Biomaterial, Bio-implant

and Bio- device.

Interaction with human tissue.
Important facts And.
Conclusion.

Biomaterial,
Bio-implant / Bio-medical device:

Biomaterial,
Bio-implant / Bio-medical
device

Bio-Implant
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,
AndIt is usually intended to remain there for a
significant period of time.

Biomaterial,
Bio-implant / Bio-medical
device

A biomaterial is any material (other

than drug), natural or synthetic, that
is used to make bio-implant, biomedical device that treats, augments,
or replaces any tissue, organ and/or
any body function.

Biomaterial,
Bio-implant / Bio-medical
device

Bio-Medical Device:
Bio-Medical Device" is "an instrument,
apparatus, implement, machine, contrivance,
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

Biomaterial,
Bio-implant / Bio-medical
device

Historical Advancement:
Biomaterials & Biomedical Devices -

Biomaterial: Classification

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

Non-biological

Biological

Biomaterials:

Biomaterial:

95% of
total BioImplant-

Biomaterial,
Bio-implant / Bio-medical
device

Non-Biological
(Synthetic) Biomaterial -

05% of
total Bio-Implant Natural
Biologic
Hybrid
Biomaterial

Metals
Orthopedics' screws/fixation
Dental Implants / filler

Non-biologicalSynthetic 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.

37.4 Ti Alloys

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 .

Steels Stainless
37.3
CoCr Alloys

Biomaterial,
Bio-implant / Bio-medical
device

Polymeric Biomaterials

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.

Biomaterial,
Bio-implant / Bio-medical
device

Non
Biodegradable

o Non-absorbable Polymer &

o Absorbable/Biodegradable

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.
Composition

Composition

Advantages

Disadvantage:

Nylon,silicones,
PTFE,UHMWPE

Resilient,
easyto
fabricate

Notstrong,deformwith
time,maydegrade

Advantages

Highlybiocompatible,inert,
highmodulusand
Aluminum
oxide,carbon, compressivestrength,good
hydroxyapatit estheticproperties
e

Natural

Disadvantage:
Brittle,
difficultto
make,poor
fatigue
resistance

Biomaterial,
Bio-implant / Bio-medical
device

Composite Biomaterials -

Biomaterial,
Bio-implant / Bio-medical
device
BIOLOGICAL BIOMATERIAL

Composites
BIOLOGIC

Fibrous
Composites

NATURAL
Stem Cells Cartilage repair
& Preservation of the knee

Porous
Composites

Composition

Advantages

Various
combinations

Strong,tailormade Difficulttomake

Disadvantage:

CORAL
GELATIN

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.

Particulate
Composites

COLLAGEN BASEDBIO-IMPLANT
REGENERATION
ORGAN REGROW.
STEM CELL BASEDBIO-IMPLANT
REGENERATION
ORGAN REGROW.

HYBRID/ OR
Semi-synthetic
BIOMATERIAL MADE FROM
COMBINATION
OF SYNTHETIC AND
BIOLOGIC COMPONENTS.

BIOLICALCell/TISSUEREGENERATION.
BIOLOGICALTISSUE/ORGANREPLACEMENT.

Biomaterial,
Bio-implant / Bio-medical
device

Biomaterial,
Bio-implant / Bio-medical
device

Biological/Natural vs.
synthetic materials -

Classification
AndEvolution of Biomaterials-

Synthetic Biomaterials:
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
4
stimulate specific cellular responses at the
molecular level in order to help the body to heal
itself.

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

Biologic Biomaterials:
Bio- replacement-3rd Generation.
Bio-regeneration- 4th Generation.

Biomaterial,
Bio-implant / Bio-medical
device

Performance Criteria
Cell and Gene-Activating Materials
Genetic Control and Activation.
Molecularly Tailored Resorbable.
Biological Replacement Biomaterial/
Tissue/ Organ.

4th Generation Biomaterial:

Biological Regenerative Biomaterial.

Biologically inert
Biocompatible
Non-viable
Mechanical strength and funtion
Amenability to engineering design,
manufacturing, and sterilization
.not found naturally within the body

Traditional
Biomaterials
And Medical Devices

Biomaterial,
Bio-implant / Biomaterial device

Next Generation
Biomaterials and Medical DevicesRevised Performance Criteria
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).

Biomaterial and Human /Biological Components

Interaction Can be broadly divided / Classified into -
Biomaterial and Protein/ Blood.
Biomaterial and Cell
Biomaterial and Soft tissue
Biomaterial and Hard Tissue/Bone.

Bio-implant And Biological Interaction:

Immediately After Implantation-

Biomaterial And
Protein, Blood, Cell And Soft Tissue Interaction:

Infection
Inflammation
Bacterial
Adhesion

Leukocyte
Adhesion and
Activation

Protein
Adsorption
.. . .....

