Podcast
Questions and Answers
What is the primary reason macrophages are activated when encountering synthetic materials?
What is the primary reason macrophages are activated when encountering synthetic materials?
How does the biocompatibility of a synthetic material affect the inflammatory response?
How does the biocompatibility of a synthetic material affect the inflammatory response?
What is the typical outcome of the late-stage tissue reaction to a synthetic material?
What is the typical outcome of the late-stage tissue reaction to a synthetic material?
What is the first step in biofilm formation on a biomaterial surface?
What is the first step in biofilm formation on a biomaterial surface?
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How do slippery liquid-infused porous surfaces (SLIPS) prevent fouling?
How do slippery liquid-infused porous surfaces (SLIPS) prevent fouling?
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Which of the following is NOT a topic covered in the course?
Which of the following is NOT a topic covered in the course?
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According to the 2018 definition, what is the primary purpose of a biomaterial?
According to the 2018 definition, what is the primary purpose of a biomaterial?
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Which of the following materials would most likely NOT be considered a biomaterial as defined by the 1986 consensus?
Which of the following materials would most likely NOT be considered a biomaterial as defined by the 1986 consensus?
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What is the primary method by which 60Co isotope sterilizes materials?
What is the primary method by which 60Co isotope sterilizes materials?
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Which is a characteristic of the environment where the 60Co isotope is stored when the irradiator is not in use?
Which is a characteristic of the environment where the 60Co isotope is stored when the irradiator is not in use?
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What is the most commonly validated dose used to sterilize medical products?
What is the most commonly validated dose used to sterilize medical products?
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Which material is NOT compatible with gamma radiation sterilization?
Which material is NOT compatible with gamma radiation sterilization?
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What are the two key effects of gamma radiation on organic matter as mentioned in the content?
What are the two key effects of gamma radiation on organic matter as mentioned in the content?
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Which of the following is a relevant material design property for the functional performance of an intraocular contact lens?
Which of the following is a relevant material design property for the functional performance of an intraocular contact lens?
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What is one characteristic that defines the biocompatibility of a material?
What is one characteristic that defines the biocompatibility of a material?
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Which design property is essential for load transmission and stress distribution in knee joint replacements?
Which design property is essential for load transmission and stress distribution in knee joint replacements?
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What factor is NOT involved in assessing the functional performance of a biomaterial?
What factor is NOT involved in assessing the functional performance of a biomaterial?
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In the context of surgical sutures, what does resorbability refer to?
In the context of surgical sutures, what does resorbability refer to?
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Which property is critical to ensure a material resists infection?
Which property is critical to ensure a material resists infection?
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Which option describes a scenario where a material might NOT demonstrate suitable functional performance?
Which option describes a scenario where a material might NOT demonstrate suitable functional performance?
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Which of these properties directly affects the mechanical performance of a resorbable suturing thread?
Which of these properties directly affects the mechanical performance of a resorbable suturing thread?
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What is a major component of injectable bone cement used in orthopedic implants?
What is a major component of injectable bone cement used in orthopedic implants?
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Which biomaterial is primarily used for soft, hydrogel contact lenses?
Which biomaterial is primarily used for soft, hydrogel contact lenses?
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What characteristic describes Poly(acrylic acid) in medical applications?
What characteristic describes Poly(acrylic acid) in medical applications?
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Which material is known for its good chemical resistance and tensile strength used in sutures?
Which material is known for its good chemical resistance and tensile strength used in sutures?
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What is one of the major uses of High Density Poly(ethylene)?
What is one of the major uses of High Density Poly(ethylene)?
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What characteristic of Poly(tetrafluorethylene) makes it suitable for vascular grafts?
What characteristic of Poly(tetrafluorethylene) makes it suitable for vascular grafts?
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What is true about Poly(dimethylsiloxane) in surgical applications?
What is true about Poly(dimethylsiloxane) in surgical applications?
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Which characteristic is associated with Poly(methyl methacrylate)?
Which characteristic is associated with Poly(methyl methacrylate)?
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What is the main purpose of the coagulation cascade in the context of biomaterials interacting with blood?
What is the main purpose of the coagulation cascade in the context of biomaterials interacting with blood?
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What is the role of thrombin in the coagulation cascade?
What is the role of thrombin in the coagulation cascade?
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Which of the following factors is NOT involved in the extrinsic pathway of the coagulation cascade?
Which of the following factors is NOT involved in the extrinsic pathway of the coagulation cascade?
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How do the extrinsic and intrinsic pathways of the coagulation cascade converge?
How do the extrinsic and intrinsic pathways of the coagulation cascade converge?
