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BIOMATERIALS-IMPLANTABLE-MEDICAL-DEVICES-AND-BIOMEDICAL-SCIENCE.pptx

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BIOMATERIALS-IMPLANTABLE-MEDICAL-DEVICES-AND-BIOMEDICAL-SCIENCE.pptx

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									 Biomaterial, Bio-implant
  and Bio- device.
 Interaction with human tissue.
 Important facts And.
 Conclusion.
      Prepared By-
 Dr. Md Nazrul Islam.
 MBBS, M.sc.(BME).
     Supervised By-
Associate Prof. Ziaul Haq -
 MBBS, MS (Orthopedic).




                              2
Biomaterial,
Bio-implant / Bio-medical device:




            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
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.
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
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
Statistics:
Biomaterials Biomedical Devices-




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

         Classification




                            Non-biological   Biological
                            Biomaterials:    Biomaterial:
                                                   05% of
                             95% of                total Bio-Implant-
                             total Bio-
                             Implant-         Natural
                                              Biologic
                                              Hybrid
                                             Biomaterial
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
                               • 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
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
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,
                    Non              inorganic nonmetallic materials.
                Biodegradable



                                Composition    Advantages                     Disadvantage :
                                               Highly biocompatible, inert,   Brittle,
                                Aluminum       high modulus and               difficult to
                                oxide, carbon, compressive strength, good     make, poor
                                hydroxyapatite esthetic properties            fatigue
                                                                              resistance
             Natural
   Biomaterial,
   Bio-implant / Bio-medical
   device
                               Composite Biomaterials -




   Composites



                 Fibrous
                Composites



                               Composition    Advantages          Disadvantage :
  Porous                       Various        Strong, tailor-made Difficult to make
Composites                     combinations


         Particulate
         Composites
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.
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
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.
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.
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
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).
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.
      Biomaterial And
      Protein, Blood, Cell And Soft Tissue Interaction:




ALL STEPS ARE
APPLICABLE
FOR ONLY BIO-INERT

BIOMATERIAL   -
FOR BIOACTIVE,
BIORESORPABLE
IMPLANT
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
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.
1 Second
    to
1 Hour:




           (Adapted from Ratner and Bryant)
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.
  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 .
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.
    Biomaterial And
    Hard Tissue/Bone Interaction-

Irregular pore structure of porous
                                      Biological Interaction -
coating in Ti5Al4V alloy for bony
 ingrowth, from Park and Lakes
[1992].
                              .
                                      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.
       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).
                                                                  .
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.
 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
 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 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
                                                             transport.
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.
  (e.g. artificial knee joint).
– Control of blood and fluid flow (e.g. artificial heart).
– Space filling (e.g. cosmetic surgery).

                Important Facts of
– Electrical stimuli (e.g. pacemaker).
– Light transmission (e.g. implanted lenses).
                Biomedical Implants/Devices -
– Sound transmission (e.g. cochlear implant).




                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).
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.
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
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:
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 .
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
Painless administration of a
                                        Mechanical Conditions of tissue exposure
vaccine by tiny                           (Nature, degree, frequency and duration).
microneedles on a skin patch.
                         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
VeriChip Human
Implantable Microchip
                           compliance.
&
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