Anti-folding and anti-bite tracheal catheter and preparation method thereof

Abstract

The invention relates to an anti-folding and anti-biting tracheal catheter and a preparation method thereof, and discloses a tracheal catheter capable of ensuring the smoothness of the upper respiratory tract of a patient by arranging uninterrupted reinforcing steel wires with different densities in an internal catheter section, an external catheter section and a transition catheter section, and a preparation method of the tracheal catheter. The catheter is characterized by comprising a catheter connector, an outer-layer tube, scale marks, an inner-layer tube, a reinforcing steel wire, an air bag, an imbedding port, a side vent hole and an inflation tube, the inner-layer tube and the outer-layer tube are of a structure with two open ends, the inner-layer tube is arranged in the outer-layer tube, the center line of the inner-layer tube coincides with the center line of the outer-layer tube, and the outer-layer tube is arranged in the outer-layer tube. The inner diameter of the outer-layer pipe is larger than the outer diameter of the inner-layer pipe, the two ends of the inner-layer pipe are flush with the two ends of the outer-layer pipe, one end of a catheter connector is embedded into one end of the inner-layer pipe, and the inner diameter from one end to the half position of the catheter connector is smaller than the inner diameter from the half position to the other end of the catheter connector.

Description

Technical Field

[0001] The present invention discloses an anti-bending and anti-bite closure endotracheal tube and a preparation method thereof, which relate to an endotracheal tube capable of ensuring that the upper respiratory tract of a patient is unobstructed and a preparation method thereof, and belong to the technical field of medical devices, and particularly to an endotracheal tube capable of ensuring that the upper respiratory tract of a patient is unobstructed by arranging uninterrupted reinforcing steel wires of different densities in an internal tube segment, an external tube segment and a transition tube segment, and a preparation method thereof. Background Art

[0002] Endotracheal intubation technology is a very important anesthesia technology. During anesthesia, a tracheal tube needs to be placed into the patient's trachea through the patient's mouth or nose to ensure that the patient's upper airway is unobstructed.

[0003] There are two main commonly used endotracheal tubes: the first is an ordinary endotracheal tube with low bending resistance. When some patients become agitated and grind their teeth after surgery, the tube section bitten by the patient can quickly return to its original shape to avoid poor ventilation caused by biting and occlusion. However, when the patient's head is excessively flexed or the neck is twisted during surgery, the ordinary endotracheal tube is prone to bend, causing ventilation obstruction in the patient, increasing the difficulty of anesthesiologists in managing the surgical process, and posing a high surgical risk. The second is a wire-reinforced endotracheal tube, the inner wall of which is wrapped with continuous, dense and uniformly dense steel wire material, which has high bending resistance and will not bend during surgery. However, when the patient becomes agitated and grinds his teeth after surgery, the tube section bitten by the patient is difficult to return to its original shape once deformed by external force due to the steel wire wrapped inside, resulting in poor ventilation and endangering the patient's life.

[0004] Publication No. CN208611535U discloses an anti-pinching endotracheal tube, which is made of a long hollow tube, including an external tube section that can be connected to a medical respiratory device, an internal tube section that can be inserted into a human trachea, and a transition tube section for connecting the internal tube section and the external tube section, wherein the transition tube section is made of an elastic hose, and both the internal tube section and the external tube section are made of a reinforced hose, and steel wires are wound inside the internal tube section and the external tube section, and there is no steel wire wound inside the transition tube section connecting the internal tube section and the external tube section, so that the internal tube section can be bent arbitrarily when inserted into the patient's trachea without bending. The tracheal tube is easy to be inserted into the patient's trachea; and the external tube section is easy to be connected to the medical respiratory equipment; at the same time, when the patient becomes agitated and bites the transition tube section after surgery, the transition tube section bitten by the patient can quickly restore its original shape to avoid poor ventilation caused by biting and occlusion; however, the steel wire inside the above-mentioned tracheal tube is discontinuous, and the actual production steps of the tracheal tube are: first, the inner tube is produced, and then the steel wire is wrapped around the inner tube, and then the steel wire is wrapped through the outer tube. After the outer tube is formed, it is cut and truncated into preset sizes by a machine, and finally other parts are installed on the cut single outer tube. During the process of winding the steel wire around the above-mentioned tracheal external tube, the discontinuity of the steel wire requires additional steps and equipment on the production line to accurately control the winding position and tightness of the steel wire, which not only increases the complexity of the production process but also affects production efficiency. In addition, the steel wire needs to be cut during the winding process. If the cut is not neat or there are burrs, gaps may easily appear at the connection between the cut steel wire and the inner tube and outer tube, resulting in low fit, which in turn causes the external tube section and the internal tube section to be insufficiently strong, and are prone to bending and breaking during use, endangering the patient's life. Summary of the invention

