Podcast
Questions and Answers
What role do surface features play in the biocompatibility of a material?
What role do surface features play in the biocompatibility of a material?
Surface features significantly influence the biocompatibility of a material by affecting how it interacts with proteins and cells.
How does controlling protein adsorption impact cellular processes?
How does controlling protein adsorption impact cellular processes?
By controlling protein adsorption, one can influence cellular processes and potentially prevent a foreign body response.
What are the main advantages of using surface coatings on implanted materials?
What are the main advantages of using surface coatings on implanted materials?
Surface coatings improve tissue-implant interface strength, increase surface area, and can reduce friction and infection risk.
Describe the significance of hydrophobic surfaces in medical devices.
Describe the significance of hydrophobic surfaces in medical devices.
What is the effect of hydrophilic surfaces on the manipulation of medical devices?
What is the effect of hydrophilic surfaces on the manipulation of medical devices?
How does surface roughening increase bioactivity in materials?
How does surface roughening increase bioactivity in materials?
What is the purpose of plasma modification in surface treatments?
What is the purpose of plasma modification in surface treatments?
Why is it important to balance surface modifications with bulk material properties?
Why is it important to balance surface modifications with bulk material properties?
What is the most common problem related to joints as we age?
What is the most common problem related to joints as we age?
Describe the structural difference between cortical and trabecular bone.
Describe the structural difference between cortical and trabecular bone.
Identify the three types of cartilage and their flexibility.
Identify the three types of cartilage and their flexibility.
What role do osteoclasts and osteoblasts play in bone health?
What role do osteoclasts and osteoblasts play in bone health?
What is the purpose of the annulus fibrosus in intervertebral discs?
What is the purpose of the annulus fibrosus in intervertebral discs?
How do hip fractures commonly occur?
How do hip fractures commonly occur?
What is the gold standard tissue graft for spinal fusion?
What is the gold standard tissue graft for spinal fusion?
Describe the significance of PEEK as a material in orthopaedics.
Describe the significance of PEEK as a material in orthopaedics.
What is the primary concern associated with metal-on-metal hip implants?
What is the primary concern associated with metal-on-metal hip implants?
Which knee injury is the most common, and what prevents it?
Which knee injury is the most common, and what prevents it?
What affects the incorporation of allografts in spinal fusion?
What affects the incorporation of allografts in spinal fusion?
Explain the difference between osteoconductive and osteoinductive materials.
Explain the difference between osteoconductive and osteoinductive materials.
What challenges do first-generation suture anchors face in arthroscopy?
What challenges do first-generation suture anchors face in arthroscopy?
What application does bio-inspired design have in orthopaedics?
What application does bio-inspired design have in orthopaedics?
What is the primary function of a biomaterial?
What is the primary function of a biomaterial?
List three important attributes of a biomaterial.
List three important attributes of a biomaterial.
What are the four possible interactions a biomaterial can have with the body?
What are the four possible interactions a biomaterial can have with the body?
Name two common metals used in biomaterials and one of their properties.
Name two common metals used in biomaterials and one of their properties.
What is a disadvantage of using metals as biomaterials?
What is a disadvantage of using metals as biomaterials?
What defines a biotolerant biomaterial?
What defines a biotolerant biomaterial?
Explain the term 'foreign body response'.
Explain the term 'foreign body response'.
Describe one example of a polymer used as a biomaterial.
Describe one example of a polymer used as a biomaterial.
What is thrombosis in the context of biomaterials?
What is thrombosis in the context of biomaterials?
How can ceramices be characterized in their applications as biomaterials?
How can ceramices be characterized in their applications as biomaterials?
How does the inflammation response occur upon the introduction of a biomaterial?
How does the inflammation response occur upon the introduction of a biomaterial?
What are biocompatible materials designed to do?
What are biocompatible materials designed to do?
What is the purpose of modifying the surfaces of biomaterials?
What is the purpose of modifying the surfaces of biomaterials?
Identify one application for biodegradable metals.
Identify one application for biodegradable metals.
What is surface degradation and how does it differ from bulk erosion?
What is surface degradation and how does it differ from bulk erosion?
What role do calcium phosphates play in ceramic degradation?
What role do calcium phosphates play in ceramic degradation?
Why is magnesium considered a significant biodegradable material?
Why is magnesium considered a significant biodegradable material?
What is the purpose of the FDA's 510(k) premarket notification?
What is the purpose of the FDA's 510(k) premarket notification?
What percentage of Class I devices are exempt from the 510(k) requirement?
