basics of- human biomaterials, implantable medical devices and biomedical science:
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Biomaterial, Bio-implant
and Bio- device.
Interaction with human tissue.
Important facts And.
Conclusion.
2
Prepared By-
Dr. Md Nazrul Islam.MBBS, M.sc.(BME).
Supervised By-
Associate Prof. ZiaulHaq -MBBS, MS (Orthopedic).
3
Biomaterial, Bio-implant / Bio-medical device:
A biomaterial is any material (other
than drug), natural or synthetic, that
is used to make bio-implant, bio-
medical device that
treats, augments, or replaces any
tissue, organ and/or any body
function.
Biomaterial, Bio-implant / Bio-medical device
Any substance other than the drug made of
Biomaterial-s that can be used for
any period of time as part of a system that
treats augments or replaces any tissues,
organ, or functions of the body,
And-
It is usually intended to remain there for a
significant period of time.
Bio-Implant
Biomaterial, Bio-implant / Bio-medical device
Bio-Medical Device:
“Bio-Medical Device" is "an
instrument, apparatus, implement, machine, contr
ivance, implant,in-vitro reagent, or related article
including any component, part or
accessory, which is:
Intended for use in the diagnosis of disease/other conditions, or in the cure, mitigation, treatment, or prevention of disease. Intended to affect the structure /function of
human system -And does not achieve any of it's primary
intended purposes through chemical action within or on
And is not dependent upon being metabolized in the Body.
Biomaterial, Bio-implant / Bio-medical device
Historical Advancement:Biomaterials & Biomedical Devices -
Romans,Chinese,and Aztecs used gold in
dentistry over 2000 years ago.
1860's: Lister develops aseptic surgical technique.
Early 1900's: Bone plates used to fix fractures.
1930's: Introduction of stainless steel, cobalt
chromium alloys.
1938 : First total hip prosthesis (P. Wiles).
1940's: Polymers in medicine: PMMA bone repair;
cellulose for dialysis; nylon sutures.
1952: Mechanical heart valve.
1953: Dacron (polymer fiber) vascular grafts.
1958: Cemented (PMMA) joint replacement .
1960: First commercial heart valves.
1970's: PEO (poly-ethylene-oxide) protein resistant
thin film coating.
1976: FDA amendment governing testing &
production of biomaterials /devices.
1976: Artificial heart W. Kolff, Prof.Emeritus U of U).
Biomaterial, Bio-implant / Bio-medical device
8
Statistics:Biomaterials Biomedical Devices-
Biomaterial, Bio-implant / Bio-medical device
Statistics:Biomaterials Biomedical Devices-
Biomaterial, Bio-implant / Bio-medical device
Biomaterial: Classification
Non-
biological
Biomaterial
s:
Biological Biomaterial:
Natural
Biologic
Hybrid
Biomaterial
95% of total Bio-Implant-
05% of total Bio-Implant-
Biomaterial, Bio-implant / Bio-medical device
Non-Biological(Synthetic) Biomaterial -
.
Non-biological-
Synthetic materials, are made of
polymer/ Metal/Ceramic or
Composite, suitable for implanting in a
living body to -
Repair
Replace
Augment
or
Regenerate
damaged or diseased parts.
Biomaterial, Bio-implant / Bio-medical device
Metals
Metals are used as biomaterials due to their excellent electrical and thermal conductivity
and mechanical properties. The first metal alloy developed specifically
for human use was the “vanadium steel” .
•Orthopedics' screws/fixation• Dental Implants / filler
Steels -
Stainless
37.3
CoCr Alloys
37.4 Ti
Alloys
Biomaterial, Bio-implant / Bio-medical device
Polymeric Biomaterials
Composition Advantages Disadvantage :
Nylon, silicones,
PTFE, UHMWPE
Resilient,
easy to
fabricate
Not strong, deform with
time, may degrade
Any one of a large and varied group of materials
consisting wholly or part of a combination of
carbon and hydrogen (hydrocarbons) It is also a
combination of oxygen, nitrogen and other
organic and inorganic elements.
o Non-absorbable Polymer &
o Absorbable/Biodegradable
Biomaterial, Bio-implant / Bio-medical device
Ceramic Biomaterials -
Ceramics are defined as the art and
science of making and using solid
articles that have as their essential
component, inorganic nonmetallic
materials. Non
Biodegradable
Natural
Composition Advantages Disadvantage
:
Aluminum
oxide,
carbon,
hydroxyapati
te
Highly biocompatible,
inert, high modulus and
compressive strength,
good esthetic properties
Brittle,
difficult to
make, poor
fatigue
resistance
Biomaterial, Bio-implant / Bio-medical device
Composite Biomaterials -
Composites
Particulate
Composites
Porous
Composites
Fibrous
Composites
Composition Advantages Disadvantage :
Various
combinations
Strong, tailor-
made
Difficult to make
Biomaterial, Bio-implant / Bio-medical device
BIOLICAL Cell/ TISSUE REGENERATION.