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What is the main difference between the extrinsic and intrinsic pathways of the coagulation cascade?
What is the main difference between the extrinsic and intrinsic pathways of the coagulation cascade?
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Which of the following is NOT a manufacturing criterion considered for biomaterials used in medical devices?
Which of the following is NOT a manufacturing criterion considered for biomaterials used in medical devices?
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What are the advantages of using biomaterials in medical devices?
What are the advantages of using biomaterials in medical devices?
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What is the 'Expected Lifetime' in the context of a medical device?
What is the 'Expected Lifetime' in the context of a medical device?
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Study Notes
Introduction to Biomedical Materials/Polymers
- Biomaterials Science: An introduction to Materials in Medicine, 3rd Edition, edited by B. D. Ratner, A. S. Hoffman, F. J. Schoen, J. E. Lemons, Elsevier 2013
Lecture Plan
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15.10.2024: Fundamentals Biomedical Materials. Selection criteria for biomaterials for medical devices (del Campo, Müller, Asensio)
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22.10.2024: Physicochemical properties of polymer materials of relevance for biomedical applications, and methods to characterize them (del Campo)
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29.10.2024: Synthetic biomedical polymers, resorbable (I) (del Campo)
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05.11.2024: Synthetic biomedical polymers, resorbable (II) (del Campo)
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12.11.2024: Synthetic biomedical polymers, non-resorbable (I) (del Campo)
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19.11.2024: Biomedical hydrogels (Asensio)
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26.11.2024: Additive Manufacture of biomedical polymers (Steudter)
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03.12.2024: Protein adsorption on surfaces. Non-fouling and non-thrombogenic polymers (Sankaran)
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10.12.2024: Immune response to biomaterials (Trujillo)
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17.12.2024: Smart Textiles, Intelligent Implants, Wearable devices and biosensors (Sankaran)
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07.01.2025: Case studies: medical devices (del Campo)
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14.01.2025: Case studies: medical devices (del Campo)
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28.01.2025: EXAM (multiple choice text) (del Campo, Asensio)
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04.02.2025: Presentations, students (del Campo, Asensio)
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11.02.2025: Presentations, students (del Campo, Asensio)
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18.02.2025: Presentations, students (del Campo, Asensio)
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Evaluation: Exam (multiple choice) and oral presentation of a commercial biomaterial as part of a commercial medical device.
Biomaterial Definition
- "A material intended to interface with biological systems, to evaluate, treat, augment or replace any tissue, organ or function of the body." (1986 Consensus Conference)
- "A material designed to take a form which can direct, through interactions with living systems, the course of any therapeutic or diagnostic procedure." (2018 Consensus Conference)
Biomaterial Examples
- External: Contact lenses, bandages, skin and wound dressings, dialysis membranes.
- Implanted: Restorative implants, sutures, stents, pacemakers, brain electrodes, implants to regulate fertility.
- Scaffolds for regenerative medicine and tissue engineering (e.g., breast implants).
- Carriers for drugs (nanomedicine).
- Man-machine interface/wearable electronics.
- Cell culture dishes or microarrays for diagnostic/theranostic assays.
Biomaterials Across Material Classes
- Metal, ceramic, polymeric, composites (examples provided in image)
Why Polymers as Biomaterials?
- Stiff/Flexible/Ductile
- Easy to process (low temperatures, various morphologies)
- Lightweight
- Organic, flexible chemistry and functionalization
- Hydrated (hydrogels)
- Cost-effective
Outline
- History/Overview Biomaterials
- Selection Criteria of Biomaterials
- Classification of Biomaterials
Biomaterials Science is a Young Field
- No "biomaterial" concept 50 years ago
- No medical device manufacturers except for external prosthetics, fracture fixation, eye implants, dental devices.
- No regulations, no understanding of biocompatibility, no courses on biomaterials.
- Today: Expected continuous growth, relevant market, stringent regulation, multidisciplinary (chemistry + biology + medicine + materials engineering).
Prehistory of Biomaterials
- 3000 BCE: Egyptians used linen sutures.
- 600 CE: Mayans used seashells.
- 1775: First example of bone fracture fixation with metal wire.
- 1829: HS Levert toxicity studies.
- 1860: Adolf Fick glass contact lenses, PMMA contact lenses developed and entered market.
- 1870's: Lister's aseptic surgical materials.
The Era of the "Surgeon Hero" (1940-1960)
- Parallel development of high-performance metals, ceramics, and especially polymers.
- Materials manufactured for cars or airplanes were adapted by surgeons for medical challenges.
- Lack of regulation; solutions tested on an ad hoc basis.