What percentage of Class I devices are exempt from the 510(k) requirement?
What is required from manufacturers seeking pre-market approval (PMA) for Class III devices?
What is required from manufacturers seeking pre-market approval (PMA) for Class III devices?
What common testing methods are used for 510(k) submissions?
What common testing methods are used for 510(k) submissions?
What happens if a device is classified as Not Substantially Equivalent (NSE)?
What happens if a device is classified as Not Substantially Equivalent (NSE)?
Define De Novo classification in the context of FDA regulations.
Define De Novo classification in the context of FDA regulations.
What does the term 'good manufacturing process' (GMP) refer to?
What does the term 'good manufacturing process' (GMP) refer to?
What are some potential risks associated with medical devices?
What are some potential risks associated with medical devices?
Which regulatory body oversees the approval of medical devices in the United States?
Which regulatory body oversees the approval of medical devices in the United States?
What is a common consequence of device recalls?
What is a common consequence of device recalls?
How do FDA classification levels (I, II, III) differ in terms of risk?
How do FDA classification levels (I, II, III) differ in terms of risk?
What is Wolff’s Law and how does it relate to the remodeling of bone?
What is Wolff’s Law and how does it relate to the remodeling of bone?
Explain the concept of stress shielding and its potential impact on bone health.
Explain the concept of stress shielding and its potential impact on bone health.
Why is fatigue testing critical for biomaterials used in biomedical implants?
Why is fatigue testing critical for biomaterials used in biomedical implants?
Describe the difference between in vitro and in vivo testing for biomaterials.
Describe the difference between in vitro and in vivo testing for biomaterials.
What is the importance of cytotoxicity testing and what does ISO 10993-5 cover?
What is the importance of cytotoxicity testing and what does ISO 10993-5 cover?
How does the concept of genotoxicity impact the development of long-term medical implants?
How does the concept of genotoxicity impact the development of long-term medical implants?
Explain how the principles of stress and wear contribute to the failure of biomaterials.
Explain how the principles of stress and wear contribute to the failure of biomaterials.
What factors can influence the degradation rate of biomaterials, particularly polymers?
What factors can influence the degradation rate of biomaterials, particularly polymers?
How do the 3 R's (Replace, Reduce, Refine) relate to ethical considerations in animal testing?
How do the 3 R's (Replace, Reduce, Refine) relate to ethical considerations in animal testing?
Discuss the role of hardness testing in predicting the performance of biomaterials.
Discuss the role of hardness testing in predicting the performance of biomaterials.
What is the significance of using standard reference materials (SRM) in biomaterial testing?
What is the significance of using standard reference materials (SRM) in biomaterial testing?
Describe the potential consequences of adverse reactions to blood-contacting medical devices.
Describe the potential consequences of adverse reactions to blood-contacting medical devices.
What is the relationship between a material's Young's modulus and its application in biomedical devices?
What is the relationship between a material's Young's modulus and its application in biomedical devices?
How does hydrolytic degradation affect the functionality of biodegradable polymers used in medicine?
How does hydrolytic degradation affect the functionality of biodegradable polymers used in medicine?
Flashcards
Surface Modifications Impact
Surface Modifications Impact
Surface features have the most significant influence on how well a material interacts with living tissue (biocompatibility).
Bulk Material Function
Bulk Material Function
The inside of a material determines its strength, durability, and how it performs its intended job.
Surface Modification Goals
Surface Modification Goals
We want to keep the core material strong while changing the surface on a tiny scale (nanometers) to improve its interaction with the body. This can make materials harder, resist rust, and work better with biological systems.
Protein Adsorption Control
Protein Adsorption Control
When a material is implanted, proteins immediately coat its surface. Cells then attach to these proteins, influencing how they behave. Controlling these proteins lets us control cellular processes.
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Foreign Body Response Prevention
Foreign Body Response Prevention
By controlling protein adsorption, we can prevent the body's natural rejection of a foreign material, leading to better integration and less inflammation.
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Hydrophobic Surface
Hydrophobic Surface
A water-repelling surface that minimizes interaction with water, like a raincoat. It's self-cleaning and can bind to proteins strongly.
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Hydrophilic Surface
Hydrophilic Surface
A water-loving surface that readily interacts with water, allowing for smooth flow. It minimizes friction and blood clotting.
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Material Interaction with the Body
Material Interaction with the Body
The properties of a material's surface, such as hydrophobicity or hydrophilicity, determine how it interacts with the biological environment in the body.
