TT 532: EVALUATION OF BIOTEXTILES
Course Justification:
This course is required in the MS Textiles: Medical Textiles Specialization. With rapid growth in the development of innovative implantable biotextile products, the student needs to appreciate the long and tortuous route from conception to commercialization, and that stringent requirements for safety and efficacy must be met prior to the product reaching the clinical marketplace. This course addresses the issues related to the process of biotextile evaluation during product development, particularly how to screen novel candidate materials and structures for biocompatibility and biostability. The students’ understanding of these issues will be enhanced by laboratory exercises that demonstrate key analytical tests used to measure 1) the host response to the biotextile, and 2) the stability of the biotextile exposed to a hostile biological environment. The scope of the course will also include an awareness of how government regulations impact the quality, inspection, risk assessment and ethical strategies applied by manufacturers during product development and production.
Resource Statement:
With the hiring of a faculty member with qualifications and experience in biomaterial science and biotextile engineering, this new course can be offered by the College of Textiles. The Burlington Textiles Library is currently expanding the scope of its collection to include titles and references in the fields of biomaterials, biotextiles, medical textiles and related devices.
In addition there is need for a biotextile teaching laboratory with appropriate equipment and facilities to undertake the various experiments planned for the course, and to facilitate the independent projects that students are required to complete. Space within the College of Textiles has been found for this laboratory, and funds are being sought and identified to permit the renovation of the space and the purchase of the necessary equipment. There will be a need for technical support to manage and maintain the laboratory and prepare samples for the analytical experiments. This laboratory facility with technical support is expected to be operational by Spring 2004.
Enrollment:
The anticipated level of enrolment is 12 students.
Consultation with Other Departments:
SYLLABUS
TT 532: EVALUATION OF BIOTEXTILES
Catalog Description
Evaluation of the performance of biotextiles and medical polymers in biological and micro-biological environments, with an emphasis on in vitro and in vivo techniques for testing the biocompatibility and biostability of implantable biomedical products. Related issues will deal with quality assurance systems, inspection and sampling plans, ISO certification, GMP’s, reference materials and organisms, and the use of accelerated tests and animal trials so as to meet regulatory requirements.
Instructor
Martin W. King
Office: Room 3305, College of Textiles
Tel: 515-1011 Fax: 515-3733 E-mail:
Office Hours.: By appointment
Textbooks
No textbook required. Selected readings will be taken from research literature and the following textbooks and placed on Reserve in the Burlington Textiles Library:
1) Braybrook J H, Biocompatibility Assessment of Medical Devices and Materials, John Wiley & Sons, Chichester, UK, 1997.
2) Ratner B D, Hoffman A S, Scheon F J and Lemmons J E. Biomaterials Science, an Introduction to Materials in Medicine. Academic Press, San Diego, CA, 1996.
3) Helmus, M N. Biomaterials in the Design and Reliability of Medical Devices, Kluwer Adademic / Plenum Publishers, New York, NY, 2003.
Course Objectives
At the completion of this course, students will be able to:
1. Select the appropriate methods for evaluating the biocompatibility, biostability, safety and efficacy of biotextile products developed for particular medical and surgical applications.
2. Explain the host reaction to implantable biotextiles and biomedical polymers in terms of their inflammatory and immunological responses, the blood coagulation pathway, and issues of local and systemic toxicity, tumorigenesis and infection.
3. Describe how in vitro and in vivo techniques may be used to predict blood/material interactions, tissue biocompatibility, chemical degradation, bioresorption, mechanical breakdown and calcification of biotextile implants.
4. Explain the value and limitations of using implant retrieval analysis, reports of device failure and accelerated fatigue testing to understand the clinical biostability of biotextiles.
5. Identify the roles of proteins, biotextile surface properties and cell/material interactions on the performance of implantable biotextiles and biomedical polymers in biological and microbiological environments.
6. Describe the development and use of voluntary consensus standards and mandatory regulatory requirements, quality assurance systems, inspection plans, GMP’s, risk assessment and standard reference materials and organisms in the development and commercialization of new biotextile products.
7. Characterize problems and limitations associated with the current methods of evaluating the biological performance of biotextiles and medical biomaterials.
