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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
Q

In vivo testing

A

Within a living system
Pros: Closer to human system
Cons: Can be difficult to interpret due to large variety of factors

26
Q

Medicine regulation path

A
  1. Pre market approval
  2. Limited clinical study
  3. Clinical Trials
  4. Long Term Follow up
  5. Testing to understand failure
27
Q

Medical Device definition

A

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
Q

FDA medical device classification

A

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
Q

Example of medical device used to improve function?

A

Intraocular lens, stents

30
Q

Examples of medical devices used to aid diagnosis?

A

Probes and catheters

31
Q

What types of materials are used for joint replacements?

A

Titanium, Ti-Al-V alloy, Co-Cr alloy, stainless steel, polyethylene, alumina

32
Q

What types of materials are used for bone plates and screws for fracture fixation?

A

Stainless steel, cobalt-chromium alloy, titanium and its alloys

33
Q

What types of materials are used for bone cement?

A

PMMA (polymethyl methacrylate)

34
Q

What types of materials are used for bone defect repair?

A

Hydroxyapatite (HA), calcium phosphates (CaP), Bioactive glasses

35
Q

What types of materials are used for dental implants?

A

Titanium, Ti-Al-V alloy, stainless steel

36
Q

Describe the types of biocompatibility?

A

Bulk: related to the design and morphological/mechanical properties of the material

Biological: related to the topography and chemistry of the material

37
Q

What are the advantages and disadvantages of steam autoclaves?

A

Adv: Liquids can be sterilized, good steam penetration, 100% effective

Dis: Not good for hydrolysable materials, corrodes metal, expensive

38
Q

What are the advantages and disadvantages of dry heat sterilization techniques?

A

Adv: Simplicity and lack of toxic residues, 100% effective

Dis: Slow procedure, penetration is poor, high temp may cause damage

39
Q

Materials that can be sterilized using steam autoclaves?

A

All critical materials that can withstand temperature and pressure

Examples: surgical implements, dressings, contact lenses

40
Q

Which materials can use dry heat for sterilization?

A

Heat stable dry powder products that are heat stable but either sensitive to moisture or not penetrated by moist heat

41
Q

What are the advantages and disadvantages of radiation?

A

Adv: kills bacteria, some viruses and fungi, leaves no residue

Dis: surface sterilization only, limited effectiveness against microbial spores

42
Q

What materials use radiation for sterilization?

A

Air and surface disinfectants

Example: sutures, gloves, gowns, face masks, dressing syringes

43
Q

What are the advantages and disadvantages of ethylene oxide?

A

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
Q

What are the advantages and disadvantages of ethylene oxide?

A

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
Q

What materials use ethylene oxide as a sterilization technique?

A

Catheters, tracheostomy tubes, mechanical heart valves, sutures

46
Q

What is the FDA and CE definition for a medical device?

A

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
Q

Describe the FDA regulatory classes?

A

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
Q

Regulatory classification in EU?

A

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
Q

What factors determine the success or failure of biomaterials?

A
  • 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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