[0005] In order to improve the above situation, the present invention provides an anti-bending and anti-bite closure endotracheal tube and a preparation method thereof, which provides an endotracheal tube and a preparation method thereof that can ensure the patient's upper respiratory tract is unobstructed by arranging uninterrupted reinforcing steel wires of different densities in an internal tube segment, an external tube segment and a transition tube segment.

[0006] The present invention provides an anti-bending and anti-biting tracheal tube and a preparation method thereof as follows: The present invention provides an anti-bending and anti-biting tracheal tube comprising a tube joint, an outer tube, a graduation mark, an inner tube, a reinforcing steel wire, an air bag, an insertion port, a side vent and an inflation tube. The inner tube and the outer tube are open at both ends. The inner tube is placed inside 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, One end of the catheter connector is embedded in one end of the inner tube, and the inner diameter from one end to the half of the catheter connector is smaller than the inner diameter from the half of the catheter connector to the other end. Preferably, the catheter connector is a medical standard endotracheal catheter connector. One end of the insertion port is connected to the other end of the inner tube, Preferably, the other end of the insertion port is an inclined surface, and the inner side surface and the outer side surface of the other end of the insertion port are connected by an arc surface. The insertion port is provided with a side vent hole. Preferably, there are a plurality of side vents, and the plurality of side vents are arranged equidistantly along the circumference of the insertion port. One end of the inflation tube is placed on the outer tube, one end of the inflation tube is connected to the outer tube, and one end of the inflation tube is close to the catheter joint. The outer tube is provided with an exhaust hole. The airbag sleeve is placed on the outer tube, the exhaust hole is located in the airbag, and one end of the airbag is close to the insertion port. Preferably, the inner diameter of the airbag gradually increases from both ends to the middle. 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 the inner wall of the outer tube. The center line of the reinforcing steel wire coincides with the center line of the inner tube. One end of the reinforcing steel wire is close to one end of the catheter connector, and the other end of the reinforcing steel wire is close to one end of the insertion port. Preferably, grooves corresponding to the reinforcing steel wires are formed on the inner tube and the inner wall of the outer tube, and the reinforcing steel wires are embedded in the grooves. The inner tube, the outer tube and the reinforcing steel wire together constitute the tracheal tube body. The tracheal tube body comprises an internal tube section, a transition tube section and an external tube section. The internal tube section is the part of the tracheal tube body close to the insertion port that can be inserted into the human trachea. The external tube section is the part of the tracheal tube body close to the tube connector that can be connected to a medical respiratory device. The transition tube section is the middle part of the tracheal tube body connecting the internal tube section and the external tube section. The transition tube section is placed in the position of the human oral cavity corresponding to the incisors. Preferably, the internal pipe section and the external pipe section are made of reinforced hose material, and the transition pipe section is made of elastic hose material. The winding density of the reinforcing steel wire in the internal pipe section and the external pipe section is greater than the winding density in the transition pipe section. Preferably, the winding density of the reinforcing steel wire from the other end of the inner layer tube to the other end of the airbag in the built-in tube section is less than the winding density of the remaining part in the built-in tube section, and is greater than the winding density in the transition tube section. Preferably, the lay pitch of the reinforcing steel wire in the external pipe section is between 0.1 cm and 0.25 cm, preferably 0.125 cm, the lay pitch from the other end of the inner tube to the other end of the airbag in the internal pipe section is between 0.3 cm and 0.65 cm, preferably 0.5 cm, the lay pitch of the remaining part in the internal pipe section is between 0.1 cm and 0.25 cm, preferably 0.125 cm, and the lay pitch in the transition pipe section is between 0.15 cm and 0.3 cm, preferably 2 cm. The side of the outer tube is provided with scale lines. One end of the scale line is close to the catheter joint, and the other end of the scale line is close to the built-in pipe section. Preferably, the scale lines are printed with medical-grade self-drying ink.

