Anti-kinking and anti-biting tracheal catheter and preparation method thereof

Abstract

The application discloses a kind of anti-bending and anti-biting closed tracheal catheter and preparation method thereof, which can ensure the smoothness of upper respiratory tract of patient by setting different density and uninterrupted reinforcing steel wire in built-in pipe section, outer pipe section and transition pipe section.The closed tracheal catheter is characterized by comprising catheter connector, outer tube, scale line, inner tube, reinforcing steel wire, air bag, insertion port, side air hole and inflation tube.The inner tube and the outer tube are of open structure at both ends, the inner tube is placed in the outer tube, the center line of the inner tube coincides with the center line of the outer tube, the inner diameter of the outer tube is larger than the outer diameter of the inner tube, and the two ends of the inner tube and the outer tube are flush.The one end of the catheter connector is embedded in one end of the inner tube, and the inner diameter of one end to one-half of the catheter connector is smaller than the inner diameter from one-half to the other end of the catheter connector.

Description

Technical Field

[0001] This invention relates to an anti-bending and anti-biting endotracheal tube and its preparation method, which is a method for preparing an endotracheal tube that can ensure the patency of the patient's upper airway. It belongs to the field of medical device technology, and specifically relates to a method for preparing an endotracheal tube that can ensure the patency of the patient's upper airway by setting reinforcing steel wires of different densities and without interruption in the internal tube segment, external tube segment and transition tube segment. Background Technology

[0002] Endotracheal intubation is a very important anesthetic technique. During anesthesia, an endotracheal tube is inserted into the patient's trachea through the mouth or nose to ensure that the patient's upper airway is open.

[0003] Currently, there are two main types of commonly used endotracheal tubes: The first type is the ordinary endotracheal tube, which has lower bending resistance. In some patients who experience postoperative teeth grinding, the segment of the tube that has been bitten off can quickly return to its original shape, avoiding poor ventilation caused by flattening and blockage. However, when the patient's head is excessively flexed or the neck is twisted during surgery, the ordinary endotracheal tube is prone to kinking, causing ventilation obstruction, increasing the difficulty for anesthesiologists to manage the surgical process, and resulting in higher surgical risks. The second type is the wire-reinforced endotracheal tube, whose inner wall is wrapped with continuous, dense, and uniformly dense steel wire, which has higher bending resistance and will not kink during surgery. However, when a patient experiences postoperative teeth grinding, the internal steel wire makes it difficult for the segment of the tube that has been bitten off to return to its original shape once deformed by external force, leading to poor ventilation and endangering the patient's life.

[0004] Publication No. CN208611535U discloses an anti-pinch endotracheal tube, which is made of a hollow long tube, including an external tube segment that can be connected to a medical respiratory device, an internal tube segment that can be inserted into the human trachea, and a transition tube segment for connecting the internal and external tube segments. The transition tube segment is made of a flexible soft tube, while the internal and external tube segments are both made of reinforced soft tubes. The internal and external tube segments have steel wires coiled inside, while the transition tube segment connecting the internal and external tube segments does not have steel wires coiled inside, allowing the internal tube segment to bend freely without bending when inserted into the patient's trachea. The endotracheal tube is designed to be easily inserted into the patient's trachea; the external tube segment is also easy to connect to medical breathing equipment; and when the patient becomes agitated and bites the transition tube segment after surgery, the transition tube segment that has been flattened by the patient can quickly return to its original shape, avoiding poor ventilation caused by flattening and blockage; however, the steel wire inside the endotracheal tube is discontinuous. The actual production steps of the endotracheal tube are: first, the inner tube is produced, then the steel wire is wound around the inner tube, then the steel wire is wrapped through the outer tube, after the outer tube is formed, it is cut to a preset size by machine, and finally other components are installed on the cut individual outer tubes. During the winding of the external endotracheal tube with steel wire, the discontinuity of the steel wire necessitates additional steps and equipment on the production line to precisely control the winding position and tightness of the steel wire. This not only increases the complexity of the production process but also affects production efficiency. Furthermore, the steel wire needs to be cut during the winding process. If the cut is not neat or has burrs, gaps may easily appear at the connection between the cut steel wire and the inner and outer tubes, resulting in poor fit. This leads to insufficient strength in the external and internal tube sections, making them prone to bending and kinking during use, endangering the patient's life. Summary of the Invention

[0005] To improve the above situation, the present invention provides an anti-bending and anti-biting endotracheal tube and its preparation method. This invention provides an endotracheal tube that can ensure the patency of the patient's upper airway by setting reinforcing steel wires of different densities and without interruption in the internal tube segment, external tube segment and transition tube segment.

