Course Syllabus. BMEN 4360: Biomaterials and Medical Devices Fall Course Information

Transcription

1 Course Syllabus Course Information Course Number/Section: BMEN Biomaterials and Medical Devices Term: Fall 2016 Days &Times: Class meets in JSOM on Mondays and Wednesdays, 8:30 AM 9:45 AM Instructor Information Professor: Dr. Danieli Rodrigues Office Phone: Office: BSB Office hours: Mondays and Wednesdays from 10:00 11:00 AM Office hour s location: Lobby of BSB building Teaching Assistant: Cedric Paul Ambulo Office hours: Tuesdays and Thursdays from noon-1pm Office hour s location: TBD cpa160130@utdallas.edu Course Description Introduction to the field of biomaterials used in the design of medical devices and to augment/replace soft and hard tissues. Discussion of bulk properties, clinical applications and in vivo behavior of different classes of natural and synthetic materials. Analysis of biological response and biocompatibility, degradation and failure processes of implantable biomaterials/devices. Overview of regulatory compliance and performance requirements for commercialization of medical devices. Students will become familiar with several classes of biomaterials and their bulk and surface properties. Lectures will discuss design and performance requirements of implants, structure-property relationships for synthetic and biological materials, and static and dynamic properties of biomaterials. Course Learning Objectives: - CLO1: Use knowledge of biomaterials and medical devices to solve problems at the interface of engineering, biology, and physiology (SO: a) - CLO 2: Report contemporary challenges related to the design and development of artificial implants using current literature (SO: j) - CLO 3: Assess the performance of biomaterials and their interactions with the biological environment (SO: e) - CLO 4: Understand the regulatory environment governing development, performance and commercialization of medical devices (SO: h) 1

2 - CLO 5: Research standard testing procedures and their relationships to US and European regulations (SO: i) - CLO 6: Recognition of professional responsibility through evaluation of clinical cases (SO: f) Suggested Textbook Biomaterials Science: An Introduction to Materials in Medicine. Buddy D. Ratner et al. 2012, 3 rd edition or 2 nd edition (2004). Introduction to Biomaterials: Basic Theory and Engineering Applications. C. Mauli Agrawal, Joo L. Ong, Mark R. Appleford, Gopinath Man. Cambridge University Press 2014, 1 st Edition. Biomaterials: A Basic Introduction. Qizhi Chen and George Thouas. CRC Press, 2014, 1 st Edition. Note that the acquisition of a textbook is not required. Lecture notes, articles, and handouts will be distributed in class or uploaded in elearning. Lectures will use a combination of materials from several books, articles and other sources. Websites Course materials (lectures, updated syllabus, solutions, handouts, project summaries) will be available on elearning.utdallas.edu. o Other important resources: - FDA: - Testing Standards: Pre-requisites/Core-requisites BMEN 2320, CHEM 1312 Course Content Outline and Tentative Schedule: 08/22, 08/24, 08/29 1. Course Overview and Introduction 1.1. Course objectives and expectations 1.2. Introduction to biomaterials science 1.3. Brief history of biomaterials: surgeon-era to engineered biomaterials 1.4. Overview of current clinical applications: cardiovascular devices and stents, dental restoration, dental implants, neural prosthesis, ophthalmology, orthopedic implants, renal, skin applications Overview of the current medical device industry 2

3 08/31, 09/07, 09/12, 09/14, 09/19 2. Basic Properties of Biomaterials 2.1. Bonding, interatomic, intermolecular, surface interactions 2.2. Bulk properties: microstructure, strength, deformation, failure, fracture 2.3. Surface properties: hydrophilic and hydrophobic interactions, surface charges 09/21-11/07 3. Classes of Materials Used in Medicine 09/21, 09/26, 09/28, 10/ Metallic biomaterials: o general characteristics and desirable properties o fabrication and processing o surface: oxide film formation and surface modification techniques o main metallic alloys used in implantable devices: Ti, SST, Nitinol, CoCrMo, CoCr, Mg, Ta 10/05, 10/ Ceramic biomaterials: o general characteristics and properties o types of bioceramics o fabrication and strengthening o applications in the field: calcium phosphates, alumina, zirconia, natural and synthetic hydroxyapatite 10/12 Midterm 10/17, 10/19, 10/24, 10/26, 10/31, 11/ Polymeric biomaterials: o general information o basic principles: molecular and chemical structure, molecular weight and polydispersity o physical behavior o synthesis: addition, free-radical, condensation polymerization o selected applications in the field: (device, drug delivery, tissue engineering) - bioinert polymers: polyethylene, acrylics (PMMA), silicones - degradable and resorbable biopolymers - hydrogels 11/ Natural and Composite materials: (TBD) o general characteristics and desirable properties o hard and soft tissues 11/09, 11/14, 11/16 5. Biomaterials Degradation in the Biological Environment 5.1. Working environment of implants in the body 5.2. Chemically assisted degradation 3

