A endotracheal intubation material, its preparation method and application

Abstract

This invention discloses an endotracheal intubation material, its preparation method, and its applications. Through modification and compounding of thermally conductive materials, it exhibits significant advantages in clinical applications. Firstly, based on medical-grade polyvinyl chloride (PVC) as a matrix, di(2-ethylhexyl) terephthalate is added as a plasticizer and high-temperature stabilizer, providing environmental stability. The modified filler includes hydroxylated boron nitride and hybridized polydopamine-modified boron nitride, which can be uniformly dispersed in PVC resin, thereby enhancing the material's protective properties and significantly improving thermal conductivity. The endotracheal intubation material of this invention has moderate flexibility and hardness, facilitating intubation; moreover, the preparation process is simple, the cost is controllable, and it is suitable for large-scale production. This material exhibits stability in intensive care and other scenarios, providing a safer and more comfortable airway management solution for clinical use.

Description

Technical Field

[0001] This invention belongs to the field of polymer biomaterials technology, specifically relating to a tracheal intubation material, as well as the preparation method and application of the tracheal intubation material. Background Technology

[0002] Endotracheal intubation refers to the insertion of a specially designed endotracheal tube into the patient's trachea through the mouth or nose, establishing a clear and effective airway and providing essential conditions for effective oxygen supply during anesthesia, surgery, or for critically ill patients. Endotracheal intubation has become an important measure to ensure the smooth progress of general anesthesia, cardiopulmonary resuscitation, and the rescue of critically ill patients with respiratory dysfunction. It is one of the most widely used, effective, and rapid means of airway management and a basic skill that medical personnel must master.

[0003] In the clinical application of endotracheal intubation, existing products have significant shortcomings in terms of the thermal conductivity of their materials. Traditional endotracheal tubes mainly use polyvinyl chloride (PVC) or silicone rubber as the main material. These materials have low thermal conductivity and are difficult to effectively conduct the heat generated during the patient's breathing. When a large amount of sputum accumulates in the patient's throat, the low temperature environment exacerbates the viscosity of the sputum, making it easier for the sputum to adhere to the surface and inside of the tube. This adhesion significantly obstructs the oxygen supply channel, causing insufficient oxygen supply and exposing the patient to the risk of temporary hypoxia. This problem is particularly prominent in respiratory medicine patients, due to the large amount of sputum in their throats.

[0004] Currently used disposable endotracheal tubes, whether cuffed or uncuffed, do not have optimized thermal conductivity in their material composition. Even with components such as reinforcing wires and fixators, the fundamental problem of heat conduction remains unresolved. Healthcare workers often need to interrupt oxygen supply when clearing sputum, further increasing the clinical risk to patients.

[0005] Therefore, developing a endotracheal intubation material with good thermal conductivity is of great clinical significance for improving the patency of patients' airways and reducing the risk of hypoxia.

[0006] In view of this, we disclose a endotracheal intubation material, its preparation method and application. Summary of the Invention

[0007] To address the shortcomings of existing technologies, the present invention aims to provide a tracheal intubation material, its preparation method, and its application.

[0008] To achieve the above objectives, the present invention proposes the following technical solution:

[0009] An endotracheal intubation material, comprising the following raw material components by weight:

[0010] 50-75 parts of polyvinyl chloride resin;

[0011] 20-30 parts of di(2-ethylhexyl) terephthalate;

[0012] Modified filler A, 1-5 parts;

[0013] Modified filler B, 5-14 parts;

[0014] 1-3 parts of hydroxyl silicone oil;

[0015] 1-2 parts of tetraethyl orthosilicate;

[0016] Additives: 0.5-1.5 parts;

[0017] The modified filler A is hydroxylated boron nitride; the modified filler B is a mixture of polydopamine-modified boron nitride.

[0018] Based on the above scheme and as a preferred embodiment of the above scheme, the hydroxylated boron nitride is prepared by mechanical ball milling.

[0019] Based on the above scheme and as a preferred embodiment of the above scheme, the polydopamine-modified boron nitride mixture includes two or more types of modified boron nitride with different sizes.

[0020] Based on the above scheme and as a preferred embodiment of the above scheme, the polydopamine-modified boron nitride mixture is composed of two modified boron nitrides of different sizes, including a first-size polydopamine-modified boron nitride and a second-size polydopamine-modified boron nitride, and the mass ratio of the two is (4-6):1.

[0021] Based on the above scheme and as a preferred embodiment of the above scheme, the boron nitride size of the first-size polydopamine-modified boron nitride is 15-20 μm, and the boron nitride size of the second-size polydopamine-modified boron nitride is 3-5 μm.

[0022] Based on the above scheme and as a preferred embodiment of the above scheme, the auxiliary agent is diisopropyl peroxide dicarbonate.

[0023] Based on the above scheme and as a preferred embodiment of the above scheme, the method for preparing the endotracheal tube material includes the following steps:

[0024] S1. Material pretreatment

[0025] By using the sol-gel reaction of ammonia water, silane materials were used to surface treat boron nitride of different sizes to prepare modified filler B, resulting in boron nitride of different sizes with different surface pretreatment.

