Coaxial guide system for bronchial occlusion

Abstract

The invention discloses a coaxial guide system for bronchial occlusion. The system comprises a bronchial occluder and a bronchoscope which are coaxially guided, wherein the occluder comprises a tube body, an expandable occluding balloon arranged at the far end, an observation window arranged at the near end of the balloon and a control channel communicated with the balloon. The observation window comprises a flexible transparent film, and a coaxial guide structure is formed between the cavity of the tube body and the bronchoscope body, so that the bronchoscope can be coaxially guided along the central axis of the tube body in a first working state, and the plugging device is guided to enter a target bronchus; in the second working state, the lens arranged at the far end of the bronchoscope can be withdrawn to the position of the observation window, and the positioning and blocking conditions of the balloon are observed through the observation window. The device is simple in structure, stable coaxial guiding can be provided in the inserting and positioning process, real-time observation is achieved in plugging operation, and the safety and accuracy of clinical operation are improved.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a coaxial guidance system for bronchial occlusion, which is suitable for single-lung ventilation, selective lobar isolation, and bronchial occlusion treatment in thoracic surgery. Background Technology

[0002] Bronchial occluders are essential tools in clinical anesthesia and thoracic surgery for achieving one-lung ventilation (OLV) or selective lobar isolation. They mechanically obstruct the target bronchus, causing the target lung tissue to collapse, thereby providing a clear surgical field and reducing interference with the healthy lung. Commonly used occluders include the Arndt® guidewire-guided occluder, the Cohen® deflectable occluder, the Fuji Univent single-lumen occluder tube, and the Rusch EZ-Blocker® Y-type occluder.

[0003] The limitations of existing occluders are mainly reflected in the following aspects: (1) Insufficient occlusion accuracy: The limited matching degree between the balloon and the bronchial anatomy often leads to incomplete occlusion and incomplete collapse of the target lung. (2) Poor positioning stability: During changes in surgical position or operation, the occluder is prone to displacement or even dislodgement, resulting in failure of lung isolation. (3) High operational complexity: Traditional occluders often require repeated insertion and removal of the bronchoscope for positioning adjustment, prolonging the operation time and increasing the difficulty of anesthesia management. (4) Limited scope of application: Existing occluders are mainly used for whole lung occlusion, which is difficult to meet the needs of selective lobar or segmental occlusion, especially in patients with tracheal stenosis, tracheal stents or airway tortuosity and deformation, the risk is higher.

[0004] For example, Arndt ® The guidewire-guided occluder uses a lasso structure to attach the occluder to the fiberoptic bronchoscope and enters the target bronchus in parallel. This parallel guidance method is usable in the main bronchus or larger bronchi, but when entering the upper pulmonary bronchi, segmental bronchi, or in patients with complex conditions such as tracheal stenosis or tracheal stents, it often fails to reach the target location due to the angle formed by the traction path, and may even pose operational risks. Furthermore, this structure requires repeated adjustments to the relative positions of the fiberoptic bronchoscope and the occluder during positioning, making the operation complex and lacking in stability.

[0005] Therefore, existing technologies cannot fully meet new clinical needs, especially in cases of selective lobar or segmental occlusion, patients with tracheal stents or stenosis, and scenarios requiring simultaneous tracheal occlusion while maintaining spontaneous ventilation. There is an urgent need to develop a novel bronchial occlusion component that improves occlusion accuracy and stability while simplifying the procedure to adapt to increasingly complex clinical applications. Summary of the Invention

[0006] To address some problems existing in the prior art, the present invention aims to provide a coaxial guidance system for bronchial occlusion. By forming a coaxial guiding structure between the occluder tube cavity and the bronchoscope body, stable guidance is achieved during insertion. Furthermore, by setting an observation window at the proximal end of the balloon, the positioning and occlusion status of the balloon can be directly observed when the bronchoscope is withdrawn to the observation window position, thereby improving the accuracy and safety of the operation.

[0007] In a first aspect, the present invention provides a coaxial guidance system for bronchial occlusion, the system comprising a bronchial occluder and a bronchoscope; the occluder comprising a tube body, an inflatable occlusion balloon disposed distally, an observation window disposed proximal to the occlusion balloon, and a control channel communicating with the balloon; the observation window comprising a flexible transparent film for forming a transparent observation area; the lumen of the tube body and the bronchoscope body form a coaxial guiding structure, such that in a first working state the bronchoscope is kept coaxially guided along the central axis of the tube body to guide the occluder into the target bronchus, and in a second working state, the lens disposed distally to the bronchoscope can be retracted to the observation window position and the balloon positioning and occlusion status can be observed through the observation window.

