Biomedical titanium alloy material and its application
With the vigorous development and major breakthrough of biotechnology, the demand for biomedical titanium alloy is growing rapidly. However, in the widely used medical titanium alloys such as TC4 and tc4eli, due to the pathogenicity of V and Al elements, the research and development of new medical titanium alloys has great practical significance and broad market prospects in China. This paper briefly describes the classification, basic properties and application basis of biomedical titanium alloys; Its development trend in medical field is pointed out; The new β Basic processing, preparation and performance evaluation methods of titanium alloy.
Biomedical titanium alloy materials are a kind of functional structural materials used in biomedical engineering, specifically for the production and manufacture of surgical implants and orthopaedic instruments. The production and preparation of titanium alloy processing materials involves the fields of metallurgy, pressure processing, composite materials and chemical industry. It is recognized as a high-tech product in the world. Titanium and titanium alloys have gradually entered the field of civil consumption from the fields of aerospace, aviation, national defense and military industry. Such as implants and medical devices in the medical and health industry; The demand for titanium processing materials is increasing for titanium golf clubs, titanium spectacle frames, titanium watches, titanium bicycles and other products in the sports leisure industry. With the vigorous development and major breakthrough of biotechnology, biomedical metal materials and products industry will develop into a pillar industry of the world economy. Among them, the demand of titanium and its alloys has also increased rapidly and steadily in recent years because of their excellent comprehensive properties, such as light weight, low elastic modulus, non-toxic and non-magnetic, corrosion resistance, high strength and good toughness. At the same time, as titanium alloy begins to enter plastic surgery and other fields, new potential market demand appears, and the titanium alloy market will grow more rapidly in the future.
Research progress of medical titanium alloy
1.1 classification of medical titanium alloys
Titanium alloys can be divided into: α Type, α+β Type and β Type 3 titanium alloy.
1.2 development trend of medical titanium alloy
After investigation, it is found that relevant researchers at home and abroad agree that the development of medical titanium alloy has experienced three landmark stages. The first stage is represented by pure titanium and Ti-6Al-4V alloy; The second stage is a new stage represented by ti-5a1-2.5fe and ti-6a1-7nb α+β Type alloy; The third stage is mainly the development and development of better biocompatibility and lower elastic modulus β- Titanium alloy stage. Ideal biomedical titanium alloy materials must meet the following conditions: good biocompatibility, low elastic modulus, low density, good anti-corrosion performance, non-toxic, high yield strength, long fatigue life, large plasticity at room temperature, easy to form, easy to cast, etc. At present, the important alloys widely used in implant materials are Ti-6A1-4V and ti-6a1-4veli. It is reported that V element can cause malignant tissue reaction and may have toxic and side effects on human body, while Al can cause osteoporosis and mental disorder; In order to solve this problem, biomaterialists are committed to exploring and studying new biomedical titanium alloy materials without V and al. Before that, it is necessary to find out what alloy elements are suitable for addition, which are non-toxic and in line with the principle of biocompatibility. It has been found that it contains non-toxic elements such as molybdenum, niobium, tantalum and zirconium β Titanium alloy contains high content of β Stable elements, and α+β Compared with type I titanium alloy, it has lower elastic modulus (E = 55 ~ 80gpa), better shear properties and toughness, and is more suitable for implantation in human body.