[0026] S2, preparation of polydopamine-modified boron nitride

[0027] The boron nitrides of different sizes pretreated in step S1 were added to deionized water, and the pH of the solution was adjusted to 8-9 with 0.1M dilute hydrochloric acid. After stirring evenly, the solution was ultrasonically treated for 25-35 minutes. Then, dopamine hydrochloride was added in the same amount as the silane material (i.e., the molar ratio was 1:1). After stirring to dissolve, the mixed solution was stirred at 450-550 rpm at room temperature for 24 hours to carry out the self-polymerization of dopamine on the boron nitride surface. After natural drying, polydopamine-modified boron nitride with different sizes was obtained.

[0028] S3, the mixture of modified filler B

[0029] The polydopamine-modified boron nitride mixture was obtained by physical mixing according to the formula, namely, modified filler B;

[0030] S4. Preparation of Modified Filler A

[0031] Hydroxylated boron nitride was prepared by mechanical ball milling, with glucose as a ball milling aid. The mixture was stirred continuously at 450-550 rpm for 12-18 hours. After sieving, washing, ultrasonic dispersion, centrifugation, precipitate collection, filtration and washing, and drying, hydroxylated boron nitride, i.e. modified filler A, was obtained.

[0032] S5, Blending Extrusion

[0033] The modified filler A, modified filler B and polyvinyl chloride prepared above are mixed in a high-speed kneader, and hydroxyl silicone oil, tetraethyl orthosilicate and additives are added and mixed evenly. The resulting mixture is added to a twin-screw extruder and reacted at 150-200°C for 1-4 hours. After the reaction is completed, the product is extruded from the twin-screw extruder and cooled to room temperature to obtain the endotracheal tube material of the present invention.

[0034] Based on the above scheme and as a preferred embodiment of the above scheme, the pH of the solution in step S2 is adjusted to 8.5, and the ultrasonic treatment time is 30 minutes.

[0035] Based on the above scheme and as a preferred embodiment of the above scheme, a temperature-measuring endotracheal cannula includes an endotracheal tube, which is made of the endotracheal cannula material.

[0036] Based on the above scheme and as a preferred embodiment, one end of the endotracheal tube is provided with a horseshoe-shaped inlet end, and the end of the endotracheal tube away from the horseshoe-shaped inlet end is equipped with a connector; a endotracheal cuff is provided on the end of the endotracheal tube near the horseshoe-shaped inlet end, and the endotracheal cuff includes a cuff body and an outer coating; an inflation tube and a temperature measuring wire are provided inside the endotracheal tube wall, one end of the inflation tube inside the endotracheal tube wall is connected to the endotracheal cuff, the other end of the inflation tube is provided with an inflation end, one end of the temperature measuring wire inside the endotracheal tube wall is connected to a temperature sensing probe, and the temperature sensing probe is located inside the endotracheal cuff, and the other end of the temperature measuring wire is provided with a temperature measuring connector.

[0037] Compared with the prior art, the technical solution of the present invention has the following beneficial effects:

[0038] This invention discloses an endotracheal intubation material, its preparation method, and its applications. Through modification and compounding of thermally conductive materials, it exhibits significant advantages in clinical applications. Firstly, based on medical-grade polyvinyl chloride (PVC) as a matrix, di(2-ethylhexyl) terephthalate is added as a plasticizer and high-temperature stabilizer, providing environmentally friendly and stable properties. The modified filler includes hydroxylated boron nitride and hybridized polydopamine-modified boron nitride, which can be uniformly dispersed in PVC resin, thereby enhancing the material's protective performance and significantly improving thermal conductivity. The endotracheal intubation material of this invention has moderate flexibility and hardness, facilitating intubation; moreover, the preparation process is simple, the cost is controllable, and it is suitable for large-scale production. This material exhibits stability in intensive care and other scenarios, providing a safer and more comfortable airway management solution for clinical use.

[0039] It should be understood that all possible combinations of the various embodiments and features disclosed in this specification fall within the scope of this disclosure, unless explicitly stated that they cannot be combined.

[0040] The foregoing and other aspects, embodiments, and features of the teachings of this invention will be more fully understood from the following description. Other additional aspects of the invention, such as features and / or beneficial effects of exemplary embodiments, will become apparent from the following description or may be learned through practice of specific embodiments according to the teachings of this invention. Attached Figure Description

[0041] The above and / or additional aspects and advantages of the present invention will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which:

[0042] Figure 1 This is a flowchart illustrating the preparation process of the endotracheal tube material of the present invention.

[0043] Figure 2 This is a schematic diagram of the endotracheal intubation structure in Embodiment 4 of the present invention;

[0044] Figure 3 This is a schematic diagram of the endotracheal intubation structure from another perspective in Embodiment 4 of the present invention;

[0045] Figure 4 For the present invention Figure 3 Enlarged structural diagram at point A in the middle;

[0046] Figure 5 This is a schematic diagram of the endotracheal intubation structure in Embodiment 5 of the present invention;

[0047] Figure 6 This is a schematic diagram of the fixing plate structure in Embodiment 5 of the present invention.

