Wikipedia

Biomaterial

"Biomaterials" redirects here. For the journal, seeBiomaterials (journal).

Abiomaterialis a substance that has beenengineeredto interact withbiological systemsfor a medical purpose – either a therapeutic (treat, augment, repair, or replace a tissue function of the body) or adiagnosticone. The corresponding field of study, calledbiomaterials scienceorbiomaterials engineering,is about fifty years old.[needs update]It has experienced steady growth over its history, with many companies investing large amounts of money into the development of new products. Biomaterials science encompasses elements ofmedicine,biology,chemistry,tissue engineeringandmaterials science.

Ahip implantis an example of an application of biomaterials

A biomaterial is different from a biological material, such asbone,that is produced by abiological system.However, "biomaterial" and "biological material" are often used interchangeably. Further, the word "bioterial" has been proposed as a potential alternate word for biologically-produced materials such as bone, or fungal biocomposites.[citation needed]Additionally, care should be exercised in defining a biomaterial asbiocompatible,since it is application-specific. A biomaterial that is biocompatible or suitable for one application may not be biocompatible in another.[1]

IUPACdefinition

Materialexploited in contact with living tissues, organisms, or microorganisms.[2][a][b][c]

Introduction

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Biomaterials can be derived either from nature orsynthesizedin the laboratory using a variety of chemical approaches utilizing metallic components,polymers,ceramicsorcomposite materials.They are often used and/or adapted for a medical application, and thus comprise the 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 aheart valve,or maybebioactivewith a more interactive functionality such ashydroxy-apatitecoatedhip implants.Biomaterials are also commonly used 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 anautograft,allograftorxenograftused as atransplantmaterial.[citation needed]

Bioactivity

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The ability of an engineered biomaterial to induce a physiological response that is supportive of the biomaterial's function and performance is known as bioactivity. Most commonly, inbioactive glassesand bioactive ceramics this term refers to the ability of implanted materials to bond well with surrounding tissue in either osteo conductive or osseo productive roles.[4]Bone implant materials are often designed to promote bone growth while dissolving into surrounding body fluid.[5]Thus for many biomaterials good biocompatibility along with good strength and dissolution rates are desirable. Commonly, bioactivity of biomaterials is gauged by the surface biomineralization in which a native layer ofhydroxyapatiteis formed at the surface. These days, the development of clinically useful biomaterials is greatly enhanced by the advent of computational routines that can predict the molecular effects of biomaterials in a therapeutic setting based on limitedin vitroexperimentation.[6]

Self-assembly

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Self-assemblyis 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 intothermodynamicallystable, structurally well-defined arrays, quite reminiscent of one of the seven crystal systems found inmetallurgyandmineralogy(e.g., face-centered cubic, body-centered cubic, etc.). The fundamental difference in equilibrium structure is in the spatial scale of theunit cell(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 andnanotechnology.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.[7][8][9]

Structural hierarchy

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Nearly all materials could be seen as hierarchically structured, since the changes in spatial scale bring about different mechanisms of deformation and damage.[10]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 earlyX-ray scatteringwork on the hierarchical structure ofhairandwoolby Astbury and Woods.[11]In bone, for example,collagenis the building block of theorganic matrix,a triple helix with diameter of 1.5 nm. Thesetropocollagenmolecules areintercalatedwith the mineral phase (hydroxyapatite,calcium phosphate) formingfibrilsthat curl intohelicoidsof 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 to 100 nm and thickness of 1 nm. They originally nucleate at the gaps between collagen fibrils.[12]

Similarly, the hierarchy ofabaloneshell begins at the nanolevel, with an organic layer having a thickness of 20 to 30 nm. This layer proceeds with single crystals ofaragonite(a polymorph of CaCO3) consisting of "bricks" with dimensions of 0.5 and finishing with layers approximately 0.3 mm (mesostructure).[13]

Crabsare arthropods, whose carapace is made of a mineralized hard component (exhibits brittle fracture) and a softer organic component composed primarily ofchitin.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 that link the interior and exterior of the shell.

Applications

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Biomaterials are used in:

  1. Joint replacements
  2. Bone plates[14]
  3. Intraocular lenses(IOLs) for eye surgery
  4. Bone cement
  5. Artificial ligaments and tendons
  6. Dental implantsfor tooth fixation
  7. Blood vessel prostheses
  8. Heart valves
  9. Skin repair devices (artificial tissue)
  10. Cochlear replacements
  11. Contact lenses
  12. Breast implants
  13. Drug delivery mechanisms
  14. Sustainable materials
  15. Vascular grafts
  16. Stents
  17. Nerve conduits
  18. Surgical sutures,clips, and staples forwound closure[15]
  19. Pins and screws for fracture stabilisation[16]
  20. Surgical mesh[17][18]

Biomaterials must be compatible with the body, and there are often issues ofbiocompatibility,which must be resolved before a product can be placed on the market and used in aclinicalsetting. Because of this, biomaterials are usually subjected to the same requirements as those undergone by newdrugtherapies.[19][20]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.