[0008] In this invention, the bronchoscope can be a flexible bronchoscope, including fiberoptic bronchoscopes and electronic bronchoscopes, with fiberoptic bronchoscopes being preferred. Fiberoptic bronchoscopes are generally thinner than electronic bronchoscopes, allowing access to smaller bronchial branches; while electronic bronchoscopes offer superior image quality and functionality, they have a slightly larger diameter. Those in the art can select the appropriate type of bronchoscope based on the teachings of this invention and specific clinical needs.

[0009] In this invention, the system can operate in two states: the first state is when the bronchoscope is in the occluder cavity and coaxially guides the occluder into the target bronchus (e.g., a lobar or segmental bronchus); the second state is when the occlusion balloon reaches the target bronchus, at which time the bronchoscope lens (e.g., the optical lens of a fiberoptic bronchoscope or the camera of an electronic bronchoscope) can be retracted to the observation window position to observe the inflation and deflation of the occlusion balloon, balloon positioning, and occlusion status against the transparent film set on the observation window.

[0010] In one embodiment, the coaxial guide structure is formed by the diameter relationship between the inner diameter of the tube cavity and the bronchoscope body, wherein the inner diameter of the tube cavity is slightly larger than the outer diameter of the bronchoscope to form a clearance fit and maintain the coaxial relationship. In the system of this invention, the bronchoscope needs to slide freely within the occluder cavity so that the operator can adjust its position, rotate it, or withdraw it. If the bronchoscope and the occluder cavity are too tightly fitted, it may lead to difficulty in insertion and removal, increasing the risk of airway injury. In addition, the bronchoscope makes a bend as it descends through the oropharynx, which can hinder sliding. Therefore, a gap fit is preferred over a completely tight fit.

[0011] In one embodiment, the tube cavity of the occluder can be matched with the shape of the bronchoscope. In a specific embodiment, the inner diameter of the tube cavity can be slightly larger than the outer diameter of the bronchoscope, forming a small gap between them. Generally, the gap is 0.1-0.5 mm, which ensures the stability of the bronchoscope without being too loose to affect coaxial positioning, balancing sliding flexibility and guiding stability.

[0012] In a preferred embodiment, the inner wall of the tube cavity may be provided with a flexible liner to prevent the bronchoscope from shifting during insertion and withdrawal.

[0013] In this invention, the tube body can be made of medical-grade polyurethane or nylon material to ensure the strength and flexibility of the cavity, so as to adapt to repeated insertion and removal of the bronchoscope. The wall thickness and material strength of the tube body are set to maintain the roundness of the cavity during the insertion and withdrawal of the bronchoscope, and to prevent coaxial displacement due to deformation under stress.

[0014] In this invention, the inner wall of the occluder is provided with a lateral observation stabilizing component near the observation window, which provides a flexible limiting effect when the bronchoscope is withdrawn in the second working state, so that the lens of the bronchoscope is stably fixed in the observation window position.

[0015] The lateral observation stabilizing component is a flexible limiting structure. This structure alters the contact state between the inner wall region of the bronchoscope and the outer wall of the bronchoscope, generating greater friction than in other regions when the bronchoscope is retracted to this region. This allows the bronchoscope to remain stably in this position and continue to retract completely with appropriate pulling force. The region where this lateral observation stabilizing component is located can be anywhere on the proximal end of the inner wall of the bronchoscope, as long as the bronchoscope lens can remain stably in the observation window position. This flexible limiting structure prevents slippage of the bronchoscope when it is retracted to this position due to gravity or other operations (e.g., simultaneous adjustment of the lens direction), making it particularly suitable for operators new to the coaxial guidance system of this invention or junior physicians unfamiliar with bronchial occlusion procedures.

[0016] In several embodiments, the lateral observation stabilizing component may be a flexible friction limiting component, including either an elastic annular element or a friction-reinforced liner.

[0017] The elastic annular component can be an O-ring (e.g., a medical silicone O-ring), a TPU elastic ring, a TPE / TPR elastomer ring, a foam elastic ring, etc. The elastic annular component can be configured in any of the following ways: an annular groove extending circumferentially on the inner wall of the bronchoscope, with a solid O-ring embedded in the groove, which is compressed and forms a circumferential friction fit with the inner wall of the bronchoscope as it passes through; a hollow elastic ring with a cavity in the middle of its cross-section, providing greater compressibility and a softer feel; an elastic component with a corrugated cross-section embedded in the annular groove, forming multi-point frictional contact as the bronchoscope passes through; and so on.

[0018] The friction-enhancing liner can be formed of an elastic material with a friction coefficient higher than that of the occluder tube material, providing a limiting effect of enhanced friction when the bronchoscope is retracted into the area of ​​the friction-enhancing liner. The friction-enhancing liner can be achieved by: arranging micro-protrusion textures in localized areas of the inner surface of the tube body; a coating or adhesive layer made of a high-friction elastic material; locally forming an elastic material liner; an elastic material combined with a micro-textured liner; locally thickened or multi-point flexible protrusions or flexible toothed structures; setting a corrugated elastic liner ring; or using adhesive elastic material sheets (e.g., attaching an elastic sheet to the inner wall of the tube body). The friction-enhancing liner can be formed through processes such as coating, co-extrusion molding, secondary injection molding / overmolding, and adhesion / attachment.