[0048] Among them: 10, endotracheal tube; 101, horseshoe-shaped insertion end; 102, depth indicator scale; 103, suction port; 20, inflation end; 201, inflation tube; 30, temperature measuring connector; 301, temperature measuring lead; 40, connection port; 50, suction port; 501, suction catheter; 60, fixation plate; 601, through groove; 602, fixation groove; 6021, winding rod; 603, overlapping block; 6031, movable shaft; 6032, sleeve block; 6033, compression limiting block; 70, guide core; 80, endotracheal cuff. Detailed Implementation

[0049] To enable those skilled in the art to better understand the technical solutions of the present invention, the preferred embodiments of the present invention are described below in conjunction with specific examples, but these should not be construed as limiting the present patent.

[0050] Unless otherwise specified, the test methods or experimental methods described in the following examples / comparative examples are conventional methods; unless otherwise specified, the reagents and materials are obtained from conventional commercial sources or prepared by conventional methods.

[0051] Existing endotracheal tube materials are mostly made of polyvinyl chloride (PVC) or silicone, which have low thermal conductivity, typically below 0.2 W / (m·K). During prolonged mechanical ventilation or high-flow oxygen therapy, temperature gradients can easily form at the interface between the tube wall and the airway mucosa, potentially leading to mucosal dryness, damage, or even inflammation. Furthermore, while some functional tubes integrate temperature measurement or drug delivery functions, the inherent thermal conductivity of the materials remains insufficient. Our approach, using PVC resin as the matrix, incorporates two high-thermal-conductivity fillers: a mixture of hydroxylated boron nitride and polydopamine-modified boron nitride. Through interface modification technology, we optimized the filler dispersion, ensuring a balance between material flexibility and thermal conductivity, and further improving the material's thermal conductivity.

[0052] Furthermore, in this invention, the hydroxylated boron nitride is prepared by mechanical ball milling. Specifically, hydroxylated boron nitride is prepared by mechanical ball milling using glucose as a milling aid. The process involves sieving, washing, ultrasonic dispersion, centrifugation, precipitate collection, filtration and washing, and drying to obtain hydroxylated boron nitride, i.e., modified filler A. Details are as follows:

[0053] Hexagonal boron nitride (99.9% purity, particle size <300nm) and glucose (analytical grade, Sinopharm Chemical Reagent Co., Ltd.) were weighed in a 1:1 mass ratio and placed in a corundum ball mill jar. An appropriate amount of zirconia grinding balls were added to assist grinding. The jar was fixed in a planetary ball mill and stirred continuously at 450-550 rpm for 12-18 hours. After ball milling, the grinding balls were separated using a 10-20 mesh sieve, and the milled product was repeatedly washed with deionized water. The washed product was ultrasonically dispersed for 25-45 minutes. The resulting dispersion was first centrifuged at 1500-2000 rpm for 5-15 minutes, and the supernatant was collected and further centrifuged at 8500-9500 rpm for 25-35 minutes. The lower precipitate was collected, filtered, washed with ethanol, and then dried in an 80℃ vacuum drying oven for 12-16 hours to obtain a white powdery solid, i.e., hydroxylated boron nitride.

[0054] Furthermore, in order to perform surface treatment on boron nitrides of different sizes from modified filler B, a silane material with a long alkyl chain was introduced onto the boron nitride surface via a sol-gel reaction with ammonia, thereby obtaining boron nitrides of different sizes with surface pretreatment. The specific steps are as follows:

[0055] 1) Add the silane material to a methyl ethyl ketone solution to prepare a silane solution with a concentration of 0.03-0.05M;

[0056] 2) Ammonia was added to the silane solution for the alcoholysis of silane, and then the solution was heated and stirred at 70°C for 1 hour; the pretreated boron nitride was dispersed into the solution to obtain a mixed solution;

[0057] 3) The mixture solution was refluxed at 70°C with vigorous stirring for 1.5-2.5 h. After the reaction was completed, the resulting solution was washed three times with methyl ethyl ketone solution. Then the modified boron nitride was redispersed in methyl ethyl ketone solution. After natural sedimentation, the solid was dried to obtain boron nitride of different sizes with surface pretreatment.

[0058] The silane material is hexadecyltrimethoxysilane, and the ammonia water has a mass percentage of 28%. Further, the molar ratio of ammonia water to silane material in step 2) is 30:1. In the structure of hexadecyltrimethoxysilane, the long hexadecyl chain provides hydrophobicity, while the trimethoxysilane group imparts hydrolytic condensation ability.

[0059] In this invention, the design of hydroxylated boron nitride helps improve the hydrophilicity and dispersion stability of boron nitride, especially in polyvinyl chloride resin systems. Di(2-ethylhexyl) terephthalate mainly acts as a plasticizer to improve the flexibility, cold resistance, and processing performance of the material. Although modified filler A and modified filler B are both boron nitride and can improve the thermal conductivity of the matrix, their main modes of action are different.

[0060] The boron nitride in modified filler A is small in size, making it easy to form point-like interconnects in the matrix, which can enhance the continuity of heat conduction and increase the fault tolerance. However, small-sized boron nitride is prone to agglomeration, so surface activation treatment is required.

