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  1. 1.  Biomaterial, Bio-implant and Bio- device. Interaction with human tissue. Important facts And. Conclusion.
  2. 2. Prepared By- Dr. Md Nazrul Islam. MBBS, Supervised By-Associate Prof. ZiaulHaq -MBBS, MS (Orthopedic). 2
  3. 3. Biomaterial,Bio-implant / Bio-medical device: 3
  4. 4. Biomaterial,Bio-implant / Bio-medicaldevice 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.
  5. 5. Biomaterial,Bio-implant / Bio-medicaldeviceBio-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.
  6. 6. Biomaterial,Bio-implant / Bio-medicaldeviceBio-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 its primary intended purposes through chemical action within or on And is not dependent upon being metabolized in the Body.
  7. 7. Biomaterial,Bio-implant / Bio-medicaldeviceHistorical Advancement:Biomaterials & Biomedical Devices - Romans,Chinese,and Aztecs used gold in dentistry over 2000 years ago.  1860s: Lister develops aseptic surgical technique.  Early 1900s: Bone plates used to fix fractures.  1930s: Introduction of stainless steel, cobalt chromium alloys.  1938 : First total hip prosthesis (P. Wiles).  1940s: 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.  1970s: 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).
  8. 8. Biomaterial,Bio-implant / Bio-medicaldeviceStatistics:Biomaterials Biomedical Devices- 8
  9. 9. Biomaterial,Bio-implant / Bio-medicaldeviceStatistics:Biomaterials Biomedical Devices-
  10. 10. Biomaterial,Bio-implant / Bio-medicalBiomaterial: Classificationdevice Non- biological Biomaterial Biological s: Biomaterial: 05% of 95% of total Bio- total Bio- Implant- Implant-  Natural  Biologic  Hybrid Biomaterial
  11. 11. Biomaterial,Bio-implant / Bio-medicaldeviceNon-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.
  12. 12. 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
  13. 13. Biomaterial,Bio-implant / Bio-medicaldevice 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
  14. 14. Biomaterial,Bio-implant / Bio-medicaldevice 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
  15. 15. Biomaterial, Bio-implant / Bio-medical device Composite Biomaterials - Composi tes Fibrous Composites Composition Advantages Disadvantage : Porous Various Strong, tailor- Difficult to makeComposites combinations made Particulate Composites
  16. 16. Biomaterial,Bio-implant / Bio-medicaldevice 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.
  17. 17. Biomaterial,Bio-implant / Bio-medicaldeviceBiological/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.
  18. 18. Biomaterial,Bio-implant / Bio-medicaldeviceClassificationAnd–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.
  19. 19. Biomaterial,Bio-implant / Bio-medicaldevice Cell and Gene-Activating Materials  Genetic Control and Activation.  Molecularly Tailored Resorbable.  Biological Replacement Biomaterial/ Tissue/ Organ.4th GenerationBiomaterial:  Biological Regenerative Biomaterial.
  20. 20. Biomaterial,Bio-implant / Bio-medicaldevice Performance Criteria Biologically inert  Biocompatible  Non-viableMechanical strength and funtion Amenability to engineering design, manufacturing, and sterilization ….not found naturally within the bodyTraditionalBiomaterialsAnd Medical Devices
  21. 21. Biomaterial,Bio-implant / Biomaterial deviceNext GenerationBiomaterials and MedicalDevices- 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).
  22. 22. Biomaterial and Human /BiologicalComponents Interaction Can be broadlydivided / Classified into -–Biomaterial and Protein/ Blood. Biomaterial and Cell Biomaterial and Soft tissue Biomaterial and Hard Tissue/Bone.
  24. 24. 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
  25. 25. 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.
  26. 26. 1 Second to1 Hour: (Adapted from Ratner and Bryant)
  27. 27. BiomaterialAnd 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.
  28. 28. 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 isdesigned with various porous surfaces that encourage tissue in growth. Interactions Between Implant and Body in Fracture .
  29. 29. Biomaterial AndHard 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.
  30. 30. Biomaterial And Hard Tissue/Bone Interaction-Irregular pore structure of porous Biological Interaction -coating in Ti5Al4V alloy for bonyingrowth, 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.
  31. 31. 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), hydroxyapatiteThe mechanism of new bone formation (Duraptite.Calcitek); bioactive compositesan bone bonding to a bioactive ceramic. Palavital). .
  32. 32. Biomaterial AndHard 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.
  33. 33.  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
  34. 34. 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
  35. 35. 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.
  36. 36. Important Facts ofBiomedicalImplants/Devices -Selectioncriteria for Biomaterials- Biomaterials and biomedical devices are used throughout the human body. 5 2 important aspects must be Consider before implantation: – Functional performance – Biocompatibility.
  37. 37. (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).
  38. 38. Important Facts ofBiomedical Implants/Devices-Selectioncriteria 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.
  39. 39. Important Facts ofBiomedical 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
  40. 40. Important Facts ofBiomedicalImplants/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:
  41. 41. Important Facts ofBiomedical Implants/Devices-Successof an Implant is Determined by-  Conditions of Patient.  Surgeon Technical Skills.  Biocompatibility of Implant.  Mechanical Properties.  Corrosion Resistance.
  42. 42. Important Facts ofBiomedical Implants/Devices-PrecautionsTo 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.
  43. 43. Important Facts ofBiomedicalImplants/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 .
  44. 44. Evolving definitions:
  45. 45. 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 andvaccine by tiny Mechanical Conditions of tissuemicroneedles on a skin patch. exposure
  46. 46.  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 andImplantable Microchip  post implantation patient
  47. 47. &
  48. 48. 6