US008969397B2 (12) United States Patent (10) Patent No.: US 8,969,397 B2 Burright et al. (45) Date of Patent: *Mar. 3, 2015 (54) SYSTEMS AND METHODS TO TREAT PAIN (58) Field of Classification Search LOCALLY CPC A61 K31/40; A61K 31/405; A61 K31/4168; A61K 31/44; A61K 31/47; A61 K47/48369; (75) Inventors: Eric N. Burright, Eagan, MN (US); A61 K9/1647 Lisa L. Shafer, Stillwater, MN (US); USPC .......... 424/424, 489: 514/275, 277, 311, 419, Bill McKay, Memphis, TN (US); John 514/423, 460, 529, 385 Zanella, Cordova, TN (US) See application file for complete search history. (73) Assignee: Warsaw Orthopedic, Inc., Warsaw, IN (56) References Cited (US) U.S. PATENT DOCUMENTS (*) Notice: Subject to any disclaimer, the term of this 4,692,147 A 9/1987 Duggan patent is extended or adjusted under 35 5,711,316 A 1/1998 Elsberry et al. 5,801, 188 A 9, 1998 Hassenbusch U.S.C. 154(b) by 265 days. 5,978,702 A 11/1999 Ward et al. This patent is Subject to a terminal dis 5,980,927 A * 1 1/1999 Nelson et al. ................. 424/425 claimer. 6,093,180 A 7/2000 Elsberry 6,180.355 B1 1/2001 Alexander et al. 6,521,259 B1* 2/2003 Chasin et al. ................. 424/489 (21) Appl. No.: 12/701.261 6,594,880 B2 7/2003 Elsberry 6,596,747 B2 7, 2003 BOS (22) Filed: Feb. 5, 2010 6,902,910 B2 6, 2005 Ni et al. 7.993,666 B2 * 8/2011 McKay et al. ................ 424/424 (65) Prior Publication Data 2002, 0071822 A1 6/2002 Uhrich 2003.0049256 A1 3/2003 Tobinick US 2010/O1590.15A1 Jun. 24, 2010 2003/OO77641 A1 4/2003 Laskowitz et al. 2003/01 19017 A1 6/2003 McSwiggen 2003. O157061 A1 8, 2003 Bennett 2003/017.5793 A1 9, 2003 Bennett et al. Related U.S. Application Data 2003.0185826 A1 10/2003 Tobinick 2004.0034357 A1 2/2004 Beane et al. (63) Continuation of application No. 1 1/460,012, filed on 2004/0052384 A1 3/2004 Ashley Jul. 26, 2006, which is a continuation-in-part of 2004/0265364 A1 12/2004 OZturk et al. application No. 10/972,157, filed on Oct. 22, 2004, 2005/0058696 A1* 3/2005 Donello et al. ............... 424/449 now abandoned. 2005.00757.01 A1 4/2005 Shafer 2005/0090549 A1 4/2005 Hildebrand et al. 2005/OO95246 A1 5, 2005 Shafer (51) Int. Cl. 2005/01297 31 A1 6/2005 Horres et al. A6 IK3 L/468 (2006.01) 2005/O180974 A1 8, 2005 Shafer A6 IK3I/00 (2006.01) A6 IK9/00 (2006.01) (Continued) A6 IK 9/16 (2006.01) FOREIGN PATENT DOCUMENTS A6 IK3I/85 (2006.01) A6 IK3I/92 (2006.01) EP 1 405 646 A2 4/2004 A6 IK3I/352 (2006.01) EP 1462111 A1 9, 2004 A6 IK3I/366 (2006.01) (Continued) A6 IK3I/38 (2006.01) OTHER PUBLICATIONS A6 IK3I/40 (2006.01) A6 IK3I/4402 (2006.01) Mercadante et al. Support. Care Cancer, vol. 7, 1999, pp. 47-50.* A6 IK3I/498 (2006.01) A6M 37/00 (2006.01) (Continued) (52) U.S. Cl. Primary Examiner — Jeffrey Stucker CPC ............... A6 IK3I/00 (2013.01); A61 K9/0019 Assistant Examiner — Stephen Gucker (2013.01); A61 K9/0024 (2013.01); A61 K 9/1647 (2013.01); A61 K3I/185 (2013.01); (74) Attorney, Agent, or Firm — Sorell Lenna & Schmidt A6 IK3I/192 (2013.01); A61 K3I/352 LLP (2013.01); A61 K3I/366 (2013.01); A61 K (57) ABSTRACT 31/381 (2013.01); A61 K3I/401 (2013.01); A6 IK3I/4168 (2013.01); A61 K3I/4402 Disclosed herein are systems and methods for contributing to (2013.01); A61 K3I/498 (2013.01); A61M the local treatment of pain. More specifically, the disclosed 37/0069 (2013.01); G0IN 2800/2842 (2013.01) systems and methods contribute to the local treatment pain by USPC ........... 514/385; 514/275; 514/277: 514/311; inhibiting the NFKB family of transcription factors. 514/419:514/423: 514/460: 514/529 14 Claims, 5 Drawing Sheets US 8,969,397 B2 Page 2 (56) References Cited Tobinick, Edward L., e al., Perispinal TNF-alpha Inhibition for Discogenic Pain, Swiss Med. Weekly, pp. 170-177, vol. 133, 2003. U.S. PATENT DOCUMENTS Malmberg, Annika B., et al., Antinociceptive Actions of Spinal Nonsteroidal Anti-inflammatory Agents on the Formalin Test in the 2005, 0182009 A1 8/2005 McSwiggen et al. Rat, The Journal of Pharmacology and Experimental Therapeutics, 2005/O1973 12 A1 9/2005 Fitzgerald et al. 1992, pp. 136-146, vol. 263. 2005/0209513 A1 9, 2005 Heruth et al. 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Cerebrospinal Fluid Concentrations of TNF-alpha During the Watterson et al., Discovery of new chemical classes of synthetic Perioperative Period, Anesthesia & Analgesia, 2001, pp. 363-369, ligands that Suppress neuroinflammatory responses, J Mol Neurosci vol. 93. 19:89-94, 2002. Dorn, Gabriele, et al., SiRNA Relieves Chronic Neuropathic Pain, Hirsch et al., The role of glial reaction and inflammation in Nucleic Acids Research, 2004, pp. 1-6, vol. 32, No. 5. Parkinson's Disease, Ann NY Acad Sci991:214-28, 2003. Igwe, Orisa J., Modulation of Peripheral Inflammation in Sensory Ito. Anti-interleukin-6 therapy for Crohn's disease, Curr Pharm Des Ganglia by Nuclear Factor KB Decoy oligodeoxynucleotide: 9:295-305, 2003. Involvement of SRC Kinase Pathway, Neuroscience Letters, 2005, pp. 114-119, vol. 381. * cited by examiner U.S. Patent US 8,969,397 B2 &#917 U.S. Patent Mar. 3, 2015 Sheet 2 of 5 US 8,969,397 B2 s s s ' ' ". ....... .''. ...: '...'......":::::: "...s.. .i. s H s s ... ." 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