[0061] Modified filler B includes at least two different sizes of modified boron nitride, which is modified with polydopamine. The use of polydopamine for modification has the following advantages: firstly, it activates the surface of the boron nitride; secondly, it is environmentally friendly and non-toxic; and thirdly, in the combination of different sizes, larger-sized boron nitride enhances conductivity stability, while smaller-sized boron nitride further supplements it. Furthermore, larger-sized boron nitride can prevent microcrack propagation and further agglomeration of smaller-sized boron nitride. In summary, an appropriate proportion of hybrid-sized polydopamine-modified boron nitride can be uniformly dispersed within polyvinyl chloride resin, thereby improving the material's protective performance.

[0062] The polyvinyl chloride resin is grade SG-8 and was purchased from Sichuan Jinlu Resin Co., Ltd.

[0063] Example 1

[0064] An endotracheal intubation material, comprising the following raw material components by weight:

[0065] 63 parts of polyvinyl chloride resin;

[0066] 21 parts of di(2-ethylhexyl) terephthalate;

[0067] Modified filler A, 2 parts;

[0068] Modified filler B, 10 parts;

[0069] 2 parts hydroxyl silicone oil;

[0070] 1.5 parts of tetraethyl orthosilicate;

[0071] 0.5 parts of auxiliary agent;

[0072] The modified filler A is hydroxylated boron nitride; the modified filler B is a mixture of polydopamine-modified boron nitride; and the additive is diisopropyl peroxide dicarbonate. Furthermore, the hydroxylated boron nitride is prepared by mechanical ball milling.

[0073] Furthermore, the polydopamine-modified boron nitride mixture is composed of two modified boron nitrides of different sizes, including a first-size polydopamine-modified boron nitride and a second-size polydopamine-modified boron nitride, with a mass ratio of 5:1.

[0074] In a preferred embodiment, the boron nitride size of the first-sized polydopamine-modified boron nitride is 16 μm, and the boron nitride size of the second-sized polydopamine-modified boron nitride is 4 μm.

[0075] Furthermore, the method for preparing the endotracheal tube material includes the following steps:

[0076] S1. Material pretreatment

[0077] By using the sol-gel reaction of ammonia water, silane materials were used to surface treat boron nitride of different sizes to prepare modified filler B, resulting in boron nitride of different sizes with different surface pretreatment.

[0078] S2, preparation of polydopamine-modified boron nitride

[0079] The boron nitrides of different sizes from the surface pretreatment in step S1 were added to deionized water, and then the pH of the solution was adjusted to 8-9 with 0.1M dilute hydrochloric acid. After stirring evenly, the solution was ultrasonically treated for 25-35 minutes. Then, an amount of dopamine hydrochloride equal to that of the silane material was added, and after stirring to dissolve, the mixed solution was stirred at 450-550 rpm at room temperature for 24 hours to carry out the self-polymerization of dopamine on the boron nitride surface. After natural drying, polydopamine-modified boron nitrides with different sizes were obtained.

[0080] S3, the mixture of modified filler B

[0081] The polydopamine-modified boron nitride mixture was obtained by physical mixing according to the formula, namely, modified filler B;

[0082] S4. Preparation of Modified Filler A

[0083] Hydroxylated boron nitride was prepared by mechanical ball milling, with glucose as a ball milling aid. The mixture was stirred continuously at 450-550 rpm for 12-18 hours. After sieving, washing, ultrasonic dispersion, centrifugation, precipitate collection, filtration and washing, and drying, hydroxylated boron nitride, i.e. modified filler A, was obtained.

[0084] S5, Blending Extrusion

[0085] The modified filler A, modified filler B and polyvinyl chloride prepared above are mixed in a high-speed kneader, and hydroxyl silicone oil, tetraethyl orthosilicate and additives are added and mixed evenly. The resulting mixture is added to a twin-screw extruder and reacted at 150-200°C for 1-4 hours. After the reaction is completed, the product is extruded from the twin-screw extruder and cooled to room temperature to obtain the endotracheal tube material of the present invention.

[0086] In the preferred embodiment, the pH of the solution in step S2 is adjusted to 8.5, and after stirring evenly, the ultrasonic treatment time is 30 minutes.

[0087] Example 2

[0088] Unlike Embodiment 1 above, an endotracheal tube material, by weight, comprises the following raw material components:

[0089] 64 parts of polyvinyl chloride resin;

[0090] 20 parts of di(2-ethylhexyl) terephthalate;

[0091] Modified filler A, 2 parts;

[0092] Modified filler B, 8 parts;

[0093] 3 parts hydroxyl silicone oil;

[0094] 1.5 parts of tetraethyl orthosilicate;

[0095] 1.5 parts of auxiliary agent;

[0096] Furthermore, the polydopamine-modified boron nitride mixture is composed of two modified boron nitrides of different sizes, including a first-size polydopamine-modified boron nitride and a second-size polydopamine-modified boron nitride, with a mass ratio of 4:1. Preferably, the boron nitride size of the first-size polydopamine-modified boron nitride is 20 μm, and the boron nitride size of the second-size polydopamine-modified boron nitride is 5 μm.

[0097] The other steps are the same as in Example 1.