[0006] The present invention provides an anti-kinking and anti-biting tracheal tube and its preparation method as follows: The anti-kinking and anti-biting tracheal tube of the present invention consists of a tube connector, an outer tube, graduation lines, an inner tube, reinforcing steel wire, an air bladder, an insertion port, a side vent, and an inflation tube.

[0007] The inner and outer tubes are open at both ends.

[0008] The inner tube is placed inside the outer tube, with the centerline of the inner tube coinciding with the centerline of the outer tube. The inner diameter of the outer tube is larger than the outer diameter of the inner tube, and the ends of the inner and outer tubes are flush.

[0009] One end of the catheter connector is embedded inside one end of the inner tube, and the inner diameter of the catheter connector from one end to the halfway point is smaller than the inner diameter from the halfway point to the other end.

[0010] Preferably, the catheter connector is a standard medical endotracheal catheter connector.

[0011] One end of the insertion port is connected to the other end of the inner tube.

[0012] Preferably, the other end of the insertion port is a bevel, and the inner and outer surfaces of the other end of the insertion port are connected by an arc surface.

[0013] The insertion port has a side vent.

[0014] Preferably, there are multiple side vents, and the multiple side vents are arranged at equal intervals along the circumference of the insertion port.

[0015] One end of the inflation tube is placed on the outer tube, and the other end of the inflation tube is connected to the outer tube. The other end of the inflation tube is also close to the conduit connector.

[0016] The outer tube has an exhaust port.

[0017] The airbag is fitted onto the outer tube, the vent is located inside the airbag, and one end of the airbag is close to the insertion port.

[0018] Preferably, the inner diameter of the airbag gradually increases from both ends to the middle.

[0019] A reinforcing steel wire is placed between the inner tube and the outer tube. The reinforcing steel wire is spirally wound around the inner tube and fits against the inner wall of the outer tube. The center line of the reinforcing steel wire coincides with the center line of the inner tube.

[0020] One end of the reinforcing wire is close to one end of the conduit connector, and the other end of the reinforcing wire is close to one end of the insertion port.

[0021] Preferably, the inner tube and the inner wall of the outer tube have grooves corresponding to the reinforcing steel wire, and the reinforcing steel wire is embedded in the grooves.

[0022] The inner tube, the outer tube, and the reinforcing steel wire together constitute the body of the endotracheal tube.

[0023] The endotracheal tube body comprises three parts: an internal tube section, a transition tube section, and an external tube section. The internal tube section is the portion of the endotracheal tube body near the insertion port that can be inserted into the human trachea. The external tube section is the portion of the endotracheal tube body near the tube connector that can be connected to a medical respiratory device. The transition tube section is the intermediate portion of the endotracheal tube body connecting the internal tube section and the external tube section. The transition tube section is positioned in the human oral cavity corresponding to the incisors.

[0024] Preferably, the internal pipe section and the external pipe section are made of reinforced flexible hose material, and the transition pipe section is made of elastic flexible hose material.

[0025] The winding density of the reinforcing steel wire in the built-in pipe section and the external pipe section is greater than the winding density in the transition pipe section.

[0026] Preferably, the winding density of the reinforcing steel wire within the built-in tube section from one end of the inner tube to the other end of the airbag is less than the winding density in the remaining portion of the built-in tube section, but greater than the winding density in the transition tube section.

[0027] Preferably, the twist pitch of the reinforcing steel wire in the outer tube section is between 0.1 cm and 0.25 cm, preferably 0.125 cm; the twist pitch in the inner tube section from the other end of the inner tube to the other end of the airbag is between 0.3 cm and 0.65 cm, preferably 0.5 cm; the twist pitch in the remaining portion of the inner tube section is between 0.1 cm and 0.25 cm, preferably 0.125 cm; and the twist pitch in the transition tube section is between 0.15 cm and 0.3 cm, preferably 2 cm.

[0028] The outer tube has graduation lines on its side.

[0029] One end of the scale line is near the conduit connector, and the other end of the scale line is near the internal tubing segment.

[0030] Preferably, the scale lines are printed using medical-grade self-drying ink.

[0031] The present invention discloses a method for preparing an anti-folding and anti-biting endotracheal tube, comprising the following steps:

[0032] Material preparation: Select suitable medical-grade high-polymer PVC material as the material for the inner and outer tubes, fold, cut and crush the PVC material into granules, and select stainless steel material as the material for the reinforcing wire;

[0033] Inner tube extrusion: The granular inner tube raw material is added to the first extruder. Under the action of heating and screw extrusion, the raw material melt gradually softens, melts and mixes evenly. The melt is pushed to the die part by the screw, where it is subjected to further pressure and shearing. It is then extruded through the specific shape channel of the die. The extruded inner tube material is sizing sleeve to make the outer diameter of the tube reach the preset size. The inner tube material is shaped by internal pressure method or external vacuum method. The sizing inner tube is then led out by traction device.