[0007] The present invention provides a method for preparing an anti-bending and anti-bite closure endotracheal tube, comprising the following steps: 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 steel wire; Inner tube extrusion: Add the granular inner tube raw material into the first extruder, and the raw material melt gradually softens, melts and mixes evenly under the action of heating and screw extrusion. The raw material melt is pushed to the die part by the screw, subjected to further pressure and shearing, and extruded through the specific shape channel of the die. The extruded inner tube passes through a sizing sleeve to make the outer diameter of the tube reach the preset size, and the inner tube is shaped by internal pressure or external vacuum method. The sized inner tube is led out by the traction device; Combination of steel wire and inner tube: The steel wire winding machine is used to tightly wind the reinforcing steel wire on the inner tube gradually led out by the traction device according to the preset spiral trajectory. In the process of winding the reinforcing steel wire, the winding density of the reinforcing steel wire at different preset positions on the inner tube is controlled by adjusting the rotation speed of the steel wire winding machine. When the parts to be wound with the steel wire are the internal tube section and the external tube section, the rotation speed of the steel wire winding machine is increased; when the parts to be wound with the steel wire are the transition tube section, the rotation speed of the steel wire winding machine is reduced; Preferably, the method for preparing an anti-bending and anti-bite closure endotracheal tube of the present invention further comprises a steel wire density winding system, wherein the steel wire density winding system comprises a signal converter, a data processor and a controller. The signal converter is placed on the steel wire winding machine, the data processor is placed on the steel wire winding machine, and the timer is placed on the steel wire winding machine. The timer is connected to the signal converter via a data line. The wire winding machine is connected to the control module via a data transmission line. 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. The signal converter can convert the electrical signal of the time data collected by the timer into a digital signal. The data processor and the signal converter perform information exchange, The steel wire density winding system mainly implements the following steps: The travel speed of the inner layer pipe gradually drawn out by the traction device Keep unchanged, the controller starts the wire winding machine and controls the rotation speed of the wire winding machine to , start winding the steel wire from the other end of the inner tube to the other end of the airbag in the corresponding built-in tube section on the inner tube, the timer collects the travel time data of the inner tube, and sends the collected travel time data to the signal converter, the signal converter converts the electrical signal of the collected travel time data into a digital signal and sends it to the data processor, the data processor calculates the travel distance of the inner tube according to the travel speed and travel time, when the travel distance is equal to the distance threshold 1, it means that it is necessary to start winding the steel wire of the remaining part of the corresponding built-in tube section on the inner tube, and control the rotation speed of the steel wire winding machine to ; When the travel distance is equal to the distance threshold 2, it means that it is necessary to start winding the steel wire of the corresponding transition pipe section on the inner layer pipe, and the rotation speed of the steel wire winding machine is controlled to When the travel distance is equal to the distance threshold 3, it means that it is necessary to start winding the steel wire corresponding to the outer pipe section on the inner layer pipe, and the rotation speed of the steel wire winding machine is controlled to When the travel distance is equal to the distance threshold 4, it means that the wire winding of a section of tracheal tube on the inner tube is completed, and the timer starts again from 0, and the rotation speed of the wire winding machine is controlled to , start winding the steel wire of the endotracheal tube on the upper and lower sections of the inner tube; Outer tube sleeve: add the granular outer tube raw material into the second extruder. Under the heating and extrusion of the screw, 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 wrapped with the reinforcing steel wire. It is subjected to further pressure and shearing action, and is extruded through the specific shape channel of the die to wrap the inner tube material and the reinforcing steel wire to ensure that the outer tube is tightly combined with the inner tube and the reinforcing steel wire to complete the production of the tracheal tube embryo. The completed tracheal tube embryo is led out by the traction device after cooling; Preferably, before the outer tube raw material melt wraps the inner tube material and the 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 and delaminating, thereby reducing the product quality of the casing; Cutting: According to the length requirements of the endotracheal tube, use laser diameter measurement and automatic cutting equipment to cut the tube blank to form multiple independent endotracheal tubes. When cutting, ensure that the incision is smooth and burr-free; Thermoforming: Each endotracheal tube is heated by a heater to bend the endotracheal tube into a preset bending radius and angle, and then cooled and formed to retain the desired shape to ensure that the bend does not rebound; Install other parts: Install the catheter connector, insertion interface, inflation tube and air bag on each endotracheal tube, use medical-grade self-drying ink to print the scale lines to complete the production of the endotracheal tube. Beneficial Effects

[0008] 1. By arranging reinforcing steel wires of different densities in the internal tube segment, the external tube segment and the transition tube segment, the bending of the internal tube segment during the insertion into the human trachea can be reduced, which facilitates the connection of the external tube segment with the medical respiratory equipment. At the same time, the transition tube segment can quickly restore its original shape after being bitten by the patient, thereby ensuring that the patient's upper respiratory tract is unobstructed.