[0098] Example 3

[0099] Unlike Embodiment 1 above, an endotracheal tube material, by weight, comprises the following raw material components:

[0100] 50 parts of polyvinyl chloride resin;

[0101] 30 parts of di(2-ethylhexyl) terephthalate;

[0102] Modified filler A, 2 parts;

[0103] Modified filler B, 12 parts;

[0104] 3 parts hydroxyl silicone oil;

[0105] 2 parts of tetraethyl orthosilicate;

[0106] 1 part of the auxiliary agent;

[0107] Furthermore, the polydopamine-modified boron nitride mixture is composed of two modified boron nitrides of different sizes, including a first-size polydopamine-modified boron nitride and a second-size polydopamine-modified boron nitride, with a mass ratio of 6:1. Preferably, the boron nitride size of the first-size polydopamine-modified boron nitride is 15 μm, and the boron nitride size of the second-size polydopamine-modified boron nitride is 3 μm.

[0108] The other steps are the same as in Example 1.

[0109] Comparative Example 1

[0110] Unlike Example 1 above, untreated boron nitride of the same type was used instead of modified filler A.

[0111] The other steps are the same as in Example 1.

[0112] Comparative Example 2

[0113] Unlike Example 1 above, untreated boron nitride of the same type was used instead of modified filler B.

[0114] The other steps are the same as in Example 1.

[0115] Comparative Example 3

[0116] Unlike Example 1 above, boron nitride is not treated with silane materials during the preparation of modified filler B.

[0117] The other steps are the same as in Example 1.

[0118] Comparative Example 4

[0119] Unlike Example 1 above, the modified filler B contains only large-sized first-size polydopamine-modified boron nitride.

[0120] The other steps are the same as in Example 1.

[0121] Comparative Example 5

[0122] Unlike Example 1 above, the modified filler B contains only small-sized second-size polydopamine-modified boron nitride.

[0123] The other steps are the same as in Example 1.

[0124] Comparative Example 6

[0125] Unlike Example 1 above, the raw material composition does not contain di(2-ethylhexyl) terephthalate.

[0126] The other steps are the same as in Example 1.

[0127] Comparative Example 7

[0128] Unlike Example 1 above, untreated boron nitride of the same type was used to replace modified filler A; and untreated boron nitride of the same type was used to replace modified filler B.

[0129] The other steps are the same as in Example 1.

[0130] Comparative Example 8

[0131] Purchase the same type of polyvinyl chloride material, without adding any additives, and conduct a performance comparison test according to the testing requirements.

[0132] The materials of Examples 1 to 3 and Comparative Examples 1 to 7 were tested and analyzed according to different testing standards. The comparison of the test results and the test standards are shown in Table 1 below.

[0133] Table 1. Test Standard Reference and Test Result Comparison Analysis Table

[0134]

[0135] It should be further noted that the thermal conductivity of polyvinyl chloride and its composites is commonly tested using a steady-state method. During testing, it is essential to ensure that the sample surface is flat and the thickness is uniform to avoid measurement errors. The instrument used is a thermal conductivity meter.

[0136] In this invention, hydroxylation treatment of boron nitride significantly improves its hydrophilicity and dispersion stability, thereby enhancing the surface smoothness of the material and reducing systematic errors in thermal conductivity. This is particularly beneficial in polyvinyl chloride (PVC) resin applications. Although modified filler A and modified filler B are both boron nitride-based materials and both enhance the thermal conductivity of the matrix, their mechanisms of action differ.

[0137] Modified filler A uses small-sized boron nitride, which can form dot-like tentacles in the matrix, enhancing the continuity and tolerance of heat conduction. However, the small size easily leads to agglomeration, which needs to be solved through surface activation treatment.

[0138] Modified filler B contains two or more modified boron nitrides of different sizes. Through near-surface treatment with silane materials and modification with polydopamine, it offers three advantages: first, it increases the surface-active groups of boron nitride; second, it ensures environmentally friendly and non-toxic properties; and third, through the combination of large and small sizes, large-sized boron nitride improves conductivity and inhibits microcrack propagation, while small-sized boron nitride supplements conductivity and prevents agglomeration. An appropriate proportion of hybrid-sized polydopamine-modified boron nitride can be uniformly dispersed in polyvinyl chloride resin, thereby enhancing the material's protective properties.

[0139] Moreover, in the comparative examples, since boron nitride was directly used to replace the modified filler, its dispersibility and stability were poor. Therefore, the thermal conductivity of the sample was lower than that of the sample containing part of the modified filler. That is, except for comparative example 8, the thermal conductivity of the sample of comparative example 7 was lower than that of the other comparative examples.

[0140] Regarding mechanical properties, when using single-size boron nitride, the proportion of first-size polydopamine-modified boron nitride is higher, resulting in a cumulative effect. Therefore, when surface treatment and interface improvement are performed, the comparative sample 4, which only uses first-size polydopamine-modified boron nitride, has better performance than the comparative sample 5, which only uses second-size polydopamine-modified boron nitride.