4 5.2. Mechanically assisted degradation 5.3. Synergistic failure modes 5.4. Review of clinical cases of implant failure (selected fields: cardiovascular, neural, tissue, arthroplasty, dental, etc.) 11/28, 11/30 6. Biocompatibility 6.1. Biological responses to biomaterials 6.2. Blood-material interactions 6.3. Toxicity and hypersensitivity 6.4. Tumors associated with biomaterials and implants 6.5. Biofilms 12/05, 12/07 7. Special Considerations for Implantable Devices and Biomaterials 7.1. Sterility and patient safety 7.2. Device failure mode analysis 7.3. Design standards and regulatory compliance 7.4. Clinical trials and market approval Final exam: TBD Grading Policy o Midterm: 30% o Final: 30% o Homework: 10% o Quizzes: 25% o Analysis of selected journal articles, summary and group participation: 5% % % 92.9%- 90.0% 89.9%- 87.0% 86.9%- 83.0% 82.9%- 80.0% 79.9%- 77.0% 76.9%- 73.0% 72.9%- 70.0% 69.9%- 67.0% 66.9%- 63.0% 62.9%- 60.0% 59.9 Letter Grade A A- B+ B B- C+ C C- D+ D D- F Course Assessment o Midterm/Final: one midterm and one final exam will be given. The final will cover topics discussed after the midterm plus selected chapters, as determined by the instructor. o Homework: will be assigned more or less in a bi-weekly basis. It may be assigned for work in groups or as an individual activity. o Quizzes: will be given weekly/bi-weekly, covering past lectures, topics discussed in journal articles, or current lectures. Quizzes will be performed in class or as take home activity (individual or in groups). The lowest grade of one assignment will be dropped. In the case student misses one quiz, the missed assignment will be considered as the drop grade. Quizzes will motivate group discussion and when done in class the instructor will be available to answer questions and provide guidance. 4

5 This activity is an excellent tool to prepare for exams and to make students to think practically about topics discussed in class. o Analysis of journal articles: students will form groups of 3 and will select one clinical application of interest (e.g. dental restoration materials, orthopedic implants, drug delivery particles, etc.). Each group will research and find a recently published journal article related to the topic selected for review. Groups will prepare a 3-page summary on the article reviewed. These summaries will be posted on elearning and topics discussed will be included in the midterm, quizzes and final exams. Due dates, paper format and schedule will be posted after the second week of classes. Group performing the review will be asked questions in class about their review. Course & Instructor Policies: Make up exams: All students are expected to take the exams on the dates posted in the class schedule and as announced by the instructor. Unavoidable conflicts must be communicated to the instructor ahead of time. Missed exams without notification in advance of the absence will result in a grade of zero for the assignment or test. Late work: No late work will be accepted. Class attendance: Class attendance is mandatory. Advance notice for any non-emergency absence to the instructor is expected. Student will lose credit for the day of non-participation in the class activity. Use of cellular phones and other electronic devices will result in your being marked absent. To be counted in attendance you must be both physically and mentally present. This is a fast-paced and highly interactive class; therefore, students are expected to participate actively. Quiz(s): No make-up quiz will be offered if a student is absent for reasons other than an emergency situation. Classroom citizenship: Each student is expected to participate in quizzes and associated discussion. Instructor will mark student participation in class during lecture/discussions. UT Dallas Syllabus Policies and Procedures The information contained in the following link constitutes the University s policies and procedures segment of the course syllabus. Please go to for these policies. The descriptions and timelines contained in this syllabus are subject to change at the discretion of the Professor. 5