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Definition
| changes in cellular and systemic physiology resulting from the implantation of a medical device |
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| the ability of a material to perform with an appropriate host response in a specific application |
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| the material has no interaction with physiological tissue |
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| the material incorporates mechanisms capable of eliciting specific cellular responses and tissue integration |
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| the ability of a material to perform appropriately in the presence of blood. lowers the tendency of coagulation (coagulation can only be eliminated completely with anticoagulants) |
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| porous coating on orthopedic implants makes the body accept the implant much better |
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| dynamic and continual process governed by effects of the material on the surrounding tissue as well as the effects of the physiological environment of the material |
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| factors governing biocompatibility |
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| chemical/physical properties, wear, corrosion, mechanical integration, leachables, implant geometry, surface properties (chemistry, topography/roughness) |
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| type of implant response where a pocket is formed around an implant adjacent to epithelial tissue |
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| type of implant response where implant site resolves into a collapsed scar for soft tissue implants or completely disappears for bone implants. desired for degradable implants |
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| type of implant response where close, possibly adhesive, approximation of nearly normal host tissue to implant without intervening fibrous capsule. this is desired for permanent implants. |
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| type of implant response where the implant is blocked off from surrounding tissue by a fibrous capsule |
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| difference between wound response and implant response |
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Definition
| starts the same (inflammation, cellular invasion, and proliferation.) after this, implant response enters chronic phase due to the continued presence of the implant. |
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Term
| chronic phase (implant response) |
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Definition
| chronic inflammation and classic foreign body response. macrophages usually only last for a couple weeks, but with implants they persist indefinitely. the macrophages also fuse into foreign body giant cells. the body also builds a wall of stromal tissue to separate the foreign body from your body. |
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part of the chronic phase of implant response. thickness is related to:
chemical activity of the material- corroding metals or leaching of polymers. thickness is proportional to the rate of release of the chemicals
motion between the tissue and implant- thickness increases with relative motion
shape of implant- thickness is greater over edges and sharp surface features
presence of electrical current- thickness is proportional to current density |
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Term
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Definition
| the process of protein accumulation at liquid/solid interfaces. protein binding to the surface is mediated by hydrophobic, van der Waals, and ionic interactions |
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| surface properties affecting hemocompatibility |
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Definition
| adsorption of blood proteins to non-endothelial surfaces initiates coagulation |
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Term
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Definition
| polyethylene oxide, makes a surface bioinert and prevents protein adsorption. |
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| patient's own tissue. no immune rejection complications because the proteins are self proteins and the immune system won't recognize. |
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Term
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Definition
| another human's tissue. usually rejected over 1-2 weeks. sometimes minimally vascularized tissues (tendons, cartilage) are tolerated. the immune system recognizes blood group proteins (A, B, O) and MHC cell surface proteins. can be controlled with immune suppressive drugs. |
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Definition
| animal tissue. always rejected within 1-2 days. difference in blood group protein and MHC |
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| synthetic material implant response |
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Definition
| involves primarily macrophages |
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Term
| naturally derived tissue implant response |
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Definition
| specific immune response mediated by lymphocytes and antibodies which recognize proteins of foreign origin. rejection is mediated by specific cell surface proteins and mostly on epithelial tissues that are bound to the plasma and therefore exposed to the ECM |
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| must be used in allogeneic grafts |
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| a variety of techniques that are used for extracting all cells and cell-associated proteins from the tissue. leaves intact the ECM. removes the basis for immune rejection in allogeneic and xenogeneic grafts. |
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Definition
| the perfect response to injury. complete restoration of the tissue structure and function. this is very rare, sometimes seen in bone or the liver. |
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Definition
| most common response to tissue damage, a repair process resulting in scar tissue |
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| absence/failure of healing |
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Definition
| occurs in the spinal cord, brain, or heart. can also occur due to a disease or the geometry of an injury. |
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| fibroblasts and the collagen they produce. this is the mechanical framework. |
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| altered biochemical composition- mostly stromal cells and not as many parenchymal cells. this decreases the biomechanics of the tissue as well |
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Definition
| inflammatory, proliferative, remodeling |
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Definition
| coagulation to stop bleeding. prevents infection |
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Definition
| granulations tissue formation- replacement of cells and ECM. angiogenesis-blood vessel formation. re-epithelialization. |
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| restoration of function/development of mechanical strength |
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| when enzymes in the blood encounter something that isnt the vascular endothelium the are activated. fibrinogen polymerization then creates a provisional matrix for the clot. the platelets then bind to the fibrin |
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Term
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Definition
| monolayer of endothelial cells, the blood contacting layer of the blood vessels |
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Definition
| food and drug association. regulation of medical devices and diagnostic products ensuring treatment efficacy and patient safety. |
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Definition
| safe medical device act. says companies must report any incidence of device malfunction. |
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Definition
| KEY POINT- not dependent on metabolism |
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Definition
| not life supporting or sustaining. simple in design |
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Definition
| must prove substantial equivalence. |
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| similar to a pre-existing device that has already been FDA approved and marketed |
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| new devices or devices that are life supporting or life sustaining. |
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Term
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Definition
| pre-market approval, must get this for class III devices |
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| premarket notification, needed for class II devices. compares the device to an already FDA approved device, and either introduces a new use for the device or just shows a significant modification. |
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| institutional animal care and use committee. group of researchers and veterinarians that oversee animal research ensuring humane conditions and minimization of pain. |
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Definition
replacement- use of a in-vitro model whenever possible
reduction- prevents duplication of research, also using the minimal amt of animals
refinement- maintain animal facilities to meet regulatory standards |
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| institutional review board. ensures that the rights and welfare of human research subjects is held most important |
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| good manufacturing procedures. basically quality control |
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| medical device reporting. FDA must know about trouble with a device. |
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| covers how to handle a recall of devices |
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| three things needed to get to market |
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Definition
regulatory approval
reimbursement
intellectual property |
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