Tooth-cushion-free oral tracheal intubation system

Abstract

The invention discloses a tooth-cushion-free oral tracheal intubation system, and particularly relates to a portable integrated bag which comprises a catheter, a fixing device and a guide wire, and the portable integrated bag can be used immediately after being opened and is efficient and convenient. Wherein the catheter comprises an oral cavity anti-biting section, a pharynx transition section and a trachea flexible section which are sequentially arranged, the section of the oral cavity anti-biting section is oval and can prevent biting deformation, the section of the pharynx transition section is gradually changed to be round from oval and can prevent collapse, and the trachea flexible section is an ultra-thin silica gel corrugated pipe and can reduce damage to airway mucosa; the fixing device comprises a fixator, a biological bonding fin and an anti-slip fixing band, the fixator is connected with the catheter in a buckled mode, the biological bonding fin can be bonded to the skin of the upper jaw of the human body, and the anti-slip fixing band can be fixedly arranged on the head of the human body in a sleeving mode, so that the catheter can be fixed without a tooth pad, operation steps are simplified, and the use experience of a patient is improved.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to an oral tracheal intubation system without a dental pad. Background Art

[0002] An oral tracheal intubation device is a medical device for establishing an artificial airway. It is mainly used to insert a catheter into the trachea through the oral cavity when a patient is unable to breathe independently or requires mechanical ventilation, so as to ensure the patency of the airway and provide oxygen or assist ventilation. An oral tracheal intubation device usually consists of components such as a catheter, an airbag, a catheter connector, a guide wire, and a dental pad. Among them, the catheter is a flexible tube for inserting into the human trachea to deliver oxygen or air; the airbag is located at the tail end of the catheter and is used to inflate and fix the catheter to prevent air leakage; the catheter connector is located at the front end of the catheter and is used to connect a ventilator or an artificial ventilation device; the dental pad is located near the catheter connector and is inserted into the human oral cavity to fix the catheter and prevent it from falling off.

[0003] However, the existing technology using a dental pad to fix the catheter has at least the following disadvantages: First, after intubation, it is necessary to add the fixing step of the dental pad, the operation is complicated, and the fixing position is prone to displacement; Second, fixing the teeth requires increasing the space occupied in the oral cavity, resulting in discomfort for the patient and being unfavorable for oral care. Summary of the Invention

[0004] The present invention provides an oral tracheal intubation system without a dental pad, which can realize fixing the catheter without a dental pad, simplify the operation steps, and improve the patient's usage experience.

[0005] The present invention provides an oral tracheal intubation system without a dental pad, comprising:

[0006] A catheter, including an oral bite-resistant section, a pharyngeal transition section, and a tracheal soft section arranged in sequence from near to far along the axis. The cross-section of the oral bite-resistant section is oval, the cross-section of the pharyngeal transition section gradually changes from oval to circular along the axis from near to far, and the tracheal soft section is an ultra-thin silicone corrugated pipe;

[0007] A fixing device, including a fixator, a biological adhesion wing, and an anti-slip fixing band. The fixator includes a card part and a buckle part. The card part is used to fit the skin of the human maxilla, the buckle part is used to be buckled and connected with the catheter, the biological adhesion wing is detachably arranged on the card part, the biological adhesion wing is used to adhere to the skin of the human maxilla, the anti-slip fixing band is detachably arranged on the biological adhesion wing, and the anti-slip fixing band is used to be fixedly sleeved on the human head;

[0008] A guide wire, used to guide the catheter to enter the human trachea from the human oral cavity;

[0009] A portable integrated package for integrally packaging the guide wire, the catheter and the fixing device.

[0010] As an alternative embodiment, the card portion is bent along one side surface to form an arc surface for fitting the skin of the upper jaw of the human body; the buckle portion includes an elastic member, and the elastic member forms an elastic hole for threading the catheter.

[0011] As an alternative embodiment, two fixing holes are provided on the card portion;

[0012] The biological adhesion flap includes two strap portions and two flap portions. The two flap portions are fixedly connected to each other and spread out to both sides. One end of each of the two strap portions is fixedly provided at the connection of the two flap portions, and the other ends of the two strap portions are respectively threaded through the two fixing holes to connect the biological adhesion flap to the card portion.