[0009] 2. The reinforcing steel wires in the internal pipe section, the external pipe section and the transition pipe section are continuous and uninterrupted, which can facilitate the winding of the reinforcing steel wires on the inner pipe, improve the fit between the reinforcing steel wires and the inner and outer pipes, reduce the complexity of the production process, and improve production efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 A three-dimensional structural diagram of an anti-bending and anti-biting endotracheal tube of the present invention; Figure 2 This is a three-dimensional structural diagram of an anti-bending and anti-bite closure endotracheal tube of the present invention, which only shows the structure of the tube connector and the insertion port; Figure 3 This is a three-dimensional structural diagram of an anti-bending and anti-bite closure endotracheal tube of the present invention, which only shows the structure of the endotracheal tube embryo before cutting. Attached photos

[0011] The components include: a catheter connector (1), an outer tube (2), a scale mark (3), an inner tube (4), a reinforcing steel wire (5), an air bag (6), an insertion port (7), a side vent (8), and an inflation tube (9). DETAILED DESCRIPTION Example

[0012] The present invention provides an anti-bending and anti-biting tracheal tube and a preparation method thereof as follows: The present invention provides an anti-bending and anti-biting tracheal tube comprising a tube joint, an outer tube, a graduation mark, an inner tube, a reinforcing steel wire, an air bag, an insertion port, a side vent and an inflation tube. The inner tube and the outer tube are open at both ends. The inner tube is placed inside 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, One end of the catheter connector is embedded in one end of the inner tube, and the inner diameter from one end to the half of the catheter connector is smaller than the inner diameter from the half of the catheter connector to the other end. Preferably, the catheter connector is a medical standard endotracheal catheter connector. One end of the insertion port is connected to the other end of the inner tube, Preferably, the other end of the insertion port is an inclined surface, and the inner side surface and the outer side surface of the other end of the insertion port are connected by an arc surface. The insertion port is provided with a side vent hole. Preferably, there are a plurality of side vents, and the plurality of side vents are arranged equidistantly along the circumference of the insertion port. One end of the inflation tube is placed on the outer tube, one end of the inflation tube is connected to the outer tube, and one end of the inflation tube is close to the catheter joint. The outer tube is provided with an exhaust hole. The airbag sleeve is placed on the outer tube, the exhaust hole is located in the airbag, and one end of the airbag is close to the insertion port. Preferably, the inner diameter of the airbag gradually increases from both ends to the middle. 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 the inner wall of the outer tube. The center line of the reinforcing steel wire coincides with the center line of the inner tube. One end of the reinforcing steel wire is close to one end of the catheter connector, and the other end of the reinforcing steel wire is close to one end of the insertion port. Preferably, grooves corresponding to the reinforcing steel wires are formed on the inner tube and the inner wall of the outer tube, and the reinforcing steel wires are embedded in the grooves. The inner tube, the outer tube and the reinforcing steel wire together constitute the tracheal tube body. The tracheal tube body comprises an internal tube section, a transition tube section and an external tube section. The internal tube section is the part of the tracheal tube body close to the insertion port that can be inserted into the human trachea. The external tube section is the part of the tracheal tube body close to the tube connector that can be connected to a medical respiratory device. The transition tube section is the middle part of the tracheal tube body connecting the internal tube section and the external tube section. The transition tube section is placed in the position of the human oral cavity corresponding to the incisors. Preferably, the internal pipe section and the external pipe section are made of reinforced hose material, and the transition pipe section is made of elastic hose material. The winding density of the reinforcing steel wire in the internal pipe section and the external pipe section is greater than the winding density in the transition pipe section. Preferably, the winding density of the reinforcing steel wire from the other end of the inner layer tube to the other end of the airbag in the built-in tube section is less than the winding density of the remaining part in the built-in tube section, and is greater than the winding density in the transition tube section. Preferably, the lay pitch of the reinforcing steel wire in the external pipe section is between 0.1 cm and 0.25 cm, preferably 0.125 cm, the lay pitch from the other end of the inner tube to the other end of the airbag in the internal pipe section is between 0.3 cm and 0.65 cm, preferably 0.5 cm, the lay pitch of the remaining part in the internal pipe section is between 0.1 cm and 0.25 cm, preferably 0.125 cm, and the lay pitch in the transition pipe section is between 0.15 cm and 0.3 cm, preferably 2 cm. The outer tube has scale marks on its side. One end of the scale line is close to the catheter joint, and the other end of the scale line is close to the built-in pipe section. Preferably, the scale lines are printed with medical-grade self-drying ink.