[0019] In another embodiment, the inner wall of the tube may be configured with a flexible tapering section near the proximal end of the observation window to form the lateral observation stabilizing component, used in the second operating state to guide the bronchoscope lens to remain in the observation window position during bronchoscope retraction. The flexible tapering section is an elastic restraint section with a slightly smaller inner diameter; when the bronchoscope is retracted to this restraint section, the friction between the outer wall and the inner wall of the occluder tube increases, allowing the bronchoscope lens to remain stably in the observation window position. It should be understood that despite the presence of the flexible tapering section, the bronchoscope can still be fully retracted when appropriate tension is applied. The flexible tapering section can be prepared by extruding the tube body in one step, followed by localized thermo-shrink / compression molding of the tube body using a mold.

[0020] It should be understood that the aforementioned flexible friction limiting components or flexible diameter reduction sections should be set within reasonable limits to ensure that the bronchoscope can be smoothly inserted into or withdrawn from the bronchial occluder.

[0021] In this invention, the strength of the tube body can be matched with the rigidity of the bronchoscope body to prevent bending or jamming during insertion and removal.

[0022] In one embodiment, the observation window can be circular or approximately circular, with its effective diameter defined as the maximum inner diameter of the opening, ensuring that the distal end of the bronchoscope can obtain a sufficient field of view. In other embodiments, the observation window can be elliptical, rectangular, or other shapes, in which case the effective diameter can be understood as the diameter of an equivalent circle, i.e., the diameter of a circle with an opening area equal to that shape. Preferably, the observation window can have a replaceable structure, such as a detachable or modular structure. Preferably, a reinforcing structure is provided around the observation window to maintain the strength of the tube wall and the flatness of the membrane.

[0023] The flexible transparent film can be made of medical-grade thermoplastic polyurethane (TPU), silicone rubber, or polyether block amide (Pebax), with a thickness of, for example, 30-120 micrometers, to balance flexibility and optical transparency. The film surface may also be coated with an anti-fogging coating, a hydrophilic coating, or an antibacterial coating to reduce the risk of condensation, reflection, or infection during observation. The film has good biocompatibility and is suitable for sterilization with ethylene oxide or low-temperature hydrogen peroxide.

[0024] It should be noted that, in order to comply with the regulatory and usage requirements for medical devices, all materials used in the system of this invention should be suitable for sterilization by ethylene oxide, low-temperature hydrogen peroxide, or gamma rays.

[0025] In one embodiment, the effective diameter of the observation window is 1.2-3 times the diameter of the distal lens of the bronchoscope. Common fiberoptic bronchoscope distal lenses have a diameter of approximately 2-4 mm (Note: In this invention, "distal" is defined as the end closest to the object or area of ​​application, corresponding to the tip of the fiberoptic bronchoscope extending along the insertion direction). Therefore, the size of the observation window must ensure that the lens can completely contact the film and obtain a clear image, while retaining a certain margin to avoid operational errors. To this end, the lower limit of the observation window size must ensure that the lens can completely cover the observation window without obstruction, while the upper limit should prevent the observation window from being too large, which could lead to a decrease in tube wall strength or inaccurate positioning. Therefore, the ratio of the effective diameter of the observation window to the diameter of the distal lens of the bronchoscope can be set to 1.2-3 times. Considering that the lens will experience a certain amount of stretching when it contacts the film, a ratio of 1.2-1.5 times is preferred.

[0026] In this invention, the control channel can be configured in any of the following ways: integrated within the tube wall and coaxially arranged with the cavity, arranged along the tube wall and parallel to the cavity, or located on the outer wall of the tube as an independent tubing. In a preferred embodiment, the control channel can be an independent inflation tubing with an interface at its proximal end for connecting to an air source or syringe. Preferably, the proximal interface of the control channel is arranged side-by-side with the bronchoscope operating handle to facilitate one-handed operation.

[0027] In this invention, in the second working state, the field of view of the bronchoscope lens at the observation window preferably includes the distal end of the occluder entering the left or right main bronchus, the occlusion balloon, the carina, the entrance of the contralateral main bronchus, and the corresponding tracheal cartilage rings and tracheal mucosa.

[0028] In a second aspect, the present invention provides a method for using the above-described system of the present invention, comprising: in a first working state, inserting a bronchoscope and coaxially guiding an occluder into a target bronchus; in a second working state, reaching the target bronchus with an occlusion balloon, retracting the lens of the bronchoscope to the observation window position, stably pressing the lens against the membrane, observing the positioning and occlusion of the balloon, and inflating or deflating the balloon through a control channel.

