| LEC # | TOPICS | READINGS |
|---|---|---|
| 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 | |
| Quiz | ||
| 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) | |
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