[0141] It is worth noting that di(2-ethylhexyl) terephthalate in the system not only acts as a plasticizer to improve the flexibility, cold resistance, and processing performance of the material, but also significantly contributes to the high-temperature mechanical stability of the material. Specifically, under normal temperature conditions, the absence of di(2-ethylhexyl) terephthalate (Comparative Example 6) has a relatively small impact on mechanical properties, and this impact is not much different from that of modified fillers; however, at high temperatures, the absence of this element leads to mechanical properties that are close to those of pure polyvinyl chloride. Moreover, di(2-ethylhexyl) terephthalate is an environmentally friendly plasticizer, free of phthalates, and not included in the list of 16 phthalate-containing plasticizers restricted for use in the EU and other regions.

[0142] Example 4

[0143] To further illustrate the application of endotracheal intubation materials, we disclose a temperature-measuring endotracheal intubation tube, including an endotracheal tube 10, which is made of the aforementioned endotracheal intubation material.

[0144] Furthermore, one end of the endotracheal tube 10 is provided with a horseshoe-shaped inlet end 101, and the end of the endotracheal tube 10 away from the horseshoe-shaped inlet end 101 is equipped with a connector 40; a tracheal cuff 80 is provided on the endotracheal tube 10 near the horseshoe-shaped inlet end 101, and the tracheal cuff 80 includes a cuff body and an outer coating; an inflation tube 201 and a temperature measuring wire 301 are provided inside the wall of the endotracheal tube 10, one end of the inflation tube 201 is connected to the tracheal cuff 80 inside the wall of the endotracheal tube 10, and the other end of the inflation tube 201 is provided with an inflation end 20; one end of the temperature measuring wire 301 is connected to a temperature sensing probe inside the wall of the endotracheal tube 10, and the other end of the temperature measuring wire 301 is provided with a temperature measuring connector 30. Generally, one or more channels are preset in the side wall of the endotracheal tube 10, and the temperature measuring wire 301 passes through the channels. It should be further noted that the other end of the temperature measuring connector 30 is a temperature sensing probe, and the temperature sensing probe is installed inside the tracheal cuff 80.

[0145] In this embodiment, the temperature-measuring endotracheal tube is inserted by medical personnel through the horseshoe-shaped insertion end 101 into the patient's airway to a predetermined position. Gas is then injected into the inflation tube 201 through the inflation end 20. The gas enters the endotracheal cuff 80 through the inflation tube 201, causing the cuff 80 to expand and conform to the inner wall of the airway, thus sealing and fixing the endotracheal tube 10. The outer coating reduces the thickness of the endotracheal cuff 80, lowering resistance during intubation. At this time, the temperature-sensing probe located inside the endotracheal cuff 80 can sense the temperature inside the patient's airway in real time and transmit the temperature signal to the temperature-sensing connector 30 via the temperature-sensing wire 301. Medical personnel can connect an external temperature-sensing device to the temperature-sensing connector 30 to conveniently and accurately obtain the patient's airway temperature data. The fixing plate 60, in conjunction with adhesive tape or other fixing materials, can stably fix the endotracheal tube 10 to the patient's face or around the mouth, preventing displacement during use.

[0146] Furthermore, a suction catheter 501 is also provided inside the wall of the endotracheal tube 10. One end of the suction catheter 501 is connected to a suction port 103 inside the wall of the endotracheal tube 10, and the suction port 103 is located on the periphery of the endotracheal tube 10 near the tracheal cuff 80. The other end of the suction catheter 501 is provided with a suction port 50, and the edge of the tracheal cuff 80 is turned inward, with the suction port 103 close to the end of the tracheal cuff 80. Preferably, the suction catheter 501 is made of medical-grade polyurethane material, which has good flexibility and flexural strength, and can maintain the patency of the lumen when bent, avoiding suctioning difficulties caused by catheter bending during suctioning. In addition, the suction catheter 501 and the wall of the endotracheal tube 10 are integrally injection molded, and the two are tightly bonded without obvious seams, avoiding sputum leakage or bacterial growth caused by gaps, further ensuring the safety of airway management.

[0147] Furthermore, the endotracheal tube 10 has depth indication scales 102 on its outer wall. The depth indication scales 102 are evenly distributed along the length of the endotracheal tube 10. During intubation, medical staff can accurately determine the depth of the endotracheal tube 10 inserted into the airway by observing the depth indication scales 102, avoiding injury to the patient due to insertion that is too deep or too shallow. At the same time, this scale design also facilitates real-time monitoring and adjustment of the intubation position during postoperative care, ensuring that the endotracheal tube is always in the optimal working position, providing a reliable positional reference for the patient's airway support treatment.

[0148] Furthermore, the endotracheal tube 10 contains a guide stylet 70. The guide stylet 70 has good shaping ability and support. Medical staff can pre-adjust the curvature of the guide stylet 70 according to the patient's airway anatomy, providing stable rigid support for the endotracheal tube 10 during intubation, helping the tube to pass smoothly through the glottis and airway narrowing areas, effectively reducing the difficulty of intubation. At the same time, the length of the guide stylet 70 is slightly shorter than that of the endotracheal tube 10, and its distal end does not exceed the front opening of the endotracheal tube 10, avoiding direct damage to the airway mucosa during intubation. After intubation is completed, it can be slowly withdrawn through the handle at the tail of the guide stylet 70. The operation is convenient and will not interfere with the established airway, which not only improves the success rate of intubation but also ensures the safety of the patient's airway.

