Biomaterials (Week 1-2) Flashcards
Biomaterial definition
“is used to make devices to replace/repair a function of the body in a safe, reliable, economic, and physiologically acceptable manner” “is any substance (other than a drug), natural or synthetic, that treats, augments, or replaces any tissue, organ, and body function”.
Biomaterials and medical devices comprised of them are commonly used as:
prosthesis in cardiovascular, orthopedic, dental ophthalmological, and reconstructive surgery interventions: surgical sutures, bio-adhesives, controlled drug release devices and particles
Biomaterials science addresses both:
therapeutics and diagnosis.
The path to create new biomaterials
1) Identification of a problem or a need. 2) Research on biomaterials (chemistry, physics of materials science biology) 3) Engineering to develop a medical device 4) Preclinical and clinical testing 5) Regulatory approval 6) Commercialization and clinical application
The success of a biomaterial or implant is highly dependent on three major factors:
1) the properties (mechanical, chemical and tribological) of the biomaterial in question 2) biocompatibility of the implant and 3) the health condition of the recipient and the competency of the surgeon.
Biocompatibility
is the ability of a material to perform with an appropriate host response in a specific application
Desirable biocompatibility
Noncarcinogenic, nonpyrogenic, nontoxic, nonallergenic, blood compatible, non-inflammatory.
Desirable attributes of Biomaterials (4)
1) biocompatibility
2) Sterilizability (Not destroyed by typical sterilizing techniques such as autoclaving, dry heat, radiation, ethylene oxide)
3) Physical characteristics (Strength, elasticity, durability)
4) Manufacturability (Machinable, moldable, extrudable)
Requirements for an implant by examining the characteristics that a bone plate must satisfy for stabilizing a fractured femur after an accident:
- Acceptance of the plate to the tissue surface (biocompatibility). 2. Pharmacological acceptability (non-toxic, non-allergenic, non- immunogenic, non-carcinogenic, etc.). 3. Chemical inert and stable (no time-dependent degradation). 4. Adequate mechanical strength. 5. Adequate fatigue life. 6. Sound engineering design. 7. Proper weight and density. 8. Relatively inexpensive, reproducible, and easy to fabricate and process for large-scale production.
Generations of Biomaterials
- 1st generation: Goal: bioinertness (minimal reaction/interaction)
- 2nd generation: Goal: bioactivity (resorbable biomaterial; controlled reaction with the physiological environment (e.g. bone bonding, drug release)
- 3rd generation: Goal: regenerate functional tissue (biointeractive, integrative, resorb able; stimulate specific cell responses at the molecular level (e.g. proliferation, differentiation, ECM, production and organization)
Materials used in each generation
- 1st generation: silicone-rubber (elastomeric polymers), pyrolitic carbon (used today to coat mechanical components of heart valves).
- 2nd generation: PLA (Polylactic acid) and other biopolymers used to deliver drugs, calcium phosphate, hydroxyapatite-containing bone fillers, nano particles for drug delivery.
- 3rd generation: regeneration of functional tissue = tissue engineering – true replacement within living tissue.
Early biomaterials:
- Gold: Malleable, inert metal (does not oxidize); used in dentistry by Chinese, Aztecs and Romans - dates 2000 years.
- Iron, brass: High strength metals; rejoin fractured femur (1775).
- Glass: Hard ceramic; used to replace eye (purely cosmetic).
- Wood: Natural composite; high strength to weight; used for limb prostheses and artificial teeth.
- Bone: Natural composite; uses: needles, decorative piercings.
- Sausage casing: cellulose membrane used for early dialysis (W Kolff).
- Other: Ant pincers. Central American Indians used to suture wounds
Most biomaterials and medical devices perform satisfactorily in-vivo, so what can go wrong?
1) No manmade construct is perfect. All man- factored devices have a failure rate.
2) Also, all humans are different with differing genetics, gender, body chemistries, living environment, and degrees of physical activity.
3) physicians implant or use these devices with varying degrees of skill.
Dental restoration materials:
materials employed for the restoration of teeth include metal alloys (amalgams, gold, stainless steel, and cobalt-chrome) and ceramics (porcelain or alumina). Other uses of restorative materials include polymers as sealants for surface lamination.
Intraocular lenses (fabricated from ….)
fabricated from a variety of transparent materials including poly(methyl methacrylate), silicone elastomers, soft acrylic polymers, and hydrogels.
Dental implants today are fabricated from …..
Pure titanium (cpTi)
Cardiovascular stents:
1) design
2) materials (3 types)
1) Tubular scaffolds,
2) made from either 316L stainless steel, nitinol (NiTi alloy) or CoCr based alloys.
Total-hip replacement prostheses: fabricated from (5 types) ……
titanium alloys (Ti6Al4V), CoCr, CoCrMo, UHMWPE, ceramics.
- Femoral stem: titanium alloy
- Femoral head: alumina-zirconia ceramic
- Acetabular cup: UHMWPE infused with vitamin E antioxidant.
Total US biomaterials expenditures (2009)
$2.5 trillion per year
Heart valve prostheses: fabricated from ……….
from carbons, metals, elastomers, plastics, fabrics, and animal or human tissues chemically pretreated.
Cardiovascular assist devices: in devices such as pacemakers the cardiac pacing leads have to ……..
Biomaterials used in the design of the leads should be……..
…… have to survive in the harsh endocardial environment.
………………stable, flexible, possess adequate conductive and resistive properties, and provide endocardial contact with the heart.
Tissue engineering is:
cell seeding and and tissue implantation
How materials are structure (2 structures)?
- Surface structure: interface with biological environment (Interactive forces)
- Bulk structure: dictates mechanical performance such as how strong, ductil and elastic a material is (attractive forces)