Easily-positioned double-lumen bronchial catheter with shared lumen and orifice, process and application

Abstract

The invention provides an easy-to-position cavity shared double-lumen bronchial catheter, which belongs to the field of medical instruments and comprises a supporting breather pipe, and a bronchial sealing bag and a main trachea sealing bag are sequentially arranged on one side of a branch breather port at the head end of the supporting breather pipe; a plurality of observation main ventilation ports are fully distributed in the supporting ventilation pipe between the bronchus sealing bag and the main trachea sealing bag in a manner of surrounding and penetrating through the side wall of the supporting ventilation pipe; the tail side of the supporting breather pipe is connected with two breathing connectors, and a thin-wall soft film breather pipe is arranged in a sealed mode and communicated with an inner cavity of any breathing connector and an inner cavity of the head side end of the supporting breather pipe. The supporting ventilation tube cavity is shared and matched with the thin-wall soft film ventilation tube, left and right single-lung ventilation can be implemented, lung isolation and positioning are facilitated by observing the main ventilation opening through a bronchofiberscope, and the device is simple in structure, convenient to use and worthy of popularization.

Description

Technical Field

[0001] The present invention mainly relates to the medical field, and in particular to an easy-to-position cavity-sharing double-lumen bronchial catheter and an application thereof. Background Art

[0002] Lung isolation technology refers to the technology of separating the ventilation pathways of both lungs at the level of the tracheal carina or bronchus, which enables the rapid development of the application of thoracoscopy in thoracic surgery. At present, lung isolation methods include: double-lumen bronchial catheters, bronchial blockers and single-lumen bronchial tubes, all of which have different advantages and disadvantages and cannot fully satisfy clinical anesthesiologists. There is an urgent need for a double-lumen bronchial catheter with a thinner outer diameter and a thicker inner diameter, which can facilitate lung collapse, suction, and lung inflation, and can be used as a single-lumen tracheal catheter when necessary. We have developed a patented product with patent number 202211112935X and patent name "A endobronchial catheter" to meet the above needs, and it is in the type inspection and registration stage.

[0003] Clinically, the perfect positioning of double-lumen endobronchial tubes depends on three technical methods: the misplacement rate of auscultation positioning is relatively high, reaching 42.9% to 54.3%. The misplacement rate of suction tube positioning is about 19%. Visual bronchoscopy positioning is the gold standard for double-lumen endobronchial tube positioning, and its final accuracy rate can reach 100%.

[0004] Literature has proven that visual bronchoscope positioning is highly correlated with the operator's proficiency, and anesthesiologists with more than three years of experience have a one-time success rate of about 90% when using visual bronchoscope positioning. Once the positioning is wrong, correction is difficult in most cases and requires repeated operations. Not only does it cause operational damage to the patient, it also brings many inconveniences to the smooth progress of the operation and even increases the risk of the operation. At the same time, when the double-lumen bronchial catheter is twisted, the ventilation opening in the main airway is deviated and partially blocked, which is not conducive to visual bronchoscope observation and positioning, nor is it conducive to ventilation. "An endobronchial catheter" also has this drawback.

[0005] In order to ensure the one-time success of intubation positioning of "an intraendobronchial catheter" by the video bronchoscope, we have further improved the product: the field of view is greatly increased, the opening area can be fully observed at the bronchial opening, it is convenient to use the video bronchoscope for inspection, the intubation positioning errors can be found and corrected at one time, and even if the catheter body is twisted during intubation, it can ensure smooth ventilation and improve the safety of use. Summary of the invention

[0006] In view of the above-mentioned defects of the prior art, the present invention provides a double-lumen bronchial catheter with a common cavity that is easy to locate and its application, comprising a supporting ventilation tube (1), wherein the opening at the head end of the supporting ventilation tube (1) is a branch ventilation port (3), and two breathing connection tubes (2) are arranged at the tail end of the supporting ventilation tube (1); a plurality of main observation ventilation ports (4) are arranged through the side wall of the supporting ventilation tube (1) in the range of 10-80 mm on the tail side of the branch ventilation port (3), and a thin-walled soft membrane ventilation tube (5) is arranged to connect the inner cavity of any one of the breathing connection tubes (2) and the inner cavity of the supporting ventilation tube (1) on the head side of the main observation ventilation port (4) through sealing and bonding, and the length and outer diameter of the thin-walled soft membrane ventilation tube (5) after expansion match the inner cavity of the supporting ventilation tube (1).

[0007] Furthermore, near the tail of the branch vent (3), on the head side of the main vent (4) for observation, a bronchial sealing bag (31) is arranged around the support vent (1), and a branch inflation tube (32) is arranged in the side wall of the support vent (1) to communicate with the inner cavity of the bronchial sealing bag (31), and the branch inflation tube (32) is arranged at the tail of the support vent (1) to communicate with the branch inflation port (33); near the tail of the main vent (4) for observation, a main tracheal sealing bag (41) is arranged around the support vent (1), and a main inflation tube (42) is arranged in the side wall of the support vent (1) to communicate with the inner cavity of the main tracheal sealing bag (41), and the main inflation tube (42) is arranged at the tail of the support vent (1) to communicate with the main inflation port (43).