Bone grafts

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Calcium sulfate(its α- and β-hemihydrates) is a well known biocompatible material that is widely used as abone graftsubstitute indentistryor as its binder.[21][22]

Heart valves

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In the United States, 49% 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 forpolyethylene terephthalate). The mesh allows for the body's tissue to grow, while incorporating the valve.[23]

Skin repair

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Main article:Tissue engineering

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 andbiodegradable.One successful scaffold is acopolymeroflactic acidandglycolic acid.[23]

Properties

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As discussed previously, biomaterials are used in medical devices to treat, assist, or replace a function within the human body. The application of a specific biomaterial must combine the necessary composition, material properties, structure, and desiredin vivoreaction in order to perform the desired function. Categorizations of different desired properties are defined in order to maximize functional results.[24][25]

Host response

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Host response is defined as the "response of the host organism (local and systemic) to the implanted material or device". Most materials will have a reaction when in contact with the human body. The success of a biomaterial relies on the host tissue's reaction with the foreign material. Specific reactions between the host tissue and the biomaterial can be generated through thebiocompatibilityof the material.[25][26]

Biomaterial and tissue interactions

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Thein vivofunctionality and longevity of any implantablemedical deviceis affected by the body's response to the foreign material.[27]The body undergoes a cascade of processes defined under theforeign body response(FBR) in order to protect the host from the foreign material. The interactions between the device upon the host tissue/blood as well as the host tissue/blood upon the device must be understood in order to prevent complications and device failure.

Tissue injury caused by device implantation causesinflammatoryand healing responses during FBR. The inflammatory response occurs within two time periods: the acute phase, and the chronic phase. The acute phase occurs during the initial hours to days of implantation, and is identified by fluid and protein exudation[28]along with a neutrophilic reaction.[29]During the acute phase, the body attempts to clean and heal the wound by delivering excess blood, proteins, and monocytes are called to the site.[30]Continued inflammation leads to the chronic phase, which can be categorized by the presence of monocytes, macrophages, and lymphocytes.[29]In addition, blood vessels and connective tissue form in order to heal the wounded area.[31]

Compatibility

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Biocompatibilityis 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 noimmune responsein a given organism, and may or may not able to integrate with a particular cell type ortissue.Immuno-informed biomaterials that direct the immune response rather than attempting to circumvent the process is one approach that shows promise.[32]The ambiguity of the term reflects the ongoing development of insights into "how biomaterials interact with thehuman body"and eventually" how those interactions determine the clinical success of amedical device(such aspacemakerorhip replacement) ". Modern medical devices andprosthesesare often made of more than one material, so it might not always be sufficient to talk about the biocompatibility of a specific material.[33]Surgical implantation of a biomaterial into the body triggers an organism-inflammatory reaction with the associated healing of the damaged tissue. Depending upon the composition of the implanted material, the surface of the implant, the mechanism of fatigue, and chemical decomposition there are several other reactions possible. These can be local as well as systemic. These include immune response, foreign body reaction with the isolation of the implant with a vascular connective tissue, possible infection, and impact on the lifespan of the implant.Graft-versus-host diseaseis an auto- and alloimmune disorder, exhibiting a variable clinical course. It can manifest in either acute or chronic form, affecting multiple organs and tissues and causing serious complications in clinical practice, both during transplantation and implementation of biocompatible materials.[34]

Toxicity

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A biomaterial should perform its intended function within the living body without negatively affecting other bodily tissues and organs. In order to prevent unwanted organ and tissue interactions, biomaterials should benon-toxic.The toxicity of a biomaterial refers to the substances that are emitted from the biomaterial whilein vivo.A biomaterial should not give off anything to its environment unless it is intended to do so. Nontoxicity means that biomaterial is: noncarcinogenic,nonpyrogenic,nonallergenic,blood compatible, andnoninflammatory.[35]However, a biomaterial can be designed to include toxicity for an intended purpose. For example, application of toxic biomaterial is studied duringin vivoandin vitrocancer immunotherapytesting. Toxic biomaterials offer an opportunity to manipulate and control cancer cells.[36]One recent study states: "Advanced nanobiomaterials, includingliposomes,polymers,andsilica,play a vital role in the codelivery of drugs andimmunomodulators.These nanobiomaterial-based delivery systems could effectively promote antitumor immune responses and simultaneously reduce toxic adverse effects. "[37]This is a prime example of how the biocompatibility of a biomaterial can be altered to produce any desired function.

