Biomateriales Flashcards

1
Q

pioneers biomaterials

A

gold, copper, wood, PMMA

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2
Q

first generation biomaterials

A

inertness

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3
Q

inertness

A

encapsulation of a system by a biomaterial that will not cause any reaction in the body

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4
Q

second generation biomaterials

A

reabsorbable or bioactive

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5
Q

biocompatibility definition

A

ability of a material to perform with an appropriate host response in an specific application

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6
Q

reabsorbable definition

A

degraded by body and the residuals are metabolised and secreted

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7
Q

bioactive definiton

A

has a growth factor which increases healing process, and an antibacterial covering which releases microorganisms and substances to reduce infections

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8
Q

third generation biomaterials

A

regeneration

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9
Q

regeneration definition

A

stimulate specific cellular responses at molecular level: tissue engineering, regenerative medicine and nanomedicine

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10
Q

biocompatibility definition

A

“ability of a biomaterial to perform its function as a medical therapy, without eliciting undesirable local or systemic effects in recipients or beneficiary, generating the most appropriate beneficial cellular or tissue response in that specific situation and optimising clinically relevant performance of therapy”

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11
Q

steps to asses biocompability

A
  1. determine potential toxicity from the contact of the device with the body
  2. determine if the device directly or by the release of material constituents produces dangerous effects
  3. evaluation of new device
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12
Q

dangerous effects that can cause a device tested for biocompability

A
  • adverse local or systemic effects (pain, swelling, necrosis)
  • be carcinogenic
  • adverse reproductive and developmental effects
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13
Q

how’s the evaluation of a new device process

A

requires data from systematic testing to ensure benefits provided by final product will exceed any potential risks posed by device biomaterials.

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14
Q

biocompability testing panel

A
  • acute, subchronic and chronic toxicity
  • irritation to skin, eyes, and mucosal surfaces
  • cytotoxicity
  • sensitisation
  • hemocompability
  • genotoxicity
  • carcinogenicity, and effects on reproduction, including developmental effects
  • short-term implantation effects
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15
Q

process to design an implant (from basic science to clinics)

A
  1. research on biomaterials (lab, scientific knowledge)
  2. engineering to develop a medical device
  3. preclinical (animals or in vitro) and clinical testing (patients, formed by 3 phases)
  4. regulatory approval
  5. commercialisation and clinical applications.
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16
Q

regulatory organisations

A

FDA, CDRH, EMA

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17
Q

what does the FDA

A

Food and Drug Asministration regulates the food, drugs, medical devices, animal feeds and drugs, cosmetics, ration emitting products

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18
Q

what does the CDRH

A

Center for Devices and Radiologic Health are regulating firms for the manufacture, repackage, relabel and/or import of medical devices in US. It regulates the radiation emitting electronic products, medical and non-medical

19
Q

what does the EMA

A

European Medicines Agency regulates the human and veterinary medicines

20
Q

classification of medical devices

A

class I, class II, class III

21
Q

what’s a class I medical device

A

those of minimal invasiveness, does not contact user internally, for example: crutches, bedpans, adhesive bandages

22
Q

what’s a class II medical device

A

posses a higher degree of invasiveness and risk than class I, but have a relatively short duration, for example: healing aids, blood pumps, catheter, contact lenses, and electrodes

23
Q

what’s a class III medical device

A

are considered more invasive and can pose immense risk to the user-implantable, for example: cardiac pacemakers, intrauterina device, intraocular lenses, heart valve, orthopaedic implant

24
Q

types of biomaterials

A

metals and alloys, ceramics, polymers, and composites

25
Q

what is a metal as a biomaterial

A

chemical element which is a goof conductor of electricity and heat, and forms cationic and ionic bonds with non-metals.

it has a high tensile, fatigue and yield strengths, good ductility and low reactivity (surrounded by oxide layer)

has corrosion resistance, mechanical shielding and produces toxicity from debris particles

it is used on bone and joint replacement and fixation, stent and heart valves, and dental restorations. it can be a passive hard tissue substitute (know or hip prosthesis, and fracture healing aids) or an active role (vascular stent, catheter guide wire, cochlear implants)