[0008] Furthermore, the plurality of main ventilation ports (4) are adjacent to the bronchial sealing bag (31) on the head side and adjacent to the main tracheal sealing bag (41) on the tail side, and the distance between the bronchial sealing bag (31) and the main tracheal sealing bag (41) on the long axis of the supporting ventilation tube (1) is greater than the distance between the opening of the right bronchus R1 and the opening of the right lower lobe bronchus R2D, or greater than the distance between the opening of the left bronchus L1 and the opening of the left lower lobe bronchus L2D.

[0009] Furthermore, the plurality of main observation vents (4) are arranged away from the branch air tube (32), and the plurality of main observation vents (4) contain 4.5 mm round holes; if the main observation vents (4) cut off the main air tube (42), the head side stump of the main air tube (42) adjacent to the main air tube sealing bag (41) is closed.

[0010] Furthermore, a support spring with a matching outer diameter is buried in the rear cavity of the support ventilation pipe (1).

[0011] A manufacturing process of a double-lumen bronchial tube with a common cavity and easy positioning, comprising the following steps:

[0012] Step 1: prepare the support ventilation tube (1) by conventional extrusion process, and prepare the bronchial sealing bag (31) and the main tracheal sealing bag (41) by blow molding process; properly bond and fix the bronchial sealing bag (31) and the main tracheal sealing bag (41) to the outside of the support ventilation tube (1);

[0013] Step 2: avoiding the bronchial inflation tube (23), cutting a plurality of main observation vents (32) around the side wall of the supporting ventilation tube (1) between the bronchial sealing bag (31) and the main tracheal sealing bag (41); heat-sealing the head side stump of the main observation vent (32) adjacent to the main tracheal sealing bag (41) and cutting off the main inflation tube (32);

[0014] Step 3: Prepare a "Y"-shaped inner cavity connector (6) by injection molding, and bond the single cavity side (61) of the connector to the rear end of the support ventilation tube (1); use a guide rope to pull a thin-walled soft membrane ventilation tube (5) longer than the support ventilation tube (1) into the cavity of the support ventilation tube (1), blow air into the thin-walled soft membrane ventilation tube (5), and make the thin-walled soft membrane ventilation tube (5) swell in the cavity of the support ventilation tube (1); seal and bond the outer wall of the head side of the thin-walled soft membrane ventilation tube (5) to the inner wall of the branch ventilation port (2), and seal and bond the outer wall of the tail side of the thin-walled soft membrane ventilation tube (5) to the inner wall of the main cavity (62A) of the double cavity side (62) of the connector;

[0015] Step 4: prepare the breathing connection tube (4A) by extrusion molding, prepare the breathing connection socket (4B) by injection molding, insert the head ends of the two breathing connection tubes (4A) into the main cavity (62A) and the secondary cavity (62B) of the connector (6) and fix them by bonding, and insert the two breathing connection sockets (4B) into the end cavities of the two breathing connection tubes (4A);

[0016] Step 5: Check the sealing performance of the bronchial sealing bag (31) and the main tracheal sealing bag (41) pipelines, check the sealing performance of each connection part, and check the straightness of the thin-walled soft membrane ventilation tube (5) in the cavity of the supporting ventilation tube (1).

[0017] A method for using a double-lumen bronchial catheter with an easy-to-locate cavity sharing function, comprising the following steps:

[0018] S1: Select a suitable model product, open the package, lubricate the tip, and insert the intubation guide core into the cavity; after anesthesia induction, use laryngoscope to expose the glottis, and insert the tip of the support ventilation tube (1) into the patient's airway according to the conventional method. The intubation depth (cm) for males = 0.11 × height (cm) + 10.53, and the intubation depth (cm) for females = 0.11 × height (cm) + 10.94;

[0019] S2: Fill the main tracheal sealing bag (41) with an appropriate amount of gas, and connect the two breathing connection sockets (4B) to the ventilator through the transfer tube for controlled breathing; lubricate the end of the fiber bronchoscope lens, and insert it into the cavity of the supporting ventilation tube (1) through the secondary cavity (62B) of the connecting piece (6), between the bronchial sealing bag (31) and the main tracheal sealing bag (41), and check the inner wall of the airway and the position of the bronchial sealing bag (31) by observing the main ventilation port (32);

[0020] S3: Two or more airway openings are observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41) under the microscope, and it is judged that the support ventilation tube (1) is inserted too deeply; the support ventilation tube (1) is pulled out backwards until only one airway opening is observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41), and the bronchial sealing bag (31) just completely enters another parallel airway opening;

[0021] Or, if no airway opening is observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41) under the microscope, it is judged that the support ventilation tube (1) is inserted too shallowly; the support ventilation tube (1) is inserted forward until only one airway opening can be observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41), and the bronchial sealing bag (31) just completely enters the other parallel airway opening;

[0022] Or, an airway opening is observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41) under the microscope, but the bronchial sealing bag (31) has not yet entered another parallel airway opening or the bronchial sealing bag (31) has entered another parallel airway opening too deeply; the intubation depth of the support ventilation tube (1) is slightly adjusted until only one airway opening is observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41), and the bronchial sealing bag (31) just completely enters another parallel airway opening; and an appropriate amount of gas is filled into the bronchial sealing bag (31);

[0023] S4: withdraw the fiberoptic bronchoscope, insert a dental pad into the mouth, and fix the position of the ventilation tube (1) with adhesive tape, and the intubation is completed;

