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83 Cards in this Set
- Front
- Back
What are five elements of the foreign body reaction. |
1. Multinucleated foreign body giant cells 2. Macrophages 3. Fibroblasts 4. Capillaries 5. Multinucleated foreign body giant cellsform upon coalescence of macrophages. |
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What are three inflammatory stimuli that lead to chronic inflammation? |
1. Chemical and Physical properties of biomaterial 2. Motion in the implant site 3. Confined to the implant site |
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What are two types of cells that merge to become foreign body giant cells? |
1. Macrophages 2. Monocytes |
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What are three types of surfaces found in biomaterials? |
1. Flat and smooth surfaces 2. Relatively rough surfaces 3. Rough surfaces |
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What is a foreign body reaction to a flat and smooth surface? |
A layer of macrophages one or two cells in thickness. |
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What is a foreign body reaction to a relatively rough surface. |
Composed of multiple layers of macrophages and foreign body giant cells at the surface. |
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What is a foreign body reaction to rough surfaces? |
Composed of macrophages and foreign body giant cells with varying degrees of granulation tissue. |
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What is the end stage of the healing process usually extending four or more weeks after implantation? |
Fibrous Encapsulation |
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What does the presence of neutrophils during the fibrous encapsulation stage of healing suggest? |
Persisiting Inflammatory Challenge |
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What does the presence of macrophages likely suggest during fibrous encapsulation? |
Production of small particles by corrosion, depolymerization, dissolution or wear. |
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What does the presence of lymphocytes likely suggest during fibrous encapsulation? |
Specific Immune Response |
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What are three factors that determine the wall thickness of a fibrous capsule? |
1. Chemical Activity Rate of the material. 2. Motion between implant and tissue 3. Shape of implant (Thicker over sharp edges) |
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What are the three possible outcomes for an implant? |
1. Resorption 2. Integration 3. Encapsulation |
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What are the 7 steps that follow implantation which ultimately end in scar formation or capsule development? |
1. Injury 2. Hemostasis 3. Inflammation 4. Acute Inflammation 5. Proliferation 6. Remodelling 7. Scar Tissue or Fibrous Capsule Development |
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What are the 7 steps that follow implantation which ultimately end in Foreign Body Giant Cell Formation? |
1. Injury 2. Hemostasis 3. Inflammation 4. Acute Inflammation 5. Chronic Inflammation 6. Proliferation 7. Foreign Body Giant Cell Formation |
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Describe neutrophil activity levels during host response to implant? |
They are the first cells to arrive on the site. Peak hours after injury (During acute stage) and decline in number after that. |
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Describe Macrophage activity levels during host response to implant? |
Second type of cell on site. Begin to appear hours after injury during the acute stage and gradually grow and peak during the granulation tissue stage |
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Describe Foreign Body Giant Cell activity levels during host response to implant? |
Third cell type to appear. Start to appear days after injury during the chronic phase and peak during the granulation tissue stage |
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Describe fibroblasts activity levels during host response to implant? |
Fourth cells type to appear. Start to appear between days and weeks after injury and peak during the granulation tissue stage. |
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What are 3 serious complications that can occur as a result of presence of biomaterials in the body? |
1. Hypersensitivity 2. Infection 3. Tumorigenesis |
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This term is also known as an allergic reaction. It is an undesired immune response mediated by the adaptive immune response. It is typically defined as unusual, excessive, or uncontrolled. |
Hypersensitivity |
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This type of complication associated with implants typically displays at least one of the following characteristics: Presence of biomaterial, Bacterial colonization of tissue, Resistance to host defence mechanisms and antibiotic treatment, presence of multiple bacteria species, absence of integration of biomaterial with the host, presence of cell damage. |
Infection |
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What are 6 signs of infection as a result of implantation? |
1. Presence of biomaterial 2. Bacterial colonization of tissue 3. Resistance to host defence mechanisms and antibiotic treatment 4. Presence of multiple bacteria species 5. Absence of integration of biomaterial with the host 6. Presence of cell damage |
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What are the 4 stages of the development of implant associated infection? |
1. Attachment 2. Adhesion 3. Aggregation 4. Dispersion |
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Which stage of infection involves bacterial attachment to surface through nonspecific interaction between pathogen and surface? |
Attachment |
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Which stage of infection involves the preliminary attachments becoming permanent through the formation of receptor-ligand interaction? |
Adhesion |