Biodegradable biomaterials

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Biodegradable biomaterials refers to materials that are degradable through naturalenzymatic reactions.The application of biodegradable synthetic polymers began in the later 1960s.[38]Biodegradable materials have an advantage over other materials, as they have lower risk of harmful effects long term. In addition to ethical advancements using biodegradable materials, they also improve biocompatibility for materials used for implantation.[38]Several properties including biocompatibility are important when considering different biodegradable biomaterials. Biodegradable biomaterials can be synthetic or natural depending on their source and type of extracellular matrix (ECM).[39]

Biocompatible plastics

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Some of the most commonly-usedbiocompatiblematerials (or biomaterials) are polymers due to their inherent flexibility and tunablemechanical properties.Medical devices made of plastics are often made of a select few including:cyclic olefin copolymer(COC),polycarbonate(PC),polyetherimide(PEI), medical gradepolyvinylchloride(PVC),polyethersulfone(PES),polyethylene(PE),polyetheretherketone(PEEK) and evenpolypropylene(PP). To ensurebiocompatibility,there are a series of regulated tests that material must pass to be certified for use. These include the United States Pharmacopoeia IV (USP Class IV) Biological Reactivity Test and the International Standards Organization 10993 (ISO 10993) Biological Evaluation of Medical Devices. The main objective of biocompatibility tests is to quantify the acute and chronic toxicity of material and determine any potential adverse effects during use conditions, thus the tests required for a given material are dependent on its end-use (i.e. blood, central nervous system, etc.).[40]

Surface and bulk properties

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Two properties that have a large effect on the functionality of a biomaterial is thesurfaceandbulk properties.[41]

Bulk propertiesrefers to the physical and chemical properties that compose the biomaterial for its entire lifetime. They can be specifically generated to mimic the physiochemical properties of the tissue that the material is replacing. They are mechanical properties that are generated from a material's atomic and molecular construction.

Important bulk properties:[42]

Surface propertiesrefers to the chemical and topographical features on the surface of the biomaterial that will have direct interaction with the host blood/tissue.[43]Surface engineering and modification allows clinicians to better control the interactions of a biomaterial with the host living system.

Important surface properties:[44]

Mechanical properties

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In addition to a material being certified asbiocompatible,biomaterials must be engineered specifically to their target application within amedical device.This is especially important in terms ofmechanical propertieswhich govern the way that a given biomaterial behaves. One of the most relevant material parameters is theYoung's Modulus,E,which describes a material'selastic response to stresses.The Young's Moduli of the tissue and the device that is being coupled to it must closely match for optimal compatibility between device and body, whether the device isimplantedor mounted externally. Matching the elastic modulus makes it possible to limit movement anddelaminationat thebiointerfacebetween implant and tissue as well as avoidingstress concentrationthat can lead tomechanical failure.Other important properties are thetensileandcompressivestrengths which quantify the maximum stresses a material can withstand before breaking and may be used to setstresslimits that a device may be subject to within or external to the body. Depending on the application, it may be desirable for a biomaterial to have high strength so that it is resistant to failure when subjected to a load, however in other applications it may be beneficial for the material to be low strength. There is a careful balance between strength and stiffness that determines how robust to failure the biomaterial device is. Typically, as theelasticityof the biomaterial increases, theultimate tensile strengthwill decrease and vice versa. One application where a high-strength material is undesired is inneural probes;if a high-strength material is used in these applications the tissue will alwaysfailbefore the device does (under appliedload) because the Young's Modulus of thedura materandcerebraltissue is on the order of 500Pa.When this happens, irreversible damage to the brain can occur, thus the biomaterial must have an elastic modulus less than or equal to brain tissue and a low tensile strength if an applied load is expected.[46][47]

For implanted biomaterials that may experiencetemperaturefluctuations,e.g.,dental implants,ductilityis important. The material must be ductile for a similar reason that the tensile strength cannot be too high, ductility allows the material to bend withoutfractureand also prevents theconcentration of stressesin the tissue when the temperature changes. The material property oftoughnessis also important for dental implants as well as any other rigid, load-bearingimplantsuch as areplacement hip joint.Toughness describes the material's ability todeformunder applied stress withoutfracturingand having a high toughness allows biomaterial implants to last longer within the body, especially when subjected to large stress orcyclically loaded stresses,like the stresses applied to ahip jointduring running.[46]

For medical devices that are implanted or attached to the skin, another important property requiring consideration is theflexural rigidity,D.Flexural rigiditywill determine how well the device surface can maintainconformalcontact with thetissuesurface, which is especially important for devices that are measuring tissue motion (strain),electrical signals(impedance), or are designed to stick to the skin withoutdelaminating,as in epidermal electronics. Since flexural rigidity depends on the thickness of the material,h,to the third power (h3), it is very important that a biomaterial can be formed intothin layersin the previously mentioned applications whereconformalityis paramount.[48]

Structure

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The molecular composition of a biomaterial determines the physical and chemical properties of a biomaterial. These compositions create complex structures that allow the biomaterial to function, and therefore are necessary to define and understand in order to develop a biomaterial. biomaterials can be designed to replicate natural organisms, a process known asbiomimetics.[49]The structure of a biomaterial can be observed at different at different levels to better understand a materials properties and function.