[0024] S5: During single-lung ventilation, the ventilator is connected to one respiratory connection socket (4B) on the corresponding side for mechanical ventilation, and the other side is open and not connected to the ventilator; during double-lung ventilation, the ventilator is connected to both respiratory connection sockets (4B) for mechanical ventilation; during spontaneous breathing, both respiratory connection sockets (4B) are open at the same time and not connected to the ventilator

[0025] Beneficial effects of the present invention:

[0026] 1. The shared "support ventilation tube" single-lumen endotracheal tube has external support and inner cavity ventilation. When used with the "thin-walled soft membrane ventilation tube", it can achieve maximum inner cavity ventilation and minimum outer cavity insertion, regardless of left or right lung ventilation, with minimal intubation damage and good ventilation effect;

[0027] 2. A large area of ​​hollowing is set through the side wall to observe the main ventilation port area. When using a visual bronchoscope to visualize the intubation, the inner wall structure of the "bronchial tree" ring can be observed at a longer distance, and the intubation positioning error can be discovered and corrected in time to ensure that the intubation positioning of the visual bronchoscope is successful at one time;

[0028] 3. At the same time, the larger "observation main vent" serves as the ventilation opening for the other lung, which can ensure smooth ventilation on the other side. When the catheter is twisted, even if part of the "observation main vent" is blocked, it can also ensure smooth ventilation;

[0029] 4. The cuff-free similar structure is particularly suitable for children. It can completely solve the century-old problem of lung isolation during pediatric thoracic surgery. It can also realize suction of sputum, lung inflation and other operations during the implementation of pediatric lung isolation, thereby improving the safety of pediatric thoracic surgery and anesthesia. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 It is a structural schematic diagram of the first embodiment of the present invention;

[0031] Figure 2 for Figure 1 Diagram of correct placement into the left bronchus and left lung ventilation;

[0032] Figure 3 for Figure 1 Diagram of correct placement into the left bronchus and right lung ventilation;

[0033] Figure 4 is a schematic structural diagram of a second embodiment of the present invention;

[0034] Figure 5 for Figure 4 Schematic diagram of correct placement into the left bronchus for bronchoendoscopy with right lung ventilation;

[0035] Figure 6 for Figure 4 Schematic diagram of bronchoendoscopy with right lung ventilation after the trachea was inserted too deep into the left bronchus;

[0036] Figure 7 is a schematic diagram of the structure of the connecting piece;

[0037] In the figure,

[0038] 1. Support the vent pipe;

[0039] 2. Breathing connection tube;

[0040] 3. Branch vent; 31. Bronchial sealing bag; 32. Branch inflation tube; 33. Branch inflation port;

[0041] 4. Main vent; 41. Main air pipe sealing bag; 42. Main inflation tube; 43. Main inflation port;

[0042] 5. Thin-walled soft film ventilation tube;

[0043] 6. Connector; 61. Single-cavity side of connector; 62. Double-cavity side of connector;

[0044] 4A, breathing connection tube; 4B, breathing connection socket; 62A, main cavity; 62B, auxiliary cavity.

[0045] A, cross section A; B, cross section B;

[0046] C1, the first observation point of the visual bronchoscope; C2, the second observation point of the visual bronchoscope; C3, the third observation point of the visual bronchoscope;

[0047] R1, right bronchus; R2U, right upper lobe bronchus; R2M, right middle lobe bronchus; R2D, right lower lobe bronchus;

[0048] L1, left bronchus; L2U, left upper lobe bronchus; L2D, left lower lobe bronchus. DETAILED DESCRIPTION

[0049] In order to make the technical solution of the present invention better understood by the technical personnel in the field, and to make the above-mentioned features, purposes and advantages of the present invention more clearly understood, the present invention is further described below in conjunction with the embodiments. The embodiments are only used to illustrate the present invention and are not used to limit the scope of the present invention.

[0050] A double-lumen bronchial catheter with a common cavity that is easy to locate and its application, comprising a supporting ventilation tube (1), wherein the opening at the head end of the supporting ventilation tube (1) is a branch ventilation port (3), and two breathing connection tubes (2) are arranged at the tail end of the supporting ventilation tube (1); a plurality of main observation ventilation ports (4) are arranged through the side wall of the supporting ventilation tube (1) in a range of 10-80 mm on the tail side of the branch ventilation port (3), and a thin-walled soft membrane ventilation tube (5) is arranged to connect the inner cavity of any one of the breathing connection tubes (2) and the inner cavity of the supporting ventilation tube (1) on the head side of the main observation ventilation port (4) through sealing and bonding, and the length and outer diameter of the thin-walled soft membrane ventilation tube (5) after expansion match the inner cavity of the supporting ventilation tube (1).

[0051] Furthermore, near the tail of the branch vent (3), on the head side of the main vent (4) for observation, a bronchial sealing bag (31) is arranged around the support vent (1), and a branch inflation tube (32) is arranged in the side wall of the support vent (1) to communicate with the inner cavity of the bronchial sealing bag (31), and the branch inflation tube (32) is arranged at the tail of the support vent (1) to communicate with the branch inflation port (33); near the tail of the main vent (4) for observation, a main tracheal sealing bag (41) is arranged around the support vent (1), and a main inflation tube (42) is arranged in the side wall of the support vent (1) to communicate with the inner cavity of the main tracheal sealing bag (41), and the main inflation tube (42) is arranged at the tail of the support vent (1) to communicate with the main inflation port (43).

