Analysis of Medical Rubber Products
According to the classification of processing methods: medical rubber products can be divided into moulded products, extruded products, calendered products, latex products, injection products and so on. From the biological safety of medical rubber products, it can be divided into two categories: in vitro and in vivo. In vitro medical rubber products include products that are indirectly in contact with human tissues or blood, and products that are indirectly and directly non-contact with human body. Medical rubber products in vivo include products in contact with tissues or blood, artificial organs, plastic materials and tissue repair materials, and some drainage devices in vivo are long-term implants, which require high biocompatibility and biological aging resistance.
Medical Rubber Products in Vitro
The common characteristics of in vitro medical rubber products are small appearance and high quality requirements. There are many types of rubber products. The first is for medical and nursing use, such as various in vitro catheters, air cushions, hot water bags, etc. The second is for the pharmaceutical industry sealed packaging accessories, such as infusion rubber plug, blood transfusion plug, spray gasket and so on. The common performance requirements of medical rubber products are purity of texture, minimal impact on human tissues, compatibility with encapsulated drugs, and absence of substances affecting drug properties due to migration.
Medical rubber products contact with various medicines, human tissues and biological organisms, and are often disinfected under high temperature, high pressure or various organic disinfectants. Some need to be stored at low temperature for a long time. The physical and mechanical properties and chemical stability of rubber materials are strictly required.
Medical Rubber Products in vivo
The main materials of medical rubber products in vivo generally include silicone rubber, polyurethane and purified natural rubber. The common characteristics are good biocompatibility, good air permeability or selective air permeability, weather aging resistance and good disinfection resistance.
Biocompatibility is a description of the interaction between biomedical materials and organisms. It is an indispensable condition for medical materials, including blood compatibility, tissue compatibility and biodegradable absorption. Biological functionality refers to the physical and chemical properties required by biomaterials to perform their functions at their implantation sites, including the ability to detect and diagnose diseases, to assist in the treatment of diseases, to meet the performance requirements of organs for maintaining or prolonging life functions, and to change drug absorption pathways to control drug release rate, location and satisfaction. Functions required for disease treatment, etc. Non-toxicity refers to chemical inertia, which means that the material itself is harmless and does not produce harmful substances.
In addition, it should have the characteristics of bio-aging resistance, physical and mechanical stability, easy processing and moulding, easy availability of materials, appropriate price, easy disinfection and sterilization, and prevent the introduction of harmful substances into the production and processing of medical polymer materials. There are often some specific requirements for medical polymer materials for different purposes. Before medical macromolecule materials can be used in clinic, the physical and mechanical properties of materials and the adaptability of materials to organism or human body must be comprehensively evaluated. Only after the evaluation, can they be used in clinic with the approval of the State Administration department.
In recent ten years, great progress has been made in the research of medical rubber materials as biocompatible materials, and many functional and serialized medical rubber products have been put into clinical application.