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This 71 page Class Notes was uploaded by Kaylee Schowalter on Monday October 26, 2015. The Class Notes belongs to BIOEN 6900 at University of Utah taught by Staff in Fall. Since its upload, it has received 70 views. For similar materials see /class/229917/bioen-6900-university-of-utah in Bioengineering at University of Utah.
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Date Created: 10/26/15
Yr odern Biomateriallrs hm 7 39TESEN 5301 MSE 5040 BIOEN 6301 PHCEU 6020 1172006 What is a biomaterial Definition Biomaterial 3 Any material of natural or of synthetic origin that comes in contact with tissue blood or biological fluids and intended for use in prosthetic diagnostic therapeutic or storage application 1172006 3 Course Goals 3 o Differentiate the various class of biomaterials o Differentiate the various analytical methods used to characterize biomaterials o Differentiate the molecular and cellular events that follow exposure of materials to tissues and fluids 0 Differentiate the various biomedical devices amp 0 Describe various aspects of biomedical device design fabrication and testing 1172006 4 Introduction to Modern Biomaterials Textbookrequired Biomaterials Science An Introduction to Materials in Medicine 2nd Edition Ratner et al Elsevier Academic Press 2004 Additional References Weblinks amp Other Reading Material Required reading material other than that in the required textbook will be announced in class and will be posted on the course web site 1172006 5 Introduction to Modern Biomaterials 5quot TA Jeff Wolchok 5855890 jwochokutahedu Xiaoyu Chen 5855890 xiaoyuchenpharmutahedu Please use WebCT to contact them use the above email only if you do not have access to WebCT 1172006 6 Grading 0 5000Ievel 75 3 exams 25 laboratory exercises o 6000Ievel 753 exams 25 project 20proposareport 5 oral presentation 1172006 7 Learning Objectives 0 I will provide you with the exam questions 0 You have to provide the answers 1172006 Course Methodology 0 Interactive lecture style format Laboratories 0 Exams will be given in class consisting of short answer and essay questions and will be closed book 1172006 9 Announcements 0 Information about labs Safety o Other important information 1172006 The Lab Experience 339 0 Lab protocols WebCT o On the first days of lab 11 12 Jan half of the students will stay and perform the lab Wednesday A and Thursday A and half will be asked to leave and return the following week Wednesday B and Thursday B 0 You will then attend lab every other week Check your schedule and determine whether the A weeks or the B weeks are better for you 0 All laboratory assignments will be submitted to the TA via WebCT If Biomaterials 5301 is not listed on your WebCT homepage please contact the TA 0 If you are registered for BIOEN 6900 No Lab 1172006 11 Lab Topics Lab 1 Introduction to Biomedical Devices Classify Your Medical Device Grading Sheet for Lab 1 Group Divisions Lab 2 Surface Characterization of Biomaterials Lab 3 Biomateria Fabrication and Testing Lab 4 ntroduction to Adhesives and Composite Structure Lab 5 Biomaterial Fabrication and Testing 2 part lab 1172006 12 Syllabus Date 09 Jan 11 Jan 13 Jan 16 Jan 18 Jan 20 Jan 23 Jan 25 Jan 27 Jan 1172006 Instructor Tresco Tresco Tresco Tresco Tresco Tresco TBA TBA TBA Topic Introduction Overview Classes of Materials Used in Medicine Martin Luther King Jr Day Holiday Polymeric Materials Part Polymeric Materials Part II Surface Properties of Biomaterials Surface Characterization Surface amp Protein Interactions Syllabus Date 30 Jan 01 Feb 03 Feb 06 Feb 08 Feb 10 Feb 1172006 Instructor Tresco Tresco Tresco Tresco Tresco Tresco Topic Acute Wound Healing Blood Clotting Chronic Wound Healing and Foreign Body Response Inflammation Part Inflammation Part II Degradation of Implanted Materials Exam l Syllabus 13 Feb 15 Feb 17 Feb 20 Feb 22 Feb 24 Feb 27 Feb 01 Mar 03 Mar 06 Mar 08 Mar 10 Mar 1172006 TBA TBA Tresco Device Development The Regulatory Environment Sterilization amp Implant Associated Infections President s Day Holiday Tresco Tresco Tresco Tresco Tresco Tresco Tresco Biomaterials Testing Surface Coatings Wound Dressings and Sutures Elastomers Intravenous Catheters Applications in Cardiology Biomaterial Fabrication Exam II Syllabus 13 Mar 15 Mar 17 Mar 20 Mar 22 Mar 24 Mar 27 Mar 29 Mar 31 Mar 03 Apr 05 Apr 07 Apr 1172006 Spring Break Spring Break Spring Break Tresco Tresco Tresco Tresco Tresco Tresco Tresco Tresco Applications in Nephrology Hydrogels Applications in Ophthalmology MetalsPart Metals Part II Applications in Orthopedics Ceramics and Bioglasses Adhesives and Sealents Applications in Dentistry Syllabus 10 Apr 12 Apr 14 Apr 17 Apr 19 Apr 21 Apr 24 Apr 26 Apr 28 Apr 1172006 Tresco Tresco Tresco Tresco Tresco Tresco Tresco Tresco Project