[0052] Furthermore, the plurality of main ventilation ports (4) are adjacent to the bronchial sealing bag (31) on the head side and adjacent to the main tracheal sealing bag (41) on the tail side, and the distance between the bronchial sealing bag (31) and the main tracheal sealing bag (41) on the long axis of the supporting ventilation tube (1) is greater than the distance between the opening of the right bronchus R1 and the opening of the right lower lobe bronchus R2D, or greater than the distance between the opening of the left bronchus L1 and the opening of the left lower lobe bronchus L2D.

[0053] Furthermore, the plurality of main observation vents (4) are arranged away from the branch air tube (32), and the plurality of main observation vents (4) contain 4.5 mm round holes; if the main observation vents (4) cut off the main air tube (42), the head side stump of the main air tube (42) adjacent to the main air tube sealing bag (41) is closed.

[0054] Furthermore, a support spring with a matching outer diameter is buried in the rear cavity of the support ventilation pipe (1).

[0055] The present invention uses a common supporting ventilation tube (1) with a single-lumen tracheal tube for external support and inner cavity ventilation, and cooperates with a "thin-wall soft membrane ventilation tube" to achieve maximum inner cavity ventilation and minimum outer cavity insertion regardless of left or right lung ventilation, with little intubation damage and good ventilation effect.

[0056] During the specific implementation, a product model that matches the inner diameter of the patient's trachea is selected (the outer diameter of the selected support ventilation tube 1 is similar to the inner diameter of the child's trachea), the head section of the support ventilation tube 1 is inserted into the child's trachea through the oral cavity and glottis, and the open branch vent 3 at the head end of the support ventilation tube 1 is inserted into the opening of one bronchus (according to clinical practice, it is often chosen to insert the branch vent 3 at the head end of the support ventilation tube 1 into the bronchial opening on the non-surgical side).

[0057] like Figure 2As shown, it is a schematic diagram of the correct placement of the left bronchus L1 and the implementation of left lung ventilation in Example 1. The funnel-shaped glottis provides sealing for the support ventilation tube 1 in the trachea, and the head end of the support ventilation tube 1 and the inner wall of the left bronchus L1 form a seal. The respiratory device is connected to the corresponding left respiratory connecting tube 2 (the corresponding part of the respiratory airflow arrow), the machine-controlled breathing is positive pressure ventilation, and the thin-walled soft membrane ventilation tube 5 is fully inflated and close to the inner wall of the support ventilation tube 1 (see Figure 2 A cross-sectional schematic diagram of the thin-walled soft membrane ventilation tube 5 has an inner cavity of similar size to the inner cavity of the supporting ventilation tube 1, forming a left lung ventilation passage. It is the mechanical ventilation channel of the passage and also the left lung suction channel ( This refers to the bidirectional flow of air).

[0058] like Figure 3 As shown, it is a schematic diagram of the correct placement of the left bronchus L1 and the implementation of right lung ventilation in Example 1. The funnel-shaped glottis also provides sealing for the support ventilation tube 1 in the trachea, and the head end of the support ventilation tube 1 and the inner wall of the left bronchus L1 form a seal. The respiratory device is connected to the corresponding right breathing connection tube 2 (the corresponding part of the breathing airflow arrow), the machine-controlled breathing is positive pressure ventilation, and the thin-walled soft membrane ventilation tube is compressed 5 times and tightly adheres to the inner wall of the support ventilation tube 1 (see Figure 3 B is a cross-sectional schematic diagram of the support ventilation tube 1, which supports the inner cavity of the ventilation tube 1 to become the right lung ventilation passage.

[0059] Thus forming It is the mechanical ventilation pathway for the passage and also the right lung suction pathway.

[0060] Further, such as Figure 5 , Figure 6 and Figure 7As shown, near the tail of the branch vent 3, on the head side of several main vents 4, a bronchial sealing bag 31 is arranged around the support vent 1, and a branch inflation tube 32 is arranged in the side wall of the support vent 1 to connect with the inner cavity of the bronchial sealing bag 31, and the branch inflation tube 32 is arranged at the tail of the support vent 1 and connected with the side wall of the branch inflation port 33. A main tracheal sealing bag 41 is arranged around the support vent 1 near the tail of several main vents 4, and a main inflation tube 42 is arranged in the side wall of the support vent 1 to connect with the inner cavity of the main tracheal sealing bag 41, and the main inflation tube 42 is arranged at the tail of the support vent 1 and connected with the main inflation port 43. When in use, the bronchial sealing bag 31 is inserted into the unilateral bronchial cavity, and a proper amount of gas is filled into the bronchial sealing bag 31 through the branch inflation port 33 outside the oral cavity and the branch inflation tube 32, so as to achieve the ventilation and sealing effect of the support ventilation tube 1 inserted into the inner cavity of the lateral bronchus; similarly, the main trachea sealing bag 41 is located in the main trachea behind the carina, and a proper amount of gas is filled into the main trachea sealing bag 41 through the main inflation port 43 and the main inflation tube 42, so as to achieve the ventilation and sealing effect of the support ventilation tube 1 inserted into the main trachea.

[0061] like Figure 6 As shown, taking the product of supporting the bronchial sealing bag 31 at the head end of the ventilating tube 1 for placement in the left bronchus as an example, when the product is correctly intubated and positioned, when the visual bronchoscope reaches the first observation point C1 of the visual bronchoscope, the structures that can be observed through the endoscope are: the bronchial sealing bag 31, the mouth of the right bronchus R1 and a section of the inner wall of the main trachea, which is the structure observed with correct positioning. At this time, half of the bronchial sealing bag 31 and the annular opening of the right bronchus R1 will appear on the visual screen. In all observation areas corresponding to the observation of the main vent 4, the visual bronchoscope can only see half of the bronchial sealing bag 31 and the annular opening of the right bronchus R1 through several observations of the main vent 4.

