Local drug delivery devices and methods for maintaining the drug coatings thereon

• US 7,261,735 B2
• Filed: 06/22/2001
• Issued: 08/28/2007
• Est. Priority Date: 05/07/2001
• Status: Expired due to Term

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Llanos, Gerard H., Lentz, David Christian
• Primary Examiner(s): Bianco; Patricia
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US09/887,464
• Publication Number:
  US 20020165608A1
• Time in Patent Office: 2,258 Days
• Field of Search: 604/95.03, 604/96.01, 604/101.02, 604/103.02, 604 51- 53, 604/500, 604/890.1, 604/891.1, 623/11, 623 142- 148, 623/1.16, 512/291, 512/56, 512/378, 512/466, 512/824, 512/521, 512/18, 512/456, 512/763, 512/44, 512/2, 512/93.2, 512/964, 424/122, 424423-424, 424/240.22
• US Class Current: 623/1.46
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/06028 by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 31/727 Heparin; Heparan
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 27/12 : containing fluorine atoms

Abstract

Local drug delivery medical devices are utilized to deliver therapeutic dosages of drugs, agents or compounds directly to the site where needed. The local drug delivery medical devices utilize various materials and coating methodologies to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Claims

1. A local drug delivery apparatus comprising:

a medical device for implantation into a treatment site of a living organism;

a layer including a rapamycin in therapeutic dosages incorporated in a polymeric matrix and affixed to the medical device for the treatment of reactions by the living organism caused by the medical device or the implantation thereof; and

a distinct and separate biocompatible, water soluble powder layer applied to an outermost surface of the polymeric matrix configured to prevent the layer affixed to the medical device from separating from the medical device prior to implantation of the medical device at the treatment site, the water-soluble powder comprising an anti-oxidant.

2. The local drug delivery apparatus according to claim 1, wherein the medical device comprises an intraluminal medical device.

3. The local drug delivery apparatus according to claim 2, wherein the intraluminal medical device comprises a stent.