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( 1 2 ) Ulllted States Patent ( 1 0 ) P a t e n t N 0 . : U S 8 , 0 2 9 , 5 1 5 B2S h i u e y ( 4 5 ) D a t e o f P a t e n t : O c t . 4 , 2 0 1 1

( 5 4 ) CORNEAL IMPLANTS AND METHODS AND 2 * l g ; g h f i l s t 6 t a 1 606m, , rc owsiet . ......... ..SYSTEMS FOR PLACEMENT 5 , 7 0 2 , 4 4 1 A 1 2 / 1 9 9 7 Zhou

5 , 8 6 8 , 7 5 2 A 2 / 1 9 9 9 Makk t a l .( 7 5 ) I n v e n t o r : Y i c h i e h S h i u e y , C u p e r t i n o , CA ( U ) 5 , 9 1 9 , 1 9 7 A 7 / 1 9 9 9 M c D o i f a i d6 , 0 5 0 , 9 9 9 A 4 / 2 0 0 0 P a r a s c h a c e t a l .( 7 3 ) A s s i g n e e : Y i c h i e h S h i u e y , S a n J o s e , CA U S ) 6 , 1 6 2 , 2 2 9 A 1 2 / 2 0 0 0 F e i n g o l d e t 3 1 .6 , 4 5 4 , 8 0 0 B2 9 / 2 0 0 2 Da l t o n e t a l .( * ) N o t i c e : S u b j e c t t o a n y d i s c l a i m e r , t h e t e r m o f h i s g i l g n m e t a 1

p a t e n t i s extended o r a d j u s t e d under 35 6 , 6 8 9 , 1 6 5 B2 2 / 2 0 0 4 J a c o b e t a 1 U . S . C . 1 5 4 ( b ) b y 3 1 9 d a y s . 6 , 7 1 2 , 8 4 8 B 1 3 / 2 0 0 4 W o l f e t a l .

6 , 7 8 6 , 9 2 6 B2 9 / 2 0 0 4 P e y r n a n( 2 1 ) A p p l . N o . : 1 1 / 7 4 1 , 4 9 6 6 , 8 5 5 , 1 6 3 B 2 2 / 2 0 0 5 P e y m a n6 , 8 5 8 , 0 3 3 B2 2 / 2 0 0 5 K o b a y a s h i

_ 6,976,997 B2 12/2005 Noolan di e t a l .(22) Med Apr- 2 7 2007 7 , 2 7 6 , 0 7 1 B2 * 10/2007 Lin e t a l . . . . . . . . . . . . . . . . . . . . . . 606/1072 0 0 2 / 0 0 2 2 8 8 1 A1 2 / 2 0 0 2 F i g u e r o a e t a l .( 6 5 ) Prior P u b l i c a t i o n Data 2 0 0 2 / 0 0 5 5 7 5 3 A1 5 / 2 0 0 2 S i l v e s t r i n i2 0 0 3 / 0 0 2 5 8 7 3 A1 2 / 2 0 0 3 OcampoUs 2007/0244559A1 001 8 > 2007 2003/0050646 A1 3/2003 Kikuchietal. . . . . . . . . . . . . . 606/1072003/0054109 A1 3 / 2 0 0 3 Quinn t a l .

R e l a t e d US. p p l i c a t i o n Data ( C o n t i n u e d )( 6 3 ) C o n t i n u a t i o n - i n - p a r t o f a p p l i c a t i o n N o . 1 1 / 3 4 1 , 3 2 0 ,? l e d on J a n . 2 6 , 2 0 0 6 , noW abandoned. OTHERPUBLICATIONS( 6 0 ) P r o v i s i o n a l a p p l i c a t i o n NO 6 0 / 6 4 8 9 4 9 ? l e d on J a n I n t e r n a t i o n a l S e a r c h R e p o r t a n d W r i t t e n O p i n i o n o f PCT p p l i c a t i o n

3 1 2 0 0 5 ' N o . P C T / U S 0 6 / 0 2 9 1 8 , d a t e d May 1 , 2 0 0 8 , 1 1 p a g e s t o t a l .C o n t i n u e d( 5 1 ) I n t . C l . ( )

A61F / 0 0 (200601) Primary Examiner* . Tho m as HughesU.S. Cl- . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Assislanl Examineri Simpson

( 5 8 ) Field of Classi?cation Search . . . . . . . . . . . . . . . . 606/107; ( 7 4 ) Anomeyl g e n t ) OrFirmiilson s o n s i n i G00drich&6 2 3 / 5 1 1 , 6 . 1 2 R o s a t iS e e a p p l i c a t i o n ? l e f o r c o m p l e t e s e a r c h h i s t o r y . ( 5 7 ) ABSTRACT( 5 6 ) R e f e r e n c e s C i t e d

U . S . PATENTDOCUMENTS4 , 7 0 6 , 6 6 6 A 1 1 / 1 9 8 7 S h e e t s4 , 9 1 9 , 1 3 0 A 4 / 1 9 9 0 S t o y e t a l .5 , 2 1 1 , 6 6 0 A 5 / 1 9 9 3 G r a s s o5,269,812 A * 12/ 1993 White . . . . . . . . . . . . . . . . . . . . . . . . . . . 128/ 8985 , 3 0 0 , 1 1 6 A 4 / 1 9 9 4 C h i r i l a e t a l .

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A ystem comprising a holloW m e m b e r s used t o d e l i v e r ac o n s t r a i n e d c o r n e a l i m p l a n t i n t o a c o r n e a l p o c k e t . The o l l o Wm e m b e r may b e t a p e r e d a n d t h e s y s t e m may f u r t h e r i n c l u d ean i m p l a n t d e f o r m a t i o n chamber and an a x i a l p u s h e r t oa d v a n c e t h e i m p l a n t t h r o u g h t h e h o l l o W m e m b e r .

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P e y r n a nJ e t h m a l a n i e t a l .He rbe rge r e t a l . . . . . . . . . . . . . 606/107S h i u e yS h i u e y e t a 1 .Le e t a l .Matsuda e t a l .

OTHERPUBLICATIONSI n t e r n a t i o n a l S e a r c h R e p o r t a n d W r i t t e n O p i n i o n o f PCT p p l i c a t i o nN o . P C T / U S 0 8 / 6 1 6 5 6 , d a t e d S e p . 1 6 , 2 0 0 8 , 9 p a g e s t o t a l .F i n a l R e j e c t i o n o f U . S . A p p l . N o . 1 1 / 3 4 1 , 3 2 0 , m a i l e d N o v . 1 9 , 2 0 0 9 ,1 2 page o t a l .* c i t e d b y examiner



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US 8 , 0 2 9 , 5 1 5 B21

CORNEALIMPLANTSANDMETHODSANDSYSTEMS FOR PLACEMENT

CROSS-REFERENCESTO RELATEDAPPLICATIONS

The p r e s e n t a p p l i c a t i o n i s a c o n t i n u a t i o n - i n - p a r t o f US.a p p l i c a t i o n S e r . N o . 1 1 / 3 4 1 , 3 2 0 , ? l e d o n J a n . 2 6 , 2 0 0 6 , Whichc l a i m s t h e b e n e ? t o f r o v i s i o n a l A p p l i c a t i o n N o . 6 0 / 6 4 8 , 9 4 9 ,? l e d J a n . 3 1 , 2 0 0 5 , t h e f u l l d i s c l o s u r e s o f Which r e i n c o r p or a t e d h e r e i n b y r e f e r e n c e .

BACKGROUND OFTHE INVENTIONF i e l d o f t h e I n v e n t i o n

T h e r e a r e many d i f f e r e n t t y p e s o f c o r n e a l i m p l a n t s t h a thave been e v e l o p e d f o r t h e t r e a t m e n t of e f r a c t i v e e r r o r andd i s e a s e . B e c a u s e o f l i m i t a t i o n s i n t h e methods o f c r e a t i n gc o r n e a l p o c k e t s , t h e s e i m p l a n t s h a v e a l l b e e n d e s i g n e d f o rp l a c e m e n t i n t h e c o r n e a by c r e a t i o n o f a c o r n e a l i n c i s i o nWhich s e i t h e r s i m i l a r i n s i Z e t o t h e s m a l l e s t dimension o f t h ei m p l a n t o r l a r g e r . R e c e n t l y , t W o m e t h o d s o f c o r n e a l p o c k e tc r e a t i o n have been devised Which can r e a t e a pocket With ane x t e r n a l o p e n i n g W i d t h t h a t i s l e s s t h a n t h e m a xi m u m n t e r n a lW i d t h o f t h e p o c k e t . These tWo method s a r e p o c k e t c r e a t i o nb y t h e f e m t o s e c o n d l a s e r a n d , o f p a r t i c u l a r i n t e r e s t , c o r n e ac u t t i n g , a s d e s c r i b e d i n US 2 0 0 4 / 0243159 and 0 2 4 3 1 6 0 ,i n v e n t e d by h e i n v e n t o r h e r e i n , t h e f u l l d i s c l o s u r e o f Which si n c o r p o r a t e d h e r e i n b y r e f e r e n c e .

I t i s a d v a n t a g e o u s t o h a v e a b i o c o m p a t i b l e c o r n e a l i m p l a n tt h a t c a n b e p l a c e d t h r o u g h a n e x t e r n a l i n c i s i o n t h a t i s l e s s t h a nt h e W i d t h o f h e i m p l a n t , e s p e c i a l l y a n e x t e r n a l i n c i s io n t h a t i sl e s s t h a n h a l f o f t h e W i d t h o f t h e i m p l a n t . A m a l l e x t e r n a li n c i s i o n d e c r e a s e s i n d u c e d s u r g i c a l a s t i g m a t i s m a n d s p e e d sup t h e r e c o v e r y t i m e f o r t h e p a t i e n t . M o r e o v e r , i t i s u s e f u l t oh a v e a r e l a t i v e l y l a r g e i m p l a n t t h a t c a n b e p l a c e d t h r o u g h ar e l a t i v e l y s m a l l i n c i s i o n . F o r e x a m p l e a l e n s i m p l a n t t h a t i sl a r g e r i s m o r e l i k e l y t o g i v e g o o d q u a l i t y v i s i o n e s p e c i a l l y i na p a t i e n t W i t h l a r g e p u p i l s . I t i s a l s o a d v a n t a g e o u s t o h a v e as i m p l e a n d r e l i a b l e d e l i v e r y s y s t e m f o r t h e c o r n e a l i m p l a n t .

I n t r a o c u l a r l e n s e s f o r c a t a r a c t s u r g e r y h a v e been e s i g n e dt o b e p l a c e d t h r o u g h a s m a l l i n c i s i o n . These s m a l l i n c i s i o nc a t a r a c t s u r g e r y l e n s e s c a n n o t p r a c t i c a l l y be used W i t h i n ac o r n e a l p o c k e t . Most s m a l l i n c i s i o n c a t a r a c t s u r g e r y l e n si m p l a n t s a r e u s u a l l y t o o t h i c k t o b e p l a c e d W i t h i n a c o r n e a lp o c k e t . F o r example t h e t y p i c a l t h i c k n e s s o f a c a t a r a c t s u rg e r y l e n s i m p l a n t i s 1 mm r m or e Which i s s u b s t a n t i a l l yt h i c k e r t h a n t h e hu man o r n e a , Which s u s u a l l y betWeen 0 . 5t o 0 . 6 m m . S o m e c o r n e a l i m p l a n t s t h a t h a v e been d e s i g n e do n l y have a t h i c k n e s s of b o u t 0 . 0 5 mm. oreover, t h e c a t ar a c t s u r g e r y l e n s i m p l a n t s h a v e h a p t i c s , Which r e e x t e n s i o n sf r o m t h e l e n s i m p l a n t d e s i g n e d t o k e e p t h e l e n s i m p l a n t ? xa t e d W i t h i n t h e c a p s u l a r b a g . H a p t i c s a r e n o t p r e s e n t a n d n o tn e c e s s a r y f o r c o r n e a l i m p l a n t s . F i n a l l y , t h e c a t a r a c t s u r g e r yl e n s i m p l a n t s a r e n o t d e s i g n e d t o b e b i o c o m p a t i bl e W i t h t h ecornea and Would o t be t o l e r a t e d a s c o r n e a l i m p l a n t s .