[0029] Preferably, the system of the present invention can be configured to be compatible with a fiberoptic bronchoscope with a diameter of 2-4 mm, and can be used for selective lobar occlusion, segmental occlusion; patients with tracheal stents; patients with tracheal stenosis; and patients who need to cooperate with tracheal occlusion while maintaining spontaneous ventilation.

[0030] Beneficial effects Compared with the prior art, the present invention has the following beneficial effects: 1. Improved precision: With coaxial guidance, the occluder can reach any bronchial location accessible to a bronchoscopy lens, achieving precise occlusion of a lung lobe or segment.

[0031] 2. Enhanced stability: The thin film of the observation window allows the lens to be placed against the image, making positioning more intuitive and reducing the risk of occluder displacement.

[0032] 3. Simplified operation, high ease of use, and high operational safety: The coaxial structure avoids the traction and angle problems of parallel guidance, reduces repeated adjustments, shortens operation time, and lowers the operational threshold in complex bronchial occlusion scenarios. The lateral observation stabilization component is more suitable for operators using the coaxial guidance system of this invention for the first time or junior doctors who are not proficient in bronchial occlusion operations, improving ease of use and operational safety, and reducing reliance on operator experience.

[0033] 4. Expanded scope of application: It can adapt to complex clinical scenarios such as tracheal stenosis, tracheal stents and airway tortuosity and deformation, while supporting patients who retain spontaneous ventilation. Attached Figure Description

[0034] Figure 1 This is a schematic diagram of the overall structure of the coaxial guidance system of the present invention. Figure 2 This is a schematic diagram of the occluder and bronchoscope in their first working state. Figure 3 This is a schematic diagram of the occluder and bronchoscope in the second working state. Figure 4 In order to be in Figure 3 The enlarged view of point A in the second working state shown. Figure 5 A schematic diagram of a lateral observation stabilization component installed inside the tube cavity. Figure label: 1. Bronchial occluder; 2. Bronchoscope; 11. Bronchus body; 12. Occlusion balloon; 13. Observation window; 14. Lateral observation stabilizing component; 21. Bronchoscope body; 22. Bronchoscope lens; 23. Operating handle Detailed Implementation To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention are described clearly and completely below. Obviously, the described embodiments are only some, not all, of the embodiments of this invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0035] Unless otherwise defined, the technical or scientific terms used in this invention shall have the ordinary meaning understood by one of ordinary skill in the art to which this invention pertains. The terms "first," "second," "third," "fourth," and similar terms used in this invention do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as "comprising" or "including" mean that the element or object preceding the word encompasses the elements or objects listed following the word and their equivalents, without excluding other elements or objects. Terms such as "connected" or "linked" are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect.

[0036] Distal or distal: In this specification, when “distal or distal” is mentioned, the term refers to the end or side that is relatively far from the operator, or the end or side that is close to the object or area being operated on.

[0037] Proximal or proximal end: In this specification, when “proximal or proximal end” is mentioned, the term generally refers to the end or side that is relatively closer to the operator or the end or side that is farther away from the object or area being operated on.

[0038] Anterior or front end: In this manual, when “anterior or front end” is mentioned, the term generally refers to the direction in which the instrument body extends along the insertion direction, and unless otherwise specified, it generally corresponds to “distal or distal”.

[0039] Rear or rear end: In this specification, when "rear or rear end" is mentioned, the term generally refers to the direction opposite to the insertion direction, and unless otherwise specified, generally corresponds to "proximal side or proximal end". Diameter: The diameter is defined as the distance between two points on the edge of a planar figure or solid (such as a circle, conical section, sphere, cube). In this document, diameter generally refers to the maximum length of an object. For objects with irregular shapes, the diameter is the length of the longest cross-section of the object. Furthermore, unless otherwise specified, diameter in this document refers to the outer diameter.

[0040] Figure 1 This is a schematic diagram of the overall structure of the coaxial guidance system of the present invention. Figure 1 As shown, the coaxial guidance system of the present invention includes a bronchial occluder 1 and a bronchoscope 2. The occluder 1 includes a tube body 11, an inflatable occlusion balloon 12 disposed at the distal end of the tube body, an observation window 13 disposed proximal to the balloon, and a control channel (not shown) communicating with the balloon. The observation window 13 is made of a flexible transparent film and is used to achieve optical observation of the lateral field of view in the second working state. The bronchoscope 2 includes a bronchoscope body 21, a bronchoscope lens 22, and an operating handle 23.

[0041] Figure 2 This is a schematic diagram of the first working state of the coaxial guidance system of the present invention. Figure 2 As shown, in the first working state, the bronchoscope 2 is inserted into the cavity of the tube body 11. The diameter of the cavity of the tube body 11 is slightly larger than the diameter of the bronchoscope body 21 to form a clearance fit, thereby constituting a coaxial guiding structure. The bronchoscope 2 guides the occluder into the target bronchus along the central axis of the tube body, achieving precise insertion.