BIOLOGICAL TISSUE / ORGAN
REPLACEMENT.
Stem cell based/ derived Cell/ Tissue.
Stem cell based/ derived- Resorbable
Collagen Medical Implant.
Stem cell based/ derived-Tissue Engine
-ering for Tissue /Organ Regeneration.
BIOLOGICAL
BIOMATERIAL
NATURAL
CORAL
GELATIN
BIOLOGIC
HYBRID/ OR
Semi-synthetic
COLLAGEN BASED-
BIO-IMPLANT
REGENERATION
ORGAN REGROW.
STEM CELL BASED-
BIO-IMPLANT
REGENERATION
ORGAN REGROW.
BIOMATERIAL MADE FROM
COMBINATION
OF SYNTHETIC AND
BIOLOGIC COMPONENTS.
Biomaterial, Bio-implant / Bio-medical device
Biological/Natural vs. synthetic materials -
• Biological/Natural pros/cons
– built-in bioactivity
– poor mechanical strength
– immunogenicity (xenologous sources)
– lot-to-lot variation, unpredictable.
• Synthetic pros/cons
– biocompatibility may be difficult to predict,
must be tested.
– mechanical and chemical properties readily
altered.
– minimal lot-to-lot variation
• Synthetic advantages: tunable and reproducible.
Biomaterial, Bio-implant / Bio-medical device
4
Biologic Biomaterials:Bio- replacement-3rd
Generation. Bio-regeneration- 4th
Generation.
• First Generation Biomaterials: materials used in applications that are requested to be inert in the human body environment. • Second Generation Biomaterials: designed to be
Bioactive Resorbable.
• Third Generation Biomaterials: by combining these two properties, they are being designed to stimulate specific cellular responses at the molecular level in order to help the body to heal itself.
Synthetic Biomaterials:
ClassificationAnd–Evolution of Biomaterials-
Biomaterial, Bio-implant / Bio-medical device
Cell and Gene-Activating Materials
Genetic Control and Activation.
Molecularly Tailored Resorbable.
Biological Replacement Biomaterial/
Tissue/ Organ.
Biological Regenerative
Biomaterial.
4th Generation
Biomaterial:
Biomaterial, Bio-implant / Bio-medical device
Traditional BiomaterialsAnd Medical Devices
Biologically inert
Biocompatible
Non-viableMechanical strength and
funtion
Amenability to engineering
design, manufacturing, and sterilization
….not found naturally within the body
Performance Criteria
Biomaterial, Bio-implant / Bio-medical device
Next Generation Biomaterials and Medical Devices-
Biologically inert
Non-viable
Biocompatible
Mechanical strength and function
Amenability to engineering design, manufacturing, and sterilization
Biodegradable
Induces cell and tissue integration
“Smart” (i.e., physiologically-responsive)
“Instructional” (i.e., controls cell fate).
Revised Performance Criteria
Biomaterial, Bio-implant / Biomaterial device
Biomaterial and Protein/ Blood.
Biomaterial and Cell
Biomaterial and Soft tissue
Biomaterial and Hard Tissue/Bone.
Biomaterial and Human /Biological
Components Interaction Can be broadly
divided / Classified into -–
Biomaterial And Protein, Blood, Cell And Soft Tissue Interaction:
ALL STEPS ARE
APPLICABLE
FOR ONLY BIO-INERT
BIOMATERIAL-
FOR
BIOACTIVE, BIORES
ORPABLE IMPLANT
Inflammation
Complement
System
Activation
Leukocyte
Adhesion and
Activation
Bacterial
Adhesion
Infection
Biomaterial
Protein
Adsorption
Biological
Tissue/ Components
. . . . . . . .