[0149] Example 5

[0150] Unlike Embodiment 4 above, the temperature measuring wire 301 and the tracheal tube 10 are co-extruded. Because the temperature measuring wire 301 and the tracheal tube 10 are manufactured using an integrated extrusion molding process, not only is the production process simplified and assembly errors reduced, but the positional stability of the temperature measuring wire 301 within the tracheal tube 10 is also ensured.

[0151] Furthermore, the temperature sensing lead 301 is a pre-embedded copper wire, and at least two pre-embedded copper wires are pre-embedded. A copper post is provided at the end of the pre-embedded copper wire furthest from the temperature sensing connector 30, and the copper post penetrates the pipe wall. In this embodiment, the copper post probe is positioned at the horseshoe-shaped inlet end 101. Preferably, the copper post is 0.3 mm thick.

[0152] In this embodiment, the pre-embedded copper wire and the endotracheal tube 10 are co-extruded to reduce the impact of wire movement or displacement on temperature measurement accuracy. Simultaneously, the absence of a cavity in the wire significantly reduces heat loss during heat transfer, further ensuring measurement accuracy. At least two pre-embedded copper wires are provided for backup; if one wire fails, the other can still transmit the temperature signal normally, ensuring the continuity of temperature measurement. The copper pillar penetrating the tube wall allows the temperature sensor probe to directly contact the environment inside the endotracheal tube, reducing intermediate steps in temperature conduction and further improving temperature measurement sensitivity and response speed. Modified boron nitride particles are uniformly dispersed in the tube wall material, enhancing the material's mechanical strength and high-temperature resistance, preventing deformation or aging of the endotracheal tube during high-temperature sterilization or long-term use, ensuring the stability and dimensional accuracy of the intubation structure. Furthermore, boron nitride has excellent insulation and chemical inertness, will not interfere with the temperature measurement circuit, and will not adversely react with the physiological environment within the airway, further improving the safety and reliability of endotracheal intubation.

[0153] Example 6

[0154] Unlike Embodiment 5 described above, we have further optimized the endotracheal tube to facilitate its use. Specifically, a fixing plate 60 is provided at one end of the endotracheal tube 10 near the connector 40, which is used for auxiliary fixation of the endotracheal tube 10.

[0155] Furthermore, a through groove 601 is provided in the middle of the fixing plate 60, and the through groove 601 can pass through the connecting port 40. Fixing grooves 602 are provided on both sides of the fixing plate 60. A winding rod 6021 is provided inside the fixing groove 602. An overlapping block 603 is provided between the through groove 601 and the fixing groove 602. A movable shaft 6031 is rotatably provided inside the overlapping block 603. A sleeve block 6032 is provided on the outer wall of the movable shaft 6031. A compression limiting block 6033 is embedded inside the sleeve block 6032. The compression limiting block 6033 and the inner wall of the sleeve block 6032 are connected by a spring. The compression limiting block 6033 can slide along the direction of the sleeve block 6032.

[0156] When the fixing plate 60 is fitted onto the endotracheal tube 10 through the through groove 601, medical personnel can use a wrapping tape or adhesive tape in conjunction with the wrapping rod 6021 to initially fix the endotracheal tube 10, preventing it from shifting during use and ensuring the stability of the structure. After the medical personnel have completed the initial fixation of the endotracheal tube 10, they can rotate the movable shaft 6031 to move the sleeve block 6032 towards the compression limiting block 6033. At this time, the compression limiting block 6033, under the elastic action of the spring, tightly adheres to the outer wall of the endotracheal tube 10, further... This design enhances the stability of the connection between the endotracheal tube 10 and the fixation plate 60. Even if the patient's position changes during treatment, it can effectively prevent the endotracheal tube 10 from loosening or shifting, providing a continuous and stable structural guarantee for subsequent ventilation treatment. At the same time, it also ensures a stable connection between the connector 40 and the endotracheal tube 10, preventing accidental detachment of the connector 40 and the endotracheal tube 10. It is worth noting that this elastic compression structure design will not cause excessive pressure on the endotracheal tube 10, and can adapt to the fixation requirements of endotracheal tubes 10 of different sizes, improving the versatility and practicality of the device.

[0157] Furthermore, the inflation end 20 can also be connected to an overpressure valve and a three-color pressure indicator cuff. The overpressure valve can monitor the pressure value at the inflation end in real time. When the inflation pressure exceeds the preset safety threshold, the overpressure valve will automatically open the pressure relief channel to quickly expel excess gas, avoiding excessive pressure inside the tracheal cuff that could cause pressure damage to the airway mucosa and effectively ensuring the patient's airway safety. The three-color pressure indicator cuff visually displays the current cuff pressure range through different colored areas. Medical staff can quickly determine whether the pressure is within the normal range simply by observing the color change of the indicator cuff without the need for additional measuring tools.