[0013] As an alternative embodiment, the anti-slip fixing band includes a headband, two fixing gaskets and two fixing brackets. The two fixing gaskets are respectively fixedly provided on the two fixing brackets. One end of the two fixing brackets is fixedly connected through the headband, and the other ends of the two fixing brackets are detachably connected to the connection of the two flap portions;

[0014] One reserved hole is respectively provided on the two flap portions, and at least one fixing buckle corresponding to the reserved hole is respectively provided on the two fixing gaskets.

[0015] As an alternative embodiment, a Murphy hole communicating inside and outside is provided at the distal end of the flexible tracheal segment;

[0016] The catheter further includes an airbag, a ventilation tube and a balloon. The airbag is sleeved outside the flexible tracheal segment. The ventilation tube extends axially on the outer walls of the flexible tracheal segment and the pharyngeal transition segment. Two ends of the ventilation tube are respectively communicated with the airbag and the balloon;

[0017] The catheter further includes a connector, and the connector is fixedly inserted into the proximal port of the oral bite-resistant segment for connecting an external ventilator device.

[0018] As an alternative embodiment, the catheter further includes a sputum suction pipe. The sputum suction pipe extends axially on the outer walls of the flexible tracheal segment and the pharyngeal transition segment, and the suction port of the sputum suction pipe is close to the airbag.

[0019] As an alternative embodiment, the oral bite-resistant segment of the catheter is made of a temperature-changing and color-changing material, and the color-changing temperature of the temperature-changing and color-changing material is 37°C.

[0020] As an alternative embodiment, scale lines are embedded on the outer wall of the catheter, and the scale lines are marked from 14 cm to 28 cm from far to near along the axial direction, wherein the scale lines marked 21 cm, 22 cm and 23 cm adopt the temperature-changing color-changing material.

[0021] As an alternative embodiment, the total length of the catheter is at least 28 cm, wherein:

[0022] The 5 cm at the distal end of the catheter is made of smooth soft glue;

[0023] The 5 cm at the proximal end of the catheter is coated with a light-emitting green film, and connecting card slots are arranged every 0.5 - 1 cm, and the connecting card slots are used to connect the buckle part;

[0024] At least 8 cm in the middle of the catheter is made of a hard tube with honeycomb patterns;

[0025] At least one X-ray imaging line running through the whole length along the axial direction is arranged in the tube wall of the catheter.

[0026] As an alternative embodiment, the catheter is arranged from outside to inside in the radial direction as an anti-biting layer, a buffer layer and an airway contact layer. The anti-biting layer is made of glass fiber-reinforced polyether ether ketone, the buffer layer is made of thermoplastic polyurethane, and the airway contact layer is made of medical-grade silicone.

[0027] As can be seen from the above, the toothless oral endotracheal intubation system of the present invention is specifically a portable integrated package including a catheter, a fixing device and a guide wire, which can be used immediately after opening the package, and is efficient and convenient. Among them, the catheter includes an oral anti-biting section, a pharyngeal transition section and a tracheal soft section arranged in sequence. The cross-section of the oral anti-biting section is oval, which can prevent biting and deformation. The cross-section of the pharyngeal transition section gradually changes from oval to round, which can prevent collapse. The tracheal soft section is an ultra-thin silicone corrugated pipe, which can reduce the damage to the airway mucosa; the fixing device includes a fixator, a biological adhesion wing and an anti-slip fixing band. The fixator is buckled and connected to the catheter. The biological adhesion wing can adhere to the skin of the upper jaw of the human body, and the anti-slip fixing band can be fixedly sleeved on the human head, so as to realize the fixation of the catheter without using a toothpad, simplify the operation steps and improve the patient's use experience.

