Highly transparent antibacterial medical TPE alloy material and preparation process thereof

Abstract

This invention discloses a highly transparent antibacterial medical TPE alloy material and its preparation process, belonging to the field of medical polymer materials technology. This material uses a thermoplastic elastomer as the matrix, compounded with compatibility aids, transparent modifiers, and antibacterial functional components, and is prepared through melt blending modification. The material is entirely free of PVC and DEHP plasticizers, possessing excellent light transmittance, flexible texture, resistance to repeated bending, and good biocompatibility. It also exhibits stable antibacterial properties and low substance release characteristics, making it widely applicable to medical infusion tubing, indwelling needle catheters, medical connecting fittings, disposable protective consumables, and other medical contact products. The preparation process is simple and controllable, with high production efficiency, meeting the usage standards and mass production requirements of medical-grade materials.

Description

Technical Field

[0001] This invention relates to the field of medical polymer composite materials technology, specifically to a highly transparent antibacterial medical TPE alloy material suitable for medical infusion consumables and sterile contact products, and its preparation process. Background Technology

[0002] As safety standards in the medical consumables industry continue to improve, the application of traditional PVC materials in high-end medical scenarios is gradually being restricted due to the high risk of plasticizers and harmful substance residues being released during production and use. Medical-grade thermoplastic elastomers (TPEs) have become the mainstream alternative to PVC due to their advantages of being non-toxic, odorless, flexible, recyclable, and requiring no plasticizers. However, ordinary medical-grade TPE materials on the market still have many shortcomings: their light transmittance is generally poor, making it difficult to clearly observe the internal medication; their antibacterial properties are weak, making them prone to bacterial growth in medical settings; their component compatibility is poor, leading to problems such as delamination, atomization, and small molecule precipitation with long-term use; and their bending resistance and aging resistance are difficult to balance, making them unsuitable for the long-term use requirements of indwelling medical consumables. Therefore, developing a medical-grade TPE alloy material with excellent light transmittance, biocompatibility and safety, stable antibacterial ability, and balanced comprehensive mechanical properties has significant practical application value. Summary of the Invention

[0003] Technical solution The purpose of this invention is to overcome the shortcomings of the prior art and provide a highly transparent antibacterial medical TPE alloy material and its preparation process. While ensuring the material's softness, toughness, and high transparency, this invention improves the material's antibacterial properties and structural stability, reduces the release of harmful substances, and is suitable for various medical contact scenarios. This invention selects SEBS as the basic elastic matrix, and combines it with highly transparent naphthenic oil to adjust the material's softness, ensuring that the substrate has basic high light transmittance properties; it adds modified polyolefin compatibilizer to improve the fusion effect of multi-component raw materials, enhance the overall structural uniformity, and avoid delamination, whitening, precipitation and other issues in later use. By adding uniformly dispersed inorganic antibacterial powder, the material itself has a long-lasting antibacterial ability, reducing bacterial adhesion and growth from the source; combined with anti-migration stabilizers, it ensures the stable distribution of antibacterial components, preventing rapid precipitation and loss, and extending the effective antibacterial period of the material. The preparation process employs a closed melt blending combined with vacuum devolatilization to effectively remove small molecule impurities and volatiles generated during production, further improving the purity and safety of the material. The entire process is carried out with gentle gradient temperature control to reduce high-temperature oxidation and yellowing of the material, maintain the material's good light transmittance, and ultimately produce a medical-grade TPE alloy material with excellent comprehensive performance. Beneficial effects The base material formula is safe and environmentally friendly, with no PVC or plasticizers added, mild biocompatibility, no obvious irritation, and suitable for medical contact use by various groups of people. The material has excellent light transmittance, allowing for clear observation of the color, flow, and bubble conditions of the internal liquid in the molded product, making it convenient for medical staff to intuitively judge its usage status. The matrix is ​​uniformly loaded with antibacterial components, providing a stable and long-lasting antibacterial effect. It can effectively inhibit the growth of common bacteria and reduce the probability of cross-infection in medical consumables. It has balanced mechanical properties, excellent flexibility, and resistance to repeated bending. It is not easy to crack or deform during daily use, resulting in a longer product lifespan. With good component compatibility and stable structure, it is not prone to stratification, atomization, or small molecule precipitation during long-term use, thus greatly improving safety. The preparation process is mature and simple, with strong processing adaptability. Various medical products can be directly formed through extrusion and injection molding processes. Mass production is easy and industrialization is convenient. Detailed Implementation Raw material pretreatment: The antibacterial powder is dispersed and pretreated to ensure that the powder particles are uniform and fine, and to avoid agglomeration during subsequent mixing. After the pretreatment is completed, the powder is dried for later use. Ingredient premixing: Weigh the SEBS matrix, high-transparency naphthenic oil, polyolefin compatibilizer, pretreated antibacterial powder, anti-migration stabilizer and processing lubricant in the set mass proportions, put them into the mixing equipment and stir evenly at room temperature to complete the preparation of the premix. Melt blending: The premixed material is fed into a twin-screw extruder, an inert gas is introduced for atmosphere protection, and the processing temperature is controlled in stages to ensure that the components are fully melted and blended. Vacuum devolatilization: During the melt processing, a vacuum negative pressure device is activated to remove small molecule volatiles and residual impurities from the material, thereby improving the purity of the material. Extrusion granulation: The molten uniform melt is extruded through a die, cooled and shaped by water cooling, and then cut into uniform granules by a pelletizing equipment, and dried to remove surface moisture. Testing and Packaging: The finished particles are tested for light transmittance, mechanical properties, antibacterial properties, biocompatibility and exudation indicators. After all items meet the standards, they are vacuum sealed and packaged, which is the finished medical TPE alloy material. This material can be directly processed into products such as medical infusion tubing, indwelling needle sheaths, medical connecting tubing, and sterile protective accessories. The finished products are safe, non-toxic, highly permeable, flexible, and have long-lasting antibacterial properties, fully complying with various industry standards for medical polymer materials.

