to be selected according to the clinical scene when used, and there is a certain technical difficulty in intubation, which is prone to intubation difficulty and misalignment.

[0092] The bronchial intubation tube designed by the application only has one ventilation tube cavity, so that the overall tube diameter is relatively thin, intubation difficulty is less likely to occur, the catheter can be used alone or in combination with a laryngeal mask, and the function is suitable for conventional lung isolation, and left and right tubes are not distinguished, and the visualization technology makes the intubation and catheter alignment operation simple and easy to master. When performing conventional lung isolation (physical isolation of the diseased lung and the healthy lung), the left and right lungs can be isolated at the tracheal carina level, and while the healthy lung is mechanically ventilated to ensure gas exchange during surgery, the diseased lung can stop breathing for a long time to maintain static state, eliminating the influence of respiratory movement on the operation of the lesion site, and providing optimal surgical conditions for surgical operation, and the left and right lung ventilation can be switched freely at any time as needed.

[0093] 2. Realize lung lobe isolation and provide conditions for lung surgery for special patients

[0094] The conventional lung isolation technology can only realize one-lung ventilation, but about 50% of the lung tissue on the opposite side is in a non-ventilation state during one-lung ventilation. Due to factors such as lack of oxygen in the lung tissue, repeated collapse and re-expansion, the non-ventilation side of the lung is prone to lung injury. For patients with impaired lung function, the conventional lung isolation technology is more likely to be unable to tolerate one-lung ventilation, thereby causing hypoxemia and hypoxia. With the popularization of health check-ups, the number of lung nodule related surgeries has increased sharply. Lung nodule related surgeries often only target a lung lobe, and if single lung lobe isolation, i.e. physical isolation of the diseased lung lobe and the healthy lung lobe, can be performed, the lung ventilation area can be greatly increased, the non-ventilation lung area can be reduced, lung injury can be reduced, lung function can be protected, the body oxygenation can be ensured, and the lung isolation tolerance of special groups can be increased. However, due to the length, tube diameter, and controllability of existing airway management tools, single lung lobe isolation or ventilation cannot be achieved.

[0095] The catheter is long and has good mobility, the catheter tip direction can be freely controlled by the tubular body operating part 4, the catheter tip can be deeply inserted into the lobar bronchus to isolate a single lobe; the shape of the "conical" inflatable cuff at the distal end of the catheter is more suitable for the opening of the lobar bronchus; the camera at the distal end of the catheter can be observed in real time, so that the catheter and the lobar bronchus can be well aligned during the operation. When performing single lobe isolation (i.e. physical isolation of the operation area and the non-operation area), the diseased lobe can be isolated at the lobar bronchus opening level, so that only the diseased lobe can be deflated and kept static during the operation, while the other healthy lobes / non-operation lobes can be normally ventilated and gas exchanged, thereby reducing the non-ventilation lung area, maximizing the oxygenation of the body, reducing lung injury and protecting lung function. At present, more and more elderly patients, patients with poor lung function due to chronic lung disease, and patients with impaired gas exchange area of the contralateral lung due to previous contralateral lung surgery cannot tolerate one-lung ventilation, and may develop hypoxemia and various serious complications during one-lung ventilation. Single lobe isolation technology increases the lung ventilation area and reduces the non-ventilation lobe area during the operation, thereby creating surgical conditions and providing safety for patients undergoing lung surgery.

[0096] 3. Provide conditions for percutaneous CT-guided interventional diagnosis and treatment, and improve the safety of airway management

[0097] Percutaneous CT-guided interventional diagnosis and treatment is a method of positioning lung lesions through real-time CT images, and performing biopsy, ablation and other operations through percutaneous puncture. During the diagnosis and treatment, the target lung nodule moves due to respiratory motion, which increases the difficulty of positioning and reduces the accuracy of ablation, and even causes collateral damage to the surrounding healthy tissue. At present, the single-lumen endotracheal tube is commonly used for double-lung ventilation, which cannot keep the target lung nodule static for a long time. If the respiration is temporarily stopped during the operation to accurately position the target lung nodule, it is not conducive to the oxygenation of the body and the protection of lung function. In addition, when the single-lumen endotracheal tube is used, the double lungs communicate through the main airway and bronchus, and it is difficult to prevent tumor / infectious tissue fluid or blood from entering the healthy lung tissue.