[0062] like Figure 7As shown, taking the bronchial sealing capsule 31 at the head end of the supporting ventilation tube 1 for placement in the left bronchus as an example, this is a schematic diagram of the error when the product is placed too deeply. When the visual bronchoscope reaches the second observation point C2 of the visual bronchoscope, the structures that can be observed through the endoscope are: the right bronchus R1 and the hollow observation area cavity of the supporting ventilation tube 1 formed by a number of main observation vents 4. The visual bronchoscope continues to move forward and reaches the third observation point C3 of the visual bronchoscope. The structures that can be observed through the endoscope are: the left upper lobe bronchus L2UL2U, part of the bronchial sealing capsule 31 and the inner cavity of the supporting ventilation tube 1. In this way, the visual bronchoscope can and can see half of the bronchial sealing capsule 31 and the annular openings of the two bronchi and branch bronchi in all observation areas corresponding to the main observation vents 4 through a number of main observation vents 4. This is a sign that the catheter is inserted too deeply. When the supporting ventilation tube 1 is too thin and the tip is inserted too deeply, the visual bronchoscope can even see the circular openings of three bronchi and branch bronchi through all the observation areas corresponding to the observation of the main ventilation opening 4. At this time, it can be judged that the intubation is too deep, and it is pulled out a little and the positioning is checked again until the visual bronchoscope can only observe one bronchial opening through all the observation areas corresponding to the observation of the main ventilation opening 4.

[0063] In short, a large area of ​​hollowing is set through the side wall to observe the main ventilation area. When using a visual bronchoscope to visualize the intubation, the inner wall structure of the "bronchial tree" ring can be observed at a longer distance, and the intubation positioning error can be discovered and corrected in time to ensure that the intubation positioning of the visual bronchoscope is successful at one time.

[0064] Since the human bronchi have a tree-like structure, the trachea branches at the carina into the left bronchus L1 and the right bronchus R1; the left bronchus L1 is further divided into the left upper lobe bronchus L2U and the left lower lobe bronchus L2D; the right bronchus R1 is divided into the right upper lobe bronchus R2U and the right bronchus middle segment, and then bifurcates through the right bronchus middle segment into the right middle lobe bronchus R2M and the right lower lobe bronchus R2D.

[0065] Therefore, when the left side is intubated too deep, after several observations, at least two holes formed by completely empty segmental bronchial openings can be observed between the main tracheal sealing bag 41 and the bronchial sealing bag 31 of the main vent 4. If the right side is intubated too deep, since the right bronchus R1 has one more branch than the left bronchus L1, after several observations, 2-3 holes formed by completely empty segmental bronchial openings can be observed between the main tracheal sealing bag 41 and the bronchial sealing bag 31 of the main vent 4. Specifically:

[0066] If the bronchial sealing bag 31 is mistakenly inserted into the opening of the right upper lobe bronchus R2U, the opening of the left bronchus L1 and the opening of the middle segment of the right bronchus can be observed;

[0067] If the bronchial sealing bag 31 is mistakenly inserted into the opening of the right lower lobe bronchus R2D, the opening of the left bronchus L1, the opening of the right upper lobe bronchus R2U and the opening of the right middle lobe bronchus R2M can be observed;

[0068] If the bronchial sealing balloon 31 is mistakenly inserted into the opening of the right middle lobe bronchus R2M, the opening of the left bronchus L1, the opening of the right upper lobe bronchus R2U and the opening of the right lower lobe bronchus R2D can be observed.

[0069] The preparation process of the present invention is as follows:

[0070] Step 1: prepare the support ventilation tube (1) by conventional extrusion process, and prepare the bronchial sealing bag (31) and the main tracheal sealing bag (41) by blow molding process; properly bond and fix the bronchial sealing bag (31) and the main tracheal sealing bag (41) to the outside of the support ventilation tube (1);

[0071] After extrusion, the support vent pipe (1) is formed into a whole long tube (with two vents on the side wall), and the long tube is cut into support vent pipes (1) of corresponding specifications by a cutting machine. After preparation, the support vent pipe (1) needs to be tested for inner and outer diameters to ensure that the inner and outer errors are within 0.05 mm. The testing method can be multi-point measurement with a vernier caliper.

[0072] The bronchial sealing bag (31) and the main tracheal sealing bag (41) are manually demoulded after blow molding, while ensuring that both are blow molded.

[0073] Before the bronchial sealing bag (31) and the main tracheal sealing bag (41) are bonded together, it is necessary to make an incision in the wall of the supporting ventilation tube (1) to connect the two ventilation channels, so as to ensure that the bronchial sealing bag (31) and the main tracheal sealing bag (41) can be connected after bonding.

[0074] The bronchial sealing bag (31) and the main tracheal sealing bag (41) can be bonded to the supporting ventilation tube (1) by glue or heat sealing. The heat sealing temperature is recommended to be between 180-240°C.

