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F O U R T H E D I T I O NB I O L O G I C A L

P E R F O R M A N C EofM A T E R I A L SFundamentals o fBiocompatibility

J o n a t h a n B l a c k

QfP) Taylor &. Francis> ^ J T a y l o r & F r a n c is G r o u p

Boca Ra ton Lon don Ne w YorkA CRC t i t le , part o f the Taylor & Francis imprin t , a member o f theTaylor & Francis Group , the academic d iv is ion of T& F In form a p lc.

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Contents

P art I G e n e ra l C o n s i d e ra t io n sC h a p t e r 1 B i o c o m p a t i b i l it y : D e f i n i t i o n s a n d I s s u e s 31.1 I n t r o d u c t i o n 31.2 B iolo gical P er f o rma nce 51.3 C o n s e n s u s D e f i n i ti o n s 61.4 D iscus sio n 71.5 T he Disc ipline of B io m aterials 101.6 A f t e r w o r d : P a r a d i g m a t i c S h if t 12R e f e r e n c e s 14B i b l i o g r a p h y 1 5

C h a p t e r 2 I n t r o d u c ti o n to t h e B i o l o g i c a l E n v i r o n m e n t 172.1 G e n e r al C o n s i d e r a t i o n s 1 72.2 C o m p a r i s o n o f E x t e rn a l a n d I n t e r n a l C o n d i t i o n s 1 72.3 P r o b l e m s i n D e f i n i ti o n o f t h e B i o l o g i c al E n v i r o n m e n t 182.4 E l e m e n t s o f t h e B i o l o g i c al E n v i r o n m e n t 2 02.5 I m pla nt L ife H isto ry 222.6 P r e i m p l a n t a t i o n H a n d l i n g E f f ec ts 2 8R e f e r e n c e s 2 9B i b l i o g r a p h y 3 0

P art I I M a t e ri a l R e s p o n s e : F u n c t io n a n dD e g r a d a t io n o f M a t er ia ls In VivoC h a p t e r 3 S w e l l i n g a n d L e a c h in g 353.1 I n t r o d u c t i o n 3 53.2 F ick ' s L aw s of Dif fusio n 353.3 A b s o r p t i o n 363.4 E x a m p l e s o f U n d e s i r a b l e A b s o r p t i o n 3 83.5 O s m o t i c E q u i l i b r i u m 4 23.6 L each ing 433.7 E x a m p l e o f P l a n n e d L e a c h i n g : D r u g R e l ea s e 4 43.8 E f fec ts o f S well ing an d L eachin g 46R e f e r e n c e s 4 6B i b l i o g r a p h y 4 7

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C h a p t e r 4 C o r ro s io n a n d D i s s o l u t i o n 494 .1 C h e m i s t r y o f C o r r o s i o n 4 94.2 C lassi f ica t io n o f R eact io ns 504 .3 T h e P o u r b a i x D i a g r a m 5 14.4 T he E lectro chemical S er ies 544 .5 C o r ro s i o n R a te 5 64.6 P o t e n ti a l- C u r r e n t R e l a ti o n s h i p s i n C o r r o s i o n 5 74 .7 F o r m s o f C o r r o s i o n 5 84.8 C o r r o s i o n i n I m p l a n t A p p l i c a ti o n s 644 .9 E n g i n e e r i n g V a r ia b le s A f f e c ti ng C o r r o s i o n R a t es 6 64.10 C o r ro s i o n F a c to r s P e c u li a r t o B i o l o g ic al E n v i r o n m e n t s 6 74.11 C eramic Disso lut io n 684 .1 2 P o l y m e r D i s s o l u t i o n 694 .1 3 F i n al R e m a r k s '. 70R e f e r e n c e s 7 0B i b l i o g r a p h y 7 1

C h a p t e r 5 R e a c t i o n s o f B i o l o g i c a l M o l e c u l e s w i t hBiom ater ia l Surfa ces 735.1 I n t r o d u c t i o n 7 35.2 D en atur a t io n 745.3 O r g an o m e t al li c C o m p o u n d s 745.4 M e c h a n i c a l A s p e c t s o f I n t e rf a c e s 775.5 R e s u l ts o f I n t e rf a c i al A d h e s i o n o f M o l e c u l e s 80

5.6 E f fec ts o f C har ge d Inter faces an d Io ns 825.7 F i na l C o m m e n t s 8 3R e f e r e n c e s 8 4B i b l i o g r a p h y 8 4

C h a p t e r 6 M e c h a n i c s o f M a t e r ia l s : D e f o r m a t i o n a n d F a i lu r e 8 76.1 I n t r o d u c t i o n 8 76.2 M e c h a n i c s o f M a t e r i a ls 8 76.3 E l as ti c M o d u l u s 9 06.4 Yield S tren gth 966.5 F racture S trength 976.6 F i n al C o m m e n t 1 04R e f e r e n c e s 1 0 4B i b l i o g r a p h y 105C h a p t e r 7 F r i ct io n a n d W e a r 1 077 .1 I n t r o d u c t i o n 1 077.2 F rictio n 1077.3 L ubr icat io n 109