[0034] The connection between the steel wire and the inner tube: The reinforcing steel wire is tightly wound onto the inner tube material, which is gradually drawn out by the traction device, by the steel wire winding machine according to the preset spiral trajectory. During the winding process, the winding density of the reinforcing steel wire at different preset positions on the inner tube material is controlled by adjusting the rotation speed of the steel wire winding machine. When the part that needs to be wound is the inner tube section or the outer tube section, the rotation speed of the steel wire winding machine is increased. When the part that needs to be wound is the transition tube section, the rotation speed of the steel wire winding machine is decreased.

[0035] Preferably, the method for preparing an anti-folding and anti-biting endotracheal tube according to the present invention further includes a wire density winding system, wherein the wire density winding system includes a signal converter, a data processor, and a controller.

[0036] The signal converter, the data processor, and the timer are all mounted on the wire winding machine.

[0037] The timer is connected to the signal converter via a data line.

[0038] The wire winding machine is connected to the control module via a data transmission line.

[0039] The signal converter is connected to the data processor via a data transmission line, and the data processor is connected to the control module via a data transmission line.

[0040] The signal converter can convert the electrical signal of the time data collected by the timer into a digital signal.

[0041] The data processor and the signal converter exchange information.

[0042] The steel wire density winding system mainly achieves the following steps:

[0043] The travel speed of the inner tube gradually drawn out by the traction device Keeping the speed constant, the controller starts the wire winding machine and controls its rotation speed to be... The machine begins winding the steel wire from one end of the inner tube to the other end of the airbag within the corresponding internal pipe segment. A timer collects the travel time data of the inner tube and sends it to a signal converter. The signal converter converts the electrical signal of the travel time data into a digital signal and sends it to a data processor. The data processor calculates the travel distance of the inner tube based on the travel speed and travel time. When the travel distance equals a distance threshold of 1, it indicates that the remaining steel wire within the corresponding internal pipe segment of the inner tube needs to be wound. The rotation speed of the wire winding machine is controlled to... When the travel distance equals the distance threshold 2, it indicates that the steel wire for the corresponding transition section on the inner layer pipe needs to be wound. The rotation speed of the steel wire winding machine is controlled as follows: When the travel distance equals the distance threshold of 3, it indicates that it is time to start winding the steel wire on the corresponding outer pipe section of the inner layer pipe. The rotation speed of the steel wire winding machine is controlled as follows: When the travel distance equals the distance threshold of 4, it indicates that the wire winding of a section of the tracheal tube on the inner layer of the tube is complete. The timer restarts from 0, and the rotation speed of the wire winding machine is controlled to... Begin the wire winding of the upper and lower sections of the inner tube;

[0044] Outer tube sleeve: The granular outer tube raw material is added to the second extruder. Under the action of heating and screw extrusion, the outer tube raw material gradually softens, melts and mixes evenly. The evenly mixed raw material melt is pushed to the die part that matches the inner tube material that has been wound with reinforcing steel wire. It is subjected to further pressure and shearing action, and is extruded through the specific shape channel of the die to form a shape that wraps the inner tube material and the reinforcing steel wire. This ensures that the outer tube is tightly bonded to the inner tube and the reinforcing steel wire, thus completing the production of the endotracheal tube preform. After cooling, the completed endotracheal tube preform is led out by the traction device.

[0045] Preferably, before the outer tube raw material melt wraps the inner tube and reinforcing steel wire, the inner tube wall needs to be heated by a heating ring to prevent the inner tube from cooling down after long-term transportation and the outer tube from failing to adhere, thus preventing delamination and reducing the product quality of the casing.

[0046] Cutting: According to the length requirements of the endotracheal tube, the tube blank is cut using laser diameter measurement and automatic cutting equipment to form multiple independent endotracheal tubes. During cutting, it is necessary to ensure that the cut is flat and free of burrs.

[0047] Thermoforming: Each tracheal tube is heated by a heater to bend it into shape with a preset bending radius and angle. It is then cooled and shaped to retain the desired shape, ensuring that the bend does not spring back.

[0048] Install other components: Install the tube connector, insertion interface, inflation tube and cuff on each endotracheal tube, and use medical-grade self-drying ink to print the scale lines to complete the fabrication of the endotracheal tube. Beneficial effects

[0049] 1. By setting reinforcing steel wires of different densities in the internal tube segment, external tube segment, and transition tube segment, the bending of the internal tube segment during insertion into the human trachea can be reduced, the connection between the external tube segment and medical breathing equipment can be facilitated, and the transition tube segment can be quickly restored to its original shape after being bitten by the patient, ensuring the patient's upper airway remains unobstructed.