[0075] Step 2: avoiding the bronchial inflation tube (23), cutting a plurality of main observation vents (32) around the side wall of the supporting ventilation tube (1) between the bronchial sealing bag (31) and the main tracheal sealing bag (41); heat-sealing the head side stump of the main observation vent (32) adjacent to the main tracheal sealing bag (41) and cutting off the main inflation tube (32);

[0076] The sidewall cutting is a single-side cutting, which can be through or non-through. The non-through version is shown in this embodiment.

[0077] The heat sealing here serves to seal the main airway sealing bag (41) to prevent air leakage. The goal of the heat sealing is to block the tail end of the airway in the wall of the supporting airway (1).

[0078] Step 3: Prepare a "Y"-shaped inner cavity connector (6) by injection molding, and bond the single cavity side (61) of the connector to the rear end of the support ventilation tube (1); use a guide rope to pull a thin-walled soft membrane ventilation tube (5) longer than the support ventilation tube (1) into the cavity of the support ventilation tube (1), blow air into the thin-walled soft membrane ventilation tube (5), and make the thin-walled soft membrane ventilation tube (5) swell in the cavity of the support ventilation tube (1); seal and bond the outer wall of the head side of the thin-walled soft membrane ventilation tube (5) to the inner wall of the branch ventilation port (2), and seal and bond the outer wall of the tail side of the thin-walled soft membrane ventilation tube (5) to the inner wall of the main cavity (62A) of the double cavity side (62) of the connector;

[0079] The connecting piece and the supporting ventilation pipe (1) are clearance-fitted and bonded by filling with glue.

[0080] After the airflow is blown into the thin-walled soft film ventilation tube (5), it will be "straightened" and will not be twisted, stacked, bent, or knotted as a whole.

[0081] Before heat sealing, the thin-walled soft membrane ventilation tube (5) needs to be expanded and supported by a tool until it fits with the supporting ventilation tube (1). The depth of the fit must at least reach the maximum opening of the bottom observation main ventilation port 32, so as to ensure that the observation main ventilation port 32 and the thin-walled soft membrane ventilation tube (5) after heat sealing form a cavity structure that can guide medical equipment (such as sputum suction tubes and endoscopes) to enter.

[0082] During heat sealing, the electromagnetic heating coil can be used to coat the supporting ventilation tube (1) to ensure that the supporting ventilation tube (1) is heat-fused to the thin-walled soft film ventilation tube (5) without the thin-walled soft film ventilation tube (5) itself being broken.

[0083] Then, the thin-walled soft film ventilation tube (5) and the connecting piece are heat-sealed. Before heat-sealing, a portion of the thin-walled soft film ventilation tube (5) that protrudes from the top of the connecting piece needs to be trimmed and removed, and the remaining portion is stretched out to fit with the inner wall of the connecting piece, and then hot-melted to complete the sealing and fixing of the thin-walled soft film ventilation tube (5) to the connecting piece.

[0084] It should be added here that, in order to avoid the misalignment and distortion of the thin-walled soft film ventilation tube (5) during subsequent assembly, transportation, and actual use, it is necessary to insert a pressure strip into the thin-walled soft film ventilation tube (5), press the marking line of the side wall of the thin-walled soft film ventilation tube (5) with the inner wall of the supporting ventilation tube (1), and then perform hot melting. The hot melting can be performed continuously at multiple points, and finally it is only necessary to ensure that the bonding point between the side wall of the thin-walled soft film ventilation tube (5) and the inner wall of the supporting ventilation tube (1) is linear.

[0085] Step 4: prepare the breathing connection tube (4A) by extrusion molding, prepare the breathing connection socket (4B) by injection molding, insert the head ends of the two breathing connection tubes (4A) into the main cavity (62A) and the secondary cavity (62B) of the connector (6) and fix them by bonding, and insert the two breathing connection sockets (4B) into the end cavities of the two breathing connection tubes (4A);

[0086] One end of the breathing connection tube (4A) is bonded to the main cavity (62A) and the auxiliary cavity (62B) of the connecting piece by adhesive.

[0087] The breathing connection socket (4B) is inserted into the other end of the breathing connection tube (4A) and sealed and fixed by interference fit.

[0088] It should be added here that after connection, the branch inflation port 33 and the main inflation port 43 need to be connected to the bronchial sealing bag (31) and the main tracheal sealing bag (41) in a conventional manner, that is, the branch inflation port 33 and the main inflation port 43 are connected to the branch inflation tube 22 and the main inflation tube 33 respectively. The connection method is similar to that of a conventional endotracheal intubation and will not be elaborated on again.

[0089] Step 5: Check the sealing performance of the bronchial sealing bag (31) and the main tracheal sealing bag (41) pipelines, check the sealing performance of each connection part, and check the straightness of the thin-walled soft membrane ventilation tube (5) in the cavity of the supporting ventilation tube (1).

[0090] The detection method of the bronchial sealing bag (31) and the main tracheal sealing bag (41) is as follows: immerse the sealing bag in water at 20°C±5°C, fill the bag with 15kPa air pressure for 15 seconds, and no bubbles are generated at each connection.

[0091] The method for testing the sealing performance of the assembly of each connection part is as follows: the outlet of the supporting ventilation tube (1) is sealed, immersed in water at 20°C ± 5°C, and an air pressure of 10 kPa is filled into the tube for 15 seconds. No bubbles are generated at each connection.

[0092] The detection method for detecting the straightness of the thin-walled soft film ventilation tube (5) is to observe whether the calibration lines of the side walls of the thin-walled soft film ventilation tube (5) are located on the same side.

