A biomaterial is any substance that has been engineered to interact with biological systems for a medical purpose - either a therapeutic (treat, augment, repair or replace a tissue function of the body) or a diagnostic one. As a science, biomaterials is about fifty years old. The study of biomaterials is called biomaterials science or biomaterials engineering. It has experienced steady and strong growth over its history, with many companies investing large amounts of money into the development of new products. Biomaterials science encompasses elements of medicine, biology, chemistry, tissue engineering and materials science.
Note that a biomaterial is different from a biological material, such as bone, that is produced by a biological system. Additionally, care should be exercised in defining a biomaterial as biocompatible, since it is application-specific. A biomaterial that is biocompatible or suitable for one application may not be biocompatible in another.
Biomaterials can be derived either from nature or synthesized in the laboratory using a variety of chemical approaches utilizing metallic components, polymers, ceramics or composite materials. They are often used and/or adapted for a medical application, and thus comprises whole or part of a living structure or biomedical device which performs, augments, or replaces a natural function. Such functions may be relatively passive, like being used for a heart valve, or may be bioactive with a more interactive functionality such as hydroxy-apatite coated hip implants. Biomaterials are also used every day in dental applications, surgery, and drug delivery. For example, a construct with impregnated pharmaceutical products can be placed into the body, which permits the prolonged release of a drug over an extended period of time. A biomaterial may also be an autograft, allograft or xenograft used as a transplant material.
Biomineralization is the process by which living organisms produce minerals, often to harden or stiffen existing tissues. Such tissues are called mineralized tissues. It is an extremely widespread phenomenon; all six taxonomic kingdoms contain members that are able to form minerals, and over 60 different minerals have been identified in organisms. Examples include silicates in algae and diatoms, carbonates in invertebrates, and calcium phosphates and carbonates in vertebrates. These minerals often form structural features such as sea shells and the bone in mammals and birds. Organisms have been producing mineralised skeletons for the past 550 million years. Other examples include copper, iron and gold deposits involving bacteria. Biologically-formed minerals often have special uses such as magnetic sensors in magnetotactic bacteria (Fe3O4), gravity sensing devices (CaCO3, CaSO4, BaSO4) and iron storage and mobilization (Fe2O3•H2O in the protein ferritin).
Self-assembly is the most common term in use in the modern scientific community to describe the spontaneous aggregation of particles (atoms, molecules, colloids, micelles, etc.) without the influence of any external forces. Large groups of such particles are known to assemble themselves into thermodynamically stable, structurally well-defined arrays, quite reminiscent of one of the 7 crystal systems found in metallurgy and mineralogy (e.g. face-centered cubic, body-centered cubic, etc.). The fundamental difference in equilibrium structure is in the spatial scale of the unit cell (or lattice parameter) in each particular case.
Molecular self-assembly is found widely in biological systems and provides the basis of a wide variety of complex biological structures. This includes an emerging class of mechanically superior biomaterials based on microstructural features and designs found in nature. Thus, self-assembly is also emerging as a new strategy in chemical synthesis and nanotechnology. Molecular crystals, liquid crystals, colloids, micelles, emulsions, phase-separated polymers, thin films and self-assembled monolayers all represent examples of the types of highly ordered structures which are obtained using these techniques. The distinguishing feature of these methods is self-organization.
Nearly all materials could be seen as hierarchically structured, especially since the changes in spatial scale bring about different mechanisms of deformation and damage. However, in biological materials this hierarchical organization is inherent to the microstructure. One of the first examples of this, in the history of structural biology, is the early X-ray scattering work on the hierarchical structure of hair and wool by Astbury and Woods. In bone, for example, collagen is the building block of the organic matrix — a triple helix with diameter of 1.5 nm. These tropocollagen molecules are intercalated with the mineral phase (hydroxyapatite, a calcium phosphate) forming fibrils that curl into helicoids of alternating directions. These "osteons" are the basic building blocks of bones, with the volume fraction distribution between organic and mineral phase being about 60/40.
