(12) United States Patent (10) Patent No.: US 9,592.243 B2 Wilsey (45) Date of Patent: *Mar
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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. W unn et al. 2007,0253994 A1 11/2007 Hildebrand 5,759,583 A 6,f 1998 Iwamotob et al. 2008, 0021074 A1 1/2008 Cartt 5,868,789 A &E s Ital 2008/0085263 A1 4/2008 Krister et al. 5,942,241 A 8/1999 Chasin et al. 2008/0091207 A1 4/2008 Truckai et al. 6,069,129 A 5/2000 Sandberg et al. 2008.OO97229 A1 4/2008 Roy et al. 6,179,862 B1 1/2001 Sawhney 2008/0269717 A1 10, 2008 Crandall et al. 6,248.345 B1 6/2001 Goldenheim et al. 2009/0020076 A1 1/2009 Ghiraldi 6,287,588 B1 9, 2001 Shih et al. 2009/0048678 A1 2/2009 Saal et al. 6,326,020 B1 12/2001 Kohane et al. 2009.0143333 A1 6/2009 Palefsky et al. 6,331,311 B1 12/2001 Brodbeck et al. 2009/0202645 A1 8, 2009 Predieri 6,428,804 B1 8, 2002 Suzuki et al. 2009, 0222096 A1 9, 2009 Trieu 6,461,631 B1 10/2002 Dunn et al. 2009/0246 123 A1 10, 2009 Zanella et al. 6,524,607 B1 2/2003 Goldenheim et al. 2009,0263319 A1 10, 2009 Wohabrebbi et al. 6,534,081 B2 3/2003 Goldenheim et al. 2009,0263.489 A1 10, 2009 Zanella 6,589,549 B2 7/2003 Shih et al. 2009,0264489 A1 10, 2009 Hildebrand et al. 6,616,946 B1 9, 2003 Meier et al. 2009/0275913 A1 11/2009 Trieu 6,630, 155 B1 10/2003 Chandrashekar et al. 6,632.457 B1 10/2003 Sawhney 2010/0239632 A1 9, 2010 Walsh 6,652,883 B2 11/2003 Goupil et al. 6,676,971 B2 1/2004 Goupil et al. OTHER PUBLICATIONS 6,710,126 B1 3, 2004 Hirt et al. 6,723,741 B2 4/2004 Jeon et al. American Burn Association, Burn Incidence and Treatment in the 6,723,814 B2 4/2004 Meier et al. 6,756,058 B2 6, 2004 Brubaker et al. United States: 2011 Fact Sheet, 1 pg. 6,773,714 B2 8, 2004 Dunn et al. QLT, Inc., Atrigel, Drug Delivery Platform, www.qltinc.com. Fort 6,921,541 B2 7/2005 Chasin et al. Collins, CO, U.S., Jul. 2006, 2 pgs. 6,974.462 B2 12/2005 Sater Lynda Cole, RN and Caroline Nesbitt, RN, A Three-Year 7,070,809 B2 7/2006 Goupil et al. Multiphase Pressure Ulcer Prevalence/Incidence Study in a 7,144,412 B2 12/2006 Wolfe et al. Regional Referral Hospital, vol. 57, Issue 1, Jan. 2011, pp. 1-5. 7,166.570 B2 1/2007 Hunter et al. Robert H. 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. Eaglstein, M.D., Patricia Mertz, B.A. and Oscar M. 8,470,360 B2 * 6/2013 McKay ......................... 424/426 Alvarez, Ph.D., Effect of Topically Applied Agents on Healing US 9,592.243 B2 Page 3 (56) References Cited OTHER PUBLICATIONS Wounds, Dept. of Dermatology, Univ. of Pittsburgh School of Medicine, Pittsburgh, PA, and Cornell Univ. Mecial Center, New York, NY, Jul.-Sep. 1984, vol. 2, No. 3, pp. 112-115. Helena Cristina Franciso Pereira Da Silva, Rodrigo Cecanho, Cephalometric changes produced by locally applied anabolic Ste roid in Wistar rats, Archives of Oral Biology 54 (2009) pp. 389-395. Daniel P. Moore, M.D., Helping your patients with spasticity reach maximal function, vol.