[0093] The method for using the above-mentioned double-lumen bronchial tube with easy-to-locate cavity sharing comprises the following steps:

[0094] S1: Select a suitable model product, open the package, lubricate the tip, and insert the intubation guide core into the cavity; after anesthesia induction, use laryngoscope to expose the glottis, and insert the tip of the support ventilation tube (1) into the patient's airway according to the conventional method. The intubation depth (cm) for males = 0.11 × height (cm) + 10.53, and the intubation depth (cm) for females = 0.11 × height (cm) + 10.94;

[0095] S2: Fill the main tracheal sealing bag (41) with an appropriate amount of gas, and connect the two breathing connection sockets (4B) to the ventilator through the transfer tube for controlled breathing; lubricate the end of the fiber bronchoscope lens, and insert it into the cavity of the supporting ventilation tube (1) through the secondary cavity (62B) of the connecting piece (6), between the bronchial sealing bag (31) and the main tracheal sealing bag (41), and check the inner wall of the airway and the position of the bronchial sealing bag (31) by observing the main ventilation port (32);

[0096] S3: Two or more airway openings are observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41) under the microscope, and it is judged that the support ventilation tube (1) is inserted too deeply; the support ventilation tube (1) is pulled out backwards until only one airway opening is observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41), and the bronchial sealing bag (31) just completely enters another parallel airway opening;

[0097] Or, if no airway opening is observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41) under the microscope, it is judged that the support ventilation tube (1) is inserted too shallowly; the support ventilation tube (1) is inserted forward until only one airway opening can be observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41), and the bronchial sealing bag (31) just completely enters the other parallel airway opening;

[0098] Or, an airway opening is observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41) under the microscope, but the bronchial sealing bag (31) has not yet entered another parallel airway opening or the bronchial sealing bag (31) has entered another parallel airway opening too deeply; the intubation depth of the support ventilation tube (1) is slightly adjusted until only one airway opening is observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41), and the bronchial sealing bag (31) just completely enters another parallel airway opening; and an appropriate amount of gas is filled into the bronchial sealing bag (31);

[0099] S4: withdraw the fiberoptic bronchoscope, insert a dental pad into the mouth, and fix the position of the ventilation tube (1) with adhesive tape, and the intubation is completed;

[0100] S5: During single-lung ventilation, the ventilator is connected to one respiratory connection socket (4B) on the corresponding side for mechanical ventilation, and the other side is open and not connected to the ventilator; during double-lung ventilation, the ventilator is connected to both respiratory connection sockets (4B) for mechanical ventilation; during spontaneous breathing, both respiratory connection sockets (4B) are open at the same time and not connected to the ventilator

[0101] The above embodiments are merely illustrative of the principles and effects of this patent application, and are not intended to limit this patent application. Anyone familiar with the technology may modify or change the above embodiments without violating the spirit and scope of this patent application. Therefore, all equivalent modifications or changes made by those with ordinary knowledge in the relevant technical field without departing from the spirit and technical ideas disclosed in this patent application should still be covered by the claims of this patent application.

Claims

1. A double-lumen bronchial catheter with a common cavity and easy positioning, characterized in that: The invention comprises a support ventilation tube (1), wherein the opening at the head end of the support ventilation tube (1) is a branch ventilation port (3), and two breathing connection tubes (2) are arranged at the tail end of the support ventilation tube (1); a plurality of observation main ventilation ports (4) are arranged through the side wall of the support ventilation tube (1) in the range of 10-80 mm at the tail side of the branch ventilation port (3); a thin-walled soft membrane ventilation tube (5) is arranged to connect the inner cavity of any breathing connection tube (2) and the inner cavity of the support ventilation tube (1) at the head side of the observation main ventilation port (4) by sealing and bonding, and the length and outer diameter of the thin-walled soft membrane ventilation tube (5) after expansion match the inner cavity of the support ventilation tube (1).

2. The double-lumen endobronchial catheter with a common cavity and easy positioning according to claim 1, characterized in that: A bronchial sealing bag (31) is arranged around the support ventilation tube (1) near the tail of the branch ventilation opening (3) and on the head side of the main ventilation openings (4) for observation. A branch inflation tube (32) is arranged in the side wall of the support ventilation tube (1) and connected to the inner cavity of the bronchial sealing bag (31). The branch inflation tube (32) is arranged at the tail of the support ventilation tube (1) and connected to the side wall. A branch inflation port (33) is arranged; a main tracheal sealing bag (41) is arranged around the support ventilation tube (1) near the tail of the main ventilation openings (4). A main inflation tube (42) is arranged in the side wall of the support ventilation tube (1) and connected to the inner cavity of the main tracheal sealing bag (41). The main inflation tube (42) is arranged at the tail of the support ventilation tube (1) and connected to the main inflation port (43).

3. The double-lumen endobronchial catheter with a common cavity and easy positioning according to claim 2, characterized in that: The plurality of main ventilating openings (4) are adjacent to the bronchial sealing sac (31) on the head side and adjacent to the main tracheal sealing sac (41) on the tail side. The distance between the bronchial sealing sac (31) and the main tracheal sealing sac (41) on the long axis of the supporting ventilating tube (1) is greater than the distance between the opening of the right bronchus R1 and the opening of the right lower lobe bronchus R2D, or greater than the distance between the opening of the left bronchus L1 and the opening of the left lower lobe bronchus L2D.

