Medical-grade PEBAX composite catheter material with low friction and thermal stability

Abstract

The invention discloses a medical grade PEBAX composite catheter material with low friction and thermal stability, and relates to the field of medical catheter materials, the medical grade PEBAX composite catheter material comprises a base material, and the base material comprises a pre-modified PEBAX base material, a composite functional additive and a ternary photo-thermal stabilizer. According to the medical-grade PEBAX composite catheter material with low friction and thermal stability, the medical-grade PEBAX composite catheter material is prepared through multi-dimensional innovation of base material pre-modification, lubricating-antibacterial synergistic additive design, ternary photo-thermal stabilizer compounding and whole-flow process optimization; the technical problems that an existing PEBAX catheter material is insufficient in lubricity, poor in thermal stability, lack of an antibacterial function and poor in multi-performance synergism are systematically solved. The material has low friction, high thermal stability, long-acting antibacterial property and excellent biocompatibility, all performance indexes are superior to those of the prior art, and the preparation process is suitable for large-scale industrial production, can be widely applied to high-end medical tubes such as interventional catheters and anesthesia catheters, and has remarkable medical industry application value and market prospect.

Description

Technical Field

[0001] This invention relates to the field of medical catheter materials, and in particular to a low-friction, thermally stable medical-grade PEBAX composite catheter material. Background Technology

[0002] PEBAX (polyether block amide) is widely used in the field of medical catheters due to its excellent flexibility and mechanical strength. However, existing PEBAX catheter materials have several technical defects that limit their application in high-end medical devices, specifically: Insufficient lubrication and poor durability: The dynamic friction coefficient of pure PEBAX catheters is usually ≥0.4. Thin-walled tubes have high resistance during assembly and are prone to adhering to impurities in blood and tissue fluid during fluid delivery. Traditional lubricants such as silicone oil are prone to migration, which not only leads to rapid decay of lubrication effect, but may also affect biocompatibility.

[0003] Limited thermal stability: During secondary heating processes (such as thermoforming and welding of conduit tips), the material is prone to oxidative degradation, resulting in a tensile strength loss of more than 20% and a significant decrease in elongation at break, making it unsuitable for complex processing techniques.

[0004] Lack of antibacterial function: In clinical use, pathogenic bacteria such as Escherichia coli and Staphylococcus aureus can easily grow on the surface of the catheter, causing iatrogenic infection. However, the existing PEBAX materials are not designed for antibacterial properties, making it difficult to meet the needs of clinical infection control.

[0005] Poor synergy of multiple properties: In existing modification schemes, additives such as lubricants and stabilizers are mostly designed for single functions. The additives are prone to antagonistic effects, which makes it impossible for the material to simultaneously achieve multiple core properties such as low friction, high thermal stability, and biocompatibility. In addition, the additives are not evenly dispersed, resulting in large fluctuations in product performance.

[0006] To address the aforementioned issues, existing technologies often employ single-additive modification or simple compounding methods, failing to provide a systematic solution from multiple dimensions, including substrate modification, additive synergistic design, and preparation process optimization. This results in limited modification effects and makes it difficult to meet the stringent requirements of high-end medical catheters.

[0007] Therefore, it is necessary to propose a low-friction, thermally stable medical-grade PEBAX composite catheter material to solve the above problems. Summary of the Invention

[0008] The main objective of this invention is to provide a low-friction, thermally stable medical-grade PEBAX composite catheter material, which can effectively solve the problems in the background art.

[0009] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A low-friction, thermally stable medical-grade PEBAX composite catheter material includes a substrate, which comprises a pre-modified PEBAX substrate, composite functional additives, and a ternary photothermal stabilizer. The components, by mass percentage, are: 88%-94% pre-modified PEBAX substrate, 4%-8% composite functional additives, and 1.5%-4% ternary photothermal stabilizer. The pre-modified PEBAX substrate is a medical-grade Arkema Pebax® 2533SA01MED pretreated with gamma ray irradiation, with a Shore hardness of 27D. The composite functional additive consists of the non-migratory lubricant EverGlide® MED300 and an antibacterial agent; The ternary photothermal stabilizer consists of FosterHLS™2533, Pebax®MH1657 and Irganox®MD1024.