The d e l i v e r y s y st e m s d e s i g n e d f o r s m a l l i n c i s i o n c a t a r a c ts u r g e r y l e n s i m p l a n t s a r e not W e l l adapted f o r use a s a d e l i ve r y s y s t e m f o r s m a l l i n c i s i o n c o r n e a l i m p l a n t s . T h e s e d e l i v e r ys y s t e m s h a v e b e e n d e s i g n e d f o r c a t a r a c t s u r g e r y l e n s i m p l a n t st h a t a r e m u c h t h i c k e r t h a n t h e u s u a l c o r n e a l i m p l a n t . Thed e l i v e r y s y s t e m s f o r s m a l l i n c i s i o n c a t a r a c t s u r g e r y l e n si m p l a n t s a r e d e s i g n e d t o accommodate a p t i c s , Which Wouldn o t be p r e s e n t on a c o r n e a l l e n s i m p l a n t .

C o r n e a l i m p l a n t s c a n b e made f e i t h e r s y n t he t i c m a t e r i a l s( e . g . p r o s t h e s e s ) o r c a n b e b i o l o g i c a l i n o r i g i n ( e . g . t r a n s p l a n t

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2g r a f t s ) . R e c e n t l y t W o neW s u r g i c a l t e c h n i q u e s f o r p l a c e m e n to f a l a m e l l a r c o r n e a l s t r o m a l e n d o t h e l i a l t r a n s p l a n t g r a f t sh a v e b e e n d e v i s e d . T h e s e s u r g i c a l t e c h n i q u e s a r e u s e f u l i n t h et r e a t m e n t of n d o t h e l i a l d i s e a s e s of h e cornea such s Fuchse n d o t h e l i a l d y s t r o p h y a n d p s e u d o p h a k i c b u l l o u s k e r a t o p a t h y .One o f t h e s e t e c h n i q u e s i s r e f e r r e d t o a s d e e p l a m e l l a r e n d o th e l i a l k e r a t o p l a s t y ( D L E K ) . I n t h i s t e c h n i q u e a p o c k e t i sm a d e W i t h i n t h e c o r n e a and d i s e a s e d c o r n e a l endothelium se x c i se d a l o n g W i t h a l a y e r o f c o r n e a l s t r o m a . H e a l t h y l a m e l l a rc o r n e a l s t r o m a l e n d o t h e l i a l t i s s u e i s t h e n t r a n s p l a n t e d i n t o t h es p a c e l e f t by h e e x c i s e d d i s e a s e d t i s s u e . A n o t h e r t e c h n i q u e i sc a l l e d D e s c e m e t s s t r i p p i n g a u t o m a t e d e n d o t h e l i a l k e r a t op l a s t y (DSAEK). n t h i s t e c h n i q u e , a l a m e l l a r c o r n e a l s t r o m a le n d o t h e l i a l t r a n s p l a n t g r a f t i s a u t o m a t i c a l l y c r e a t e d u s i n ge i t h e r a microkeratome o r a l a s e r . The diseased o r n e a l endoth e l i u m i s s t r i p p e d aWay W i t h s u r g i c a l i n s t r u m e n t s a n d t h e nt h e l a m e l l a r c o r n e a l s t r o m a l e n d o t h e l i a l t r a n s p l a n t g r a f t i si n s e r t e d i n t o t h e a n t e r i o r chamber t h r o u g h a f u l l t h i c k n e s sc o r n e a l i n c i s i o n . The r a f t i s t h e n h e l d i n p l a c e a g a i n s t t h es t r i p p e d p o s t e r i o r c o r n e a l s t r o m a l s u r f a c e by a n a i r b u b b l eu n t i l t h e g r a f t i s a b l e t o h e a l i n p o s i t i o n .

I n b o t h DLEK nd DSAEK t i s a d v a n t a g e o u s t o b e a b l e t oi n s e r t a r e l a t i v e l y l a r g e t r a n s p l a n t a t r a u m a t i c a l l y t h r o u g h as m a l l c o r n e a l o r s c l e r a l i n c i s i o n . A a r g e r t r a n s p l a n t h a s m o r ec o r n e a l e n d o t h e l i a l c e l l s a n d s h o u l d p r o d u c e b e t t e r r e s u l t s i nt h e t r e a t m e n t of c o r n e a l e n d o t h e l i a l d i s e a s e s . HoWever, as i g n i ? c a n t p r o b l e m W i t h p r i o r a r t m e t h o d s o f i n s e r t i n g c o rn e a l t r a n s p l a n t s i n t o t h e a n t e r i o r chamber t h r o u g h a s m a l li n c i s i o n i s t h a t t h e y a l l i n v o l v e f o l d i n g o f t h e t r a n s p l a n t a n dg r a s p i n g o f t h e t r n s p l n t W i t h f o r c e p s . M o r e o v e r , t h e t r a n sp l a n t i s t y p i c a l l y s e v e r e l y c o m p r e s s e d a s i t p a s s e s t h r o u g h t h ec o r n e a l i n c i s i o n . I t h a s been e m o n s t r a t e d t h r o u g h t h e u s e o fv i t a l s t a i n i n g t e c h n i q u e s t h a t many o f t h e d e l i c a t e c o r n e a le n d o t h e l i a l c e l l s o f a t r a n s p l a n t a r e k i l l e d d u r i n g t h e p r i o r a r ti n s e r t i o n p r o c e s s . L i k e c o r n e a l t r a n s p l a n t g r a f t s f o r DSAEKo r DLEK, s y n t h e t i c c o r n e a l i m p l a n t s e . g . c o r n e a l i n l a y p r o st h e s e s a r e a l s o very d e l i c a t e . I n many c a s e s , t h e s e c o r n e a li n l a y s m a y be a s t h i n a s 30 t o 40 m i c r o n s , Which make themv e r y e a s i l y t o r n by f o r c e p s . T h e r e f o r e , t h e r e i s a l s o a n e e d f o ra n i m p r o v e d method o p l a c e t h e s e c o r n e a l i n l a y s a t r a u m a t ic a l l y t h r o u g h a s m a l l i n c i s i o n .

D e l i v e r y s y s t e m s f o r p l a c e m e n t o f i n t r a o c u l a r l e n s e s( I O L s ) i n t o t h e p o s t e r io r c h a m b e r t h r o u g h a s m a l l i n c i s i o nh a v e b e e n d e s c r i b e d . H o W e v e r , t h e s e d e l i v e r y s y s t e m sd e s i g n e d f o r s m a l l i n c i s i o n c a t a r a c t s u r g e r y IOLs r e n o t W e l la d a p t e d f o r u s e a s a d e l i v e r y s y s t e m f o r c o r n e a l i m p l a n t st h r o u g h a s m a l l i n c i s i o n . F o r e x a m p l e , a t y p i c a l i n t r a o c u l a rl e n s i m p l a n t may e 1 mm r m or e i n t h i c k n e s s , Whereas t h et y p i c a l c o r n e a l t r a n sp l a n t f o r DLEK r DSAEK s betWeen0 . 1 t o 0 . 1 5 mm n t h i c k n e s s . Moreover, a s h a s been notedb e f o r e , t h e t h i c k n e s s o f a c o r n e a l i n l a y p r o s t h e s i s m a y b e a sl i t t l e a s 30 o 40 i c r o n s . I n a d d i t i o n , t h e s i Z e and s h a p e o f anIOL s d i f f e r e n t from t h a t o f a c o r n e a l t r a n s p l a n t . An OL st y p i c a l l y 1 2 t o 1 3 mm n l e n g t h and 5 t o 6 mm i d e , Whereasa c o r n e a l t r a n s p l a n t Would y p i c a l l y b e c i r c u l a r i n s h a p e a n dWould ha v e a diameter of t o 9 mm. n t h e case of cornealp r o s t h e s i s i n l a y , t h e d i a m e t e r may r a n g e from 1 mm o 1 0m m . F i n a l l y , IOL d e l i v e r y s y s t e m s a r e d e s i g n e d t o g r e a t l yc o m p r e s s t h e IOL d u r i n g t h e i n s e r t i o n p r o c e s s , W h e r e a s t h i st y p e o f c o m p r e s s i o n Would b e l i k e l y t o e i t h e r damage o rd e s t r o y a l i v i n g c o r n e a l t r a n s p l a n t . The amount o f c o m p r e ss i o n u s e d f o r IOL d e l i v e r y s y st e m s c o u l d a l s o damage t h emuch h i n n e r c o rn e a l i m p l a n t s .

BRIEF SUMMARY OFTHE INVENTIONI m p r o v e d s y s t e m s a n d m e t h o d s f o r i m p l a n t i n g c o r n e a l

i m p l a n t s a r e p r o v i d e d b y t h e p r e s e n t i n v e n t i o n . T h e p h a s e



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c o r n e a l i m p l a n t r e f e r s t o a n y n a t u r a l ( b i o l o g i c a l ) o r s y nt h e t i c i m p l a n t o r g r a f t t h a t may b e i m p l a n t e d i n t o a humanc o r n e a . These systems and methods can p l a c e a c o r n e a li m p l a n t t h r o u g h a c o r n e a l i n c i s i o n t h a t i s s u b s t a n t i a l l y l e s st h a n t h e W i d t h o f t h e i m p l a n t . The p l a c e m e n t o f t h e i m p l a n tm a y be W i t h i n o r betWeen any of t h e l a y e r s of t h e c o r n e ai n c l u d i n g e p i t h e l i u m , B o W m a n s m e m b r a n e , s t r o m a ,D e s c e m e t s m e m b r a n e , a n d e n d o t h e l i u m . I n p r e f e r r e da s p e c t s , t h e c o r n e a l i n c i s i o n i s e q u a l o r l e s s t h a n h a l f o f t h eW i d t h o f t h e i m p l a n t . I n a d d i t i o n a l p r e f e r r e d a s p e c t s , t h es y s t e m a l l o W s t h e p l a c e m e n t o f a c o r n e a l i m p l a n t t h r o u g h a ni n c i s i o n t h a t i s l e s s t h a n o r e q u a l t o 3 mm, Which a d v a n t ag e o u s l y a v o i d s t h e n e e d f o r s u t u r i n g o f t h e i n c i s i o n i n mostc a s e s and a l s o g r e a t l y d e c r e a s e s t h e c h a n c e o f unWantedi n d u c e d a s t i g m a t i s m .

I n a c c o r d a n c e W i t h a ? r s t a s p e c t o f t h e p r e s e n t i n v e n t i o n ,t h e c o r n e a l i m p l a n t i s r e v e r s i b l y d e f o r m a b l e i n s h a p e t o a l l o Wi t s p a s s a g e t h r o u g h a c o r n e a l i n c i si o n t h a t i s e q u a l o r l e s s t h a nh a l f o f t h e W i d t h o f t h e i m pl a n t . The c o r n e a l i m p l a n t i s b i oc o m p a t i b l e W i t h t h e c o r n e a , t h e e y e , a n d t h e b o d y . I n c e r t a i ne m b o d i m e n t s , s y n t h e t i c m a t e r i a l Which c a n meet h e s e c r i t er i a may o t e n t i a l l y b e u s e d f o r t h e i m p l a n t . S u i t a b l e s y n t h e t i cm a t e r i a l s i n c l u d e one o r more compounds s e l e c t e d from t h eg r o u p c o n s i s t i n g o f c o l l a g e n , p o l y u r e t h a n e s , p o l y ( 2 - h yd r o x y e t h y l m e t h a c r y l a t e ) , p o l y v i n y l p y r o l i d o n e , p o l y g l y c e ro l m e t h a c r y l a t e , p o l y v i n y l a l c o h o l , p o l y e t h y l e n e g l y c o l , p o l ym e t h a c r y l i c a c i d , s i l i c o n e s , a c r y l i c s , p o l y ? u o r o c a r b o n s , a n dp o l y m e r s W i t h p h o s p h o c h o l i n e . I n o t h e r e m b o d i m e n t s , t h eg r a f t s m a y c o m p r i s e hu man c o r n e a s h a r v e s t e d f o r u s e i nt r a n s p l a n t s . I n t h e f u t u r e , b i o l o g i c a l c o r n e a i m p l a n t s may b eo b t a i n e d from o t h e r s o u r c e s s u c h a s a n i m a l s , g e n e t i c a l l ymodi?ed a n i m a l s , i n v i t r o c e l l c u l t u r e , o r t h e l i k e .

