Analysis of medical rubber products
according to the classification of processing methods, medical rubber products can be divided into molded products, extruded products, calendered products, latex products, injection molded products, etc. Based on the biological safety of medical rubber products, they can be divided into in vitro and in vivo. In vitro medical rubber products include products that are in indirect contact with human tissue or blood, and products that are not in indirect or direct 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 internal drainage devices, which are long-term implanted, so they have high requirements for biocompatibility and biological aging resistance
in vitro medical rubber products
the common characteristics of in vitro medical rubber products are small appearance, high quality requirements and many categories, which are mainly divided into two categories: the first is rubber parts for medical and nursing use, such as various in vitro catheters and air cushions, hot water bags, etc; The second is the accessories for sealed packaging in the pharmaceutical industry, such as infusion rubber plugs, blood transfusion plugs, spray sealing gaskets, etc. The common performance requirements of medical rubber products are that the texture is pure, the impact on human tissue is as small as possible, and it is compatible with the encapsulated drugs, and there is no substance that affects the performance of drugs due to migration
medical rubber products will contact with various drugs, human tissues and biological organisms, and often disinfect under high temperature and high pressure or in various organic disinfectants; Some also need to be stored for a long time under low temperature conditions, and the physical and mechanical properties and chemical property 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 materials, polyurethane materials and purified natural rubber. The common characteristics are good biocompatibility, good air permeability or selective air permeability, excellent weather aging resistance and disinfection resistance
biocompatibility describes the interaction between biomedical materials and organisms, and is an essential condition for medical materials, including blood compatibility, tissue compatibility and biodegradation absorption; Biological functionality refers to the physical and chemical properties required by biological materials to perform functions at their implantation sites, including the ability to check and diagnose diseases; It can assist in the treatment of diseases; It can meet the performance requirements of organs for maintaining or prolonging life function; It can change the way of drug absorption, control the speed and location of drug release, and meet the requirements of disease treatment; Non toxic, that is, chemical inertia, means that the material itself is harmless and does not produce harmful substances
in addition, it should also have biological aging resistance, physical and mechanical stability, easy processing and molding, easy availability of materials, appropriate price, and easy disinfection and sterilization; And we should also prevent the introduction of substances harmful to human body in the production and processing of medical polymer materials. There are often some specific requirements for medical polymer materials for different purposes. Before medical polymer materials enter clinical application, it is necessary to comprehensively evaluate the physical and mechanical properties of the materials themselves and the adaptability between the materials and organisms or human bodies. After passing the evaluation, they can be used in clinical practice with the approval of the national administrative department
medical rubber products with different materials
in recent ten years, great progress has been made in the research of medical rubber materials as biological adaptive materials, and many functional and serialized medical rubber products have been put into clinical application
natural rubber products
natural rubber is the earliest used medical elastomer. Because it contains more impurities and the used compounding agents have greater stimulation and response to human body, it can be used in human body only after purification and modification. The purification of natural rubber mainly uses deacidifying protein purification method and the method of adding protein and non-ionic surfactant. The purified natural rubber needs to choose a suitable vulcanization system, such as vulcanization with organic peroxide or radiation vulcanization to make the required rubber products. Natural rubber has excellent elasticity and is widely used in various medical products such as tubes, belts, plugs and gloves; However, its biological aging resistance is poor, and it is generally used for in vitro medical rubber products
polyurethane products
polyurethane, also known as polyurethane rubber, is an elastomer material with more urethane groups in the main chain. Generally, it is polymerized by polyether, polyester, polyolefin and other oligomers with polyols and polyisocyanates on the relevant policies and future healthy development of "1035" new materials or diamine chain extenders. It is a kind of polymer material between general rubber and plastic, with high elasticity of rubber and high strength of plastic. It has a wide range of hardness, excellent wear resistance, and outstanding biocompatibility, especially anticoagulation. It is often used as blood pump material for artificial heart
silicone rubber products
silicone rubber polymer is a chain structure connected by Si-O bonds, and its main composition is linear polysiloxane. Si-O-Si bond is its main chain, which is helical, so that the polarity of silicon oxygen bond counteracts each other, and the side chains are generally low polarity or non-polar groups, so the polarity of the whole macromolecule is very low, which makes silicone rubber show hydrophobicity, oxidation resistance and aging resistance. In addition, the polarity of the Si-O bond in the main chain and the Si-C bond in the side chain are similar to ionic bonds, and there are no cracking, oxidation and other reactions at the normal use temperature (below 250 ℃), so it has excellent heat resistance, can be used as medical devices, artificial organs and drug delivery systems, and has good biocompatibility with human bodies. Due to the small intermolecular force of silicone rubber, its film has better air permeability than ordinary rubber and plastic waxing film, and has strong selectivity for different air permeability, such as gas exchange membrane, medical products, in vivo artificial organs, etc
1) as an artificial organ
