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Biomaterials > From Concept to Clinic > Flashcards

From Concept to Clinic Flashcards

1
Q

Autograft

A

Transplant from one site to another within the patient’s own body.
Problem: Detrimental to donor site, painful and long recovery time

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2
Q

Allograft

A

Transplant from another human being.

Problem: Lack of donor availability, disease transmission and immune rejection risk.

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3
Q

Xenograph

A

Transplant from another species

Risk of disease transmission or rejection

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4
Q

Larry Hench’s Bioglass

A

Bioctive glass system
High amounts of Ca, P, and sodium oxide.
Instabilities in glass which allow interaction with water, production of ions, and integrative surface layer
Used in dental and possibly ulcer healing applications

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5
Q

Intravascular stents

A

Expandable meshes that hold the lumen open after PTCA

Early dev was done in late 70s starting with stainless steel and silver solder

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6
Q

Replacement of diseased part examples

A

Metallic hip joint
Prosthetic heart valve
Dental implants

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7
Q

Examples of assisted healing

A

Sutures

Biodegradable bone screws

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8
Q

Thresh yielding

A

Transfer of stress from one material to another

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9
Q

Total hip replacement materials

A

CoCr
Alumina
Titanium
UHMWPE

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10
Q

Metallic advantages

A

High strength, ductility, modulus

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11
Q

Metallic disadvantages

A

High density, Stress Shielding, Corrosion

Difficult processing in ambient conditions

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12
Q

Ceramic advantages

A

Corrosion Resistance
Chemistry of material can be changed to dictate the degradation rate
Hard and wear resistant

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13
Q

Ceramic disadvantages

A

Brittle

Low toughness strength in tension

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14
Q

Polymer advantages

A

Tailoring of properties through chemistry

Generally easy processing

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15
Q

Polymer disadvantages

A

Tend to deform with time

Lack strength

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16
Q

Composites advantage

A

Tailoring of properties

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17
Q

Composites disadvantage

A

Difficult to process

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18
Q

Biocompatibility

A

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

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19
Q

Bioinert material

A

No response from tissues

Thin interface grows over time

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20
Q

Bioactive material

A

Formation of chemical bond between tissues and implant

21
Q

Bioresorbable

A

Implant degrades and is replaced by surrounding tissues with time

22
Q

General processing route of a typical metallic implant device

A
  1. Mineral deposits
  2. Metallic raw materials in bulk form
  3. Stock shapes
  4. Preliminary implant device
23
Q

Sterilization techniques

A

Autoclaves
Dry heat
Radiation
Ethylene oxide

24
Q

In vitro testing

A

Outside a living system
Pros: Rapid, not expensive, and minimizes animal testing
Cons: may not be relevant to the complex nature of a living system

25
In vivo testing
Within a living system Pros: Closer to human system Cons: Can be difficult to interpret due to large variety of factors
26
Medicine regulation path
1. Pre market approval 2. Limited clinical study 3. Clinical Trials 4. Long Term Follow up 5. Testing to understand failure
27
Medical Device definition
Instrument, apparatus, or similar related articles that involve: 1. Diagnosis, cure, mitigation, treatment, or prevention of a disease or condition 2. Structure or function of body 3. Non-achievement of intended use through chemical action 4. Non dependence upon being metabolized
28
FDA medical device classification
Class 1: Devices generally low risk and non invasive Class 2: Medium risk and include non invasive and short term invasive devices Class 3: Generally high risk long term implantable devices
29
Example of medical device used to improve function?
Intraocular lens, stents
30
Examples of medical devices used to aid diagnosis?
Probes and catheters
31
What types of materials are used for joint replacements?
Titanium, Ti-Al-V alloy, Co-Cr alloy, stainless steel, polyethylene, alumina
32
What types of materials are used for bone plates and screws for fracture fixation?
Stainless steel, cobalt-chromium alloy, titanium and its alloys
33
What types of materials are used for bone cement?
PMMA (polymethyl methacrylate)
34
What types of materials are used for bone defect repair?
Hydroxyapatite (HA), calcium phosphates (CaP), Bioactive glasses
35
What types of materials are used for dental implants?
Titanium, Ti-Al-V alloy, stainless steel
36
Describe the types of biocompatibility?
Bulk: related to the design and morphological/mechanical properties of the material Biological: related to the topography and chemistry of the material
37
What are the advantages and disadvantages of steam autoclaves?
Adv: Liquids can be sterilized, good steam penetration, 100% effective Dis: Not good for hydrolysable materials, corrodes metal, expensive
38
What are the advantages and disadvantages of dry heat sterilization techniques?
Adv: Simplicity and lack of toxic residues, 100% effective Dis: Slow procedure, penetration is poor, high temp may cause damage
39
Materials that can be sterilized using steam autoclaves?
All critical materials that can withstand temperature and pressure Examples: surgical implements, dressings, contact lenses
40
Which materials can use dry heat for sterilization?
Heat stable dry powder products that are heat stable but either sensitive to moisture or not penetrated by moist heat
41
What are the advantages and disadvantages of radiation?
Adv: kills bacteria, some viruses and fungi, leaves no residue Dis: surface sterilization only, limited effectiveness against microbial spores
42
What materials use radiation for sterilization?
Air and surface disinfectants Example: sutures, gloves, gowns, face masks, dressing syringes
43
What are the advantages and disadvantages of ethylene oxide?
Adv: low processing temperature and wide range of compatible materials Dis: Cost of gas and engineering controls required to assure safe low residual products
44
What are the advantages and disadvantages of ethylene oxide?
Adv: low processing temperature and wide range of compatible materials Dis: Cost of gas and engineering controls required to assure safe low residual products
45
What materials use ethylene oxide as a sterilization technique?
Catheters, tracheostomy tubes, mechanical heart valves, sutures
46
What is the FDA and CE definition for a medical device?
An instrument, apparatus, implement, machine, contrivance, implant, in vivo reagent that involves: 1. Diagnosis, cure, mitigation, treatment or prevention of a disease of condition 2. The structure or function of the body 3, The non-achievement of intended use through chemical action 4. Non-dependence upon being metabolized
47
Describe the FDA regulatory classes?
Class 1: low-risk non-invasive (ex. bandaids) Class 2: medium risk and non-invasive/ short-term invasive (ex. catheters) Class 3: high risk and long-term implantable (ex. THR)
48
Regulatory classification in EU?
Class 1: low risk non invasive Class 2a: medium risk non invasive/ short term invasive Class 2b: relates to implantable devices that include restorable implants Class 3: high risk long term implantable
49
What factors determine the success or failure of biomaterials?
- Humans vary in age, gender, genetics, etc. - Physicians implant biomaterials to varying degrees of skill - Biomaterials can undergo problems, complications, compromises

Biomaterials (18 decks)

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