I n a p r e f e r r e d e m b o d i m e n t , t h e m a t e r i a l c o m p r i s e s ah y d r o g e l . I n a d d i t i o n a l p r e f e r r e d e m b o d i m e n t s , t h e m a t e r i a lc o m p r i s e s p o l y m e t h a c r y l i c a c i d - c o h y d r o x y e t h y l m e t h a c r yl a t e (PHEMA/MAA). n o t h e r p r e f e r re d e m b o d i m e n t s , h o l e so r p o r e s m a y be p r o v i d e d i n t h e i m p l a n t t o i n c r e a s e biocomp a t i b i l i t y o f h e i m p l a n t b y a l l o W i n g n u t r i t i v e s u b s t a n c e s a n dg a s s e s ( e . g . , W a t e r , g l u c o s e , a n d o x y g e n ) t o p a s s e a s i l yt h r o u g h t h e i m p l a n t i n o r d e r t o m a i n t a i n h e a l t h y m e t a b o l i s mi n t h e c o r n e a . I n s t i l l o t h e r p r e f e r r e d e m b o d i m e n t s , t h e p o l ymer a t e r i a l may a v e t h e r m o p l a s t i c p r o p e r t i e s s u c h t h a t t h ei m p l a n t W i l l have one d e s i r e d s h a p e a t one t e m p e r a t u r e andt h e n deform i n t o a n o t h e r d e s i r e d s h a p e a t a s e c o n d t e m p e r at u r e . I n y e t o t h e r p r e f e r r e d a s p e c t s , t h e c o r n e a l i m p l a n t maycomprise one o r m o r e s e p a r a t e , s m a l l e r components t h a t canb e a s s e m b l e d i n s i t u p l a c e d i n s i d e t h e c o r n e a l p o c k e t . S u c h i ns i t u a s s e m b l y a d v a n t a g e o u s l y m i n i m i Z e s t h e i n c i s i o n s i Z eneeded o i n s e r t a c o r n e a l i m p l a n t .

The o r n e a l i m p l a n t may e o f a n y s h a p e t h a t a l l o W s t t o b ep l a c e d W i t h i n a c o r n e a l p o c k e t . I n p r e f e r r e d e m b o d i m e n t s ,t h e c o r n e a l i m p l a n t i s s u b s t a n t i a l l y r o u n d . I n a l t e r n a t e p r ef e r r e d e m b o d i m e n t s , t h e c o r n e a l i m p l a n t i s n o t r o u n d . Ac o r n e a l i m p l a n t Which s n o t r o u n d h a s t h e a d v a n t a g e t h a t t i sl e s s l i k e l y t o r o t a t e W i t h i n a c o r n e a l p o c k e t . T h i s p r o p e r t y i su s e f u l i n t h e i m p l a n t s W h i c h c o r r e c t f o r a s t i g m a t i s m .

I n p r e f e r r e d o t h e r e m b o d i m e n t s , t h e c o r n e a l i m p l a n t i s al e n s . The l e n s c a n be a m o n o f o c a l , m u l t i f o c a l , F r e s n e l , d i ff r a c t i v e , p r i s m a t i c , o r o t h e r t y p e o f l e n s t h a t c a n be used t ot r e a t r e f r a c t i v e e r r o r ( s u c h a s m y o p i a , h y p e r o p i a , o r a s t i g m at i s m ) p r e s b y o p i a , o r o c u l a r d i s e a s e eg a c u l a r d e g e n e r at i o n . The e n s m a y l s o be m a d e of polymer h a t can have t sr e f r a c t i v e p r o p e r t i e s a d j u s t e d p e r m a n e n t l y o r r e v e r s i b l y b ye l e c t r o m a g n e t i c e n e r g y a s d e s c r i b e d i n US. P a t e n t A p p l i c at i o n 2003/0173691 t o J e t h m a l a n i .T h e c o r n e a l i m p l a n t u s u a l l y c o m p r i s e s a p r o s t h e s i s t h a t i sused t o r e p l a c e o r augment a p o r t i o n of t h e c o r n e a . Such

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4i m p l a n t s a r e u s e f u l i n r e s t o r i n g o p t i c a l c l a r i t y o r s t r u c t u r a li n t e g r i t y t o t h e c o r n e a i n l i e u o f c o r n e a l t r a n s p l a n t a t i o n . Thec o r n e a l p r o s t h e s i s may e u s e d t o r e p l a c e o n l y a p a r t i a l t h i c kn e s s p o r t i o n of h e cornea o r a f u l l t h i c k n e s s p o r t i o n of h ec o r n e a . I n p r e f e r r e d a s p e c t s , t h e c o r n e a l i m p l a n t may b ec o a t e d W i t h e x t r a c e l l u l a r m a t r i x p r o t e i n s s u c h a s c o l l a g e n ,? b r o n e c t i n , l a m i n i n , s u b s t a n c e P , i n s u l i n - l i k e g r o W t h f a c t o rI , o r p e p t i d e s e q u e n c e s s u c h a s ? b r o n e c t i n a d h e s i o n - p r o m o ti n g p e p t i d e ( F A P ) . I n a d d i t i o n a l p r e f e r r e d a s p e c t s , t h e s ee x t r a c e l l u l a r m a t r i x p r o t e i n s and p e p t i d e s a r e t e t h e r e d o ro t h e r W i s e bound o t h e e p i t h e l i a l s i d e o f t h e c o r n e a l i m p l a n tby h e methods e s c r i b e d i n US. a t . N o . 6 , 6 8 9 , 1 6 5 , t o J a c o be t a l . Such s u r f a c e t r e a t m e n t s a r e i n t e n d e d t o promote p i t h el i a l i Z a t i o n on h e s u r f a c e of c o r n e a l i m p l a n t .

I n a l t e r n a t e p r e f e r r e d e m b o d i m e n t s , t h e s u r f a c e o f t h e c o rn e a l i m p l a n t may h a v e a t e x t u r e t h a t p r o m o t e s e p i t h e l i a l i Z at i o n on t h e s u r f a c e o f t h e c o r n e a l i m p l a n t . T e x t u r e s, s u c h a ss u r f a c e i n d e n t a t i o n s , may b e a p p l i e d t o t h e s u r f a c e o f t h ec o r n e a l i m p l a n t t o p r o m o t e e p i t h e l i a l i Z a t i o n , a s d e s c r i b e d i nUS. P a t . No. 6 , 4 5 4 , 8 0 0 t o Dalton e t a l .

I n y e t o t h e r a l t e r n a t e p r e f e r r e d e m b o d i m e n t s , t h e c o r n e a li m p l a n t m a y b e m a n u f a c t u r e d from a m a t e r i a l t h a t p r o m o t e se p i t h e l i a l i Z a t i o n on t h e s u r f a c e o f t h e c o r n e a l i m p l a n t .E x a m p l e s o f s u c h m a t e r i a l s i n c l u d e p o l y m e r s s e l e c t e d f r o mt h e g r o u p c o n s i s t i n g o f c o l l a g e n a n d N - i s o p r o p y l a c r y l a m i d e ,c o l l a g e n a n d l - e t h y l - 3 , 3 ( d i m e t h y l - a m i n o p r o p y l ) - c a r b o d ii m i d e a s W e l l a s c o l l a g e n a n d N - h y d r o x y s u c c i n i m i d e (EDC/N H S ) . I n f u r t h e r p r e f e r r e d a s p e c t s , t h e p o l y m e r may a d d it i o n a l l y c o n t a i n e x t r a c e l l u l a r m a t r i x p r o t e i n s s u c h a s? b r o n e c t i n , l a m i n i n , s u b s t a n c e P , i n s u l i n - l i k e g r o W t h f a c t o rI , o r p e p t i d e s e q u e n c e s s u c h a s ? b r o n e c t i n a d h e s i o n - p r o m o ti n g o r p e p t i d e ( F A P ) .

O p t i o n a l l y , a t l e a s t a p o r t i o n o f t h e d e v i c e may c o n t a i nh o l e s o r be porous i n n a t u r e s o a s t o promote groWth ofc o r n e a l t i s s u e i n t o a n d t h r o u g h t h e i m p l a n t i n o r d e r t o p r omote r e t e n t i o n a n d b i o c o m p a t i b i l i t y . S u c h p o r o u s i m p l a n t sm a y be f a b r i c a t e d a s d e s c r i b e d i n US. P a t . No. 6 , 9 7 6 , 9 9 7 t oNoolandi e t a l . and US. P a t . No. 5 , 3 0 0 , 1 1 6 t o C h i r i l a e t a l .

O p t i o n a l l y , a t l e a s t a p o r t i o n o f t h e l e n s o r o t h e r c o rn e a li m p l a n t m a y be c o l o r e d . C o l o r a t i o n can be u s e f u l f o r c o sm e t i c p u r p o s e s o r f o r t h e r a p e u t i c p u r p o s e s e . g . t r e a t m e n t ofa n i r i d i a . F o r e x a m p l e , m e t h o d s o f a p p l y i n g b i o c o m p a t i b l ei n k s , Which r e W e l l knoWn i n c o l o r e d c o n t a c t l e n s manufact u r i n g , may b e u s e d t o c o l o r t h e c o r n e a l i m p l a n t . P a r t i c u l a rc o l o r i n g methods a r e d e s c r i b e d i n US. P a t e n t A p p l i c a t i o n s2 0 0 3 / 0 0 5 4 1 0 9 and 2 0 0 3 / 0 0 2 5 8 7 3 , t h e d i s c l o s u re s o f Whicha r e i n c o r p o r a t e d h e r e i n b y r e f e r e n c e . I n a l t e r n a t e p r e f e r r e da s p e c t s , t h e c o r n e a l i m p l a n t may b e c o l o r e d W i t h p h o t o s e ns i t i v e i n k s t h t c h a n g e c o l o r W i t h e x p o s u r e t o e l e c t r o m a g n e t i cW a v e s . T h i s a l l o W s t h e c o l o r o f t h e c o r n e a l i m p l a n t t o bea d j u s t e d p e r m a n e n t l y o r r e v e r s i b l y b y e x p o s u r e t o e l e c t r om a g n e t i c Waves i n v i v o .

O p t i o n a l l y , t h e c o r n e a l i m p l a n t may a l s o c o n t a i n a n u l t r av i o l e t ? l t e r compound f t h e b e n Z o p h e n o n e t y p e s u c h a s 3 - ( 2B e n Z y o t r i a Z o l y l ) - 2 - H y d r o x y - 5 - T e r t - O c t y l - B e n Z y l M e t ha c r y l A m i d e .

I n y e t o t h e r a l t e r n a t e p r e f e r r e d e m b o d i m e n t s , t h e c o r n e a li m p l a n t may b e a d e v i c e . E x a m p l e s o f p o t e n t i a l i m p l a n td e v i c e s i n c l u d e m i n i a t u r e cameras and aqueous g l u c o s em o n i t o r s .

The i m p r o v e d c o r n e a l i m p l a n t s o f h e p r e s e n t i n v e n t i o n a r ed e f o r m a b l e i n t o a r e d u c e d Width s h a p e t h a t a l l o W s p a s s a g et h r o u g h a c o r n e a l i n c i s i o n t h a t i s s u b s t a n t i a l l y l e s s t h a n t h eW i d t h o f t h e i m p l a n t When undeformed o r un c o n s t r a i n e d . I np r e f e r r e d a s p e c t s , t h e i n c i s i o n W i l l b e l e s s t h a n o r e q u a l t oo n e - h a l f o f t h e W i d t h o f t h e i m p l a n t .



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A y s t e m a c c o r d i n g t o t h e p r e s e n t i n v e n t i o n c o m p r i s e s ah o l l o w m e m b e r and m p l a n t mover r o t h e r a x i a l p u s h e r usedt o d e l i v e r a c o r n e a l i m p l a n t t h a t h a s been c o n s t r a i n e d t o ? ti n s i d e an a x i a l holloW p a s s a g e of t h e holloW member. Thei m p l a n t m a y b e deformed o r c o n s t r a i n e d i n any s h a p e o rc o n ? g u r a t i o n h a v i n g a r e d u c e d W i d t h t h a t a l l o W s i t t o b e ? ti n s i d e of t h e holloW m e m b e r e . g . , r o l l e d o r f o l d e d . Byreduced Width i t i s meant t h a t a maximum Width o f t h ei m p l a n t , s u c h a s a d i a m e t e r o f a c i r c u l a r l e n s , i s r e d u c e d b ysome h r e s h o l d a m o u n t , t y p i c a l l y by t l e a s t o n e - h a l f ( 5 0 ) ,o f t e n b y t l e a s t 60 , and sometimes by 6 5 o r m o r e .A y s t e m a c c o r d i n g t o t h e p r e s e n t i n v e n t i o n c o m p r i s e s a

holloW m e m b e r and i m p l a n t m o v e r used o d e l i v e r a c o r n e a li m p l a n t t h a t h a s been r e s t r a i n e d t o ? t i n s i d e o f t h e h o l l o Wmember. Once h e c o r n e a l i m p l a n t i s i n s i d e t h e h o l l o W memb e r , t h e i m p l a n t m o v e r i s used t o m o v e t h e i m p l a n t i n t o ac o r n e a l p o c k e t o r t h e a n t e r i o r c h a m b e r .

