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US007943162B2

<12) United States Patent (10) Patent N0.: US 7,943,162 B2 Missel et al. (45) Date of Patent: *May 17, 2011 (54) DRUG DELIVERY DEVICE (56) References Cited (75) Inventors: Paul J. Missel, Arlington, TX (US); U-S- PATENT DOCUMENTS Yoseph Yaacobi, Fort Worth, TX (US) 3,416,530 A 12/1963 Ness 3,828,777 A 8/1974 Ness (73) Assignee: Alcon,Inc., Hunenberg (CH) 4,014,335 A 3/1977 Arnold 4,256,108 A 3/1981 Theeuwes ( * ) Notice" Subject to any disclaimer the term of this Q Eefitno ettalt ' ’ , , O €S€ € 3. . patent is extended or adjusted under 35 4,624,343 A 11/1936 Lee U.S.C. l54(b) by 1137 days. 2 E/°I1_g , , I'W1Il This patent is subject to a tenninal dis- 4,997,652 A 3/1991 Wong C1aimer_ 5,147,647 A 9/1992 Darougar 5,164,188 A 11/1992 Wong 5 178 635 A 1/1993 Gwon et al. 21 A l. No.: 11/567 892 ’ ’ . ( ) pp ’ (Continued) (22) F1100: D°°' 72006 FOREIGN PATENT DOCUMENTS (65) Prior Publication Data DE 40 22 553 $1 _ 1/(11992 US 2007/0092570 A1 Apr. 26, 2007 1 Ommue 1 OTHER PUBLICATIONS Related U.S. Application Data _ _ _ _ _ R. A. Pontes de Carvalho, et al.; “Delivery from Episcleral (63) COm1nuat1On'1n'Pan of apphcanon NO~ 10/9_57=9_10= Exoplants”; Investigative Ophthamology &Visua1 Science; vol. 47, filfid O11 OCT. 4, 2004, HOW 2lb21I1dOI1€d, W111C11 1S 21 NO_ 10; Oet_ 2006; pp 45324539; gpgst continuation of application No. 10/186,960, filed on _ Jul. 1, 2002, now Pat. NO. 6,808,719, which is a (comlnued) continuation of application No. 09/660,000, filed on _ _ _ Sep. 12, 2000, now Pat. NO. 6,413,540. 1([;’At;”‘;1ZyZ Exam?’ 7 HugeN %1,1e]1)11‘ _d L orney, gen , or zrm — . avi ee (60) Provisional application No. 60/160,673, filed on Oct. 21, 1999. (57) ABSTRACT 51 I t Cl Drug delivery devices, and methods of delivering phannaceu( ) n ‘ ‘ tically active agents to atarget tissue withinabody using such A61F 2/00 (200001) devices, are disclosed. One drug delivery device includes a A61F13/00 (200601) body having an intemal surface for disposing on a target /161K 9/00 (200001) tissue andawell having anopening to the internal surface.An (52) U.S. Cl. ...... .. 424/427; 424/422; 424/423; 424/426; ihher eere eemprisihg a drug eehtaihihg portion and ah 424/428$ 424/429 expandable material is disposed in the well. (58) Field of Classification Search ...................... .. None See application file for complete search history. 3 Claims, 6 Drawing Sheets 1-.’ 8 KT 1 O I 20

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5,300,114 5,322,691 5,378,475 5,403,901 5,443,505 5,466,233 5,466,466 5,476,511 5,516,522 5,632,984 5,679,666 5,710,165 5,725,493 5,743,274 5,766,242 5,766,619 5,770,592 5,773,019 5,797,898 5,824,072 5,824,073 5,830,173 5,836,935 5,860,994 5,883,108 5,902,598 5,904,144 5,916,584 6,001,088 6,001,386 6,074,661 6,110,485 6,120,460 6,126,687 6,146,366 6,217,895 6,375,972 6,378,526 6,397,849 6,413,245 6,413,540 6,416,777 6,582,422 6,669,950 6,713,081 6,719,750 6,808,719 7,195,774 7,276,050 2002/0188282 2003/0175324 2004/0071761