[0158] In summary, this invention discloses an endotracheal intubation material, its preparation method, and its application. Applying this endotracheal intubation material to clinical endotracheal intubation preparation, coupled with a 0.3mm diameter copper pillar thermal bridge design, reduces the response delay time in clinical trials from over 8 seconds to 0.07 seconds, representing a 113-fold increase in response rate; the radial thermal resistance error is reduced from 0.5℃ to 0.08℃. Therefore, the endotracheal intubation material of this invention possesses excellent thermal conductivity and is medically and environmentally friendly, and its further promotion and use are recommended.

[0159] While the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the invention. Those skilled in the art can make various modifications and refinements without departing from the spirit and scope of the invention. Therefore, the scope of protection of the present invention shall be determined by the claims.

Claims

1. A endotracheal intubation material, characterized in that, By weight, it includes the following raw material components: 50-75 parts of polyvinyl chloride resin; 20-30 parts of di(2-ethylhexyl) terephthalate; Modified filler A, 1-5 parts; Modified filler B, 5-14 parts; 1-3 parts of hydroxyl silicone oil; 1-2 parts of tetraethyl orthosilicate; Additives: 0.5-1.5 parts; The modified filler A is hydroxylated boron nitride; the modified filler B is a mixture of polydopamine-modified boron nitride; the hydroxylated boron nitride is prepared by mechanical ball milling; the polydopamine-modified boron nitride mixture is composed of two modified boron nitrides of different sizes, including a first-size polydopamine-modified boron nitride and a second-size polydopamine-modified boron nitride, and the mass ratio of the two is (4-6):1; the boron nitride size of the first-size polydopamine-modified boron nitride is 15-20 μm, and the boron nitride size of the second-size polydopamine-modified boron nitride is 3-5 μm.

2. The endotracheal tube material according to claim 1, characterized in that, The additive is diisopropyl peroxide dicarbonate.

3. The method for preparing the endotracheal tube material according to any one of claims 1-2, characterized in that, Includes the following steps: S1. Material pretreatment By using the sol-gel reaction of ammonia water, silane materials were used to surface treat boron nitride of different sizes to prepare modified filler B, resulting in boron nitride of different sizes with different surface pretreatment. S2, preparation of polydopamine-modified boron nitride The boron nitrides of different sizes from the surface pretreatment in step S1 were added to deionized water, and then the pH of the solution was adjusted to 8-9 with 0.1M dilute hydrochloric acid. After stirring evenly, the solution was ultrasonically treated for 25-35 minutes. Then, an amount of dopamine hydrochloride equal to that of the silane material was added, and the solution was stirred and dissolved. The mixture was then stirred at room temperature at a speed of 450-550 rpm for 24 hours to carry out the self-polymerization of dopamine on the boron nitride surface. After natural drying, polydopamine-modified boron nitrides with different sizes were obtained. S3, the mixture of modified filler B The polydopamine-modified boron nitride mixture was obtained by physical mixing according to the specified ratio, namely, modified filler B; S4. Preparation of Modified Filler A Hydroxylated boron nitride was prepared by mechanical ball milling, with glucose as a ball milling aid. The mixture was stirred continuously at 450-550 rpm for 12-18 hours. After sieving, washing, ultrasonic dispersion, centrifugation, precipitate collection, filtration and washing, and drying, hydroxylated boron nitride, i.e. modified filler A, was obtained. S5, Blending Extrusion The modified filler A, modified filler B and polyvinyl chloride prepared above are mixed in a high-speed kneader, and hydroxyl silicone oil, tetraethyl orthosilicate and additives are added and mixed evenly. The resulting mixture is added to a twin-screw extruder and reacted at 150-200°C for 1-4 hours. After the reaction is completed, the product is extruded from the twin-screw extruder and cooled to room temperature to obtain the endotracheal tube material of the present invention.

4. The method for preparing an endotracheal tube material according to claim 3, characterized in that, The pH of the solution in step S2 is adjusted to 8.5, and after stirring evenly, it is subjected to ultrasonic treatment for 30 minutes.

5. The application of an endotracheal tube material in a temperature-measuring endotracheal tube, characterized in that, The endotracheal tube includes an endotracheal tube (10), which is made of the endotracheal tube material according to any one of claims 1-4.

6. The application of the endotracheal tube material according to claim 5 in temperature-measuring endotracheal tubes, characterized in that, One end of the endotracheal tube (10) is provided with a horseshoe-shaped inlet end (101), and the other end of the endotracheal tube (10) away from the horseshoe-shaped inlet end (101) is equipped with a connector (40); the endotracheal tube (10) is provided with a tracheal cuff (80) near the horseshoe-shaped inlet end (101), and the tracheal cuff (80) includes a cuff body and an outer coating; an inflation tube (201) and a temperature measuring wire are provided inside the wall of the endotracheal tube (10). (301) The inflation conduit (201) is connected to the tracheal cuff (80) at one end inside the wall of the tracheal conduit (10), and the inflation end (20) is provided at the other end of the inflation conduit (201). The temperature measuring wire (301) is connected to the temperature sensing probe at one end inside the wall of the tracheal conduit (10), and the temperature sensing probe is located inside the tracheal cuff (80). The temperature measuring wire (301) is provided with a temperature measuring connector (30) at the other end.

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