Polymers in Medicine and Surgery

335 Pages·1975·7.093 MB·English

by  W. J. Kolff (auth.), Richard L. Kronenthal, Zale Oser, E. Martin (eds.)

POLYMER SCIENCE AND TECHNOLOGY
Volume 8
POLYMERS IN MEDICINE
AND SURGERY
POLYMER SCIENCE AND TECHNOLOGY
Editorial Board:
William J. Bailey C. A. J. Hoeve
University of Maryland Texas A&M University
College Park. Maryland College Station, Texas
Yoichi Ishida
J. P. Berry Osaka University
Rubber and Plastics Research Association Toyonaka. Osaka. Japan
of Great Britain
Frank E. Karasz
Shawbury
University of Massachusetts
Shrewsbury, England Amherst, Massachusetts
A. T. DiBenedetto Osias Solomon
The University of Connecticut Poly technical Institute of Bucharest
Storrs. Connecticut Bucharest, Romania
Volume 1 • STRUCTURE AND PROPERTIES OF POLYMER FILMS
Edited by Robert W. Lenz and Richard S. Stein. 1972
Volume 2. WATER-SOLUBLE POLYMERS
Edited by N. M. Bikales. 1973
Volume 3 • POLYMERS AND ECOLOGICAL PROBLEMS
Edited by James Guillet. 1973
Volume 4' RECENT ADVANCES IN POLYMER BLENDS, GRAFTS, AND BLOCKS
Edited by L. H. Sperling' 1974
Volume 5 .ADVANCES IN POLYMER FRICTION AND WEAR {Parts A and BI
Edited by Lieng-Huang Lee. 1974
Volume 6' PERMEABILITY OF PLASTIC FILMS AND COATINGS
TO GASES, VAPORS, AND LIQUIDS
Edited by Harold B. Hopfenberg' 1974
Volume 7' BIOMEDICAL APPLICATIONS OF POLYMERS
Edited by Harry P. Gregor' 1975
Volume 8 • POLYMERS IN MEDICINE AND SURGERY
Edited by Richard L. Kronenthal, Zale Oser, and E. Martin. 1975
Volume 9. ADHESION SCIENCE AND TECHNOLOGY {Parts A and BI
Edited by Lieng-Huang Lee. 1975
A Continuation Order Plan Is available for this series. A continuation order will bring
delivery of each new volume immediately upon publication. Volumes are billed
only upon actual shipment. For further information please contact the publisher.
POLYMER SCIENCE AND TECHNOLOGY
Volume 8
POLYMERS IN MEDICINE
AND SURGERY
Edited by
Richard L. Kronenthal
Ethicon Inc.
Somerville, New Jersey
Zale Oser
Patient Care Division
Johnson and Johnson
New Brunswick, New Jersey
and
E. Martin
Ethicon Inc.
Somerville, New Jersey
PLENUM PRESS· NEW YORK AND LONDON
Library of Congress Cataloging in Publication Data
Main entry under title:
Polymers in medicine and surgery.
(Polymer science and technology; v. 8)
"Proceedings of the Johnson & Johnson symposium held in Morristown, New
Jersey, July 11-12,1974."
Includes bibliographical references.
1. Polymers in medicine-Congresses. 2. Prosthesis-Congresses. I. Kronenthal,
Richard L. II. Oser, Zale. III. Martin, E. IV. Johnson and Johnson, inc. V. Series.
[DNLM: 1. Polymers-Congresses. 2. Biocompatible materials-Congresses. 3.
Biomedical engineering-Congresses. QT34 P783 1974]
R857.P6P64 610'.28 75-33684
ISBN-13: 978-1-4684-7746-7 e-ISBN-13: 978-1-4684-7744-3
DOl: 10.1007/ 978-1-4684-7744-3
Proceedings of the Johnson & Johnson Symposium held in Morristown,
New Jersey, July 11-12,1974
© 1975 Plenum Press, New York
Softcover reprint of the hardcover 1st edition 1975
A Division of Plenum Publishing Corporation
227 West 17th Street, New York, N.Y. 10011
United Kingdom edition published by Plenum Press, London
A Division of Plenum Publishing Company, Ltd.
Davis House (4th Floor), 8 Scrubs Lane, Harlesden, London, NW10 6SE, England
All rights reserved
No part of this book may be reproduced, stored in a retrieval system, or transmitted,
in any form or by any means, electronic, mechanical, photocopying, microfilming,
recording, or otherwise, without written permission from the Publisher
HANS H. ZINSSER, M.D.
It was with deep regret that we learned of the untimely death
of Hans Zinsser on August 14, 1974, less than five weeks after
his participation in this Symposium.
Combining unusual abilities in both clinical medicine and the
physical sciences, particularly electronics, Dr. Zinsser made
important contributions to ~he study of pyelonephritis, kidney
calculi and urological problems related to space medicine. He
was a member of many scientific organizations including the
New York Academy of Medicine, and the International Federation
of Medical Electronics; he was a member of the advisory boards
of the Institute of Radio Engineers and of the American Chemical
Society, and was a member of the Associate Editorial Board of the
New York State Journal of Medicine.
We keenly feel the loss we have all sustained and we will miss
a distinguished scientist, clinician and good friend. This volume
of contributions is dedicated to his memory.
v
PREFACE
The past decade has witnessed a vigorous growth in activities
toward the development of a variety of biomedical devices ranging
from the simple A-V shunt to the complex artificial heart. Re
search and development teams have been created comprising engi
neers, material scientists and clinicians and, perhaps for the
first time, such groups are collaboratively bringing their respec
tive talents to bear on problems associated with defects in the
human organism. These collaborations have resulted in a prolifera
tion of new information and a rapid and continuing redefinition of
