HUMAN BIOMATERIALS, IMPLANTABLE MEDICAL DEVICES AND BIOMEDICAL SCIENCE:

1.  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).
2

4. Biomaterial,
Bio-implant / Bio-medical device:
3

5. 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.

6. 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,
And-
It is usually intended to remain there for a
significant period of time.

7. 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.

8. 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).

9. Biomaterial,
Bio-implant / Bio-medical
device
Statistics:
Biomaterials Biomedical Devices-
8

10. Biomaterial,
Bio-implant / Bio-medical
device
Statistics:
Biomaterials Biomedical Devices-

11. Biomaterial,
Bio-implant / Bio-medical
Biomaterial: Classification
device
Non-
biological
Biomaterial Biological
s: Biomaterial:
05% of
95% of total Bio-
total Bio- Implant-
Implant-  Natural
 Biologic
 Hybrid
Biomaterial

12. 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.

13. Biomaterial,
Bio-implant / Bio-medical
device
Metals
•Orthopedics' screws/fixation
• Dental Implants / filler
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” .
37.4 Ti
Alloys
Steels -
Stainless
37.3
CoCr Alloys

14. 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.
o Non-absorbable Polymer &
o Absorbable/Biodegradable
Composition Advantages Disadvantage :
Nylon, silicones, Resilient, Not strong, deform with
PTFE, UHMWPE easy to time, may degrade
fabricate

15. 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
Non
Biodegradable materials.
Composition Advantages Disadvantage
:
Highly biocompatible, Brittle,
Aluminum inert, high modulus and difficult to
oxide, compressive strength, make, poor
carbon, good esthetic properties fatigue
Natura hydroxyapati resistance
l te

16. Biomaterial,
Bio-implant / Bio-medical
device
Composite Biomaterials -
Composi
tes
Fibrous
Composites
Composition Advantages Disadvantage :
Porous Various Strong, tailor- Difficult to make
Composites combinations made
Particulate
Composites

17. Biomaterial,
Bio-implant / Bio-medical
device
BIOLOGICAL
BIOMATERIAL
BIOLOGIC
 Stem cell based/ derived Cell/ Tissue.
 Stem cell based/ derived- Resorbable
Collagen Medical Implant.
NATURAL  Stem cell based/ derived-Tissue Engine
-ering for Tissue /Organ Regeneration.
 CORAL
 GELATIN  COLLAGEN BASED- HYBRID/ OR
BIO-IMPLANT
Semi-synthetic
REGENERATION
ORGAN REGROW. BIOMATERIAL MADE FROM
 STEM CELL BASED- COMBINATION
BIO-IMPLANT OF SYNTHETIC AND
REGENERATION BIOLOGIC COMPONENTS.
ORGAN REGROW.
BIOLICAL Cell/ TISSUE REGENERATION.
BIOLOGICAL TISSUE / ORGAN
REPLACEMENT.

18. 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.

19. Biomaterial,
Bio-implant / Bio-medical
device
Classification
And–Evolution 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.
 Biologic Biomaterials:
Bio- replacement-3rd
Generation.
 Bio-regeneration- 4th
Generation.

20. Biomaterial,
Bio-implant / Bio-medical
device
Cell and Gene-Activating Materials
 Genetic Control and Activation.
 Molecularly Tailored Resorbable.
 Biological Replacement Biomaterial/
Tissue/ Organ.
4th Generation
Biomaterial:
 Biological Regenerative
Biomaterial.

21. Biomaterial,
Bio-implant / Bio-medical
device
Performance Criteria
Biologically inert
 Biocompatible
 Non-viableMechanical strength and
funtion
Amenability to engineering
design, manufacturing, and sterilization
….not found naturally within the body
Traditional
Biomaterials
And Medical Devices

22. Biomaterial,
Bio-implant / Biomaterial device
Next Generation
Biomaterials and Medical
Devices-
Revised 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).

23. 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.