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Stress Shielding
Stress Shielding
A phenomenon where a strong implant weakens the surrounding bone because it carries most of the load, preventing the natural bone remodeling process.
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Wolff's Law
Wolff's Law
A principle stating that bone adapts to the loads placed upon it. Bone will become denser and stronger under higher stress, and weaker under lower stress.
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Young's Modulus
Young's Modulus
A measure of a material's stiffness or resistance to deformation under tension or compression. A higher Young's modulus indicates a stiffer material.
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Ultimate Tensile Strength (UTS)
Ultimate Tensile Strength (UTS)
The maximum stress a material can withstand before it breaks under tension.
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Fracture Toughness
Fracture Toughness
A measure of a material's resistance to the growth of cracks. A higher fracture toughness indicates a material that can withstand cracks better.
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Elongation at Break
Elongation at Break
The amount of deformation a material undergoes before breaking under tension. A higher elongation at break indicates a more ductile material.
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Ultimate Compressive Strength
Ultimate Compressive Strength
The maximum stress a material can withstand before it breaks under compression.
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Fatigue
Fatigue
The weakening of a material under repeated loading, even if the load is below the material's yield strength. It can lead to cracks and eventual failure.
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Fatigue Fracture
Fatigue Fracture
A fracture caused by fatigue, typically occurring at a stress level below the material's ultimate tensile strength.
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Fretting Fatigue
Fretting Fatigue
A type of fatigue failure caused by the combination of cyclic stress and friction between moving components.
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Corrosion Fatigue
Corrosion Fatigue
A type of fatigue failure caused by the combination of cyclic stress and corrosion.
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Wear
Wear
The gradual loss of material due to friction. Can lead to device loosening and particle generation, potentially causing inflammation.
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Aseptic Loosening
Aseptic Loosening
The loosening of an implant due to wear debris generating an inflammatory response, leading to bone resorption and implant failure.
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Hardness
Hardness
A measure of a material's resistance to indentation. A hard material is resistant to wear and scratching.
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In Vitro Testing
In Vitro Testing
Testing performed outside of a living organism, typically in a laboratory setting. This can include cell culture assays or material characterization tests.
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Surface Degradation
Surface Degradation
Polymer degradation starting from the exterior surface, often caused by factors like water erosion.
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Bulk Erosion
Bulk Erosion
Polymer degradation occurring evenly throughout the entire material, leading to a faster decrease in strength over time.
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Bioactive Glass
Bioactive Glass
A type of ceramic material used in biomaterials that forms a strong bond with bone tissue.
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Magnesium in Biomaterials
Magnesium in Biomaterials
A lightweight, biocompatible metal used in biodegradable implants. It degrades rapidly, making it suitable for temporary applications.
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FDA Classification: Class I
FDA Classification: Class I
Devices with low risk, often used externally like bandages, gloves, and stethoscopes.
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FDA Classification: Class II
FDA Classification: Class II
Devices with moderate risk, including those that come in contact with bodily fluids like blood pressure cuffs and syringes.
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FDA Classification: Class III
FDA Classification: Class III
Devices with high risk, typically those implanted in the body like pacemakers and stents.
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510(k) Premarket Notification
510(k) Premarket Notification
A pathway for FDA approval where a manufacturer demonstrates substantial equivalence to an existing, safe, and effective device.
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Substantially Equivalent (SE)
Substantially Equivalent (SE)
An FDA decision indicating a new device is as safe and effective as a previously approved similar device.
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Pre-Market Approval (PMA)
Pre-Market Approval (PMA)
A rigorous FDA pathway for class III devices, requiring extensive testing and demonstration of safety and effectiveness.
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De Novo Classification
De Novo Classification
An FDA pathway for devices that are not substantially equivalent to existing devices, but offer a benefit and have moderate risk.
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Medical Device Records (MDR)
Medical Device Records (MDR)
Information collected on recalls of medical devices, providing insight into potential issues and safety concerns.
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MAUDE Database
MAUDE Database
A database of individual reports on medical devices, providing valuable information for safety monitoring and risk management.
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Tendons
Tendons
Connective tissue that connects muscles to bones, enabling movement and force transmission.
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Ligaments
Ligaments
Connective tissue that connects bones to bones, providing stability and limiting excessive joint movement.
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Osteoarthritis
Osteoarthritis
A type of arthritis that occurs when the protective cartilage that cushions the ends of your bones wears down over time. This causes pain, stiffness, and swelling in the joint.
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What is the main component of the musculoskeletal system?
What is the main component of the musculoskeletal system?