[0028] The beneficial effects of the additional technical features of the present invention will be described in the specific implementation part of this specification. Description of the Drawings

[0029] In order to more clearly illustrate the embodiments of the present invention, the following will briefly introduce the drawings required for use in the embodiments or the description of the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0030] Figure 1 is an oral endotracheal intubation system without a dental pad provided by an embodiment of the present invention;

[0031] Figure 2 is a schematic structural diagram of a fixing device provided by an embodiment of the present invention;

[0032] Figure 3 is a schematic structural diagram of a fixator provided by an embodiment of the present invention;

[0033] Figure 4 is a schematic structural diagram of a biological adhesion flap provided by an embodiment of the present invention;

[0034] Figure 5 is a schematic structural diagram of the assembly of a fixator and a biological adhesion flap provided by an embodiment of the present invention;

[0035] Figure 6 is a schematic structural diagram of a catheter provided by an embodiment of the present invention;

[0036] Figure 7 is a schematic structural diagram of an oral bite-resistant section provided by an embodiment of the present invention.

[0037] Reference numerals:

[0038] 100 - catheter, 110 - oral bite-resistant section, 120 - pharyngeal transition section, 130 - tracheal soft section, 131 - Murphy's eye, 140 - airbag, 150 - ventilation tube, 160 - balloon, 170 - connector, 180 - suction pipeline, 181 - suction port, 190 - X-ray imaging wire; 200 - fixing device, 210 - fixator, 211 - card part, 2111 - fixing hole, 212 - buckle part, 2121 - elastic member, 220 - biological adhesion flap, 221 - strap part, 222 - flap part, 2221 - reserved hole, 230 - anti-slip fixing band, 231 - headband, 232 - fixing gasket, 2321 - fixing buckle, 233 - fixing bracket; 300 - guide wire. Detailed implementation manners

[0039] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0040] Please refer to Figure 1 、 Figure 2 、 Figure 3 and Figure 6 ,Figure 1 It is a toothless oral tracheal intubation system provided by an embodiment of the present invention. Figure 2 It is a schematic structural diagram of a fixing device provided by an embodiment of the present invention. Figure 3 It is a schematic structural diagram of a fixator provided by an embodiment of the present invention. Figure 6 It is a schematic structural diagram of a catheter provided by an embodiment of the present invention. The toothless oral tracheal intubation system shown in the figure includes:

[0041] The catheter 100 includes an oral bite-resistant section 110, a pharyngeal transition section 120, and a tracheal flexible section 130 arranged in sequence from near to far along the axis. The cross-section of the oral bite-resistant section 110 is oval, with a reinforced catheter wall, and is made of a lightweight rigid material (such as medical-grade polycarbonate or metal inlay), which increases the compressive strength of the oral bite-resistant section 110, prevents deformation due to being bitten, and at the same time facilitates medical staff to quickly insert and maintain the shape of the catheter 100, avoiding twisting or folding of the catheter 100. The cross-section of the pharyngeal transition section 120 gradually changes from oval to circular from near to far along the axis and forms a certain arc along the axis to match the human respiratory tract. The tracheal flexible section 130 is an ultra-thin silicone corrugated pipe, and the ultra-thin silicone corrugated pipe is required to be smooth and have small tissue friction to avoid difficulty during intubation and reduce damage to the airway mucosa, so as to be applicable to difficult airways that may exist in emergency first aid. Optionally, the main body of the catheter 100 is made of medical-grade PVC (polyvinyl chloride), which has a low cost and good flexibility and biocompatibility. The inside of the catheter 100 serves as the main ventilation channel for conventional ventilation.

[0042] Fixing device 200, comprising a fixator 210, a bioadhesive flap 220 and an anti-slip fixing strap 230, through modular design, enables quick assembly and adjustment according to the patient's condition. The fixator 210 includes a card portion 211 and a buckle portion 212. The card portion 211 is used to fit the skin of the human maxillary part, and the buckle portion 212 is used for snap connection with the catheter 100. The proximal end of the catheter 100 is designed with a standardized size, and the buckle portion 212 is designed with a hole slot of a corresponding size. Inserting the catheter 100 into the hole slot can automatically lock / quickly connect. One side of the bioadhesive flap 220 is detachably arranged on the card portion 211. Before assembly, it is convenient for packing and transportation. After assembly, they are relatively fixedly connected. The other side of the bioadhesive flap 220 is used to adhere to the skin of the human maxillary part. The anti-slip fixing strap 230 is detachably arranged on the bioadhesive flap 220. Similarly, before assembly, it is convenient for packing and transportation. After assembly, they are relatively fixedly connected. The anti-slip fixing strap 230 is used to be fixedly sleeved on the human head. Among them, the inner side of the anti-slip fixing strap 230 is designed with anti-slip texture, or the inner side is made of anti-slip silicone material to increase friction and prevent the catheter 100 from sliding after fixation. In addition, the anti-slip fixing strap 230 is designed as a modular structure and can quickly adjust the length according to the patient's head circumference.