[0042] Figure 3 This is a schematic diagram of the second working state of the coaxial guidance system of the present invention. Figure 3 As shown, in the second working state (i.e., after the occluder 1 has been guided into place), the bronchoscope lens 22 is retracted to the observation window 13 position, and the positioning and occlusion of the balloon 12 are observed through the transparent film installed on the observation window. Figure A shows that the bronchoscope lens 22 has been retracted and is against the transparent film on the observation window 13.

[0043] Figure 4 In order to be in Figure 3 The enlarged view of point A in the second operating state is shown. Figure 4 As shown, the effective diameter of the observation window 13 is 1.2–3 times the diameter of the distal bronchoscope lens 22 (indicated by the dashed line) to ensure that the field of view of the lens 22 covers the balloon 12 and surrounding anatomical structures. The transparent film installed on the observation window 13 can be made of a flexible transparent film material, such as medical TPU, silicone rubber, or Pebax, and an anti-fogging or hydrophilic coating can be further applied to the surface of the transparent film.

[0044] Figure 5 This is a schematic diagram of a lateral observation stabilizing component 14 located on the inner wall of the tube near the observation window 13. (See diagram below.) Figure 5 As shown, a lateral observation stabilizing component 14 is provided on the inner wall near the tube body. This component provides a flexible limiting effect during bronchoscope retraction in the second working state, ensuring the bronchoscope lens remains stably positioned at the observation window. Figure 5 In the middle, the stabilizing component 14, viewed from the side, is in the form of an elastic ring or a friction-enhanced inner liner, such as an O-ring, a TPU elastic ring, a TPE / TPR elastomer ring, a foam elastic ring; an elastic material inner liner, a high-friction elastic material coating, an adhesive elastic sheet, etc.

[0045] Below, in conjunction with the appendix Figure 1-5 The illustrated embodiments demonstrate the method of using the coaxial guidance system of the present invention.

[0046] I. Preparation Stage (see...) Figure 1 ) The operator prepares a bronchial occluder 1 and a bronchoscope 2. The occluder includes a tube body 11, a distal inflatable occluder balloon 12, an observation window 13 located proximal to the balloon, and a control channel communicating with the balloon. A flexible transparent membrane is installed on the observation window 13. The bronchoscope includes a body 21, a distal lens 22, and an operating handle 23. The proximal interface of the control channel (not shown in the figure) connects to an air source or syringe for subsequent balloon inflation.

[0047] II. Insertion Phase: First Working State (see...) Figure 2 ) The operator inserts the bronchoscope 2 into the lumen of the bronchus tube 11. Since the inner diameter of the lumen is slightly larger than the outer diameter of the bronchoscope, a clearance fit is formed, thus creating a coaxial guiding structure. During insertion, the bronchoscope moves along the central axis of the tube, guiding the occluder into the target bronchus for precise insertion.

[0048] III. Withdrawal and Observation Phase: Second Working State (see...) Figure 3 and Figure 4 ) Once the occluder reaches the target position, the operator slowly retracts the bronchoscope to the observation window 13. Due to the lateral observation stabilizing component 14 at the proximal end, the bronchoscope lens 22 can remain stably positioned at the observation window. As the bronchoscope retracts to the area of ​​the lateral observation stabilizing component, the operator will feel a change in feel, from "smooth" to "slightly damped," due to the flexible limiting effect of the component. This allows the operator to visually determine that the lens 22 has reached the observation window. At this point, the operator can observe the positioning and occlusion of the balloon 12 through the flexible transparent film observation window via the lens 22. The field of view of the lens 22 can also be adjusted by bending a control wire located at the distal end of the bronchoscope 2 to adjust the direction of the lens 22.

[0049] IV. Balloon Inflation and Monitoring The operator inflates or deflates the balloon 12 via the control channel. The control channel is an independent tubing arranged along the tube wall, with an interface at the proximal end for connecting to the air source. In the second working state, the lens's field of view covers the distal end of the occluder, the balloon, the carina, the main bronchial inlet, and the corresponding tracheal cartilage rings and tracheal mucosa, enabling real-time monitoring.

[0050] V. Limitation and Stability Observation (see) Figure 5 ) To prevent the lens from shifting at the observation window or sliding due to other operations, a lateral observation stabilizing component 14 is provided at the near end of the tube. This component provides a flexible limiting function in the second operating state, ensuring that the lens is stably pressed against the observation window film, thereby improving observation clarity and operational safety.

[0051] Through the above-described usage, the system of this invention, via five stages—insertion, withdrawal, observation, inflation, and monitoring—enables precise insertion of the occluder in the first working state, real-time observation of balloon positioning in the second working state, and inflation and monitoring via a control channel. The system is compact in structure, has a clear operating procedure, and is suitable for clinical scenarios such as lobar septation, bleeding control, and ventilation management.

