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The materials used in medical plastic products are various, mainly based on biomedical materials. It is a synthetic polymer material with certain biocompatibility. These materials have special performance and special functions, and can be used in the fields of human organs, surgical repair, physical therapy rehabilitation, diagnosis, examination and treatment, etc., and have no adverse effects on human tissues and blood.
At present, there are more than 90 varieties of medical polymer materials in the world, and more than 180 kinds of products have been produced, including: silicone rubber, polyurethane and its block copolymer, polyester nylon, polypropylene, polyolefin, Polycarbonate, polyether, polysulfone, polyacrylate, and the like. Because each material has different properties, it can be used on products for different applications.
At present, countries around the world are paying more and more attention to the research of biomedical materials. According to the statistical analysis of LOWELL University in Massachusetts, more than 90% of medical plastics with an annual consumption value of US$3.1 billion are used to manufacture in vitro medical products. The specific consumption ratio is: low density poly Ethylene 22%, polyvinyl chloride 20%, polystyrene 20%, high density polyethylene 12%, polypropylene 10%, thermosetting polyester 4%, polyurethane 2%, acrylate 2%, nylon 2%, epoxy Resin 1%. At the same time, polyaldehydes, celluloses, thermoplastic polyesters, polycarbonates, polysulfones, polyphenylene oxides, silicones, urea-formaldehydes, etc. account for 5%. Among them, polyurethane And silicone rubber is mainly used to make high value-added medical products that can be implanted in the body and in contact with blood, and disposable articles made of plastic modified polyvinyl chloride are widely used in clinic.
It can be seen that the plastic materials currently used for medical products are mainly polyolefins. Among them, polyethylene, polypropylene, polystyrene and abs have been widely used in medical plastic products due to their wide range of materials, low price and stable performance.
Polyvinyl chloride (PVC) is a commonly used material for the manufacture of medical catheters. Since the melting point of PVC is very close to the decomposition temperature, and its glass transition temperature is high, the hardness of the material is large, and processing is difficult. Therefore, plasticizers and other additives are generally added to the PVC resin to lower the melting point and vitrification. Temperature to increase the flexibility of the material.
A recent study showed that some PVC-made catheters, especially some interventional catheters, are less biocompatible. In general, the main factors affecting the biocompatibility are the migration of plasticizers and the toxicity of the dissolution. The amount of migration and dissolution depends mainly on the formulation and preparation process, and the choice of plasticizer is particularly important. To this end, most of the foreign countries currently use polyurethane materials to manufacture interventional catheters. In China, because medical polyurethane materials are difficult to purchase in the market, they can only be imported from abroad, so that most of the domestically produced pipes are made of PVC materials, and the performance and quality of the products cannot be compared with imported products.
According to statistics, the annual consumption of medical PVC pellets in China is 40,000 to 50,000 tons, which is mainly used in various pipeline products such as infusion (blood) devices, and is growing at a rate of about 10% per year. At present, there are more than 10 enterprises specializing in the production of medical PVC pellets in China, which does not include PVC pellets production enterprises for self-production.
Polyurethane (PU) is a generic term for polyadditions of polyethers, polyesters and diisocyanates. At present, PU, ​​especially for medical catheters and human organs, is a polyether polyurethane. This material has good elongation and warpage resistance under low stress load, and it is back. Elasticity, fatigue resistance and water resistance are very good, coupled with its blood compatibility, making it widely used in interventional catheters. At present, this material is under development in China and has not been popularized and applied.
In the past 10 years, medical polymer materials and their products have maintained an annual growth rate of around 20%, and their development trend can be compared with the information industry and the automobile industry.
With the rapid growth in demand for medical polymer materials (for example, the annual growth rate of artificial joint demand in China is as high as 30%, much higher than 4% in the US), biomedical materials and their products will also be faster. development of.
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