(12) United States Patent (10) Patent No.: US 9,675,696 B2 Chamness (45) Date of Patent: *Jun
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USOO967.5696B2 (12) United States Patent (10) Patent No.: US 9,675,696 B2 Chamness (45) Date of Patent: *Jun. 13, 2017 (54) METHOD AND USE FOR INCREASING OTHER PUBLICATIONS EFFICACY OF ANT-ADHESIVE COMPOSITIONS IN CONTROLLING Borgens et al. “Immediate Recovery from spinal cord injury through NFLAMMATION AND PAN molecular repair of nerve membranes with polyethylene glycol FASEB J. 2000, 14, pp. 27-35.* (75) Inventor: Kathy L. Chamness, Memphis, TN Kaptanoglu et al., “Effects of magnesium Sulphate in experimental (US) spinal cord injury: evaluation with ultrastructural findings and early (73) Assignee: Warsaw Orthopedic, Inc., Warsaw, IN clinical results,” Journal of Clinical Neuroscience (2003); vol. 10, No. 3, pp. 329-334. (US) Borgens R B and Bohnert D., “Rapid recovery from spinal cord (*) Notice: Subject to any disclaimer, the term of this injury after Subcutaneously administered polyetheylene glycol.” patent is extended or adjusted under 35 Journal of Neuroscience Research (2001); vol. 66, pp. 1179-1186. Ditor D S et al., “Effects of polyethylene glycol and magnesium U.S.C. 154(b) by 1557 days. Sulfate administration on cinically relevant neurological outcomes after spinal cord injury in the rat.” Journal of Neuroscience This patent is Subject to a terminal dis Research (2007); vol. 85, pp. 1458-1467. claimer. The International Search Report and the Written Opinion of the International Searching Authority in PCT/US2007/067580. (21) Appl. No.: 11/598.397 Apan, A. et al., Postoperative magnesium Sulphate infusion reduces analgesic requirements in spinal anaesthesia, European Journal of Anaesthesiology, May 2004:21:766-769. (22) Filed: Nov. 14, 2006 Bhatia, A. et al., Effect of Intraoperative Magnesium Infusion on Perioperative Analgesia in Open Cholecystectomy, Journal of Clini (65) Prior Publication Data cal Anesthesia, Jun. 2004; 16(4):262-265. Bigal, ME et al., Intravenous magnesium Sulphate in the acute US 2008/O112921 A1 May 15, 2008 treatment of migraine without aura and migrain with aura, Cephalalgia, Jan. 2002:22(5):345-353. Bolcal, C. et al., Comparison of Magnesium Sulfate With Opioid (51) Int. Cl. and NSAIDs on Postoperative Pain Management After Coronary A6 IK 8/72 (2006.01) Artery Bypass Surgery, Journal of Cardiothoracic and Vascular A6 IK 45/06 (2006.01) Anesthesia, Dec. 2005; 19(6):714-718. A 6LX 3L/77 (2006.01) Brill, S. et al., Efficacy of intravenous magnesium in neuropathic pain, British Journal of Anaesthesia, May 2002;89(5):711-714. A6 IK33/06 (2006.01) Cete, Y. et al. 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Primary Examiner — James Rogers 2005/OO74495 A1 4/2005 Schwartz et al. 2006/0067.976 A1 3f2006 Ferraro et al. ................ 424/426 (57) ABSTRACT 2007/0258938 A1 1 1/2007 Roy et al. A method and kits thereof for increasing the efficiency of anti-adhesive compositions by parenterally administering a FOREIGN PATENT DOCUMENTS composition comprising an effective amount of at least one pharmaceutically-acceptable anti-adhesive non-ionic poly GB 1250304 A 10, 1971 mer to a site of injury, controlling inflammation at the site of GB 1286.351 A 8, 1972 injury, and reducing pain. WO WOO1,285.44. A 4/2001 WO 02092107 11 2002 16 Claims, 5 Drawing Sheets US 9,675,696 B2 Page 2 (56) References Cited Bittner, G.D. et al., Reconnection of severed nerve axons with polyethylene glycol, Brain Research, 1986: 367(1-2):351-355. Shapiro, S. et al., Oscillating field stimulation for complete spinal OTHER PUBLICATIONS cord injury in humans: a Phase 1 trial, J Neurosurg Spine, Jan. 2005; Russell, I.J. et al., Treatment of Fibromyalgia Syndrome with Super 2(1):3-10. Resende, M.A. et al., Local transcutaneous electrical stimulation Malic R: A Randomized, Double Blind, Placebo Controlled, Cross (TENS) effects in experimental inflammatory edema and pain, over Pilot Study, Journal of Rheumatology, May 1995:22(5):953 European Journal of Pharmacology, Sep. 2004: 504(1):217-222. 958. Kwon, et al. “Magnesium Chloride in a Polyethylene Glycol Tramer, M.R. et al., Magnesium bier's block for treatment of Formulation as a Neuroprotective Therapy for Acute Spinal Cord Chronic limb pain: a randomised, double-blind, cross-over study, Injury: Preclinical Refinement and Optimization.” Journal of Pain, Sep. 2002:99(1-2):235-241. Neurotrauma 26, 1379-1393 (Aug. 2009). 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The Lancet, Administered Magnesium Sulfate: A Study in Humans with Acute Feb. 2004:363(94.07):439-445. Brain Injury Undergoing Prolonged Induced Hypermagnesemia,” Saver, J.L. et al., Prehospital Neuroprotective Therapy for Acute Crit. Care Med., 33(3), 661-666 (Mar. 2005). Stroke: Results of the Field Administration of Stroke Therapy Journal of Spinal Cord Medicine, 34(6), 620-621 (2011). Magnesium (FAST-MAG) Pilot Trial, Stroke, Mar. 2004:35(5):106 108. * cited by examiner U.S. Patent Jun. 13, 2017 Sheet 1 of 5 US 9,675,696 B2 FIG.1 HO-- (CH-O-CH--OH H l U.S. Patent Jun. 13, 2017 Sheet 2 of 5 US 9,675,696 B2 FG. 2 U.S. Patent Jun. 13, 2017 Sheet 3 of 5 US 9,675,696 B2 Polyoxyethylene sorbitan monoester -h-irrO --h- -N- W Polyoxyethylene sorbitan triester U.S. Patent Jun. 13, 2017 Sheet 4 of 5 US 9,675,696 B2 FIG. 4 O O-CH-Cl, Poly(lactide) O O-CH-C Poly(glyco?ide) O H O || | || Om b.Cam C. OmrCwm C t Poly(lactide-co-glycolide) O-(CH)-o-Ci Polycapirolactone -- o-e- O CHs. t Poly(actlde-co-capfolactone) U.S. Patent Jun. 13, 2017 Sheet S of 5 US 9,675,696 B2 FIG.S US 9,675,696 B2 1. 2 METHOD AND USE FOR INCREASING Sci., 88, p. 8072 (1991); Ferguson, et al., J. Immunol. 150, EFFICACY OF ANT-ADHESIVE p. 1172 (1993). Results of in vivo experiments suggest that COMPOSITIONS IN CONTROLLING the inhibition of VLA-4-dependent cell adhesion should NFLAMMATION AND PAIN prevent, inhibit or alter several inflammatory and autoim mune pathologies.