In another level of complexity, the hydroxyapatite crystals are mineral platelets that have a diameter of approximately 70–100 nm and thickness of 1 nm. They originally nucleate at the gaps between collagen fibrils.
Similarly, the hierarchy of abalone shell begins at the nanolevel, with an organic layer having a thickness of 20–30 nm. This layer proceeds with single crystals of aragonite (a polymorph of CaCO3) consisting of "bricks" with dimensions of 0.5 and finishing with layers approximately 0.3 mm (mesostructure).
Crabs are arthropods whose carapace is made of a mineralized hard component (which exhibits brittle fracture) and a softer organic component composed primarily of chitin. The brittle component is arranged in a helical pattern. Each of these mineral ‘rods’ (1 μm diameter) contains chitin–protein fibrils with approximately 60 nm diameter. These fibrils are made of 3 nm diameter canals which link the interior and exterior of the shell.
Biomaterials are used in:
- Joint replacements
- Bone plates
- Intraocular lenses (IOLs) for eye surgery
- Bone cement
- Artificial ligaments and tendons
- Dental implants for tooth fixation
- Blood vessel prostheses
- Heart valves
- Skin repair devices (artificial tissue)
- Cochlear replacements
- Contact lenses
- Breast implants
- Drug delivery mechanisms
- Sustainable materials
- Vascular grafts
- Nerve conduits
- Surgical sutures, clips, and staples for wound closure
- Pins and screws for fracture stabilisation
- Surgical mesh
Biomaterials must be compatible with the body, and there are often issues of biocompatibility which must be resolved before a product can be placed on the market and used in a clinical setting. Because of this, biomaterials are usually subjected to the same requirements as those undergone by new drug therapies.
All manufacturing companies are also required to ensure traceability of all of their products so that if a defective product is discovered, others in the same batch may be traced.
In the United States, 45% of the 250,000 valve replacement procedures performed annually involve a mechanical valve implant. The most widely used valve is a bileaflet disc heart valve, or St. Jude valve. The mechanics involve two semicircular discs moving back and forth, with both allowing the flow of blood as well as the ability to form a seal against backflow. The valve is coated with pyrolytic carbon, and secured to the surrounding tissue with a mesh of woven fabric called Dacron (du Pont's trade name for polyethylene terephthalate). The mesh allows for the body's tissue to grow while incorporating the valve.
Most of the time, ‘artificial’ tissue is grown from the patient’s own cells. However, when the damage is so extreme that it is impossible to use the patient's own cells, artificial tissue cells are grown. The difficulty is in finding a scaffold that the cells can grow and organize on. The characteristics of the scaffold must be that it is biocompatible, cells can adhere to the scaffold, mechanically strong and biodegradable. One successful scaffold is a copolymer of lactic acid and glycolic acid.
Biocompatibility is related to the behavior of biomaterials in various environments under various chemical and physical conditions. The term may refer to specific properties of a material without specifying where or how the material is to be used. For example, a material may elicit little or no immune response in a given organism, and may or may not able to integrate with a particular cell type or tissue. The ambiguity of the term reflects the ongoing development of insights into how biomaterials interact with the human body and eventually how those interactions determine the clinical success of a medical device (such as pacemaker or hip replacement). Modern medical devices and prostheses are often made of more than one material—so it might not always be sufficient to talk about the biocompatibility of a specific material. 
Biopolymers are polymers produced by living organisms. Cellulose and starch, proteins and peptides, and DNA and RNA are all examples of biopolymers, in which the monomeric units, respectively, are sugars, amino acids, and nucleotides. Cellulose is both the most common biopolymer and the most common organic compound on Earth. About 33% of all plant matter is cellulose.
- The notion of exploitation includes utility for applications and for fundamental research to understand reciprocal perturbations as well.
- The definition “non-viable material used in a medical device, intended to interact with biological systems” recommended in ref. cannot be extended to the environmental field where people mean “material of natural origin”.
- This general term should not be confused with the terms biopolymer or biomacromolecule. The use of “polymeric biomaterial” is recommended when one deals with polymer or polymer device of therapeutic or biological interest.
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