[0010] Preferably, the parameters for the γ-ray irradiation pretreatment are: irradiation dose of 20-30 kGy, irradiation atmosphere of nitrogen, and epoxy content on the substrate surface of the substrate after irradiation of 0.8-1.2 mmol / g.

[0011] Preferably, the antibacterial agent contains 3%-5% nano-silver by mass, and the surface-grafted polyether chains are polyoxyethylene-polyoxypropylene block copolymers with a grafting rate of 15%-20%.

[0012] Preferably, the surface of the pre-modified PEBAX substrate is incorporating epoxy functional groups, which meet the USP Class VI and ISO 10993 biocompatibility standards.

[0013] Preferably, the EverGlide® MED300 accounts for 2%-5% of the substrate mass, and the antibacterial agent is medical-grade nano-silver-doped hydroxyapatite with surface-grafted polyether chains, accounting for 0.5%-1.5% of the substrate mass.

[0014] Preferably, the FosterHLS™2533 accounts for 0.5%-1.2% of the substrate mass, the Pebax®MH1657 accounts for 0.5%-1.0% of the substrate mass, and the Irganox®MD1024 accounts for 0.3%-0.8% of the substrate mass.

[0015] Preferably, the material has a dynamic friction coefficient ≤0.20, and after secondary heating at 170-190℃ for 30 minutes, the tensile strength retention rate is ≥98% and the elongation at break retention rate is ≥94%.

[0016] Preferably, the material has a 24-hour antibacterial rate of ≥99% against Escherichia coli and Staphylococcus aureus, a cytotoxicity rating of Grade 1, and no sensitization.

[0017] Preferably, the preparation steps include: S1: Substrate pre-modification: Medical-grade Arkema Pebax® 2533SA01MED particles are placed in a nitrogen atmosphere and irradiated with γ-rays at a dose of 20-30kGy to obtain pre-modified PEBAX substrate; S2: Raw material drying. The pre-modified PEBAX substrate, EverGlide® MED300, antibacterial agent, Foster HLS™ 2533, Pebax® MH1657, and Irganox® MD1024 are dried in two steps: first, pre-drying at 80℃ for 2 hours, and then deep drying at 105℃ for 3 hours, controlling the moisture content of the raw materials to ≤0.05%. S3: Blending and granulation, all dried components are added to a twin-screw extruder, and after extrusion, they are water-cooled and pelletized to obtain composite granules; S4: Extrusion molding, the composite granules are added to a single screw extruder, the extrusion temperature is controlled at 180-195℃, and the material is extruded through a die to form a thin-walled pipe with a wall thickness of 0.1-0.5mm; S5: Surface activation. The formed tube is placed in a plasma treatment device in an argon atmosphere and treated with 30W power for 3 minutes to obtain a low-friction, thermally stable medical-grade PEBAX composite catheter material.

[0018] Preferably, in S3, the process of the twin-screw extruder is as follows: temperature control is performed in three temperature zones: 160-170℃ in the feeding section, 185-195℃ in the melting section, and 190-200℃ in the homogenization section, and the screw speed is adjusted in a gradient of 150r / min → 180r / min → 200r / min.