[0052] The following provides detailed operating instructions for three typical clinical application scenarios of the coaxial guidance system of the present invention.

[0053] I. Occlusion of the bronchus in the left upper lobe of the lung 1. Indications: When left upper lobe surgery (such as lobectomy, wedge resection, local tumor resection) requires selective collapse of the left upper lobe while preserving ventilation of the left lower lobe (e.g., after a right pneumonectomy); when local bleeding in the left upper lobe requires emergency isolation and hemostasis; when infection or abscess in the left upper lobe requires prevention of the spread of secretions.

[0054] 2. Operating steps: (1) Preparation stage: After completing the induction of general anesthesia and endotracheal intubation, the bronchial occluder is placed on the fiberoptic bronchoscope, the airtightness of the occlusion balloon is checked, and the control channel connection is confirmed to be intact.

[0055] (2) Entering the trachea: A fiberoptic bronchoscope fitted with an occluder (i.e., the coaxial guidance system of the present invention) is inserted through the tracheal tube. The distal end of the fiberoptic bronchoscope extends about 2-3 cm from the distal end of the occluder, maintaining a coaxial relationship.

[0056] (3) Identify the carina: Under direct vision with a fiberoptic bronchoscope, identify the tracheal carina and confirm the anatomical relationship between the openings of the left and right main bronchi.

[0057] (4) Enter the left main bronchus: guide the bronchoscope into the left main bronchus, proceed along the left main bronchus, and identify the opening of the left upper lobe bronchus (usually located on the upper lateral wall about 3-5 cm from the beginning of the left main bronchus).

[0058] (5) Enter the left upper lobe bronchus: Adjust the distal end of the bronchoscope to face the left upper lobe bronchus opening and confirm that the lens has been completely entered into the left upper lobe bronchus.

[0059] (6) Pushing the occluder: Under the guidance of the bronchoscope, push the bronchial occluder forward along the coaxial direction of the bronchoscope, so that the distal end of the occluder and the balloon part enter the left upper lobe bronchus. Keep the position of the bronchoscope stable during the pushing process to ensure that the coaxial guidance remains unchanged.

[0060] (7) Withdraw the bronchoscope to the observation window: Withdraw the bronchoscope backward to the observation window position near the occluder (about 1 cm from the lower edge of the balloon). After the bronchoscope lens is withdrawn, it rests at the transparent film observation window.

[0061] (8) Inflation occlusion: Slowly inject air into the balloon through the control channel (usually 2-5 ml, the specific volume is adjusted according to the bronchial diameter), and observe the balloon inflation in real time through the observation window. If necessary, adjust the bending control wire at the distal end of the fiberoptic bronchoscope to adjust the direction of the lens and adjust the field of view.

[0062] (9) Confirm the occlusion location: Confirm the following anatomical landmarks through the observation window: The balloon completely occludes the opening of the left upper lobe bronchus; the opening of the left lower lobe bronchus is not blocked by the balloon and remains unobstructed; there are no signs of pressure, whitening or damage to the mucosa of the left main bronchus.

[0063] (10) Fixation and monitoring: After confirming that the occlusion position is correct, fix the proximal end of the occluder and record the balloon inflation volume. During the operation, the bronchoscope can be retracted to the observation window position at any time to observe the occlusion status through the transparent film.

[0064] 3. Precautions The left upper lobe bronchus has many branching variations; therefore, a chest CT scan should be performed before the procedure to understand the individual's anatomical characteristics. The balloon should not be over-inflated to avoid compressing adjacent blood vessels and bronchi. The occlusion position should be rechecked after any changes in patient position during the procedure.

[0065] II. Left main bronchial occlusion in patients with subglottic stenosis and tracheal silicone stent. 1. Indications: Patients who have previously had a silicone tracheal stent implanted due to tracheal stenosis (such as scar stenosis after long-term endotracheal intubation, post-tracheal tumor surgery, tracheomalacia, etc.) and require left thoracic surgery or left lung isolation. In these patients, because the stent occludes the space within the tracheal lumen, traditional parallel occluders (such as Arndt guidewire-guided occluders) are difficult to pass through the stenotic segment or may interfere with the stent.

[0066] 2. Operating Procedures (1) Preoperative assessment: Carefully review chest CT images to assess the location, length, inner diameter of the tracheal stent, and the distance between the distal end of the stent and the carina. Measure the diameter at the narrowest point of the stent lumen and select a combination of fiberoptic bronchoscope and occluder with matching outer diameter.

[0067] (2) Instrument selection: Select a bronchoscope with a smaller outer diameter (e.g., 1.8-2.8 mm) to ensure that the maximum outer diameter of the coaxial combination of bronchoscope and occluder is smaller than the diameter of the narrowest part of the stent cavity. Usually, a combination with an overall outer diameter of no more than 4-5 mm is selected.

