(12) United States Patent (10) Patent No.: US 8,956,642 B2 Hobot Et Al

(12) United States Patent (10) Patent No.: US 8,956,642 B2 Hobot Et Al

USOO8956642B2 (12) United States Patent (10) Patent No.: US 8,956,642 B2 Hobot et al. (45) Date of Patent: Feb. 17, 2015 (54) BUPIVACAINE FORMULATION INA 4,735,804 A 4, 1988 Caldwell et al. POLYORTHOESTER CARRIER 4,758.436 A 7, 1988 Caldwell et al. 4,764,364 A 8, 1988 Heller et al. 4,765,973 A 8, 1988 Heller (75) Inventors: Christopher M. Hobot, Tonka Bay, MN 4,767,627 A 8, 1988 Caldwell et al. (US); Michael E. Benz, Ramsey, MN 4,780,319 A 10/1988 Zentner et al. (US); Keith R. Hildebrand, Houlton, 4,855,132 A 8, 1989 Heller et al. WI (US); Bryant J. Pudil, Plymouth, 4,898,928 A 2f1990 Heller et al. MN (US) 4.946,931 A 8, 1990 Heller et al. 4,957,998 A 9, 1990 Heller et al. (73) Assignee: Medtronic, Inc., Minneapolis, MN (US) 5,030,4575,013,821 A 7,5/1991 1991 N.Heller s et al. 5,108,755 A 4, 1992 Daniels et al. (*) Notice: Subject to any disclaimer, the term of this 5,211,951 A 5/1993 Sparer et al. patent is extended or adjusted under 35 35. A 1. E. gyet al. U.S.C. 154(b) by 1112 days. 5,374,681.- - w A 12/1994 Kronerget al. et al. 5,461,140 A 10, 1995 Heller et al. (21) Appl. No.: 12/426,005 5.487,739 A 1/1996 Aebischer et al. 5,587,507 A 12/1996 Kohnet al. (22) Filed: Apr. 17, 2009 5,618,563 A 4/1997 Berde et al. 5,700,485 A 12/1997 Berde et al. (65) Prior PublicationO O Data 5,747,0605,747,058 A 5/1998 TiptonSackler et et al. al. US 2009/O2O2436A1 Aug. 13, 2009 5,752.930 A 5/1998 Rise et al. 5,801, 188 A 9/1998 Hassenbusch, III et al. O O 5,824,343 A 10/1998 Ng et al. Related U.S. Application Data 5,837,228 A 11/1998 Shih et al. (60) Provisional application No. 61/046,343, filed on Apr. 3.26 A E. ity 1 18, 2008, provisional application No. 61/046,201, - - - be ea. filed on Apr. 18, 2008, provisional application No. (Continued) 61/046.213, filed on Apr. 18, 2008. FOREIGN PATENT DOCUMENTS 51) Int. Cl. (51) 2/00 (2006.01) EP O 168277 B1 1, 1986 EP O 168277 B2 1, 1986 AOIN 43/40 (2006.01) A6 IK3I/445 (2006.01) (Continued) A6IL 3L/I6 (2006.01) OTHER PUBLICATIONS (52) U.S. Cl. CPC ............... A6 IK3I/445 (2013.01); A61L 3 1/16 Moniche et al., in Anesthesiology 2002, 96,725-741.* (2013.01); A61 L 2300/402 (2013.01); A61 L (Continued) 2300/602 (2013.01) USPC - - - - - - - - - - - grgrrr. 424/426; 514/330 Primary Examiner — Dennis Heyer (58) Field of Classification Search Assistant Examiner — Daniel M Podgorski O See application file for complete search history. Attorney, Agent, or Firm — Sorell Lenna & Schmidt (56) References Cited (57) ABSTRACT U.S. PATENT DOCUMENTS Effective treatments of pain, such as chronic pelvic pain, for 2.957.856. A 10, 1960 G 1 extended periods of time are provided. The treatments 3.948,254 A 4, 1976 S.A. include the administration of one or more drug depots 4,079038 A 3, 1978 Choi et al. intraspinally wherein the drug depots include an effective 4,093,709 A 6, 1978 Choi et al. amount of bupivacaine formulated within a polyorthoester. 