[0013] During use, before the operation, the anesthesiologist uses medical tools to insert the insertion port of the embedded tube segment into the patient's trachea, controls the length of the tracheal tube entering the patient's trachea by the scale line, and uses a syringe to add an appropriate amount of gas to the air bag through the inflation tube so that the air bag blocks the gap between the outer wall of the outer layer of the embedded tube segment and the inner wall of the patient's trachea, and connects the other end of the catheter connector to the medical respiratory equipment, so that the tracheal tube can be used.

[0014] The present invention provides a method for preparing an anti-bending and anti-bite closure endotracheal tube, comprising the following steps: 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 steel wire; Inner tube extrusion: Add the granular inner tube raw material into the first extruder, and the raw material melt gradually softens, melts and mixes evenly under the action of heating and screw extrusion. The raw material melt is pushed to the die part by the screw, subjected to further pressure and shearing, and extruded through the specific shape channel of the die. The extruded inner tube passes through a sizing sleeve to make the outer diameter of the tube reach the preset size, and the inner tube is shaped by internal pressure or external vacuum method. The sized inner tube is led out by the traction device; Combination of steel wire and inner tube: The steel wire winding machine is used to tightly wind the reinforcing steel wire on the inner tube gradually led out by the traction device according to the preset spiral trajectory. In the process of winding the reinforcing steel wire, the winding density of the reinforcing steel wire at different preset positions on the inner tube is controlled by adjusting the rotation speed of the steel wire winding machine. When the parts to be wound with the steel wire are the internal tube section and the external tube section, the rotation speed of the steel wire winding machine is increased; when the parts to be wound with the steel wire are the transition tube section, the rotation speed of the steel wire winding machine is reduced; Preferably, the method for preparing an anti-bending and anti-bite closure endotracheal tube of the present invention further comprises a steel wire density winding system, wherein the steel wire density winding system comprises a signal converter, a data processor and a controller. The signal converter is placed on the steel wire winding machine, the data processor is placed on the steel wire winding machine, and the timer is placed on the steel wire winding machine. The timer is connected to the signal converter via a data line. The wire winding machine is connected to the control module via a data transmission line. 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. The signal converter can convert the electrical signal of the time data collected by the timer into a digital signal. The data processor and the signal converter perform information exchange, The steel wire density winding system mainly implements the following steps: The travel speed of the inner layer pipe gradually drawn out by the traction device Keep unchanged, the controller starts the wire winding machine and controls the rotation speed of the wire winding machine to , start winding the steel wire from the other end of the inner tube to the other end of the airbag in the corresponding built-in tube section on the inner tube, the timer collects the travel time data of the inner tube, and sends the collected travel time data to the signal converter, the signal converter converts the electrical signal of the collected travel time data into a digital signal and sends it to the data processor, the data processor calculates the travel distance of the inner tube according to the travel speed and travel time, when the travel distance is equal to the distance threshold 1, it means that it is necessary to start winding the steel wire of the remaining part of the corresponding built-in tube section on the inner tube, and control the rotation speed of the steel wire winding machine to ; When the travel distance is equal to the distance threshold 2, it means that it is necessary to start winding the steel wire of the corresponding transition pipe section on the inner layer pipe, and the rotation speed of the steel wire winding machine is controlled to When the travel distance is equal to the distance threshold 3, it means that it is necessary to start winding the steel wire corresponding to the outer pipe section on the inner layer pipe, and the rotation speed of the steel wire winding machine is controlled to When the travel distance is equal to the distance threshold 4, it means that the wire winding of a section of tracheal tube on the inner tube is completed, and the timer starts again from 0, and the rotation speed of the wire winding machine is controlled to , start winding the steel wire of the endotracheal tube on the upper and lower sections of the inner tube; Outer tube sleeve: add the granular outer tube raw material into the second extruder. Under the heating and extrusion of the screw, 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 wrapped with the reinforcing steel wire. It is subjected to further pressure and shearing action, and is extruded through the specific shape channel of the die to wrap the inner tube material and the reinforcing steel wire to ensure that the outer tube is tightly combined with the inner tube and the reinforcing steel wire to complete the production of the tracheal tube embryo. The completed tracheal tube embryo is led out by the traction device after cooling; Preferably, before the outer tube raw material melt wraps the inner tube material and the 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 and delaminating, thereby reducing the product quality of the casing; Cutting: According to the length requirements of the endotracheal tube, use laser diameter measurement and automatic cutting equipment to cut the tube blank to form multiple independent endotracheal tubes. When cutting, ensure that the incision is smooth and burr-free; Thermoforming: Each endotracheal tube is heated by a heater to bend the endotracheal tube into a preset bending radius and angle, and then cooled and formed to retain the desired shape to ensure that the bend does not rebound; Install other parts: Install the catheter connector, insertion interface, inflation tube and air bag on each endotracheal tube, use medical-grade self-drying ink to print the scale lines to complete the production of the endotracheal tube.