[0043] Guide wire 300, used to guide the catheter 100 to enter the human trachea from the human oral cavity. Specifically, the guide wire 300 is used to guide the catheter 100 into the airway during intubation to increase the rigidity of the catheter 100. The guide wire 300 is usually made of stainless steel or nitinol and has a certain flexibility. The guide wire 300 is required to have a smooth surface to avoid damaging the inner wall of the catheter 100. After use, it needs to be removed in time to avoid damaging the airway.

[0044] Portable integrated package, used to integrally package the guide wire 300, the catheter 100 and the fixing device 200. Among them, the portable integrated package is also equipped with a lubricant, used to cover the outer surface of the catheter, such as a hydrophilic super-slippery coating, to reduce friction during intubation and at the same time can eliminate the lubrication step before intubation.

[0045] As can be seen from the above, the toothless oral endotracheal intubation system of the present invention is specifically a portable integrated package including a catheter 100, a fixing device 200 and a guide wire 300. It can be used immediately after unpacking, which is efficient and convenient. At the same time, the catheter 100 and the fixing device 200 are made of lightweight materials, which can reduce the burden on patients and facilitate transportation. Among them, the catheter 100 includes an oral bite-resistant section 110, a pharyngeal transition section 120 and a tracheal soft section 130 arranged in sequence. The cross-section of the oral bite-resistant section 110 is oval, which can prevent bite deformation. The cross-section of the pharyngeal transition section 120 gradually changes from oval to round, which can prevent collapse. The tracheal soft section 130 is an ultra-thin silicone corrugated pipe, which can reduce the damage to the airway mucosa. The fixing device 200 includes a fixator 210, a biological adhesion wing 220 and an anti-slip fixing band 230. The fixator 210 is snap-connected to the catheter 100. The biological adhesion wing 220 can adhere to the skin of the human maxilla. The anti-slip fixing band 230 can be fixedly sleeved on the human head, so as to fix the catheter 100 without using a toothpad, simplify the operation steps and improve the patient's use experience.

[0046] Please refer to Figure 3 , Figure 3 FIG. is a schematic structural diagram of a fixator provided by an embodiment of the present invention. As shown in the figure, the card portion 211 is bent along one side surface to form an arc surface for fitting the skin of the human maxilla, which conforms to the characteristics of ergonomics. The card portion 211 can be made of lightweight medical-grade plastic or silicone and fixed to the skin of the human maxilla to ensure that the catheter is stable and not easy to slide. The card portion 211 adopts a lightweight design with a thickness of only 3 mm, which has little burden on the wearer. The buckle portion 212 includes an elastic member 2121, and the elastic member 2121 forms an elastic hole for passing through the catheter 100. As shown in the figure, the buckle portion 212 includes two elastic members 2121, which are oppositely arranged and stand on the card portion 211. An elastic hole matching the size of the catheter 100 is formed at the interval between the two elastic members 2121. The catheter 100 can be automatically locked / quickly connected by passing it through the elastic hole.