[0098] The present application designs to freely control the catheter tip direction by means of the tube body operation part 4 to perform single lung lobe isolation at the level of lobar bronchus; the shape design of the "conical" inflatable cuff at the distal end of the catheter is more suitable for the opening of the lobar bronchus; the camera at the distal end of the catheter can be ensured to be in good alignment with the lobar opening bronchus during the whole process of the operation, and the physical isolation of the operation area and the non-operation area at the level of the secondary bronchus is realized. The target lobe is isolated through the lobar bronchus and remains static during the intervention operation, which can improve the accuracy of lung nodule ablation and reduce the collateral heat or cold damage to the surrounding normal tissue caused by respiratory movement; after the target lobe is isolated, the communication between the blood and secretions of the lobe and the healthy lobe can also be blocked. Once unexpected massive bleeding occurs during diagnosis and treatment, the bleeding can be confined to a separate lobe to ensure the safety of the patient's life.

[0099] 4. Provide operation conditions for multi-technology composite bronchoscope diagnosis and treatment integrated robot system, and improve the safety of airway management.

[0100] The multi-technology composite bronchoscope diagnosis and treatment integrated robot system checks and treats "suspected lung nodules" through the natural cavity of the human body, which has the characteristics of small trauma, quick recovery and high patient comfort. However, this new technology also brings new challenges to airway management during the operation. On the one hand, both the multi-technology composite bronchoscope and the airway management tool need to function through the common space of the trachea. The multi-technology composite bronchoscope has a complex structure and a relatively large outer diameter, with a maximum outer diameter of 7mm, and 1-2mm space is required for clinical operation, which makes it difficult to coexist with traditional airway management tools in the airway; on the other hand, the operation and treatment of the multi-technology composite bronchoscope are complex and diverse, with many uncontrollable factors. When a single-lumen endotracheal tube or laryngeal mask is used for double-lung ventilation operation, respiratory movement increases the difficulty of positioning and reduces the accuracy of ablation, and tumor / infectious tissue fluid may enter the main bronchus after puncture and ablation. If unexpected massive bleeding occurs during diagnosis and treatment, a large amount of blood may enter the healthy lung tissue in a short time, causing gas exchange disorder, affecting oxygenation of the body, and threatening life safety.

[0101] The present application is a single-lumen tube, which can be designed to have a relatively thin catheter diameter to meet the surgical operation requirements of the multi-technology composite bronchoscope diagnosis and treatment integrated robot system, while maximizing the safety of the patient during diagnosis and treatment. The multi-technology composite bronchoscope can enter the airway parallel to the tube body outside the tube body to perform diagnosis and treatment operation, which makes up for the deficiency that the multi-technology composite bronchoscope cannot enter the airway through the lumen of the existing clinical lung isolation airway management tool to perform diagnosis and treatment operation.

[0102] For the multi-technology composite bronchoscope diagnosis and treatment operation related to the lung, the catheter is placed in the main bronchus of the non-operation side lung, and the left / right side lung is isolated at the tracheal carina level. For patients with poor lung function who cannot tolerate unilateral lung ventilation, before the multi-technology composite bronchoscope reaches the target site for diagnosis and treatment, the designed catheter can be placed in the diseased lobe opening for single lobe isolation, and then the bronchoscope related diagnosis and treatment operation is performed, which not only provides an excellent diagnosis and treatment operation environment, but also realizes the physical isolation of the operation area and the non-operation area.

[0103] For the multi-technology composite bronchoscope diagnosis and treatment operation related to the mediastinum, the catheter is placed in the main airway, the first inflatable cuff is contracted, and the second inflatable cuff is inflated above the carina to physically isolate the double lungs from the main airway. While ensuring the bronchoscope to diagnose and treat the mediastinal space occupying, it does not affect normal double lung ventilation. Once unexpected bleeding occurs during the diagnosis and treatment of the mediastinal space occupying, the second inflatable cuff moves to the bleeding point under the inflated state to compress and stop bleeding, and the first inflatable cuff is inflated to isolate the main airway from the double lungs or unilateral lung, thereby maximizing the safety of the patient's life.