[0050] Second, the reinforcing steel wires in the built-in pipe section, external pipe section, and transition pipe section are continuous and uninterrupted, which facilitates the winding of the reinforcing steel wires onto the inner pipe, improves the fit between the reinforcing steel wires and the inner and outer pipes, reduces the complexity of the production process, and improves production efficiency. Attached Figure Description

[0051] Figure 1 This is a three-dimensional structural diagram of an anti-folding and anti-biting endotracheal tube according to the present invention;

[0052] Figure 2 This is a three-dimensional structural diagram of an anti-bending and anti-biting endotracheal tube according to the present invention, which only shows the structure of the tube connector and the insertion port.

[0053] Figure 3 This is a three-dimensional structural diagram of an anti-bending and anti-biting tracheal tube according to the present invention, which only shows the structure of the tracheal tube embryo before cutting.

[0054] Attached Figure

[0055] The components are: catheter connector (1), outer tube (2), scale line (3), inner tube (4), reinforcing steel wire (5), airbag (6), insertion port (7), side vent (8), and inflation tube (9). Detailed Implementation Example

[0056] The present invention provides an anti-kinking and anti-biting tracheal tube and its preparation method as follows: The anti-kinking and anti-biting tracheal tube of the present invention consists of a tube connector, an outer tube, graduation lines, an inner tube, reinforcing steel wire, an air bladder, an insertion port, a side vent, and an inflation tube.

[0057] The inner and outer tubes are open at both ends.

[0058] The inner tube is placed inside the outer tube, with the centerline of the inner tube coinciding with the centerline of the outer tube. The inner diameter of the outer tube is larger than the outer diameter of the inner tube, and the ends of the inner and outer tubes are flush.

[0059] One end of the catheter connector is embedded inside one end of the inner tube, and the inner diameter of the catheter connector from one end to the halfway point is smaller than the inner diameter from the halfway point to the other end.

[0060] Preferably, the catheter connector is a standard medical endotracheal catheter connector.

[0061] One end of the insertion port is connected to the other end of the inner tube.

[0062] Preferably, the other end of the insertion port is a bevel, and the inner and outer surfaces of the other end of the insertion port are connected by an arc surface.

[0063] The insertion port has a side vent.

[0064] Preferably, there are multiple side vents, and the multiple side vents are arranged at equal intervals along the circumference of the insertion port.

[0065] One end of the inflation tube is placed on the outer tube, and the other end of the inflation tube is connected to the outer tube. The other end of the inflation tube is also close to the conduit connector.

[0066] The outer tube has an exhaust port.

[0067] The airbag is fitted onto the outer tube, the vent is located inside the airbag, and one end of the airbag is close to the insertion port.

[0068] Preferably, the inner diameter of the airbag gradually increases from both ends to the middle.

[0069] A reinforcing steel wire is placed between the inner tube and the outer tube. The reinforcing steel wire is spirally wound around the inner tube and fits against the inner wall of the outer tube. The center line of the reinforcing steel wire coincides with the center line of the inner tube.

[0070] One end of the reinforcing wire is close to one end of the conduit connector, and the other end of the reinforcing wire is close to one end of the insertion port.

[0071] Preferably, the inner tube and the inner wall of the outer tube have grooves corresponding to the reinforcing steel wire, and the reinforcing steel wire is embedded in the grooves.

[0072] The inner tube, the outer tube, and the reinforcing steel wire together constitute the body of the endotracheal tube.

[0073] The endotracheal tube body comprises three parts: an internal tube section, a transition tube section, and an external tube section. The internal tube section is the portion of the endotracheal tube body near the insertion port that can be inserted into the human trachea. The external tube section is the portion of the endotracheal tube body near the tube connector that can be connected to a medical respiratory device. The transition tube section is the intermediate portion of the endotracheal tube body connecting the internal tube section and the external tube section. The transition tube section is positioned in the human oral cavity corresponding to the incisors.

[0074] Preferably, the internal pipe section and the external pipe section are made of reinforced flexible hose material, and the transition pipe section is made of elastic flexible hose material.

[0075] The winding density of the reinforcing steel wire in the built-in pipe section and the external pipe section is greater than the winding density in the transition pipe section.

[0076] Preferably, the winding density of the reinforcing steel wire within the built-in tube section from one end of the inner tube to the other end of the airbag is less than the winding density in the remaining portion of the built-in tube section, but greater than the winding density in the transition tube section.

