Drug/drug delivery systems for the prevention and treatment of vascular disease

• US 8,236,048 B2
• Filed: 04/27/2004
• Issued: 08/07/2012
• Est. Priority Date: 05/12/2000
• Status: Active Grant

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.), Wyeth (Pfizer Inc.)
• Inventors: Falotico, Robert, Siekierka, John, Llanos, Gerard H., Kopia, Gregory A., Carter, Andrew J.
• Primary Examiner(s): Bianco, Patricia M
• Assistant Examiner(s): Nguyen, Camtu T
• Application Number:
  US10/833,200
• Publication Number:
  US 20050033261A1
• Time in Patent Office: 3,024 Days
• Field of Search: 623/1.42, 623/1.44, 623/1.45, 623/1.46
• US Class Current: 623/1.42
• 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 2250/0068 the pharmaceutical product being in a reservoir
• 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 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/434 of enzymes
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

A drug and drug delivery system may be utilized in the treatment of vascular disease. A local delivery system is coated with rapamycin or other suitable drug, agent or compound and delivered intraluminally for the treatment and prevention of neointimal hyperplasia following percutaneous transluminal coronary angiography. The local delivery of the drugs or agents provides for increased effectiveness and lower systemic toxicity.

Claims

1. A drug delivery device comprising:

an intraluminal medical device, the intraluminal medical device including a stent having a fenestrated structure, the stent comprising a plurality of bands and links defining a substantially tubular device with openings;

a polymeric coating affixed to the bands and links of the fenestrated structure, the polymeric coating including first and second layers; and

a therapeutic dosage of rapamycin incorporated into the polymeric coating for treatment of intimal hyperplasia, constrictive vascular remodeling, and inflammation caused by injury, the rapamycin being incorporated into the first layer of the polymeric coating, the first layer comprising a solution of ethylene-co-vinylacetate and polybutylmethacrylate, and the second layer, comprising polybutylmethacrylate and acting as a diffusion layer, the first layer having a thickness in the range from about eight microns to about twelve microns and the second layer having a thickness in the range from about one micron to about two microns, the rapamycin being configured for release over a period of about seven to thirty days and having a dosage in the range from about 35 to 430 micrograms per 15 to 18 mm length stents thereby producing a peak 50 to 55 percent reduction in neointimal hyperplasia.