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Which stage of infection involves the formation of a biofilm which protects the micro organisms from phagocytosis and provide a favorible environment for the microbes to grow? |
Aggregation |
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Which stage of infection involves the bacteria travelling away from the colony to otherr areas of the body. |
Dispersion |
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This type of complication associated with implants typically presents as the formation of a mass of uncontrolled proliferating cells. |
Tumorigenesis |
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What are three stages of tumorigenesis? |
1. Initiation 2. Latency 3. Promotion |
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This stage of tumorigenesis involves the implantation of the biomaterial which leads to a malignant transformation of DNA. |
Initiation |
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This stage of tumorigenesis invlves the obvious presence of tumor growth around the implant. |
Promotion |
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What are two main pathways for malignant transformations? |
1. Chemical Carcinogenesis 2. Foreign Body Carcinogenesis |
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This type of malignant transformation is possible near the biomaterial since the tumors are likely a result of substance being leached from the implant. |
Chemcal Carcinogenesis |
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This type of malignant transformation may be related to surface or bulk properties of the implant or alterations in the local environment? |
Foreign Body Carcinogenesis |
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What are five possible causes of foreign body carcinogenesis? |
1. Bulk chemical properties of the implant 2. Physiochemical surface properties of the implant 3. Viral contamination of the implant 4. Interruption of cellular communication due to the presence of the implant 5. Local tissue damage leading to insufficient nutrient exchange |
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This type of tumor is a neoplasm of glandular epithelium and can be benign or melignant. |
Adenoma |
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This type of tumor is a cancer arising in an epithelium and account for 90 percent of human cancers. |
Carcinoma |
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This type of tumor is a cancer arising in mesenchyme derived tissue (i.e. connective tissue and muscle). |
Sarcoma |
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Why has the definiton of biocompatibly materials been changed from inert material to include material with minimal interaction with their environment. |
It is unlikely to find a material that is totally inert, but the physiological response to any biomaterial is kept within acceptable bounds. |
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What type of materials will produce a higher ratio of macrophages and foreign body giant cells than smooth components? |
High surface area to volume ratio fabrics and porous structures |
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Provide 3 examples of bulk properties. |
1. Chemical properties 2. Structure 3. Purity and presence of leachables |
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Provide 4 examples of surface properties |
1. Smoothness 2. Geometry 3. Hydrophilicity 4. Surface Charge |
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Provide 3 examples of mechanical properties of biomaterials. |
1. Elastic Modulus 2. Stability 3. Fixation |
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Provide 4 examples of long-term structural integrity properties to design for in biomaterials. |
1. Fatigue and fracture loading 2. Wear 3. Creep 4. Stress corrosion cracking |
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Provide 4 examples of systemic effects caused by implants. |
1. Embolization (Leading to blood vessel occlusion) 2. Hypersensitivity 3. Implant elements in blood 4. Lymphatic particle transport |
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Provide 4 ways that a host can physically affect an implant. |
1. Abrasive, adhesive, and delamination wear 2. Fatigue and fracture 3. Stress corrosion cracking 4. General corrosion |
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Proved 3 ways that a host can biologically affect an implant. |
1. Absorption of substances from the tissue 2. Enzymatic degredation 3. Calcification |
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What are 3 host factors that determine the success of an implant. |
1. Age and health status of patient 2. Immunological/metaboloc status of host 3. Effectiveness of surgeon |
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What are 7 components of biocompatibility testing that help characterize and evaluate the structure and response relationship of the biomaterial as well as the reproducability of the results? |
1. Cell toxicity 2. Thrombogenecity 3. Inflammatory Response 4. Animal Tests 5. Clinical Trials 6. FDA Regulations 7. ASTM/ISO standard |
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What is the main goal of level I biocompatibility testing? What are four elements that help accomplish this? |
Bulk-characterization tests to identify the polymer and confirm it meets specifications Elements involve tests for: 1. Surface topography 2. Cleanliness 3. Chemical structure and composition 4. Toxixity |
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What is the main goal of level II biocompatibility testing? What are three elements that help accomplish this? |
Gathering detailed information of specific elements of structural and functional behavior that may relate to performance. Elements involve tests for: 1. Surface chemistry 2. Morphology 3. Interfacial properties |
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What is the first event in blood-surface interactions and is crucial in understanding surface-induced thrombosis? |
Adsorption of plasma proteins |
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What are four types of In Vitro tests for estimating biocompatibility? |