silicone rubber can be embedded in the human body for a long time. As an indispensable component in the body, it can be divided into long-term and short-term products retained in the body. Including: products retained in the body for a long time include hydrocephalus drainage device, artificial lung, optic membrane implant, larynx, artificial finger, palm joint, artificial tympanic membrane, dental impression, artificial tendon, artificial heart valve accessories, etc; The products that are left in the body for a short time and play the role of fluid replacement, rescue, drainage and injection, anti adhesion or defoaming include venous catheters, catheters, arteriovenous external fistula tubes, peritoneal dialysis tubes, contact glasses, blood transfusion tubes, pressure relief tubes, thoracic drainage tubes, gastroscopic cannulas, otitis media ventilation tubes, fluid catheters, nasal cannulas and other catheters for digestive system and abdominal surgery products
hydrocephalus drainage device is the earliest silicone rubber implant. So far, silicone rubber is still the only material of this device. The first research on artificial tympanic membrane began in 1960, which is to patch silicone rubber membrane with a structure similar to human tympanic membrane on the perforated tympanic membrane. Composite artificial meninges are used to repair traumatic dural defects and dural and spinal dural defects caused by resection of tumors in the base or infiltration area of the dura. Silicone rubber artificial finger joints have been on the market since 1963. The development of prosthetic heart valve products began in 1964, but because the foreign body effect of silicone rubber can not be completely eliminated, it is easy to cause cancer, and there is a trend to be gradually replaced
2) application in cosmetic surgery and repair
such as artificial skull repair; Nylon and polyester fiber are used as artificial skin after reinforcement; Hidden glasses to improve vision; Repair the defects of face; Repair forehead, nose, jaw, jaw, neck, etc; The treatment of external ear defects and now controversial artificial breast. In recent years, silicone rubber breast implants have been found to have adverse side effects on human body. First, the tensile strength is not enough, which will rupture and tear after being implanted into the body for a certain time, making the beauty disfigured; Second, the X-ray is only partially transmitted, so that the tumors that may exist in the breast can not be detected, thus delaying treatment and endangering life. Based on this high risk, polyurethane/polycarbonate copolymer and silicone polymer composites have been developed to replace silicone rubber as breast implant materials
3) application in medical devices
silicone rubber can be used as a catheter to be inserted into a certain part of the human body for a short time, and the top 10 key areas for rescue and treatment are: new generation information technology industry, advanced CNC machine tools and robots, aerospace equipment, marine engineering equipment and high-tech ships, advanced rail transit equipment, energy-saving and new energy vehicles, power equipment, agricultural equipment, new materials Important auxiliary materials and means for various cases of biomedicine and high-performance medical devices; Such as static intubation for fluid replacement for patients with liver insufficiency and burns, as well as primary supplies such as urinary catheters, infusion tubes, pressure relief tubes, thoracic drainage tubes, otitis media ventilation tubes, gastric lavage tubes, enemas, etc. It can also be used in artificial heart lung machine, membrane artificial lung, suction head of fetal attractor, medical electrode plate matrix, packaging materials of biosensors, etc. Medical silicone tubes are used in many medical fields. The development trend of medical silicone tubes used in human body is micro, thin-walled, multi cavity, and one tube can be used for multiple purposes, such as sampling, lavage, infusion, etc
4) application in drug delivery system
silicone rubber can be used as the carrier of drug delivery system, such as encapsulated drug capsules, subcutaneous implants, uterine implants, vaginal rings, skin absorbing preparations (such as various plasters), and injectable silicone rubber can be used in female permanent sterilization. In addition, silicone rubber can also be used for non-surgical sterilization of female fallopian tubes. This method is ideal and has become an important method for women who can accept permanent sterilization measures
silicone rubber is used as an encapsulated drug capsule, and the encapsulated drugs include various steroid compounds, prostaglandins, antibiotics, sedatives, sleeping pills, anticancer drugs, anesthetics, etc. In addition, silicone rubber can also be used as defoamer to treat some diseases. For example, at present, the daily order of sharing bicycles in the whole industry in China is about 50million, which is used to rescue acute pulmonary edema, which can quickly dredge the respiratory tract, improve the hypoxia condition, and reduce or avoid the death of suffocation due to foam blocking the airflow; Suffering from a cold and cough is due to the foaming of bronchial secretion. Eating syrup containing silicone oil will have an antifoaming effect, so the cough is greatly weakened and the effect is remarkable
5) other applications
in addition to the above applications, silicone rubber can also be used in the field of Biomedical Engineering, mainly including medical devices, medical electrodes, and packaging materials for biological implanted sensors
the intraperitoneal chemotherapy drug delivery device needs to be changed frequently. It is an all silica gel implantable intraperitoneal chemotherapy catheter system. The device is made of medical silicone rubber and consists of a medicine storage box and a catheter. The medical electrode (plate) is in contact with the human body, so the material is required to be soft, comfortable, physiologically inert, non-toxic to the human body, non irritating to the skin, and good ventilation. In the process of use, it also bears high temperature and high pressure, solvent disinfection, and its performance is not affected. To meet the above requirements, silicone rubber as a substrate is more appropriate. Biosensors are widely used and have become possible in vivo applications. Among them, two kinds of biosensors, biomedical electrodes and implanted sensors, are typical examples of in vivo applications
biosensors for transplantation usually need a layer of packaging material to separate the surrounding physiological environment. therefore
LINK
Copyright © 2011 JIN SHI