[0015] The other end of the insertion port is an inclined surface, and the design that the inner side surface and the outer side surface of the other end of the insertion port are connected by an arc surface can increase the cross-sectional area of ​​the other end of the insertion port, ensure that there is a larger connection area between the built-in tube segment and the patient's trachea, and at the same time, avoid the edge of the insertion port from causing damage to the patient's trachea during the process of the built-in tube segment being inserted into the patient's trachea, so that it is safer to use; The inner diameter of the airbag is designed to gradually increase from both ends to the middle. When the airbag is inflated through the inflation tube to expand the airbag, the shape of the inner diameter gradually increasing from both ends to the middle can better fit the curved or irregular inner wall of the patient's trachea, which helps to improve the sealing effect of the airway; The inner tube and the inner wall of the outer tube are provided with grooves corresponding to the reinforcing steel wires. The design of the reinforcing steel wires being embedded in the grooves can effectively reduce the sliding or displacement of the reinforcing steel wires on the inner tube and the outer tube, so that the connection between the reinforcing steel wires and the inner tube and the outer tube is tighter; The internal pipe section and the external pipe section are made of reinforced hose material, the transition pipe section is made of elastic hose material, the winding density of the reinforcing steel wire in the internal pipe section and the external pipe section is greater than the winding density of the reinforcing steel wire in the transition pipe section, and the reinforced hose material is matched with the reinforcing steel wire with a larger density, so that the material strength of the internal pipe section and the external pipe section can be greater than the material strength of the transition pipe section, so that the internal pipe section is easier to insert into the human trachea and is not easy to bend; the external pipe section is easier to connect with the medical breathing equipment; the transition pipe section is placed in the position corresponding to the incisors in the human mouth, even if the patient becomes agitated after the operation and bites the transition pipe section, the bitten transition pipe section will still restore its original shape through the elasticity of the hose itself, even if the transition pipe section is wrapped with reinforcing steel wire, the density of the reinforcing steel wire is relatively small, and the rebound effect on the transition pipe section is relatively small, so it can avoid the occurrence of the situation where the transition pipe section is bitten and hinders the patient's breathing difficulties; The winding density of the reinforcing steel wire from the other end of the inner tube to the other end of the airbag in the built-in tube section is less than the winding density of the remaining part in the built-in tube section, and is greater than the winding density in the transition tube section. This design enables the connection of the built-in tube section and the external tube section on two adjacent tracheal tubes in the tracheal tube embryo before cutting to be wound with reinforcing steel wires of a relatively low density, which can reduce the occurrence of stress concentration at the connection after cutting. During the use of the tracheal tube, especially when it is bent, stretched or subjected to external forces, it can reduce the breakage or damage at the connection, thereby improving the durability and safety of the tracheal tube. The scale lines are printed with medical-grade self-drying ink, which is environmentally friendly and not easy to fall off, so that the anesthesiologist can accurately control the length of the tracheal tube that penetrates into the patient's trachea, ensuring safety of use.

[0016] The purpose of ensuring that the patient's upper respiratory tract is unobstructed is achieved by arranging uninterrupted reinforcing steel wires of different densities in the internal tube segment, the external tube segment and the transition tube segment.