O p t i o n a l l y , t h e s y s t e m may u r t h e r c o m p r i s e a d e f o r m a t i o nchamber Where h e i m p l a n t i s deformed i n t o a s h a p e and s i Z et h a t W i l l ? t i n s i d e t h e h o l l o W member. I n p r e f e r r e d a s p e c t s ,t h e d e f o r m a t i o n c h a m b e r may c o n t a i n r i d g e s , p r o t r u s i o n s ,i n d e n t a t i o n s , o r r e c e s s e s Which e l p t o m a i n t a i n and u i d e t h eo r i e n t a t i o n o f t h e c o r n e a l i m p l a n t W i t h i n t h e d e f o r m a t i o nc h a m b e r d u r i n g t h e d e f o r m a t i o n p r o c e ss . I n f u r t h e r p r e f e r r e da s p e c t s t h e d e f o r m a t i o n chamber i l l be a s i Z e t h a t i s a p p r op r i a t e f o r t h e t y p e o f c o r n e a l i m p l a n t W h i c h i s b e i n g u s e d . F o rexample i n t h e c a s e o f a c o r n e a l t r a n s p l a n t , t h e minimumi n t e r n a l dimensions of an open deformation chamber s h o u l dbe betWeen 6 and 1 0 m m , more p r e f e r a b l y betWeen 8 and 9mm. n t h e c a s e o f a c o r n e a l i m p l a n t p r o s t h e s i s , t h e minimumi n t e r n a l d i m e n s i o n s o f an open e f o r m a t i o n chamber dimens i o n s s h o u l d be betWeen 1 mm nd 10 mm, ore p r e f e r a b l ybetWeen 0 mm nd mm. n a d d i t i o n a l p r e f e r r e d a s p e c t s t h edeformation a r e a may e t a p e r e d o r f u n n e l s h a p e d , i . e . n a rroWer one end than on t h e o t h e r e n d . The tapered o r f u n n e ls h a p e a d v a n t a g e o u s l y f a c i l i t a t e s t h e c o r n e a l i m p l a n t t o b er e s t r a i n e d t o a s m a l l e r d i a m e t e r c o n ? g u r a t i o n .I n o t h e r p r e f e r r e d a s p e c t s , t h e i n t e r i o r o f t h e h o l l o W memb e r may o n t a i n r i d g e s, p r o t r u s i o n s , i n d e n t a t i o n s , o r r e c e s s e sWhich h e l p t o m a i n t a i n and g u i d e t h e o r i e n t a t i o n o f t h e c o rn e a l i m p l a n t a s i t t r a v e l s i n s i d e o f t h e h o l l o W member. I na d d i t i o n a l p r e f e r r e d a s p e c t s , t h e i n t e r i o r o f t h e h o l l o W memb e r may o n t a i n r i d g e s, p r o t r u s i o n s , i n d e n t a t i o n s , o r r e c e s s e sWhich g u i d e s a l a m e l l a r c o r n e a l s t r o m a l e n d o t h e l i a l t r a n sp l a n t t o deform i n a Way Which a l l o W s i t t o t r a v e l t h r o u g h as m a l l i n c i s i o n W i t h o u t t h e n e e d f o r f o l d i n g o r b e i n g g r a s p e dby f o r c e p s . The s y s t e m i s d e s i g n e d t o a l l o W a c o r n e a l t r a n sp l a n t t o be l a c e d t h r o u g h an n c i s i o n e q u a l o r l e s s t h a n 3 m m .H o W e v e r , t h e s y s t e m c a n a l s o b e u s e d t o p l a c e a n i m p l a n tt h r o u g h an i n c i s i o n t h a t i s g r e a t e r t h a n 3 mm.

O p t i o n a l l y , t h e s y s t e m may b e d e s i g n e d t o b e s t e r i l e a n dd i s p o s a b l e f o r s i n g l e u s e . T h i s a d v a n t a g e o u s l y d e c r e a s e s t h ec h a n c e f o r c o n t a m i n a t i o n and i n f e c t i o n . I t a l s o o b v i a t e s t h eneed o r t h e s u r g e o n t o a u t o c l a v e o r t o p r o v i d e o t h e r methodso f s t e r i l i Z a t i o n s u c h a s e t h y l e n e o x i d e . To i n s u r e t h a t t h esystem i l l be both t e r i l e and s i n g l e u s e o n l y We an add oneo r m or e of h e f o l l o W i n g f e a t u r e s . I n p r e f e r r e d a s p e c t s one o rmore components o f t h e s y s t e m m a y be ma d e o f a polymerWhich i l l melt o r deform i n t o an unusable shape upon u t oc l a v i n g . I n a d d i t i o n a l p r e f e r r e d a s p e c t s , t h e s y s t e m may a v ea one Way l o c k i n g mechanism, s u c h t h a t once t h e t i p of h ei m p l a n t m o v e r r a v e l s t o a c e r t a i n d i s t a n c e , t h e i m p l a n t m o v e ri s l o c k e d i n p o s i t i o n i n s i d e o f t h e h o l l o W member, t h u s p r ev e n t i n g r e l o a d i n g o f a n o t h e r c o r n e a l i m p l a n t . I n a l t e r n a t i v ep r e f e r r e d a s p e c t s , t h e s y s t e m may b e a s s e m b l e d t h r o u g h t h euse of breakable t a b s or s n a p s , Which alloWs t h e secure

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6a s s e m b l y o f t h e d i s p o s a b l e c o m p o n e n t , b u t W h i c h a r e e a s i l yd e s t r o y e d i f t h e r e i s a n a t t e m p t t o d i s a s s e m b l e t h e s y s t e m f o rr e u se.

O p t i o n a l l y , t h e s y s t e m may e d e s i g n e d s o t h a t t h e c o r n e a li m p l a n t i s p r e - l o a d e d i n s i d e o f t h e h o l l o W member p r i o r t ou s e by h e s u r g e o n . T h i s a d v a n t a g e o u s l y m i n i m i Z e s t h e n e e df o r m a n i p u l a t i o n o f t h e d e l i c a t e c o r n e a l i m p l a n t b y t h e s u rg e o n , Which c o u l d r e s u l t i n damage t o t h e c o r n e a l i m p l a n t .

Once h e c o r n e a l i m p l a n t i s i n s i d e t h e h o l l o W member, t h ei m p l a n t mover o r o t h e r a x i a l p u s h e r i s used t o engage andp u s h t h e i m p l a n t i n t o t h e c o r n e a l p o c k e t . O p t i o n a l l y , t h es y s t e m m a y f u r t h e r c o m p r i s e a d e f o r m a t i o n chamber Wheret h e i m p l a n t i s deformed i n t o a s h a p e a n d s i Z e t h a t W i l l ? ti n s i d e t h e h o l l o W m e m b e r . I n o t h e r p r e f e rr e d a s p e c t s , t h ed e f o r m a t i o n c h a m b e r may o n t a i n r i d g e s , p r o t r u s i o n s , i n d e nt a t i o n s , o r r e c e s s e s Which h e l p t o m a i n t a i n o r i e n t a t i o n of h ec o r n e a l i m p l a n t W i t h i n t h e d e f o r m a t i o n c h a m b e r d u r i n g t h ed e f o r m a t i o n p r o c e s s . O p t i o n a l l y , t h e h o l l o W m e m b e r i st a p e r e d , i . e . , narroWer a t a d i s t a l end t h a n a t a proximal e n d .Such t a p e r i n g a l l o W s a d d i t i o n a l d e f o r m a t i o n ( s i Z e o r W i d t hr e d u c t i o n ) o f h e i m p l a n t a s i t i s a d v a n c e d t h r o u g h t h e h o l l o Wm e m b e r and a s s e s o u t t h r o u g h a s m a l l e r d i s t a l o p e n i n g . Thei n t e r i o r o f t h e h o l l o W m e m b e r may c o n t a i n r i d g e s , p r o t r us i o n s , i n d e n t a t i o n s , o r r e c e s s e s Which h e l p t o m a i n t a i n o r i e nt a t i o n o f t h e c o r n e a l i m p l a n t a s i t t r a v e l s i n s i d e o f t h e h o l l o Wm e m b e r . T h e s y s t e m f o r i m p l a n t p l a c e m e n t i s d e s i g n e d t oa l l o W an i m p l a n t t o be p l a c e d i n t o a c o r n e a l p o c k e t W i t h ane n t r y i n c i s i o n t h a t i s e q u a l o r l e s s t h a n o n e - h a l f o f t h e W i d t ho f t h e i m p l a n t , h o W e v e r , t h e s y st e m c a n a l s o b e u s e d t o p l a c ean i m p l a n t t h r o u g h a c o r n e a l i n c i s i o n t h a t i s g r e a t e r t h a no n e - h a l f o f t h e W i d t h o f t h e i m p l a n t .

BRIEF DESCRIPTIONOFTHE DRAWINGSF I G S . 1 A , 1 B , 1 C , a n d 1D i l l u s t r a t e p r i o r a r t c o r n e a li m p l a n t s .FIGS. 2A h r o u g h 2C i l l u s t r a t e s a ? r s t embodiment o f

a p p a r a t u s o f t h e p r e s e n t i n v e n t i o n .FIGS. 3A h r o u g h 3 C i l l u s t r a t e s i d e v i e W s o f a c o r n e a li m p l a n t a s i t i s a d v a n c e d a n d c o n s t r a i n e d by h e a p p a r a t u s o fFIGS. 2A-2C.

FIGS. 4A h r o u g h 4D i l l u s t r a t e a s e c o n d embodiment o ft h e a p p a r a t u s o f t h e p r e s e n t i n v e n t i o n .

FIGS. 5A h r o u g h 5D l l u s t r a t e s i d e v i e W s o f a c o r n e a li m p l a n t a s i t i s a d v a n c e d a n d c o n s t r a i n e d by h e a p p a r a t u s o fFIGS. 4A-4D.

FIGS. 6A h r o u g h 6 C l l u s t r a t e a t h i r d embodiment o f t h ea p p a r a t u s o f t h e p r e s e n t i n v e n t i o n .

FIGS. 7A nd 7B i l l u s t r a t e u s e o f t h e a p p a r a t u s of FIGS.6A-6C i n i m p l a n t i n g an i m p l a n t i n a c o r n e a .

F I G S . 8A h r o u g h 8D l l u s t r a t e p r e f e r r e d c o r n e a l i m p l a n t si n a c c o r d a n c e W i t h t h e p r e s e n t i n v e n t i o n .

F I G S . 9 A h r o u g h 9F l l u s t r a t e a f u r t h e r i m p l a n t a t i o n p r ot o c o l i n a c c o r d a n c e W i t h t h e p r e s e n t i n v e n t i o n .

F I G S . 10A t h r o u g h 10F i l l u s t r a t e a f u r t h e r i m p l a n t a t i o np r o t o c o l i n a c c o r d a n c e W i t h t h e p r e s e n t i n v e n t i o n s .

F I G S . 11A t h r o u g h 11F i l l u s t r a t e a f u r t h e r i m p l a n t a t i o np r o t o c o l i n a c c o r d a n c e W i t h t h e p r e s e n t i n v e n t i o n s .

FIGS. 12A and 12B i l l u s t r a t e a t o o l i n a c c o r d a n c e With h ep r i n c i p l e s o f t h e p re s e n t i n v e n t i o n f o r c o l l a p s i n g a n d a d v a n ci n g a c o r n e a l i m p l a n t .

FIGS. 13A nd 1 3 B i l l u s t r a t e an a l t e r n a t i v e t o o l i n accord a n c e W i t h t h e p r i n c i p l e s o f h e p r e s e n t i n v e n t i o n f o r c o l l a p si n g a n d a d v a n c i n g a c o r n e a l i m p l a n t .

FIGS. 14A and 14C r e c r o s s- s e c t i o n a l vieWs of h e t o o l of13A and 13B shoWing h e i m p l a n t a s i t i s advanced s shoWni n F I G S . 15A h r o u g h 1 5 C .



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FIGS. 15A h r o u g h 15D l l u s t r a t e u s e o f t h e t o o l o f FIGS.13A n d 13B f o r a d v a n c i n g a n d r e d u c i n g t h e c r o s s- s e c t i o n o fa n i m p l a n t i n a c c o r d a n c e W i t h t h e p r i n c i p l e s o f t h e p r e s e n ti n v e n t i o n .