[0077] Preferably, the twist pitch of the reinforcing steel wire in the outer tube section is between 0.1 cm and 0.25 cm, preferably 0.125 cm; the twist pitch in the inner tube section from the other end of the inner tube to the other end of the airbag is between 0.3 cm and 0.65 cm, preferably 0.5 cm; the twist pitch in the remaining portion of the inner tube section is between 0.1 cm and 0.25 cm, preferably 0.125 cm; and the twist pitch in the transition tube section is between 0.15 cm and 0.3 cm, preferably 2 cm.

[0078] The outer tube has graduation lines on its side.

[0079] One end of the scale line is near the conduit connector, and the other end of the scale line is near the internal tubing segment.

[0080] Preferably, the scale lines are printed using medical-grade self-drying ink.

[0081] During use, before the surgery, the anesthesiologist uses medical tools to insert the insertion port of the internal tube into the patient's trachea. The length of the endotracheal tube entering the patient's trachea is controlled by the scale lines. An appropriate amount of gas is injected into the cuff through the inflation tube using a syringe, so that the cuff seals the gap between the outer wall of the internal tube and the inner wall of the patient's trachea. The other end of the tube connector is then connected to the medical breathing equipment, thus enabling the use of the endotracheal tube.

[0082] The present invention discloses a method for preparing an anti-folding and anti-biting endotracheal tube, comprising the following steps:

[0083] Material preparation: Select suitable medical-grade high-polymer PVC material as the material for the inner and outer tubes, fold, cut and crush the PVC material into granules, and select stainless steel material as the material for the reinforcing wire;

[0084] Inner tube extrusion: The granular inner tube raw material is added to the first extruder. Under the action of heating and screw extrusion, the raw material melt gradually softens, melts and mixes evenly. The melt is pushed to the die part by the screw, where it is subjected to further pressure and shearing. It is then extruded through the specific shape channel of the die. The extruded inner tube material is sizing sleeve to make the outer diameter of the tube reach the preset size. The inner tube material is shaped by internal pressure method or external vacuum method. The sizing inner tube is then led out by traction device.

[0085] The connection between the steel wire and the inner tube: The reinforcing steel wire is tightly wound onto the inner tube material, which is gradually drawn out by the traction device, by the steel wire winding machine according to the preset spiral trajectory. During the winding process, the winding density of the reinforcing steel wire at different preset positions on the inner tube material is controlled by adjusting the rotation speed of the steel wire winding machine. When the part that needs to be wound is the inner tube section or the outer tube section, the rotation speed of the steel wire winding machine is increased. When the part that needs to be wound is the transition tube section, the rotation speed of the steel wire winding machine is decreased.

[0086] Preferably, the method for preparing an anti-folding and anti-biting endotracheal tube according to the present invention further includes a wire density winding system, wherein the wire density winding system includes a signal converter, a data processor, and a controller.

[0087] The signal converter, the data processor, and the timer are all mounted on the wire winding machine.

[0088] The timer is connected to the signal converter via a data line.

[0089] The wire winding machine is connected to the control module via a data transmission line.

[0090] The signal converter is connected to the data processor via a data transmission line, and the data processor is connected to the control module via a data transmission line.

[0091] The signal converter can convert the electrical signal of the time data collected by the timer into a digital signal.

[0092] The data processor and the signal converter exchange information.

[0093] The steel wire density winding system mainly achieves the following steps:

[0094] The travel speed of the inner tube gradually drawn out by the traction device Keeping the speed constant, the controller starts the wire winding machine and controls its rotation speed to be... The machine begins winding the steel wire from one end of the inner tube to the other end of the airbag within the corresponding internal pipe segment. A timer collects the travel time data of the inner tube and sends it to a signal converter. The signal converter converts the electrical signal of the travel time data into a digital signal and sends it to a data processor. The data processor calculates the travel distance of the inner tube based on the travel speed and travel time. When the travel distance equals a distance threshold of 1, it indicates that the remaining steel wire within the corresponding internal pipe segment of the inner tube needs to be wound. The rotation speed of the wire winding machine is controlled to... When the travel distance equals the distance threshold 2, it indicates that the steel wire for the corresponding transition section on the inner layer pipe needs to be wound. The rotation speed of the steel wire winding machine is controlled as follows: When the travel distance equals the distance threshold of 3, it indicates that it is time to start winding the steel wire on the corresponding outer pipe section of the inner layer pipe. The rotation speed of the steel wire winding machine is controlled as follows: When the travel distance equals the distance threshold of 4, it indicates that the wire winding of a section of the tracheal tube on the inner layer of the tube is complete. The timer restarts from 0, and the rotation speed of the wire winding machine is controlled to... Begin the wire winding of the upper and lower sections of the inner tube;

[0095] Outer tube sleeve: The granular outer tube raw material is added to the second extruder. Under the action of heating and screw extrusion, the outer tube raw material gradually softens, melts and mixes evenly. The evenly mixed raw material melt is pushed to the die part that matches the inner tube material that has been wound with reinforcing steel wire. It is subjected to further pressure and shearing action, and is extruded through the specific shape channel of the die to form a shape that wraps the inner tube material and the reinforcing steel wire. This ensures that the outer tube is tightly bonded to the inner tube and the reinforcing steel wire, thus completing the production of the endotracheal tube preform. After cooling, the completed endotracheal tube preform is led out by the traction device.