Report clue Degradable MaterialsPart l Degradable MaterialsPart ll Applications in Drug Delivery Applications in Tissue Engineering Project Presentations Project Presentations Project Presentations Exam lll Biomaterials Graduate Project 5 Purpose 0 To apply knowledge of biomaterial properties to a material selection biomedical device design problem 1172006 Suggested Process 1172006 Select a Class III biomedical device that has or is being developed for commercial use Identify the various major parts of the device or implant provide a drawing or illustration and list the biomaterials used This may involve contacting the manufacturer andor locating the appropriate information within the patent literature Using the peerreviewed literature describe what is known of the biocompatibility of the device Justify the selection of the materials used with regards to similar successful applications physical characteristics suitability for processing manufacture cost and favorable federal regulations amp Provide an alternative biomaterial solution to improve biocompatibility and justify your selection based upon relevant peerreviewed literature List benefits and drawbacks of the existing components and those of the proposed alternative Timeline 339 0 Project proposal due Feb 17th 2 page maximum and bibliographic sources use endnote if available It should describe the selected device and propose ideas for completing the project This will enable the instructor to provide feedback on the project topic 0 Final report due April 28th 25 pages maximum Times New Roman 11 point 0 Oral project presentations of 12 minutes during final three lecture periods 11 72006 20 Headlines Biocoral Inc Announces Approval of its French Patent Monday January 9 901 am ET NEW YORK January 9 PRNewswireFirstCall Biocoral Inc OTCBB Newg announced today that recently the French Patent Office Institut National de la Propriete Industrielle quotlNPlquot approved and granted a company patent called quotDevice for delivering of Biomaterial into a determined portion of bonequot 1172006 21 Headlines CryoLife Receives FDA Approval of New Larger Delivery System for BioGlueR Surgical Adhesive Disposable Syringe Provides Surgeons with Improved Site Access and Ease of Use ATLANTA Jan 12 PRNewswireFirstCaII CryoLife Inc NYSE a biomaterials and biosurgical device company today announced that it has received approval from the Food and Drug Administration FDA for a new 10ml disposable syringe for BioGlue Surgical Adhesive 11 72006 22 Headlines Tny Pharma39s Anesthetic Coated Surgical Mesh Combination Product Assigned to 39Device39 Center at FDA TyRX plans to initiate clinical trials in the first half of 2006 MONMOUTH JUNCTION NJ Jan 9 PRNewswire Tny Pharma Inc announced today that its Anesthetic Coated Surgical Mesh has received a designation of quotCombination Product with Device Primary Mode of Action PMOAquot from the Office of Combination Products at the US Food and Drug Administration FDA This designation and assignment to the Center for Devices and Radiologic Health CDRH has historically indicated a faster regulatory and commercial timeline for a product as compared to when the FDA considers a combination product to be a quotdrugquot 11 72006 23 Headlines Angiotech Initiates Antilnfective CVC US Pivotal Study ADVANCING NOVEL APPROACH TO PREVENT MEDICAL DEVICE INFECTIONS VANCOUVER Jan 5 PRNewswire FirstCall Angiotech Pharmaceuticals Inc NASDAQ TSX ANP today announced the initiation of its United States pivotal study examining an antimicrobial central venous catheter CVC This US multicenter study is designed to evaluate the efficacy of a CVC coated with the drug 5Flourouracil 5FU a nontraditional antiinfective agent The study enrolled its first patient last week in Rapid City South Dakota and will involve approximately 600 patients at 20 centers in the United States 11 72006 24 Headlines CeTaQ announces MCA testing for lasers in medical biomedical device manufacturing Jan 09 2006 Ce TaQ Americas announces the availability of Machine Capability Analysis MCA testing applicable to laser systems CeTaQ39s test methodology measures the width of the laser cut as well as beam size and consistency comparing the actual result with the programmed pattern and process settings The test method is applicable to lasers used in such processes as cutting welding and scribing stencil cutting laser marking such as matrix labeling and other applications such as drilling All types of lasers including UV excimer and DPSS can be evaluated 11 72006 25 Headlines Antibacterial coatings on hip and knee implants cut infection rates Putting antibacterial coatings on hip and knee implants and biomedical devices such as catheters could cut infection rates following surgery and significantly reduce health care costs and improve quality of life