(12) United States Patent (10) Patent No.: US 9,592.243 B2 Wilsey (45) Date of Patent: *Mar

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(12) United States Patent (10) Patent No.: US 9,592.243 B2 Wilsey (45) Date of Patent: *Mar USO09592243B2 (12) United States Patent (10) Patent No.: US 9,592.243 B2 Wilsey (45) Date of Patent: *Mar. 14, 2017 (54) MEDICAL DEVICES AND METHODS (58) Field of Classification Search COMPRISING AN ANABOLICAGENT FOR CPC ... A61L 2400/06; A61L 31/06; A61L 31/148: TREATMENT OF AN INURY A61L 31/16: A61L 26/0019; (Continued) (71) Applicant: Warsaw Orthopedic, Inc., Warsaw, IN (US) (56) References Cited (72) Inventor: Jared T. Wilsey, Memphis, TN (US) U.S. PATENT DOCUMENTS 4,624,255 A 11/1986 Schenck et al. (73) Assignee: Warsaw Orthopedic, Inc., Warsaw, IN 4,742,054 A 5, 1988 Naftchi (US) (Continued) (*) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 FOREIGN PATENT DOCUMENTS U.S.C. 154(b) by 0 days. WO O3005961 A2 1, 2003 WO 2005034998 A2 4/2005 This patent is Subject to a terminal dis WO 2007OO5177 A1 1, 2007 claimer. (21) Appl. No.: 14/085,444 OTHER PUBLICATIONS Chhipa et al “Formulation Optimization of Sustained Release (22) Filed: Nov. 20, 2013 Pellets of Itopride Hydrochloride using Different Polymers,” Jour (65) Prior Publication Data nal of Pharmacy Research 2009 2(8) 1404-1408).* (Continued) US 2014/0107088 A1 Apr. 17, 2014 Primary Examiner — Suzanne Ziska Related U.S. Application Data (63) Continuation-in-part of application No. 13/093,479, (57) ABSTRACT filed on Apr. 25, 2011. Improved medical devices and methods are provided com prising an anabolic agent for healing an injury. These (51) Int. Cl. improved medical devices and methods can enhance healing A6 IK3I/58 (2006.01) in injuries from traumatic soft tissue injury, Surgical injuries, A6 IK 47/34 (2006.01) burn, traumatic brain injuries, musculotendinous injuries, musculoskeletal conditions, bone injury or other injuries or (Continued) maladies, which can be chronic or non-chronic in origin. In (52) U.S. Cl. Some embodiments, the medical device comprises a drug CPC .............. A6 IK3I/58 (2013.01); A61K 38/27 depot that releases the anabolic agent over at least 2 days to (2013.01); A61K 38/28 (2013.01); A61K 38/30 enhance healing of an injury. (2013.01); (Continued) 8 Claims, 1 Drawing Sheet low lose of local Estatiot Systeic Starozoic Accelerates foici tieairag k-k's 3: r to Nothing Applied Conto: x Starozoic ing or Ray (3. {3, 5 fig Rays 2, 3, and 8 Rart 3ieties 8 foci: Starozoic-r&aised Arias US 9,592.243 B2 Page 2 (51) Int. Cl. 2002/0009454 A1 1/2002 Boone et al. 2002/0090398 A1 7, 2002 Dunn et al. A6IL 26/00 (2006.01) 2002/O122771 A1 9, 2002 Holland et al. A6 IK 38/27 (2006.01) 2002/0127269 A1 9/2002 Waring et al. A6 IK 38/28 (2006.01) 2003/0022927 A1 1/2003 Jeon et al. A6 IK 38/30 (2006.01) 2003.0185873 A1 10, 2003 Chasin et al. 2003/0203044 A1 10, 2003 Moravec A6IL 3L/06 (2006.01) 2003/0204191 A1 10, 2003 Sater et al. A6IL 3L/4 (2006.01) 2003,0224033 A1 12/2003 Li et al. A6IL 3L/6 (2006.01) 2004f0072799 A1 4, 2004 Li et al. (52) U.S. Cl 2004/0082540 A1 4/2004 Hermida Ochoa AV e. we 2004/0097468 A1 5, 2004 Sunil CPC ............ A61K 47/34 (2013.01); A61L 26/009 2004.01098.93 A1 6/2004 Chen et al. (2013.01); A61L 26/0019 (2013.01); A61L 2004/0214793 A1 10, 2004 Hermida Ochoa 2005/0059744 A1 3/2005 Donello et al. 26/0066 (2013.01); A61L 31/06 (2013.01); 2005/012965.6 A1 6/2005 Goupil et al. A61L 3 1/148 (2013.01); A61L 3 1/16 2005. O142163 A1 6/2005 Hunter et al. (2013.01); A61L 2300/222 (2013.01); A61 L 2005/0175709 A1 8/2005 Baty, III et al. 2300/414 (2013.01); A61 L 2300/43 (2013.01); 2005, 0186261 A1 8, 2005 Avelar et al. 2005/O197293 A1 9, 2005 Mellis et al. A61 L 2300/604 (2013.01); A61 L 2400/06 2005/0222684 A1 10, 2005 Ferree (2013.01) 2005/0287218 A1 12/2005 Chaouk et al. (58) Field of Classification Search 2005/0288789 A1 12/2005 Chaouk et al. CPC ............... A61L 26/009; A61L 26/0066; A61L 2006, OO74422 A1 4/2006 Story et al. 2006/0106361 A1 5, 2006 Muni et al. 2300/222: A61L 2300/414; A61L 2006/0147488 A1* 7/2006 Wohlert ........................ 424/423 2300/43; A61L 2300/604; A61K 38/27; 2006, O148903 A1 7/2006 Burch et al. A61K 38/28: A61K 38/30; A61K 47/34: 2006, O183786 A1 8/2006 Wang A61K 31/58; C08L 67/04 2006, O189944 A1 8/2006 Campbell et al. See application file for complete search history. 2006/0228391 A1 10/2006 Seyedin et al. 2007,0004790 A1 1/2007 Chow et al. 2007/0066568 A1 3/2007 Dalton et al. ................... 514.80 (56) References Cited 2007/0093.907 A1 4/2007 Goupil et al. 2007. O150061 A1 6, 2007 Trieu U.S. PATENT DOCUMENTS 2007. O156180 A1 7/2007 Jaax et al. 2007/O185497 A1 8, 2007 Cauthen et al. E. A 29: i. 2007/0202074 A1 8/2007 Shalaby 5.571882. A 1/1996 R SO 2007/0243225 A1 10/2007 McKay - J. f etter h 2007/0243228 A1 10/2007 McKay Sgt. A S. Yagh Jr. 2007/0248639 A1 10/2007 Demopulos et al. 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Demling, MD., Oxandrolone, an anabolic steroid, 7,220.281 B2 5/2007 Lambrecht et al. enhances the healing of a cutaneous wound in the rat, Wound Repair 7,229,441 B2 6, 2007 Trieu et al. and Regeneration, Mar.-Apr. 2000, Boston, MA pp. 97-102. 7,235,043 B2 6, 2007 Gellman et al. Robert H. Demling. MD. The Role of Anabolic Hormones for 7,287,983 B2 10/2007 Ilan O . Lemling, MD, 7,318,840 B2 1/2008 McKay Wound Healing in Catabolic States, Journal of Burns and Wounds, 7,361,168 B2 4/2008 Makower et al. Brigham & Women's Hospital, Boston, MA, and Harvard Medical 7,367,978 B2 5/2008 Drewry et al. School, Boston, MA. 2005, vol. 4, pp. 46-62. 7,829, 110 B2 11/2010 Wohlert William H. 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