Complement
System
Activation

Biomaterial
ALL STEPS ARE
APPLICABLE
FOR ONLY BIO-INERT

Biological
Tissue/ Components

BIOMATERIALFOR BIOACTIVE,
BIORESORPABLE
IMPLANT

Biomaterial
And Tissue Interaction 1Second
to
1Hour:

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)

Biomaterial And
Hard Tissue/Bone Interaction

Biomaterial
And Soft tissue Interaction Materials:
Short-Term Reaction:
Polyethylene
1. Different protein
Hydroxyapatitie
adsorption
Polyurethane
2. Varied activation of
Silicone
host response
pHEMA
PTFE
Pyrolytic carbon
Gold
Titanium

Biomaterial and Hard tissue/ Bone

Interaction Can be Classified into -

Long-Term Reaction:
1. Fibrous
Encapsulation

or Scaffold Interaction.
Hydrophilic/Hydrophobic
Metal/ceramic/polymer
Hard/soft

SameResult
(longterm)

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.

Biomaterial And
Hard Tissue/Bone 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 .

Biomaterial And
Hard Tissue/Bone Interaction-

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 polycrystalline Al2O3.

Irregular
pore
structure of
porous
coating in
Ti5Al4V
alloy for
bony
ingrowth,
from Park
and Lakes
[1992].

Biological Interaction Forms mechanical attachment

.

Biodegradable/
Bioresorption or Scaffold Interaction -

Bioactive Interaction --

Osteoblast
cell
attachment
on a
composite
Biomaterial
surface-SEM.

The mechanism of new bone formation

an bone bonding to a bioactive ceramic.

via
bone in growth into pores.
Tissue response is complex, with
several factors affecting it.
Pores must be >100 m
diameter
so that capillaries can provide
blood
supply to ingrown connective
tissue porous inert implants.
Example-Hydroxy-apatite coated
porous implants.

Biomaterial And
Hard Tissue/ Bone Interaction

Biomaterial And
Hard Tissue/Bone Interaction-

Morphological Interaction

Biological Interaction
Bioactive Interaction
Biodegradable/ Bioresorption

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
5
(HCA) on surface,
when implanted
Example-Bioactive glasses, bioactive glassceramics (Ceravital), hydroxyapatite
(Duraptite.Calcitek); bioactive composites
Palavital).
.

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.
5
Examples: Calcium sulfate, Tri-calcium phosphate
(TCP ).
Challenge: Meeting strength requirements and
short- term mechanical performance while
regeneration of tissues is occurring.

 Protein adsorption
Blood material interactions
Coagulation
Fibrinolysis

Embolization
Hypersensitivity
Elevation of implant elements in the blood
Lymphatic particle transport

Platelet adhesion, activation, release

Complement activation
Leukocyte adhesion, activation
Hemolysis
Toxicity
Modification of normal healing
Encapsulation
Foreign body reaction
Pannus formation
Infection
Tumorgenesis

Effect
of the Host on the Implant Physical mechanical effects
Abrasive wear
Fatigue
Stress corrosion, cracking Corrosion
Degeneration and dissolution
Biological effects
Absorption of substances from tissues
Enzymatic degradation
Calcification

Biomaterials
Tissue Interactions ChartLocal
Interactions
(Atbiomaterialtissueinterface)
Physicalmechanical
Bloodmaterialinteractions effects
Wear
Toxicity
Fatigue
Modificationof
Corrosion
healing
Stresscorrosion
Exaggerated
cracking
Inflammation
Proneto
Biologicaleffects
Infection
Adsorptionoftissue
Constituentsby
implant
Enzymaticdegradation
Calcification

Systemic
Interactions

Device
AssociatedComplications

Thrombosis/
thromboembolism
Infection
Exuberantor
Elevationof
defectivehealing
implantelements Biomaterialsfailure
Adverselocaltissue
inblood
reaction
Adversesystemiceffect.
Lymphatic
Embolization

Hypersensivity

transport.

Important Facts of
Biomedical Implants/Devices -

Important Facts of
Biomedical Implants/Devices -

Selection
criteria for Biomaterials-

Selection
criteria for BiomaterialsFunctional performance:

Biomaterials and biomedical devices are used throughout the human

body.

2 important aspects must be Consider before implantation:

Functional performance

Biocompatibility.

Loadtransmissionandstress
distribution
(e.g.bonereplacement).
Articulationtoallowmovement
(e.g.artificialkneejoint).
Controlofbloodandfluidflow
(e.g.artificialheart).
Spacefilling(e.g.cosmetic
surgery).
Electricalstimuli(e.g.
pacemaker).
Lighttransmission(e.g.
implantedlenses).
Soundtransmission(e.g.
cochlearimplant).

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).

Important Facts of
Biomedical Implants/Devices -

Selection
criteria for BiomaterialsBiocompatibilityfrom differences
between
living and non-living
materials.
Bio-implants trigger
inflammation
or foreign body
response.

Important Facts of
Biomedical Implants/Devices -

Host /Implant Factors:

Which Determines bio-compatibility-

Age and health status

Arises

Biological Compatibility

Host Factors:

Implant Factors:

Chemical Compatibility
Mechanical Compatibility
Nontoxic,
Non-carcinogenic.

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 -

Immunological status
Metabolic status
proper implantation
Tissue damage
Contamination and
Choice of surgeon
Bulk Properties:
Surface Properties:
Mechanical Properties:
Long-term Structural Integrity:

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.

Conclusion
And Our Consensus:

Contraindications
Our Consensus :

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 postoperative instruction, including individuals
who abuse drugs and/or alcohol .

Painless administration of a
vaccine by tiny
Micro-needles on a skin patch.

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 duration).

Conclusion
And Our Consensus:

Our Consensus :

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.