[0019] Compared with the prior art, the present invention has the following beneficial effects: This low-friction, thermally stable medical-grade PEBAX composite catheter material, through multi-dimensional innovation including substrate pre-modification, lubrication-antibacterial synergistic additive design, ternary photothermal stabilizer compounding, and full-process process optimization, systematically solves the technical challenges of insufficient lubricity, poor thermal stability, lack of antibacterial function, and poor synergy of multiple properties in existing PEBAX catheter materials. The material combines low friction, high thermal stability, long-lasting antibacterial effect, and excellent biocompatibility, with all performance indicators superior to existing technologies. Furthermore, its manufacturing process is suitable for large-scale industrial production, making it widely applicable to high-end medical tubing such as interventional catheters and anesthesia catheters, demonstrating significant medical industry application value and market prospects. Attached Figure Description

[0020] Figure 1 This is a flowchart of the preparation process of the present invention. Detailed Implementation

[0021] To make the technical means, creative features, objectives and effects of this invention easier to understand, the invention will be further described below in conjunction with specific embodiments.

[0022] Example 1: like Figure 1 As shown, a low-friction, thermally stable medical-grade PEBAX composite catheter material includes a substrate, which comprises a pre-modified PEBAX substrate, composite functional additives, and a ternary photothermal stabilizer. The components, by mass percentage, are: 88%-94% pre-modified PEBAX substrate, 4%-8% composite functional additives, and 1.5%-4% ternary photothermal stabilizer. The pre-modified PEBAX substrate is a medical-grade Arkema Pebax® 2533SA01MED pre-treated with γ-ray irradiation, with a Shore hardness of 27D and epoxy functional groups introduced on its surface, meeting the USP Class VI and ISO 10993 biocompatibility standards. The composite functional additive consists of the non-migratory lubricant EverGlide® MED300 and an antibacterial agent. EverGlide® MED300 accounts for 2%-5% of the substrate mass, and the antibacterial agent is medical-grade nano-silver-doped hydroxyapatite with surface-grafted polyether chains, accounting for 0.5%-1.5% of the substrate mass. The ternary photothermal stabilizer consists of FosterHLS™2533, Pebax®MH1657, and Irganox®MD1024, with FosterHLS™2533 accounting for 0.5%-1.2% of the substrate mass, Pebax®MH1657 accounting for 0.5%-1.0% of the substrate mass, and Irganox®MD1024 accounting for 0.3%-0.8% of the substrate mass. The material has a dynamic friction coefficient ≤0.20, a tensile strength retention rate ≥98% and an elongation at break retention rate ≥94% after secondary heating at 170-190℃ for 30 min, a 24-hour antibacterial rate ≥99% against Escherichia coli and Staphylococcus aureus, a cytotoxicity rating of Grade 1 and no sensitization.

[0023] The parameters for gamma-ray irradiation pretreatment were: irradiation dose of 20-30 kGy, irradiation atmosphere of nitrogen, and epoxy content of substrate surface of 0.8-1.2 mmol / g after irradiation.

[0024] The antibacterial agent contains 3%-5% nano-silver by mass, and the surface-grafted polyether chains are polyoxyethylene-polyoxypropylene block copolymers with a grafting rate of 15%-20%.

[0025] The preparation steps include the following: S1: Substrate pre-modification: Medical-grade Arkema Pebax® 2533SA01MED particles are placed in a nitrogen atmosphere and irradiated with γ-rays at a dose of 20-30kGy to obtain pre-modified PEBAX substrate; S2: Raw material drying. The pre-modified PEBAX substrate, EverGlide® MED300, antibacterial agent, Foster HLS™ 2533, Pebax® MH1657, and Irganox® MD1024 are dried in two steps: first, pre-drying at 80℃ for 2 hours, and then deep drying at 105℃ for 3 hours, controlling the moisture content of the raw materials to ≤0.05%. S3: Blending and granulation. All dried components are added to a twin-screw extruder. Temperature is controlled in three zones: 160-170℃ in the feeding section, 185-195℃ in the melting section, and 190-200℃ in the homogenization section. The screw speed is adjusted in a gradient of 150r / min → 180r / min → 200r / min. After extrusion, the product is water-cooled and pelletized to obtain composite granules. S4: Extrusion molding, the composite granules are added to a single screw extruder, the extrusion temperature is controlled at 180-195℃, and the material is extruded through a die to form a thin-walled pipe with a wall thickness of 0.1-0.5mm; S5: Surface activation. The formed tube is placed in a plasma treatment device in an argon atmosphere and treated with 30W power for 3 minutes to obtain a low-friction, thermally stable medical-grade PEBAX composite catheter material.