2 Application of titanium alloy
2.1 medical basis of titanium alloy
2.2 medical and orthopedic fields of titanium alloy
Market situation with the development of titanium alloy, the increase of titanium varieties and the reduction of price, the application of titanium in civil industry has doubled. CFDA divides medical devices into three levels according to their safety from high to low, and the three-level governments supervise and manage them respectively. Implants made of titanium and titanium alloy materials belong to the third category of medical devices and are high-value consumables. The sub industries with market segments accounting for more than 5% include in vitro diagnosis, heart, imaging diagnosis, orthopedics, ophthalmology and plastic surgery. Among them, in vitro diagnosis, orthopedics and cardiac intervention are the fastest-growing high-value consumables in China. The application of biomedical titanium and its alloy materials has experienced three landmark stages: in the early 1950s, first in Britain and the United States, commercial pure titanium was used to manufacture bone plates, screws, intramedullary nails and hip joints. Mathys of Switzerland also uses ti-6a1-7nb alloy to manufacture non reamed interlocking intramedullary nail system (including tibia, humerus and femur) and hollow screws for the treatment of femoral neck fractures. Porous Ni Ti (pnt) alloy bioactive material manufacturing cervical and lumbar interbody fusion cage Canadian biorthex company has developed a cervical and lumbar interbody fusion cage made of porous Ni Ti alloy patented material actipore GA for the treatment of orthopedic spinal injury. new type β Titanium alloy is an advanced material that can be used in orthopedics, dentistry and vascular intervention. The orthopedic medical device industry accounts for 9% of the global medical device market share and is still growing rapidly. The orthopedic medical device market is mainly divided into four areas: trauma, joint, spine and others. Among them, trauma is the only subdivided field that has not been occupied by foreign enterprises. The main reason is that the products in this field have low technical content, are easy to copy, and the operation is less difficult. Many secondary and tertiary hospitals can carry out it, which can not be fully covered by foreign enterprises. Trauma products can be divided into internal fixation and external fixation devices. Internal fixation trauma products include intramedullary nails, bone plates and screws. In 2012, trauma accounted for 34%, joints 28%, spine 20% and others 18% in the domestic orthopedic market. Large joints are high-end medical devices with high technical barriers. At present, mainstream hospitals mainly import orthopedic materials. There is still a gap between domestic and imported products in terms of technology, design, R & D, materials, surface treatment process, etc. Artificial joints are mainly divided into artificial knee, hip, elbow, shoulder, finger and toe joints, among which the most important joint replacement includes hip and knee, accounting for more than 95% of the global joint replacement market. Spinal implant devices include thoracolumbar screw plate system, cervical screw plate system and fusion cage system. The intervertebral fusion cage system is mainly used for the treatment of intervertebral disc replacement. It is also the most important segment, accounting for about half of the whole spinal implant market.
The superior performance of titanium alloy makes it a leading position in the medical field. With the breakthrough of biotechnology and the great demand of medical application, the material design and preparation technology of titanium alloy has developed rapidly. At present, the main medical titanium alloys produced are α+β Type titanium alloy. In terms of preparation process, the production of TC4 (tc4eli) currently occupies the main market share. β Because of its certain advantages in biocompatibility and mechanical compatibility, T-type titanium alloy has become the research hotspot of new medical titanium alloy and the most potential technology in the field of medical implants. In the future, the production technology of titanium alloy should develop towards the direction of low modulus, high strength, good biocompatibility and mechanical compatibility. From the development trend, β Type titanium alloy will become the future development direction and the mainstream of medical titanium alloy market.
Biomedical titanium alloy materials are a kind of functional structural materials used in biomedical engineering, specifically for the production and manufacture of surgical implants and orthopaedic instruments. The production and preparation of titanium alloy processing materials involves the fields of metallurgy, pressure processing, composite materials and chemical industry. It is recognized as a high-tech product in the world. Titanium and titanium alloys have gradually entered the field of civil consumption from the fields of aerospace, aviation, national defense and military industry. Such as implants and medical devices in the medical and health industry; The demand for titanium processing materials is increasing for titanium golf clubs, titanium spectacle frames, titanium watches, titanium bicycles and other products in the sports leisure industry. With the vigorous development and major breakthrough of biotechnology, biomedical metal materials and products industry will develop into a pillar industry of the world economy. Among them, the demand of titanium and its alloys has also increased rapidly and steadily in recent years because of their excellent comprehensive properties, such as light weight, low elastic modulus, non-toxic and non-magnetic, corrosion resistance, high strength and good toughness. At the same time, as titanium alloy begins to enter plastic surgery and other fields, new potential market demand appears, and the titanium alloy market will grow more rapidly in the future.
Research progress of medical titanium alloy
1.1 classification of medical titanium alloys
Titanium alloys can be divided into: α Type, α+β Type and β Type 3 titanium alloy.