Joints
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What are the main components of the extracellular matrix (ECM)?
What are the main components of the extracellular matrix (ECM)?
Collagen, proteoglycan, water, elastin, and hydroxyapatite (bone only)
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Cortical bone
Cortical bone
The dense, hard outer layer of bone that makes up about 80% of total bone mass. It has a low porosity, meaning it has fewer spaces within it.
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Trabecular bone
Trabecular bone
The spongy, inner layer of bone that is more porous than cortical bone. It is more actively involved in remodeling.
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Osteoclasts
Osteoclasts
Cells that break down bone tissue, removing old or damaged bone.
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Osteoblasts
Osteoblasts
Cells that create new bone tissue, building and repairing bone.
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Osteocytes
Osteocytes
Mature bone cells that maintain bone tissue and help regulate bone remodeling.
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Elastic cartilage
Elastic cartilage
The most flexible type of cartilage, found in the ear, auditory tube, and larynx.
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Hyaline cartilage
Hyaline cartilage
The second most flexible type of cartilage, found in articular cartilage in joints, the nose, and lungs.
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Fibrocartilage
Fibrocartilage
The least flexible type of cartilage, found in the annulus fibrosus of discs, between pubic bones, and other areas that need to resist tension and compression.
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Nucleus pulposus
Nucleus pulposus
The soft, gelatinous center of the intervertebral disc that helps absorb shock and maintain the disc's height.
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Annulus fibrosus
Annulus fibrosus
The tough, fibrous outer ring of the intervertebral disc that encases the nucleus pulposus and resists multi-axial loading.
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Cartilage endplate
Cartilage endplate
A thin layer of hyaline cartilage that separates the intervertebral disc from the vertebral body and allows for nutrient transport.
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What are the 3 main types of orthopaedic hardware?
What are the 3 main types of orthopaedic hardware?
Screws, plates, pins, wires, rods, nails, suture anchors, spinal cages, and joint replacements.
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What is a biomaterial?
What is a biomaterial?
A material utilized in medicine to support, enhance, or replace damaged tissue or a biological function. It's biocompatible, meaning it doesn't harm the body, and can be natural or synthetic.
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What is biocompatibility?
What is biocompatibility?
A biomaterial's ability to not cause harm to the host body. This includes being non-toxic, non-allergenic, non-thrombogenic, non-carcinogenic, non-mutagenic, and non-inflammatory.
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What are the four interaction types between a biomaterial and the body?
What are the four interaction types between a biomaterial and the body?
A biomaterial can (1) hurt you, (2) dissolve, (3) be surrounded by a protective layer, or (4) integrate with tissue.
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What are metals as biomaterials?
What are metals as biomaterials?
Metals composed of metallic elements with small amounts of nonmetals, commonly used in medical implants due to their strength and resistance to fatigue. Examples include titanium, stainless steel, and cobalt-chromium.
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What are the pros and cons of using metals as biomaterials?
What are the pros and cons of using metals as biomaterials?
Pros: strong, resistant to fatigue, ductile, easily sterilized. Cons: prone to stress shielding, corrosion, and wear.
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What is 'stress shielding' in relation to biomaterials?
What is 'stress shielding' in relation to biomaterials?
When an implant carries the load, preventing the surrounding tissue from working and potentially weakening it.
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What are ceramics as biomaterials?
What are ceramics as biomaterials?
Inorganic compounds of metallic and nonmetallic elements, known for their strength, chemical inertness, and bioactivity, commonly used for dental and hip implants.
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What are the pros and cons of using ceramics as biomaterials?
What are the pros and cons of using ceramics as biomaterials?
Pros: strong, chemically inert, high compressive strength, biodegradable or bioactive. Cons: hard to manufacture, brittle, prone to fracture, can loosen, only have compressive strength.
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What are polymers as biomaterials?
What are polymers as biomaterials?
Long chains of molecules with a carbon backbone, known for their ease of manufacture, moldability, and biodegradability, commonly used for implants and drug delivery.
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What are the pros and cons of using polymers as biomaterials?
What are the pros and cons of using polymers as biomaterials?
Pros: easy to manufacture and modify, can be bendable and biodegradable. Cons: poor strength, prone to wear and tear.
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What is the 'foreign body response' to biomaterials?
What is the 'foreign body response' to biomaterials?
The immune response to an implanted device, leading to encapsulation by scar tissue, which can affect implant function.
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What is inflammation in relation to biomaterials?
What is inflammation in relation to biomaterials?