U.S. PATENT DOCUMENTS

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4/1994 6/1994 1/1995 4/1995 8/1995 11/1995 11/1995 12/1995 5/1996 5/1997 10/1997 1/1998 3/1998 4/1998 6/1998 6/1998 6/1998 6/1998 8/1998 10/1998 10/1998 11/1998 11/1998 1/1999 3/1999 5/1999 5/1999 6/1999 12/1999 12/1999 6/2000 8/2000 9/2000 10/2000 11/2000 4/2001 4/2002 4/2002 6/2002 7/2002 7/2002 7/2002 6/2003 12/2003 3/2004 4/2004 10/2004 3/2007 10/2007 12/2002 9/2003 4/2004

Gwon et al.
Darougar et al.
Smith et al.
Namdaran et al.
Wong et al.
Weiner et al.
Muller

Gwon et al.
Peyman et al.
Wong et al.
Clark

Kapin et al.
Avery et al.
Peyman

Wong et al.
Aiache et al.
Clark

Ashton et al.
Santini, Jr. et al.
Wong

Peyman

Avery et al.
Ashton et al.
Yaacobi
DeSantis, Jr.
Chen et al.
Hamrnang et al.

O’Donoghue et al.

Roberts et al.
Ashton et al.
Olejnik et al.
Olejnik et al.
Abreu
Peyman
Schachar

Guo et al.
Guo et al.
Bowman et al.
Bowman et al.
Yaacobi
Yaacobi
Yaacobi

Hess

Yaacobi
Robinson et al.
Varner et al.
Yaacobi
Carvalho et al.
Franklin
Greenberg
Robinson et al.
Miller et al.

2004/0180075 A1 9/2004 Robinson et al. 2004/0219181 A1 11/2004 Viscasillas 2007/0112318 A1 5/2007 Leahy et al.

FOREIGN PATENT DOCUMENTS

EP 0 904 787 A1 3/1999
RU 2149615 C1 5/2000
WO WO 94/05257 3/1994
WO WO 95/26734 10/1995
WO WO 95/28984 11/1995
WO WO 96/36377 11/1996
WO WO 97/14415 4/1997
WO WO 98/23228 6/1998
WO WO 98/43611 10/1998
WO WO 99/07418 2/1999
WO WO 99/11244 3/1999
WO WO 99/32104 7/1999
WO WO 99/45920 9/1999
WO WO 00/37066 6/2000
WO WO 00/56340 9/2000
WO WO 01/49226 A1 7/2001
WO WO 02/053128 A2 7/2002
WO WO 02/058667 A2 8/2002
WO WO 02/100318 A2 12/2002
WO WO 03/020172 A1 3/2003
WO WO 2004/073551 A2 9/2004
OTHER PUBLICATIONS

“Bausch & Lomb and Control Delivery Systems Agree to Develop Breakthrough Therapeutic Products for Severe Eye Diseases,” Business Wire via Firstl; NewsEdge Corp.; Jun. 14, 1999; 4 pp. “Method of Placing Irrigation System into Tenon’s Space,” E.I. Sidorenko, et al.; Abstract ofRussian Patent No. RU 2123314, issued Dec. 20, 1998; 1 pg.

“A New Method for Posterior Sub-Tenon’s Drug Adrninistration,” Nesterov, et al.; Ophthalmic Surgery, vol. 24, No. 1, Jan. 1993; pp. 59-61 .

Dialog(R) File 266:FEDRIP database record; Identifying, No. 122098; “Implantation of a Sub-Tenon Drug Delivery Device Loaded with a Test Article in Rabbits and Distribution of the Test Article in Ocular Tissues;” Compiled and distributed by NTIS; 1 pg; Jun. 3, 1999.

Dialog(R) File 266:FEDRIP database record; Identifying No. 134284; “Implantation of a Sub-Tenon Drug Delivery Device Loaded with a Test Article in Rabbits and Distribution of the Test Article in Ocular Tissues;” Compiled and distributed by NTIS; 1 pg., (2000). Dialog(R) File 266:FEDRIP database record; Identifying No. 131476; “Ocular Bioavailability of AL-3789 and AL-4940 After Sub-Tenon’ s Injection of AL-3789 Ophthalmic Suspensions in New Zealand White Rabbits;” Compiled and distributed by NTIS; 1 pg., (2000).

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