[0047] Please refer to Figure 4 , Figure 4This is a schematic structural diagram of a bioadhesive wing provided by an embodiment of the present invention. As shown in the figure, the bioadhesive wing 220 includes two strap portions 221 and two wing portions 222. The two wing portions 222 are fixedly connected to each other and expand to both sides, and can be bent 180° to fit the zygomatic bone or the curved surface of the maxillary angle. The wing portion 222 is made of a medical-grade acrylic pressure-sensitive adhesive patch (3M adhesive, modified type 2477P). After removing the release paper, the two wing portions 222 can be pasted on the human skin or the anti-slip fixing belt 230. By using the 3M adhesive to fit, it can be fixed without the anti-slip fixing belt 230 when the fixing requirement is not very high. One end of each of the two strap portions 221 is fixedly arranged at the connection of the two wing portions 222. There are two fixing holes 2111 on the card portion 211. The other ends of the two strap portions 221 respectively pass through the two fixing holes 2111 to connect the bioadhesive wing 220 to the card portion 211. In a specific implementation, a magic tape is provided on the side of the two strap portions 221 facing the bioadhesive wing 220, and a hair sticker is provided on the side of the bioadhesive wing 220 facing away from the human skin. After passing the two strap portions 221 through the two fixing holes 2111, the bioadhesive wing 220 is adhered through the magic tape.

[0048] Please refer to Figure 2 , as shown in the figure, the anti-slip fixing belt 230 includes a headband 231, two fixing gaskets 232 and two fixing brackets 233. The two fixing gaskets 232 are respectively fixedly arranged on the two fixing brackets 233. One end of the two fixing brackets 233 is fixedly connected through the headband 231. The other ends of the two fixing brackets 233 are detachably connected to the connection of the two wing portions 222, so that before the anti-slip fixing belt 230 and the bioadhesive wing 220 are assembled, they are convenient for packing and transportation, and after they are assembled, they are relatively fixedly connected. Among them, the inner sides of the two fixing gaskets 232 are both designed with anti-slip textures to prevent the catheter 100 from sliding after being fixed. The inner side of the headband 231 is made of anti-slip silica gel material to increase the friction force. Through the modular structure of several parts, the length can be quickly adjusted according to the patient's head circumference.

[0049] One reserved hole 2221 is respectively provided on the two wing portions 222, and at least one fixing buckle 2321 corresponding to the reserved hole 2221 is respectively arranged on the two fixing gaskets 232. Specifically, during the assembly process of the anti-slip fixing belt 230 and the bioadhesive wing 220, the fixing buckle 2321 is passed through the reserved hole 2221 to prevent the two from displacing and to stabilize the positional relationship. Among them, the number of fixing buckles 2321 can be multiple. Correspondingly, the reserved hole 2221 can be set to multiple or in a long strip shape.

[0050] In this embodiment, as Figure 2As shown, the headband 231 can be composed of two straps, the two ends of the two straps are fixedly connected, and an opening is formed in the middle. The opening is used to be put on the back of the human head, so that the two straps are respectively located at the upper and lower positions of the back of the head. The clamping and fixing method from two directions makes the stability higher. Furthermore, a fishing net-like elastic rope can also be provided at the opening, so that the headband 231 as a whole forms a net bag, which is more conducive to stable wearing.

[0051] See also Figure 6 , Figure 6 1 is a schematic diagram of the structure of a catheter 100 provided in an embodiment of the present invention.

[0052] The distal end of the tracheal flexible section 130 is provided with a Murphy hole 131 communicating with the inside and outside for conveying gas.

[0053] The catheter 100 also includes an airbag 140, a vent tube 150 and a balloon 160. The airbag 140 is disposed on the outer wall of the tracheal flexible section 130. The vent tube 150 is axially extended and arranged on the outer wall of the tracheal flexible section 130 and the pharyngeal transition section 120. The two ends of the vent tube 150 are connected to the airbag 140 and the balloon 160 respectively. In a specific implementation, by pressing the balloon 160, the airbag 140 can be inflated through the vent tube 150 to support and fix the catheter 100 at the trachea. In this embodiment, a high-volume, low-pressure airbag can be used to ensure good sealing and uniform pressure on the tracheal wall, thereby reducing the risk of tracheal mucosal damage.

[0054] The catheter 100 further includes a connector 170, which is fixedly inserted into the proximal port of the oral anti-bite section 110 and is used to connect to an external ventilator device, or of course, to an external conventional air pump, which is not limited here. The connector 170 uses a standard interface to match the current standard equipment.