Bio-implant And Biological Interaction:Immediately After Implantation-
BiomaterialAnd Tissue Interaction -
Macrophages
Fibrosis
The temporal variation in the acute inflammatory
response, chronic inflammatory
response, granulation tissue development, and
foreign body reaction to implanted biomaterials.
(Adapted from Ratner and Bryant)
1 Second
to
1 Hour:
Materials:Short-Term Reaction:Long-Term Reaction:
Polyethylene 1. Different protein 1. Fibrous
Hydroxyapatitie adsorption Encapsulation
Polyurethane 2. Varied activation of
Silicone host response
pHEMA
PTFE
Pyrolytic carbon
Gold
Titanium
Hydrophilic/Hydrophobic
Metal/ceramic/polymer
Hard/soft
Same Result
(long term)
Sequence of events involved in inflammatory and wound healing responses
leading to foreign body giant cell formation.
This shows the importance of Th2 lymphocytes in thetransient chronic
inflammatory phase with the production of IL-4 and IL-13, which can
inducemonocyte/macrophage fusion to form foreign body giant cells.
BiomaterialAnd Soft tissue Interaction -
Biomaterial And Hard Tissue/Bone Interaction
Biomaterial and Hard tissue/ Bone
Interaction Can be Classified into -
Morphological Interaction
Biological Interaction
Bioactive Interaction
Biodegradable/ Bioresorption
or Scaffold Interaction.
This implant for a total hip replacement is
designed with various porous surfaces that
encourage tissue in growth.
Interactions Between Implant and Body in Fracture .
.
Morphological Interaction -
Implant is inert or nearly inert
Device: dense, nonporous, nearly
inert.
Mechanism: mechanical interlocking
Does not form bond with tissue
(bone).
Tissue response is dependent on fit
rather than chemistry.
Example: single crystal and poly-
crystalline Al2O3.
Biomaterial And Hard Tissue/Bone Interaction-
Biomaterial And Hard Tissue/Bone Interaction-
.
Biological Interaction -
Forms mechanical attachment via bone “in growth” into pores.
Tissue response is complex, with several factors affecting it.
Pores must be >100 µm diameter so that capillaries can provide blood supply to ingrown connective tissue porous inert implants.
Example-Hydroxy-apatite coated porous implants.
Irregular pore structure of porous
coating in Ti5Al4V alloy for bony
ingrowth, from Park and Lakes
[1992].
5
.
Bioactive Interaction --
Surface-reactive materials; elicits a
specific biological response at the
surface.
Direct attachment by chemical bonding
with bone Implant reacts chemically, at
the surface- Dense, nonporous.
Formation of a hydroxy-carbonate apatite
(HCA) on surface, when implanted
Example-Bioactive glasses, bioactive glass-
ceramics (Ceravital), hydroxyapatite
(Duraptite.Calcitek); bioactive composites
Palavital)..
The mechanism of new bone formationan bone bonding to a bioactive ceramic.
Biomaterial And Hard Tissue/Bone Interaction-
Osteoblast cell attachment on a composite Biomaterial surface-SEM.
5
Biomaterial And Hard Tissue/ Bone Interaction
.
Biodegradable/
Bioresorption or Scaffold Interaction -
Resorption rates must match “repair” rates of
body tissue.
Constituents of resorbable implant must be
metabolically acceptable.
Designed to degrade with time, and replaced
with natural tissues.
Reactions will persist until components have been
removed.
Examples: Calcium sulfate, Tricalcium phosphate
(TCP ).
Challenge: Meeting strength requirements and
short- term mechanical performance while
regeneration of tissues is occuring.
Protein adsorption
Blood material interactions
Coagulation
Fibrinolysis
Platelet adhesion, activation, release
Complement activation
Leukocyte adhesion, activation
Hemolysis
Toxicity
Modification of normal healing
Encapsulation
Foreign body reaction
Pannus formation
Infection
Tumorgenesis
Embolization Hypersensitivity Elevation of implant elements in the blood Lymphatic particle transport
Physical – mechanical effects• Abrasive wear• Fatigue• Stress corrosion, cracking Corrosion• Degeneration and dissolutionBiological effects• Absorption of substances from tissues• Enzymatic degradation• Calcification
Effect of the Host on the Implant -
Local
Interactions
(At biomaterial–tissue interface)Systemic
Interactions
Device-
Associated Complications
• Blood–material
interactions
• Toxicity
• Modification of
healing
• Exaggerated
Inflammation
• Prone to
Infection
Physical-mechanical
effects
• Wear
• Fatigue
• Corrosion
• Stress-corrosion cracking
Biological effects
• Adsorption of tissue
Constituents by implant
• Enzymatic degradation
• Calcification
•Embolization
•Hypersensivity
• Elevation of
implant elements
in blood
•
Lymphatic t
ransport.
