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

• US 20050033261A1
• Filed: 04/27/2004
• Published: 02/10/2005
• Est. Priority Date: 05/12/2000
• Status: Active Grant

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Wyeth (Pfizer Inc.)
• Inventors: Carter, Andrew J., Falotico, Robert, Kopia, Gregory A., Llanos, Gerard H., Siekierka, John
• Granted Patent: US 8,236,048 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• 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 cell cycle inhibitors that act selectively at a G1 phase of a cell cycle incorporated into the polymeric coating for treatment of intimil hyperplasia, constrictive vascular remodeling, and inflammation caused by injury, the cell cycle inhibitors that act selectively at a G1 phase of a cell being incorporated into the first layer of the polymeric coating and the second layer acting as a diffusion layer, the total thickness of the polymeric coating is in the range from about one micron to about twenty microns with 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.

2. The drug delivery device according to claim 1 wherein the cell cycle inhibitors comprise inhibitors of cyclin dependent kinases involved with progression of cell cycle through G1 phase of the cell cycle.

3. The drug delivery device according to claim 2, wherein inhibitors of cyclin dependent kinases are taken from the group of flavopiridol and its structural analogs, agents that elevate endogenous P27 kinase inhibiting protein, staurosporin and related small molecules, or protein kinase inhibitors, including the class of tyrphostins that selectively inhibit protein kinase to antagonize signal transduction in smooth muscle in response to a range of growth factors.