93698259 biomaterials implantable medical devices and biomedical science

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


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.


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: Classification

Non-biological Biomaterials:

Biological Biomaterial:

Natural Biologic Hybrid Biomaterial

Natural Biologic Hybrid Biomaterial

95% of total Bio-Implant-

05% of total Bio-Implant-


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.


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


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


Composite Biomaterials -

Composites

Particulate Composites

Porous Composites

Porous Composites

Fibrous Composites

Composition Advantages Disadvantage:Variouscombinations

Strong,tailormade Difficulttomake


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.


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.


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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-


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

Tissue/ Organ.

Biological Regenerative Biomaterial.

4th Generation Biomaterial:


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


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:

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-


.

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.


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.

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).



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).

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.

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:


Success of an Implant is Determined by-

Conditions of Patient. Surgeon Technical Skills. Biocompatibility of Implant. Mechanical Properties. Corrosion Resistance.


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.


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 :

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:

93698259 biomaterials implantable medical devices and biomedical science

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