DETAILED DESCRIPTIONF I G . 1A hows t o p vieW of c a t a r a c t s u r g e r y l e n s i m p l a n t2 . A o u n d o p t i c 5 o f t h e i m p l a n t 2 h a s h a p t i c s 1 0 W h i c h

e x t e n d f r o m t h e p e r i p h e r y o f t h e o p t i c . The h a p t i c s 1 0 a r eu s e d t o h e l p t h e o p t i c c e n t e r a n d ? x a t e W i t h i n t h e c a p s u l a rb a g . FIG. 1B shoWs a s i d e vieW of a c a t a r a c t s u r g e r y l e n si m p l a n t o p t i c 5 . N o t e t h a t t h e t h i c k n e s s t l o f t h e o p t i c 5 i st y p i c a l l y 1 mm r m or e and s s u b s t a n t i a l l y g r e a t e r t h a n t h e0 . 5 t o 0 . 6 mm h i c k n e s s of h e h u m a n c o r n e a . The t h i c k n e s sof h e o p t i c 5 makes t i n a p p r o p r i a t e f o r u s e a s a c o r n e a l l e n si m p l a n t . F I G . 1C shoWs a t o p vieW o f a c o r n e a l i m p l a n t 1 5 .Note t h e r e a r e no h a p t i c s on t h e c o r n e a l i m p l a n t . FIG. 1DshoWs a s i d e vieW o f c o r n e a l i m p l a n t 1 5 . Note h a t t h e t h i c kn e s s t 2 i s s u b s t a n t i a l l y l e s s t h a n c a t a r a c t s u r g e r y l e n s i m p l a n t5 . The h i c k n e s s t 2 o f c o r n e a l i m p l a n t 1 5 Would n g e n e r a l b el e s s t h a n t h e t h i c k n e s s of h e human c o r n e a .

F I G . 2A s h o W s a c o r n e a l i m p l a n t d e l i v e r y s y s t e m 1 8 i np a r t i a l s e c t i o n . A o l l o W m e m b e r 2 0 h a v i n g a d i s t a l t i p 2 1( W h i c h i s p r e f e r a b l y b e v e l e d o r c h a m f e r e d ) d e ? n e s h o l l o Wa x i a l p a s s a g e 25 (eg an a x i a l l u m e n ) . A x i a l p u s h e r 3 0 h a s at i p 3 5 t h a t e n g a g e s a c o r n e a l i m p l a n t 1 5 t h a t h a s b e e ndeformed i n s h a p e and c o n s t r a i n e d t o ? t i n s i d e t h e h o l l o Wa x i a l p a s s a g e 25 o f t h e holloW m e m b e r 0 , a s shoWn i n F I G .2 B . The c r o s s - s e c t i o n o f h o l l o W p a s s a g e 2 5 m a y b e c i r c u l a r ,p o l y g o n a l , o r a n y o t h e r s h a p e t h a t i s c o n d u c i v e t o c o n s t r a i ni n g t h e c o r n e a l i m p l a n t 1 5 . T h e h o l l o W a x i a l p a s s a g e 2 5 o f h eh o l l o W member 2 0 may c o n t a i n r i d g e s , p r o t r u s i o n s , i n d e n t at i o n s , o r r e c e s s e s (noW s h o W n ) Which h e l p t o m a i n t a i n o r i e nt a t i o n o f t h e c o r n e a l i m p l a n t a s i t a d v a n c e s d i s t a l l y o f t h eh o l l o W member ( n o t s h o W n ) . A x i a l p u s h e r 3 0 e n g a g e s o n eend o f t h e c o n s t r a i n e d c o r n e a l i m p l a n t 1 5 t o a d v a n c e t h ec o n s t r a i n e d i m p l a n t t h r o u g h h o l l o W p a s s a g e 2 5 . F I G . 2CshoWs t h e c o n s t r a i n e d c o r n e a l i m p l a n t 1 5 e m e r g i n g from ad i s t a l end o f t h e h o l l o W p a s s a g e 25 s t i l l i n i t s deformed andc o n s t r a i n e d c o n ? g u r a t i o n . By p l a c i n g t h e t i p o f t h e h o l l o Wm e m b e r 20 t h r o u g h an i n c i s i o n i n t h e c o r n e a , t h e c o r n e a li m p l a n t 1 5 may b e a d v a n c e d i n t o t h e c o r n e a l p o c k e t ( n o tshoWn) t h r o u g h e v e n a v e r y s m a l l i n c i s i o n . I n p r e f e r r e da s p e c t s , t h e c o r n e a l i m p l a n t i s a b l e t o p a s s t h r o u g h a n e n t r yi n c i s i o n t h a t i s l e s s t h a n o n e - h a l f t h e W i d t h o f t h e c o r n e a li m p l a n t . I n t h o s e c a s e s , t h e holloW m e m b e r W i l l have ane x t e r n a l Width from 0 . 5 mm o 5 mm, r e f e r a b l y from 1 mmt o 3 mm nd an i n t e r n a l Width f r o m 0 . 3 mm o 4 . 8 mm,p r e f e r a b l y from 0 . 8 mm o 2 . 8 mm.

F I G . 3A shoWs a s i d e vieW o f c o r n e a l i m p l a n t 1 5 i n i t sn o n - d e f o r m e d , n o n - c o n s t r a i n e d s h a p e . F I G S . 3B a n d 3CshoWs an end on vieW of h e c o r n e a l i m p l a n t 15 a s i t i s m o v e dW i t h i n t h e h o l l o W m e m b e r 2 0 . Note t h a t t h e c o r n e a l i m p l a n t1 5 h a s been deformed and c o n s t r a i n e d i n t o a r o l l e d con?gur a t i o n . The r o l l e d c o n ? g u r a t i o n W i l l p r e f e r a b l y h a v e a diame t e r i n t h e range from 0 . 3 mm o 4 . 8 mm, m o r e p r e f e r a b l yfrom . 6 mm o 2 . 6 mm, o ? t i n t o t h e holloW passage 25 of h eh o l l o W m e m b e r 0 .

F I G S . 4A-4D s h o W s a c o r n e a l i m p l a n t d e l i v e r y s y s t e mWith deformation chamber 27 and deforming m e m b e r 8 .I n t h i s embodiment f t h e i n v e n t i o n , t h e c o r n e a l i m p l a n t 1 5 i sp l a c e d i n t o t h e chamber 27 i n a n u n c o n s t r a i n e d and undeformed c o n ? g u r a t i o n and i s t h e n deformed i n t o a f o l d e d o rr o l l e d c o r n e a l i m p l a n t 1 7 W i t h i n d e f o r m a t i o n c h a m b e r 2 7 byd e f o r m i n g member 2 8 . D e f o r r n i n g member 2 8 i s movedW i t h i n d e f o r m a t i o n chamber 27 t o deform and f o l d c o r n e a l

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8i m p l a n t 15 i n t o a f o l d e d o r r o l l e d c o r n e a l i m p l a n t 1 7 . F I G . 4Cs h o W s a x i a l p u s h e r 3 0 e n g a g i n g d e f o r m e d c o r n e a l i m p l a n t 1 7by i m p l a n t mover i p 3 5 . F I G . 4D s h o W s d e f o r m e d a n d f o l d e dc o r n e a l i m p l a n t 1 7 . A x i a l p u s h e r 3 0 e n g a g e s c o r n e a l i m p l a n t1 7 t o p u s h t h e d e f o r m e d c o n s t r a i n e d i m p l a n t i n s i d e h o l l o Wp a s s a g e 2 5 . F I G . 4D shoWs t h a t c o r n e a l i m p l a n t 1 7 h a s beena d v a n c e d by a x i a l p u s h e r 3 0 o u t o f t h e h o l l o W p a s s a g e 2 5W h i l e r e t a i n i n g a c o n s t r a i n e d s h a p e . The o n s t r a i n e d c o n ? g ur a t i o n o f c o r n e a l i m p l a n t 1 7 a l l o W s p a s s a g e i n t o t h e c o r n e a lp o c k e t ( n o t s h o W n ) t h r o u g h a s m a l l i n c i s i o n . T h e p r e s e n c e o ft h e o p t i o n a l d e f o r m a t i o n c h a m b e r 2 7 a n d d e f o r m i n g member2 8 , a d v a n t a g e o u s l y a l l o W s t h e c o r n e a l i m p l a n t 1 5 t o b e e a s i l ydeformed i n t o a c o n ? g u r a t i o n t h a t W i l l a l l o W i t t o b e p l a c e dt h r o u g h a s m a l l c o r n e a l i n c i s i o n i n t o a c o r n e a l p o c k e t .

F I G S . 5A-5D shoW s i d e v i e W s o f t h e c o r n e a l i m p l a n t 1 5b e i n g deformed i n t o an exemplary deformed and f o l d e d o rp l e a t e d c o r n e a l i m p l a n t 1 7 .

FIGS. 6A-6C shoW a t o p vieW of an a l t e r n a t i v e c o r n e a li m p l a n t d e l i v e r y s y s t e m 1 0 0 . I n t h i s embodiment a c o r n e a li m p l a n t 115 i s p l a c e d i n t o a d e f o r m a t i o n a r e a 1 2 2 . When h eWings 123 of h e deformation a r e a a r e c l o s e d , a deformat i o n c h a m b e r 1 2 4 ( F I G . 6 B ) i s f o r m e d W h i c h d e f o r m s t h ec o r n e a l i m p l a n t 1 1 5 . I n t h i s e m b o d i m e n t , t h e c o r n e a l i m p l a n t1 1 5 i s f o l d e d i n h a l f . A i p 1 3 2 o f an x i a l p u s h e r 1 3 0 e n g a g e sc o r n e a l i m p l a n t 1 1 5 . The h o l l o W m e m b e r 120 i s t a p e r e d s ot h a t holloW passage 126 i s narroWer a t a d i s t a l end 121 t h a ti n s e r t s i n t o t h e c o r n e a l p o c k e t . T h i s a l l o W s t h e c o r n e a li m p l a n t 115 o be deformed n t o an even s m a l l e r c r o s s - s e c t i o na s t h e i m p l a n t i s a d v a n c e d d i s t a l l y a n d t h r o u g h t h e d i s t a l e n d1 2 1 . A d v a n t a g e o u s l y i n t h i s e m b o d i m e n t , t h e i m p l a n t movert i p 1 3 2 may a l s o b e d e f o r m a b l e t o ? t W i t h i n t h e n a r r o W i n gh o l l o W p a s s a g e 1 2 6 .

FIG. 7A shoWs a s i d e c r o s s - s e c t i o n a l vieW of c o r n e a li m p l a n t 1 1 5 b e i n g i n s e r t e d i n t o c o r n e a l p o c k e t 1 4 0 . F I G . 7Bs h o W s t h e ? n a l s h a p e o f c o r n e a l i m p l a n t 1 1 5 a f t e r i t h a s b e e ni n s e r t e d i n t o c o r n e a l p o c k e t 140 and u n f u r l e d o r o t h e r W i s eexpanded back o i t s u n c o n s t r a i n e d s i Z e W i t h i n c o r n e a 1 4 5 .

FIG. 8A l l u s t r a t e s a c r o s s - s e c t i o n a l vieW of a c o r n e a li m p l a n t p r o s t h e s i s 5 0 C o r n e a l i m p l a n t 5 0 i s m e a n t t o r e p l a c ea p o r t i o n o f t h e a n t e r i o r l a y e r s o f t h e c o r n e a . I n t h i s embodiment h e r e i s a c e n t r a l o p t i c 5 2 t h a t p r o t r u d e s a n t e r i o r l y f r o ma r i m 5 4 . I n p r e f e r r e d a s p e c t s , t h e c e n t r a l o p t i c Would p r ot r u d e a n t e r i o r l y from t h e r i m by 1 t o 600 m i c r o n s . Morep r e f e r a b l y , t h e c e n t r a l o p t i c W o u l d p r o t r u d e a n t e r i o r l y f r o mt h e r i m b y 5 0 t o 4 0 0 m i c r o n s . The e n t r a l o p t i c 5 2 W i l l r e p l a c ed i s e a s e d a n t e r i o r c o r n e a l t i s s u e t h a t h a s been r e m o v e d . Ther i m 5 4 i s d e s i g n e d t o p a r t l y o r f u l l y a r o u n d t h e c e n t e r o f o p t i cand o ? t W i t h i n t h e p e r i p h e r a l r e c e s s e s of c o r n e a l p o c k e t i no r d e r t o a n c h o r t h e c o r n e a l i m p l a n t p r o s t h e s i s t o t h e c o r n e a .The rim may e a continuous s k i r t a s i l l u s t r a t e d o r may ec r e n e l l a t e d o r o t h e r W i s e d i s t r i b u t e d i n s e c t i o n s a b o u t t h ep e r i p h e r y o f t h e c e n t e r o p t i c . F I G . 8B shoWs a t o p vieW o fc o r n e a l i m p l a n t p r o s t h e s i s 5 0 W h i c h s h o W s t h e c e n t r a l o p t i c52 and h e rim 4 . The rim 54 m a y p t i o n a l l y c o n t a i n h o l e s o rbe porous i n n a t u r e s o a s t o promote groWth of o r n e a l t i s s u ei n t o a n d t h r o u g h t h e i m p l a n t , i n o r d e r t o p r o m o t e r e t e n t i o na n d b i o c o m p a t i b i l i t y .