POLICIES AND PROCEDURES
Prerequisites
The prerequisites for this course are ZO 160, TC203, TMS 211, CH220 or their equivalent. If you do not have the prerequisites, please see the instructor at the conclusion of the first class period. It is the student’s responsibility to satisfy course prerequisites, or to obtain permission of the instructor to take this course.
Grading
Tests 20%
Independent project 25%
Attendance 5%
Laboratory Reports 30%
Final Exam 20%
· Late homework and laboratory reports will be penalized at the rate of 10% per weekday after the due date. Solutions for the tests will be posted on the course webpage.
· The course will be graded on a plus/minus scale as follows:
97-100: A+93-96: A
90-92: A-
87-89: B+
83-86: B / 80-82: B-
77-79: C+
73-76: C
70-72: C- / 67-69: D+
63-66: D
60-62: D-
59 or less: F
· At the discretion of the instructor students may be given an incomplete (IN) grade for work not completed during the semester. Eligibility for an incomplete grade will be determined on a case by case basis. See the following website for more information on incomplete grades. http://www.ncsu.edu/provost/academic_policies/grading/reg.htm
Attendance
· Attendance in lecture and laboratory classes is expected and will be monitored with the circulation of an attendance list at the beginning of each class. Absences will be excused on health and compassionate grounds. Students who are late or absent will lose attendance marks which will account for 5% of their final grade.
· Students may with prior approval of the instructor make up work missed during excused absences within a previously agreed time period. Students will not be allowed to make up work missed during unexcused absences.
Academic Integrity
The NCSU Code of Student Conduct may be found at http://www.fis.ncsu.edu/ncsulegal/41.03-codeof.htm. Students are expected to comply with this code. Cheating in this course will result in severe disciplinary action, including loss of marks for the test, assignment or report in question.
Students with Disabilities
Reasonable accommodations will be made for students with disabilities. In order to take advantage of available accommodations, students must register with Disability Services for Students at 1900 Student Health Center, Campus Box 7509, 515-7653.
http://www.ncsu.edu/provost/offices/affirm_action/dss/
For more information on NC State's policy on working with students with disabilities, please see
http://www.ncsu.edu/provost/hat/current/appendix/appen_k.html
Course Scope and Schedule
Week / Topic / Lab & Other Assignments1 / Overview of Biotextile Science / Lab #1
2 / Measuring Biotextile Biocompatibility, Protein adsorption / Lab #2
3 / Blood/biotextile material interactions / Lab #3
4 / Measuring biotextile thrombogenicity / Lab #4 and Test 1
5 / Measuring host/biotextile inflammatory response / Lab #5
6 / Measuring host/biotextile immunological response / Lab #6
7 / Measuring biotextile cytotoxicity, calcification and infection / Lab #7 and Test 2
8 / Methods for Measuring Biostability and Bioresorption / Lab #8
9 / Mechanical & chemical methods for measuring degradation / Lab #9
10 / Accelerated fatigue testing of synthetic & natural biotextiles / Project
11 / Biotextile implant retrieval analysis / Project and Test 3
12 / Bio-Evaluation in a Regulatory Environment, Standardized testing and use of standard reference materials and organisms / Project
13 / Quality assurance systems, inspection plans, and GMP’s in commercial biotextile manufacturing operations / Project
14 / Risk assessment and ethical issues in biotextile manufacture / Project
15 / Oral presentations of independent projects
Laboratory Experiences and Topics for Independent Project
The weekly laboratory experiments will be selected from the following list of topics. In addition students will be expected to select a topic from this list to pursue as an independent project.
1. Measuring surface energy of biotextiles
2. Competitive protein adsorption (eg from plasma) on biotextile surfaces
3. Effect of surface modification on protein adsorption
4. Measurement of thrombogenicity and initial blood/biotextile material response
5. Histological techniques for observing inflammatory response of biotextiles
6. Fluorescence microscopy to identify cell signalling proteins
7. Cytotoxicity by cell culture of L929 murine fibroblasts in presence of extractables
8. Measuring rate of resorption of resorbable biotextiles by enzymatic and pH hydrolysis
9. Mechanical and chemical methods of measuring degradation of biotextiles
10. Cell adhesion by organotypic culture of embryonic endothelial cells
11. Techniques for measuring dermal hypersensitivity
12. Microbiological methods of measuring activity of antimicrobial agents
13. Analysis of retrieved biotextile implants
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