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20.451

Design of Medical Devices and Implants

Graduate · Historical course

Spring 2006

This design course targets the solution of clinical problems by use of implants and other medical devices. Topics include the systematic use of cell-matrix control volumes; the role of stress analysis in the design process; anatomic fit, shape and size of implants; selection of biomaterials; instrumentation for surgical implantation procedures; preclinical testing for safety and efficacy, including risk/benefit ratio assessment evaluation of clinical performance and design of clinical trials. Student project materials are drawn from orthopedic devices, soft tissue implants, artificial organs, and dental implants.

Readings

  • A textbook for the course, known as TORA, is:
    Listed reading
  • Yannas, I. V. Tissue and Organ Regeneration in Adults . New York, NY: Springer, 2001. ISBN: 9780387952147.
    Listed reading
  • This page presents various outlines, notes, textbook selections, and journal articles assigned for some class sessions.
    Listed reading
  • TORA = Yannas, I. V. Tissue and Organ Regeneration in Adults . New York, NY: Springer-Verlag, 2001. ISBN: 9780387952147.
    Listed reading
  • Chapter 1 Outline ( PDF ) ↗
    Listed reading
  • TORA. Chapter 1.
    Listed reading
  • LEC #: 2 · TOPICS: Principles of Implant Design / Design Parameters: Permanent versus Absorbable Devices · READINGS: Chapter 2 Outline ( PDF ) ↗
    Reading assignment
  • LEC #: 3 · TOPICS: The Missing Organ and its Replacement · READINGS: TORA. Chapter 1.
    Reading assignment
  • LEC #: 4 · TOPICS: Criteria for Materials Selection · READINGS: TORA. Chapter 1.
    Reading assignment
  • LEC #: 5 · TOPICS: Tissue Engineering I: Scaffolds · READINGS: Langer, Robert, and Joseph P. Vacanti. “Tissue Engineering.” Science, New Series 260, no. 5110 (May 14, 1993): 920-926.
    Reading assignment
  • TORA. Chapters 6, 7, and 10.
    Listed reading
  • 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.
    Listed reading
  • LEC #: 11 · TOPICS: Degradation of Devices: Natural and Synthetic Polymers · READINGS: Spector, Myron. “Biomaterials.” Chapter 19 in Plastic Surgery . Vol. 1. Edited by B. M. Achauer, et al. Mosby: St. Louis, 2000. ISBN: 9780815110194.
    Reading assignment
  • LEC #: 12 · TOPICS: Biocompatibility: Scar Formation and Contraction · READINGS: TORA. Chapters 1, 2, and 4.
    Reading assignment
  • LEC #: 16 · TOPICS: Federal Regulation of Devices II · READINGS: What is CE Marking? ↗
    Reading assignment
  • Mitchell, L. Shannon, and Laura E. Niklason. “Requirements for Growing Tissue-Engineered Vascular Grafts.” Cardiovascular Pathology 12 (2003): 59-64.
    Listed reading
  • 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.
    Listed reading
  • 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.
    Listed reading
  • Rabkin, Elena, and Frederick J. Schoen. “Cardiovascular Tissue Engineering.” Cardiovascular Pathology II (2002): 305-317.
    Listed reading
  • LEC #: 21 · TOPICS: Devices for Nerve Regeneration · READINGS: TORA. Chapter 6.
    Reading assignment
Sources