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    Add as FriendBasics of HUMAN BIOMATERIALS, IMPLANTABLE MEDICAL DEVICES AND BIOMEDICAL SCIENCE

    by: Dr. Md Nazrul

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    1 : © Biomaterial, Bio-implant and Bio- device. Interaction with human tissue. Important facts And. Conclusion. Basics of-
    2 : 2 Prepared By- Dr. Md Nazrul Islam. MBBS, M.sc.(BME). Supervised By- Associate Prof. Ziaul Haq - MBBS, MS (Orthopedic).
    3 : Biomaterial, Bio-implant and Bio-device. Biomaterial and Biological Components Interaction. Important facts and direction for use. Conclusion And Our Consensus. S e c t I o N s -
    4 : 3 Biomaterial, Bio-implant / Bio-medical device: Overview-
    5 : Biomaterial 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:
    6 : 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:
    7 : 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:
    8 : 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:
    9 : 8 Statistics: Biomaterials Biomedical Devices- Biomaterial, Bio-implant / Bio-medical device:
    10 : Statistics: Biomaterials Biomedical Devices- Biomaterial, Bio-implant / Bio-medical device:
    11 : Biomaterial: Classification Biomaterial: Non-biological Biomaterials: Biological Biomaterial: Natural Biologic Hybrid Biomaterial 95% of total Bio-Implant- 05% of total Bio-Implant- Biomaterial, Bio-implant / Bio-medical device:
    12 : 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:
    13 : 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” . Orthopedics' screws/fixation Dental Implants / filler Biomaterial, Bio-implant / Bio-medical device:
    14 : 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. Non-absorbable Polymer & Absorbable/Biodegradable Drug Delivery Devices. Ear/ ocular implants Skin Implant. Cartilage implant. Dental, Maxillo-facial and ortho-implants, Biomaterial, Bio-implant / Bio-medical device:
    15 : 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. Ear/ Ocular implants Dental, Maxillo-facial and ortho-implants, Biomaterial, Bio-implant / Bio-medical device:
    16 : Composite Biomaterials - Ear/ Ocular implants Dental, Maxillo-facial and ortho-implants. Biomaterial, Bio-implant / Bio-medical device:
    17 : Stem Cells Cartilage repair & Preservation of the knee BIOLICAL Cell/ TISSUE REGENERATION. BIOLOGICAL TISSUE / ORGAN REPLACEMENT. 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/ OR Semi-synthetic COLLAGEN BASED- BIO-IMPLANT REGENERATION ORGAN REGROW. STEM CELL BASED- BIO-IMPLANT REGENERATION ORGAN REGROW. BIOMATERIAL MADE FROM COMBINATION OF SYNTHETIC AND BIOLOGIC COMPONENTS. • Nature-derived (e.g., plant - derived) • Naturally-derived (e.g., Cell, tissue-) Biomaterial, Bio-implant / Bio-medical device:
    18 : 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:
    19 : 4 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: Classification And–Evolution of Biomaterials- Biomaterial, Bio-implant / Bio-medical device:
    20 : 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:
    21 : Traditional Biomaterials and Medical Devices Biologically inert Biocompatible Non-viable Mechanical strength and function Amenability to engineering design, manufacturing, and sterilization ….not found naturally within the body Performance Criteria Biomaterial, Bio-implant / Bio-medical device:
    22 : Next Generation Biomaterials and Medical Devices- 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). Revised Performance Criteria Biomaterial, Bio-implant / Biomaterial device:
    23 : 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 -– Biological Components and Biomaterial Interaction-
    24 : Sequence of host reactions following implantation – Injury Serum / Plasma Protein And Biomaterial Clotting Cascade And Biomaterial. Host Cell And Biomaterial Interaction. Provisional matrix formation. Acute Inflammation (Exaggerated). Chronic Inflammation (Sp. for foreign-body). Granulation tissue formation. Foreign-body reaction. Fibrosis/Fibrous encapsulation/Non-capsulation . Biological Components and Biomaterial Interaction- Biomaterial And Protein, Blood, Cell And Soft Tissue Interaction: All steps are Applicable for only Bio-inert Biomaterial- For Bioactive, Bioresorpable Implant
    25 : Biomaterial Protein Adsorption Biological Tissue/ Components . . . . . . . . Biological Components and Biomaterial Interaction- Bio-implant And Biological Interaction: Immediately After Implantation-
    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. Biological Components and Biomaterial Interaction-
    27 : (Adapted from Ratner and Bryant) Biological Components and Biomaterial Interaction-
    28 : 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 Gold Titanium Same Result (long term) 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 Soft tissue Interaction - Biological Components and Biomaterial Interaction-
    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 . Biological Components and Biomaterial Interaction-
    30 : . 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. Biological Components and Biomaterial Interaction- Biomaterial And Hard Tissue/Bone Interaction-
    31 : 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 µm 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]. Biological Components and Biomaterial Interaction-
    32 : 5 . 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 formation an bone bonding to a bioactive ceramic. Biological Components and Biomaterial Interaction- Biomaterial And Hard Tissue/Bone Interaction- Osteoblast cell attachment on a composite Biomaterial surface-SEM.
    33 : 5 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, Tricalcium phosphate (TCP ). Challenge: Meeting strength requirements and short- term mechanical performance while regeneration of tissues is occuring. Biological Components and Biomaterial Interaction-
    34 : Effect of the Implant on the Host- 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 Biological Components and Biomaterial Interaction-
    35 : Embolization Hypersensitivity Elevation of implant elements in the blood Lymphatic particle transport Physical – mechanical effects Abrasive wear Fatigue Stress corrosion, cracking Corrosion Degeneration and dissolution Biological effects Absorption of substances from tissues Enzymatic degradation Calcification Effect of the Host on the Implant - Biological Components and Biomaterial Interaction-
    36 : Biomaterials– Tissue Interactions Chart- Biological Components and Biomaterial Interaction-
    37 : Important Facts of Biomedical Implants/Devices -
    38 : 5 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 -
    39 : 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 - – 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 : 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.
    41 : Biomaterials: Biocompatibility status- E E E E E E E E E E M M M M M M M L L L L DEPENDS ON COMPOSITION OF MATERIAL Important Facts of Biomedical Implants/Devices -
    42 : 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 -
    43 : 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 -
    44 : 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 -
    45 : 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 -
    46 : Evolving definitions:
    47 : 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 and Mechanical Conditions of tissue exposure (Nature, degree, frequency and duration). Painless administration of a vaccine by tiny microneedles on a skin patch. Our Consensus :
    48 : 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:
    49 : We Are Grateful To : Professor Shamimul Haq Associate Prof. Dr. Ziaul Haq Associate Prof. Dr Paritosh Chandra Debenath Associate Prof. Dr. Sheikh Abbas Uddin Ahmed Associate Prof. Dr. Md Golam Kabir Miah Associate Prof. Dr. Monoarul Islam Associate Surgeon Dr. Aminur Rahman Assistant Prof. Kazi Shamim uzzaman Assistant Prof. S.M. Quamrul Akther Sanju Assistant Prof. Bahar Uddin Dr. Ibnul Hasan of Department of Orthopedic And Mr Sanouar Hossain & Kazi Afsar Uddin of THE ACME Laboratories, Dhaka, Bangladesh. Sponsored By: THE ACME- Laboratories Ltd, Dhaka, Bangladesh. &
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