Biomaterials Science: An Integrated Clinical and Engineering Approach

320 Pages·2012·3.757 MB·English

by  Yitzhak Rosen, Noel Elman

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NOEL ELMAN
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an informa business New York, NY 10017
2 Park Square, Milton Park
Abingdon, Oxon OX14 4RN, UK
BIOMATERIALS
SCIENCE
An Integrated Clinical
and Engineering Approach
Philip John Stephens
Frank J. Devlin
James R. Cheeseman
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BIOMATERIALS
SCIENCE
An Integrated Clinical
and Engineering Approach
Philip John Stephens
Frank J. Devlin
James R. Cheeseman
Edited by
YITZHAK ROSEN
Boca Raton London New York
CRC Press is an imprint of the
Taylor & Francis Group, an informa business
CRC Press
Taylor & Francis Group
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Boca Raton, FL 33487-2742
© 2012 by Taylor & Francis Group, LLC
CRC Press is an imprint of Taylor & Francis Group, an Informa business
No claim to original U.S. Government works
Version Date: 20120510
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Contents
Foreword ...............................................................................................................vii
Authors ....................................................................................................................ix
Contributors ............................................................................................................xi
1 Introduction .....................................................................................................1
Yitzhak Rosen, Noel Elman, Emanuel Horowitz
2 Principles of Clinical and Engineering Integration in
Hemocompatibility ........................................................................................5
Yitzhak Rosen, Noel Elman
3 Medical Applications of Micro-Electro-Mechanical Systems
(MEMS) Technology ....................................................................................29
Michael A. Huff
4 Nanoparticles to Cross Biological Barriers .............................................85
Thomas Moore, Elizabeth Graham, Brandon Mattix, Frank Alexis
5 Biomaterials, Dental Materials, and Device Retrieval and
Analysis ........................................................................................................123
Jack E. Lemons
6 Biomaterials and the Central Nervous System: Neurosurgical
Applications of Materials Science ...........................................................135
Urvashi M. Upadhyay
7 Biomaterials in Obstetrics and Gynecology .........................................149
David Shveiky, Yael Hants
8 Tissue Engineering: Focus on the Cardiovascular System ................165
Ayelet Lesman, Shulamit Levenberg
9 Tissue Engineering: Focus on the Musculoskeletal System ..............191
Michael Keeney, Li-Hsin Han, Sheila Onyiah, Fan Yang
10 Regulatory Challenges in Biomaterials: Focus on Medical
Devices ....................................................................................................223
Pablo Gurman, Orit Rabinovitz-Harison, Tim B. Hunter
v
vi Contents
11 Innovative Product Development and Technology Adoption for
Medical Applications .................................................................................271
Stephen M. Jarrett
Appendix: Some Examples of FDA-Approved Products ...........................293
Pablo Gurman
Index .....................................................................................................................303
Foreword
Biomaterials science is a multi-disciplinary field. The book offers a good
overview of biomaterials as medical devices, drug delivery and tissue engi-
neering systems. The emphasis is on integrating clinical and engineering
approaches. In particular, the book covers various applications of bioma-
terials in unmet clinical needs in a variety of fields which include tissue
engineering of musculoskeletal and cardiovascular tissues, neurosurgery,
hemocompatibility, Micro-Electro Mechanical Systems (MEMS), nanoparti-
cle based drug delivery, dental implants, and obstetrics/gynecology. It also
covers areas such as regulatory challenges and commercialization issues.
Robert Langer
Institute Professor
David H. Koch Institute for Integrative Cancer Research
Harvard-MIT Division of Health Science and Technology
Chemical Engineering Department
Massachusetts Institute of Technology
Summary
This book provides a comprehensive list of applications summarized as
follows:
• Hemocompatibility. Overview of clinical and engineering integration
and its role and importance; examples of stents and their c hallenges.
This chapter discusses examples of special clinical states such as
hypercoagulability in pregnancy and patient individual differences.
• Nanoparticles. This chapter provides a review of drug delivery
methods, challenges, and complications. These include various
nanoparticle-based systems and their functionalization with target-
ing molecules for various applications.