4,131,648 A 12/1978 Choi et al. By administration of one or more drug depots, one can relieve 3.SS- A 2.878 SSC pain caused by diverse sources, including but not limited to 4. i80,646 A 12, 1979 Choi et al. chronic pelvic pain syndromes, spinal disc herniation (i.e. 4,304.767 A 12/1981 Heller et al. sciatica), spondilothesis, Stenosis, discongenic back pain and 4.389,330 A 6, 1983 Tice et al. joint pain, as well as pain that is incidental to Surgery. In some is: A 1 i 3. instein et al. embodiments, the relief can be for at least thirty days, at least 4,532,335- K - A 7/1985 Helwingget al. S1Xty days, at least one hundred days or at least one hundred 4,549,010 A 10/1985 Sparer et al. and thirty-five days. 4,638.045 A 1, 1987 Kohn et al. 4,639,366 A 1, 1987 Heller 21 Claims, 6 Drawing Sheets US 8,956,642 B2 Page 2 (56) References Cited 2005, 00792O2 A1 4/2005 Chen et al. 2005/0090548 A1 4/2005 Hildebrand et al. U.S. PATENT DOCUMENTS 2005/0090549 A1 4/2005 Hildebrand et al. 2005/O197341 A1 9, 2005 Woolfetal. 5,939,453 8, 1999 Heller et al. 2005/0228451 A1 10, 2005 Jaax et al. 5,942,241 8, 1999 Chasin et al. 2005/0281879 A1* 12/2005 Chen et al. .................... 424/486 5,968,542 10, 1999 Tipton 2006/0034887 A1 2/2006 Pelissier ....................... 424/426 5,968,543 10, 1999 Heller et al. 2006, 0046961 A1 3/2006 McKay et al. 5,980,927 11, 1999 Nelson et al. ................. 424/425 2007,0253994 A1* 11/2007 Hildebrand ................... 424/422 6,001,386 12, 1999 Ashton et al. 2007,0265355 A1 11/2007 Benz et al. 6,007,843 12, 1999 Drizen et al. 2008.0033140 A1 2/2008 Alkatout et al. 6,096,344 8, 2000 Liu et al. 2008/0286326 A1 11/2008 Benco 6,120,491 9, 2000 Kohn et al. 6,133,402 10, 2000 Coates et al. FOREIGN PATENT DOCUMENTS 6,214,370 4, 2001 Nelson et al. 6,214,387 4, 2001 Berde et al. EP O 202 159 B1 11, 1986 6,238,702 5, 2001 Berde et al. EP O 208 617 B1 1, 1987 6,248.345 6, 2001 Goldenheim et al. EP O 473 223 B1 3, 1992 6,368,315 4, 2002 Gillis et al. EP O 102 265 B1 7, 1992 6,413,536 T/2002 Gibson et al. EP O 524 831 A1 1, 1993 6,465,458 10, 2002 Wong et al. EP 1 142596 A1 10, 2001 6,514,516 2, 2003 Chasin et al. EP 1 225 172 A1 T 2002 6,524,606 2, 2003 Ng et al. WO WO90, 12605 A1 11, 1990 6,524,607 2, 2003 Goldenheim et al. WO WO 97.25366 A1 7/1997 6,534,081 3, 2003 Goldenheim et al. WO WOO1? 