• Thrombosis/
thromboembolism
• Infection
• Exuberant or
defective healing
• Biomaterials failure
• Adverse local tissue reaction
• Adverse systemic effect.
Biomaterials–Tissue Interactions Chart-
5
Selection criteria for Biomaterials-
Biomaterials and biomedical
devices are used throughout the
human body.
2 important aspects must be
Consider before implantation:
– Functional performance
– Biocompatibility.
Important Facts of Biomedical Implants/Devices -
Functional performance:
– Load transmission and stress distribution
(e.g. bone replacement).
– Articulation to allow movement
(e.g. artificial knee joint).
– Control of blood and fluid flow
(e.g. artificial heart).
– Space filling (e.g. cosmetic surgery).
– Electrical stimuli (e.g. pacemaker).
– Light transmission (e.g. implanted lenses).
– Sound transmission (e.g. cochlear implant).
Selection criteria for Biomaterials-
Important Facts of Biomedical Implants/Devices -
(e.g. artificial knee joint).– Control of blood and fluid flow (e.g. artificial heart).– Space filling (e.g. cosmetic surgery).– Electrical stimuli (e.g. pacemaker).– Light transmission (e.g. implanted lenses).– Sound transmission (e.g. cochlear implant).
Biocompatibility-
• Arises from differences between living and non-living materials.
• Bio-implants trigger inflammationor foreign body response.
Important Facts of Biomedical Implants/Devices -Selection criteria for Biomaterials-
Biological Compatibility
Chemical Compatibility
Mechanical Compatibility
Nontoxic,
Non-carcinogenic.
Biomaterials: Biocompatibility status-
E E E E
E
E
E
E E E
M
M M
M M M M
L
L L
L
DEPENDS ON COMPOSITION OF MATERIAL
Important Facts of Biomedical Implants/Devices -
Host /Implant Factors:Which Determines bio-compatibility-
Bulk Properties:
Surface Properties:
Mechanical Properties:
Long-term Structural Integrity:
Age and health status
Immunological status
Metabolic status
proper implantation
Tissue damage
Contamination and
Choice of surgeon
Host Factors:
Implant Factors:
Important Facts of Biomedical Implants/Devices -
Success of an Implant is Determined by-
Conditions of Patient.
Surgeon Technical Skills.
Biocompatibility of Implant.
Mechanical Properties.
Corrosion Resistance.
Important Facts of Biomedical Implants/Devices -
Precautions To Be Taken For The Patients of-
Documented Renal diseases.
Cardiovascular diseases
precluding elective surgery.
Metabolic bone diseases.
Radiation bone therapy.
Patient on steroid medication.
Long-term infection / Chronic
infection.
Pregnancy and nursing.
Important Facts of Biomedical Implants/Devices -
Contraindications
• Severe vascular or neurological disease •Uncontrolled diabetes.• Severe degenerative disease.• Severely impaired renal function.• Hyper-calcemia, abnormal calcium metabolism • Existing acute or chronic infections, especially
at the site of the operation.• Inflammatory bone disease such as osteomyelitis• Malignant tumors.
Patients who cannot or will not follow post-
operative instruction, including individuals
who abuse drugs and/or alcohol .
Important Facts of Biomedical Implants/Devices -
Evolving definitions:
Biomaterials/ Bio-devices are of very
important instrument of medical science.
End-use application must be a
consideration.
Compatibility in one application may not be
compatible for another.
Material and device characteristics and
properties to consider –
Chemical,
Physical,
Electrical,
Toxicological,
Morphological and
Mechanical Conditions of tissue
exposure
(Nature, degree, frequency and
Painless administration of a
vaccine by tiny
microneedles on a skin patch.
VeriChip Human
Implantable Microchip
Merely, we give attention to asses
Biocompatibility,
Functional performance and
patient compliance:
Those points should be assed before
Implantation.
We should have to be more/very careful
about –
Absolute indication,
Choice of biomaterial,
Biocompatibility,
Functional performance,
Proper implantation and
post implantation patient
compliance.
&
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