[0017] It should be noted that, unless otherwise clearly specified and limited, the terms "placed", "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection method such as a folding connection, a rivet connection, a pin connection, a bonding connection and a welding connection, or a detachable connection method such as a threaded connection, a snap connection and a hinge connection, or an integral connection, or an electrical connection, or a direct connection, or an indirect connection through an intermediate medium, or the internal connection of two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0018] It should be further pointed out that, when describing the above specific embodiment, for the sake of simplicity and clarity, only the differences between the above specific embodiment and other embodiments are described, but those skilled in the art should know that the above specific embodiment itself is also an independent technical solution.

Claims

1. An anti-bending and anti-biting endotracheal tube, characterized by: The invention is composed of a catheter joint, an outer tube, a scale mark, an inner tube, a reinforcing steel wire, an airbag, an insertion port, a side vent and an inflation tube. The inner tube is placed in the outer tube, one end of the catheter joint 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, a side vent is provided on the insertion port, one end of the inflation tube is placed on the outer tube, one end of the inflation tube is communicated with the outer tube, an exhaust hole is provided on the outer tube, the airbag sleeve is placed on the outer tube, the exhaust hole is located in the airbag, 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 with the inner wall of the outer tube.

2. The anti-bending and anti-biting endotracheal tube according to claim 1, characterized in that The inner tube, the outer tube and the reinforcing steel wire together constitute a tracheal tube body, and the tracheal tube body includes three parts: an internal tube section, a transition tube section and an external tube section. The winding density of the reinforcing steel 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 steel wire in the internal tube section from the other end of the inner tube to the other end of the airbag is less than the winding density of the remaining part in the internal tube section, and is greater than the winding density in the transition tube section. Graduation lines are arranged on the side of the outer tube.

3. The anti-bending and anti-biting endotracheal tube according to claim 1, characterized in that The inner tube and the outer tube are structures with both ends open, 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, the two ends of the inner tube and the outer tube are flush, the inner diameter from 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, the catheter connector is a medical standard tracheal catheter connector, the other end of the insertion port is a bevel, and the inner side surface and the outer side surface of the other end of the insertion port are connected by an arc surface.

4. The anti-bending and anti-bite endotracheal tube according to claim 1, characterized in that There are multiple side vents, which are equidistantly arranged along the circumference of the insertion port. One end of the inflation tube is close to the catheter 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.

5. The anti-bending and anti-bite endotracheal tube according to claim 1, characterized in that The center line of the reinforcing steel wire coincides with the center line of the inner tube, one end of the reinforcing steel wire is close to one end of the catheter connector, and the other end of the reinforcing steel wire is close to one end of the insertion port. Grooves corresponding to the reinforcing steel wire are provided on the inner tube and the inner wall of the outer tube, and the reinforcing steel wire is embedded in the grooves.

6. The anti-bending and anti-bite endotracheal tube according to claim 1, characterized in that One end of the scale line is close to the catheter joint, and the other end of the scale line is close to the built-in pipe section. The scale line is printed with medical-grade self-drying ink.

7. The anti-bending and anti-biting endotracheal tube according to claim 2, characterized in that The internal tube section is the part of the tracheal tube body close to the insertion port that can be inserted into the human trachea, the external tube section is the part of the tracheal tube body close to the tube connector that can be connected to a medical respiratory device, and the transition tube section is the middle part of the tracheal tube body connecting the internal tube section and the external tube section. The transition tube section is placed in the position of the human oral cavity corresponding to the incisors.

8. The anti-bending and anti-bite endotracheal tube according to claim 2 or 7, characterized in that The built-in pipe section and the external pipe section are made of reinforced hose material, the transition pipe section is made of elastic hose material, the lay length of the reinforcing steel wire in the external pipe section is between 0.1cm and 0.25cm, preferably 0.125cm, the lay length from the other end of the inner layer tube to the other end of the airbag in the built-in pipe section is between 0.3cm and 0.65cm, preferably 0.5cm, the lay length of the remaining part in the built-in pipe section is between 0.1cm and 0.25cm, preferably 0.125cm, and the lay length in the transition pipe section is between 0.15cm and 0.3cm, preferably 2cm.