for patients researchers at the University of Australia have found A significant number of hip and knee implants are prone to infection after surgery and in many cases are not amenable to treatment with antibiotics according to Hans Griesser Professor of Surface Science and Deputy Director of UniSA39s an institute 11 72006 26 Introduction 00 Biomaterials Science A m Multidisciplinary Endeavor Definitions o Biomateriala nonviable material used in a medical device to interact with biological systems 0 Biocompatibilitythe ability of a material to perform with an appropriate host response in a specific appHca on 1172006 3 r 4 1 1 n W H F1 g 390 a Biological Response to 3555 Contact with Materials 55quot A study of the molecular and cellular events that follow contact with biological fluids or tissues whether in vitro or in vivo from initial contact to the eventual culmination of the response 1172006 Biocompatible A general term meaning that a biomaterial device or construct can be brought into direct contact with living tissue without o causing a harmful tissue reaction pain swelling or necrosis that could compromise function 0 causing a systemic toxic reaction or 0 having tumorigenic potential 1172006 Biocompatibility testing include procedures designed to evaluate cytotoxicity acute subchronic and chronic toxicity irritation to skin eyes and mucosal surfaces sensitization hemocompatibility shortterm implantation effects genotoxicity carcinogenicity and effects on reproduction including developmental effects 1172006 U 4 1 4 D W H H a 393 1 Applications in Orthopedics 339 1quot film 1172006 31 Applications in Dentistry 55 11 72006 32 Cardi ovascular Appli cat IONS C 39gtquot VT Cardiovascular Applications 1172006 In Ophthalomolgy 1172006 36 In Neurology if mumlimnmmmm umwmmdumlm kommhnollwlmp cnlwu mmmmngnnmuhmdpba holdinpbnbymmmmw WWW 9 Implant mammnwdwmm lmamkalllqnuh Wt amhmviww uwl w me www Internal Medicine Samar Insulln pump determines ulstributes yucca levels appropriall Ind transmits insulin Into dhdor mn 11 72006 38 In Nephrology 55 11 72006 39 In Drug Delivery 55 11 72006 40 Future Applications Tissue Replacement 11 72006 41 quotAsk courageous questions Do not be satisfied with superficial answers Carl Sagan 11 72006 42 Examples of Biomaterials Applic 1172006 44 11 72006 45 The upgrade M D R F T H A N H U M A N SEARCH INSIDE a V V a SEARCH INSIDE 1 RADICAL EVOLUTION 1 V infr J EL39 GAR REAU 1172006 O 0 I I 0 0 SEARCH mannerm FA N TA 5 T I C VOYAGE RAY KURZWEIL TERRY GROSSMAN MD 46 Are medical devices monolithic 0 NO 0 Composites o Many diverse materials a Dependent on applications 1172006 Biomaterials Research in Industry 0 is dominated as much by the regulatory approval process and submission requirements as by the physical mechanical and chemical properties of the medical device 1172006 Definition Biomaterial FDA 339 quotan instrument apparatus implement machine contrivance implant in vitro reagent or other similar or related article including a component part or accessory which is recognized in the official National Formulary or the United States Pharmacopoeia or any supplement to them intended for use in the diagnosis of disease or other conditions or in the cure mitigation treatment or prevention of disease in man or other animals or intended to affect the structure or any function of the body of man or other animals and which does not achieve any of it39s primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of 1 7 2006its primary intended purposesquot 49 The Food and Drug Administration wwwfdagov 5r Regulates m EggPrescription OvertheCounter Generic Medical Devices 0 Animal Feed and DruqsLivestock Pets 0 CosmeticsSafety Labeling 0 Radiation Emittinq ProductsCell Phones Lasers Microwaves 11 72006 50 Center for Devices and Radiologic Health CDRH wwwfdargdvcdrhi o Responsible for regulating firms who manufacture repackage relabel andor import medical devices sold in the United States 1172006 51 BIOMATERIAL OR MEDICAL C900 DEVICE 2 FDA neither approves materials nor maintains a list f approved materials 0 the properties and safety of materials must be carefully assessed with respect to the specific application in question and its degree of patient contact 0 the final assessment must be performed on the finished product under actual use conditions a W V 3922 Ith 311 I 1172006 Manufacture of a Medical 5555 Device 3 materials selection types of tests required for evaluation depend on the physical and chemical nature of its materials and the nature of the device39s exposure to the body its physical properties cost and availability may be acceptable but might contain toxic chemical components screen the candidate materials at an early stage to eliminate those that are toxic and select those that are sufficiently biocompatible or nontoxic for their