the frontiers of progress. It was to keep pace with these changes,
and provide an updated view of the state of the art that this meeting
was conceived.
The present volume marks the publication of the proceedings
of the Johnson & Johnson Symposium held in Morristown,
New Jersey, on July 11 and 12, 1974. It surveys the applications
of polymers to medical and surgical problems and contains discus
sions on the biocompatibility of polymers, polymers as biomate
rials, and the use of polymers in prosthetic devices and drug re
lease systems. In addition, the Symposium offers recent perspec
tives on the critical problems of the material-tissue interface, the
design criteria for silicone-based systems, and the varied use of
polymers in artificial hearts, kidneys, eyes and lungs.
This Symposium was designed to provide an atmosphere for a
stimulating and productive discussion among scientists and clini
cians in the fields of biomaterials, biomedical engineering, pharma
cology, urology, ophthalmology, orthopedics, pulmonary and car
diovascular diseases, and biomedical device development. It is
hoped that researchers who were unable to attend the meeting will
benefit by reviewing the proceedings.
vii
viii PREFACE
The editors are particularly indebted to Dr. John Da Vanzo,
Dr. Jacob Struck, Jr., Mr. Frank Servas and Dr. Douglas
Walkling whose collaboration in organizing the Symposiwn was in
valuable and to Mrs. Carol Volpi who skillfully, cheerfully and
sometimes tearfully typed the manuscript.
Finally, the sponsorship of the Symposium by the Johnson &
Johnson Council of Research Directors and, in particular, the in
spired guidance of Mr. Foster B. Whitlock, Vice Chairman of the
Board of Directors, Johnson & Johnson, and Dr. Charles Artandi,
Vice President of Research, Ethicon, Inc., is gratefully acknowl
edged.
Richard L. Kronenthal
Zale Oser
E. Martin
August, 1975
CONTENTS
Artificial Organs and Their Impact. . . . . . . . . . . . .. 1
W. F. Kolff
Biomedical Polymers - An Introduction 29
Donald J. Lyman
Hydrogels - A Broad Clas s of Biomaterials . . . . . . . .. 33
Allan S. Hoffman
Necessary Considerations for Selecting a Polymeric
Material for Implantation with Emphasis on
Polyurethanes . . . . . . . . . . . . . . . . . . . . . 45
Garth L. Wilkes
Surface-Bonded Heparin 77
R. D. Falb
Silicones. . .... 87
John W. Boretos
Membranes ...... . 99
Harold B. Hopfenberg
Collagen: A Biological Plastic 109
Kurt H. Stenzel, Teruo Miyata,
and Albert L. Rubin
Biodegradable Polymers in Medicine and Surgery 119
Richard L. Kronenthal
ix
x CONTENTS
Blood Compatibility of Synthetic Polymers:
Perspective and Problems ........ . 139
R. E. Baier
Porous Polymeric Orthopedic Implants 161
Samuel F. Hulbert and L. S. Bowman
Skin Interfacing Techniques . . . . . 167
C. Wm. Hall and J. J. Ghidoni
Polymers in the Genitourinary Tract 175
Hans H. Zinsser
Biological Model Systems for the Testing of the
Toxicity of Biomaterials ........... . 181
John Autian
Silicone Based Release Systems ..... . 205
Gordon W. Duncan, Donald R. Kalkwarf,
and Jack T. Veal
Microcapsule Drug Delivery Systems 213
Joseph A. Bakan
Drug Delivery Systems: Design Criteria 237
Donald R. Cowsar
Controlled Release of Biologically Active Agents 245
Seymour Yolles
Polymers in Biomedical Devices: Materials for
Artificial Heart and Circulatory Assist Devices 263
William S. Pierce
Improved Biomaterials for Artificial Lung
Membranes ............... . 287
Warren M. Zapol and John Ketteringham
Materials for Use in the Eye . . . . . . . . 313
Miguel F. Refojo
Index ..... 333
ARTIFICIAL ORGANS AND THEIR IMPACT
W. J. Kolff
Division of Artificial Organs, Department of Surgery,
and The Institute for Biomedical Engineering, Univer
sity of Utah, Salt Lake City, Utah 84112
AR TIFICIAL KIDNEYS
While artificial kidneys are being applied to 40, 000 people
throughout the world, the search for the molecules most respon
sible for the clinical picture of uremia goes on. We have always
held that uremia is not due to a single toxin but to the summation
of all the substances retained in kidney failure and other factors
that occur as well.
Although we do not wish to blame any particular molecule,
Dr. Scribner in Seattle has some reason to believe that middle
sized molecules, or "midill molecules may be important for the
distressing symptoms of neuropathy in patients sustained with
artificial kidneys. The peritoneal membrane, being more perme
able than most cellophanes, is effective in removing these mole
cules (see later). A very promising way to remove larger mole
cules is with charcoal.
Charcoal Artificial Kidney. Our Drs. Andrade and Lentz have
coated carefully washed activated carbon (charcoal) with Hydron
(Fig. 1). Hydron is the material that is used in soft contact lenses.
Dr. Andrade can now flow blood directly over this charcoal. The
charcoal retains its capacity to adsorb molecules on its surface
but it does very little, if any damage to the blood cells and platelets.
Charcoal artificial kidneys will do best what the cellophane or
usual artificial kidneys do the least well, that is, the removal of