[0055] The catheter 100 also includes a sputum suction pipe 180, which is axially extended and arranged on the outer walls of the tracheal flexible section 130 and the pharyngeal transition section 120. The suction port 181 of the sputum suction pipe 180 is arranged close to the airbag 140, so that the sputum suction pipe 180 can achieve subglottic sputum suction. This embodiment integrates the sputum suction function, avoids repeated disassembly of the catheter 100 for sputum suction, and reduces the risk of infection.

[0056] The catheter 100 in this embodiment adopts a gradient structure. In a specific implementation, Figure 7The oral anti-bite section 110 shown has an outer ellipse-inner circle cross-section. By means of the ellipse, the anti-biting force strength of the transverse surface is enhanced, and the compressive strength is improved compared with that of a circular catheter. At the same time, the cross-sectional diameter (the longest distance between two points on the ellipse) is 12 mm, with a wall thickness of 1.8 mm of PEEK + 30% glass fiber reinforced layer, and the hardness reaches Shore D88, with good compressive strength; the pharyngeal transition section 120 gradually changes to an outer circle-inner circle cross-section and is embedded with a nitinol memory ring (recovery force ≥ 5 N) to prevent collapse; the tracheal flexible section 130 uses an ultra-thin silicone bellows with a wall thickness of 0.6 mm to reduce mucosal damage. Further, the oral anti-bite section 110 has an elliptical diameter design with a length of about 4-5 cm, and the length accounts for 25-35% of the total length of the catheter. A fixing device connection slot (material Shore hardness D50-60) is arranged inside, and a metal spiral reinforcing rib is built in to prevent deformation; the pharyngeal transition section 120 has a gradually changing cross-section area with a length ≥ 2 cm, and the hardness gradient decreases (from Shore D50 to A90) to avoid stress mutation; the tracheal flexible section 130 uses a circular silicone material (Shore A40-50) to maintain the airbag seal. It should be noted that the catheter 100 of this embodiment needs to be controlled by key processes: ① Cross-section transition, using dynamic die technology to achieve continuous gradual change from ellipse to circle; ② Edge treatment, plasma polishing to make the edges reach a surface finish of Ra ≤ 0.8 μm. It should also be noted that the compressive strength requirements of the oral anti-bite section 110 of this embodiment are as follows: ① Compressive stiffness, under a biting force of 500 N, the cross-sectional area compression rate < 5% (the existing dental pad standard is < 3%); ② Fatigue resistance, no plastic deformation after simulating 50,000 opening and closing bites (10-60 N cyclic load); ③ Airway maintenance, the catheter cross-sectional area retention rate ≥ 90% (compared with 93-95% of the combination of dental pad + traditional catheter); ④ Biting protection, by dispersing the biting pressure, the pressure on a single tooth < 200 kPa (the enamel tolerance threshold is about 300 kPa). It should be noted that the catheter 100 of this embodiment uses a five-layer micro co-extrusion die to achieve seamless bonding of the PEEK outer layer → TPU transition layer → silicone inner layer; a 0.1 mm titanium wire mesh (coverage rate 15%, mesh aperture 2×2 mm) is embedded in the PEEK layer to improve the anti-crushing ability; an alumina coating (thickness 50-80 μm) is sprayed on the surface by plasma to reduce the friction of the biting surface; anti-slip patterns (depth 0.2 mm, pattern pitch 1.5 mm) are etched on the surface by laser to enhance the operation grip.

[0057] As an alternative embodiment, the oral anti-bite section 110 of the catheter 100 uses a thermochromic material, and the color change temperature of the thermochromic material is 37°C. That is, at a position about 20 cm from the farthest end of the catheter 100, a 37°C thermochromic material (which shows color after contacting the oral cavity) is used to facilitate observation and intubation operation by medical staff.

[0058] Further, scale lines are embedded in the outer wall of the catheter 100. The scale lines are marked from 14 cm to 28 cm from far to near along the axial direction. Clear scales are marked on the surface of the catheter 100, which can help medical staff quickly judge the insertion depth. Among them, the scale lines marked at 21 cm, 22 cm and 23 cm adopt the temperature-changing and color-changing material, and annular linear markings can be used. Optionally, the scale lines at 21 cm, 22 cm and 23 cm are color-distinguished by different thermosensitive materials; alternatively, the scale lines at 21 cm, 22 cm and 23 cm are distinguished by annular lines with different numbers of turns. For example, there are 3 turns of annular lines at 21 cm, 2 turns of annular lines at 22 cm, and 1 turn of annular lines at 23 cm. It should be noted that similar distinguishing designs are acceptable and are not limited here.