[0026] Example 2: This invention achieves a leapfrog improvement in the comprehensive performance of materials through synergistic innovation in substrate pre-modification, composite functional additive design, ternary photothermal stabilizer compounding, and preparation process optimization. The specific technical solution is as follows: Pre-modified PEBAX substrate: Medical-grade Arkema Pebax® 2533SA01MED is used as the base material, with a Shore hardness of 27D, meeting USP Class VI and ISO 10993 biocompatibility standards. Pretreatment with gamma rays under a nitrogen atmosphere using an irradiation dose of 20-30 kGy introduces epoxy functional groups onto the surface of the PEBAX molecular chains, with the functional group content controlled at 0.8-1.2 mmol / g. The introduction of epoxy groups significantly improves the interfacial bonding between the substrate and additives, prevents additive agglomeration, and ensures uniform and stable material properties. Composite functional additives: These additives synergistically combine non-migratory lubricants and antibacterial agents, achieving both low friction and long-lasting antibacterial effects. The lubricant used is EverGlide® MED300 (Nantong Qunhan), added at 2%-5% of the substrate mass. This non-migratory polymer additive exhibits excellent compatibility with PEBAX substrates, forming a stable lubricating film on the material surface and significantly reducing the coefficient of friction. The antibacterial agent is medical-grade nano-silver doped with hydroxyapatite and grafted with polyether chains, added at 0.5%-1.5% of the substrate mass. Nano-silver exhibits broad-spectrum antibacterial properties, while hydroxyapatite enhances biocompatibility. The surface-grafted polyoxyethylene-polyoxypropylene block copolymer has a similar molecular chain structure to PEBAX, effectively preventing antibacterial agent migration and improving its dispersibility in the substrate. The mass fraction of nano-silver in the antibacterial agent is 3%-5%, with a grafting rate controlled at 15%-20%, ensuring a balance between antibacterial efficacy and biocompatibility.

[0027] Ternary photothermal stabilizer compound: A ternary compound system is used to replace the traditional binary stabilizer, taking into account both thermal stability and antibacterial stability. Among them, FosterHLS™2533 is a medical-grade antioxidant-antiUV composite stabilizer, which is added at 0.5%-1.2% of the substrate mass and can inhibit free radical degradation during secondary heating. Pebax® MH1657 (Arkema): A heat-stable polyether block amide, added at a rate of 0.5%-1.0% of the substrate mass, to improve the thermal stability of the material during melt processing.

[0028] Irganox® MD1024 (BASF): A novel hindered phenolic stabilizer, added at 0.3%-0.8% of the substrate mass, which can synergize with the previous two stabilizers to enhance thermal stability and inhibit the oxidation failure of nano-silver under light and heating conditions.

[0029] To optimize the preparation process based on the above: The material properties are improved through a combination of stepwise drying, temperature-zone gradient extrusion, and plasma surface activation. Two-step drying process: First, pre-dry at 80℃ for 2 hours to remove adsorbed water from the surface of the raw material; then, deep dry at 105℃ for 3 hours to completely remove internal bound water, control the moisture content of the raw material to ≤0.05%, and avoid bubble defects during processing.

[0030] Temperature-zone gradient extrusion: The twin-screw extruder is divided into a feeding section, a melting section, and a homogenization section, with the temperatures controlled at 160-170℃, 185-195℃, and 190-200℃ respectively. The screw speed is adjusted in a gradient from 150r / min to 180r / min to 200r / min to ensure that the raw materials are fully melted and uniformly mixed.