Atomic structure

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Rutherford modelof lithium-7's atomic structure

The arrangement ofatomsandionswithin a material is one of the most important structural properties of a biomaterial. Theatomic structureof a material can be viewed at different levels, thesub atomiclevel, atomic ormolecularlevel, as well as theultra-structurecreated by the atoms and molecules.Intermolecular forcesbetween the atoms and molecules that compose the material will determine its material and chemical properties.[50]

The sub atomic level observes the electrical structure of an individual atom to define its interactions with other atoms and molecules. The molecular structure observes the arrangement of atoms within the material. Finally the ultra-structure observes the 3-D structure created from the atomic and molecular structures of the material. The solid-state of a material is characterized by the intramolecular bonds between the atoms and molecules that comprise the material. Types of intramolecular bonds include:ionic bonds,covalent bonds,andmetallic bonds.These bonds will dictate the physical and chemical properties of the material, as well as determine the type of material (ceramic,metal,orpolymer).

Microstructure

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A unit cell shows the locations of lattice points repeating in all directions.

Themicrostructureof a material refers to the structure of an object, organism, or material as viewed at magnifications exceeding 25 times.[51]It is composed of the different phases of form, size, and distribution of grains, pores, precipitates, etc. The majority of solid microstructures arecrystalline,however some materials such as certain polymers will not crystallize when in the solid state.[52]

Crystalline structure

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Crystalline structureis the composition of ions, atoms, and molecules that are held together and ordered in a 3D shape. The main difference between a crystalline structure and anamorphousstructure is the order of the components. Crystalline has the highest level of order possible in the material where amorphous structure consists of irregularities in the ordering pattern.[53]One way to describe crystalline structures is through thecrystal lattice,which is a three-dimensional representation of the location of a repeating factor (unit cell) in the structure denoted withlattices.[54]There are 14 different configurations of atom arrangement in a crystalline structure, and are all represented underBravais lattices.[citation needed]

Defects of crystalline structure

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Main article:Crystallographic defect

During the formation of a crystalline structure, different impurities, irregularities, and other defects can form. These imperfections can form through deformation of the solid, rapid cooling, or high energy radiation.[55]Types of defects include point defects, line defects, as well as edge dislocation.

Macrostructure

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Macrostructure refers to the overall geometric properties that will influence the force at failure, stiffness, bending, stress distribution, and the weight of the material. It requires little to no magnification to reveal the macrostructure of a material. Observing the macrostructure reveals properties such ascavities,porosity,gas bubbles,stratification,andfissures.[56]The material's strength and elastic modulus are both independent of the macrostructure.

Natural biomaterials

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Biomaterials can be constructed using only materials sourced from plants and animals in order to alter, replace, or repair human tissue/organs. Use of natural biomaterials were used as early as ancient Egypt, where indigenous people used animal skin as sutures. A more modern example is a hip replacement using ivory material which was first recorded in Germany 1891.[57]

Valuable criteria for viable natural biomaterials:

Examples of natural biomaterials:

Biopolymers

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Main article:Biopolymer

Biopolymers arepolymersproduced by living organisms.Celluloseandstarch,proteinsandpeptides,andDNAandRNAare all examples of biopolymers, in which themonomericunits, respectively, aresugars,amino acids,andnucleotides.[60]Cellulose is both the most common biopolymer and the most common organic compound on Earth. About 33% of all plant matter is cellulose.[61][62]On a similar manner, silk (proteinaceous biopolymer) has garnered tremendous research interest in a myriad of domains including tissue engineering and regenerative medicine, microfluidics, drug delivery.[63][64]

See also

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Footnotes

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  1. ^The notion of exploitation includes utility for applications and for fundamental research to understand reciprocal perturbations as well.[2]
  2. ^The definition "non-viable material used in a medical device, intended to interact with biological systems" recommended in ref.[3]cannot be extended to the environmental field where people mean "material of natural origin".[2]
  3. ^This general term should not be confused with the termsbiopolymerorbiomacromolecule.The use of "polymeric biomaterial" is recommended when one deals withpolymeror polymer device of therapeutic or biological interest.[2]

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