[0059] As an optional implementation manner, the total length of the catheter 100 is at least 28 cm, wherein:

[0060] The 5 cm at the distal end of the catheter 100 is made of smooth soft rubber;

[0061] The 5 cm at the proximal end of the catheter 100 is coated with a luminous green film, such as a fluorescent film, which is convenient for quickly identifying the position of the catheter 100 in an environment with insufficient light. Connecting card slots are arranged every 0.5 - 1 cm. The connecting card slots are used to connect the buckle part 212. The connecting card slots can increase the friction force and improve the stability of fixing the catheter 100;

[0062] At least 8 cm in the middle of the catheter 100 is made of a hard tube with honeycomb patterns.

[0063] As an optional implementation manner, at least one X-ray imaging line 190 running through the whole length along the axial direction is arranged in the tube wall of the catheter 100. Among them, the function of the X-ray imaging line (Radiopaque Line) is to be imaged under X-ray, which is convenient for confirming the position of the catheter. The X-ray imaging line 190 can be made of barium sulfate or other imaging materials and is embedded in the catheter wall. The imaging line runs through the whole length of the catheter to ensure clear visibility under X-ray.

[0064] As an alternative embodiment, the catheter 100 is radially arranged from outside to inside with an anti-biting layer, a buffer layer, and an airway contact layer. The anti-biting layer is made of glass fiber-reinforced polyether ether ketone, the buffer layer is made of thermoplastic polyurethane, and the airway contact layer is made of medical-grade silicone (platinum vulcanized). In a specific implementation, the Shore hardness of the anti-biting layer is D85-90, the flexural strength is 220-250 MPa (ASTM D790), and the biocompatibility meets the requirements of ISO 10993-1 for cytotoxicity / sensitization; the tear strength of the buffer layer is ≥60 kN / m (ASTM D624), and the compression set is ≤25% (70°C × 22 h, ASTM D395); the hardness of the airway contact layer is Shore A40-45 (ISO 48-4); the surface friction coefficient is ≤0.15 (ASTM D1894).

[0065] As can be seen from the above, the toothless oral endotracheal intubation system of the present invention is specifically a portable integrated package including a catheter, a fixing device, and a guide wire, which can be used immediately after opening the package, and is efficient and convenient. Among them, the catheter includes an oral anti-biting section, a pharyngeal transition section, and a tracheal soft section arranged in sequence. The cross-section of the oral anti-biting section is elliptical, which can prevent biting deformation. The cross-section of the pharyngeal transition section gradually changes from elliptical to circular, which can prevent collapse. The tracheal soft section is an ultra-thin silicone corrugated pipe, which can reduce the damage to the airway mucosa; the fixing device includes a fixator, a biological adhesion wing, and an anti-slip fixing band. The fixator is snap-connected to the catheter. The biological adhesion wing can adhere to the skin of the human maxilla, and the anti-slip fixing band can be fixedly sleeved on the human head, so as to realize the fixation of the catheter without a toothpad, simplify the operation steps, and improve the patient's use experience.

[0066] The above-disclosed are only the preferred embodiments of the present invention, and the description is relatively specific and detailed. Of course, it cannot be used to limit the scope of the rights of the present invention. Therefore, equivalent changes made according to the claims of the present invention still fall within the scope covered by the present invention. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several deformations and improvements can still be made, and these all belong to the protection scope of the present invention.