[0031] Plasma surface activation: The formed tube is treated with argon atmosphere plasma for 3 minutes at 30W power to further improve the adhesion of the surface lubricating film and extend the lubrication durability.

[0032] This invention is achieved through: Substrate pre-modification design: Epoxy functional groups are introduced by γ-ray irradiation, which solves the problems of uneven additive dispersion and weak interfacial bonding, and makes the material performance fluctuation range ≤5%.

[0033] Lubrication-antibacterial synergistic design: Combining non-migratory lubricants with surface-modified antibacterial agents achieves both low friction (friction coefficient ≤0.20) and long-lasting antibacterial function (antibacterial rate ≥99%, lasting ≥3 years), filling the gap in existing technologies.

[0034] The ternary stabilizer compound: Through the synergistic effect of the three stabilizers, it not only improves the stability of the material after secondary heating (tensile strength retention rate ≥98%), but also protects the antibacterial agent from failure, thus solving the problem of insufficient function of a single stabilizer.

[0035] The entire process was optimized: the combination of step-by-step drying, gradient extrusion and plasma activation avoided internal defects in the material, improved the yield, and enhanced the durability of surface properties.

[0036] The low-friction, thermally stable medical-grade PEBAX composite catheter material prepared by this invention has the following advantages: Excellent and long-lasting lubrication performance: The dynamic friction coefficient is reduced to ≤0.20, which is more than 50% lower than that of pure PEBAX. The assembly resistance of thin-walled conduits is reduced by 50%, the fluid delivery velocity is increased by 20%-25%, and the lubrication effect can be maintained for ≥3 years.

[0037] Significantly improved thermal stability: After secondary heating (holding at 170-190℃ for 30 minutes), the tensile strength retention rate is ≥98% and the elongation at break retention rate is ≥94%. It can be adapted to complex processing techniques such as thermoforming and welding of conduit tips, with almost no degradation in mechanical properties.

[0038] Long-lasting antibacterial and biocompatible: ≥99% antibacterial rate against Escherichia coli and Staphylococcus aureus in 24 hours, effectively reducing the risk of iatrogenic infection; all components meet medical standards, pass ISO10993-4 / 5 / 10 tests, cytotoxicity rating 1, and are non-sensitizing.

[0039] Balanced processing and performance: The material's fatigue resistance is improved by 25%, and it can withstand ≥50 bending cycles without cracking; the additives are evenly dispersed, the product batch stability is excellent, and it is suitable for large-scale industrial production.

[0040] Example 3: like Figure 1 As shown, a low-friction, thermally stable medical-grade PEBAX composite catheter material comprises: Composition: 93% pre-modified PEBAX substrate, 3.5% EverGlide® MED300, 1.0% nano-silver doped hydroxyapatite, 0.8% Foster HLS™ 2533, 1.0% Pebax® MH1657, 0.7% Irganox® MD1024.

[0041] Preparation process parameters: γ-ray irradiation dose 25 kGy; two-step drying (80℃×2h+105℃×3h); twin-screw extruder temperature (feeding section 165℃, melting section 190℃, homogenization section 195℃); screw speed gradient (150→180→200 r / min); plasma treatment (30W×3min); extrusion molding of a 0.3 mm thick conduit.

[0042] Performance test results: Dynamic friction coefficient (with water medium): 0.19; Secondary heating (185℃×30min): tensile strength retention rate 98.5%, elongation at break retention rate 95%; Antibacterial properties: 99.6% antibacterial rate against Escherichia coli and 99.5% antibacterial rate against Staphylococcus aureus; Biocompatibility: Cytotoxicity rating 1, no sensitization; Fatigue resistance: No cracks after 50 bending cycles (bending angle 180°).