[0096] Preferably, before the outer tube raw material melt wraps the inner tube and reinforcing steel wire, the inner tube wall needs to be heated by a heating ring to prevent the inner tube from cooling down after long-term transportation and the outer tube from failing to adhere, thus preventing delamination and reducing the product quality of the casing.

[0097] Cutting: According to the length requirements of the endotracheal tube, the tube blank is cut using laser diameter measurement and automatic cutting equipment to form multiple independent endotracheal tubes. During cutting, it is necessary to ensure that the cut is flat and free of burrs.

[0098] Thermoforming: Each tracheal tube is heated by a heater to bend it into shape with a preset bending radius and angle. It is then cooled and shaped to retain the desired shape, ensuring that the bend does not spring back.

[0099] Install other components: Install the tube connector, insertion interface, inflation tube and cuff on each endotracheal tube, and use medical-grade self-drying ink to print the scale lines to complete the fabrication of the endotracheal tube.

[0100] The other end of the insertion port is a bevel, and the inner and outer surfaces of the other end of the insertion port are connected by an arc surface. This design increases the cross-sectional area of ​​the other end of the insertion port, ensuring a larger communication area between the internal tube segment and the patient's trachea. At the same time, it avoids damage to the patient's trachea by the edge of the insertion port during the insertion of the internal tube segment into the patient's trachea, making it safer to use.

[0101] The design of the airbag with its inner diameter gradually increasing from both ends to the middle allows it to better fit the curved or irregular inner wall of the patient's trachea when inflated through the inflation tube, thus improving the airway sealing effect.

[0102] The inner tube and the inner wall of the outer tube have grooves corresponding to the reinforcing wire. The design of the reinforcing wire being embedded in the grooves can effectively reduce the sliding or displacement of the reinforcing wire on the inner tube and the outer tube, making the connection between the reinforcing wire and the inner tube and the outer tube tighter.

[0103] The internal and external tubing sections are made of reinforced tubing material, while the transition section is made of elastic tubing material. The reinforcing wire is wound at a higher density in the internal and external tubing sections than in the transition section. This reinforced tubing material, combined with the denser reinforcing wire, ensures that the internal and external tubing sections are stronger than the transition section, making the internal tubing easier to insert into the trachea and less prone to bending. It also makes the external tubing easier to connect to medical breathing equipment. The transition section is positioned in the oral cavity corresponding to the incisors. Even if the patient becomes agitated post-operatively and bites down on the transition section, the bitten section will still recover its original shape due to the elasticity of the tubing itself. Even though the transition section is wrapped with reinforcing wire, the low density of the reinforcing wire has minimal impact on the rebound of the transition section, thus preventing the transition section from being bitten shut and causing breathing difficulties for the patient.

[0104] The design that the reinforcing wire is wound with a lower density of reinforcing wire at the connection between the inner tube and the outer tube in the inner tube section than at the other part of the inner tube section, but higher than at the transition tube section, allows for the winding of a smaller density of reinforcing wire at the connection between the inner tube section and the outer tube section of two adjacent tracheal tubes in the tracheal tube blank before cutting. This reduces stress concentration at the connection after cutting and reduces the risk of breakage or damage at the connection during use of the tracheal tube, especially when subjected to bending, stretching or external force, thus improving the durability and safety of the tracheal tube.

[0105] The scale lines are printed with medical-grade self-drying ink, making them environmentally friendly and less prone to falling off. This allows anesthesiologists to accurately control the length of the endotracheal tube inserted into the patient's trachea, ensuring safe use.

[0106] The goal is to ensure the patient's upper airway remains unobstructed by using reinforcing steel wires of varying densities and continuous reinforcement within the internal, external, and transitional tubing sections.

[0107] It should be noted that, unless otherwise explicitly specified and limited, the terms "placed," "connected," and "linked" should be interpreted broadly. For example, they can refer to fixed connections such as folded edges, rivets, pins, adhesives, and welds; detachable connections such as threaded connections, snap-fit ​​connections, and hinges; integral connections; electrical connections; direct connections; or indirect connections via an intermediate medium; or internal connections between two components. Those skilled in the art can understand the specific meaning of these terms in this invention based on the specific circumstances.