F I G . 8C shoWs a c r o s s - s e c t i o n a l vieW o f c o r n e a l i m p l a n tp r o s t h e s i s 60 Which s meant o r e p l a c e a f u l l - t h i c k n e s s a r e aof h e c o r n e a . I n t h i s embodiment h e r e i s an n t e r i o r p o r t i o no f c e n t r a l o p t i c 6 2 Which p r o t r u d e s a n t e r i o r l y f r o m a r i m 6 4 .The n t e r i o r p o r t i o n o f c e n t r a l o p t i c 6 2 W i l l r e p l a c e d i s e a s e da n t e r i o r c o r n e a l t i s s u e t h a t h a s b e e n r e m o v e d . I n p r e f e r r e da s p e c t s , t h e c e n t r a l o p t i c W o u l d p r o t r u d e a n t e r i o r l y f r o m t h er i m by 1 t o 6 0 0 m i c r o n s . More p r e f e r a b l y , t h e c e n t r a l o p t i cWould r o t r u d e a n t e r i o r l y f r o m t h e r i m by 5 0 t o 4 0 0 m i c r o n s .I n a d d i t i o n c o r n e a l i m p l a n t p r o s t h e s i s 6 0 h a s a p o s t e r i o r



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US 8 , 0 2 9 , 5 1 5 B2p o r t i o n o f c e n t r a l o p t i c 6 6 W h i c h p r o t r u d e s p o s t e r i o r l y f r o mr i m 6 4 . I n p r e f e r r e d a s p e c t s , t h e c e n t r a l o p t i c W o u l d p r o t r u d ep o s t e r i o r l y f r o m t h e r i m b y 1 t o 9 0 0 m i c r o n s . More p r e f e ra b l y , t h e c e n t r a l o p t i c W o u l d p r o t r u d e p o s t e r i o r l y f r o m t h e r i mb y 5 0 t o 8 0 0 m i c r o n s . T h e p o s t e r i o r p o r t i o n o f e n t r a l o p t i c 6 3W i l l r e pl a c e d i s e a s e d p o s t e r i o r c o r n e a l t i s s u e t h a t h a s b e e nr e m o v e d . The r i m 6 4 W i l l a n c h o r c o r n e a l i m p l a n t p r o s t h e s i s6 0 W i t h i n t h e p e r i p h e r a l r e c e s s e s o f t h e c o r n e a l p o c k e t andp r o v i d e a W a t e r - t i g h t s e a l . The r i m 6 4 may p t i o n a l l y c o n t a i nh o l e s o r b e porous i n n a t u r e s o a s t o promote growth ofc o r n e a l t i s s u e i n t o and t h r o u g h t h e i m p l a n t , i n o r d e r t o p r omote r e t e n t i o n and b i o c o m p a t i b i l i t y . The r i m may b e formedfrom any o f t h e l e n s m a t e r i a l s d e s c r i b e d a b o v e .

FIGS. 9A-9F shoW method of r e a t i n g an n t e r i o r c o r n e a ld i s e a s e p r o c e s s u s i n g t h e m e t h o d s a n d a p p a r a t u s o f t h ep r e s e n t i n v e n t i o n . I n e a c h FIGS. 9 A - F , a c r o s s - s e c t i o n a l vieWof h e cornea i s seen a bov e and a t o p vieW i s seen beloW. I nF I G . 9A t i s shoWn h a t p o c k e t 4 0 h a s b e e n c r e a t e d p o s t e r i o rt o a n t e r i o r d i s e a s e d cornea 4 3 . FIG. 9 B shoWs t h a t a n t e r i o rd i s e a s e d c o r n e a 43 h a s been e x c i s e d With a c i r c u l a r t r e p h i n e( n o t s h o W n ) t o c r e a t e a n o p e n t o p h a v i n g a p e r i p he r a l p o c k e t .The edge o f t h e e x c i s i o n i s shoWn s 4 5 . F I G . 9B a l s o shoWsc o r n e a l i m p l a n t 5 0 r e s t i n g i n t h e d e f o r m a t i o n a r e a 1 2 2 . I nF I G . 9C h e h o l l o W m e m b e r 120 a s been n s e r t e d i n t o p o c k e t4 0 t h r o u g h e x t e r n a l o p e n i n g 4 2 a n d c o r n e a l i m p l a n t 5 0 h a sbeen o l d e d i n h a l f W i t h i n d e f o r m a t i o n chamber 2 4 . F I G . 9DshoWs h a t c o r n e a l i m p l a n t 5 0 h a s b e e n f u r t h e r d e f o r m e d i n t oa more c o m p a c t s h a p e by t s movement t h r o u g h n a r r o W i n gh o l l o W p a s s a g e 1 2 6 a n d s b e i n g e x t r u d e d i n t o p o c k e t 4 0 . F I G .9E shoWs t h a t c o r n e a l i m p l a n t 50 h a s been r e s t o r e d t o i t so r i g i n a l s h a p e W i t h i n c o r n e a l p o c k e t 4 0 . C e n t r a l o p t i c 5 2 ? l l st h e s p a c e l e f t by e x c i s e d d i s e a s e d a n t e r i o r c o r n e a 4 3 andr e s t o r e s o p t i c a l c l a r i t y t o t h e c o r n e a . HolloW m e m b e r 120 andi m p l a n t mover 0 h a v e b e e n WithdraWn from c o r n e a l p o c k e t4 0 . F I G . 9F shoWs h e ? n a l a p p e a r a n c e o f c o r n e a l i m p l a n t 5 0? x a t e d W i t h i n c o r n e a l p o c k e t 4 0 .

FIGS. 10A-10F shoW a method of r e a t i n g a f u l l - t h i c k n e s sc o r n e a l d i s e a s e ( e . g . p s e u d o p h a k i c b u l l o u s k e r a t o p a t h y )t h r o u g h t h e u s e o f h e p r e s e n t i n v e n t i o n . I n e a c h F I G S . 1 0 A - F ,a c r o s s - s e c t i o n a l vieW of h e cornea i s seen above and a topvieW s s e e n b e l o W . I n F I G . 10A t i s shoWn h a t p o c k e t 40 h a sbeen c r e a t e d W i t h i n t h e l a y e r s o f t h e d i s e a s e d c o r n e a 4 1 . Thep o c k e t d i v i d e s t h e c o r n e a i n t o d i s e a s e d a n t e r i o r c o r n e a 43 andd i s e a s e d p o s t e r i o r c o r n e a 4 4 . F I G . 10B shoWs t h a t a n t e r i o rd i s e a s e d c o r n e a 43 h a s been e x c i s e d With a c i r c u l a r t r e p h i n e( n o t s h o W n ) . The d g e o f h e e x c i s i o n i s shoWn n d a s h e d i n e sa s 4 5 . F I G . 10B a l s o shoWs c o r n e a l i m p l a n t 6 0 r e s t i n g i n t h edeformation c h a r t e r o r a r e a 1 2 2 . I n FIG. 10C t h e holloWm e m b e r 1 2 0 h a s b e e n i n s e r t e d i n t o p o c k e t 4 0 t h r o u g h e x t e rn a l o p e n i n g 4 2 a n d c o r n e a l i m p l a n t 6 0 h a s b e e n f o l d e d i n h a l fW i t h i n deformation chamber 1 2 2 . FIG. 10D shoWs t h a t c o rn e a l implant 6 0 h a s been f u r t h e r deformed i n t o a m o r e comp a c t s h a p e b y i t s m o v e m e n t t h r o ug h n a r r o W i n g h o l l o W p a ss a g e 1 2 6 and i s b e i n g e x t r u d e d i n t o p o c k e t 4 0 . F I G . 10Es h o W s t h a t c o r n e a l i m p l a n t 6 0 h a s b e e n r e s t o r e d t o i t s o r i g i n a ls h a p e W i t h i n c o r n e a l p o c k e t 4 0 . A n t e r i o r o p t i c 6 2 ? l l s t h es p a c e l e f t b y t h e e x c i s e d d i s e a s e d a n t e r i o r c o r n e a 4 3 . I np r e f e r r e d a s p e c t s , a f t e r c o r n e a l i m p l a n t 6 0 h a s b e e n p o s it i o n e d i n t h e p o c k e t , t h e p o s t e r i o r d i s e a s e d c o r n e a 44 c a n bee x c i s e d W i t h loW r o ? l e curved o r n e a l s c i s s o r s o r some t h e rc u t t i n g t o o l ( e . g . p l a s m a b l a d e ) i n s e r t e d t h r o u g h e x t e r n a lo p e n i n g 4 2 . F I G . 10F shoWs t h e ? n a l a p p e a r a n c e o f c o r n e a li m p l a n t p r o s t h e s i s 6 0 . N o t e t h a t t h e r i m 6 4 a n c h o r s c o r n e a li m p l a n t p r o s t h e s i s 6 0 W i t h i n t h e p e r i p h e r a l r e c e s s e s o f t h ec o r n e a l p o c k e t a n d p r o v i d e s a W a t e r - t i g h t s e a l . I n t h i se m b o d i m e n t , p o s t e r i o r o p t i c 6 3 p r o t r u d e s t h r o u g h t h e s p a c el e f t b y e x i c i se d d i s e a s e d c o r n e a 4 4 . H o W e v e r , p o s t e r i o r o p t i c

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6 5

1 06 3 i s o p t i o n a l a n d i s n o t n e c e s s a r i l y r e q u i r e d f o r t h e c o r n e a li m p l a n t t o p r o p e r l y f u n c t i o n . I t i s t o b e u n d e r s t o o d t h a t t h er e l a t i v e d i m e n s i o n s , s h a p e s , a n d a n g l e s o f h e a n t e r i o r c e n t r a lo p t i c 6 2 , p o s t e r i o r c e n t r a l o p t i c 6 3 , a n d r i m 6 4 , may e a c h b emodi?ed t o promote improved r e t e n t i o n a s W e l l a s o p t i c a lq u a l i t i e s a l l i n k e e p i n g W i t h i n t h e s c o p e o f t h e p r e s e n t i n v e nt i o n .

