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bioe exam 2
wound healing, regulatory, biocompatibility
55
Engineering
Undergraduate 2
10/02/2013

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Term
host response
Definition
changes in cellular and systemic physiology resulting from the implantation of a medical device
Term
biocompatibility
Definition
the ability of a material to perform with an appropriate host response in a specific application
Term
bioinert
Definition
the material has no interaction with physiological tissue
Term
bioactive
Definition
the material incorporates mechanisms capable of eliciting specific cellular responses and tissue integration
Term
hemocompatibility
Definition
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)
Term
example of bioactivity
Definition
porous coating on orthopedic implants makes the body accept the implant much better
Term
biocompatibility
Definition
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
Term
factors governing biocompatibility
Definition
chemical/physical properties, wear, corrosion, mechanical integration, leachables, implant geometry, surface properties (chemistry, topography/roughness)
Term
extrusion
Definition
type of implant response where a pocket is formed around an implant adjacent to epithelial tissue
Term
resorption/degradation
Definition
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
Term
integration
Definition
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.
Term
encapsulation
Definition
type of implant response where the implant is blocked off from surrounding tissue by a fibrous capsule
Term
difference between wound response and implant response
Definition
starts the same (inflammation, cellular invasion, and proliferation.) after this, implant response enters chronic phase due to the continued presence of the implant.
Term
chronic phase (implant response)
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.
Term
FBGC
Definition
foreign body giant cell
Term
capsule formation
Definition
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
Term
protein adsorption
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
Term
surface properties affecting hemocompatibility
Definition
adsorption of blood proteins to non-endothelial surfaces initiates coagulation
Term
PEO
Definition
polyethylene oxide, makes a surface bioinert and prevents protein adsorption.
Term
autologous graft
Definition
patient's own tissue. no immune rejection complications because the proteins are self proteins and the immune system won't recognize.
Term
allogeneic graft
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.
Term
xenogeneic graft
Definition
animal tissue. always rejected within 1-2 days. difference in blood group protein and MHC
Term
synthetic material implant response
Definition
involves primarily macrophages
Term
naturally derived tissue implant response
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
Term
MHC
Definition
major histocompatability
Term
immunosuppresion
Definition
must be used in allogeneic grafts
Term
de-cellularization
Definition
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.
Term
regeneration
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.
Term
wound healing
Definition
most common response to tissue damage, a repair process resulting in scar tissue
Term
absence/failure of healing
Definition
occurs in the spinal cord, brain, or heart. can also occur due to a disease or the geometry of an injury.
Term
parenchymal cells
Definition
specialized cells
Term
stromal cells
Definition
fibroblasts and the collagen they produce. this is the mechanical framework.
Term
scar tissue
Definition
altered biochemical composition- mostly stromal cells and not as many parenchymal cells. this decreases the biomechanics of the tissue as well
Term
phases of wound healing
Definition
inflammatory, proliferative, remodeling
Term
inflammatory phase
Definition
coagulation to stop bleeding. prevents infection
Term
proliferative phase
Definition
granulations tissue formation- replacement of cells and ECM. angiogenesis-blood vessel formation. re-epithelialization.
Term
remodeling phase
Definition
restoration of function/development of mechanical strength
Term
coagulation
Definition
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
Term
vascular endothelium
Definition
monolayer of endothelial cells, the blood contacting layer of the blood vessels
Term
FDA
Definition
food and drug association. regulation of medical devices and diagnostic products ensuring treatment efficacy and patient safety.
Term
SMDA
Definition
safe medical device act. says companies must report any incidence of device malfunction.
Term
medical device
Definition
KEY POINT- not dependent on metabolism
Term
class I device
Definition
not life supporting or sustaining. simple in design
Term
class II device
Definition
must prove substantial equivalence.
Term
substantial equivalence
Definition
similar to a pre-existing device that has already been FDA approved and marketed
Term
class III device
Definition
new devices or devices that are life supporting or life sustaining.
Term
PMA
Definition
pre-market approval, must get this for class III devices
Term
510(k)
Definition
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.
Term
IACUC
Definition
institutional animal care and use committee. group of researchers and veterinarians that oversee animal research ensuring humane conditions and minimization of pain.
Term
3 R's
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
Term
IRB
Definition
institutional review board. ensures that the rights and welfare of human research subjects is held most important
Term
GMP
Definition
good manufacturing procedures. basically quality control
Term
MDR
Definition
medical device reporting. FDA must know about trouble with a device.
Term
ASTM F561-05A
Definition
covers how to handle a recall of devices
Term
three things needed to get to market
Definition
regulatory approval
reimbursement
intellectual property
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