- Key milestones include: development of nylon sutures, cellulose for vascular wrapping (and detecting fibrotic reaction), PMMA, polyethylene implants, implantable pacemakers, Teflon for dialysis, artificial heart pumps.
The First "Plastics"
- Historical timeline of polymer development (e.g., PVC, Celloid, Galalithe, etc.).
The Era of Designed Biomaterials (1960s)
- New materials designed specifically for medical applications (biodegradable polymers, bioactive ceramics).
- Development of technologies for biomaterial fabrication (polyester fibers, cellulose acetate).
- Modification of materials for specific biological properties (e.g., heparin surface modification).
- 1976 regulation for testing and production of medical devices.
Most Biomaterials Applied Today
- Based on biomaterials from the 1960-1980s.
- Examples provided.
Poly(methyl methacrylate) (PMMA)
- Major component of injectable bone cement, intraocular lenses, and hard contact lenses.
- Amorphous, transparent and glassy at room temperature.
Poly(2-hydroxymethyl methacrylate) (PHEMA)
- Major component of soft, hydrogel contact lenses.
- Transparent, hydrophilic, non-fouling (low protein adsorption).
Poly(acrylic acid) (PAA)
- Major component of dental cements (mixed with inorganic salts) and mucoadhesive hydrogels
High Density Poly(ethylene) (HDPE)
- Major uses: artificial hips and prosthetic joints, tubing for drains and catheters.
- Mechanically resistant, tough, wear resistant.
Poly(propylene) (PP)
- Sutures, meshes for hernia repair.
- Good chemical, tensile strength
Poly(tetrafluoroethylene) (PTFE, Teflon):
- Catheters, vascular grafts (Gore-Tex), blood storage bags, dialysis tubes.
- Flexible
- Low surface energy, low protein adsorption.
Poly(dimethylsiloxane) (PDMS)
- Prostheses, heart valves, breast implants, nose reconstruction.
- Soft elastomer
- High oxygen permeability, low protein adsorption.
Poly(ethyleneterephthalate) (PET, Dacron)
- Sutures, fabrics, meshes for hernia repair, ligament reconstruction.
- High tensile strength, mostly used in fiber form.
Poly(D,L-lactide-co-glycolide) (PLGA)
- Resorbable surgical sutures, drug delivery, orthopedic appliances.
- Degradable.
Polyurethanes
- Pacemaker insulation, catheters, vascular grafts, heart assist pumps, artificial heart bladders, and wound dressing
- Tough elastomers, flexibility in the properties depending on monomer selection.
Biomaterials Development: Research to Biomedical Product
- Traditional design parameters
- Active clinical feedback; new parameters, animal models vs. human outcome
- In vitro testing, In vivo studies
- Mechanism screening, high-throughput scaffolds, manage large data, systems biology
- Clinical testing
The Contemporary Era: Responsive Carriers for Drug Delivery
- Resorbable, responsive carriers for drug delivery
The Contemporary Era: Microneddle Skin Patches
- Drug delivery devices
The Contemporary Era: Devices for Health Monitoring
- Wearables for sensing with multiple functions.
The Contemporary Era: 3D Bioprinting
- 3D printed medical devices
- 3D printed organs
The Contemporary Era : Biomaterials for Tissue Engineering
- 3D scaffolds for tissue regeneration.
Evolving View of Biomaterial Interactions With Immune System
- Historical evolution of understanding.
Fouling, Biofilms, Infection
- Biofilm formation
Antifouling Surfaces in Nature
- Examples in nature
Slippery Liquid-Infused Porous Surfaces (SLIPS)
- Example of a non-fouling surface
Thrombogenicity
- Biomaterials in contact with blood
The Coagulation Cascade
- Sequence of thrombotic interactions
The Major Factors Determining a Biomaterial Choice
- Key factors for biomaterial selection
Manufacturing Criteria
- Cost-effective processing, upscaling
- Packaging
- Stability, lifetime
- Marketing requirements
- Sterilization
What is the XXX Life of a Medical Device?
- Shelf life, expiration date, expected lifetime, end of life, service life, life cycle.
Sterilization Methods
- Autoclaving
- Ethylene Oxide (EO) gas sterilization
y-Radiation Sterilization
- Sterilization using ionizing radiation.
Economic Issues
- Regulations, safety, competing products, market size, healthcare system.
Classification of Polymeric Biomaterials
- Source, Durability, Safety/Regulation.
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Description
This quiz explores the fundamentals of biomedical materials, including selection criteria, physicochemical properties, and various types of synthetic polymers. It also covers important applications like hydrogels and protein interactions on surfaces. Prepare to enhance your understanding of materials used in medical devices.