FIGS. 11A-11F shoW an embodiment of c o r n e a l i m p l a n tt h a t c a n be assembled W i t h i n t h e c o r n e a l p o c k e t . By assemb l i n g i n d i v i d u a l s m a l l e r p i e c e s o f t h e c o r n e a l i m p l a n t W i t h i nt h e c o r n e a l p o c ke t , a r e l a t i v e l y l a r g e c o r n e a l i m p l a n t c a n b ec o n s t r u c t e d W h i l e u s i n g a r e l a t i v e l y s m a l l e x t e r n a l i n c i s i o n .The o p p o r t i o n o f FIGS. 11A and 11B shoW c r o s s - s e c t i o n a lvieW of a cornea With an i n t r a - s t r o m a l p o c k e t . The bottomp o r t i o n of F IG. 11A shoWs a t o p doWn vieW of c o r n e a Withan n t r a - s t r o m a l p o c k e t . I n b o t h FIGS. 11A and 1 1 B , i t can bes e e n t h a t t h e ? r s t h a l f o f t h e rim 70 h a s a l r e a d y been i n s e r t e di n s i d e t h e p o c k e t . A e c o n d h a l f o f h e r i m 7 4 i s b e i n g i n s e r t e dt h r o u g h t h e s m a l l e x t e r n a l i n c i s i o n . Note t h a t b e c a u s e t h ec o r n e a l t i s s u e i s p a r t i a l l y e l a s t i c , t h e r i m may b e made o f ar e l a t i v e l y r i g i d m a t e r i a l e . g . p o l y m e t h y l m e t h a c r y l a t e(PMMA) n d t i l l b e i n s e r t e d t h r o u g h t h e e x t e r n a l o p e n i n g 4 2t h a t i s l e s s t h a n h a l f o f t h e d i a m e t e r o f t h e a s s e m b l e d c o r n e a li m p l a n t . The e r t i c a l d a s h e d l i n e s i n t h e t o p o f t h e ? g ur e a n dt h e c i r c u l a r d a s h e d l i n e s i n t h e bottom ? g u r e r e p r e s e n t a no p e n i n g 7 6 l e f t by a c i r c u l a r d i s k o f a n t e r i o r s t r o m a l t i s s u et h a t h a s been e x c i s e d (eg w i t h a t r e p h i n e ) . F I G S . 11C and11D shoW h a t t h e o p t i c 7 2 may t i n t o o p e n i n g 7 6 . F I G S . 11Eand 11F shoW t h a t t h e o p t i c 72 h a s been a t t a c h e d t o t h e tWoh a l v e s o f t h e r i m 7 0 and 7 4 t o c o m p l e t e a s s e m b l y o f t h ec o r n e a l i m p l a n t . T h e i n d i v i d u a l p i e c e s o f t h e c o r n e a l i m p l a n tmay b e a t t a c h e d t o e a c h o t h e r b y i n t e r l o c k i n g ? t t i n g s ( n o ts h o W n ) , by g l u e , o r a n y o t h e r a p p r o p r i a t e m e c h a n i c a l o rc h e m i c a l method f ? x a t i o n . I n t h i s embodiment f h e i n v e nt i o n t h e c o r n e a l i m p l a n t i s shoWn a s a t h r e e p i e c e p r o s t h e s i st h a t r e p l a c e s p a r t o f t h e c o r n e a . H o W e v e r , i t i s t o b e u n d e rs t o o d t h a t t h e i n v e n t i o n i n c l u d e s any c o r n e a l i m p l a n t t h a t c a nbe assembled a s tWo o r m o r e p i e c e s Within a c o r n e a l p o c k e t .FIGS. 12A-12B r e end vieWs of h e back of deformationcham be r 86 on a holloW m e m b e r 80 Which shoW hoW h ep r e s e n c e o f a p r o t r u s i o n 82 W i t h i n t h e d e f o r m a t i o n chambercan h e l p t o maintain h e o r i e n t a t i o n of c o r n e a l i m p l a n t 90 a si t i s pushed i n an a x i a l d i r e c t io n . Deformation chamber 8 6i n c l u d e s t h r e e h i n g e d s e c t i o n s 8 0 a , 8 0 b , a n d 8 0 0 W h i c h makeup a holloW m e m b e r Which opens i n o r d e r t o r e c e i v e c o r n e a li m p l a n t 9 0 . At t h e l a t e r a l a s p e c t s o f d e f o r m a t i o n a r e a 80 a r etWo p r o t r u s i o n s 8 2 , Which h e l p t o h o l d t h e r i m 9 4 o f c o r n e a li m p l a n t 9 0 i n p l a c e . F I G . 12B s h o W s hoW s e c t i o n s 8 0 a , 8 0 b ,a n d 8 0 0 c a n b e c l o s e d b y p u t t i n g t o g e t h e r t h e W i n g s 8 4 ( W h i c ht o g e t h e r form a n a x i a l p u s h e r o r i m p l a n t m o v e r ) t o c r e a t eh o l l o W m e m b e r 80 and d e f o r m a t i o n chamber 8 6 . C o r n e a li m p l a n t 9 0 i s noW s e c u r e l y ? x a t e d W i t h i n t h e h o l l o W d e f o rm a t i o n chamber 6 by h e pr o t r u s i o n s 8 2 a n d c a n b e manipul a t e d . The o r n e a l i m p l a n t 9 0 c a n t h e n b e mov ed x i a l l y a l o n gh o l l o W m e m b e r 80 by a n a x i a l p u s h e r o r o t h e r i m p l a n t mover( n o t s h o W n ) W i t h o u t i n a d v e r t e n t r o t a t i o n o f t h e c o r n e a li m p l a n t .

P l e a s e n o t e a t l e a s t some p o r t i o n o f t h e c o r n e a l i m p l a n tc o u l d be c o l o r e d i n any o f t h e embodiments o f t h e i n v e n t i o nt o enhance t h e a e s t h e t i c appearance of h e eye o r t o d e c r e a s et h e amount o f l i g h t e x p o s u r e t o t h e e y e (eg f o r t r e a t m e n t o fa n i r i d i a ) .R e f e r r i n g noW t o FIGS. 13A and 1 3 B , a c o r n e a l i m p l a n ti n s e r t i o n d e v i c e 200 i n c l u d e s a deformation chamber 202d e ? n e d b y t W o - c i r c u l a r h i n g e d s e c t i o n s 2 0 4 . The h i n g e d s e ct i o n s 204 a r e a t t a c h e d t o W i n g s 206 Which p e r m i t t h e h i n g e ds e c t i o n s t o b e c l o s e d i n o r d e r t o c a p t u r e t h e c o r n e a l i m p l a n t C ,



31/54

US 8 0 2 9 5 1 5 B21 1

a f t e r t h e i m p l a n t h a s b e e n i n t r o d u c e d i n t o t h e d e f o r m a t i o nc h a m b e r a s shown n F I G . 13B.

P r o t r u s i o n s 210 h a v i n g i n t e r i o r a r c u a t e s u r f a c e s 212 a r ea t t a c h e d t o t h e hinged s e c t i o n s 204 s o t h a t t h e s u r f a c e s 212form a d i a l l y i n w a r d l y d i r e c t e d r a m p s a s i l l u s t r a t e d i n F I G .1 4 A . T h u s a f t e r t h e c o r n e a l i m p l a n t C s i n t r o d u c e d i n t o t h ed e f o r m a t i o n chamber 0 2 a s i l l u s t r a t e d i n F I G . 1 3 B c l o s u r eo f t h e chamber u s i n g t h e W i n g s 2 0 6 W i l l c u r l t h e c o r n e a li m p l a n t C n t o a C shaped r o ? l e a s shoWn n F I G . 14A. h i scan be an advantage over t h e c o r n e a l i n s e r t i o n t o o l embodiment o f F I G S . 12A a n d 12B Where h e e d g e s o f t h e i m p l a n ta r e h e l d i n a g e n e r a l l y o p e n c o n ? g u r a t i o n by h e o u t W a r d l yf a c i n g s u r f a c e s o f p r o t r u s i o n s 8 2 .

I n a s p e c i ? c embodiment o f t h e c o r n e a l i m p l a n t i n s e r t i o nd e v i c e o f t h e p r e s e n t i n v e n t i o n t h e c o r n e a l i m p l a n t C omp r i s e s a l a m e l l a r c o r n e a l s t r o m a l e n d o t h e l i a l t r a n s p l a n t g r a f to f a p p r o x i m a t e l y 9 n d i a m e t e r and 100 pm n t h i c k n e s s .The deformation chamber 220 has a diameter o r Width D fa p p r o x i m a t e l y 9 n o r d e r t o r e c e i v e t h e c o r n e a l i m p l a n t Cs u c h t h a t i t s e d g e s a r e d i s p o s e d be n e a t h t h e a r c u a t e s u r f a c e s212 o f t h e p r o t r u s i o n s 2 1 0 a s i l l u s t r a t e d i n F I G . 1 3 B .

R e f e r r i n g noW o F I G S . 1 5 A h r o u g h 1 5 C a p u s h e r s h a f t230 a v i n g a f o r W a r d me mbe r 232 may e advanced n t o t h ed e f o r m a t i o n chamber 2 0 2 o f t h e c o r n e a l i m p l a n t i n s e r t i o nd e v i c e 2 0 0 . The f o r W a r d e l e m e n t 232 W i l l h a v e a p r o ? l eWhich s s i m i l a r t o t h e s h a p e o f t h e h o l l o W p a s s a g e s o t h a t tcan a s s o v e r t h e p r o t r u s i o n s 210 and i l l t y p i c a l l y be comp r e s s i b l e s o t h a t t c a n p a s s i n t o a t a p e r e d r e g i o n 240 o f t h ei n s e r t i o n d e v i c e a s shoWn i n F I G . 15D. T h u s t h e f o r W a r dme mbe r 232 W i l l ? r s t be i n t r o d u c e d i n t o t h e c o n s t a n t - d i a me t e r p o r t i o n o f t h e d e f o r m a t i o n chamber 2 0 2 a s shoWn i nF I G . 1 5 B a n d u s e d t o a d v a n c e t h e c o r n e a l i m p l a n t C f o rW a r d l y . The h a f t 3 0 a n d f o r W a r d member 3 2 W i l l c o n t i n u et o b e a d v a n c e d s o t h a t t h e c o r n e a l i m p l a n t C s pushed fromt h e d i s t a l t i p o f h e t a p e r e d r e g i o n 2 4 0 a s shoWn n F I G . 1 5 C .As t h e c o r n e a l i m p l a n t C s a d v a n c e d t s e d g e s W i l l b e

curved o r e v e r t e d i n W a r d l y a s i l l u s t r a t e d i n FIGS. 1 4 At h r o u g h 1 4 C . I n F I G . 1 4 A t h e c o r n e a l i m p l a n t C s shoWn st i s i n F I G . 15A. A s t a d v a n c e s f o r W a r d l y a s shoWn n F I G .1 5 B t h e c o r n e a l i m p l a n t C s r e d u c e d i n d i a m e t e r W i t h t h ee d g e s b e i n g p u s h e d r a d i a l l y i n W a r d l y a s s h o W n i n F I G . 1 4 B .F i n a l l y a s t h e c o r n e a l i m p l a n t C s r e l e a s e d f r o m t h e p r o x i m a lt i p o f t h e t a p e r e d r e g i o n 2 4 0 t h a s a s i g n i ? c a n t l y r e d u c e dd i a m e t e r a s shoWn i n F I G . 1 4 C . I t i s p a r t i c u l a r l y d e s i r a b l et h a t t h e c o r n e a l i m p l a n t C e reduced i n s i Z e t o a s g r e a t ane x t e n t a s p o s s i b l e b u t t h a t t h e l e a d i n g t i p s o f t h e i m p l a n t n o tt o u c h t h e i n t e r i o r s u r f a c e j u s t a s shoWn i n F I G . 1 4 C . T h i sr e d u c e s t h e damage o r trauma o t h e d e l i c a t e c o r n e a l e n d o th e l i a l c e l l s d u r i n g t h e i m p l a n t a t i o n p r o t o c o l .

W h i l e t h e a b o v e i s a c o m p l e t e d e s c r i p t i o n o f t h e p r e f e r r e de m b o d i m e n t s o f t h e i n v e n t i o n v a r i o u s a l t e r n a t i v e s modi?c a t i o n s a n d e q u i v a l e n t s may b e u s e d . T h e r e f o r e t h e a b o v ed e s c r i p t i o n s h o u l d n o t be t a k e n a s l i m i t i n g t h e s c o p e o f t h ei n v e n t i o n W h i c h i s d e ? n e d b y t h e a p p e n d e d c l a i m s .

What s c l a i m e d i s :1 . A ethod f o r d e l i v e r i n g a b i o l o g i c a l c o r n e a l i m p l a n t

h a v i n g a n e x t e r i o r s u r f a c e a n i n t e r i o r s u r f a c e a n d l a t e r a l l yo p p o s e d e d g e s t o a c o r n e a s a i d method o m p r i s i n g :

c o n s t r a i n i n g t h e i m p l a n t s o t h a t t h e l a t e r a l l y o p p o s e d e d g e se v e r t i n W a r d l y t o p r o v i d e a C - s h a p e d p r o ? l e ;a d v a n c i n g t h e i m p l a n t t h r o u g h a c h a m b e r W i t h a p r o t r u s i o n

d i s p o s e d b e t W e e n t h e l a t e r a l l y o p p o s e d e d g e s t o f u r t h e re v e r t t h e e d g e s a n d r e d u c e t h e W i d t h o f t h e i m p l a n t ; a n dr e l e a s i n g t h e c o n s t r a i n e d b i o l o g i c a l c o r n e a l i m p l a n t i n t ot h e cornea o r a n t e r i o r chamber a t t h e reduced W i d t hW h e r e i n p r i o r t o r e l e a s e t h e l a t e r a l l y o p p o s e d e d g e s o f

20

25

30

35

40

45

50

55

60

6 5

1 2t h e b i o l o g i c a l c o r n e a l i m p l a n t r e m a i n e v e r t e d b u t d o n o tt o u c h t h e i n t e r i o r s u r f a c e o f t h e b i o l o g ic a l c o r n e a li m p l a n t s u c h t h a t damage o t h e i m p l a n t i s r e d u c e d .