Claims

1. A highly transparent antibacterial medical TPE alloy material, characterized in that, It is prepared from raw materials comprising the following parts by weight: 45-65 parts SEBS matrix, 20-35 parts high-transparency naphthenic oil, 8-15 parts polyolefin compatibilizer, 1.5-3.5 parts antibacterial powder, 0.3-1.2 parts anti-migration stabilizer, and 0.2-0.8 parts processing lubricant; The raw materials are melt-blended, modified, and extruded to obtain an alloy substrate. The material contains no PVC or phthalic plasticizers and has comprehensive properties such as high transparency, bending resistance, antibacterial and bacteriostatic properties, and low adsorption.

2. The high-transparency antibacterial medical TPE alloy material according to claim 1, characterized in that: The antibacterial powder is an inorganic composite antibacterial component with uniform particle size, which can be evenly dispersed inside the material matrix and release antibacterial active ingredients steadily during the use of the material.

3. The high-transparency antibacterial medical TPE alloy material according to claim 1, characterized in that: The polyolefin compatibilizer is a maleic anhydride-grafted modified elastomer, which can enhance the interfacial bonding force between the raw material components, improve the overall compatibility of the material, and prevent delamination and whitening after long-term use.

4. The high-transparency antibacterial medical TPE alloy material according to claim 1, characterized in that: The material preparation process employs a combination of melt blending and vacuum devolatilization to reduce the residue of small molecule volatiles and decrease the amount of substances released during the material's use.

5. The high-transparency antibacterial medical TPE alloy material according to claim 1, characterized in that: The material has good light transmittance, excellent overall flexibility, and is not prone to cracking or creases after repeated bending. It also has a good inhibitory effect on common pathogens.

6. A preparation process for a highly transparent antibacterial medical TPE alloy material, characterized in that, The preparation steps include the following: Raw material pretreatment → precise proportioning and mixing → closed melt blending → vacuum devolatilization modification → extrusion and water-cooled strand drawing → pelletizing and drying → testing and packaging; The entire preparation process employs gradient temperature control and inert gas atmosphere protection, ultimately yielding medical-grade antibacterial TPE alloy particles.