[0043] Example 4: like Figure 1 As shown, a low-friction, thermally stable medical-grade PEBAX composite catheter material comprises: Composition: 91% pre-modified PEBAX substrate, 4.0% EverGlide® MED300, 1.5% nano-silver doped hydroxyapatite, 1.0% Foster HLS™ 2533, 1.0% Pebax® MH1657, 0.5% Irganox® MD1024.

[0044] Preparation process parameters: γ-ray irradiation dose 30 kGy; two-step drying (80℃×2h+105℃×3h); twin-screw extruder temperature (feeding section 170℃, melting section 195℃, homogenization section 200℃); screw speed gradient (150→180→200 r / min); plasma treatment (30W×3min); extrusion molding of a 0.2 mm thick conduit.

[0045] Performance test results: Dynamic friction coefficient (with water medium): 0.18; Secondary heating (190℃×30min): Tensile strength retention rate 98%, elongation at break retention rate 94%; Antibacterial properties: 99.8% antibacterial rate against Escherichia coli and 99.7% antibacterial rate against Staphylococcus aureus; Biocompatibility: Cytotoxicity rating 1, no sensitization; Fatigue resistance: No cracks after 50 bending cycles (bending angle 180°).

[0046] Example 5: like Figure 1 As shown, a low-friction, thermally stable medical-grade PEBAX composite catheter material comprises: Composition: 94% pre-modified PEBAX substrate, 2.5% EverGlide® MED300, 0.8% nano-silver doped hydroxyapatite, 0.7% Foster HLS™ 2533, 0.8% Pebax® MH1657, 0.4% Irganox® MD1024.

[0047] Preparation process parameters: γ-ray irradiation dose 20 kGy; two-step drying (80℃×2h+105℃×3h); twin-screw extruder temperature (feeding section 160℃, melting section 185℃, homogenization section 190℃); screw speed gradient (150→180→200 r / min); plasma treatment (30W×3min); extrusion molding of a 0.5 mm thick conduit.

[0048] Performance test results: Dynamic friction coefficient (with water medium): 0.20; Secondary heating (170℃×30min): Tensile strength retention rate 99%, elongation at break retention rate 96%; Antibacterial properties: 99.2% antibacterial rate against Escherichia coli and 99.1% antibacterial rate against Staphylococcus aureus; Biocompatibility: Cytotoxicity rating 1, no sensitization; Fatigue resistance: No cracks after 50 bending cycles (bending angle 180°).

[0049] The performance of medical-grade PEBAX composite catheter materials prepared by existing technologies and those described in Examples 3 and 5 of this invention are compared in the following comparison table:

[0050] This invention systematically solves the technical problems of insufficient lubricity, poor thermal stability, lack of antibacterial function, and poor synergy of multiple properties in existing PEBAX catheter materials through multi-dimensional innovation, including substrate pre-modification, design of lubricating-antibacterial synergistic additives, compounding of ternary photothermal stabilizers, and optimization of the entire process. The material possesses low friction, high thermal stability, long-lasting antibacterial effect, and excellent biocompatibility. All performance indicators are superior to existing technologies, and the manufacturing process is suitable for large-scale industrial production. It can be widely used in high-end medical tubing such as interventional catheters and anesthesia catheters, and has significant medical industry application value and market prospects.

[0051] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. A low-friction, thermally stable medical-grade PEBAX composite catheter material, comprising a substrate, said substrate comprising a pre-modified PEBAX substrate, composite functional additives, and a ternary photothermal stabilizer, wherein the components, by mass percentage, are: 88%-94% pre-modified PEBAX substrate, 4%-8% composite functional additives, and 1.5%-4% ternary photothermal stabilizer, characterized in that: The pre-modified PEBAX substrate is medical-grade Arkema Pebax® 2533SA01MED, which has been pretreated by γ-ray irradiation and has a Shore hardness of 27D. The composite functional additive consists of the non-migratory lubricant EverGlide® MED300 and an antibacterial agent; The ternary photothermal stabilizer consists of FosterHLS™2533, Pebax®MH1657 and Irganox®MD1024.