4. The double-lumen endobronchial catheter with a common cavity and easy positioning according to claim 2, characterized in that: The plurality of main observation vents (4) are all arranged away from the branch inflation tube (32), and the plurality of main observation vents (4) contain 4.5 mm round holes; if the main observation vents (4) cut off the main inflation tube (42), the head side stump of the main inflation tube (42) adjacent to the main trachea sealing bag (41) is closed.

5. The double-lumen endobronchial catheter with a common cavity and easy positioning according to claim 1, characterized in that: A support spring with a matching outer diameter is buried in the rear cavity of the support ventilation pipe (1).

6. A manufacturing process for a double-lumen bronchial catheter with easy-to-position cavity sharing, characterized in that: The steps include: Step 1: prepare the support ventilation tube (1) by conventional extrusion process, and prepare the bronchial sealing bag (31) and the main tracheal sealing bag (41) by blow molding process; properly bond and fix the bronchial sealing bag (31) and the main tracheal sealing bag (41) to the outside of the support ventilation tube (1); Step 2: avoiding the bronchial inflation tube (23), cutting a plurality of main observation vents (32) around the side wall of the supporting ventilation tube (1) between the bronchial sealing bag (31) and the main tracheal sealing bag (41); heat-sealing the head side stump of the main observation vent (32) adjacent to the main tracheal sealing bag (41) and cutting off the main inflation tube (32); Step 3: Prepare a "Y"-shaped inner cavity connector (6) by injection molding, and bond the single cavity side (61) of the connector to the rear end of the support ventilation tube (1); use a guide rope to pull a thin-walled soft membrane ventilation tube (5) longer than the support ventilation tube (1) into the cavity of the support ventilation tube (1), blow air into the thin-walled soft membrane ventilation tube (5), and make the thin-walled soft membrane ventilation tube (5) swell in the cavity of the support ventilation tube (1); seal and bond the outer wall of the head side of the thin-walled soft membrane ventilation tube (5) to the inner wall of the branch ventilation port (2), and seal and bond the outer wall of the tail side of the thin-walled soft membrane ventilation tube (5) to the inner wall of the main cavity (62A) of the double cavity side (62) of the connector; Step 4: prepare the breathing connection tube (4A) by extrusion molding, prepare the breathing connection socket (4B) by injection molding, insert the head ends of the two breathing connection tubes (4A) into the main cavity (62A) and the secondary cavity (62B) of the connector (6) and fix them by bonding, and insert the two breathing connection sockets (4B) into the end cavities of the two breathing connection tubes (4A); Step 5: Check the sealing performance of the bronchial sealing bag (31) and the main tracheal sealing bag (41) pipelines, check the sealing performance of each connection part, and check the straightness of the thin-walled soft membrane ventilation tube (5) in the cavity of the supporting ventilation tube (1).

7. A method for using a double-lumen bronchial catheter with an easy-to-position cavity sharing function, characterized in that: The steps include: S1: Select a suitable model product, open the package, lubricate the tip, and insert the intubation guide core into the cavity; after anesthesia induction, use laryngoscope to expose the glottis, and insert the tip of the support ventilation tube (1) into the patient's airway according to the conventional method. The intubation depth (cm) for males = 0.11 × height (cm) + 10.53, and the intubation depth (cm) for females = 0.11 × height (cm) + 10.94; S2: Fill the main tracheal sealing bag (41) with an appropriate amount of gas, and connect the two breathing connection sockets (4B) to the ventilator through the transfer tube for controlled breathing; lubricate the end of the fiber bronchoscope lens, and insert it into the cavity of the supporting ventilation tube (1) through the secondary cavity (62B) of the connecting piece (6), between the bronchial sealing bag (31) and the main tracheal sealing bag (41), and check the inner wall of the airway and the position of the bronchial sealing bag (31) by observing the main ventilation port (32); S3: Two or more airway openings are observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41) under the microscope, and it is judged that the support ventilation tube (1) is inserted too deeply; the support ventilation tube (1) is pulled out backwards until only one airway opening is observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41), and the bronchial sealing bag (31) just completely enters another parallel airway opening; Or, if no airway opening is observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41) under the microscope, it is judged that the support ventilation tube (1) is inserted too shallowly; the support ventilation tube (1) is inserted forward until only one airway opening can be observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41), and the bronchial sealing bag (31) just completely enters the other parallel airway opening; Or, under the microscope, an airway opening is observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41), but the bronchial sealing bag (31) has not yet entered another parallel airway opening or the bronchial sealing bag (31) has entered another parallel airway opening too deeply; the intubation depth of the support ventilation tube (1) is slightly adjusted until only one airway opening is observed between the bronchial sealing bag (31) and the main tracheal sealing bag (41), and the bronchial sealing bag (31) just completely enters another parallel airway opening; and an appropriate amount of gas is filled into the bronchial sealing bag (31); S4: withdraw the fiberoptic bronchoscope, insert a dental pad into the mouth, and fix the position of the ventilation tube (1) with adhesive tape, and the intubation is completed; S5: During single-lung ventilation, the ventilator is connected to one respiratory connection socket (4B) on the corresponding side for mechanical ventilation, and the other side is open and not connected to the ventilator; during double-lung ventilation, the ventilator is simultaneously connected to two respiratory connection sockets (4B) for mechanical ventilation; during spontaneous breathing, both respiratory connection sockets (4B) are open at the same time and not connected to the ventilator.

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