2 . A ethod s i n c l a i m 1 W h e r e i n c o n s t r a i n i n g c o m p r i s e sc l o s i n g s e m i - c i r c u l ar h a l v e s of d e f o r m a t i o n chamber on h ei m p l a n t W h e r e i n e a c h h a l f c a r r i e s a n i n W a r d l y d i r e c t e d rampt o e v e r t t h e e d g e s o f t h e i m p l a n t i n W a r d l y a s t h e h a l v e s a r ec l o s e d .

3 . A ethod a s i n c l a i m 1 W h e r e i n a d v a n c i n g c o m p r i s e sp u s h i n g a p u s h e r member g a i n s t a r e a r e d g e o f t h e c o r n e a li m p l a n t .

4 . A ethod s i n c l a i m 3 Wherein f o r W a r d p o r t i o n of h ep u s h e r member o n f o r m s t o t h e i n t e r i o r o f t h e t a p e r e d chamb e r a s t h e p u s h e r member s p u s h e d .

5 . A ethod s i n c l a i m 1 W h e r e i n t h e b i o l o g i c a l i m p l a n tc o m p r i s e s a l a m e l l a r c o r n e a l s t r o m a l e n d o t h e l i a l t r a n s p l a n t .

6 . A ethod s i n c l a i m 1 W h e r e i n t h e p r o t r u s i o n e x t e n d so v e r t h e e n t i r e l e n g t h o f h e chamber and e m a i n s betWeen h eo p p o s e d e d g e s u n t i l t h e c o n s t r a i n e d i m p l a n t i s r e l e a s e d .

7 . A ethod s i n c l a i m 6 W h e r e i n t h e chamber s t a p e r e dt o a reduced Width i n t h e d i r e c t i o n o f advancement o f t h ei m p l a n t .

8 . A y s t e m f o r d e l i v e r i n g c o r n e a l i m p l a n t s s a i d s y s t e mc o m p r i s i n g :a d e f o r m a t i o n chamber a v i n g a p r o x i m a l e n d a d i s t a l e n d

and a p a i r o f s e m i - c i r c u l a r h a l v e s h i n g e d t o e a c h o t h e ra l o n g a c o m m o n i d e each s e m i - c i r c u l a r h a l f h a v i n g ani n W a r d l y o r i e n t e d a r c u a t e s u r f a c e a l o n g a n o p p o s i t es i d e s a i d s u r f a c e s b e i n g a d a p t e d t o e v e r t o p p o s i t e e d g e so f an i m p l a n t having an x t e r i o r s u r f a c e and an n t e r i o rs u r f a c e When a i d i m p l a n t i s p l a c e d b e t W e e n t h e s u r f a c e so f t h e d e f o r m a t i o n chamber s t h e h a l v e s a r e c l o s e d ;

a holloW mem ber having a proximal end and a d i s t a l endcon?gured f o r i n s e r t i o n i n t o a p o c k e t W i t h i n a c o r n e aand a v i n g a n a x i a l h o l l o W p a s s a g e Which a p e r s i n t h ed i s t a l d i r e c t i o n W h e r e i n t h e a x i a l h o l l o W p a s s a g e i sa t t a c h e d t o a d i s t a l end of t h e d e f o r m a t i o n c h a m b e rr e c e i v e s t h e i m p l a n t i n a n a r c u a t e c o n ? g u r a t i o n andi n c l u d e s i n W a r d l y o r i e n t e d a r c u a t e s u r f a c e s Which f u rt h e r e v e r t t h e o p p o s i t e e d g e s o f t h e c o r n e a l i m p l a n tr a d i a l l y i n W a r d l y a s t h e i n s e r t i s a x i a l l y a d v a n c e dt h r o u g h t h e p a s s a g e W h e r e i n t h e i n W a r d l y o r i e n t e da r c u a t e s u r f a c e s of h e holloW mem ber r e d i s p o s e d ono p p o s i t e s i d e s o f a p r o t r u s i o n W h i c h e x t e n d s a x i a l l yt h r o u g h t h e h o l l o W p a s s a g e t o f o r m i n W a r d l y d i r e c t e dramps t o c u r l t h e o p p o s i t e e d g e s o f t h e i m p l a n t i n t o aC - s h a p e W h e r e i n t h e o p p o s i t e e d g e s a r e e v e r t e d b u t d on o t t o u c h t h e i n t e r i o r s u r f a c e o f t h e i m p l a n t a s t h ei m p l a n t i s a d v a n c e d ; a n d

a n a x i a l p u s h e r d i s p o s e d t o b e a d v a n c e d t h r o u g h t h e d e f o rmation chamber and t h e h o l l o W a x i a l p a s s a g e o f t h eholloW me mbe r o engage and x i a l l y advance t h e c o rn e a l i m p l a n t t h r o u g h t h e h o l l o W p a s s a g e .

9 . A y s t e m a s i n c l a i m 8 f u r t h e r c o m p r i s i n g a c o r n e a li m p l a n t c o n s t r a i n e d W i t h i n t h e deformation chamber on ad i s t a l s i d e o f t h e a x i a l p u s h e r .

1 0 . A y s t e m a s i n c l a i m 8 W h e r e i n t h e a x i a l p u s h e r i st a p e r e d i n a d i s t a l d i r e c t i o n .

1 1 . A y s t e m a s i n c l a i m 1 0 W h e r e i n t h e a x i a l p u s h e r i sdeformable s o t h a t i t W i l l r e d u c e i n d i a m e t e r a s t i s d i s t a l l ya d v a n c e d t h r o u g h t h e t a p e r e d h o l l o W p a s s a g e .

1 2 . A y s t e m a s i n c l a i m 1 1 W h e r e i n t h e a x i a l p u s h e r h a s ac r o s s - s e c t i o n a l p r o ? l e Which s s i m i l a r i n s h a p e t o t h e c r o s ss e c t i o n a l p r o ? l e o f t h e d e f o r m a t i o n chamber and h e h o l l o Wp a s s a g e .



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EXHIBIT 2



33/54

C O R N E A L G R A F T

C

O

R

O N

E T



34/54

EndoGlide System

PATENT APPLIED

Minimal endothelial damage -double coiling of the donor, no

contact with wound, endoforceps

grip stromal edge only

Minimal endothelial touch during

donor coiling - double coil

Minimal endothelial touch when thedonor is pulled through the wound

No folding assists with unfolding and

orientation in the anterior chamber

Can be used in small eyes with

shallow anterior chambers or high

vitreous pressure

Transparent cartridge allows for good

visualisation

Stable anterior chamber throughout

insertion procedure closed eye system

Reliable consistent results

Supplied sterile for single use only.

Advantages

Developed with:

Professor Donald Tan

FRCSE FRCSG FRCOphth FAMSMedical Director,

Singapore National Eye Centre.

Chairman,

Singapore Eye Research Institute,

Department of Ophthalmology,

National University of Singapore.

DSAEK Corneal transplantation is undergoinga paradigm shift with the development of

Endothelial Keratoplasty.

The main focus today is to reduce iatrogenic

damage of donor endothelium caused by

manipulation and insertion of the donor

through a small incision.

The EndoGlide is a device for surgeons to use

which consistently delivers a donor lenticule

through a small incision, with minimal

endothelial loss, whilst making the insertionprocedure relatively reliable and consistent,

with the surgeon in full control of the donor

at all stages of insertion.

A new DSAEK donor delivery system

with reduced endothelial cell loss.

Introducer and Glide Cartridge



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Ultrathin and standard DSAEK

procedures

Designed to deliver Ultrathin Donor

Endothelium in a controlled manner with

minimum endothelial cell loss.

Accommodates donor material

up to 9.50mm diameter and

70-250 micron in thickness.

Supplied one per box

Supplied sterile for single use only

Standard DSAEK procedures

Designed to deliver Donor Endothelium

in a controlled manner with minimum

endothelial cell loss. To accept both

anterior and posterior lenticules.

Accommodates donor material

up to 9.50mm diameter and

130-250 microns in thickness.



51-820 EndoGlide Classic

51-823 EndoGlide Ultrathin

Modern technology,

materials and design

are at the heart of the

Coronet programme

and drives our

product innovation.



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The most important part of a trephine is the blade.

All CORONET trephines utilise the unique CORONETblade technology to create an ultra-sharp cutting edge

of reliable and repeatable quality.

The ultra-sharp, thin-profile cutting edge

minimises damage to the endothelial cells and

reduces undercut and tissue distortion.



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51-840 Recipient Vacuum Trephine

Blade progresses 63 microns downward

per quarter turn and 250 microns per full

rotation

Marker pin allows the operator to

calculate the quarter and full turns

through which the blade has progressed.



Sterilisation by Ethylene Oxide (EO)

Declared 3-year shelf life

Trephine Size (mm) Code

6.50 51-840-6.50

6.75 51-840-6.757.00 51-840-7.00

7.25 51-840-7.25

7.50 51-840-7.50

7.75 51-840-7.75

8.00 51-840-8.00

8.25 51-840-8.25

8.50 51-840-8.50

8.75 51-840-8.75

9.00 51-840-9.00

9.50 51-840-9.50

Patent Applied



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6.00 51-850-6.00

6.25 51-850-6.25

6.50 51-850-6.50

6.75 51-850-6.75

7.00 51-850-7.007.25 51-850-7.25

7.50 51-850-7.50

7.75 51-850-7.75

8.00 51-850-8.00

8.25 51-850-8.25

8.50 51-850-8.50

8.75 51-850-8.75

9.00 51-850-9.00

9.25 51-850-9.25

9.50 51-850-9.50

9.75 51-850-9.75

Patent Protected

The unique CORONET Donor Trephine

Punch has been designed to award the

surgeon with best approach and

visualisation.

100% visualisation of the graft at all times

Graft tissue may be manipulated throughthe windows for optimal positioning

The ultra-sharp, thin profile blade

minimises damage to the endothelial

cells and reduces undercut

Cover protects the graft from

contamination during transfer

Marker holes in base assist when

centering the tissue and reduces the

likelihood of bubbles forming under

the epithelial tissue



The CORONET Donor Trephine Vacuum

Punch has all the benefits of the donor

trephine punch with the additional vacuum

function.



Sterilisation by Ethylene Oxide (EO)



6.00 51-835-6.00

6.25 51-835-6.256.50 51-835-6.50

6.75 51-835-6.75

7.00 51-835-7.00

7.25 51-835-7.25

7.50 51-835-7.50

7.75 51-835-7.75

8.00 51-835-8.00

8.25 51-835-8.25

8.50 51-835-8.50

8.75 51-835-8.75

9.00 51-835-9.00

9.25 51-835-9.259.50 51-835-9.50

9.75 51-835-9.75

Patent Protected

51-850 Donor Trephine Punch

51-835 Donor Trephine Vacuum Punch



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Size (mm) Code

6.00 51-900-6.00

6.25 51-900-6.25

6.50 51-900-6.50

6.75 51-900-6.75

7.00 51-900-7.00

7.25 51-900-7.25

7.50 51-900-7.50

7.75 51-900-7.75

8.00 51-900-8.00

8.25 51-900-8.25

8.50 51-900-8.50

8.75 51-900-8.75

9.00 51-900-9.00

9.25 51-900-9.25

9.50 51-900-9.50

9.75 51-900-9.75



Sterilisation by Gamma Irradiation


51-900 Standard Trephine

Size (mm) Code Code

300 micron 400 micron

7.00 51-860-7.00 51-865-7.00

7.50 51-860-7.50 51-865-7.50

8.00 51-860-8.00 51-865-8.00

8.50 51-860-8.50 51-865-8.50

51-860 Guarded Trephine (300 micron)

51-865 Guarded Trephine (400 micron)

The CORONET Guarded Trephine has

been designed to meet the requirementsof the surgeon when performing a lamellar

keratoplasty.

The fixed blade depth awards the surgeon

control over the blade penetration.

Suitable for both recipient and donor

Especially useful for any lamellar

technique

Choice of two fixed-depth blades;

300 microns or 400 microns

Cross hair to assist with centralisation

300 micron



Sterilisation by Gamma Irradiation

Declared 5- year shelf life



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51-901 Standard Trephine with cross hair

Size (mm) Code

6.00 51-901-6.00

6.25 51-901-6.256.50 51-901-6.50

6.75 51-901-6.75

7.00 51-901-7.00

7.25 51-901-7.25

7.50 51-901-7.50

7.75 51-901-7.75

8.00 51-901-8.00

8.25 51-901-8.25

8.50 51-901-8.50

8.75 51-901-8.75

9.00 51-901-9.009.25 51-901-9.25

9.50 51-901-9.50


Supplied sterile for single use only Sterilisation by Gamma Irradiation

Declared 5-year shelf l

keramed v. network medical products et. al

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