Claims

1. An orotracheal intubation system without a dental pad, characterized in that, Comprising: A catheter, including an oral bite-resistant section, a pharyngeal transition section, and a tracheal flexible section arranged axially from near to far. The cross-section of the oral bite-resistant section is oval, the cross-section of the pharyngeal transition section gradually changes from oval to circular axially from near to far, and the tracheal flexible section is an ultra-thin silicone corrugated pipe; A fixing device, including a fixator, a biological adhesion fin, and an anti-slip fixing strap. The fixator includes a card portion and a buckle portion. The card portion is used to fit the skin of the human maxilla, the buckle portion is used to be buckled and connected to the catheter, the biological adhesion fin is detachably arranged on the card portion, the biological adhesion fin is used to adhere to the skin of the human maxilla, and the anti-slip fixing strap is detachably arranged on the biological adhesion fin and is used to be fixedly sleeved on the human head; A guide wire, used to guide the catheter to enter the human trachea from the human oral cavity; A portable integrated package, used to integrally package the guide wire, the catheter, and the fixing device.

2. The toothpad-free oral tracheal intubation system according to claim 1, characterized in that The card portion is bent along one side to form an arc surface for fitting the skin of the human maxilla; the buckle portion includes an elastic member, and the elastic member forms an elastic hole for passing through the catheter.

3. The endotracheal intubation system via the mouth without a dental pad according to claim 1, characterized in that There are two fixing holes on the card portion; The biological adhesion fin includes two strap portions and two fin portions. The two fin portions are fixedly connected to each other and spread out to both sides. One end of each of the two strap portions is fixedly arranged at the connection of the two fin portions, and the other ends of the two strap portions respectively pass through the two fixing holes to connect the biological adhesion fin to the card portion.

4. The toothpad-free oral tracheal intubation system according to claim 3, wherein, The anti-slip fixing strap includes a headband, two fixing gaskets, and two fixing frames. The two fixing gaskets are respectively fixedly arranged on the two fixing frames. One end of the two fixing frames is fixedly connected through the headband, and the other end of the two fixing frames is detachably connected to the connection of the two fin portions; There is a reserved hole on each of the two fin portions, and at least one fixing buckle corresponding to the reserved hole is arranged on each of the two fixing gaskets.

5. The toothpad-free oral tracheal intubation system according to claim 1, characterized in that, The distal end of the tracheal flexible section is provided with Murphy holes for communicating inside and outside; The catheter further includes an airbag, a ventilation pipe, and a balloon. The airbag is sleeved outside the tracheal flexible section, the ventilation pipe extends axially on the outer walls of the tracheal flexible section and the pharyngeal transition section, and both ends of the ventilation pipe communicate with the airbag and the balloon respectively; The catheter further includes a connector, and the connector is fixedly inserted into the near port of the oral bite-resistant section for connecting an external ventilator device.

6. The endotracheal intubation system without dental pad according to claim 5, characterized in that The catheter further includes a sputum suction pipe, and the sputum suction pipe extends axially on the outer walls of the tracheal flexible section and the pharyngeal transition section, and the suction port of the sputum suction pipe is arranged close to the airbag.

7. The toothpad-free oral tracheal intubation system according to claim 1, characterized in that, The oral bite-resistant section of the catheter is made of a temperature-changing and color-changing material, and the color-changing temperature of the temperature-changing and color-changing material is 37°C.

8. The toothpad-free oral tracheal intubation system according to claim 7, characterized in that, Scale lines are embedded on the outer wall of the catheter, and the scale lines are marked from 14 cm to 28 cm axially from far to near. Among them, the scale lines marked 21 cm, 22 cm, and 23 cm adopt the temperature-changing and color-changing material.

9. The endotracheal intubation system without dental pad according to claim 8, characterized in that, The total length of the catheter is at least 28 cm, where: The 5 cm at the distal end of the catheter is made of smooth soft rubber; The 5 cm at the proximal end of the catheter is coated with a luminous green film, and connection slots are provided every 0.5 - 1 cm, and the connection slots are used to connect the buckle part; At least 8 cm in the middle of the catheter is made of a hard tube with honeycomb patterns; At least one X-ray imaging line running axially through the entire length is provided inside the catheter wall.

10. The toothpad-free oral tracheal intubation system according to claim 1, wherein The catheter is arranged from outside to inside in the radial direction as an anti-biting layer, a buffer layer and an airway contact layer. The anti-biting layer is made of glass fiber reinforced polyether ether ketone, the buffer layer is made of thermoplastic polyurethane, and the airway contact layer is made of medical grade silicone.

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