Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach: An integrated approach

Portada
Springer Science & Business Media, 30 nov 1993 - 303 páginas
are then selected and must meet the general 'biocompatibility' require ments. Prototypes are built and tested to include biocompatibility evalua tions based on ASTM standard procedures. The device is validated for sterility and freedom from pyrogens before it can be tested on animals or humans. Medical devices are classified as class I, II or III depending on their invasiveness. Class I devices can be marketed by submitting notification to the FDA. Class II and III devices require either that they show equivalence to a device marketed prior to 1976 or that they receive pre-marketing approval. The time from device conception to FDA approval can range from months (class I device) to in excess of ten years (class III device). Therefore, much planning is necessary to pick the best regulatory approach. 2. Wound Dressings and Skin Replacement 2.1 Introduction Wounds to the skin are encountered every day. Minor skin wounds cause some pain, but these wounds will heal by themselves in time. Even though many minor wounds heal effectively without scarring in the absence of treatment, they heal more rapidly if they are kept clean and moist. Devices such as Band-Aids are used to assist in wound healing. For deeper wounds, a variety of wound dressings have been developed including cell cultured artificial skin. These materials are intended to promote healing of skin damaged or removed as a result of skin grafting, ulceration, burns, cancer excision or mechanical trauma.
 

Índice

Scope and Markets For Medical Implants
1
12 Markets for medical implants
2
13 Materials of construction
4
14 Preclinical and clinical biocompatibility evaluation
25
15 Biology of transplantation of tissue products matching
29
16 Federal Food and Drug Administration FDA regulations
38
17 Summary
44
Wound Dressings and Skin Replacement
46
54 Mechanical properties of aorta and valve
167
55 Repair of cardiovascular tissue
179
56 Pathophysiology of aortic and valvular diseases
181
57 Aorta and heart valve replacements
183
58 Cardiac valve replacements
189
59 Summary
192
Facial Implants
194
62 Biochemistry of facial tissues
199

22 Biochemistry of skin
51
23 Mechanical properties of skin
57
24 Repair of skin
62
25 Incidence of skin wounds
66
26 Wound dressings
73
27 Summary
91
Replacement of Skeletal Tissues
92
32 Anatomy and physiology of tendons and ligaments
93
33 Biochemistry and biophysics
96
34 Mechanical properties of ligament
100
35 Repair of Ligament
103
36 Clinical evaluation of ligament function
105
37 ACL Reconstruction using biological and synthetic materials
107
38 Total joint replacement
113
39 Materials used in total knee replacement
116
310 Summary
118
Biomaterials Used In Ophthalmology
120
42 Anatomy of the eye
121
43 Biochemistry of eye structures
123
44 Mechanical properties of ocular tissues
125
45 Corneal wound healing
126
47 Intraocular lenses
143
48 Contact lens materials
145
49 Eye shields
148
410 Other ocular materials
149
411 Summary
151
Cardiovascular Implants
153
53 Anatomy and physiology of blood components
164
63 Mechanical properties of facial tissues
200
64 Repair of facial structures
204
65 Types of procedures performed in facial plastic surgery
206
66 Synthetic implant materials
213
67 Solid facial implants
216
68 Mesh materials
219
Dental Implants
220
72 Impression materials
221
73 Denture base resins
225
75 Cements for restorations
229
76 Dental porcelains
231
78 Other materials collagen
232
79 Summary
235
Breast implants
236
82 Anatomy and physiology of the breast
237
83 Psychology of breast augmentation
239
84 Types of breast implants
240
85 Complications associated with use of breast implants
243
86 Complications with polyurethanecovered implants
247
87 Implant placement
248
89 Summary
249
510 k and PMA Regulatory Filings in The US
250
92 Components of a 510 k regulatory filing
252
93 Premarket approval PMA application
255
References
262
Index
301
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Página 265 - Bell, E., Ivarsson, B., Merrill, C. (1979) Production of a tissue-like structure by contraction of collagen lattices by human fibroblasts of different proliferative potential in vitro.
Página 269 - Charnley J. Postoperative infection after total hip replacement with special reference to air contamination in the operating room.
Página 266 - Birk. DE. Fitch. JM. Babiarz. JP and Linsenmayer. TF (1988) Collagen type I and V are present in the same fibril in the avian corneal stroma. J. Cell Biol.. 106.
Página 276 - Harris, W. H., The synovial-like membrane at the bone-cement interface in loose total hip replacements and its proposed role in bone lysis, J.
Página 287 - NOYES, FR, and GROOD, ES: The Strength of the Anterior Cruciate Ligament in Humans and Rhesus Monkeys.
Página 280 - The diagnostic accuracy of ruptures of the anterior cruciate ligament comparing the Lachman test, the anterior drawer sign, and the pivot shift test in acute and chronic knee injuries.

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