|I. Principles Of Implant Design (Working Paradigms)|
|1||Clinical Problems Requiring Implants for Solution||
Chapter 1 Outline (PDF)
TORA. Chapter 1.
|2||Principles of Implant Design / Design Parameters: Permanent versus Absorbable Devices||Chapter 2 Outline (PDF)|
|3||The Missing Organ and its Replacement||TORA. Chapter 1.|
|4||Criteria for Materials Selection||TORA. Chapter 1.|
|5||Tissue Engineering I: Scaffolds||Langer, Robert, and Joseph P. Vacanti. "Tissue Engineering." Science, New Series 260, no. 5110 (May 14, 1993): 920-926.|
|6||Tissue Engineering II: Cells and Regulators|
|7||Case Study of Organ Regeneration||
TORA. Chapters 6, 7, and 10.
Yannas, I. V., et al. "Wound Tissue Can Utilize a Polymeric Template to Synthesize a Functional Extension of Skin." Science, New Series 215, no. 4529 (January 8, 1982): 174-176.
|II. Design Parameters|
|8||Design Specifications: Biomaterials Survey|
|9||Biocompatibility: Local and Systemic Effects|
|10||Design Specifications: Tissue Bonding and Modulus Matching|
|11||Degradation of Devices: Natural and Synthetic Polymers||Spector, Myron. "Biomaterials." Chapter 19 in Plastic Surgery. Vol. 1. Edited by B. M. Achauer, et al. Mosby: St. Louis, 2000. ISBN: 9780815110194.|
|12||Biocompatibility: Scar Formation and Contraction||TORA. Chapters 1, 2, and 4.|
|13||Degradation of Devices: Corrosion and Wear|
|14||Federal Regulation of Devices I||
FDA Guidance for Industry documents:
E6 Good Clinical Practice: Consolidated Guidance (PDF)
E10 Choice of Control Group and Related Issues in Clinical Trials (PDF)
|15||Oral Presentations of Proposals for Design II|
|16||Federal Regulation of Devices II||What is CE Marking?|
|III. Design Solution In-use|
|17||Scaffolds for Cartilage Repair|
|18||Implants for Bone|
|19||Implants for Plastic Surgery|
|20||Cardiovascular Prostheses: Heart Valves and Blood Vessels||
Mitchell, L. Shannon, and Laura E. Niklason. "Requirements for Growing Tissue-Engineered Vascular Grafts." Cardiovascular Pathology 12 (2003): 59-64.
Niklason, L. E., J. Gao, W. M. Abbot, K. K. Hirschi, S. Houser, R. Marini, and R. Langer. "Functional Arteries Grown in Vitro." Science 284 (April 16, 1999): 489-493.
Schoen, Frederick J., and Robert J. Levy. "Tissue Heart Valves: Current Challenges and Future Research Perspectives." Founder's Award, 25th Annual Meeting of the Society for Biomaterials, Providence, RI, April 28-May 2, 1999.
Rabkin, Elena, and Frederick J. Schoen. "Cardiovascular Tissue Engineering." Cardiovascular Pathology II (2002): 305-317.
|21||Devices for Nerve Regeneration||TORA. Chapter 6.|
|22||Musculoskeletal Soft Tissues: Meniscus, Intervertebral Disk|
|23||Dental and Otologic Implants|
|24||Other Devices: Spinal Cord, Heart Lung|
|25||Final Oral Presentation of Designs (Mock FDA Panel)|