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7.4 W ear 1147.5 C o n c l u s i o n s 12 2R e f e r e n c e s t 122B i b l io g r a p h y 1 23I n t e r p a r t 1 I m p l a n t M a t e r ia l s : P r o p e r t i es 1 2511.1 I ntro du ct io n 12511.2 M eta ls 12611.3 P o lym ers 12911.4 C era m ics 13111.5 C o m po si tes 132R e f e r e n c e s 1 3 4B i b l i o g r a p h y 1 3 5

P a rt I I I H o s t R e s p o n s e : B i o l o g i c a l E f f ec ts o f I m p l a n t sC h a p t e r 8 T h e I n fl a m m a t o ry P r o c e s s 1 398.1 In tro du ct io n 1398.2 T h e I n f l a m m a t o r y R e s p o n s e 1398.3 In f ectio n 1508.4 E f f ects o f I m p l a n t D e g r a d a t i o n P r o d u c t s 1 558.5 A F i n al C o m m e n t 16 0R e f e r e n c e s 16 0B i b l i o g r a p h y 1 6 2

C h a p t e r 9 C o a g u l a t io n a n d H e m o l y s i s 16 59.1 I n t r o d u c t i o n 1 659.2 T h e C o a g u l a t i o n C a s c a d e 1 659.3 A p p r o a c h e s t o T h r o m b o r e s is t a n t M a t er ia l s D e v e l o p m e n t 1709.4 H em o lysis 1769.5 F i n a l C o m m e n t s 1 79R e f e r e n c e s 1 8 0B i b l i o g r a p h y 1 8 1

C h a p t e r 1 0 A d a p t a t io n 18310.1 In tro du ct io n 18310.2 T issue G ro w th S tra tegies 18310.3 E x a m p l e s o f A d a p t a t i o n i n I m p l a n t A p p l i c a ti o n s 18610.4 A F i na l C o m m e n t o n A d a p t a t i o n 197R e f e r e n c e s 1 9 9B i b l i o g r a p h y 2 0 1

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C h a p t e r 1 1 In Vitro T i s s u e G r o w t h a n d R e p l a n t a t i o n 2 0311.1 G e n e r a l C o n s i d e r a t i o n s 2 0 311.2 W ha t I s T issue E ngin eer ing ? 20411.3 T h e C e l l- R e c e p t o r P a r a d i g m 2 0611.4 M atr ices an d C el l S o urces 21011.5 T h i n k i n g T w i ce a b o u t T i ss u e E n g i n e e r i n g 2 1411.6 S o m e F i n al C o m m e n t s 2 20R ef e r e n c e s 2 2 2B i b l io g r a p h y 2 23

C h a p t e r 1 2 A l l e r g i e F o r e ig n B o d y R e s p o n s e 2 2512.1 S p e cif ic v s . N o n s p e c if i c R e s p o n s e 2 2512.2 M e c h a n i s m s o f I m m u n e R e s p o n s e 2 261 2.3 C l a ss e s o f H y p e r s e n s i t i v i t y R e a c ti o n s 2 301 2.4 H y p e r s e n s i t i v i t y R e a c t io n s A s s o c i a t e d w i t h I m p l a n t s 2 301 2.5 F i n al C o m m e n t 2 40R ef e r e n c e s 2 4 1B i b l i o g r a p h y 2 4 3

C h a p t e r 1 3 C h e m i c a l a n d F o r e i g n - B o d y C a r c i n o g e n e s i s 2 4513.1 Def inition s 2451 3.2 C h e m i c a l C a r c i n o g e n e s i s 2 461 3.3 F o r e ig n B o d y C a r c i n o g e n e s i s 2 5 713 .4 N o n s p e c if i c C a r c i n o g e n e s i s 2 621 3.5 E v i d e n c e f o r I m p l a n t C a r c i n o g e n e s i s i n H u m a n s 2 6 3R ef e r e n c e s 2 6 8B i b l i o g r a p h y 2 70

C h a p t e r 1 4 M i n er al M e t a b o li s m 2731 4.1 I n t r o d u c t i o n 2 7 31 4.2 I r o n M e t a b o l i s m 2 7414.3 C h r o m i u m M e t ab o l is m 2 8314 .4 H u m a n D i e t a r y M e t a l I n t a k e 2 85R ef e r e n c e s 2 8 8B i b l i o g r a p h y 2 8 9

C h a p t e r 1 5 S y s t e m i c D i s t r i b u t i o n a n d E x c re ti on 2 9 11 5.1 I n t r o d u c t i o n 2 9115.2 M o v e m e n t o f S o l id B o d ie s 2 9115.3 T ransp o r t o f Disso lved S pecies 29615.4 Distr ib ut io n an d E xcret io n o f Disso lved S pecies 301