[0068] (3) Anesthesia induction: After general anesthesia induction, use a laryngeal mask airway to control ventilation and ensure that the occluder can pass through smoothly.

[0069] (4) Passing through the stent section: Insert the fiberoptic bronchoscope with the occluder into the trachea. When passing through the stent section, the operation should be slow and gentle, and the fiberoptic bronchoscope should be kept in the center to avoid friction with the stent wall. The advantage of the coaxial structure is that the overall outer diameter is minimized, reducing interference with the stent.

[0070] (5) Identify the distal stent and the carina: After the bronchoscope passes through the stent, identify the distal edge of the stent and the tracheal carina. Confirm the distance between the distal stent and the carina to assess the space for occluder placement.

[0071] (6) Enter the left main bronchus: guide the fiberoptic bronchoscope across the carina to enter the left main bronchus and confirm that the left main bronchus is patent.

[0072] (7) Pushing the occluder: Push the occluder coaxially along the fiberoptic bronchoscope so that the balloon portion enters the left main bronchus. During the pushing process, ensure that the occluder tube passes smoothly through the stent section to avoid jamming.

[0073] (8) Withdrawal of observation: Withdraw the bronchoscope lens to the observation window position. At this time, the observation window may be located inside the stent or at the distal end of the stent. Observe the positional relationship between the saccule and the carina through the transparent membrane. If necessary, adjust the bending control wire at the distal end of the bronchoscope to adjust the direction of the lens and adjust the field of view.

[0074] (9) Inflation and confirmation: Inflate the balloon slowly and confirm through the observation window that the balloon completely blocks the left main bronchus; the balloon does not cross the carina and affect the ventilation of the right main bronchus; and the balloon does not have direct contact or interference with the tracheal stent.

[0075] (10) Continuous monitoring: Given the special nature of the airway anatomy in patients with stents, the frequency of checking the occlusion position should be increased during the operation. Every 30 minutes or after a change in body position, the bronchoscope should be placed in the observation window to confirm the occlusion status.

[0076] 3. Precautions Coaxial guidance design offers several key advantages in this scenario. For example, compared to parallel occluders, the coaxial structure has a smaller overall outer diameter, making it easier to pass through narrowed sections and stent cavities. The procedure should be performed gently throughout to avoid stent displacement or damage to the airway mucosa. The balloon should be positioned away from the stent edge to prevent lateral pressure on the stent. If the stent is positioned low and too close to the carina, the feasibility and safety of occluder placement should be assessed.

[0077] III. Left main bronchial occlusion for unintubated patients under general anesthesia with preserved spontaneous breathing. 1. Indications: Patients undergoing non-intubated thoracoscopic surgery (NIVATS) requiring operative lung collapse; elderly patients or those with poor cardiopulmonary reserve who cannot tolerate conventional one-lung ventilation; and patients requiring rapid recovery of spontaneous breathing and cough reflex postoperatively. This type of anesthetic technique preserves the patient's spontaneous breathing and requires airway manipulation under sedation.

[0078] 2. Anesthesia Preparation: Administer sedatives (such as propofol or dexmedetomidine) via target-controlled infusion (TCI) or continuous infusion to maintain moderate sedation (Ramsay sedation score 3-4), preserving spontaneous breathing. Provide adequate surface airway anesthesia: 2% lidocaine is sprayed nasally or orally to adequately anesthetize the pharynx and glottis; Administer intratracheal lidocaine (usually 2-4 ml) via cricothyroid membrane puncture or the working channel of a fiberoptic bronchoscope to suppress the cough reflex. Perform a cervical vagal nerve block on the surgical side to suppress the lung stretch-cough reflex. Establish high-flow nasal cannula oxygen therapy (HFNC) or nasopharyngeal airway oxygen administration to maintain oxygenation during the procedure.

[0079] 3. Operating Procedures (1) Equipment preparation: Select a bronchoscope with a smaller outer diameter (e.g., 1.8-2.8 mm) and fit it with an appropriate occluder. Confirm that the high-flow oxygen therapy equipment is operating normally and prepare emergency airway management equipment.

[0080] (2) Oral or nasal access: Choose the oral or nasal route according to the patient's specific condition. The nasal route is less irritating to the patient but the passage is narrower; the oral route has a wider passage but requires the use of a mouth gag. Slowly insert the fiberoptic bronchoscope with the occluder through the selected route.

[0081] (3) Glottic observation and passage: Observe the movement of the glottis under direct vision with a fiberoptic bronchoscope. Wait for the glottis to open, and quickly pass through the glottis when the patient inhales and the vocal cords abduct. A small amount of lidocaine can be added to reduce stimulation when passing through the glottis.

[0082] (4) Endotracheal procedures: After entering the trachea, confirm the location of the carina and guide the fiberoptic bronchoscope into the left main bronchus. The entire procedure should be performed as gently and quickly as possible to minimize airway irritation to patients who retain spontaneous breathing.

