Description
This book covers two areas, the first detailing the concepts and technologies of drug-device combination products. The second area includes case studies of important products that either significantly shape our technologies and thinking, or contribute to current healthcare practice. The book: * Discusses where drugs and devices work, where they fail, and when they need to work with each other * Reviews interactions between human bodies and the drug-device combination products the measurements of these interactions * Covers how a drug-device combination product is developed, tested, and regulated * Includes case studies of steroid releasing leads, AOA treated tissue heart valves, intrathecal drug delivery pumps, infuse bone grafts, drug eluting stents, and antimicrobial meshes FOREWORD vii PREFACE ix PART I BACKGROUNDS 1 1 Addressing Medical Device Challenges with Drug-Device Combinations 3 2 Historical Survey of Drug Delivery Devices 39 3 Development of Combination Product Drug Delivery Systems 66 4 Drug-Material Interactions, Materials Selection, and Manufacturing Methods 89 PART II PRODUCTS 117 5 Steroid-Releasing Lead 119 6 Thromboresistant Vascular Graft 142 7 Device-Enabled Drug Infusion Therapies 182 8 Promus Element Plus(r): A Drug-Eluting Stent 214 9 Infuse(r) Bone Graft 241 INDEX 261