1.2 development trend of medical titanium alloy
After investigation, it is found that relevant researchers at home and abroad agree that the development of medical titanium alloy has experienced three landmark stages. The first stage is represented by pure titanium and Ti-6Al-4V alloy; The second stage is a new stage represented by ti-5a1-2.5fe and ti-6a1-7nb α+β Type alloy; The third stage is mainly the development and development of better biocompatibility and lower elastic modulus β- Titanium alloy stage. Ideal biomedical titanium alloy materials must meet the following conditions: good biocompatibility, low elastic modulus, low density, good anti-corrosion performance, non-toxic, high yield strength, long fatigue life, large plasticity at room temperature, easy to form, easy to cast, etc. At present, the important alloys widely used in implant materials are Ti-6A1-4V and ti-6a1-4veli. It is reported that V element can cause malignant tissue reaction and may have toxic and side effects on human body, while Al can cause osteoporosis and mental disorder; In order to solve this problem, biomaterialists are committed to exploring and studying new biomedical titanium alloy materials without V and al. Before that, it is necessary to find out what alloy elements are suitable for addition, which are non-toxic and in line with the principle of biocompatibility. It has been found that it contains non-toxic elements such as molybdenum, niobium, tantalum and zirconium β Titanium alloy contains high content of β Stable elements, and α+β Compared with type I titanium alloy, it has lower elastic modulus (E = 55 ~ 80gpa), better shear properties and toughness, and is more suitable for implantation in human body.
2 Application of titanium alloy
2.1 medical basis of titanium alloy
2.2 medical and orthopedic fields of titanium alloy
Market situation with the development of titanium alloy, the increase of titanium varieties and the reduction of price, the application of titanium in civil industry has doubled. CFDA divides medical devices into three levels according to their safety from high to low, and the three-level governments supervise and manage them respectively. Implants made of titanium and titanium alloy materials belong to the third category of medical devices and are high-value consumables. The sub industries with market segments accounting for more than 5% include in vitro diagnosis, heart, imaging diagnosis, orthopedics, ophthalmology and plastic surgery. Among them, in vitro diagnosis, orthopedics and cardiac intervention are the fastest-growing high-value consumables in China. The application of biomedical titanium and its alloy materials has experienced three landmark stages: in the early 1950s, first in Britain and the United States, commercial pure titanium was used to manufacture bone plates, screws, intramedullary nails and hip joints. Mathys of Switzerland also uses ti-6a1-7nb alloy to manufacture non reamed interlocking intramedullary nail system (including tibia, humerus and femur) and hollow screws for the treatment of femoral neck fractures. Porous Ni Ti (pnt) alloy bioactive material manufacturing cervical and lumbar interbody fusion cage Canadian biorthex company has developed a cervical and lumbar interbody fusion cage made of porous Ni Ti alloy patented material actipore GA for the treatment of orthopedic spinal injury. new type β Titanium alloy is an advanced material that can be used in orthopedics, dentistry and vascular intervention. The orthopedic medical device industry accounts for 9% of the global medical device market share and is still growing rapidly. The orthopedic medical device market is mainly divided into four areas: trauma, joint, spine and others. Among them, trauma is the only subdivided field that has not been occupied by foreign enterprises. The main reason is that the products in this field have low technical content, are easy to copy, and the operation is less difficult. Many secondary and tertiary hospitals can carry out it, which can not be fully covered by foreign enterprises. Trauma products can be divided into internal fixation and external fixation devices. Internal fixation trauma products include intramedullary nails, bone plates and screws. In 2012, trauma accounted for 34%, joints 28%, spine 20% and others 18% in the domestic orthopedic market. Large joints are high-end medical devices with high technical barriers. At present, mainstream hospitals mainly import orthopedic materials. There is still a gap between domestic and imported products in terms of technology, design, R & D, materials, surface treatment process, etc. Artificial joints are mainly divided into artificial knee, hip, elbow, shoulder, finger and toe joints, among which the most important joint replacement includes hip and knee, accounting for more than 95% of the global joint replacement market. Spinal implant devices include thoracolumbar screw plate system, cervical screw plate system and fusion cage system. The intervertebral fusion cage system is mainly used for the treatment of intervertebral disc replacement. It is also the most important segment, accounting for about half of the whole spinal implant market.
The superior performance of titanium alloy makes it a leading position in the medical field. With the breakthrough of biotechnology and the great demand of medical application, the material design and preparation technology of titanium alloy has developed rapidly. At present, the main medical titanium alloys produced are α+β Type titanium alloy. In terms of preparation process, the production of TC4 (tc4eli) currently occupies the main market share. β Because of its certain advantages in biocompatibility and mechanical compatibility, T-type titanium alloy has become the research hotspot of new medical titanium alloy and the most potential technology in the field of medical implants. In the future, the production technology of titanium alloy should develop towards the direction of low modulus, high strength, good biocompatibility and mechanical compatibility. From the development trend, β Type titanium alloy will become the future development direction and the mainstream of medical titanium alloy market.