26
Q

examples of metals as biomaterials

A
  • stainless steel (316L)
  • cobalt-chromium alloys
  • titanium and titanium-based alloys
  • amalgam and gold
  • nickel- titanium
27
Q

stainless steel (316L)

A

frequently with chromium, increase corrosion resistance in biomaterials

28
Q

cobalt-chromium alloys

A

good in long-term performance without fatigue stress (repeated cycles) and an excellent corrosion resistance

29
Q

amalgam and gold

A

are mercury alloys used in tooth filling and dentistry

30
Q

nickel-titanium

A

has shape-memory effect by temperature, it is used in dental arch wires, blood vessel stents.

31
Q

alloys

A

non-homogenous mixture or metallic solid solution composed by two or more elements.

examples: shape memory-alloys (Ni-T), magnesium based alloys, cobalt based alloys, aluminium alloys

32
Q

what are ceramics in biomaterials

A

are inorganic, non-metallic solid formed by heating at high temperatures and subsequent cooling, joined by ionic or covalent bonding in metallic and non-metallic elements.

they are inert or bioactive in the body, present high wear resistance, a high modulus and compressive strain, and fine aesthetic properties (dental)

also they are brittle (low fracture result), low tensile strength (except fibres) and poor fatigue resistance (flaw tolerance)

used in bone and joint replacements and dental implants

33
Q

types of ceramics

A
  • amorphous ceramics: have lack of detectable crystallinity, glassy or vitreous
  • glass-ceramics: have polycrystalline solids by controlled crystallisation (devitrification) of glasses. they were amorphous and became crystalline
34
Q

examples of ceramics as biomaterials

A
  • aluminia
  • zirconia
  • calcium phosphates
  • silica-based glasses
  • pyrolytic carbon
35
Q

aluminia

A

presents high hardness, low friction and low wear. It is also brittle

36
Q

zirconia or zirconium oxyde

A

has better properties than aluminia

37
Q

calcium phosphates (hydroxyapatite)

A

main component of natural hard tissues (bone, teeth, shells) but can produce pathological calcifications (urinary stones, calculus)

38
Q

silica-based glasses or glass ceramics

A

used in bone cement and dental restorations

39
Q

pyrolytic carbon

A

is a partially crystallised carbon, has a coating. It is highly compatible with blood, used in heart vales and blood vessel walls

40
Q

what are polymers in a biomaterials manner

A

are large molecules, with repeated structural units, joined by hydrogen-carbon covalent bonds.

they are easy to manufacture shapes, easy modified to an application, have variety of mechanical properties and may be degradable

have low wear resistance, they are leachable, difficult to sterilise, and may be not degradable.

they are used in sutures, vascular prosthesis, drug delivery systems, lenses, soft-tissue replacement, adhesives.

41
Q

types of polymers according to origin

A
  • natural polymers: origin from plant or animal, are non-toxic and biodegradable, low cost, and variable immunogenicity according to its composition (proteins can cause an immune reaction). Used for wound healing, sutures and grafts.
  • synthetic polymers: are non-degradable and tunable, allowing its reproducibility and non-immunogenic
42
Q

examples of natural polymers

A
  • collagen: natural component of ECM - used for guided tissue regeneration, drug delivery, implants, burns
  • gelatin: used in food, capsules for drugs and for tissue engineering
  • alginate: used in food, Pharma, cosmetics
  • hyaluronate: made of hyaluronic acid, used in derma fillers and cosmetics
    -chitosan: vaccine delivery, wound dressing, sutures, hemodyalisis membranes, skin graft
  • silk: used in sutures, blood vessel repairing, tissue engineering
  • cellulose: wound healing, blood vessel
43
Q

examples of synthetic polymers

A
  • PVC
  • PE
  • PP
  • PMMA: used in blood pumps and reservoirs
  • PS: tissue cultures flasks
  • PTFE: catheter + artificial vascular graft.
  • rubbers: silicone (PDMS)