93698259 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.
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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, 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
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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).
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
Biomaterial: Classification
Non-biological Biomaterials:
Biological Biomaterial:
Natural Biologic Hybrid 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 .
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 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,easytofabricate
Notstrong,deformwithtime,maydegrade
Any one of a large and varied group of materialsconsisting wholly or part of a combination ofcarbon and hydrogen (hydrocarbons) It is also acombination of oxygen, nitrogen and otherorganic 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.
Ceramics are defined as the art and science of making and using solid articles that have as their essential component,
inorganic nonmetallic materials. NonBiodegradable
Natural
Composition Advantages Disadvantage:
Aluminumoxide,carbon,hydroxyapatite
Highlybiocompatible,inert,highmodulusandcompressivestrength,goodestheticproperties
Brittle,difficulttomake,poorfatigueresistance
Biomaterial, Bio-implant / Bio-medical device
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Composite Biomaterials -
Composites
Particulate Composites
Porous Composites
Porous Composites
Fibrous Composites
Composition Advantages Disadvantage:Variouscombinations
Strong,tailormade Difficulttomake
Biomaterial, Bio-implant / Bio-medical device
Stem Cells Cartilage repair & Preservation of the knee
BIOLICALCell/TISSUEREGENERATION.BIOLOGICALTISSUE/ORGANREPLACEMENT.
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.
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/ ORSemi-synthetic
COLLAGEN BASED-BIO-IMPLANTREGENERATIONORGAN REGROW.
STEM CELL BASED-BIO-IMPLANTREGENERATIONORGAN 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
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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:ClassificationAndEvolution 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
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Next Generation Biomaterials and Medical Devices-
Biologically inertNon-viable BiocompatibleMechanical strength and functionAmenability 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 AREAPPLICABLEFOR ONLY BIO-INERT
BIOMATERIAL-FOR BIOACTIVE, BIORESORPABLEIMPLANT
InflammationInflammation
Complement System
Activation
Complement System
Activation
Leukocyte Adhesion and
Activation
Leukocyte Adhesion and
Activation
Bacterial AdhesionBacterial Adhesion
Infection
Biomaterial
Protein Adsorption
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)(Adapted from Ratner and Bryant)
1Secondto
1Hour:
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Materials: Short-Term Reaction: Long-Term Reaction:Polyethylene 1. Different protein 1. FibrousHydroxyapatitie adsorption EncapsulationPolyurethane 2. Varied activation of Silicone host response pHEMAPTFEPyrolytic carbonGoldTitanium
Hydrophilic/HydrophobicMetal/ceramic/polymerHard/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.
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 m 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].
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.
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.
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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, Tri-calcium phosphate (TCP ).
Challenge: Meeting strength requirements and short- term mechanical performance while regeneration of tissues is occurring.
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Protein adsorption Blood material interactions
CoagulationFibrinolysis
Platelet adhesion, activation, releaseComplement activationLeukocyte adhesion, activationHemolysis
Toxicity Modification of normal healing
EncapsulationForeign body reactionPannus 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 -
LocalInteractions
(Atbiomaterialtissueinterface)Systemic
Interactions
DeviceAssociatedComplications
BloodmaterialinteractionsToxicityModificationofhealingExaggeratedInflammationPronetoInfection
PhysicalmechanicaleffectsWearFatigueCorrosionStresscorrosioncracking
BiologicaleffectsAdsorptionoftissueConstituentsby
implantEnzymaticdegradationCalcification
Embolization
Hypersensivity
Elevationofimplantelementsinblood Lymphatic
transport.
Thrombosis/thromboembolismInfectionExuberantordefectivehealingBiomaterialsfailureAdverselocaltissuereactionAdversesystemiceffect.
BiomaterialsTissue Interactions Chart-
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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 -
Loadtransmissionandstressdistribution(e.g.bonereplacement).
Articulationtoallowmovement(e.g.artificialkneejoint).
Controlofbloodandfluidflow(e.g.artificialheart). Spacefilling(e.g.cosmeticsurgery). Electricalstimuli(e.g.pacemaker). Lighttransmission(e.g.implantedlenses). Soundtransmission(e.g.cochlearimplant).
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Biocompatibility- Arises from differences between
living and non-living materials. Bio-implants trigger inflammation
or foreign body response.
Important Facts of Biomedical Implants/Devices -
Selection criteria for Biomaterials-
Biological Compatibility Chemical Compatibility Mechanical Compatibility Nontoxic, Non-carcinogenic.
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 - Conclusion
And Our Consensus:
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 andMechanical Conditions of tissue exposure
(Nature, degree, frequency and duration).Painless administration of a vaccine by tiny Micro-needles on a skin patch.
Our Consensus :
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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.
Our Consensus :
Conclusion And Our Consensus:
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