intended use Chemical constituents and potential extractables should be identified and quantitated for overall safety assessment of the device 11 72006 53 Biomaterials Science is an 5555 Interdisciplinary Affair 55339 Biomaterialists include physical scientists engineers dentists biological scientists surgeons and veterinary practitioners in industry government clinical specialties and academic settings 1172006 The Society For Biomaterials 5 A professional society which promotes advances in all phases of materials research and development by encouragement of cooperative educational programs clinical applications and professional standards in the biomaterials field Internationally recognized leaders in the biomaterials field participate in the Society and sponsored events wwwablomaterialsorg 1172006 39 quot TOR BIOMA39l39ERlALS 31 lei II autop allquot pHaTligling 97 55 Relevant Biomaterials 5555 Journals 5Equot Journal of Biomedical Materials Research Biomaterials Journal of Biomaterials Science Polymer Edition Journal of Biomaterials Applications Journal of Materials Science Materials in Medicine journal of Biomedical Materials Research haniluEmruu mmmsm mKME i biomateljials applicatlons u A um Relevant Websites 0 Biomaterials Network wwwbiomatnet a Medical Device Information wwwdevicelinkcom a Medical Materials Engineering reference wwwenqineerindreferencecom 0 United States Patents and Trademarks Office wwwusgtogov 0 General searchGoogle wwwciooqlecom o MEDLINEwwwncbinihqoventrezduervfcqi 11 72006 57 2 Polymer lemovai a Catheler for maximum flexibility K I 1172006 How many different types of biomaterials are in use today 55 AWNING IM 11 72006 59 Fact The FDA regulates 100000 different products that represent at least 1700 Different Types of Biomedical Devices 11 72006 60 Broad Classification O 00 Types of Blomaterlals 339 o ceramics o metals polymers synthetic and natural 1172006 61 Material Science Logic 000 Petri emaamm x 0 oc innuieiwe egm meefe 9 nge i i gfexeeeenmg 39 oPhyeuCon oBfke cg ee 11 72006 62 Bioinertness vs Bioactivity 5r Bioactive materials play a more aggressive role in the body While a biocompatible material should affect the equilibrium of the body as little as possible a bioactive material recruits specific interactions between the material and surrounding tissue 11 72006 63 Requirements of Biomaterials 5 A biomaterial must be 0 inert or specifically interactive o biocompatible 0 mechanically and chemically stable or a biodegradable o processable for manufacturability 0 nonthrombogenic if bloodcontacting e sterilizable 11 72006 64 Ceramics 0 Inorganic compounds that contain metallic and nonmetallic elements for which interatomic bonding is ionic or covalent and which are generally formed at high temperatures 0 Derivation From the Greek word quotkeramosquot meaning the art and science of making and using solid articles formed by the action of heat on earthy raw materials 0 Most ceramics occur as minerals o 1 The abundance of elements and geochemical characteristics of the earth s crust govern mineral types 0 2 Composition of Earth s Crust 84 O Si Al O50 Fe5K25 Si26Ca3Mg2 Al8Na25H1 11 72006 65 Ceramics 5 Advantages inert in body high wear resistance high modulus stiffness amp compressive strength fine esthetic properties for dental applications Disadvantages brittle low tensile strength poor fatigue resistance 11 72006 66 Ceramic Applications 55 artificial hip knee prostheses spinal fusion devices dentalcrowns bridges implants and caps o inner ear and cochear Implants cochlear Implants 0 drug delivery devices and 11 72006 67 Ceramics 0 Alumina Zirconium Calcium phosphate Silica pyrrolytic carbon hydroxyapatite are common 0 Porous ceramic materials exhibit much lower strengths but have been found extremely useful as coatings for metallic implants o The coating aids in tissue fixation of the implant by providing a porous surface for the surrounding tissue to grow into and mechanically interlock and 0 Certain ceramics are considered bioactive ceramics if they establish bonds with bone tissue 11 72006 68 Metals o closely packed crystal structure the type of bonding in metals and metal alloys render them valuable as load bearing implants as well as internal fixation devices used for orthopedic applications as well as dental implants 0 when processed suitably they contribute high tensile fatigue and yield strengths low reactivity and good ductility to the stems of hip implant devices and 0 Their properties depend on the processing method and purity of the metal however and the selection of the material must be made appropriate to its intended use 1172006 Metals Manufacturing 39 7 1 2n 4 4 Solid Made of fatal Hip System 11 72006 70 Other Uses of Metals if quot Jquot Stents 1172006 Catheters 71
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