1. Cytotoxicity 2. Hemocompatibility 3. Mutagenicity 4. Hypersensitivity |
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What are three examples of cytotoxicity test? |
1. Elution or extraction test 2. Agar or agarose test 3. Direct contact test |
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What are two examples of hemocompatibility tests? |
1. Hemolysis test 2. Clotting and complement activation |
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Provide an example of a Mutagenecity test |
Ames Test |
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Provide two examples of hypersensitivity test. |
1. Lymphocyte transformation test 2. Leukocyte migration inhibition test |
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The abilty to cause death or damage at the cellular level by direct cell lysis or by fatally altering cellular metabolism? |
Cytotoxicity |
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Which cytotoxicity test aims to determine toxic doses and changes in cell growth or proliferation by comparing to non treated cells over a 24 to 72 hour period? |
Elution Test |
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Which cytotoxicity test is performed by placing the the material over a layer of agar/agarose and covering cells for 24 hours. Components of the material diffuse through the layer to the cell and the cytotoxicity of the diffusable materials is measured. |
Agar Overlay Test |
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Which cytotoxicity test is performed by measuring changes in cell growth or proliferation in a manner similar to the elution test? |
Direct contacct test. |
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What type of test is used to evaluate the effect of material on blood coagulation processes, thrombus formation, and hemolysis (Destruction of RBCs)? |
Hemocompatibility Tests |
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What is a material called that modifies the genome of a host (Also called genotoxic). |
Mutagenes |
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Which genotoxicity test uses a mutant line of bacteria (Usually salmonella or E. Coli) that must be supplied with histadine to grow and are cultured in a histadine free environment. This test checks for materials that that mutate the bacteria back to a histadine independant state. |
Ames Test |
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The leukocyte migration inhibition and lymphocyte transformational test which estimate delayed hypersensitivity reaction to implant materials and their released components are examples of what type of test? |
Hypersensitivity test |
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What are four types of in vivo tests? |
1. Short-term implantation tests 2. Long-term functional tests 3. Sensitization tests 4. Irritation tests |
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Which type of in vivo test involves subcutaneous, intramuscular and intraperitoneal implantation tests to evluate general tissue necrosis, fibrosis and inflammation. |
Short-term implantation tests |
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Which type of in vivo test uses the device or compositionally identical prototypes to simulate intended end-use in an animal model and then test for functionality and histopathological evaluation. |
Long-term functional test |
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Which in vivo test invovles guinea pigs, occluded patch tests, and open epicutaneous tests? |
Sensitization |
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Which in vivo test checks for skin, ocular, and mucosal irritation? |
Irritation test |
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What are 5 types of animal tests? |
1. Nonfunctional tests 2. Function tests 3. Genotoxicity tests 4. Cancerogenity tests 5. Irritation test |
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What are the negative systemic effect of animal testing with regards to implantion? |
Chemicals released from implant materials are distributed by blood and lymphatic system and damage organs and tissues. |
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What are the 4 categories of the systemic effects that result from animal testing? |
1. Acute (24 hrs) 2. Sub-Acute (14-28 days) 3. Sub-Chronic (10% of animal's life span) 4. Chronic (Longer than 10% of an animmal's life span) |
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What is the standard practice for running a clinical trial for a new drug. |
A double-blind study in which a placebo is randomly distributed. |
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Why is the standard practice for drug related clinical trials not possible to be used for implants? |
It is not possible to conceal an implant (Or lack thereof) from the patient and/or the surgeon (Double blind practice is not possible). |
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How many phases are in a typical clinical trial. |
Three |
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What does Phase 1 of a clinical trial usually involve? |
Biomaterial being tested on a small group (60-80 people) |
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What does Phase 2 of a clinical trial usually involve? |
Biomaterial being tested on large group (100-300 people) |
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What does Phase 3 of a clinical trial usually involve? |
Comparison of the effectiveness of the new treatment with a standard of management (1000-3000) |
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Which animal test looks for alterations in DNA or chromosomal structure or other DNA or gene damage that results in permanent inheritable changes in cell function. |
Genotoxicity Test |
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What type of animal is usually used to harvest opthalmological materials for an Ocular irritation test? |
Rabbit |
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Which type of animal test involves determining whether chemicals or compounds that may be released from biomaterials elicit sensitization reactions (i.e. redness and swelling). |
Cancergenity Test |