[0108] It should be further noted that, in order to keep the description simple and clear, the above specific embodiments only describe the differences between them and other embodiments. However, those skilled in the art should know that the above specific embodiments are also independent technical solutions.

Claims

1. A bronchodilator that is resistant to kinking and biting, characterized in that: It consists of a catheter connector, an outer tube, graduation lines, an inner tube, reinforcing wires, an air bladder, an insertion port, a side vent, and an inflation tube. The inner tube is placed inside the outer tube. One end of the catheter connector is embedded in one end of the inner tube. One end of the insertion port is connected to the other end of the inner tube. The insertion port has a side vent. One end of the inflation tube is placed on the outer tube and is connected to the outer tube. The outer tube has an exhaust port. The air bladder is fitted onto the outer tube, and the exhaust port is located inside the air bladder. A reinforcing wire, spirally shaped, is placed between the inner and outer tubes. The reinforcing wire is wound around the inner tube and fits against the inner wall of the outer tube. The inner tube, the outer tube, and the reinforcing wire together constitute the endotracheal tube body. The endotracheal tube body includes three parts: an internal tube section, a transition tube section, and an external tube section. The winding density of the reinforcing wire in the internal tube section and the external tube section is greater than the winding density in the transition tube section. The winding density of the reinforcing wire in the internal tube section from the other end of the inner tube to the other end of the air bladder is less than the winding density in the rest of the internal tube section, but greater than the winding density in the transition tube section. The outer tube has graduation lines on its side.

2. The anti-folding and anti-biting endotracheal tube according to claim 1, characterized in that... The inner and outer tubes are open at both ends. The centerline of the inner tube coincides with the centerline of the outer tube. The inner diameter of the outer tube is larger than the outer diameter of the inner tube. The two ends of the inner and outer tubes are flush. The inner diameter of the catheter connector from one end to halfway point is smaller than the inner diameter from halfway point to the other end. The catheter connector is a standard medical endotracheal catheter connector. The other end of the insertion port is a bevel. The inner and outer surfaces of the other end of the insertion port are connected by an arc surface.

3. The anti-folding and anti-biting endotracheal tube according to claim 1, characterized in that... There are multiple side vents, which are arranged equidistantly around the insertion port. One end of the inflation tube is close to the conduit connector, and one end of the airbag is close to the insertion port. The inner diameter of the airbag gradually increases from both ends to the middle.

4. The anti-folding and anti-biting endotracheal tube according to claim 1, characterized in that... The centerline of the reinforcing wire coincides with the centerline of the inner tube. One end of the reinforcing wire is close to one end of the conduit connector, and the other end of the reinforcing wire is close to one end of the insertion port. The inner tube and the inner wall of the outer tube have grooves corresponding to the reinforcing wire, and the reinforcing wire is embedded in the grooves.

5. The anti-folding and anti-biting endotracheal tube according to claim 1, characterized in that... One end of the scale line is close to the catheter connector, and the other end of the scale line is close to the internal tube segment. The scale line is printed with medical-grade self-drying ink.

6. The anti-folding and anti-biting endotracheal tube according to claim 1, characterized in that... The built-in tube segment is the portion of the tracheal tube body near the insertion port that can be inserted into the human trachea. The external tube segment is the portion of the tracheal tube body near the tube connector that can be connected to a medical breathing device. The transition tube segment is the middle portion of the tracheal tube body connecting the built-in tube segment and the external tube segment. The transition tube segment is placed in the human oral cavity at the location corresponding to the incisors.

7. A bronchodilator with anti-knock and anti-bite properties according to claim 6, characterized in that... The internal and external tubing sections are made of reinforced flexible tubing, while the transition section is made of elastic flexible tubing. The twist pitch of the reinforcing steel wire in the external tubing section is between 0.1 cm and 0.25 cm, preferably 0.125 cm. The twist pitch in the internal tubing section from the other end of the inner tube to the other end of the airbag is between 0.3 cm and 0.65 cm, preferably 0.5 cm. The twist pitch in the remaining portion of the internal tubing section is between 0.1 cm and 0.25 cm, preferably 0.125 cm. The twist pitch in the transition section is between 0.15 cm and 0.3 cm, preferably 2 cm.

