Drug delivery device for providing local analgesia, local...

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert

Reexamination Certificate

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Reexamination Certificate

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08034368

ABSTRACT:
The invention relates to a drug delivery device for providing local analgesia, local anesthesia or nerve blockade at a site in a human or animal in need thereof, the device comprising a fibrillar collagen matrix; and at least one drug substance selected from the group consisting of amino amide anesthetics, amino ester anesthetics and mixtures thereof, the at least one drug substance being substantially homogeneously dispersed in the collagen matrix, and the at least one drug substance being present in an amount sufficient to provide a duration of local analgesia, local anesthesia or nerve blockade which lasts for at least about one day after administration.

REFERENCES:
patent: 2006/0280801 (2006-12-01), Kronenthal
patent: 53579 (1981-06-01), None
Friess, “Collagen—Biomaterial for Drug Delivery”, European Journal of Pharmaceutics or Biopharmaceutics, vol. 45, Issue 2, Mar. 1998, pp. 113-136.
Bartholdy et al., “Preoperative infiltration of the surgical area enhances postoperative analgesia of a combined low-dose epidural bupivacaine and morphine regimen after upper abdominal surgery”, Acta Anaesthesiologica Scandinavica 1994 38:262-265.
Cobby et al., “Wound infiltration with local anaesthetic after abdominal hysterectomy”, British Journal of Anaesthesia 1997 78:431-432.
Gupta et al., “Postoperative Pain After Abdominal Hysterectomy:A Double-Blind Comparison Between Placebo and Local Anesthetic Infused Intraperitoneally”, Anesth Analg 2004 99:1173-1179.
Hannibal et al., “Preoperative Wound Infiltration with Bupivacaine Reduces Early and Late Opioid Requirement After Hysterectomy”, Anesth Analg 1996 83:376-381.
Klein et al., “Infiltration of the abdonimal wall with local anaesthetic after total abdominal hysterectomy has no opioid-sparing effect”, British Journal fo Anaesthesia 2000 84(2):248-249.
Leung et al. “Effect of Pre-Incision Skin Infiltration on Post-Hysterectomy Pain-A Double-Glind Randomized Controlled Trial”, Anaesth Intensive Care 2000 28:510-516.
Moiniche et al., “A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdonimal operations”, British Journal of Anaesthesia 1998 81:377-383.
Ng et al., “The Analgesic Effects of Intraperitoneal and Incisional Bupivacaine with Epinephrine After Total Abdonimal Hysterectomy”, Anesth Analg 2002 95:158-162.
Sinclair et al., “Postoperative pain relief by topical lidocaine in the surigcal wound of hysterectomized patients”, Acta Anaesthesiologica Scandinavica 1996 40:589-954.
Victory et al., “Effect of Preincision versus Postincision Infiltration with Bupivacaine on Postoperative Pain”, Journal of Clinical Anesthesia 1995 7:192-196.

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