• Neurosurgery/Neurology. This chapter provides a review of exam-
ples of devices and their integration barriers and complications. The
challenges from a clinician point of view are discussed.
• Dental. Odontological – Engineering Integration. This chapter pro-
vides an insightful review on the need to combine clinical and mate-
rials engineering to design new materials for dental applcations.
Various materials are described with their impact.
vii
viii Foreword
• BioMEMS. Biological Micro-Electro-Mechanical-Systems. This chap-
ter provides a technological review of devices. A number of examples
are described, as well as microdevices, materials, and integration
challenges.
• Tissue Engineering. Musculoskeletal description. This chapter
provides methodologies for scaffolding in this area. Hydrogels are
described for this purpose as well as the use of designated stem
cells. Also, the use of electrospun nanofibers and supercritical CO
2
are described.
• Tissue Engineering. Cardiovascular application. This chapter pro-
vides methodologies for scaffolding. Hydrogels, polymeric porous
scaffolding, biomaterial free tissue engineering and various stem
cells are described.
• Obstetrics and Gynecology. Clinical integration. This chapter pro-
vides a comprehensive insight related to a number of issues in this
field, including: fetal toxicity; understanding the histological, physi-
ological aspects; design of new materials and devices. A number of
cases are described, including an example of clinical and engineer-
ing integration with a copper intrauterine device releases copper
ions into the endometrium.
• FDA. Regulation/Ethic. This chapter provides an overview of clini-
cal trials and regulation. The differences between various regulation
administrations in the world are described. Radiological applica-
tions are also discussed. Excellent case studies are used.
• Commercialization. Transition. This chapter provides an under-
standing of market needs and transitioning into the market.
Diagrams are used to describe a useful process to achieve market
endpoints.
• Appendix. FDA references. This appendix provides relevant refer-
ences related to the regulatory processes.
Janet Zoldan
Research Scientist
David H. Koch Institute for Integrative Cancer Research
Chemical Engineering Department
Massachusetts Institute of Technology
Authors
Yitzhak Rosen, MD, is a graduate of the Tel Aviv University of Medicine.
He is currently a visiting research scientist at the Institute for Soldier
Nanotechnologies, Massachusetts Institute of Technology. He is also
the president and CEO of Superior NanoBioSystems LLC, a biomedi-
cal company. He has served in the Israel Defense Forces (IDF) as a
medical officer and physician in militarily active areas. He completed a
medical internship at the Rabin Medical Center and has worked at the
Oncology Institutes of both the Rabin and the Sheba Medical Centers
in Israel. He has invented a microfluidic chip platform, funded by the
Defense Advanced Research Projects Agency (DARPA), for effecting
extremely rapid blood typing and cross-matching for mass casualties in
collaboration with the MEMS and Nanotechnology Exchange. In addition,
he is the inventor of several medical ultrasound technologies. At Johns
Hopkins University, he has been an invited lecturer in the area of nano-
technology in medicine for several years at the Biology Department for
full-time undergraduate students. He has also taught a full course at the
Department of Materials Science and Engineering at Johns Hopkins in
biomaterials science for full-time undergraduate students. He took part
in several key humanitarian medical relief missions as a medical doctor
in Haiti in January 2010, immediately after the earthquake, and then in
May 2010. He also worked as a medical doctor with the Global Medical
Brigades Chapter, School of Public Health, Johns Hopkins University,
in several remote areas in Honduras in June 2010. He is the author of
publications in the fields of clinical medicine and micro- and nanotech-
nologies.
Noel Elman, PhD, is currently a research scientist at the Institute for Soldier
Nanotechnologies at the Massachusetts Institute of Technology (MIT). He
leads a research group focused on biomedical technologies based on nano-
and microtechnologies for both diagnostics and therapeutics. He received
his BS and Master’s degrees in Electrical Engineering from Cornell
University, where he focused on the development of micro-opto-electro-
mechanical systems (MOEMS). He received his PhD degree in Physical
Electronics from the Department of Electrical Engineering at Tel Aviv
University in 2006. His PhD thesis focused on the development of a new
family of biosensors based on the unique integration of living whole cells
with semiconductor, MOEMS, and nanotechnologies. His postdoctoral
studies at the Department of Materials and Engineering at MIT focused
on the development of biomedical microdevices based on MEMS and
nanotechnologies for both therapeutics and diagnostics. He is also the
ix