8. The anti-folding and anti-biting endotracheal tube according to claim 1, characterized in that... The method for preparing the anti-knock and anti-bite endotracheal tube includes the following steps: (1) Material preparation: Select appropriate medical-grade polymer PVC material as the material for the inner and outer tubes, fold, cut and crush the PVC material into granules, and select stainless steel material as the material for the reinforcing wire; (2) Inner tube extrusion: The granular inner tube raw material is added to the first extruder. Under the action of heating and screw extrusion, the raw material melt is gradually softened, melted and mixed evenly. The melt is pushed to the die part by the screw and subjected to further pressure and shearing. It is extruded through the specific shape channel of the die. The extruded inner tube material is sized by a sizing sleeve to make the outer diameter of the tube reach the preset size. The inner tube material is shaped by internal pressure method or external vacuum method. The sized inner tube is led out by the traction device. (3) Combination of steel wire and inner tube: The reinforcing steel wire is tightly wound onto the inner tube material gradually drawn out by the traction device by the steel wire winding machine according to the preset spiral trajectory. During the winding process of the reinforcing steel wire, the winding density of the reinforcing steel wire at different preset positions on the inner tube material is controlled by adjusting the rotation speed of the steel wire winding machine. When the part that needs to be wound is the inner tube section and the outer tube section, the rotation speed of the steel wire winding machine is increased. When the part that needs to be wound is the transition tube section, the rotation speed of the steel wire winding machine is decreased. (4) Outer tube sleeve: The granular outer tube raw material is added to the second extruder. Under the action of heating and screw extrusion, the outer tube raw material gradually softens, melts and mixes evenly. The evenly mixed raw material melt is pushed to the die part that matches the inner tube material that has been wound with reinforcing steel wire. It is subjected to further pressure and shearing action, and is extruded through the specific shape channel of the die to form the inner tube material and reinforcing steel wire, ensuring that the outer tube is tightly combined with the inner tube and reinforcing steel wire, thus completing the production of the tracheal tube preform. After cooling, the completed tracheal tube preform is pulled out by the traction device. Before the outer tube raw material melt wraps the inner tube and reinforcing steel wire, the inner tube wall needs to be heated by a heating ring to prevent the inner tube from cooling down after long-term transportation and the outer tube from failing to adhere, thus preventing delamination and reducing the product quality of the casing. (5) Cutting: According to the length requirements of the endotracheal tube, the tube blank is cut using laser diameter measurement and automatic cutting equipment to form multiple independent endotracheal tubes. During cutting, it is necessary to ensure that the cut is flat and burr-free. (6) Thermoforming: Each tracheal tube is heated by a heater to bend and shape it into a pre-set bending radius and angle. Then, it is cooled and shaped to retain the required shape and ensure that the bend does not spring back. (7) Install other components: Install the tube connector, insertion interface, inflation tube and cuff on each endotracheal tube, and use medical grade self-drying ink to print the scale lines to complete the fabrication of the endotracheal tube; The method for preparing the anti-folding and anti-biting endotracheal tube also includes a steel wire density winding system.

9. A bronchodilator with anti-knock and anti-bite properties according to claim 8, characterized in that... The wire density winding system includes a signal converter, a data processor, and a controller. The signal converter, data processor, and timer are all mounted on the wire winding machine. The timer is connected to the signal converter via a data line. The wire winding machine is connected to the controller via a data transmission line. The signal converter is connected to the data processor via a data transmission line. The data processor is connected to the controller via a data transmission line. The signal converter converts the electrical signal of the time data collected by the timer into a digital signal. The data processor and signal converter interact. The wire density winding system mainly implements the following steps: the inner layer tube material, gradually drawn out by the traction device, maintains a constant travel speed v. The controller starts the wire winding machine, controlling its rotation speed to 2v, and begins winding the wire from one end of the inner layer tube to the other end of the airbag within the corresponding internal tube segment. The timer collects the travel speed of the inner layer tube material. The system collects travel time data and sends the collected travel time data to a signal converter. The signal converter converts the electrical signal of the collected travel time data into a digital signal and sends it to a data processor. The data processor calculates the travel distance of the inner layer pipe based on the travel speed and travel time. When the travel distance equals a distance threshold of 1, it indicates that the winding of the steel wire on the remaining part of the corresponding built-in pipe section on the inner layer pipe needs to begin, and the rotation speed of the steel wire winding machine is controlled at 8V. When the travel distance equals a distance threshold of 2, it indicates that the winding of the steel wire needs to begin. The steel wire is wound around the corresponding transition section of the inner tube. The rotation speed of the steel wire winding machine is controlled at 0.5V. When the travel distance is equal to the distance threshold 3, it means that the steel wire of the corresponding outer tube section of the inner tube needs to be wound. The rotation speed of the steel wire winding machine is controlled at 8V. When the travel distance is equal to the distance threshold 4, it means that the steel wire winding of a section of the tracheal tube on the inner tube is finished. The timer starts counting again from 0. The rotation speed of the steel wire winding machine is controlled at 2V, and the steel wire winding of the upper and lower sections of the tracheal tube on the inner tube begins.

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