43528 A2 6, 2001 6,551,290 4, 2003 Elsberry et al. WO WOO1f85139 A2 11/2001 6,571,125 5/2003 Thompson WO WOO1f85139 A3 11, 2001 6,594,880 T/2003 Elsberry WO WOO2,381.85 A2 5, 2002 6,601,386 8, 2003 Hori et al. WO WOO2,381.85 A3 5, 2002 6,602,975 8, 2003 Hubbell et al. WO WO O2/O92661 A1 11, 2002 6,613,355 9, 2003 Ng et al. WO WOO3,O37381 A1 5, 2003 6,667,371 12, 2003 Ng et al. WO WO 03/044076 A1 5, 2003 6,699,908 3, 2004 Sackler et al. WO WOO3,O72057 A2 9, 2003 6,703,389 3, 2004 Wong et al. WO WO 2005/OO9408 A2 2, 2005 6,790.458 9, 2004 Ng et al. WO WO 2005/OO9408 A3 2, 2005 6,793.938 9, 2004 Sankaram WO WO 2005/092337 A1 10/2005 6,822,000 11/2004 Ng et al. WO WO 2005/120435 A2 12/2005 6,861,068 3, 2005 Ng et al. WO WO 2007/133751 A2 11/2007 6,863,782 3, 2005 Newsome et al. WO WO 2008.005371 A2 1, 2008 6,921,541 7/2005 Chasin et al. 6,933,328 8, 2005 Schacht OTHER PUBLICATIONS 6,946,145 9, 2005 Ng et al. 6,969,383 11/2005 Hildebrand Al Malyan et al. in the Journal of Craniofacial Surgery 17,(2) 302 6,982,089 1, 2006 Tobinick 313, 2006.* 7,045,589 5, 2006 Heller et al. 7,163,694 1/2007 Heller et al. Einmahletal. in Investigative Ophthamology & Visual Science 42(3) 7,288,609 10, 2007 Pacetti 695-700 (2001).* 7,319,132 1, 2008 Musa Deng et al. in Pharmaceutical Development and Technology vol. 8, 2002fOO37300 3, 2002 Ng et al. No. 1, pp. 31-38, 2003.* 2002/0114835 8, 2002 Sackler et al. Kim et al. (International Journal of Pharmacuetics, 2005, 304, 165 2002/0176844 11, 2002 Ng et al. 177). 2003.0114394 6, 2003 Levine et al. PCT International Search Report, PCT/US2009/041 107, Mailed Oct. 2003. O138474 T/2003 Ng et al. 28, 2009. 2003/O152630 8, 2003 Ng et al. Anderson et al., “General Acid Catalysis of Ortho Ester Hydrolysis”. 2003/0170288 9, 2003 Carr et al. J. Org. Chem, 37(12): 1993-1996, Jun. 16, 1972. 2003/O185873 10, 2003 Chasin et al. Barret al., “PostSurgical Pain Management with Poly(ortho esters)”. 2003/0212148 11, 2003 Ng et al. 2004/OOO1872 1, 2004 Shih et al. Adv. Drug Deliv. Rev., 54(7): 1041-1048, Oct. 16, 2002. 2004/OO33251 2, 2004 Sparer et al. Chiang et al., “Effect of Phenyl Substitution on Ortho Ester 2004/OO39437 2, 2004 Sparer et al. Hydrolysis”. J.A.C.S., 96(14);4494-4499, Jul. 10, 1974. 2004.?00479.11 3, 2004 Lyu et al. Crivello et al., "Ketene Acetal Monomers: Systhesis and Character 2004/0086.569 5, 2004 Sparer et al. ization”. J.

View Full Text

Details

  • File Type
    pdf
  • Upload Time
    -
  • Content Languages
    English
  • Upload User
    Anonymous/Not logged-in
  • File Pages
    21 Page
  • File Size
    -

Download

Channel Download Status
Express Download Enable

Copyright

We respect the copyrights and intellectual property rights of all users. All uploaded documents are either original works of the uploader or authorized works of the rightful owners.

  • Not to be reproduced or distributed without explicit permission.
  • Not used for commercial purposes outside of approved use cases.
  • Not used to infringe on the rights of the original creators.
  • If you believe any content infringes your copyright, please contact us immediately.

Support

For help with questions, suggestions, or problems, please contact us