2. The low-friction, thermally stable medical-grade PEBAX composite catheter material according to claim 1, characterized in that: The parameters for the γ-ray irradiation pretreatment are: irradiation dose of 20-30 kGy, irradiation atmosphere of nitrogen, and epoxy content of substrate surface of 0.8-1.2 mmol / g after irradiation.

3. The low-friction, thermally stable medical-grade PEBAX composite catheter material according to claim 1, characterized in that: The antibacterial agent contains 3%-5% nano-silver by mass, and the surface-grafted polyether chains are polyoxyethylene-polyoxypropylene block copolymers with a grafting rate of 15%-20%.

4. The low-friction, thermally stable medical-grade PEBAX composite catheter material according to claim 1, characterized in that: The pre-modified PEBAX substrate surface is incorporating epoxy functional groups, which meet the USP Class VI and ISO 10993 biocompatibility standards.

5. The low-friction, thermally stable medical-grade PEBAX composite catheter material according to claim 1, characterized in that: The EverGlide® MED300 accounts for 2%-5% of the substrate mass, and the antibacterial agent is medical-grade nano-silver-doped hydroxyapatite with surface-grafted polyether chains, accounting for 0.5%-1.5% of the substrate mass.

6. The low-friction, thermally stable medical-grade PEBAX composite catheter material according to claim 1, characterized in that: The FosterHLS™2533 accounts for 0.5%-1.2% of the substrate mass, Pebax®MH1657 accounts for 0.5%-1.0% of the substrate mass, and Irganox®MD1024 accounts for 0.3%-0.8% of the substrate mass.

7. The low-friction, thermally stable medical-grade PEBAX composite catheter material according to claim 1, characterized in that: The material has a dynamic friction coefficient ≤0.20, and after secondary heating at 170-190℃ for 30 min, the tensile strength retention rate is ≥98% and the elongation at break retention rate is ≥94%.

8. The low-friction, thermally stable medical-grade PEBAX composite catheter material according to claim 7, characterized in that: The material exhibits a 24-hour antibacterial rate of ≥99% against Escherichia coli and Staphylococcus aureus, a cytotoxicity rating of Grade 1, and no sensitization.

9. The low-friction, thermally stable medical-grade PEBAX composite catheter material according to claim 1, characterized in that: The preparation steps include the following: S1: Substrate pre-modification: Medical-grade Arkema Pebax® 2533SA01MED particles are placed in a nitrogen atmosphere and irradiated with γ-rays at a dose of 20-30kGy to obtain pre-modified PEBAX substrate; S2: Raw material drying. The pre-modified PEBAX substrate, EverGlide® MED300, antibacterial agent, Foster HLS™ 2533, Pebax® MH1657, and Irganox® MD1024 are dried in two steps: first, pre-drying at 80℃ for 2 hours, and then deep drying at 105℃ for 3 hours, controlling the moisture content of the raw materials to ≤0.05%. S3: Blending and granulation, all dried components are added to a twin-screw extruder, and after extrusion, they are water-cooled and pelletized to obtain composite granules; S4: Extrusion molding, the composite granules are added to a single screw extruder, the extrusion temperature is controlled at 180-195℃, and the material is extruded through a die to form a thin-walled pipe with a wall thickness of 0.1-0.5mm; S5: Surface activation. The formed tube is placed in a plasma treatment device in an argon atmosphere and treated with 30W power for 3 minutes to obtain a low-friction, thermally stable medical-grade PEBAX composite catheter material.

10. The low-friction, thermally stable medical-grade PEBAX composite catheter material according to claim 1, characterized in that: In S3, the process of the twin-screw extruder is as follows: temperature control is performed in three temperature zones: 160-170℃ in the feeding section, 185-195℃ in the melting section, and 190-200℃ in the homogenization section. The screw speed is adjusted in a gradient of 150r / min → 180r / min → 200r / min.

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