[0104] 5. Reduce iatrogenic damage to vocal cords, throat soft tissue and airway, and improve patient comfort

[0105] The incidence and severity of postoperative hoarseness and throat pain are directly related to the size of the tracheal tube diameter. The currently commonly used lung isolation airway management tools all have the problem of thicker tube diameter and harder catheter texture, which may cause damage to the vocal cords, throat soft tissue and airway due to direct contact and static compression. In the dynamic process of intubation, extubation and intraoperative positioning and use, it may also cause friction damage.

[0106] The designed catheter has a thinner diameter and a softer texture, which can effectively reduce or avoid static compression and dynamic damage to the vocal cords, throat soft tissue and airway during operation, reduce postoperative hoarseness and throat pain, prevent tracheal mucosa from being damaged, and improve patient comfort and satisfaction.

[0107] 6. Optimize the airway management process of composite operation

[0108] The clinical demand for intraoperative diagnosis and operation of multi-technology composite bronchoscopy in lung-related surgery is gradually increasing, such as preoperative lesion positioning and preoperative biopsy to determine histological diagnosis. The outer diameter of multi-technology composite bronchoscopy is relatively thick, and it cannot pass through the lumen or outside of the double-lumen endotracheal tube. At present, when performing composite surgical operation, a single-lumen tracheal tube with a larger diameter (ID 8.0mm) or a laryngeal mask is used for airway management, and the fiberoptic bronchoscopy diagnostic operation is completed, and then a double-lumen endotracheal tube is replaced for lung isolation and surgery. Repeated intubation and extubation not only prolongs the clinical operation time, but also increases the mechanical stimulation of the vocal cords, throat soft tissues and airway of the patient.

[0109] The present application is designed for the lung isolation operation requirement related to the integrated diagnosis and treatment of pulmonary nodules. When using multi-technology composite bronchoscopy for diagnosis and treatment, the present application is designed to enter the airway in parallel with the fiberoptic bronchoscope, the present application is designed to be placed in the healthy side of the main airway for lung isolation and mechanical ventilation, and the multi-technology composite bronchoscope is placed in the affected side of the lung for related diagnosis and treatment. After the fiberoptic bronchoscopy diagnostic operation is completed, it is directly withdrawn, and immediate surgical treatment can be performed without the need for tube replacement operation. The clinical operation is more time-saving and labor-saving, and the management is flexible, which also reduces the damage caused by repeated intubation and extubation.

[0110] 7. The same airway management tool meets the needs of multiple surgeries and operations, facilitates medical personnel, and reduces medical costs

[0111] Different airway management tools are needed for different lung-related surgeries and operations, and medical personnel need to spend a lot of effort and time cost in clinical selection, training and use. Traditional lung isolation ventilation technology cannot meet the needs of updated and iterative minimally invasive surgical operation technology, and may even increase the discomfort and risk of patients during the perioperative period.

[0112] The present application is designed for the lung isolation requirement related to the integrated diagnosis and treatment of pulmonary nodules, and realizes the isolation of the surgical area and the non-surgical area. It can not only meet and improve the airway management requirement of traditional lung-related surgery, but also greatly increase the airway management safety of new diagnosis and treatment operations such as interventional surgery and endoscopic treatment, while ensuring the life of the patient, it also makes the clinical practice of medical personnel more convenient, and indirectly reduces the medical cost.

[0113] It should be noted that the present application is not limited to the above-mentioned embodiments, and the above-mentioned embodiments can be combined to form new embodiments without conflict, which all belong to the protection scope of the present application. The present application is not limited to the specific structures and processes described above and shown in the drawings. For the sake of brevity, detailed descriptions of well-known methods are omitted here. In the above-mentioned embodiments, several specific steps are described and shown as examples. However, the method process of the present application is not limited to the specific steps described and shown, and those skilled in the art can make various changes, modifications and additions, or change the order between steps, after understanding the spirit of the present application.