[0083] (5) Pushing the occluder: After the fiberoptic bronchoscope reaches the left main bronchus, push the occluder along the coaxial direction. The advantage of the coaxial guiding structure is that a single lumen passes through the glottis, which causes less stimulation to the glottis compared to the parallel structure.

[0084] (6) Withdrawal and observation: Withdraw the bronchoscope lens to the observation window position and confirm through the transparent membrane that the balloon is located in the left main bronchus and that its positional relationship with the carina and right main bronchus is correct. If necessary, adjust the bending control wire at the distal end of the bronchoscope to adjust the direction of the lens and adjust the field of view.

[0085] (7) Inflation occlusion: Slowly inflate the balloon. At this time, the patient still maintains spontaneous breathing, the right lung continues to ventilate normally, and the left lung gradually collapses. The occlusion effect can be monitored in real time through the observation window.

[0086] (8) After completion, remove the bronchoscope: After confirming that the occlusion position is correct, completely remove the bronchoscope from the occluder channel. The proximal end of the occluder can be fixed to the patient's mouth and nose or connected to the anesthesia circuit stent.

[0087] (9) Maintenance and monitoring: Monitor the patient's respiratory rate, tidal volume and blood oxygen saturation during the operation. If it is necessary to check the occlusion position, the fiberoptic bronchoscope can be reinserted into the occluder cavity to the observation window position at any time.

[0088] 4. Precautions Patients who maintain spontaneous breathing are more sensitive to airway manipulation, and the procedure should be performed as gently and quickly as possible. Adequate surface anesthesia of the airway is crucial for a successful procedure. The advantages of the coaxial guidance system of this invention are: its overall outer diameter is smaller than that of parallel systems, and a single tube passing through the glottis causes less stimulation to the vocal cords, making it suitable for procedures that preserve spontaneous breathing. Maintain high-flow oxygen therapy throughout the procedure and monitor blood oxygen saturation. Have emergency airway equipment readily available; if the patient experiences severe coughing or hypoxemia, the occluder should be immediately removed and an artificial airway established.

[0089] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features therein, and such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A coaxial guiding system for bronchial occlusion, characterized in that, The system includes a bronchial occluder and a bronchoscope; The occluder includes a tube, an inflatable occlusion balloon located at the distal end, an observation window located at the proximal end of the occlusion balloon, and a control channel communicating with the balloon. The observation window includes a flexible transparent film for forming a transparent observation area; The lumen of the tube body and the bronchoscope body form a coaxial guiding structure, so that in the first working state, the bronchoscope is kept coaxially guided along the central axis of the tube body to guide the occluder into the target bronchus. In the second working state, the lens located at the distal end of the bronchoscope can be retracted to the observation window position and the balloon positioning and occlusion status can be observed through the observation window.

2. The coaxial guiding system according to claim 1, characterized in that, The first working state is when the bronchoscope is in the cavity of the occluder and coaxially guides the occluder into the target bronchus; the second working state is when the occlusion balloon reaches the target bronchus.

3. The coaxial guiding system according to claim 1, characterized in that, The coaxial guide structure is formed by the diameter relationship between the inner diameter of the tube cavity and the diameter of the bronchoscope body, wherein the inner diameter of the tube cavity is slightly larger than the outer diameter of the bronchoscope to form a clearance fit and maintain the coaxial relationship.

4. The coaxial guiding system according to claim 1, characterized in that, The inner wall of the occluder has a lateral observation stabilizing component near the observation window, which provides a flexible limiting effect when the bronchoscope is withdrawn in the second working state, so that the lens of the bronchoscope remains stably in the observation window position.

5. The coaxial guiding system according to claim 4, characterized in that, The lateral observation stabilizing component is a flexible friction limiting component, including either an elastic ring or a friction-enhancing inner liner.

6. The coaxial guiding system according to claim 4, characterized in that, The inner wall of the tube is configured to have a flexible narrowing section near the observation window to form the lateral observation stabilizing component, which guides the bronchoscope lens to remain in the observation window position during bronchoscope retraction in the second working state.

7. The coaxial guiding system according to claim 1, characterized in that, The flexible transparent film is made of medical-grade thermoplastic polyurethane, silicone rubber, or polyether block amide.

8. The coaxial guiding system according to claim 1, characterized in that, The observation window is circular or elliptical, and its effective diameter is 1.2-3 times the diameter of the distal lens of the bronchoscope.

9. The system according to claim 1, characterized in that, The control channel is an independent inflation line, with an interface at the near end for connecting to an air source or syringe.

10. The system according to claim 1, characterized in that, In the second working state, the field of view of the bronchoscope lens at the observation window includes the distal end of the occluder entering the left or right main bronchus, the occlusion balloon, the carina, the entrance of the contralateral main bronchus, and the corresponding tracheal cartilage rings and tracheal mucosa.

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