9. The anti-bending and anti-bite endotracheal tube according to claim 1, characterized in that The method for preparing the anti-clamping endotracheal tube comprises 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 particles, and select stainless steel material as the material for the reinforcing steel 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 raw material melt is pushed to the die part by the screw, subjected to further pressure and shearing action, and extruded through a specific shape channel of the die. The extruded inner tube passes through a sizing sleeve to make the outer diameter of the tube reach a preset size, and the inner tube is shaped by internal pressure or external vacuum. The sized inner tube is led out by a traction device; (3) Combination of steel wire and inner tube: The steel wire winding machine is used to tightly wind the reinforcing steel wire on the inner tube gradually led out by the traction device according to a preset spiral trajectory. During the process of winding the reinforcing steel wire, the winding density of the reinforcing steel wire at different preset positions on the inner tube is controlled by adjusting the rotation speed of the steel wire winding machine. When the parts to be wound with the steel wire are the internal tube section and the external tube section, the rotation speed of the steel wire winding machine is increased; when the parts to be wound with the steel wire are the transition tube section, the rotation speed of the steel wire winding machine is reduced; (4) Outer tube sleeve: The granular outer tube raw material is added into the second extruder. Under the action of heating and extrusion of the screw, 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 wrapped with the reinforcing steel wire. It is subjected to further pressure and shearing action, and is extruded through the specific shape channel of the die to wrap the inner tube material and the reinforcing steel wire, ensuring that the outer tube is tightly combined with the inner tube and the reinforcing steel wire, thus completing the production of the tracheal tube blank. The completed tracheal tube blank is led out by the traction device after cooling; Before the outer tube raw material melt wraps the inner tube material and the 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 and delaminating, thereby reducing the product quality of the casing; (5) Cutting: According to the required length of the endotracheal tube, use laser diameter measurement and automatic cutting equipment to cut the tube blank to form multiple independent endotracheal tubes. During cutting, ensure that the incision is smooth and burr-free; (6) Thermoforming: Each endotracheal tube is heated by a heater so that the endotracheal tube is bent into a shape with a preset bending radius and angle, and then cooled and formed to retain the desired shape to ensure that the bend does not rebound; (7) Install other parts: Install the catheter connector, insertion interface, inflation tube and balloon on each endotracheal tube, and use medical-grade self-drying ink to print the scale lines to complete the production of the endotracheal tube; The method for preparing the anti-clamping endotracheal tube also includes a steel wire density winding system.

10. The anti-bending and anti-bite endotracheal tube according to claim 9, characterized in that The steel wire density winding system includes a signal converter, a data processor and a controller. The signal converter is placed on the steel wire winding machine, the data processor is placed on the steel wire winding machine, and the timer is placed on the steel wire winding machine. The timer is connected to the signal converter through a data line, and the steel wire winding machine is connected to the control module through a data transmission line. The signal converter is connected to the data processor through a data transmission line, and the data processor is connected to the control module through a data transmission line. The signal converter can convert the electrical signal of the time data collected by the timer into a digital signal, and the data processor and the signal converter exchange information. The steel wire density winding system mainly implements the following steps: the travel speed v of the inner layer pipe gradually led out by the traction device remains unchanged, the controller starts the steel wire winding machine, controls the rotation speed of the steel wire winding machine to be 2v, and starts to wind the steel wire from the other end of the inner layer pipe to the other end of the airbag in the corresponding built-in pipe section on the inner layer pipe, and the timer collects the inner layer pipe material. The travel time data is collected and sent to the signal converter. The signal converter converts the electrical signal of the collected travel time data into a digital signal and sends it to the data processor. The data processor calculates the travel distance of the inner layer pipe according to the travel speed and travel time. When the travel distance is equal to the distance threshold 1, it means that it is necessary to start winding the steel wire of the remaining part of the corresponding built-in pipe section on the inner layer pipe, and control the rotation speed of the steel wire winding machine to 8v; when the travel distance is equal to the distance threshold 2, it means that it is necessary to start Wrap the steel wire corresponding to the transition pipe section on the inner tube, control the rotation speed of the steel wire winding machine to 0.5v, when the travel distance is equal to the distance threshold 3, it means that it is necessary to start winding the steel wire corresponding to the external pipe section on the inner tube, and control the rotation speed of the steel wire winding machine to 8v. When the travel distance is equal to the distance threshold 4, it means that the steel wire winding of a section of tracheal tube on the inner tube is completed, and the timer starts again from 0, controls the rotation speed of the steel wire winding machine to 2v, and starts steel wire winding of the upper and lower sections of tracheal tube on the inner tube.

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