24. Biomaterial And
Protein, Blood, Cell And Soft Tissue Interaction:
ALL STEPS ARE
APPLICABLE
FOR ONLY BIO-INERT
BIOMATERIAL -
FOR
BIOACTIVE, BIORES
ORPABLE IMPLANT

25. Bio-implant And Biological Interaction:
Immediately After Implantation-
Infection
Inflammation
Bacterial
Adhesion Leukocyte
Adhesion and
Activation
Complement
System
Activation
Protein
Adsorption . . . .
.. . .
Biomaterial
Biological
Tissue/ Components

26. Biomaterial
And 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.

27. 1 Second
to
1 Hour:
(Adapted from Ratner and Bryant)

28. Biomaterial
And Soft tissue Interaction -
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 Hydrophilic/Hydrophobic
Gold Same Result
Metal/ceramic/polymer
(long term)
Titanium Hard/soft
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.

29. 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 .

30. 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 poly-
crystalline Al2O3.

31. Biomaterial And
Hard Tissue/Bone Interaction-
Irregular pore structure of porous
Biological Interaction -
coating in Ti5Al4V alloy for bony
ingrowth, from Park and Lakes
Forms mechanical attachment via
[1992].
.
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.

32. Biomaterial And
Hard Tissue/Bone Interaction-
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.
Osteoblast cell
attachment on a  Formation of a hydroxy-carbonate apatite
5
composite
Biomaterial (HCA) on surface, when implanted
surface-SEM.
Example-Bioactive glasses, bioactive glass-
ceramics (Ceravital), hydroxyapatite
The mechanism of new bone formation
(Duraptite.Calcitek); bioactive composites
an bone bonding to a bioactive ceramic. Palavital).
.

33. 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. 5
 Examples: Calcium sulfate, Tricalcium phosphate
(TCP ).
 Challenge: Meeting strength requirements and
short- term mechanical performance while
regeneration of tissues is occuring.

34.  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

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

36. Biomaterials–
Tissue Interactions Chart-
Local
Interactions Device-
Systemic Associated Complications
(At biomaterial–tissue interface) Interactions
Physical-mechanical
• Blood–material effects
interactions • Wear • Thrombosis/
• Toxicity • Fatigue •Embolization thromboembolism
• Modification of • Corrosion • Infection
• Stress-corrosion cracking
•Hypersensivity
healing • Exuberant or
• Elevation of defective healing
• Exaggerated Biological effects
Inflammation • Adsorption of tissue implant elements • Biomaterials failure
• Prone to Constituents by implant in blood • Adverse local tissue reaction
Infection • Enzymatic degradation • Adverse systemic effect.
• Calcification •
Lymphatic t
ransport.

38. Important Facts of
Biomedical
Implants/Devices -
Selection
criteria for Biomaterials-
Biomaterials and biomedical
devices are used throughout the
human body.
5
2 important aspects must be
Consider before implantation:
– Functional performance
– Biocompatibility.

39. (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).
Important Facts of
– Light transmission (e.g. implanted lenses).
Biomedical
– Sound transmission (e.g. cochlear implant).
Implants/Devices -
Selection
criteria for Biomaterials-
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).

40. Important Facts of
Biomedical Implants/Devices
-
Selection
criteria for Biomaterials-
Biocompatibility-
• Arises from differences between
living and non-living materials.
• Bio-implants trigger inflammation
or foreign body response.
Biological Compatibility
 Chemical Compatibility
 Mechanical Compatibility
 Nontoxic,
 Non-carcinogenic.

41. Important Facts of
Biomedical Implants/Devices
-
Biomaterials:
Biocompatibility status-
E
E E E E
L E M M
M E L L
E L E E
M M M M
DEPENDS ON COMPOSITION OF MATERIAL

42. Important Facts of
Biomedical
Implants/Devices -
Host /Implant Factors:
Which Determines bio-compatibility-
Age and health status
 Immunological status
 Metabolic status
Host Factors:
 proper implantation
 Tissue damage
 Contamination and
 Choice of surgeon
 Bulk Properties:
Implant Factors:  Surface Properties:
 Mechanical Properties:
 Long-term Structural Integrity:

43. 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.

44. 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.

45. 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 .

46. Evolving definitions:

47. 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,
Painless administration of a
Morphological and
vaccine by tiny Mechanical Conditions of tissue
microneedles on a skin patch.
exposure

48.  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,
VeriChip Human  Proper implantation and
Implantable Microchip
 post implantation patient

49. &

50. 6