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15.5 F i n al C o m m e n t 3 11R e f e r e n c e s 3 1 2B i b l i o g r a p h y 3 1 5

C h a p t e r 1 6 E f f e c t s o f D e g r a d a t i o n P r o d u c t s o n R e m o t eOr gan Fu n c t ion 31716.1 I ntro du ct io n 317

16.2 E xam ples of S ystem ic E ffects 31816.3 A R e v i e w o f S y s t em i c A s p e c t s o f H o s t R e s p o n s e 3 2116.4 A F i n al C o m m e n t 3 23R e f e r e n c e s 3 2 5B i b l i o g r a p h y 3 2 6

I n t e r p a r t 2 I m p l a n t M a t e r ia l s : C l i n i c a l P e r fo r m a n c e 3 2712.1 In tro du ct io n 32712.2 A n E x a m p l e : T o t al H i p R e p l a c e m e n t 3 3012.3 A F inal W o rd 332R e f e r e n c e s 3 3 2B i b l i o g r a p h y 3 3 3

P a rt I V M e t h o d s o f T e s ti n g f o r B i o l o g i c a l P e r f o r m a n c e

C h a p t e r 1 7 In Vitro T e st M e t h od s 33717.1 T est S trateg ies 33717.2 In Vitro T est T ypes , 33817.3 T issue C ul tur e T ests 33817.4 B loo d C o ntact T ests 34717.5 F i n al C o m m e n t s 3 50R e f e r e n c e s 3 5 1B i b l i o g r a p h y 3 5 3

C h a p t e r 1 8 In Vivo I m p l a n t M o d e l s 3 5518.1 In tro du ct io n 35518.2 T est T ypes 35818 .3 A F i n al C o m m e n t 3 70R e f e r e n c e s 3 7 0B i b l i o g r a p h y 3 7 3A p p e n d i c e s 374

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C h a p t e r 1 9 C l i n i c a l T e s t i n g o f I m p l a n t M a t e r i a ls 3 8319.1 G o al o f C l in ical T r ials 38319.2 D esig n of C linical T rials 3841 9.3 C o n c l u s i o n s f r o m C l in i c a l T r ia ls 3 9219.4 A spects o f the De cis ion fo r G ene ral C l in ical U se 3941 9.5 F i n a l C o m m e n t s 3 98R e f e r e n c e s 4 0 0B i b li o g r a p h y 4 01C h a p t e r 2 0 S t a n d a r d iz a t io n a n d R e g u l a t i o n o f

I m pla n t M a ter ia l s 4 0 320.1 His to r ical P erspec t ive 4032 0.2 D r u g S t a n d a r d i z a t i o n A c t iv i ti e s 4 0 42 0.3 B i o m a t e ri a ls S t a n d a r d i z a t i o n A c t iv i ti e s 4 062 0.4 U . S . F e d e r a l R e g u l a t i o n o f M e d i c a l D e v i c e s a n d B i o m a t e r ia l s 4 1 52 0.5 R e g u l a t i o n o f M a t e r i a l s f o r I m p l a n t s 4 192 0.6 T h e B i o m a t e r i a ls S u p p l y " C r i s i s " 4 22R e f e r e n c e s 4 2 3B i b l i o g r a p h y 4 2 4

C h a p t e r 2 1 D e s i g n a n d S e l e c t i o n o f I m p l a n t M a t e ri a ls 4 272 1.1 I n t r o d u c t i o n 4 2721.2 T he D esign P ro cess 4292 1.3 T h e V a l ue o f P r o s p e c t i v e D e s i g n 4 38R e f e r e n c e s 4 3 9B i b l i o g r a p h y 4 40

C h a p t e r 2 2 C l i n i c a l P e r fo r m a n c e o f B i o m a t e r i a l s 4 4122.1 His to r ical A spec ts 4412 2.2 P r o c e d u r e s f o r D e v i c e R e t r i e v a l a n d A n a l y s i s 4 4 32 2.3 C o m m o n C o n c e r n s a b o u t D e v i ce R e t ri e va l a n d A n a l y si s 4 4 72 2.4 P r o p o s e d N a t i o n a l I m p l a n t D a t a R e t ri e va l a n d A n a l y s isP r o g r a m ( N I D R A ) 4502 2.5 E l e m e n ts o f a N I D R A S y s te m 4 512 2.6 A u t o p s y R e t r ie v a l S t u d i e s 4 552 2.7 C o n c l u d i n g R e m a r k s 4 56R e f e r e n c e s 4 5 7B i b li o g r a p h y 4 57

Glossary 459G . l I n t r o d u c t i o n 4 59G .2 G l o s s a r y 4 60

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G .3 D e p r e c a t e d T e r m s 4 69R e f e r e n c e s 4 7 0

Index 471