[0114] It should also be noted that the exemplary embodiments mentioned in the present application describe some methods or systems based on a series of steps or devices. However, the present application is not limited to the order of the above-mentioned steps, that is, the steps can be performed in the order mentioned in the embodiments, or in an order different from that in the embodiments, or several steps can be performed simultaneously.

[0115] The above is only a specific implementation of the present application, and those skilled in the art can clearly understand that, for the convenience and brevity of description, the specific working process of the above-mentioned system, module and unit can refer to the corresponding process in the foregoing method embodiments, which will not be described here. It should be understood that the protection scope of the present application is not limited thereto, and any person skilled in the art can easily think of various equivalent modifications or replacements within the technical range disclosed by the present application, which should be covered within the protection scope of the present application.

Claims

1. A tip-controlled endotracheal cannula, characterized in that, The endotracheal cannula includes an endotracheal tube and a first inflatable cuff and a second inflatable cuff spaced apart along the outer wall of the endotracheal tube. It also includes a camera disposed within the wall of the endotracheal tube between the first and second inflatable cuffs. The camera is used to capture images of its tip. The endotracheal tube extends from the proximal end to the distal end and forms a lumen inside. The distal end of the endotracheal tube has a first opening, and the proximal end has a second opening. The first inflatable cuff is located near the first opening, and both the first and second inflatable cuffs are connected to the inflatable lumen inside the endotracheal tube wall. At least one ventilation hole is provided on the endotracheal tube between the first inflatable cuff and the second inflatable cuff, the ventilation hole penetrating the wall of the endotracheal tube and communicating with the lumen of the endotracheal tube. The endotracheal tube has an elastic membrane in its lumen, and the elastic membrane has at least one third opening that communicates with the lumen of the endotracheal tube. The third opening is offset from the ventilation hole. It also includes a control component for controlling the elastic membrane to switch between closing and opening the ventilator. The control component is a third inflatable cuff located between the inner wall of the endotracheal tube and the elastic membrane, and offset from the ventilator along the longitudinal axis of the endotracheal tube. The third inflatable cuff is located at the distal end of the ventilator. The third inflatable cuff can switch between an inflated state and a deflated state. When the third inflatable cuff is inflated, it blocks the lumen of the endotracheal tube, and airflow can enter the ventilation port through the third opening of the elastic membrane. When the third inflatable cuff is deflated, the elastic membrane blocks the ventilation port, and airflow can flow through the third inflatable cuff and its surface elastic membrane toward the distal end of the endotracheal tube lumen.

2. The tip-controlled endotracheal cannula according to claim 1, characterized in that, The elastic membrane is fixed to the inner wall of the endotracheal tube at least at its proximal and distal ends, wherein the distal end of the elastic membrane extends beyond the third inflatable cuff and is located at the distal end of the third inflatable cuff, and the proximal end of the elastic membrane extends beyond the ventilation port and is located at the proximal end of the ventilation port.

3. The tip-controlled endotracheal cannula according to claim 2, characterized in that, The elastic membrane is designed to compress the third inflatable cuff when the third inflatable cuff is in a contracted state, thereby increasing the cross-sectional area of ​​that section of the endotracheal tube.

4. The tip-controlled endotracheal cannula according to claim 3, characterized in that, At least one ventilation hole protrudes from the inner wall of the tracheal tube to form a ventilation tube, and the ventilation tubes are arranged sequentially along the longitudinal axis of the camera near the camera.

5. The tip-controlled endotracheal cannula according to claim 4, characterized in that, Along the longitudinal axis of the endotracheal tube, from the proximal end to the distal end, the height of the multiple ventilation tubes protruding from the inner wall of the lumen gradually increases.

6. The tip-controlled endotracheal cannula according to claim 5, characterized in that, 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.

7. The tip-controlled endotracheal cannula according to any one of claims 4-6, characterized in that, At least one of the air inlets of the ventilation tube is inclined at an angle from the proximal end to the distal end along the longitudinal axis of the tracheal tube.

8. The tip-controlled endotracheal cannula according to any one of claims 4-6, characterized in that, The ventilation tube is fixed by being inserted into a through hole formed in the wall of the endotracheal tube.

Images