A natural immune response to injury, characterized by redness, swelling, heat, and pain, which can be acute (immediate) or chronic (long-term).
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What is thrombosis in relation to biomaterials?
What is thrombosis in relation to biomaterials?
Blood-material interaction that triggers blood clotting, which can be caused by the material or surgery.
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What is a biodegradable biomaterial?
What is a biodegradable biomaterial?
A material designed to degrade and be replaced by natural tissue over time, often used for temporary implants or scaffolds.
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What are the most common biomaterials used for?
What are the most common biomaterials used for?
Biomaterials have a wide range of applications, including medical implants, promoting healing, regenerating tissues, biosensing, and drug delivery systems.
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Introduction to Biomaterials
- A biomaterial is a material used in medical applications to support, enhance, or replace damaged tissue or biological functions.
- Biomaterials are used in close contact with living tissue.
- They can be natural or synthetic, and either therapeutic or diagnostic.
- Common applications include medical implants, methods to promote healing, regenerated human tissues, tissue engineering, biosensors (e.g., glucose monitoring devices), and drug delivery systems.
- Biocompatibility is a crucial attribute, meaning the biomaterial should cause no harm to the host body. This includes being non-toxic, non-allergenic, non-thrombogenic, non-carcinogenic, non-mutagenic, and non-inflammatory.
- Biomaterials should have appropriate mechanical properties matching those of the native tissue, which may be achieved in various ways, such as through dissolution, surrounding protective layers, or bonding/integrating with the tissue.
Types of Biomaterials
- Metals: Composed of metallic elements with small amounts of non-metallic elements.
- Metallic bonds with atoms arranged in an orderly structure.
- Good conductors of electricity and heat.
- Ductile, meaning they can be deformed before breaking.
- Often strong but prone to corrosion.
- Polymers: A broad class of compounds based primarily on non-metallic elements, often natural or synthetic and mostly organic.
- Ceramics: Inorganic compounds primarily composed of metallic and non-metallic elements, often covalently or ionically bonded.
- Often thermally stable, strong, hard, and rigid, with resistance to wear, friction, and corrosion.
- Composites: Composed of multiple materials for combining the best qualities of each. Can be natural or synthetic.
The Body's Response to Biomaterials
- Local responses include inflammation at the implant site, which can be acute or chronic potentially leading to encapsulation.
- Foreign body reactions are immune responses.
- Systemic responses also occur, including toxicity from releases of wear and corrosion particles, allergic reactions, and hypersensitivity due to galvanic corrosion.
Bioactive Materials and Surface Modifications
- Surface features significantly impact biocompatibility more than the bulk material.
- Controlling protein adsorption can influence the body's response through prevention of foreign body reactions.
- Some processes enhance biocompatibility like changing surface coatings and patterning.
Biomaterial Fatigue and Failure
- Biomaterials might experience fatigue or fracture during repetitive loading in the body as a result of tiny defects.
- Critical locations need to be identified, along with manufacturing defects.
- Environmental factors like temperature and damaging chemicals can be additional concerns.
- Wear and corrosion mechanisms can affect fatigue/failure.
In Vitro Testing of Biomaterials
- In vitro tests are performed in a test tube or outside an organism (e.g., using cell cultures).
- Standards (e.g., ISO and ASTM) are crucial for safety and effectiveness.
- Cytotoxicity, hemocompatibility, and genotoxicity are specific test considerations.
- In vitro testing provides insights for in vivo studies and design considerations to translate to real-world situations.
In Vivo Testing of Biomaterials
- In vivo tests focus on animal studies, which follow testing standards.
- Measurements are taken to assess cell/tissue responses to an implanted biomaterial.
- This provides insights into design considerations.
- Testing methodologies involve determining various local and systemic reactions to ensure compatibility and safety in animal models, or through human trials.
Selection of Animal Models
- Animal models are critical for understanding in vivo reactions to new biomaterials.
- Selection is based on factors including device function, location, species, age, gender, and diet.
- Ethical issues in animal testing are critical for the conduct of animal trials, which include ensuring humane treatment.
- The Three R's (Replace, Reduce, Refine) are crucial concepts for reducing suffering in animal models.
Degradation of Biomaterials
- Degradation can occur due to heat, light, or chemical reaction and is a topic that needs careful consideration.
- Hydrolysis can involve breakdown of a material through a reaction with water.
- Ceramics and metals also subject to various types of degradation.
Regulatory Pathways
- FDA (Food and Drug Administration) regulatory pathways are distinct for different types of medical devices, based on risk assessment.
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